Annual Report
2024
Discovered
and Developed
Four Novel FDA-
Approved Programs
Deep Expertise in
Neuroscience Drug
Development
Fully-Integrated
Organization with
R&D and Commercial
Capabilities
Growing Blockbuster
Commercial Product
in INGREZZA with
Strong IP
Future Blockbuster
Opportunity with
CRENESSITY
Industry-Leading
Portfolio of Muscarinic
Compounds
NEUROCRINE DISCOVERED / DEVELOPED
Our Pipeline Today – 12 Programs
Phase 1
Phase 2
Phase 3
NEUROLOGY
valbenazine (VMAT2 Inhibitor) Dyskinetic Cerebral Palsy
NBI-’986 (M4 Antagonist) Movement Disorders
NBI-’355 (Nav1.2/1.6) Epilepsy
NEUROPSYCHIATRY
valbenazine (VMAT2 Inhibitor) Adjunctive Treatment of Schizophrenia
osavampator /NBI-’845 (AMPA) Inadequate Response to Treatment in Major Depressive Disorder
NBI-’568 (M4 Agonist) Schizophrenia
NBI-’770 (NMDA NR2B NAM) Major Depressive Disorder
NBI-’570 (M1/M4 Agonist) Schizophrenia-CNS Indications
NBI-‘567 (M1 Agonist) CNS Indications
NBI-’569 (M4 Agonist) CNS Indications
NBI-’890 (VMAT2 Inhibitor) CNS Indications
NBI-’675(VMAT2 Inhibitor) CNS Indications
1. Mitsubishi Tanabe Pharma Corporation (MTPC) has commercialization rights in Japan
and other select Asian markets
2. AbbVie has global commercialization rights
IN THE U.S.
1
2
2
IN THE U.S. AND EU
IN EUROPE
BUILDING A LEADING NEUROSCIENCE-FOCUSED COMPANY
ˆ˧˥ˢˡ˚ʹ˜ˡ˔ˡ˖˜˔˟˃˥ˢЃ˟˘ That Can
ˆ˨ˣˣˢ˥˧ˆ˜˚ˡ˜Ѓ˖˔ˡ˧˅ʙʷʼˡ˩˘˦˧ˠ˘ˡ˧
Industry-Leading
Muscarinic Pipeline
Potential Areas for Development
Alzheimer’s Disease • Bipolar Disorder Lewy Body Dementia
•
Parkinson’s Disease
Schizophrenia • Dystonia • Parkinson’s Disease Tremor
NEUROCRINE BIOSCIENCES, INC.
6027 Edgewood Bend Court
San Diego, CA 92130
Notice of Annual Meeting of Stockholders
To Be Held on May 21, 2025
TO THE STOCKHOLDERS:
NOTICE IS HEREBY GIVEN that the 2025 Annual Meeting of Stockholders of Neurocrine Biosciences, Inc., a Delaware
corporation (the “Company”), will be held on May 21, 2025, at 10:30 a.m., local time, at the Company’s corporate offices located at
6027 Edgewood Bend Court, San Diego, California 92130, for the following purposes as more fully described in the Proxy Statement
accompanying this Notice:
1.
The election of the four nominees for Class II directors named herein to the Board of Directors to serve for a term of
three years;
2.
An advisory vote on the compensation paid to the Company’s named executive officers;
3.
To approve the Company’s 2025 Equity Incentive Plan;
4.
To approve an amendment and restatement of the Company’s 2018 Employee Stock Purchase Plan;
5.
The ratification of the appointment of Ernst & Young LLP as the Company’s independent registered public accounting
firm for the fiscal year ending December 31, 2025; and
6.
To transact such other business as may properly come before the Annual Meeting of Stockholders or any continuation,
adjournment or postponement thereof.
Only stockholders of record at the close of business on March 24, 2025 are entitled to receive notice of and to vote at the
Annual Meeting of Stockholders.
All stockholders are invited to attend the Annual Meeting of Stockholders in person. However, we strongly urge our
All stockholders are invited to attend the Annual Meeting of Stockholders in person. However, we strongly urge our
stockholders not to attend the Annual Meeting in person and to instead submit proxy votes. Our Annual Meeting will be purely
stockholders not to attend the Annual Meeting in person and to instead submit proxy votes. Our Annual Meeting will be purely
functional in format to comply with the relevant legal requirements. There will be no presentations or exhibitions. No refreshments
functional in format to comply with the relevant legal requirements. There will be no presentations or exhibitions. No refreshments
ill b
id d
will be provided. Your vote is important. Whether or not you plan to attend the Annual Meeting, we encourage you to submit
your proxy or voting instructions as soon as possible to vote your shares. You may vote over the Internet, as well as by telephone
or by mailing a proxy or voting instruction form. Please review the instructions on each of your voting options described in these
proxy materials. Stockholders attending the Annual Meeting may vote in person even if they have returned a proxy. If you hold shares
through an account with a brokerage firm, bank or other nominee, please follow the instructions you receive from such firm, bank or
other nominee to vote your shares.
By Order of the Board of Directors,
Darin Lippoldt
Chief Legal Officer and Corporate Secretary
San Diego, California
April 9, 2025
Important Notice Regarding the Availability of Proxy Materials for the Stockholders’
Meeting to be Held on May 21, 2025 at 10:30 a.m. Local Time at
6027 Edgewood Bend Court, San Diego, California 92130.
The Proxy Statement and Annual Report to stockholders are available at
www.proxyvote.com
p
y
. Please have the control number on your proxy card available.
A copy of the Company’s Annual Report to the Securities and Exchange Commission on Form 10-K for the fiscal year ended
December 31, 2024 is available without charge upon written request to the Company’s Corporate Secretary at
6027 Edgewood Bend Court, San Diego, California 92130.
TABLE OF CONTENTS
Proxy Summary
1
Compensation Philosophy and Obje
b ctives
49
About the Annual Meeting
2
Overall Compensation Determination Process
50
Security Ownership of Certain Beneficial Owners and
Management
5
Components of Executive Compensation
53
Our Board of Directors
7
2024 Named Executive Offi
f cer Compensation Decisions
55
General
7
Other Featur
t
es of our Executive Compensation Program
59
Director Biographies of Class II Directors Nominated for
Reelection at the 2025 Annual Meeting of Stockholders
7
Offi
f cer Equity Ownership Guidelines
60
Director Biographies of Class I and Class III Directors not
Nominated for Reelection at the 2025 Annual Meeting of
Stockholders
8
Equity Trading Policies and Procedur
d
es
60
The Board of Directors and Corporate Governance Matters
11
Equity Grant Practices
61
General
11
Compensation Recoupment Policy
61
Corporate Governance Best Practices
11
Tax and Accounting Considerations
61
Board of Directors Overview
12
Risk Analysis of Our Compensation Program
62
Board Leadership Structure
t
12
Executive Compensation and Other Information
63
Board Independence
13
Summary
r Compensation Table
a
63
Classified Board Structure
t
13
Grants of Plan-Based Awards During 2024
64
Overboa
r
rding Policy
13
Agreements with Named Executive Offi
f cers Effe
f ctive During
Fiscal Year 2024
65
Director Refreshment
13
Executive Severance Plan
66
Board and Committee Meetings During 2024
14
Amendment and Restatement of Employment Arrangements
67
Information About Board Committees
14
Outstanding Equity Awards at Fiscal Year-End
68
Compensation Committee Interlocks and Insider Participation
15
Option Exercises and Stock Vested During the Year
69
Director Nomination Process
15
Potential Payments upon Termination or Change-in-Control
70
Board Self-A
f
ssessment
15
CEO Pay Ratio
74
Board Educ
d
ation
16
Item 402(v) Pay Versus Perfor
f
mance
75
Identification and Evaluation of Nominees for Director
16
Policies and Practices Related to the Grant of Certain Equity
Awards Close in Time to the Release of Material Nonpublic
Information
78
Proxy Access
16
Directors Compensation Summary
79
Process for Stockholder Communications with the Board of
Directors
16
Non-Employee Director Compensation Philosophy
79
Role of Board in Risk Oversight
17
Non-Employee Director Compensation for 2024
80
Corporate Responsibility
17
Director Compensation Table
a
80
Risk Assessment Concerning Compensation Practices and
Policies
17
Non-Employee Director Compensation for 2025
81
Role of Board in Succession Planning
17
Non-Employee Director Equity Ownership Guidelines
81
Policy Regarding Board Member Attendance at the Company's
Annual Meeting
17
Additional Information
81
Report of the Audit Committee
18
Related Person Transactions
81
Principal Accountant Fees and Services
19
Other Matters
81
Compensation Committee Report
20
Additional Information
81
Proposal One: Election of Directors
21
Special Note Regarding Forward-Looking Statements
82
Proposal Two: Advisory Vote on Compensation Paid to the
Company's Named Executive Offi
f cers
23
Appendix A - 2025 Equity Incentive Plan
Proposal Three: Approval of the Company's 2025 Equity
Incentive Plan
24
Appendix B - 2018 Employee Stock Purchase Plan
Proposal Four: Approval of an Amendment and
Restatement of the 2018 Employee Stock Purchase Plan
36
Equity Compensation Plans
41
Proposal Five: Ratification of Appointment of Independent
Registered Public Accounting Firm
42
Executive Offi
f cers
43
Compensation Discussion and Analysis
45
Executive Summary
45
[THIS PAGE INTENTIONALLY LEFT BLANK]
PROXY SUMMARY
This summary highlights infor
f
mation that is described in more detail elsewhere in this proxy statement. This summary does
not contain all the information you should consider before you vote, and you should read the entire proxy statement careful
f ly before
voting.
General Infor
f
mation
Annual Meeting of Stockholders
Meeting Date:
May 21, 2025
Time:
10:30 a.m. Local Time
Place:
6027 Edgewood Bend Court, San Diego, California 92130
Record Date:
March 24, 2025
How to Vote
Your vote is very important. Whether or not you plan to attend the Annual Meeting, we hope you will vote as soon as
possible. You may vote in the following ways:
Telephon
e
e: Call 1-800-690-6903 from any touch-tone telephone to transmit your voting instruc
r
tions up until 11:59 P.M.
Eastern Time the day before the meeting date. Have your proxy card in hand when you call and then follow the
instructions. Easy-to-follow voice prompts allow you to subm
u
it your proxy and confir
f m your instructions have been
properly recorded.
Internet: Visit www.proxyvote.com to transmit your voting instruc
r
tions and for
f
electronic delivery o
r
f information via
the Internet up u
u
ntil 11:59 P.M. Eastern Time the day befor
f
e the meeting date. As with telephone voting, you can confirm
f
that your instructions have been properly recorded.
Mail: Mark, sign and date your proxy card and retur
t
n it in the postage-paid envelope we have provided or retur
t
n it to
Vote Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY 11717.
Matters to be Voted On
Matter
Board of Directors
Recommendation
Page Reference for
More Information
Proposal One: Elect Class II Directors
FOR all nominees
21
Proposal Two: Advisory vote on executive compensation
FOR
23
Proposal Three: Approve 2025 Equity Incentive Plan
FOR
24
Proposal Four: Approve an amendment and restatement of the Company's
2018 Employee Stock Purchase Plan
FOR
36
Proposal Five: Ratify E
f
rnst & Young LLP as independent registered public
accounting firm
FOR
42
1
6027 Edgewood Bend Court
San Diego, California 92130
PROXY STATEMENT
This Proxy is solicited on behalf of Neurocrine Biosciences, Inc., a Delaware corporation (the “Company” or “Neurocrine
Biosciences”), for us
f
e at its 2025 Annual Meeting of Stockholders (the “Annual Meeting”) to be held on May 21, 2025 beginning at
10:30 a.m., local time, or at any continuations, postponements or adjournments thereof for
f
the purposes set for
f
th in this proxy
statement and the accompanying Notice of Annual Meeting of Stockholders. The Annual Meeting will be held at the Company’s
corporate offices, located at 6027 Edgewood Bend Court, San Diego, Californi
f
a 92130. The Company’s phone number is
(858) 617-7600.
ABOUT THE ANNUAL MEETING
Why d
h
id
d
I receive these proxy
o
materials?
l
The Company has sent you these proxy materials because the Board of Directors of the Company is soliciting your proxy to
vote at the Annual Meeting, including at any adjournments or postponements of the Annual Meeting.
We intend to mail these proxy materials on or about
a
April 9, 2025 to all stockholders of record entitled to vote at the Annual
Meeting.
What is the purpos
r
e of t
o
he
t
Annual Meet
M
in
t
g?
At the Annual Meeting, stockholders will act upon
u
the matters outlined in these proxy materials, including the election of the
four nominees for
f
Class II directors named herein; an advisory vote on the compensation paid to the Company’s named executive
offi
f cers; approval of the Company’s 2025 Equity Incentive Plan; approval of an amendment and restatement of the Company’s 2018
Employee Stock Purchase Plan; and ratification of the appointment of Ernst & Young LLP as the Company’s independent registered
public accounting fir
f m for
f
the fis
f cal year ending December 31, 2025.
Who can atte
t nd the Annual Meet
M
in
t
g?
All stockholders of record at the close of business on March 24, 2025 (the “Record Date”), or their duly appoint
a
ed proxies,
may attend the Annual Meeting. If you attend, please note that you may be asked to present valid pictur
t
e identification, such as a
driver’s license or passport. Cameras, recording devices and other electronic devices will not be permitted at the Annual Meeting.
Please also note that if you hold your shares in “street name” (that is, through a broker or other nominee), you will need to bring a
copy of a brokerage statement refle
f cting your stock ownership as of the record date and check in at the registration desk at the Annual
Meeting.
Who is e
i
ntitl
t
ed
l
to vote at the Annual Meet
M
in
t
g?
Stockholders of record at the close of business on the Record Date are entitled to receive notice of and to participate in the
Annual Meeting. At the close of business on the Record Date, 98,938,234 shares of the Company’s common stock, $0.001 par value
per share, were issued and outstanding. If you were a stockholder of record on that date, you will be entitled to vote all of the shares
that you held on that date at the Annual Meeting, or any continuations, postponements or adjournments of the Annual Meeting.
Each outstanding share of the Company’s common stock will be entitled to one vote on each proposal considered at the
Annual Meeting.
2
What constitutes a quorum? What are broker non-votes? What are advisory vo
r
tes?
The presence at the Annual Meeting, in person or by proxy, of the holders of a majority of the aggregate voting power of the
common stock outstanding on the Record Date will constitute a quorum, permitting the Company to conduct its business at the Annual
Meeting. As of the Record Date, 98,938,234 shares of common stock, representing the same number of votes, were outstanding. Thus,
the presence of the holders of common stock representing at least 49,469,118 shares will be required to establ
a ish a quorum. The
presence of a quorum
r
will be determined by the Inspector of Elections (the “Inspector”).
Proxies received but marked as abstentions, as well as “broker non-votes,” will be included in the calculation of the number
of shares considered to be present at the Annual Meeting. Broker non-votes occur when a holder of shares in “street name” does not
give instructions to the broker or nominee holding the shares as to how to vote on “non-routine” matters. Under the rules and
interpretations of the New York Stock Exchange (the “NYSE”), “non-routine” matters are matters that may subs
u
tantively affe
f ct the
rights or privileges of stockholders, such as mergers, stockholder proposals and elections of directors, even if not contested. In
addition, as required by Section 957 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, advisory votes on
executive compensation are non-routine matters for which brokers do not have discretionary authority to vote shares held by account
holders. Only ratific
f ation of our independent registered public accounting firm under Proposal Five is considered a routine matter,
meaning that if you do not return voting instructions to your broker by its deadline, your shares may be voted by your broker in its
discretion on Proposal Five.
The vote on Proposal Two is advisory. The outcome of this vote will not be binding on the Company or the Board of Directors
and will not create or imply any change to the fiduciary duties of the Board of Directors. However, the Company and the Board of
Directors will consider the results of the advisory vote on Proposal Two in making future decisions about compensation of the
Company’s named executive offi
f cers.
How do I vote my shares in person at the Annual Meetin
t
g?
You may vote your shares held in your name as the stockholder of record in person at the Annual Meeting. You may vote your
shares held beneficially in street name in person at the Annual Meeting only if you obtain a legal proxy from the broker, bank, trus
r
tee,
or nominee that holds your shares giving you the right to vote the shares. Even if you plan to attend the Annual Meeting, we
recommend that you also subm
u
it your proxy or voting instructions as described below so that your vote will be counted if you later
decide not to attend the Annual Meeting.
How can I vote my shares with
i
out atte
t ndin
d
g the Annual Meetin
t
g?
Whether you hold shares directly as the stockholder of record or beneficially in street name, you are encouraged to direct how
your shares are voted without attending the Annual Meeting. If you are a stockholder of record, you are encouraged to vote by proxy.
You can vote by proxy over the Internet, by mail or by telephone pursuant to instructions provided on the enclosed proxy card. If you
hold shares beneficially in street name, you may also vote by proxy over the Internet or you can also vote by telephone or mail by
following the voting instruction form provided to you by your broker, bank, trus
r
tee, or nominee. The deadline for voting by telephone
or electronically is 11:59 p.m., Eastern Time, on May 20, 2025.
Who will
i
bear the cost of solicitin
i
g
n votes for the Annual Meetin
t
g?
To the extent such costs are incurred, the cost of solicitation of proxies will be borne by the Company. The Company will
reimburse expenses incurred by brokerage firms and other persons representing beneficial owners of shares in forwarding solicitation
material to beneficial owners. To assist in soliciting proxies (votes), the Company has retained the profes
f
sional proxy solicitation firm
Alliance Advisors, LLC, at an approximate cost of $30,000. Proxies also may be solicited by certain of the Company’s directors,
offi
f cers and regular employees, without additional compensation, personally, by telephone or by other appropriate means.
Can I change my vote afte
f r I return my proxy?
Yes. Even afte
f r you have subm
u
itted your proxy, you may change your vote at any time before the proxy is exercised by filing
with the Corporate Secretary of
r
the Company either a notice of revocation or a duly executed proxy bearing a later date. Your proxy
will also be revoked if you attend the Annual Meeting and vote in person; however, we encourage you to vote your shares via the
Internet, telephone or mail, and instructions regarding all three methods of voting are provided on the proxy card. If you hold shares
through an account with a brokerage firm, bank or other nominee, please follow the instructions you receive from such firm, bank or
other nominee to vote your shares.
What does it mean if I receive more than one set of proxy materials?
l
If you receive more than one set of proxy materials, then your shares of common stock are registered in more than one name or
are registered in different accounts. Please complete a proxy for each separate set of proxy materials that you receive to ensure that all
of your shares are voted.
3
What are the Board of Dire
i
ctor
t
s’ re
r
commendat
d io
t ns?
Unless you give other instructions on your proxy, the persons named as proxy holders on the proxy will vote in accordance
with the recommendations of the Board of Directors. The Board of Directors’ recommendation is set forth together with the
description of each item in this Proxy Statement. In summary,
r
the Board of Directors unanimously recommends a vote:
•
for
f
election of the four nominees for Class II Directors named herein (see Proposal One);
•
for
f
an advisory vote on the compensation paid to the Company’s named executive offi
f cers (see Proposal Two);
•
for
f
approval of the Company’s 2025 Equity Incentive Plan (see Proposal Three);
•
for
f
approval of an amendment and restatement of the Company’s 2018 Employee Stock Purchase Plan (see Proposal
Four); and
•
for
f
ratification of the appointment of Ernst & Young LLP as the Company’s independent registered public accounting
firm for the fiscal year ending December 31, 2025 (see Proposal Five).
With respect to any other matter that properly comes before the meeting, the proxy holders will vote as recommended by the
Board of Directors or, if no recommendation is given, in their own discretion.
What vote is required to approve each item?
Election of Directors. The affirm
f
ative vote of a plurality of the shares represented in person or by proxy at the Annual
Meeting and entitled to vote on the election of directors is required for the election of directors. A properly executed proxy marked
“WITHHOLD AUTHORITY” with respect to the election of one or more directors will not be voted with respect to the director or
directors indicated, although it will be counted for purpos
r
es of determining whether there is a quorum.
Other Items. For each other item, the affirm
f
ative vote of the holders of a majority of the shares represented in person or by
proxy and entitled to vote on the item will be required for approval. A properly executed proxy marked “ABSTAIN” with respect to
any such matter will not be voted, although it will be counted for purposes of determining the number of shares represented in person
or by proxy at the Annual Meeting. Accordingly, an abstention will have the effe
f ct of a negative vote for each item. If you hold
your shares in “street name” through a broker or other nominee, your broker or nominee will not be permitted to exercise voting
discretion with respect to each of the matters to be acted upon, other than Proposal Five. Thus, if you do not give your broker or
nominee specific instructions, your shares will not be voted on and will not be counted for any other matter to be acted upon, other
than Proposal Five. Shares represented by such “broker non-votes” will, however, be counted in determining whether there is a
quorum.
r
Who countst the votes?
Votes cast by proxy or in person at the Annual Meeting will be tabul
a
ated by the Inspector.
How can I find
i
out the resultst of the voting at
n
the Annual Meetin
t
g?
Preliminary vot
r
ing results will be announced at the Annual Meeting. In addition, final voting results will be published in a
current report on Form 8-K that we expect to file with the SEC within four business days afte
f r the Annual Meeting. If final voting
results are not availabl
a e to us in time to file a Form 8-K within four business days afte
f r the meeting, we intend to file a Form 8-K to
publish preliminary
r results and, within four business days afte
f r the final results are known to us, file an amended Form 8-K to publish
the final results.
What proxy materialsl are availa
i blel on the internet?
The Proxy Statement and annual report to stockholders are availabl
a e under the “Investors” tab on our
a
corporate website at
www.neurocrine.com, and at www.proxyvote.com. However, you can only vote your shares at www.proxyvote.com. Please have the
control number on your proxy card availabl
a e.
4
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The fol
f lowing tabl
a e sets for
f
th certain information regarding the ownership of our common stock as of March 24, 2025 by
(i) each director; (ii) each of the executive officers named in the Summary Compensation Table; (iii) our executive officers and
directors as a group; and (iv) all those known by us to be benefic
f ial owners of more than fiv
f e percent of our common stock. Unless
otherwise indicated in the footnot
f
es to this tabl
a e and subj
u ect to community property laws where applicable, we believe that each of the
stockholders named in this table has sole voting and investment power with respect to the shares indicated as beneficially owned.
Applicable percentages are based on 98,938,234 shares of common stock outstanding on March 24, 2025, adju
d sted as required by rul
r es
promulgated by the SEC. The table is based upon
u
information supplied by our executive officers, directors and principal stockholders
and a review of Schedules 13D and 13G, if any, filed with the SEC. Unless otherwise indicated below, the address for
f
each beneficial
owner listed is c/o Neurocrine Biosciences, Inc., 6027 Edgewood Bend Court, San Diego, CA 92130.
Name and Address of Beneficia
f
l Owner
Number of
Shares of
Common Stock
Percent of
Common Stock
Stockholders Owning Greater than 5%:
BlackRock, Inc. (1) ..................................................................................................................................
13,647,679
13.8 %
The Vanguard Group (2)..........................................................................................................................
10,129,687
10.2 %
Directors and Named Executive Offi
f cers:
Kyle W. Gano, Ph.D. (3)..........................................................................................................................
582,261
*
Matthew C. Abernethy (4) .......................................................................................................................
336,274
*
Eric Benevich (5)....................................................................................................
267,575
*
Jude Onyia, Ph.D. (6)...............................................................................................................................
184,489
*
Eiry W. Roberts, M.D. (7)........................................................................................................................
271,937
*
William H. Rastetter, Ph.D. (8)................................................................................................................
167,514
*
Kevin C. Gorman, Ph.D. (9).....................................................................................................................
1,556,898
1.6 %
Gary A. Lyons (10) ..................................................................................................................................
204,829
*
Johanna Mercier (11) ...............................................................................................................................
46,544
*
George J. Morrow (12).............................................................................................................................
84,143
*
Leslie V. Norwalk (13).............................................................................................................................
41,276
*
Christine A. Poon (14) .............................................................................................................................
14,424
*
Richard F. Pops (15).................................................................................................................................
111,555
*
Shalini Sharp (16).....................................................................................................................................
43,258
*
Stephen A. Sherwin, M.D. (17)................................................................................................................
75,617
*
All current executive officers and directors as a group (19 persons) (18)...............................................
4,717,401
4.8%
*
Represents beneficia
f
l ownership of less than one percent (1%) of the outstanding shares of the Company’s common stock as of March 24, 2025.
(1)
Based on Amendment No. 12 to Schedule 13G filed by BlackRock, Inc. (“BlackRock”) on January 23, 2024, reporting ownership as of December 31, 2023.
According to such filin
f
g, BlackRock beneficially owns 13,647,679 shares of common stock and sole voting power as to 12,980,857 shares of common stock.
Various persons have the right to receive or the power to direct the receipt of dividends from, or the proceeds fro
f
m the sale of shares of the common stock
held by BlackRock. No one person’s interest in the common stock held by BlackRock is more than five percent of the Company’s total outstanding common
stock. The principal business address for
f
BlackRock Inc. is listed in such filin
f
g as 50 Hudson Yards, New York, NY 10001.
(2)
Based on Amendment No. 9 to Schedul
d e 13G filed by The Vanguard Group, Inc. (“Vanguard Group”) on March 6, 2025, reporting ownership as of Februa
r
ry
28, 2025. According to such filin
f
g, Vanguard Group beneficially owns 10,129,687 shares of common stock and sole voting power as to 0 shares of common
stock. Various persons have the right to receive or the power to direct the receipt of dividends from, or the proceeds fro
f
m the sale of shares of the common
stock held by Vanguard Group. No one other person’s interest in the common stock held by Vanguard Group is more than five percent of the Company’s total
outstanding common stock. The principal business address for
f
the Vanguard Group is listed in such filin
f
g as 100 Vanguard Blvd., Malvern, PA 19355.
(3)
Consists of (a) 140,107 shares of common stock and (b) 442,154 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of
March 24, 2025.
(4)
Consists of (a) 35,810 shares of common stock and (b) 300,464 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of
March 24, 2025.
(5)
Consists of (a) 44,849 shares of common stock and (b) 222,726 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of
March 24, 2025.
(6)
Consists of (a) 18,289 shares of common stock and (b) 166,200 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of
March 24, 2025.
(7)
Consists of (a) 35,640 shares of common stock and (b) 236,297 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of
March 24, 2025. 34,455 of the outstanding shares of common stock are held by The Stephen Taylor and Eiry W. Roberts Joint Trus
r
t Agreement, of which Dr.
Eiry has voting and investment power.
(8)
Consists of (a) 37,491 shares of common stock, (b) 127,154 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of
March 24, 2025, and (c) 2,869 shares of common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025. All of the
outstanding shares of common stock are held by the Rastetter Family Trus
r
t established September 2, 2010, of which Dr. Rastetter has voting and investment
power.
(9)
Consists of (a) 524,209 shares of common stock, and (b) 1,032,689 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of
March 24, 2025. All of the outstanding shares of common stock are held by The Gorman & Blais Family Trus
r
t, of which Dr. Gorman has voting and
investment power.
5
(10)
Consists of (a) 119,047 shares of common stock, (b) 84,347 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of
March 24, 2025, and (c) 1,435 shares of common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025. 113,064 of
the outstanding shares of common stock are held by the Gary A. Lyons Revocable Living Trus
r
t U/A 6/8/12, of which Mr. Lyons has voting and investment
power.
(11)
Consists of (a) 2,100 shares of common stock, (b) 43,009 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of March 24,
2025, and (c) 1,435 shares of common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025.
(12)
Consists of (a) 4,199 shares of common stock, (b) 77,075 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of March 24,
2025, and (c) 2,869 shares of common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025.
(13)
Consists of (a) 994 shares of common stock, (b) 38,847 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of March 24,
2025, and (c) 1,435 shares of common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025.
(14)
Consists of (a) 12,989 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of March 24, 2025, and (b) 1,435 shares of
common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025.
(15)
Consists of (a) 31,611 shares of common stock, (b) 77,075 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of March 24,
2025, and (c) 2,869 shares of common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025.
(16)
Consists of (a) 994 shares of common stock, (b) 40,829 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of March 24,
2025, and (c) 1,435 shares of common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025.
(17)
Consists of (a) 10,673 shares of common stock, (b) 62,075 shares of common stock issuable pursuant to stock options exercisabl
a e within 60 days of March 24,
2025, and (c) 2,869 shares of common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025.
(18)
Consists of (a) 1,078,221 shares of common stock held by our current directors and executive offi
f cers, (b) 3,620,529 shares of common stock issuable
pursuant to stock options held by our current directors and executive offi
f cers that are exercisabl
a e within 60 days of March 24, 2025, and (c) 18,651 shares of
common stock issuable pursuant to the vesting of restricted stock units within 60 days of March 24, 2025.
Delinquent Section 16(a) Reports
Section 16(a) of the Securities Exchange Act of 1934, as amended, requires the Company’s offi
f cers and directors, and persons
who beneficially own 10% or greater of a registered class of the Company’s equity securities, to file reports of ownership on Form 3
and reports of changes in ownership on Form 4 or Form 5 with the SEC. Such offi
f cers, directors and 10% or greater stockholders are
also required by SEC rules to furnish the Company with copies of all Section 16(a) forms they file. Based solely on its review of the
copies of such forms received by it, and written representations from certain reporting persons, the Company believes that its offi
f cers,
directors and 10% or greater stockholders complied with all Section 16(a) filing requirements applicable to them during the fiscal year
ended December 31, 2024, except that one report covering a transaction related to a charitabl
a e contribution was inadvertently filed late
by the Company on behalf of Dr. Sherwin due to an administrative oversight.
6
OUR BOARD OF DIRECTORS
General
The Company’s bylaws, as amended and restated, provide that the Board of Directors is comprised of eleven directors. The
Company’s Certificate of Incorporation provides that the Board of Directors is divided into three classes. There are currently four
directors in Class I (William H. Rastetter, Ph.D., George J. Morrow, Leslie V. Norwalk, and Christine A. Poon), four directors in
Class II (Kyl
K e W. Gano, Ph.D., Richard F. Pops, Shalini Sharp,
r
and Stephen A. Sherwin, M.D.), and three directors in Class III (Kevin
C. Gorman, Ph.D., Gary A. Lyons, and Johanna Mercier). With the exception of Kyle W. Gano, Ph.D., who is the Chief Executive
Offi
f cer ("CEO") of the Company, and Kevin C. Gorman, Ph.D., who retired as CEO of the Company effe
f ctive October 11, 2024, all
current members of the Board of Directors meet the definition of “independent director” under the Nasdaq Stock Market qualification
standards.
The directors in Class I hold offi
f ce until the 2027 Annual Meeting of Stockholders, the directors in Class II hold offi
f ce until
the 2025 Annual Meeting of Stockholders, and the directors in Class III hold offi
f ce until the 2026 Annual Meeting of Stockholders
(or, in each case, until their earlier resignation, removal from offi
f ce, or death). Afte
f r each such election, the directors in each such case
will then serve in succeeding terms of three years and until a successor is duly elected and qualified. Offi
f cers of the Company serve at
the discretion of the Board of Directors. There are no family relationships among the Company’s directors and executive offi
f cers.
The term of offi
f ce for directors Kyle W. Gano, Ph.D., Richard F. Pops, Shalini Sharp,
r
and Stephen A. Sherwin, M.D. will
expire at the 2025 Annual Meeting of Stockholders.
Director Biographies of Class II Directors Nominated for Reelection at the 2025 Annual Meeting of Stockholders
Kyle W. Gano, Ph.D. was appointed to serve as President and CEO of the Company in October 2024 afte
f r having served as
Chief Business Development and Strategy Offi
f cer since 2020 and Chief Business Development Offi
f cer since 2011. From 2001 to
2011, Dr. Gano held several positions of increasing responsibility at the Company spanning marketing analytics to business
development. He has served on the Company’s Board of Directors since October 2024 and currently serves on the Board of Directors
of the Pharmaceutical Research and Manufact
f
ur
t
ers of America (PhRMA). Dr. Gano received his B.S. in Chemistry
r from the
University of Oregon, B.S. in Biochemistry
r from the University of Washington, and his M.B.A. and Ph.D. in Organic Chemistry
r from
the University of California, Los Angeles.
Dr. Gano has been instrumental in shaping the Company's strategy and culture through various senior management roles he
has held at Neurocrine Biosciences for over a decade. Additionally, his significant expertise in business and corporate development
activities and deep knowledge of the Company's products and pipeline of therapeutic candidates provides valuable insights to our
Board of Directors.
Richard F. Pops
o
has served on the Board of Directors since April 1998. Mr. Pops is the Chairman and Chief Executive
Offi
f cer of Alkermes plc. He joined Alkermes as Chief Executive Offi
f cer in February 1991. Under his leadership, Alkermes has grown
from a privately held research-based company with 25 employees to an international, publicly traded pharmaceutical company with
more than 2,000 employees. In addition to Alkermes, he currently serves on the Board of Directors of the Biotechnology Innovation
Organization (BIO) and the Pharmaceutical Research and Manufact
f
ur
t
ers of America (PhRMA). Previously, Mr. Pops served on the
Board of Directors of Epizyme, Inc., a biotechnology company focused on epigenetics, and Acceleron Pharma, Inc., a
biopharmaceutical company. He holds a B.A. in Economics from Stanford University.
The continued service of Mr. Pops to the Company’s Board of Directors is based on his leadership experience and track record
for growing companies, his strength in business strategy and his financial acumen and capital markets experience. In addition,
Mr. Pops is recognized for his service to the biopharmaceutical industry
r as a member of the Boards of the Biotechnology Innovation
Organization and the Pharmaceutical Research and Manufact
f
ur
t
ers of America. His breadth and range of industry
r experience from
operations and strategy is a significant contribution to the Board of Directors.
Shalini Sharp has served as a member of our Board of Directors since February 2020. Ms. Sharp
r served as Executive Vice
President and Chief Financial Offi
f cer of Ultragenyx Pharmaceuticals Inc., a publicly traded biopharmaceutical company, from 2012 to
2020. Previously, from 2003 to 2012, Ms. Sharp he
r
ld positions of increasing responsibility at Agenus, Inc., a publicly traded clinical-
stage immune-oncology company, including as Chief Financial Offi
f cer, and also served as a member of its Board of Directors from
2012 to 2018. Earlier in her career, Ms. Sharp
r worked at Elan Pharmaceuticals, McKinsey & Company, and Goldman Sachs. Ms.
Sharp
r currently serves on the Boards of Directors of BeiGene, Ltd., a publicly traded oncology company, Organon & Co, a publicly
traded healthcare company, and Septerna, Inc., a clinical-stage biotechnology company. Ms. Sharp
r previously served on the Board of
Directors of Mirati Therapeutics, prior to its acquisition by Bristol-Myers Squibb Company, Sutro Biopharma, Inc., Panacea
Acquisition Corp., prior to its merger with Nuvation Bio, Precision BioSciences, Inc., TB Alliance, Array Biopharma, prior to its
acquisition by Pfiz
f er, and Agenus Inc. She holds a B.A. and an M.B.A. from Harvard University.
The continued service of Ms. Sharp
r to the Company’s Board of Directors is based on her extensive experience as a Chief
Financial Offi
f cer of a public company, her financial acumen, and her management and leadership skills.
7
Step
t
hen A. Sherwin, M.D. has served on the Board of Directors since April 1999. Dr. Sherwin currently divides his time
between advisory work in the lifef sciences industry
r and patient care and teaching in his specialty of medical oncology. He is a Clinical
Profes
f
sor of Medicine at the University of Califor
f
nia, San Francisco, and a volunteer Attending Physician in Hematology-Oncology at
the Zuckerbe
r
rg San Francisco General Hospital. Dr. Sherwin currently serves on the Board of Directors of Biogen Inc., a publicly
traded company. He is an Advisory Partner with Third Rock Ventures and a member of the Scientific Steering Committee of the
Parker Institute for Cancer Immunotherapy.
a
Previously, Dr. Sherwin was Chairman and Chief Executive Offi
f cer of Cell Genesys, a
cancer immunotherapy
a
company, from 1990 until the company’s merger in 2009 with BioSante Pharmaceuticals (now ANI
Pharmaceuticals). He was also a Co-founder and Chairman of Abgenix, an antibody company which was acquired by Amgen in 2006,
and co-founder and Chairman of Ceregene, a gene therapy company which was acquired by Sangamo Biosciences in 2013. From 1983
to 1990, Dr. Sherwin held various positions in clinical research at Genentech, most recently that of Vice President. Prior to 1983, he
was on the stafff of the National Cancer Institute. In addition, Dr. Sherwin previously served on the Board of Directors of Aduro
d
Biotech, BioPlus Acquisition Corporation, and Neon Therapeutics. He also served on the Board of Directors of the Biotechnology
Innovation Organization (BIO) from 2001 to 2014 and as its Chairman from 2009 to 2011, and was a member of the President’s
Council of Advisors in Science and Technology (PCAST) Working Group on Drug
r
Development from 2011 to 2013. Dr. Sherwin
holds a B.A. in biology, summa cum laude, from Yale University and an M.D. from Harvard Medical School, is board-certified in
internal medicine and medical oncology, and is a Fellow of the American College of Physicians.
The continued service of Dr. Sherwin for election to the Company’s Board of Directors is based on his experience and
credentials in the biotechnology industry
r as the former Chief Executive Offi
f cer of Cell Genesys, Inc., the former Chairman and co-
founder of Abgenix, Inc., the Chairman and co-founder of Ceregene, Inc., and his positions at Genentech, Inc. and the National Cancer
Institute. In addition to his biotechnology credentials, Dr. Sherwin’s medical expertise in internal medicine and medical oncology
provides a unique contribution to the Board of Directors.
Director Biographies of Class I and Class III Directors not Nominated for Reelection at the 2025 Annual Meeting of
Stockholders
Kevin
i
C. Gorman, Ph.D. has served on the Board of Directors since January 2008. Dr. Gorman served as the President and
CEO of the Company from January 2008 through October 2024, afte
f r having served as Executive Vice President and Chief Operating
Offi
f cer beginning in 2006. Prior to that, he served as Executive Vice President and Chief Business Offi
f cer, and Senior Vice President
of Business Development. Dr. Gorman currently serves as a director of Xencor, Inc. a publicly traded clinical-stage biopharmaceutical
company. From 1990 until 1993, Dr. Gorman was a principal of Avalon Medical Partners, L.P. where he was responsible for the early
stage founding of the company and several other biotechnology companies such as Onyx Pharmaceuticals, Inc., Metra Biosystems,
Inc., Idun
d
Pharmaceuticals, Inc. and ARIAD Pharmaceuticals, Inc. Dr. Gorman received his Ph.D. in immunology and M.B.A. in
Finance from the University of Californi
f
a, Los Angeles and did further post-doctoral training at The Rockefeller University.
The continued service of Dr. Gorman on the Company’s Board of Directors is based on the fact that as the Company's former
CEO of the Company, Dr. Gorman has extensive knowledge of our commercial products and our product candidates, our employees
and the industry
r in which we operate. Dr. Gorman has also demonstrated exceptional leadership skills, sound business judgment and a
strong commitment to the Company.
Gary A. Lyons has served on the Board of Directors since joining Neurocrine Biosciences in February 1993. Mr. Lyons served
as the President and CEO of the Company from Februa
r
ry 1993 through January 2008. Prior to joining the Company, Mr. Lyons held a
number of senior management positions at Genentech, Inc., including Vice President of Business Development and Vice President of
Sales. Mr. Lyons is currently the Chairman of the Board of Directors of Travere Therapeutics, a publicly traded ultra-orphan disease
commercial-stage company. Mr. Lyons previously served on the Board of Directors of Rigel Pharmaceuticals, Inc., Fresh Tracks
Therapeutics, Inc. (formerly Brickell Biotech, Inc.), Eledon Pharmaceuticals, Inc. (formerly Novus Therapeutics), and Facet Biotech
Corporation. Mr. Lyons holds a B.S. in Marine Biology from the University of New Hampshire and an M.B.A. from Northwestern
University’s J.L. Kellogg Gradua
d
te School of Management.
The continued service of Mr. Lyons on the Company’s Board of Directors is based on Mr. Lyons’ extensive business
development and corporate governance experience and, as the Company’s former CEO, his in-depth understanding of the Company’s
strategic plans, business operations, management and culture. With this history with the Company and management, Mr. Lyons brings
a unique perspective and point of view to the Company’s Board of Directors.
Johanna Mercier has served on the Board of Directors since April 2021. Ms. Mercier serves as the Chief Commercial Offi
f cer
of Gilead Sciences, overseeing the global commercialization of the company’s medicines across virology, oncology and inflammation.
She has been central to Gilead’s portfol
f io diversification, strengthening the company’s long-term growth prospects, expanding patient
access and shaping commercial strategy. Ms. Mercier led the swift launch and global access strategy of Gilead’s COVID-19 antiviral
on an accelerated timeline during the height of the COVID-19 pandemic, while also driving Gilead’s response to the crisis, including
product donations. Today, she leads effort
f
s to establ
a ish a new investigational product as a long-acting option for HIV prevention, and
to expand access for people in high-incidence, resource-limited countries through innovative launch preparations and voluntary
r
licensing agreements. A passionate advocate for the future of transfor
f
mational healthcare and improving patient access on a global
scale, Ms. Mercier also serves on the Board of Directors of Arcus Biosciences, Inc., a publicly traded company, and the University of
Southern Californi
f
a’s Leonard D. Schaeffer
f
Center for Health Policy and Economics. Prior to joining Gilead in 2019, Johanna spent
25 years at Bristol-Myers Squibb, where she held senior leadership roles across the U.S. and international markets. She received her
bachelor’s degree in biology from the University of Montreal and her MBA from Concordia University.
The continued service of Ms. Mercier on the Company’s Board of Directors is based on Ms. Mercier’s extensive
commercialization experience at both Gilead Sciences and Bristol-Myers Squibb, as well as her executive leadership experience across
geographies and in all aspects of the commercial business.
8
George J.
r
Morrow has served on the Board of Directors since October 2015. Mr. Morrow served as Executive Vice President,
Global Commercial Operations at Amgen Inc., a global biotechnology company, from 2003 until his retirement in 2011. He joined
Amgen in 2001 as Executive Vice President, Worldwide Sales and Marketing. His responsibilities included oversight of all
commercial functions for Amgen’s broad spectrum of products in more than 50 countries worldwide, and the introduction of multiple
new products into global markets. From 1992 to 2001, Mr. Morrow held executive management and commercial positions within
several subs
u
idiaries of Glaxo Wellcome, including Group
u Vice President for Commercial Operations (U.S.), Managing Director
(U.K.), and most recently as President and Chief Executive Offi
f cer of Glaxo Wellcome, Inc. (U.S.). Mr. Morrow currently serves on
the Board of Directors of Align Technology, Inc., a publicly traded global medical device company. He has previously served on the
boards of Vical, Inc., Otonomy, Inc., Glaxo Wellcome, Inc., Human Genome Sciences, Inc., Safeway, Inc., National Commerce Bank,
the John Hopkins School of Publ
u ic Health, and the Duke University Fuqua School of Business. Mr. Morrow holds a B.S. in Chemistry
r
from Southampton College, Long Island University, an M.S. in Biochemistry
r from Bryn
r
Mawr College and an M.B.A. from Duke
University.
The continued service of Mr. Morrow on the Company’s Board of Directors is based on his extensive commercialization
experience at Amgen, his broad executive experience at GlaxoSmithKline Inc., and his years of experience in corporate governance as
a board member of several publicly traded companies. Mr. Morrow’s board experience, leadership experience and commercialization
expertise prove valuable strategic insights to the Board of Directors.
Leslie
l
V. Norwalk has served on the Board of Directors since September 2019. Since 2007, Ms. Norwalk has served as
Strategic Counsel to healthcare companies at Epstein Becker Green, EBG Advisors, and National Health Advisors. Ms. Norwalk
advises several private equity firms on healthcare matters. She serves as a director of CVS Health Corporation, Globus Medical, Inc.,
Modivcare Inc., and Arvinas, Inc., all publicly traded companies, as well as several privately held healthcare companies. Ms. Norwalk
previously served on the Board of Directors of Centene, Endologix, Magellan Health, NuVasive, Inc., prior to its acquisition by
Globus Medical, and Press Ganey. Ms. Norwalk began her career in the public sector in The White House Offi
f ce of Presidential
Personnel under the first Bush administration, following which, she practiced law at the Washington, D.C. offi
f ce of Epstein Becker
Green, P.C. From 2001 to 2007, she served in several roles at the Centers for Medicare & Medicaid Services (CMS) under the George
W. Bush administration, including serving as Deputy Administrator, and Counselor and Policy Advisor, before assuming the role of
Acting Administrator. Ms. Norwalk holds a J.D. from the George Mason University School of Law and a B.A. in Economics and
International Relations from Wellesley College.
The continued service of Ms. Norwalk to the Company’s Board of Directors is based on her deep knowledge of, and
experience with, the healthcare industry
r and government regulations, as well as corporate governance and risk management. Such
knowledge and experience provides valuable guidance and insight to the Board of Directors.
Christin
t
e A. Poon has served on the Board of Directors since July 2023. Ms. Poon is hthe former Executive-in-Resididence in hthe
Department of Management and Human Resources at hthe Max M.
i
Fi h
sher Collllege of Bu isiness at
h
The
h
Ohio State Univer isi yty,
h
where h
she
serv d
ed as Dean and hthe John W. Be y
rry, Sr.
h
Ch iair in Bu isiness from 2009 to 2014.
h
She serv d
ed as
i
Vice
h
Ch iairman and Me b
mber of hthe
Board f
d of
i
Directors of Johnson & Johnson from 2005 untilil her re itiremen i
t in March 2009. Ms. Poon join
join d
ed Johnson & Johnson in 2000
as Company Group
h
Ch iair in hthe
h
Pharmaceu itic lals Group.
h
She became a
b
member of Johnson & Johnson’s Execu itive Committee and
Wo lrldwidide
h
Ch iair,
h
Pharmaceutic lals Group, in 2001, and serv d
ed as Wo lrldwidide
h
Ch iair, Medidi icines and Nu i i
tritionals, from 2003 to 2005.
Prior to joinin
to joining Johnson & Johnson, h
she spent
y
15 years at Bris l
tol-
y
Myers Sq ibb
uibb in va irious ma
g
nagement posi i
itions. Ms. Poon was lalso
a
i
Vice
h
Ch iair of hthe Supe
u
rvisory
r Board f
d of Royal
h
Phili
ilips
l
Electr
i
onics and a
b
member of hthe Board f
d of
i
Directors of De icibel
h
Therapeu itics,
Inc.
h
She currentlyly serves on hthe Board f
d of
i
Directors of Pr d
ud
r
en itial
i
Financi l
ial, Inc., Regeneron
h
Pharmaceu itic lals, Inc.,
h
where h
she currently
tly
serves as hthe le d
ad ind
d
di
dependent director, and
h
The
h
Sher i
win-
i
Willi
lliams Company. Ms. Poon was named Woman of hthe Year by
by hthe
He lal hthcare Bu isinesswomen’s Asso iciation in 2004 and named Bu isiness Le d
ader of hthe Future by
by
/
CNBC/
l
Wall Street Journal i
l in 2005.
The continued service of Ms. Poon on the Company’s Board of Directors is based on her expertise in U.S. and international
business operations, including extensive experience in capi
a tal allocation, and her strategic and operational knowledge of the
pharmaceutical industry.
r
William H.
i
Rastet
t te
t r, Ph.D. has served on the Board of Directors since February 2010 and as Chairman of the Board of
Directors since May 2011. Currently, he serves as the Chairman of the Board of Directors for Fate Therapeutics, a publicly traded
company focused on cellular therapies, as well as for Daré Bioscience, Inc. (previously known as Cerulean Pharma Inc.), a publicly
traded company focused on women’s healthcare. Dr. Rastetter also serves on the Board of Directors for Regulus Therapeutics Inc., a
publicly traded company focused on RNA-based therapeutics, and on the Board of Directors of Iambic, Inc., a private company using
artificial intelligence and labor
a
atory automation to design and develop medicinal chemicals initially for oncology indications.
Dr. Rastetter previously served on the board of Grail, Inc., a private company developing deep sequencing approaches for disease
diagnosis, with an initial focus on the early diagnosis of cancer. Dr. Rastetter serves as an advisor to Illumina Ventures, and is the
Chairman of San Diego Squared, a nonprofit
f
focused on STEM awareness and educ
d
ation for student
t
s in underserved communities.
Dr. Rastetter was a partner in the venture capital firm, Venrock, from 2006 through early 2013 and was Executive Chairman of Biogen
Idec, Inc. from 2003 to 2005. Earlier, he served as Chairman and Chief Executive Offi
f cer of IDEC Pharmaceuticals Corporation until
its merger with Biogen Inc. in 2003; he joined IDEC Corporation as its Chief Executive Offi
f cer at the company’s founding in 1986.
From 1984 to 1986, Dr. Rastetter was Director of Corporate Ventur
t
es at Genentech, where from 1982 to 1984 he held scientific
f
positions. He held a series of faculty positions including Associate Profes
f
sor at the Massachusetts Institute of Technology (“MIT”)
from 1975 to 1982. Dr. Rastetter has an S.B. degree in Chemistry
r from MIT and received M.A. and doctorate degrees in Chemistry
r
from Harvard University.
9
The continued service of Dr. Rastetter on the Company’s Board of Directors is based on Dr. Rastetter’s scientific and technical
expertise combined with his business experience in leading rapidly grow
a
ing companies in the lifef sciences industry.
r
The Company’s
continued growth is dependent on scientific and technical advances, and the Board of Directors believes that Dr. Rastetter offers
f
both
strategic and technical insight into the risks and opportunities associated with our business. In addition, Dr. Rastetter’s board and
executive leadership experience at other lifef sciences companies provides valuable strategic and governance insight to the Board of
Directors as a whole.
10
THE BOARD OF DIRECTORS AND CORPORAT
R
E GOVERNANCE MATTERS
General
We have long believed that good corporate governance is i
i
mportant to ensure that Neurocrine Biosciences is managed for
f
the
long-term benefit
e
of its s
t
tockholde
k
rs. We periodically review our corporate governance policies and practices. The
T
Board of D
o
irectors
has adopted Corporate Governance Guidelines which descr
d
ibe our corporate governance practices and address corpor
r
ate
governance issu
i
es such as Board compos
m
ition, responsibilities and director qualifications. The
T
se guidelines are available at
www.neurocrine.com.
Corporate Governance Best Practices
We are committed to maintaining strong corporate governance practices that promote the long-term interests of the Company
and our stockholders and help strengthen the oversight functions of our management and Board of Directors. Additional inform
f
ation
about our corporate governance policies and practices, including our committee charters, Corporate Governance Guidelines, Code of
Business Conduct and Ethics, Comprehensive Compliance Program, and Incentive Compensation Recoupment Policy, can be found
on our website, www.neurocrine.com. Additionally, for more infor
f
mation on our commitment to corporate responsibility, including
environmental matters and other key initiatives, please see our latest corporate responsibility disclosures, which can be found on our
website under the “Corporate Responsibility” section. We believe these effort
f
s refle
f ct the best interests of our patients, our
stockholders and the communities in which we operate and serve. The information posted on or accessible through our website is not
incorporated into this Proxy Statement.
We believe that our strong corporate governance practices empower our independent directors to exercise effective oversight
of our business generally and our management team specifically, including the performance of our CEO.
The fol
f lowing tabl
a e highlights some of our key corporate governance practices:
Corporate Governance Best Practices
☒
Director resignation policy for di
f
rectors receiving less than
majority support
u
☒Stockholder abi
a lity to call special meetings
☒
Director overboarding policy
☒Stockholder action by written consent
☒
Policies ensuring our Board is comprised of directors with a
range of skills, professional experience, ideas and viewpoints
☒No poison pill in for
f
ce
☒
Separate Chairman and CEO
☒Clawback policy
☒
All directors attended at least 75% of Board and relevant
committee meetings
☒New director orientation and continuing director
educ
d
ation
☒
Code of Business Conduct and Ethics
☒Executive sessions of independent directors held at every
regular Board meeting
☒
Annual board and committee assessment
☒Active stockholder engagement
☒
Proxy access for
f
stockholders
☒Robust commitment to corporate responsibility
11
Board of Directors Overview
As we continue to focus on discovering and developing life-changing treatments for pa
f
tients with under-addressed
neurological, neuroendocrine, and neuropsychiatric disorders, we rely on our talented and experienced Board to provide leadership,
guidance and oversight. Our Board is comprised of individuals with a strong background in executive leadership, capital management
and allocation, scientific research and drug development experience, and Company and industry k
r
nowledge. We believe that our
directors’ varied backgrounds and experiences result in different perspectives, ideas, and viewpoints, which make our Board more
effe
f ctive in carrying out its dut
d ies. We believe that our directors hold themselves to the highest standards of integrity and that they are
committed to representing the long-term interests of our stockholders.
The fol
f lowing matrix highlights the mix of key skills and experiences of our director nominees and continuing directors. This
matrix is intended to depict notable areas of focus for
f
each director, and not having a mark does not mean that a particular director
does not possess that skill or experience. Nominees have developed competencies in these skills through educ
d
ation, direct experience
and oversight responsibilities. Additional biographical information on each nominee is set out above.
Experience, Expertise, or
Attribute
Director Nominees
Continuing Directors
Kyle
Gano,
Ph.D.
Richard
Pops
Shalini
Sharp
Stephen
Sherwin,
M.D.
Kevin
Gorman,
Ph.D.
Gary
Lyons
Johanna
Mercier
George
Morrow
Leslie
Norwalk
Christine
Poon
William
Rastetter,
Ph.D.
Industry E
r
xpertise
Finance / Capi
a tal Management
and Allocation
Commercial Experience
Scientific Research & Drug
Development Experience
Governance / Public Company
Board
Investor Relations /
Stockholder Engagement
International Markets
Government Affa
f irs / Publ
u ic
Policy
Executive Leadership
Experience
Accounting / Financial
Reporting
Risk Oversight / Risk
Management
Human Capital Management
IT / Cybersecurity
Pricing and Market Access -
U.S.
Board Leadership Structure
It is the Company’s policy to separate the roles of CEO and Chairman of the Board. This separation recognizes the
independent roles of the Board of Directors, Chairman of the Board and CEO. The Board of Directors sets Company strategy and
provides oversight and accountability for the CEO and Company management. The Chairman of the Board presides over the Board of
Directors and provides guidance to the CEO. The CEO and the balance of the Board of Directors set Company goals with the CEO
providing leadership and day to day oversight in furtherance of those goals. The Company believes that separation of the Board of
Directors and Company leadership reinforces the independence of the Board of Directors in its oversight of the business and affa
f irs of
the Company, and creates an environment that is more conducive to objective evaluation and oversight of management’s performance,
increasing management accountability and improving the abi
a lity of the Board of Directors to monitor whether management’s actions
are in the best interests of the Company and its stockholders.
12
Board Independence
The Board of Directors annually reviews the independence of each of the directors. With the exception of Kyle Gano, Ph.D.,
the Company's current CEO, and Kevin Gorman, Ph.D., the Company's former CEO, all current members of the Board of Directors
meet the definition of “independent director” under the Nasdaq Stock Market qualification standards.
Classified Board Structure
The Board of Directors is divided into three classes, designated Class I, Class II and Class III. Our Nominating / Corporate
Governance Committee annually reviews the Company’s classified Board structur
t
e to evaluate whether it continues to be the
appropriate structur
t
e for the Company. At this time, the Nominating / Corporate Governance Committee and the Board continue to
believe that maintaining this structur
t
e is appropriate and beneficial to our stockholders. Specifically, the Nominating / Corporate
Governance Committee and the Board believe that the classified board structur
t
e:
•
promotes stability and continuity, allowing our Board and management to remain focused on our long-term strategic
objectives;
•
enhances independence of our non-employee directors by decreasing potential pressures from special interest groups or
others who may have motives or interests contrary to the creation of sustainable stockholder value; and
•
allows for the development of institutional knowledge at the board level, which is particularly important in the
pharmaceutical industry, given
r
the multi-year development cycles of our clinical programs.
The Board and the Nominating / Corporate Governance Committee will periodically review and continue to consider whether
the classified Board structur
t
e aligns with the Company’s long-term strategic objectives.
Overboarding Policy
The overboarding policy set forth in our Corporate Governance Guidelines limits directors to a maximum of five public
company boards, with named executive offi
f cers of public companies limited to a maximum of three public company boards and
members of the Audit Committee limited to a maximum of three public company audit committees unless such director is a retired
CPA, CFO or controller (or has similar experience).The Nominating / Corporate Governance Committee reviews our overboarding
policy as part of its annual review of our corporate governance practices, which includes the Corporate Governance Guidelines, and
compliance with our overboarding policy is reviewed at least annually by the Nominating / Corporate Governance Committee. All
directors are currently compliant with our overboarding policy.
Certain proxy advisory firms have adopted overboarding policies, where they will recommend a vote against directors who
serve on what the proxy advisory firm believes to be too many boards. Further, certain institutional investors will vote against
directors if they believe they are overboarded. These policies are generally intended to address concerns that directors on multiple
boards may lack sufficient time to perform their board duties effe
f ctively. The Nominating / Corporate Governance Committee and the
Board acknowledge these concerns, but believe additional factors should be considered in determining whether a director serving on
multiple boards should continue to serve on the Company’s Board of Directors. Among other things, the Board of Directors believe
that consideration should be given to the skills and abilities that a director brings to the Board, how a director contributes to the overall
mix of perspectives and backgrounds on the Board, and whether the director dedicates the appropriate time, attention and energy to his
or her director duties. The Board of Directors discusses these considerations generally in connection with its evaluation and
assessment process and specific
f ally with both current Board members and director candidates who serve on multiple boards of
directors.
Director Refreshment
The Nominating / Corporate Governance Committee recognizes that it is desirabl
a e to maintain a balance of longer-tenured
directors whose experience and institutional knowledge provide them with a nuanced understanding of the Company and its
operations, with newer directors who contribute fresh perspectives. Accordingly, the Nominating / Corporate Governance Committee
and the Board have determined not to adopt mandatory retirement ages or tenure limits. Although the Board acknowledges that some
stockholders have concerns regarding directors with longer service, the Board believes that such directors provide critical expertise
and informed judgment to Board deliberations and decisions. In particular, the continuity such tenured directors provide facilitates
meaningful
f
contributions to, and more effe
f ctive oversight of, management through the full breadth of the drug discovery and
development process. While the Nominating / Corporate Governance Committee and the Board consider tenure when evaluating the
Board's composition, they believe that imposing rigid restrictions would deprive the Board of the invaluable knowledge and leadership
that experienced of members of the Board are able to offer
f
to the Company.
13
Board and Committee Meetings During 2024
The Board of Directors held a total of seven meetings during 2024. For 2024, the Board of Directors had an Audit Committee,
a Compensation Committee, a Nominating / Corporate Governance Committee, and a Science and Medical Technology Committee.
Charters for
f
each of these committees have been establ
a ished and approved by the Board of Directors and current copies of the charters
for each of the committees have been posted on the Company’s website at www.neurocrine.com.
During 2024, all directors in office at that time attended at least 75% of the total number of meetings of the Board of
Directors and committees of the Board of Directors on which they served.
Information About Board Committees
The table below provides membership infor
f
mation for each of the committees of the Board during 2024. In December 2024,
our Board appr
a
oved revisions to the membership of our committees (see page 21 for our Board's current committee membership).
Committee Composition
Name of Director
Committee
Audit
Compensation
Nominating /
Corporate
Governance
Science and
Medical
Technology
William H. Rastetter, Ph.D. (Board Chair)
MEMBER
Kevin C. Gorman, Ph.D.
Gary A. Lyons
MEMBER
Johanna Mercier
MEMBER
George J. Morrow
MEMBER
MEMBER
Leslie V. Norwalk
CHAIR
Christine A. Poon(1)
MEMBER
MEMBER
Richard F. Pops(2)
CHAIR
MEMBER
Shalini Sharp
CHAIR
MEMBER
Stephen A. Sherwin, M.D.(3)
MEMBER
CHAIR
(1)
Ms. Poon joined the Audit Committee effective February 1
r
2, 2024 and the Nominating / Corporate Governance Committee effective February 6, 2
r
024.
(2)
Mr. Pops was a member of the Audit Committee through Februa
r
ry 12, 2024.
(3)
Dr. Sherwin was a member of the Nominating / Corporate Governance Committee through Februa
r
ry 6, 2024.
The Company’s Audit Committee is comprised entirely of directors who meet the independence requirements set forth in
Nasdaq Stock Market Rul
R e 5605(c)(2)(A). Information regarding the func
f
tions performed by the committee, its membership, and the
number of meetings held during the fiscal year is set for
f
th in the “Report of the Audit Committee,” included in this Proxy Statement.
The Board of Directors has determined that Ms. Sharp,
r
Ms. Poon and Dr. Sherwin are “audit committee fin
f ancial experts” within the
meaning of item 407(d)(5) of SEC Regulation S-K. This committee met nine times dur
d
ing 2024.
The Compensation Committee reviews and recommends to the Board of Directors the compensation of executive offi
f cers and
other employees of the Company. Under its charter, the Compensation Committee may form, and delegate authority to, subcommittees
as appropriate. Each member of the Compensation Committee is an “independent director” as defin
f ed by Nasdaq Stock Market Rule
R
5605(a)(2). This committee met nine times dur
d
ing 2024. Please also refer to “Role of the Compensation Committee” section under the
section titled “Compensation Discussion and Analysis” for additional information regarding the role of the Compensation Committee.
The Nominating / Corporate Governance Committee is responsible for recommending nominees for election to the Board of
Directors, developing and implementing policies and practices relating to corporate governance, and providing oversight with respect
to the fol
f lowing matters: corpor
r
ate responsibility, supply chain risk, quality systems and drug safety. The Nominating / Corporate
Governance Committee also administers the Company’s Code of Business Conduct and Ethics (the “Code”), which applies to all of
the Company’s officers, directors and employees, and is availabl
a e on the Company’s website at www.neurocrine.com. If we make any
subs
u
tantive amendments to the Code or grant any waiver from a provision of the Code to any executive officer or director, we will
promptly disclose the natur
t
e of the amendment or waiver on our website or in a current report on Form 8-K. The functions of this
committee also include consideration of the composition of the Board of Directors and recommendation of individuals for election as
directors of the Company. The Nominating / Corporate Governance Committee will consider nominees recommended by
stockholders, provided such nominations are made pursuant to the Company’s bylaws and applicable law. Each member of the
Nominating / Corporate Governance Committee is an “independent director” as defin
f ed by Nasdaq Stock Market Rul
R e 5605(a)(2).This
committee met five times dur
d
ing 2024.
14
In January 2024, the Board formed the Science and Medical Technology Committee, which provides oversight of significant
scientific judgments relating to the Company’s research and development, including clinical development, activities, portfol
f io, and
potential business development transactions.
Dr. Rastetter serves as a member of the Science and Medical Technology Committee and also regularly attends other
committee meetings in his role as Board Chair.
Compensation Committee Interlocks and Insider Participation
During 2024, the Compensation Committee consisted of George J. Morrow, Richard F. Pops, and Shalini Sharp.
r
No
interlocking relationship existed between any member of the Compensation Committee and any member of any other company’s
Board of Directors or compensation committee.
Director Nomination Process
In selecting non-incumbent candidates and reviewing the qualifications of incumbent candidates for the Board of Directors, the
Nominating / Corporate Governance Committee considers the Company’s corporate governance principles, which include the
following:
•
Directors should possess the highest ethics, integrity and values, and be committed to representing the long-term
interest of the stockholders. They also must have experience they can draw upon to help direct the business strategies
of the Company together with sound judgment. They must be actively engaged in the pursuit of information relevant to
the Company’s business and must construc
r
tively engage their fellow Board members and management in dialogue and
the decision-making process.
•
Directors must be willing to devote sufficient time to carrying out their duties and responsibilities effe
f ctively, and
should be committed to serve on the Board of Directors for an extended period of time.
•
Directors should notify
f the Chairman of the Board and Chairman of the Nominating / Corporate Governance
Committee in the event of any significant change in their employment responsibilities or affi
f liations. Director
nominees should meet the director qualific
f ation requirements set forth in the Company’s Corporate Governance
Guidelines.
•
In evaluating director nominees, the Nominating / Corporate Governance Committee considers the following factors:
personal and profes
f
sional integrity, ethics and values including any potential confli
f cts of interest; experience in
corporate management and the biopharmaceutical industry,
r
such as serving as an offi
f cer or former offi
f cer of a publicly
held company; experience as a board member of another publicly held company; and additionally, for nominees
seeking re-election, meeting attendance, and participation and compliance with Company policies.
It is the Company’s policy to have a range of skills, profes
f
sional experience, educ
d
ation, associations, achievements, training,
points of view and individual qualities and attributes represented on the Board of Directors. The Nominating / Corporate Governance
Committee considers these characteristics when assessing board composition and evaluating candidates for election or re-election to
the Board of Directors.
The Nominating / Corporate Governance Committee’s goal is to assemble a Board of Directors that brings to the Company a
variety of perspectives and skills derived from high quality business and profes
f
sional experience. Our current Board is comprised of
eleven directors. The directors’ demographic background includes gender diversity (four directors) and ethnic diversity (two
directors).
In addition to the foregoing, the Nominating / Corporate Governance Committee Charter and Corporate Governance
Guidelines set forth minimum criteria for director nominees. The Nominating / Corporate Governance Committee may also consider
such other facts as it may deem are in the best interests of the Company and its stockholders. The Nominating / Corporate Governance
Committee does believe that several members of the Board of Directors meet the criteria for an “audit committee financial expert” as
defined by SEC rules. We believe that all of our directors should have a reputation for honesty, integrity and highest ethical standards,
and should demonstrate business acumen, an ability to exercise sound judgment and a commitment to serve the Company.
Board Self-A
f
ssessment
The Nominating / Corporate Governance Committee ensures that each member of the Board, the Committees, and the Chair of
the Board are assessed annually aimed at enhancing effe
f ctiveness. Directors complete a number of different evaluations in order to
provide performance feedba
d
ck and suggestions for improved effe
f ctiveness or contributions. The assessments are done by way of a
questionnaire prepared and distributed by our external corporate counsel, Cooley LLP. The assessments are treated on a confid
f ential
basis, with the results tallied on an anonymous basis for review. The results of the evaluation are analyzed by Cooley LLP, our Chief
Legal Offi
f cer, the Nominating / Corporate Governance Committee, and the Board, who decide whether any changes are needed to the
Board’s processes, procedur
d
es, composition or Committee structur
t
e. The evaluation carried out for the 2024 calendar year indicated
that all individuals and groups were effe
f ctively fulfilling their responsibilities.
15
Board Education
The Board recognizes the importance of ongoing director educ
d
ation. In order to facilitate the Board’s educ
d
ational development,
the Board regularly meets with management and are given periodic presentations on our business and recent business developments.
When the Board meets in person, Members of the Board also attend dinners on the evening before regularly scheduled Board
meetings. Generally, at these dinners the Board meets with senior decision-makers within the Company or outside experts in order to
enhance the Board’s understanding of our business and affa
f irs. In addition, on an annual basis an external expert meets with the
Nominating / Corporate Governance Committee to discuss best practices and new developments relating to corporate governance and
the operation of public company boards. The Company also provides funding for members of the Board of Directors to attend outside
director continuing educ
d
ation programs sponsored by educ
d
ational and other institutions.
Identification and Evaluation of Nominees for Director
The Nominating / Corporate Governance Committee identifies nominees for director by first evaluating the current members
of the Board of Directors willing to continue in service. Current members with qualifications and skills that are consistent with the
Nominating / Corporate Governance Committee’s criteria for service and who are willing to continue are considered for re-
nomination, balancing the value of continuity of service by existing members of the Board of Directors with that of obtaining
members who would offer
f
a new perspective. If any member of the Board of Directors does not wish to continue in service, or if the
Board of Directors decides not to re-nominate a member for re-election, the Nominating / Corporate Governance Committee identifies
the desired skills and experience of a new nominee in light of the criteria above. The Nominating / Corporate Governance Committee
generally polls the Board of Directors and members of management for their recommendations and may also seek input from third-
party search firms. The Nominating / Corporate Governance Committee may also seek input from industry
r experts or analysts. The
Nominating / Corporate Governance Committee reviews the qualifications, experience and background of the candidates. Final
candidates are then interviewed by the Company’s independent directors and executive management. In making its determinations, the
Nominating / Corporate Governance Committee evaluates each individual in the context of the Company’s Board of Directors as a
whole, with the objective of assembling a group that can best perpetua
t
te the success of the Company and represent stockholder
interests through the exercise of sound judgment. Afte
f r review and deliberation of all feedba
d
ck and data, the Nominating / Corporate
Governance Committee makes its recommendation to the Board of Directors.
We have not received director candidate recommendations from the Company’s stockholders and do not have a formal policy
regarding consideration of such recommendations. However, any recommendations received from stockholders will be evaluated in
the same manner that potential nominees suggested by members of our Board of Directors, management or other parties are evaluated.
Accordingly, our Board of Directors believes a formal policy regarding consideration of such recommendations is unnecessary.
All of the nominees for director standing for election at the 2025 Annual Meeting of Stockholders (other than Dr. Gano) were
most recently re-elected as directors at our 2022 Annual Meeting of Stockholders. The Board elected Dr. Gano as a director, effe
f ctive
October 11, 2024, in connection with his appointment as our CEO. Dr. Gano's appointment as our CEO was the result of succession
planning process managed by the Nominating / Corporate Governance Committee and the full Board.
Proxy Access
In Februa
r
ry 2023, our Board of Directors amended and restated our bylaws to provide for proxy access, which, subj
u ect to
certain limitations as set forth in our bylaws, allows a stockholder or a group of no more than 20 stockholders owning at least three
percent or more of the voting power of our outstanding capi
a tal stock continuously for at least three years to nominate and include in
our Proxy Statement for an annual meeting director nominees constituting up to the greater of two individuals or 20% of the number
of directors in offi
f ce, provided that (i) the number of such nominees may not exceed 50% of the number of directors in the class whose
term expires at such annual meeting and (ii) the stockholders satisfy
f the procedur
d
al, disclosure and other requirements specified in our
bylaws. For further information, please see “Additional Information”. The foregoing description of the stockholder proxy access
provision included in our bylaws does not purpor
r
t to be complete and is qualified in its entirety by reference to our bylaws.
Process for Stockholder Communications with the Board of Directors
Stockholders of the Company wishing to communicate with the Company’s Board of Directors or an individual director may
send a written communication to the Board of Directors or such director c/o Neurocrine Biosciences, Inc., 6027 Edgewood Bend
Court, San Diego, CA 92130, Attn: Corporate Secretary.
r
Each communication must set forth:
•
the name and address of the Company stockholder on whose behalf the communication is sent; and
•
the number of Company shares that are beneficially owned by such stockholder as of the date of the communication.
Each stockholder communication will be reviewed by the Company’s Corporate Secretary
r to determine whether it is
appropriate for presentation to the Board or such director. Examples of inappropriate communications include advertisements,
solicitations or hostile communications.
Communications determined by the Corporate Secretary
r to be appropriate for presentation to the Board or such director will be
subm
u
itted to the Board or such director on a periodic basis.
16
Role of Board in Risk Oversight
While the Board of Directors has ultimate oversight responsibility for the risk management process, it has delegated portions
of this responsibility to various committees. The Board of Directors and its committees oversee risk throughout the business with
focus on financial risk, legal/compliance risk, scientific/clin
f
ical development risk, cybersecurity risk management, and strategic risk.
The Audit Committee focuses on major financial risk exposures and the steps our management has taken to monitor and control these
exposures. The Audit Committee also has oversight of risk related to data privacy, technology and information and cybersecurity,
including: (i) access to various reports, summaries or presentations related to cybersecurity threats, risk, and mitigation (ii) the
potential impact of those exposures on the Company’s business, financial results, operations and reputation, (iii) the steps management
has taken to monitor and mitigate such exposures, (iv) the Company’s information governance policies and programs and (v) major
legislative and regulatory developments that could materially impact the Company’s privacy and data security risk exposure. The
Nominating / Corporate Governance Committee and Audit Committee each focus on legal/compliance risk with the Nominating /
Corporate Governance Committee taking the lead on the governance and management process and compliance oversight with respect
to the following matters: corporate responsibility, supply
u
chain risk, quality systems and drug safety. The Audit Committee takes the
lead on SEC reporting and compliance. The Compensation Committee addresses compensation policies and practices as they relate to
risk management practices and risk-taking incentives. The participation of the full Board of Directors in setting the Company’s
business strategy incorporates assessment of scientific and strategic risks for the Company overall. Additionally, in January
r 2024, the
Board of Directors formed the Science and Medical Technology Committee, which provides oversight of significant scientific
f
judgments relating to the Company’s research and development, including clinical development, activities, portfol
f io, and potential
business development transactions.
Corporate Responsibility
At Neurocrine Biosciences, we uphold an unwavering spirit of ingenuity and seek to provide lifesav
f
ing solutions to patients
who have great needs, but few options. We believe operating both responsibly and effi
f ciently is paramount to creating long-term value
for our Company and stakeholders. Our focus as a Company is to operate with the highest standards of business ethics, adhere to the
highest product quality and safety standards, invest in our people and communities in which we live and work, and minimize our
impact on the environment. For more information on our commitment to corporate responsibility, including environmental matters and
other key initiatives, please see our latest corporate responsibility disclosures, which can be found on our website,
www.neurocrine.com, under the “Corporate Responsibility” section. The information posted on or accessible through our website is
not incorporated into this Proxy Statement.
Risk Assessment Concerning Compensation Practices and Policies
During 2024, the Compensation Committee conducted an assessment of how the Company’s compensation policies and
practices relate to risk management practices and risk-taking incentives. As part of the process, the Compensation Committee engaged
the services of an external, independent compensation consulting firm to conduct an independent risk assessment. Based on this
assessment, the Compensation Committee concluded that the Company’s compensation policies and practices are consistent with
industry pr
r
actices for similar biopharmaceutical companies and do not create risks that are reasonably likely to have a material adverse
effe
f ct on the Company.
Role of the Board in Succession Planning
A key responsibility of the Board is succession planning for the CEO and other members of the executive management team.
In consultation with the Company's CEO and Chief Human Resources Offi
f cer, the Compensation Committee oversees succession
planning relating to the Company's executive offi
f cers. Succession planning for the Company's CEO is conducted by the full Board to
ensure that development, retention and succession plans for the CEO align with the Company's short and long-term strategic goals.
Additionally, the Compensation Committee discusses executive management talent, including the readiness of individuals to take on
additional leadership roles and developmental opportunities needed to prepare senior leaders for greater levels of responsibility. The
review and assessment conducted by the Board and its committees includes a review of both a long-term succession plan and an
emergency succession plan.
In suppor
u
t of the Company’s commitment to investing in its employees, high-potential leaders are provided with the
opportunity to meet with Board members through formal presentations and at informal events. This engagement gives the Board
insight into the Company’s talent and helps to facilitate a regular review and discussion of leadership development and succession
planning at the Board and Committee level.
In May 2024, we announced that Dr. Gorman would retire as the Company's CEO effe
f ctive October 11, 2024. Prior to the
announcement of Dr. Gorman's retirement, the Board undertook a comprehensive leadership development and succession planning
process to identify
f the right leader to take the Company into the next phase of growth. Afte
f r a robust and thorough process, the Board
named Dr. Gano, formerly the Company's Chief Business Development and Strategy Offi
f cer, to succeed Dr. Gorman as the
Company’s CEO effe
f ctive October 11, 2024. Dr. Gorman continues to serve of the Company's Board.
Policy Regarding Board Member Attendance at the Company’s Annual Meeting
The Company does not have a formal policy regarding attendance by members of the Board of Directors at the Annual
Meeting. Directors Dr. Gorman and Dr. Rastetter attended the 2024 Annual Meeting of Stockholders.
17
REPORT OF THE AUDIT COMMITTEE
The following Repor
e
t of the Audit Committee does not constitute soliciting material and should not be deemed filed or
incorporated by refe
e rence into any other Company filing under the Securities Act of 1933, as amended, or the Securities Exchange Act
of 1934, as amended, except
e
to the extent the Company specifi
i cally incorporates this Repor
e
t by refe
e rence therein.
The Audit Committee oversees the Company’s financial reporting process on behalf of the Board of Directors. Management
has the primary
r responsibility for the Company’s financial statements and the reporting process, including the Company’s systems of
internal controls. In fulfillin
f
g its oversight responsibilities, the Audit Committee has reviewed and discussed with management the
Company’s audited financial statements as of and for the year ended December 31, 2024, including a discussion of the quality, not just
the acceptabi
a lity, of the accounting principles, the reasonableness of significant judgments and the clarity of disclosures in the
financial statements.
The Audit Committee also has reviewed and discussed the Company’s audited financial statements as of and for the year
ended December 31, 2024 with the Company’s independent registered public accounting firm, who are responsible for expressing an
opinion on the confor
f
mity of those audited financial statements with accounting principles generally accepted in the United States, as
well as their judgments as to the quality, not just the acceptabi
a lity, of the Company’s accounting principles and such other matters as
are required to be discussed with the Audit Committee under the applicable requirements of the Publ
u ic Company Accounting
Oversight Board (United States) (the “PCAOB”) and the Securities and Exchange Commission. The independent registered public
accounting firm also is responsible for performing an independent audit of the Company’s internal control over financial reporting in
accordance with the auditing standards of the PCAOB. In addition, the Audit Committee has discussed the independent registered
public accounting firm’s independence from management and the Company, including the matters in the written disclosures and the
letter from the independent registered public accounting firm required by applicable requirements of the PCAOB and considered the
compatibility of non-audit services with the auditors’ independence.
The Audit Committee discussed with the Company’s independent registered public accounting firm the overall scope and
plans for their audits. The Audit Committee meets with the independent registered public accounting firm, with and without
management present, to discuss the results of their examinations, their evaluations of the Company’s internal controls, and the overall
quality of the Company’s financial reporting.
In reliance on the reviews and discussions referred to above, the Audit Committee recommended to the Board of Directors that
the audited financial statements be included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024,
for filing with the Securities and Exchange Commission. The Audit Committee and the Board of Directors are also seeking
stockholder ratification of the selection of the Company’s independent registered public accounting firm for the year ending
December 31, 2025.
Respectful
f ly subm
u
itted by:
AUDIT COMMITTEE
Shalini Sharp
Christine A. Poon
Stephen A. Sherwin, M.D.
18
Principal Accountant Fees and Services
The aggregate fee
f
s billed to the Company by Ernst & Young LLP, the Company’s independent registered public accounting
firm, for
f
the indicated services for each of the last two fiscal years were as fol
f lows:
2024
2023
Audit fees
f
(1)................................................................................................................................................................ $
1,754,055
$
1,708,578
Audit related fees (2)....................................................................................................................................................
—
—
Tax fees
f
(3)...................................................................................................................................................................
575,236
545,664
Total.............................................................................................................................................................................. $
2,329,291
$
2,254,242
(1)
Audit fees co
f
nsist of fees
f
for professional services performed by Ernst & Young LLP for the integrated audit of the Company’s annual fin
f ancial statements
and internal control over fin
f ancial reporting and review of financial statements included in the Company’s 10-Q filin
f
gs and services that are normally
provided in connection with statutor
t
y a
r
nd regulatory f
r
ilin
f
gs or engagements.
(2)
Audit related fees consist of fees
f
for assurance and related services performed by Ernst & Young LLP that are reasonably related to the performance of the
audit or review of the Company’s fin
f ancial statements.
(3)
Tax fees consist of fees
f
for professional services performed by Ernst & Young LLP with respect to tax compliance, tax advice and tax planning. Total
includes appr
a
oximately $322,000 in 2024 and $263,000 in 2023 for tax compliance.
The Audit Committee has considered whether the provision of non-audit services is compatible with maintaining the
independence of Ernst & Young LLP and has concluded that the provision of such services is compatible with maintaining the
independence of that firm.
f
All of the services rendered by Ernst & Young LLP were pre-approved by the Audit Committee in
accordance with the Audit Committee pre-appr
a
oval policy described below.
The Company’s Audit Committee has establ
a ished a policy that all audit and permissible non-audit services provided by the
Company’s independent registered public accounting fir
f m will be pre-approve
a
d by the Audit Committee. These services may include
audit services, audit related services, tax services and other services. The Audit Committee considers whether the provision of each
non-audit service is compatible with maintaining the independence of the Company’s registered public accounting fir
f m. Pre-approval
is detailed as to the particular service or category o
r
f services and is generally subj
u ect to a specific budget. The Company’s independent
registered public accounting fir
f m and management are required to periodically (at least quarterly) report to the Audit Committee
regarding the extent of services provided by the independent registered public accounting fir
f m in accordance with this pre-approval,
and the fees for the services performed to date.
19
COMPENSATION COMMITTEE REPORT
The following Repor
e
t of the Compensation Committee does not constitute soliciting material and should not be deemed filed or
incorporated by refe
e rence into any other Company filing under the Securities Act of 1933, as amended, or the Securities Exchange Act
of 1934, as amended, except
e
to the extent the Company specifi
i cally incorporates this Repor
e
t by refe
e rence therein.
The Compensation Committee of the Company has reviewed and discussed the Compensation Discussion and Analysis
required by Item 402(b) of Regulation S-K with management and, based on such review and discussions, the Compensation
Committee recommended to the Board of Directors that the Compensation Discussion and Analysis be included in this Proxy
Statement.
Respectful
f ly subm
u
itted by:
COMPENSATION COMMITTEE
George J. Morrow
Richard F. Pops
Shalini Sharp
20
PROPOSAL ONE: ELECTION OF DIRECTORS
The Company’s bylaws, as amended, provide that the Board of Directors is comprised of eleven directors. The Company’s
Certificate of Incorpor
r
ation provides that the Board of Directors is divided into three classes. There are currently four directors in
Class I (William H. Rastetter, Ph.D., George J. Morrow, Leslie V. Norwalk, and Christine A. Poon), four di
f
rectors in Class II (Kyle
K
W. Gano, Ph.D., Richard F. Pops, Shalini Sharp, and Stephen A. Sherwin, M.D.), and three directors in Class III (Kevin C.
Gorman, Ph.D., Gary A. Lyons, and Johanna Mercier). With the exception Kyl
K e W. Gano, Ph.D., who is the CEO of the Company,
and Kevin C. Gorman, Ph.D., who retired as CEO of the Company effective October 11, 2024, all current members of the Board of
Directors meet the defin
f ition of “independent director” under the Nasdaq Stock Market qualification standards. Additionally, our
Corporate Governance Guidelines contain a director resignation policy, which provides that any director nominee who receives a
greater number of votes “withheld” than votes “for
f
” such election shall tender his or her resignation to the Board of Directors. The
Nominating / Corporate Governance Committee will consider all of the relevant facts and circumstances and recommend to the Board
of Directors whether to accept or reje
e ct the resignation. The Board of Directors will act on the Nominating / Corporate Governance
Committee's recommendation within 90 days of the annual meeting. Following the Board’s decision on the Nominating / Corporate
Governance Committee’s recommendation, the Company will publicly disclose the Board’s decision whether to accept the resignation
as tendered in a Form 8-K file
f
d with the Securities and Exchange Commission (the "SEC").
The directors in Class I hold office until the 2027 Annual Meeting of Stockholders, the directors in Class II hold office until
the 2025 Annual Meeting of Stockholders and the directors in Class III hold office until the 2026 Annual Meeting of Stockholders (or,
in each case, until their earlier resignation, removal fro
f
m office, or death). After each such election, the elected directors will then
serve in succeeding terms of three years and until a successor is dul
d y elected and qualified. Offi
f cers of the Company serve at the
discretion of the Board of Directors. There are no fam
f
ily relationships among the Company’s directors and executive offic
f ers.
The term of offic
f e for di
f
rectors Kyl
K e W. Gano, Ph.D., Richard F. Pops, Shalini Sharp, and Stephen A. Sherwin, M.D. will
expire at the 2025 Annual Meeting of Stockholders.
Nominees for Election at the Annual Meeting
All of the nominees (Kyl
K e W. Gano, Ph.D., Richard F. Pops, Shalini Sharp, and Stephen A. Sherwin, M.D.) are currently
Class II directors of the Company. Information about
a
the nominees is set forth below as of the date of this Proxy Statement:
Name of Director
Age
Position in the Company
Director Since
Kyle W. Gano, Ph.D................................................................................
52
Chief Executive Offic
f er and Director
2024
Richard F. Pops (1)(2) .............................................................................
62
Director
1998
Shalini Sharp (2)(3) .................................................................................
50
Director
2020
Stephen A. Sherwin, M.D. (1)(3) ............................................................
76
Director
1999
Directors Continuing in Offi
f ce
The Class I and III directors will remain in office afte
f r the 2025 Annual Meeting of Stockholders. The names and certain other
current information about
a
the directors whose terms of offi
f ce continue afte
f r the Annual Meeting are set for
f
th below:
Name of Director
Age
Position in the Company
Director Since
William H. Rastetter, Ph.D. (1)...............................................................
76
Chairman of the Board
2010
Kevin C. Gorman, Ph.D. (1)....................................................................
67
Director
2008
Gary A. Lyons (1) ...................................................................................
73
Director
1993
Johanna Mercier (4) ................................................................................
55
Director
2021
George J. Morrow (2)(4).........................................................................
73
Director
2015
Leslie V. Norwalk (4)..............................................................................
59
Director
2019
Christine A. Poon (3)(4)..........................................................................
72
Director
2023
(1)
Member of the Science and Medical Technology Committee.
(2)
Member of the Compensation Committee.
(3)
Member of the Audit Committee.
(4)
Member of the Nominating / Corporate Governance Committee.
21
Vote Required
The nominees receiving the affirm
f
ative vote of a plurality of the shares represented in person or by proxy at the 2025 Annual
Meeting of Stockholders and entitled to vote on the election of directors will be elected to the Board of Directors. If a nominee
receives a greater number of votes “withheld” than votes “for
f
” such election, the nominee shall tender his or her resignation to the
Board of Directors in accordance with our director resignation policy. The Nominating / Corporate Governance Committee will
consider all of the relevant factors and recommend to the Board of Directors whether to accept or reje
e ct the resignation. The Board of
Directors will act on the Nominating / Corporate Governance Committee's recommendation within 90 days of the annual meeting.
Following the Board’s decision on the Nominating / Corporate Governance Committee’s recommendation, the Company will publicly
disclose the Board’s decision whether to accept the resignation as tendered in a Form 8-K filed with the SEC.
Votes withheld from any director are counted for purposes of determining the presence or absence of a quorum, but have no
other legal effe
f ct under Delaware law.
Unless otherwise instructed, the proxy holders will vote the proxies received by them for the Company’s Class II nominees
named above. If any of the Company’s nominees is unable or declines to serve as a director at the time of the Annual Meeting, the
proxies will be voted for any subs
u
titute nominee who is designated by the present Board of Directors, or alternatively, the Board of
Directors may leave a vacancy on the Board of Directors or reduce the size of the Board of Directors. It is not expected that any of the
Company’s nominees will be unable or will decline to serve as a director. The Board of Directors unanimously recommends that
stockholders vote “FOR” the Class II nominees named above.
22
PROPOSAL TWO: ADVISORY VOTE ON
COMPENSATION PAID TO THE COMPANY’S NAMED EXECUTIVE OFFICERS
General
At the 2023 Annual Meeting of Stockholders, the Board of Directors, as a matter of good corporate governance, recommended
that the stockholders approve an advisory vote on Named Executive Offi
f cer compensation (“say-on-pay”) on an annual basis.
Approximately 99% of the stockholder votes cast at the 2023 Annual Meeting of Stockholders were for the Company’s
recommendation, and in response the Company holds an annual say-on-pay vote. This annual vote is not intended to address any
specific compensation item, but rather the overall compensation of the Company’s Named Executive Offi
f cers and the philosophy,
policies and practices described in this Proxy Statement.
Summary of the Company’s Executive Compensation Philosophy
The Compensation Committee of the Board of Directors bases its executive compensation decisions on a number of objectives
which include aligning management incentives with interests of stockholders, providing competitive compensation, appropriately
balancing compensation risk in the context of the Company’s business strategy and meeting evolving compensation governance
standards. The philosophy of the Compensation Committee in establ
a ishing the Company’s compensation policy for executive offi
f cers
as well as all other employees is to:
•
align compensation plans with both short-term and long-term goals and objectives of the Company and stockholder
interests;
•
attract and retain highly skilled individuals by offeri
f
ng compensation that compares favorably to other employers who
are competing for availabl
a e employees;
•
incentivize employees through a mix of base salary, bonus amounts based on achievement of defined corporate and
personal goals and long-term equity awards to generate returns for stockholders; and
•
pay for performance by ensuring that an ever-increasing percentage of an individual’s compensation is performance-
based as they progress to higher levels within the Company.
As discussed below in the Compensation Discussion and Analysis, we believe we have adopted a compensation philosophy
that provides strong alignment between executive pay and performance based on strategic goals designed to provide both near-term
and long-term growth in stockholder value. The historical approval rates, on an advisory basis, for the Company’s executive
compensation program have been over 92% for each of the 2022, 2023 and 2024 Annual Meetings of Stockholders. The
Compensation Committee and our Board of Directors believe that this level of approval of our executive compensation program is
indicative of our stockholders’ strong suppor
u
t of our compensation philosophy and goals as well as the overall administration of
executive compensation by the Compensation Committee and the Board of Directors.
You are being asked to approve on an advisory basis, the compensation paid to the Company’s Named Executive Offi
f cers as
set forth in the Compensation Discussion and Analysis, Summary
r Compensation Tabl
a e and related notes and narrative set forth herein.
This vote is not intended to address any specific compensation item, but rather the overall compensation of the Company’s Named
Executive Offi
f cers and the philosophy, policies and practices described in this Proxy Statement.
Vote Required
The say-on-pay vote is advisory and therefor
f
e not binding on the Company, the Compensation Committee or the Board of
Directors. However, we value the opinions of our stockholders and will review and will continue to consider the outcome of this
advisory vote when making future compensation decisions for our Named Executive Offi
f cers and will evaluate whether any actions
are necessary to address the stockholders’ concerns. Approval of this advisory vote requires the affirm
f
ative vote of the majority
of shares represented in person or by proxy and entitled to vote on the item. The Board of Directors unanimously recommends
voting “FOR” approval of the Company’s Named Executive Offi
f cers compensation.
23
PROPOSAL THREE: APPROVAL OF THE COMPANY'S 2025 EQUITY INCENTIVE PLAN
We are asking our stockholders to approve the Neurocrine Biosciences, Inc. 2025 Equity Incentive Plan (the “2025 Plan”) at
the Annual Meeting. The 2025 Plan is intended to be the successor to the Neurocrine Biosciences, Inc. 2020 Equity Incentive Plan (the
“2020 Plan”).
Why We Are Asking Our Stockholders to Approve the 2025 Plan
Currently, we maintain the 2020 Plan to grant equity awards to our employees, directors and consultants. We are seeking
stockholder approval of the 2025 Plan to increase the number of shares availabl
a e for the grant of stock options, restricted stock unit
awards and other awards, which will enable us to have a competitive equity incentive program to compete with our peer group for key
talent. If the 2025 Plan is approved by our stockholders, no additional awards will be granted under the 2020 Plan on or afte
f r the date
of the Annual Meeting.
Approval of the 2025 Plan by our stockholders will allow us to continue to grant stock options, restricted stock unit awards and
other awards at levels determined appropriate by the Board of Directors or Compensation Committee. The 2025 Plan will also allow
us to continue to utilize a broad array of equity incentives in order to secure and retain the services of our employees, directors and
consultants, and to provide long-term incentives that align the interests of our employees, directors and consultants with the interests
of our stockholders.
Requested Shares
If this Proposal Three is approved by our stockholders, then subj
u ect to adju
d stment for certain changes in our capitalization, the
aggregate number of shares of our common stock that may be issued under the 2025 Plan will not exceed (A) the sum of (i) 7,800,000
new shares and (ii) the Prior Plans’ Returning Shares (as defined in the 2025 Plan and described below), as such shares become
availabl
a e from time to time, minus (B) one share for each share of our common stock subj
u ect to an appreciation award granted under
the 2020 Plan afte
f r the Record Date but prior to the date of the Annual Meeting and 2.43 shares for each share of our common stock
subj
u ect to a full value award granted under the 2020 Plan afte
f r the Record Date and prior to the date of the Annual Meeting.
Stockholder Approval
If this Proposal Three is approved by our stockholders, the 2025 Plan will become effe
f ctive as of the date of the Annual
Meeting and no additional awards will be granted under the 2020 Plan on or afte
f r such date. In the event that our stockholders do not
approve this Proposal Three, the 2025 Plan will not become effe
f ctive and the 2020 Plan will continue to be effe
f ctive in accordance
with its terms.
Why You Should Vote to Approve the 2025 Plan
Equity
i
Awards Are an Impor
m
tant Part of Our Compensation Philosophy
o
The Board of Directors believes that the grant of equity awards is a key element underlying our ability to attract, retain and
motivate our employees, directors and consultants because of the strong competition for highly trained and experienced individuals
among biopharmaceutical companies. Therefor
f
e, the Board of Directors believes that the 2025 Plan is in the best interests of our
business and our stockholders and unanimously recommends a vote in favor of this Proposal Three.
The 2025 Plan will allow us to continue to utilize equity awards as long-term incentives to secure and retain the services of our
employees, directors and consultants, consistent with our compensation philosophy and common compensation practice for our
industry.
r
To date, equity awards have been a key aspect of our program to attract and retain key employees, directors and consultants.
We believe the use of equity awards strongly aligns the interests of our employees with those of our stockholders by placing a
considerable proportion of our employees’ total compensation “at risk” because it is contingent on the appreciation in value of our
common stock. In addition, we believe equity awards encourage employee ownership of our common stock and promote retention
through the reward of long-term Company performance.
We Carefu
e
lly Manage
a
the Use of Equity
i
Awards and Diluti
i
on is Reasonable
Our compensation philosophy reflects broad-based eligibility for equity awards, and we grant awards to subs
u
tantially all of our
employees. However, we recognize that equity awards dilute existing stockholders, and, therefor
f
e, we are mindful to responsibly
manage the growth of our equity compensation program. We are committed to effe
f ctively monitoring our equity compensation share
reserve, including our “burn rate,” to ensure that we maximize stockholders’ value by granting the appropriate number of equity
awards necessary to attract, reward, and retain employees, directors and consultants.
24
The fol
f lowing tabl
a e provides detailed infor
f
mation regarding our burn rate and the activity related to our equity incentive plans
for 2024, 2023 and 2022.
2024
2023
2022
Total number of shares of common stock subj
u ect to stock options granted
1,500,000
1,900,000
2,200,000
Total number of shares of common stock subj
u ect to full value awards granted
1,200,000
1,400,000
1,300,000
Weighted-average number of shares of common stock outstanding
100,400,000
97,700,000
95,800,000
Burn Rate (1)
2.69%
3.38%
3.65%
(1)
Burn Rate is calculated as (shares subj
u ect to stock options granted + shares subj
u ect to full value awards granted)/weighted average common stock outstanding.
Overhang
r
The fol
f lowing tabl
a e provides certain information regarding our use of equity awards as of the Record Date.
As of
Record Date
Total number of shares of common stock subj
u ect to outstanding stock options (1)
10,775,842
Weighted-average exercise price of outstanding stock options
$100.10
Weighted-average remaining term of outstanding stock options
6.65
Total number of shares of common stock subj
u ect to outstanding full value awards
3,282,004
Total number of shares of common stock availabl
a e for gr
f
ant under the 2020 Plan (2)
6,397,328
Total number of shares of common stock availabl
a e for gr
f
ant under the Neurocrine Biosciences, Inc. Inducement Plan (2)
55,182
Total number of shares of common stock subj
u ect to outstanding stock options and outstanding full value awards
14,057,846
Total number of shares of common stock outstanding
98,938,234
Per-share closing price of common stock as reported on Nasdaq Global Select Market
$115.60
(1)
Such outstanding stock options are not entitled to any dividends or dividend equivalent rights. As of the Record Date, there were no other outstanding
appreciation awards.
(2)
As of the Record Date, there were no shares of common stock availabl
a e for gr
f
ant under any of our equity incentive plans, other than the 2020 Plan and the
Neurocrine Biosciences, Inc. Inducement Plan. However, the shares availabl
a e for gr
f
ant under the 2020 Plan will not be availabl
a e for gr
f
ant under the 2025 Plan
and if this Proposal Three is appr
a
oved by our stockholders, no additional awards will be granted under the 2020 Plan on or afte
f r the date of the Annual
Meeting.
The Siz
S e of O
o
ur Share Reserve Inc
I
rease Request Is Reasonable
If this Proposal Three is appr
a
oved by our stockholders, then subject to adju
d stment for certain changes in our capitalization, we
will have 7,800,000 new shares availabl
a e for gr
f
ant under the 2025 Plan, plus the Prior Plans’ Returning
t
Shares (as defin
f ed in the 2025
Plan and described below), as such shares become availabl
a e fro
f
m time to time, minus (i) one share for
f
each share of our common
stock subject to an appreciation award granted under the 2020 Plan afte
f r the Record Date and prior to the date of the Annual Meeting
and (ii) 2.43 shares for each share of our common stock subj
u ect to a full value award granted under the 2020 Plan afte
f r the Record
Date and prior to the date of the Annual Meeting.
The 2025 Plan
l
Combines Compensation and Governance Best Pra
P
ctic
t es
The 2025 Plan includes provisions that are designed to protect our stockholders’ interests and to refle
f ct corporate governance
best practices, including:
•
Sto
S ckholder appr
a
oval is required for addi
f
tional shares. The 2025 Plan does not contain an annual “evergreen” provision. The
2025 Plan authorizes a fix
f ed number of shares, so that stockholder approva
a
l is required to issue any additional shares.
•
Repricing is not allowed without
t
stockholder approval
a
. The 2025 Plan prohibits the repricing of stock options and stock
appreciation rights granted under the 2025 Plan without prior stockholder approva
a
l.
•
No liberal share counting of s
o
tock options or stock appr
a
eciation right
g s.
t
Shares that are reacquired or withheld (or not issued)
by us to satisfy the exercise price or a tax withholding obligation with respect to stock options or stock appr
a
eciation rights
will not become availabl
a e again for issuance under the 2025 Plan.
•
No d
N
iscounted stock opt
o ions or stock appr
a
eciation rights
g
. All stock options and stock appreciation rights granted under the
2025 Plan must have an exercise price equal to or greater than the fai
f r market value of our common stock on the date the
stock option or stock appreciation right is granted.
25
•
Limit on non-employ
m
ee director compensation. The aggregate value of all compensation granted or paid by us to any
individual for service as a non-employee director with respect to any period commencing on the date of the annual
stockholders meeting for a particular year and ending on the date immediately prior to the date of the annual stockholders
meeting for the next subs
u
equent year (such period, the “annual period”), including awards granted under the 2025 Plan and
cash fees paid to such non-employee director, will not exceed $750,000 in total value. In addition, the aggregate value of any
equity award(s) granted by us to any individual for service as a non-employee director upon or in connection with his or her
initial election or appointment to the Board of Directors will not exceed $1,500,000 in total value (such that the aggregate
compensation granted or paid by us to any individual for service as a non-employee director with respect to an annual period
in which such individual is first appointed or elected to the Board of Directors will not exceed $2,250,000 in total value). For
purpos
r
es of these limitations, the value of any equity awards is calculated based on the grant date fair value of such awards
for financial reporting purposes.
•
Awards subject to forfei
f ture/c
e lawback. Awards granted under the 2025 Plan will be subj
u ect to recoupment in accordance with
the Neurocrine Biosciences, Inc. Incentive Compensation Recoupment Policy and any other clawback policy that the
Company adopts. In addition, the Board may impose other clawback, recovery or recoupment provisions in an award
agreement, including a reacquisition right in respect of previously acquired shares or other cash or property upon the
occurrence of cause.
•
Restrictions on dividends. The 2025 Plan provides that dividends or dividend equivalents may not be paid or credited to stock
options or stock appreciation rights. In addition, with respect to any award other than a stock option or stock appreciation
right, the 2025 Plan provides that (i) no dividends or dividend equivalents may be paid with respect to any shares of our
common stock subj
u ect to such award before the date such shares have vested, (ii) any dividends or dividend equivalents that
are credited with respect to any such shares will be subj
u ect to all of the terms and conditions applicable to such shares under
the terms of the applicable award agreement (including any vesting conditions), and (iii) any dividends or dividend
equivalents that are credited with respect to any such shares will be forfeited to us on the date such shares are forfeited to or
repurchased by us due to a failure to vest.
•
No liberal change in contro
t
l definition
e
. The change in control definition in the 2025 Plan is not a “liberal” definition. A
change in control transaction must actua
t
lly occur in order for the change in control provisions in the 2025 Plan to be
triggered.
•
Material amendments require stockholder approval. Consistent with Nasdaq rules, the 2025 Plan requires stockholder
approval of any material revisions to the 2025 Plan. In addition, certain other amendments to the 2025 Plan require
stockholder approval.
Vote Required
At the Annual Meeting, the stockholders are being asked to approve the 2025 Plan. The affirm
f
ative vote of the holders of a
majority of the shares represented in person or by proxy at the Annual Meeting and entitled to vote on the item will be required to
approve the 2025 Plan. The Board of Directors unanimously recommends voting “FOR” the approval of the 2025 Plan.
Summary of the 2025 Plan
The material featur
t
es of the 2025 Plan are described below. The following description of the 2025 Plan is a summary only
r
and
is qualifie
f d in its entirety by reference to the complete text of the 2025 Plan. Stockholders are urged to read the actua
t
l text of the 2025
Plan in its entirety, which is attached hereto as Appendix A.
Purpose
The 2025 Plan is designed to secure and retain the services of our employees, non-employee directors and consultants, to
provide incentives for such persons to exert maximum effort
f
s for the success of the Company and our affi
f liates, and to provide a
means by which such persons may be given an opportunity to benefit from increases in the value of our common stock. The 2025 Plan
is also designed to align employees’ interests with stockholder interests.
Successor to 2020 Plan
l
The 2025 Plan is intended to be the successor to the 2020 Plan. If the 2025 Plan is approved by our stockholders, no additional
awards will be granted under the 2020 Plan on or afte
f r the date of the Annual Meeting. If the 2025 Plan is not approved by our
stockholders, the 2025 Plan will not become effe
f ctive and the 2020 Plan will continue to be effe
f ctive in accordance with its terms.
Type
y
s of Awards
The terms of the 2025 Plan provide for the grant of incentive stock options, nonstatutory stock options, stock appreciation
rights, restricted stock awards, restricted stock unit awards, performance awards, and other awards.
26
Shares Availa
i blel for Awards
Subj
u ect to adju
d stment for certain changes in our capi
a talization, the aggregate number of shares of our common stock that may
be issued under the 2025 Plan will not exceed: (A) the sum of (i) 7,800,000 new shares and (ii) the Prior Plans’ Returning Shares (as
defined below), as such shares become availabl
a e from time to time; minus (B) one share for each share of our common stock subj
u ect to
an appreciation award granted under the 2020 Plan afte
f r the Record Date and prior to the date of the Annual Meeting and 2.43 shares
for each share of our common stock subj
u ect to a full value award granted under the 2020 Plan afte
f r the Record Date but prior to the
date of the Annual Meeting.
The “Prior Plans’ Returning Shares” are shares of our common stock subj
u ect to outstanding awards granted under the 2020
Plan or the Neurocrine Biosciences, Inc. 2011 Equity Incentive Plan (collectively referred to as the “Prior Plans” in this Proposal
Three) that afte
f r the Record Date: (i) are not issued because such award or any portion thereof expires or otherwise terminates without
all of the shares covered by such award having been issued; (ii) are not issued because such award or any portion thereof is settled in
cash; (iii) are forfeited back to or repurchased by us because of the failure to meet a contingency or condition required for the vesting
of such shares; or (iv) are reacquired or withheld (or not issued) by us to satisfy a tax withholding obligation in connection with a full
value award granted under a Prior Plan.
The share reserve of the 2025 plan will not be reduced by any of the following shares of our common stock and such shares
will remain availabl
a e for issuance under the 2025 Plan: (i) any shares subj
u ect to an award granted under the 2025 Plan that are not
issued because such award or any portion thereof expires or otherwise terminates without all of the shares covered by such award
having been issued; and (ii) any shares subj
u ect to an award granted under the 2025 Plan that are not issued because such award or any
portion thereof is settled in cash.
The following shares of our common stock (collectively, the “2025 Plan Returning Shares”) will become availabl
a e again for
issuance under the 2025 Plan: (i) any shares issued pursuant to an award granted under the 2025 Plan that are forfeited back to or
repurchased by us because of the failure to meet a contingency or condition required for the vesting of such shares; and (ii) any shares
that are reacquired or withheld (or not issued) by us to satisfy a tax withholding obligation in connection with a full value award
granted under the 2025 Plan.
The following shares of our common stock will not revert to the share reserve of the 2025 Plan or become availabl
a e again for
issuance under the 2025 Plan: (i) any shares that are reacquired or withheld (or not issued) by us to satisfy the exercise or purchase
price of an award granted under the 2025 Plan or a Prior Plan (including any shares subj
u ect to such award that are not delivered
because such award is exercised through a reduction of shares subj
u ect to such award); (ii) any shares that are reacquired or withheld
(or not issued) by us to satisfy a tax withholding obligation in connection with an appreciation award granted under the 2025 Plan or a
Prior Plan; (iii) any shares repurchased by us on the open market with the proceeds of the exercise or purchase price of an award
granted under the 2025 Plan or a Prior Plan; and (iv) in the event that a stock appreciation right granted under the 2025 Plan or a Prior
Plan is settled in shares, the gross number of shares subj
u ect to such award.
The number of shares of our common stock availabl
a e for issuance under the 2025 Plan will be reduced by: (i) one share for
each share issued pursuant to an appreciation award granted under the 2025 Plan; and (ii) 2.43 shares for each share issued pursuant to
a full value award granted under the 2025 Plan.
The number of shares of our common stock availabl
a e for issuance under the 2025 Plan will be increased by: (i) one share for
each Prior Plans’ Returning Share or 2025 Plan Returning Share subj
u ect to an appreciation award; and (ii) 2.43 shares for each Prior
Plans’ Returning Share or 2025 Plan Returning Share subj
u ect to a full value award that returns to the 2025 Plan.
For purpos
r
es of this Proposal Three, (i) an “appreciation award” is a stock option or a stock appreciation right with respect to
which the exercise or strike price is at least 100% of the fair market value of our common stock on the date of grant and (ii) a “ful
f l
value award” is a stock award that is not an appreciation award.
Eligibility
l
Under the terms of the 2025 Plan, all of our (including our affi
f liates’) employees, non-employee directors and consultants are
eligible to participate in the 2025 Plan and may receive all types of awards other than incentive stock options. Incentive stock options
may be granted under the 2025 Plan only to our (including our affi
f liates’) employees. Generally, we do not provide equity grants to
consultants.
As of the Record Date, we (including our affi
f liates) had approximately 1,900 employees, 10 non-employee directors, and
approximately 26 consultants.
Administr
d
ation
t
The 2025 Plan will be administered by our Board of Directors, which may in turn delegate some or all of the administration of
the 2025 Plan to a committee or committees composed of members of the Board of Directors. Our Board of Directors has delegated
concurrent authority to administer the 2025 Plan to our Compensation Committee, but may, at any time, revest in itself some or all of
the power delegated to our Compensation Committee. Our Board of Directors and Compensation Committee are each considered to be
a Plan Administrator for purpos
r
es of this Proposal Three.
27
Subj
u ect to the terms of the 2025 Plan, the Plan Administrator may determine the recipients, the types of awards to be granted,
the number of shares of our common stock subj
u ect to or the cash value of awards, and the terms and conditions of awards granted
under the 2025 Plan, including the period of their exercisabi
a lity and vesting. The Plan Administrator also has the authority to provide
for accelerated exercisabi
a lity and vesting of awards. Subj
u ect to the limitations set forth below, the Plan Administrator also determines
the fair market value applicable to an award and the exercise or strike price of stock options and stock appreciation rights granted
under the 2025 Plan.
The Plan Administrator may also delegate to one or more executive offi
f cers the authority to designate employees who are not
executive offi
f cers to be recipients of certain awards and the number of shares of our common stock subj
u ect to such awards. Under any
such delegation, the Plan Administrator will specify the total number of shares of our common stock that may be subj
u ect to the awards
granted by such executive offi
f cer. The executive offi
f cer may not grant an award to himself or herself.
Repr
e
icing; Cancellatio
l
n and Re-Gra
G
nt of Stock
t
Options or Stock
t
Appr
p
eciatio
t n Righ
i
ts
Under the 2025 Plan, except in connection with a corporate transaction or a change in control or an adju
d stment for certain
changes in our capitalization, or unless our stockholders have approved such an action within 12 months prior to such an event, the
Plan Administrator does not have the authority to reprice any outstanding stock option or stock appreciation right by (1) reducing the
exercise or strike price of the stock option or stock appreciation right or (2) canceling any outstanding stock option or stock
appreciation right that has an exercise or strike price greater than the then-current fair market value of our common stock in exchange
for cash or other awards.
Dividends
d and Dividend Equivalents
The 2025 Plan provides that dividends or dividend equivalents may not be paid or credited to stock options or stock
appreciation rights. With respect to any award other than a stock option or stock appreciation right, the 2025 Plan provides that
dividends or dividend equivalents may be paid or credited with respect to any shares of our common stock subj
u ect to such award, as
determined by the Plan Administrator and specified in the applicable award agreement; provided
d
, how
d
ever, that (i) no dividends or
dividend equivalents may be paid with respect to any such shares before the date such shares have vested, (ii) any dividends or
dividend equivalents that are credited with respect to any such shares will be subj
u ect to all of the terms and conditions applicable to
such shares under the terms of the applicable award agreement (including any vesting conditions), and (iii) any dividends or dividend
equivalents that are credited with respect to any such shares will be forfeited to us on the date such shares are forfeited to or
repurchased by us due to a failure to vest.
Limit
i
on Non-Em
-
pl
m oy
l
ee Dire
i
ctor
t
Compensation
The aggregate value of all compensation granted or paid by us to any individual for service as a non-employee director with
respect to any period commencing on the date of the annual stockholders meeting for a particular year and ending on the date
immediately prior to the date of the annual stockholders meeting for the next subs
u
equent year (such period, the “annual period”),
including awards granted under the 2025 Plan and cash fees paid to such non-employee director, will not exceed $750,000 in total
value. In addition, the aggregate value of any equity award(s) granted by us to any individual for service as a non-employee director
upon or in connection with his or her initial election or appointment to the Board of Directors will not exceed $1,500,000 in total value
(such that the aggregate compensation granted or paid by us to any individual for service as a non-employee director with respect to an
annual period in which such individual is first appointed or elected to the Board of Directors will not exceed $2,250,000 in total
value). For purpos
r
es of these limitations, the value of any equity awards is calculated based on the grant date fair value of such awards
for financial reporting purposes.
Stock
t
Options
Stock options may be granted under the 2025 Plan pursuant to stock option agreements. The 2025 Plan permits the grant of
stock options that are intended to qualify
f as incentive stock options, or ISOs, and nonstatutory stock options, or NSOs.
The exercise price of a stock option granted under the 2025 Plan may not be less than 100% of the fair market value of the
common stock subj
u ect to the stock option on the date of grant and, in some cases (see “Limitations on Incentive Stock Options”
below), may not be less than 110% of such fair market value.
28
The term of stock options granted under the 2025 Plan may not exceed ten years from the date of grant and, in some cases (see
“Limitations on Incentive Stock Options” below), may not exceed five years from the date of grant. Except as otherwise provided in a
participant’s stock option agreement, other written agreement with us or one of our affi
f liates or as otherwise determined by the Plan
Administrator, if a participant’s service relationship with us or any of our affi
f liates (referred to in this Proposal Three as “continuous
service”) terminates (other than for cause (as defined in the 2025 Plan) or the participant’s death or disabi
a lity (as defined in the 2025
Plan)), the participant may exercise any vested stock options for up to three months following the participant’s termination of
continuous service. Except as otherwise provided in a participant’s stock option agreement, other written agreement with us or one of
our affi
f liates or as otherwise determined by the Plan Administrator, if a participant’s continuous service terminates due to the
participant’s disabi
a lity, the participant may exercise any vested stock options for up to 12 months following the participant’s
termination due to the participant’s disabi
a lity. Except as otherwise provided in a participant’s stock option agreement, other written
agreement with us or one of our affi
f liates or as otherwise determined by the Plan Administrator, if a participant’s continuous service
terminates due to the participant’s death (or the participant dies within a specified period following termination of continuous service),
the participant’s beneficiary
r may exercise any vested stock options for up to 18 months following the participant’s death. Except as
explicitly provided otherwise in a participant’s stock option agreement, other written agreement with us or one of our affi
f liates or as
otherwise determined by the Plan Administrator, if a participant’s continuous service is terminated for cause, all stock options held by
the participant will terminate upon the participant’s termination of continuous service and the participant will be prohibited from
exercising any stock option from and afte
f r such termination date. Except as otherwise provided in a participant’s stock option
agreement, other written agreement with us or one of our affi
f liates or as otherwise determined by the Plan Administrator, the term of a
stock option may be extended if a participant’s continuous service terminates for any reason other than for cause and, at any time
during the applicable post-termination exercise period, the exercise of the stock option would be prohibited by applicable laws or the
sale of any common stock received upon such exercise would violate our insider trading policy. In no event, however, may a stock
option be exercised afte
f r its original expiration date.
In addition, the current form of stock option agreement for employees under the 2025 Plan provides that if an employee’s
continuous service terminates due to the employee’s retirement (as defined in the employee’s stock option agreement and described
below), the employee’s stock option will become fully vested as of the date of such retirement, and the employee may exercise such
stock option for up to 12 months following such retirement. For purposes of the foregoing, “retirement” generally means a termination
of an employee’s continuous service upon or afte
f r the employee has reached age 60 with at least five years of continuous service,
provided that the employee complies with any other requirements in the Company’s then-current policy regarding retirement.
Acceptabl
a e forms of consideration for the purchase of our common stock pursuant to the exercise of a stock option under the
2025 Plan will be determined by the Plan Administrator and may include payment: (i) by cash, check, bank draftf or money order
payable to us; (ii) pursuant to a program developed under Regulation T as promulgated by the Federal Reserve Board; (iii) by delivery
r
to us of shares of our common stock (either by actua
t
l delivery or
r
attestation); (iv) by a net exercise arrangement (for NSOs only); or
(v) in other legal consideration approved by the Plan Administrator.
Stock options granted under the 2025 Plan may become exercisabl
a e in cumulative increments, or “vest,” as determined by the
Plan Administrator at the rate specified in the stock option agreement. Shares covered by different stock options granted under the
2025 Plan may be subj
u ect to different vesting schedules as the Plan Administrator may determine.
The Plan Administrator may impose limitations on the transfer
f ability of stock options granted under the 2025 Plan in its
discretion. Generally, a participant may not transfer
f
a stock option granted under the 2025 Plan other than by will or the laws of
descent and distribution. However, the Company may permit transfer
f
of a stock option in a manner that is not prohibited by applicable
tax and securities laws. The Company may, for example, permit a stock option to be transfer
f red pursuant to a domestic relations order.
In addition, subj
u ect to approval by the Company, a participant may designate a beneficiary
r who may exercise the stock option
following the participant’s death. Stock options may not be transfer
f red to a third-party financial institution for value without prior
stockholder approval.
Limitatio
i
ns on Incentiv
t e Stock
t
Options
In accordance with current federal tax laws, the aggregate fair market value, determined at the time of grant, of shares of our
common stock with respect to ISOs that are exercisabl
a e for the first time by a participant during any calendar year under all of our
stock plans may not exceed $100,000. The stock options or portions of stock options that exceed this limit or otherwise fail to qualify
f
as ISOs are treated as NSOs. No ISO may be granted to any person who, at the time of grant, owns or is deemed to own stock
possessing more than 10% of our total combined voting power unless the following conditions are satisfied:
•
the exercise price of the ISO must be at least 110% of the fair market value of the common stock subj
u ect to the ISO on the
date of grant; and
•
the term of the ISO must not exceed five years from the date of grant.
Subj
u ect to adju
d stment for certain changes in our capi
a talization, the aggregate maximum number of shares of our common stock
that may be issued pursuant to the exercise of ISOs under the 2025 Plan is 7,800,000 shares.
29
Stock
t
Appr
p
eciatio
t n Righ
i
ts
Stock appreciation rights may be granted under the 2025 Plan pursuant to stock appreciation right agreements. Each stock
appreciation right is denominated in common stock share equivalents. The strike price of each stock appreciation right will be
determined by the Plan Administrator, but will in no event be less than 100% of the fair market value of the common stock subj
u ect to
the stock appreciation right on the date of grant. The term of stock appreciation rights granted under the 2025 Plan may not exceed ten
years from the date of grant. The Plan Administrator may also impose restrictions or conditions upon the vesting of stock appreciation
rights that it deems appropriate. The appreciation distribution payable upon exercise of a stock appreciation right may be paid in
shares of our common stock, in cash, in a combination of cash and stock, or in any other form of consideration determined by the Plan
Administrator and set forth in the stock appreciation right agreement. Stock appreciation rights will be subj
u ect to the same conditions
upon termination of continuous service and restrictions on transfer
f
as stock options under the 2025 Plan.
Restricted Stock
t
Awards
Restricted stock awards may be granted under the 2025 Plan pursuant to restricted stock award agreements. A restricted stock
award may be granted in consideration for cash, check, bank draftf or money order payable to us, the participant’s services performed
for us, or any other form of legal consideration acceptabl
a e to the Plan Administrator. Shares of our common stock acquired under a
restricted stock award may be subj
u ect to forfeiture to or repurchase by us in accordance with a vesting schedule to be determined by
the Plan Administrator. Rights to acquire shares of our common stock under a restricted stock award may be transfer
f red only upon
such terms and conditions as are set forth in the restricted stock award agreement. Upon a participant’s termination of continuous
service for any reason, any shares subj
u ect to restricted stock awards held by the participant that have not vested as of such termination
date may be forfeited to or repurchased by us.
Restricted Stock
t
Unit Awards
Restricted stock unit awards may be granted under the 2025 Plan pursuant to restricted stock unit award agreements. Payment
of any purchase price may be made in any form of legal consideration acceptabl
a e to the Plan Administrator. A restricted stock unit
award may be settled by the delivery of
r
shares of our common stock, in cash, in a combination of cash and stock, or in any other form
of consideration determined by the Plan Administrator and set forth in the restricted stock unit award agreement. Restricted stock unit
awards may be subj
u ect to vesting in accordance with a vesting schedule to be determined by the Plan Administrator. Except as
otherwise provided in a participant’s restricted stock unit award agreement or other written agreement with us, restricted stock units
that have not vested will be forfeited upon the participant’s termination of continuous service for any reason.
Perfor
f
ma
r
nce Awards
The 2025 Plan allows us to grant performance awards. A performance award is an award that may vest or may be exercised, or
that may become earned and paid, contingent upon the attainment of certain performance goals during a performance period. A
performance award may require the completion of a specified period of continuous service. The length of any performance period, the
performance goals to be achieved during the performance period, and the measure of whether and to what degree such performance
goals have been attained will be determined by the Plan Administrator in its discretion. In addition, to the extent permitted by
applicable law and the applicable award agreement, the Plan Administrator may determine that cash may be used in payment of
performance awards.
Performance goals under the 2025 Plan will be based on any one or more of the following performance criteria: (1) earnings
(including earnings per share and net earnings, in either case before or afte
f r any or all of: inte
f
rest, taxes, depreciation and amortization,
legal settlements or other income (expense), or stock-based compensation, other non-cash expenses and changes in deferred revenue);
(2) total stockholder return; (3) return on
t
equity or average stockholder’s equity; (4) return on assets, investment, or capital employed;
(5) stock price; (6) margin (including gross margin); (7) income (befor
f
e or afte
f r taxes); (8) operating income; (9) operating income
afte
f r taxes; (10) pre-tax profit
f ; (11) operating cash flow; (12) sales, prescriptions, or revenue targets; (13) increases in revenue or
product revenue; (14) expenses and cost reduction goals; (15) improvement in or attainment of working capital levels; (16) economic
value added (or an equivalent metric); (17) market share; (18) cash flow; (19) cash flow per share; (20) cash burn; (21) share price
performance; (22) debt reduction; (23) implementation or completion of projects or processes (including, without limitation, discovery
of a pre-clinical drug
r
candidate, recommendation of a drug candidate to enter a clinical trial, clinical trial initiation, clinical trial
enrollment and dates, clinical trial results, regulatory filing subm
u
issions, regulatory filing acceptances, regulatory or advisory
committee interactions, regulatory approvals, presentation of studi
t
es and launch of commercial plans, compliance programs or
educ
d
ation campaigns); (24) customer satisfaction; (25) stockholders’ equity; (26) capital expenditures; (27) debt levels; (28)
financings; (29) operating profit
f
or net operating profit
f ; (30) growth of net income or operating income; (31) billings; (32) employee
hiring; (33) funds from operations; (34) budget management; (35) strategic partnerships or transactions (including acquisitions, joint
ventures or licensing transactions); (36) engagement of thought leaders and patient advocacy groups; (37) enhancement of intellectua
t
l
property portfol
f io, filing of patent applications and granting of patents; (38) litigation preparation and management; and (39) any other
measure of performance selected by the Plan Administrator.
30
Performance goals may be based on a Company-wide basis, with respect to one or more business units, divisions, affi
f liates or
business segments, and in either absolute terms or relative to the performance of one or more comparable companies or the
performance of one or more relevant indices. The Plan Administrator is authorized to make appropriate adju
d stments in the method of
calculating the attainment of perfor
f
mance goals for a performance period as follows: (1) to exclude restructur
t
ing and/or other
nonrecurring charges; (2) to exclude exchange rate effe
f cts, as applicable, for non-U.S. dollar denominated performance goals; (3) to
exclude the effe
f cts of changes to generally accepted accounting principles; (4) to exclude the effe
f cts of any statutory
t
adju
d stments to
corporate tax rates; (5) to exclude the effe
f cts of items that are “unusual” in nature or occur “infre
f quently” as determined under
generally accepted accounting principles; (6) to exclude the dilutive effe
f cts of acquisitions or joint ventures; (7) to assume that any
business divested by us achieved performance objectives at targeted levels during the balance of a performance period following such
divestiture; (8) to exclude the effe
f ct of any change in the outstanding shares of our common stock by reason of any stock dividend or
split, stock repurchase, reorganization, recapitalization, merger, consolidation, spin-off, combination or exchange of shares or other
similar corporate change, or any distributions to common stockholders other than regular cash dividends; (9) to exclude the effe
f cts of
stock based compensation and the award of bonuses under our bonus plans; (10) to exclude costs incurred in connection with potential
acquisitions or divestitures that are required to be expensed under generally accepted accounting principles; (11) to exclude the
goodwill and intangible asset impairment charges that are required to be recorded under generally accepted accounting principles; (12)
to exclude the effe
f cts of the timing of acceptance for review and/or approval of subm
u
issions to the U.S. Food and Drug
r
Administration
or any other regulatory body; and (13) to make other appropriate adju
d stments selected by the Plan Administrator.
In addition, the Plan Administrator retains the discretion to define the manner of calculating the performance criteria it selects
to use for a performance period and to reduce or eliminate the compensation or economic benefit due upon the attainment of any
performance goal.
Othe
t
r Awards
Other forms of awards valued in whole or in part by reference to, or otherwise based on, our common stock, including the
appreciation in value thereof, may be granted either alone or in addition to other awards under the 2025 Plan. Subj
u ect to the terms of
the 2025 Plan, the Plan Administrator will have sole and complete authority to determine the persons to whom and the time or times at
which such other awards will be granted, the number of shares of our common stock to be granted and all other terms and conditions
of such other awards.
Clawback
l
Policy
Awards granted under the 2025 Plan will be subj
u ect to recoupment in accordance with the Neurocrine Biosciences, Inc.
Incentive Compensation Recoupment Policy and any other clawback policy that the Company adopts. In addition, the Board may
impose other clawback, recovery or recoupment provisions in an award agreement, including a reacquisition right in respect of
previously acquired shares or other cash or property upon the occurrence of cause.
Changes to Capi
a tal
i
Stru
t
cture
In the event of certain capitalization adju
d stments, the Plan Administrator will appropriately and proportionately adju
d st: (i) the
class(es) and maximum number of shares of our common stock subj
u ect to the 2025 Plan; (ii) the class(es) and maximum number of
shares of our common stock that may be issued pursuant to the exercise of ISOs; and (iii) the class(es) and number of shares of our
common stock and the exercise, strike or purchase price per share of our common stock subj
u ect to outstanding awards.
Corporatet Transactio
t n and Change in Control
t
The following applies to each outstanding award under the 2025 Plan in the event of a corporate transaction (as defined in the
2025 Plan and described below) or a change in control (as defined in the 2025 Plan and described below), unless provided otherwise in
the applicable award agreement, in any other written agreement between a participant and the Company or an affi
f liate, or in any
director compensation policy of the Company. For purpos
r
es of this Proposal Three, the term “Transaction” will mean such corporate
transaction or change in control.
In the event of a Transaction, any awards outstanding under the 2025 Plan may be assumed, continued or subs
u
titut
t ed for by
any surviving or acquiring corporation (or its parent company) (such entity, the “acquiring entity”), and any reacquisition or
repurchase rights held by us with respect to the award may be assigned to the acquiring entity. If the acquiring entity does not assume,
continue or subs
u
titute for such awards, then (i) with respect to any such awards that are held by participants whose continuous service
has not terminated prior to the effe
f ctive time of the Transaction (such participants, the “current participants”), the vesting (and
exercisabi
a lity, if applicable) of such awards will be accelerated in full (and with respect to any such awards that are subj
u ect to
performance-based vesting conditions or requirements, vesting will be deemed to be satisfied at the greater of (x) the target level of
performance or (y) the actua
t
l level of performance measured in accordance with the applicable performance goals as of the date of the
Transaction) to a date prior to the effe
f ctive time of the Transaction (contingent upon the effe
f ctiveness of the Transaction), and such
awards will terminate if not exercised (if applicable) at or prior to the effe
f ctive time of the Transaction, and any reacquisition or
repurchase rights held by us with respect to such awards will laps
a
e (contingent upon the effe
f ctiveness of the Transaction), and (ii) any
such awards that are held by participants other than current participants will terminate if not exercised (if applicable) at or prior to the
effective time of the Transaction, except that any reacquisition or repurchase rights held by us with respect to such awards will not
terminate and may continue to be exercised notwithstanding the Transaction.
31
Notwithstanding the foregoing, in the event any outstanding award under the 2025 Plan held by a participant will terminate if
not exercised at or prior to the effe
f ctive time of a Transaction, the Plan Administrator may provide that the participant may not
exercise such award but instead will receive a payment equal in value to the excess, if any, of (i) the value of the property the
participant would have received upon the exercise of such award, over (ii) any exercise price payable by the participant in connection
with such exercise.
Except as otherwise provided in the applicable award agreement, in any other written agreement between a participant and the
Company or an affi
f liate, in any severance plan of the Company governing the participant’s awards under the 2025 Plan, or in any
director compensation policy of the Company, in the event that an employee or director’s continuous service is involuntarily
terminated without cause (including any such termination due to such employee or director’s death or disabi
a lity) upon or within 12
months following the effe
f ctive time of a Transaction, the vesting (and exercisabi
a lity, if applicable) of any assumed awards (as defined
in the 2025 Plan and described below) held by such employee or director as of the date of such termination will be accelerated in full
(and with respect to any such awards that are subj
u ect to performance-based vesting conditions or requirements, vesting will be deemed
to be satisfied at the greater of (x) the target level of performance or (y) the actua
t
l level of performance measured in accordance with
the applicable performance goals as of the date of such termination), effe
f ctive as of the date of such termination. For purposes of the
foregoing, an “assumed award” generally means any outstanding award under the 2025 Plan that was assumed or continued, or any
outstanding similar award that was granted in subs
u
titution for an award under the 2025 Plan, in each case by the acquiring entity in
connection with the appl
a
icable Transaction.
Under the 2025 Plan, a “corporate transaction” generally means the consummation of any one or more of the following events:
(1) a sale or other disposition of all or subs
u
tantially all of our assets; (2) a sale or other disposition of more than 50% of our
outstanding securities; (3) a merger, consolidation or similar transaction where we do not survive the transaction; or (4) a merger,
consolidation or similar transaction where we do survive the transaction but the shares of our common stock outstanding immediately
before such transaction are converted or exchanged into other property by virtue of
t
the transaction.
Under the 2025 Plan, a “change in control” generally means the occurrence of any one or more of the following events: (1) the
acquisition by any person, entity or group of our securities representing more than 50% of the combined voting power of our then
outstanding securities, other than by virtue of
t
a merger, consolidation, or similar transaction; (2) a merger, consolidation or similar
transaction in which our stockholders immediately before such transaction do not own, directly or indirectly, more than 50% of the
combined voting power of the surviving entity (or the parent of the surviving entity) in subs
u
tantially the same proportions as their
ownership immediately prior to such transaction; (3) our stockholders approve a plan of our complete dissolution or liquidation, or our
complete dissolution or liquidation otherwise occurs; (4) a sale, lease, exclusive license or other disposition of all or subs
u
tantially all of
our assets, other than to an entity, more than 50% of the combined voting power of which is owned by our stockholders in
subs
u
tantially the same proportions as their ownership of our outstanding voting securities immediately prior to such transaction; or (5)
when a majority of our Board of Directors becomes comprised of individuals who were not serving on our Board of Directors on the
date the 2025 Plan was adopted by our Compensation Committee (the “incumbent Board of Directors”), or whose nomination,
appointment, or election was not approved by a majority of the incumbent Board of Directors still in offi
f ce.
Plan
l
Amendments and Termination
t
The Plan Administrator will have the authority to amend or terminate the 2025 Plan at any time. However, except as otherwise
provided in the 2025 Plan, no amendment or termination of the 2025 Plan may materially impair a participant’s rights under his or her
outstanding awards without the participant’s consent.
We will obtain stockholder approval of any amendment to the 2025 Plan as required by applicable law and listing
requirements. No incentive stock options may be granted under the 2025 Plan afte
f r March 13, 2035, which is the day before the tenth
anniversary of
r
the date the 2025 Plan was adopted by our Compensation Committee.
U.S. Federal Income Tax Consequences
The following is a summary of
r
the principal United States federal income tax consequences to participants and us with respect
to participation in the 2025 Plan. This summary is not intended to be exhaustive and does not discuss the income tax laws of any local,
state or foreign jurisdiction in which a participant may reside. The information is based upon current federal income tax rules and
therefor
f
e is subj
u ect to change when those rules change. Because the tax consequences to any participant may depend on his or her
particular situation, each participant should consult the participant’s tax adviser regarding the federal, state, local and other tax
consequences of the grant or exercise of an award or the disposition of stock acquired under the 2025 Plan. The 2025 Plan is not
qualified under the provisions of Section 401(a) of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”),
and is not subj
u ect to any of the provisions of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”). Our
ability to realize the benefit of any tax deductions described below depends on our generation of taxable income as well as the
requirement of reasonableness and the satisfaction of our tax reporting obligations.
Nonstatutory Stock
t
Options
Generally, there is no taxation upon the grant of an NSO if the stock option is granted with an exercise price equal to the fair
market value of the underlying stock on the grant date. Upon exercise, a participant will recognize ordinary income equal to the
excess, if any, of the fair market value of the underlying stock on the date of exercise of the stock option over the exercise price. If the
participant is employed by us or one of our affi
f liates, that income will be subj
u ect to withholding taxes. The participant’s tax basis in
32
those shares will be equal to his or her fair market value on the date of exercise of the stock option, and the participant’s capital gain
holding period for those shares will begin on that date.
Subj
u ect to the requirement of reasonableness, the provisions of Section 162(m) of the Internal Revenue Code, and the
satisfaction of a tax reporting obligation, we will generally be entitled to a tax deduction equal to the taxable ordinary income realized
by the participant.
Incentive Stock
t
Options
The 2025 Plan provides for the grant of stock options that are intended to qualify
f as “incentive stock options,” as defined in
Section 422 of the Internal Revenue Code. Under the Internal Revenue Code, a participant generally is not subj
u ect to ordinary income
tax upon the grant or exercise of an ISO. If the participant holds a share received upon exercise of an ISO for more than two years
from the date the stock option was granted and more than one year from the date the stock option was exercised, which is referred to
as the required holding period, the difference, if any, between the amount realized on a sale or other taxable disposition of that share
and the participant’s tax basis in that share will be long-term capi
a tal gain or loss.
If, however, a participant disposes of a share acquired upon exercise of an ISO before the end of the required holding period,
which is referred to as a disqualifying di
f
sposition, the participant generally will recognize ordinary income in the year of the
disqualifying di
f
sposition equal to the excess, if any, of the fair market value of the share on the date of exercise of the stock option
over the exercise price. However, if the sales proceeds are less than the fair market value of the share on the date of exercise of the
stock option, the amount of ordinary
r income recognized by the participant will not exceed the gain, if any, realized on the sale. If the
amount realized on a disqualifying disposition exceeds the fair market value of the share on the date of exercise of the stock option,
that excess will be short-term or long-term capital gain, depending on whether the holding period for the share exceeds one year.
For purpos
r
es of the alternative minimum tax, the amount by which the fair market value of a share of stock acquired upon
exercise of an ISO exceeds the exercise price of the stock option generally will be an adju
d stment included in the participant’s
alternative minimum taxable income for the year in which the stock option is exercised. If, however, there is a disqualifying
f
disposition of the share in the year in which the stock option is exercised, there will be no adju
d stment for alternative minimum tax
purpos
r
es with respect to that share. In computing alternative minimum taxable income, the tax basis of a share acquired upon exercise
of an ISO is increased by the amount of the adju
d stment taken into account with respect to that share for alternative minimum tax
purpos
r
es in the year the stock option is exercised.
We are not allowed a tax deduction with respect to the grant or exercise of an ISO or the disposition of a share acquired upon
exercise of an ISO afte
f r the required holding period. If there is a disqualifying di
f
sposition of a share, however, we will generally be
entitled to a tax deduction equal to the taxable ordinary income realized by the participant, subj
u ect to the requirement of
reasonableness, the provisions of Section 162(m) of the Internal Revenue Code, and provided that either the employee includes that
amount in income or we timely satisfy our reporting requirements with respect to that amount.
Restricted Stock
t
Awards
Generally, the recipient of a restricted stock award will recognize ordinary income at the time the stock is received equal to the
excess, if any, of the fair market value of the stock received over any amount paid by the recipient in exchange for the stock. If,f
however, the stock is not vested when it is received (for example, if the employee is required to work for a period of time in order to
have the right to sell the stock), the recipient generally will not recognize income until the stock becomes vested, at which time the
recipient will recognize ordinary income equal to the excess, if any, of the fair market value of the stock on the date it becomes vested
over any amount paid by the recipient in exchange for the stock. A recipient may, however, file an election with the Internal Revenue
Service, within 30 days following his or her receipt of the restricted stock award, to recognize ordinary income, as of the date the
recipient receives the restricted stock award, equal to the excess, if any, of the fair market value of the stock on the date the restricted
stock award is granted over any amount paid by the recipient for the stock.
The recipient’s basis for the determination of gain or loss upon the subs
u
equent disposition of shares acquired from a restricted
stock award will be the amount paid for such shares plus any ordinary income recognized either when the stock is received or when
the stock becomes vested.
Subj
u ect to the requirement of reasonableness, the provisions of Section 162(m) of the Internal Revenue Code, and the
satisfaction of a tax reporting obligation, we will generally be entitled to a tax deduction equal to the taxable ordinary income realized
by the recipient of the restricted stock award.
33
Restricted Stock
t
Unit Awards
Generally, the recipient of a restricted stock unit award structur
t
ed to comply with the requirements of Section 409A of the
Internal Revenue Code or an exception to Section 409A of the Internal Revenue Code will recognize ordinary income at the time the
stock is delivered equal to the excess, if any, of the fair market value of the stock received over any amount paid by the recipient in
exchange for the stock. To comply with the requirements of Section 409A of the Internal Revenue Code, the stock subj
u ect to a
restricted stock unit award may generally only be delivered upon one of the following events: a fixed calendar date (or dates),
separation from service, death, disabi
a lity or a change in control. If delivery oc
r
curs on another date, unless the restricted stock unit
award otherwise complies with or qualifies for an exception to the requirements of Section 409A of the Internal Revenue Code
(including delivery upon
r
achievement of a performance goal), in addition to the tax treatment described above, the recipient will owe
an additional 20% federal tax and interest on any taxes owed.
The recipient’s basis for the determination of gain or loss upon the subs
u
equent disposition of shares acquired from a restricted
stock unit award will be the amount paid for such shares plus any ordinary income recognized when the stock is delivered.
Subj
u ect to the requirement of reasonableness, the provisions of Section 162(m) of the Internal Revenue Code, and the
satisfaction of a tax reporting obligation, we will generally be entitled to a tax deduction equal to the taxable ordinary income realized
by the recipient of the restricted stock unit award.
Stock
t
Appr
p
eciatio
t n Righ
i
ts
Generally, if a stock appreciation right is granted with an exercise price equal to the fair market value of the underlying stock
on the grant date, the recipient will recognize ordinary income equal to the fair market value of the stock or cash received upon such
exercise.
Subj
u ect to the requirement of reasonableness, the provisions of Section 162(m) of the Internal Revenue Code, and the
satisfaction of a tax reporting obligation, we will generally be entitled to a tax deduction equal to the taxable ordinary income realized
by the recipient of the stock appreciation right.
Sectio
t n 162(m)
(
Limitatio
i
ns
Under Section 162(m) of the Internal Revenue Code, compensation paid to any publicly held corporation’s “covered
employees” that exceeds $1 million per taxable year for any covered employee is generally non-deductible. Awards granted under the
2025 Plan will be subj
u ect to the deduction limit under Section 162(m) of the Internal Revenue Code and will not be eligible to qualify
f
for the performance-based compensation exception under Section 162(m) of the Internal Revenue Code pursuant to the transition
relief provided by the Tax Cuts and Jobs Act. For further information regarding the deduction limit under Section 162(m) of the
Internal Revenue Code and such transition relief, please see the section entitled “Compensation Discussion and Analysis—Tax and
Accounting Considerations—Internal Revenue Code Section 162(m).”
34
New Plan Benefit
f s under the 2025 Plan
The fol
f lowing tabl
a e sets for
f
th certain infor
f
mation regarding future benefits under the 2025 Plan.
Name
Position
Number of
Shares
Kyle W. Gano, Ph.D.
Chief Executive Offic
f er
(1)
Kevin C. Gorman, Ph.D.
Former Chief Executive
Offi
f cer
(1)
Matthew C. Abernethy
Chief Financial Offic
f er
(1)
Eric Benevich
Chief Commercial Offic
f er
(1)
Jude Onyia, Ph.D.
Chief Scientific Offi
f cer
(1)
Eiry W. Roberts, M.D.
Chief Medical Offi
f cer
(1)
All current executive officers as a group
(1)
All current directors who are not executive officers as a group
(2)
All current employees, including current offi
f cers who are not executive officers, as a group
(1)
(1)
Awards granted under the 2025 Plan to our executive officers and other employees are discretionary and are not subj
u ect to set benefits
f
or amounts under the
terms of the 2025 Plan, and the Board of Directors and the Compensation Committee have not granted any awards under the 2025 Plan that are subject to
stockholder appr
a
oval of this Proposal Three. Accordingly, the benefits
f
or amounts that will be received by or allocated to our executive officers and other
employees under the 2025 Plan are not determinable.
(2)
Awards granted under the 2025 Plan to our non-employee directors are discretionary and are not subj
u ect to set benefits
f
or amounts under the terms of the 2025
Plan, and the Board of Directors and the Compensation Committee have not granted any awards under the 2025 Plan that are subject to stockholder appr
a
oval
of this Proposal Three. However, pursuant to our current equity compensation program for non-employee directors, each of our current non-employee
directors are granted annual awards in the form of a stock option, a restricted stock unit award, or a stock option and a restricted stock unit award, depending
on each individual’s election, on the date of each of our annual meetings of stockholders, provided that such individual is a non-employee director on such
date and will be continuing as a non-employee director following such date. The total dollar value of each non-employee director’s annual awards in 2025 will
be $400,000. The number of shares of our common stock subj
u ect to each such award will be based on the valuation methodology establ
a ished by the Board,
which is in part based on the fai
f r market value of our common stock on the grant date and, therefor
f
e, is not determinable at this time. On and afte
f r the date of
the Annual Meeting, any such awards will be granted under the 2025 Plan if this Proposal Three is appr
a
oved by our stockholders.
Registration with the SEC
If this Proposal Three is appr
a
oved by our stockholders, we will fil
f e a Registration Statement on Form S-8 with the SEC with
respect to the shares of our common stock to be registered pursuant to the 2025 Plan, as soon as reasonably practicable following
stockholder appr
a
oval.
Vote Required
At the Annual Meeting, the stockholders are being asked to approve
a
the Company’s 2025 Equity Incentive Plan. The
affirm
f
ative vote of the holders of a majority of the shares represented in person or by proxy at the Annual Meeting and entitled to vote
on the item will be required to appr
a
ove the Company’s 2025 Equity Incentive Plan. The Board of Directors unanimously
recommends voting “FOR” the approval of the Company’s 2025 Equity Incentive Plan.
35
PROPOSAL FOUR: APPROVAL OF AN AMENDMENT AND
RESTATEMENT OF THE 2018 EMPLOYEE STOCK PURCHASE PLAN
We are asking our stockholders to approve an amendment and restatement of the Neurocrine Biosciences, Inc. 2018 Employee
Stock Purchase Plan (the “ESPP”) at the Annual Meeting. We refer to such amendment and restatement of the ESPP in this proxy
statement as the “Amended ESPP”.
The Amended ESPP contains the following material change from the ESPP:
•
The aggregate number of shares of our common stock that may be issued under the ESPP has been increased by 800,000
shares under the Amended ESPP, subj
u ect to adju
d stment for certain changes in our capitalization.
Approval of the Amended ESPP will allow us to continue to provide our employees with the opportunity to acquire an
ownership interest in the Company through their participation in the Amended ESPP, thereby encouraging them to remain in our
service and more closely aligning their interests with those of our stockholders.
If this Proposal Four is approved by our stockholders, then subj
u ect to adju
d stment for certain changes in our capitalization, an
additional 800,000 shares of our common stock will be availabl
a e for issuance under the Amended ESPP. As of the Record Date, a total
of 278,066 shares of our common stock remained availabl
a e for issuance under the ESPP. We do not maintain any other employee
stock purchase plans. As of the Record Date, a total of 98,938,234 shares of our common stock were outstanding.
If this Proposal Four is approved by our stockholders, the Amended ESPP will become effe
f ctive as of the date of the Annual
Meeting. In the event that our stockholders do not approve this Proposal Four, the Amended ESPP will not become effe
f ctive and the
ESPP will continue in its current form.
Summary of the Amended ESPP
The material featur
t
es of the Amended ESPP are described below. The following description of the Amended ESPP is a
summary only and is qualified in its entirety by reference to the complete text of the Amended ESPP. Stockholders are urged to read
the actua
t
l text of the Amended ESPP in its entirety, which is attached hereto as Appendix B.
Purpose
The purpos
r
e of the Amended ESPP is to provide a means by which our employees may be given an opportunity to purchase
shares of our common stock, to assist us in retaining the services of our employees, to secure and retain the services of new employees
and to provide incentives for such persons to exert maximum effort
f
s for our success. The rights to purchase common stock granted
under the Amended ESPP are intended to qualify
f as options issued under an “employee stock purchase plan” as that term is defined in
Section 423(b) of the Internal Revenue Code.
Admi
d
nistra
i
tion
The Board of Directors has the power to administer the Amended ESPP and may also delegate administration of the Amended
ESPP to a committee comprised of one or more members of the Board of Directors. The Board of Directors has delegated
administration of the Amended ESPP to the Compensation Committee, but may, at any time, revest in itself some or all of the powers
previously delegated to the Compensation Committee. The Board of Directors and the Compensation Committee are each considered
to be a Plan Administrator for purposes of this Proposal Four. The Plan Administrator has the final power to construe
r
and interpret
both the Amended ESPP and the rights granted under it. The Plan Administrator has the power, subj
u ect to the provisions of the
Amended ESPP, to determine when and how rights to purchase our common stock will be granted, the provisions of each offeri
f
ng of
such rights (which need not be identical), and whether employees of any of our parent or subs
u
idiary companies will be eligible to
participate in the Amended ESPP.
Stock Subject to Amended ESPP
Subj
u ect to adju
d stment for certain changes in our capi
a talization, the maximum number of shares of our common stock that may
be issued under the Amended ESPP is 1,700,000 shares, which is equal to the sum of (i) 300,000 shares that were approved at our
2018 annual meeting of stockholders, (ii) 600,000 shares that were approved at our 2022 annual meeting of stockholders, and (iii) an
additional 800,000 shares that are subj
u ect to approval by our stockholders under this Proposal Four. If any rights granted under the
Amended ESPP terminate without being exercised in full, the shares of common stock not purchased under such rights again become
availabl
a e for issuance under the Amended ESPP. The shares of common stock issuable under the Amended ESPP will be shares of
authorized but unissued or reacquired common stock, including shares repurchased by us on the open market.
36
Offe
f rings
The Amended ESPP will be implemented by offeri
f
ngs of rights to purchase our common stock to all eligible employees. The
Plan Administrator will determine the duration of each offeri
f
ng period, provided that in no event may an offeri
f
ng period exceed 27
months. The Plan Administrator may establ
a ish separate offeri
f
ngs which vary in terms (although not inconsistent with the provisions of
the Amended ESPP or the requirements of applicable laws). Each offeri
f
ng period will have one or more purchase dates, as determined
by the Plan Administrator prior to the commencement of the offeri
f
ng period. The Plan Administrator has the authority to alter the
terms of an offeri
f
ng prior to the commencement of the offeri
f
ng period, including the duration of subs
u
equent offeri
f
ng periods. When an
eligible employee elects to join an offeri
f
ng period, he or she is granted a right to purchase shares of our common stock on each
purchase date within the offeri
f
ng period. On the purchase date, all contributions collected from the participant are automatically
applied to the purchase of our common stock, subj
u ect to certain limitations (which are described further below under “Eligibility”).
The Plan Administrator has the discretion to structur
t
e an offeri
f
ng so that if the fair market value of our common stock on the first
trading day of a new purchase period within the offeri
f
ng period is less than or equal to the fair market value of our common stock on
the first day of the offeri
f
ng period, then that offeri
f
ng will terminate immediately as of that first trading day, and the participants in
such terminated offeri
f
ng will be automatically enrolled in a new offeri
f
ng beginning on the first trading day of such new purchase
period.
Eligibility
Any individual who is employed by us (or by any of our parent or subs
u
idiary companies if such company is designated by the
Plan Administrator as eligible to participate in the Amended ESPP) may participate in offeri
f
ngs under the Amended ESPP, provided
such individual has been employed by us (or our parent or subs
u
idiary, if applicable) for such continuous period preceding the first day
of the offeri
f
ng period as the Plan Administrator may require, but in no event may the required period of continuous employment be
equal to or greater than two years. In addition, the Plan Administrator may provide that an employee will not be eligible to be granted
purchase rights under the Amended ESPP unless such employee is customarily employed for more than 20 hours per week and five
months per calendar year. The Plan Administrator may also provide in any offeri
f
ng that certain of our employees who are “highly
compensated” as defined in the Internal Revenue Code are not eligible to participate in the Amended ESPP.
No employee will be eligible to participate in the Amended ESPP if,f immediately afte
f r the grant of purchase rights, the
employee would own, directly or indirectly, stock possessing 5% or more of the total combined voting power or value of all classes of
our stock or of any of our parent or subs
u
idiary companies, including any stock which such employee may purchase under all
outstanding purchase rights and options. In addition, no employee may purchase more than $25,000 worth of our common stock
(determined based on the fair market value of the shares at the time such rights are granted) under all our employee stock purchase
plans and any employee stock purchase plans of our parent or subs
u
idiary companies for each calendar year during which such rights
are outstanding.
As of the Record Date, we had approximately 1,900 employees.
Participation in the Amended ESPP
S
An eligible employee may enroll in the Amended ESPP by delivering to us, prior to the date selected by the Plan
Administrator as the beginning of an offeri
f
ng period, an agreement authorizing contributions which may not exceed the maximum
amount specified by the Plan Administrator, but in any case which may not exceed 15% of such employee’s earnings during the
offeri
f
ng period. Each participant will be granted a separate purchase right for each offeri
f
ng in which he or she participates. Unless an
employee’s participation is discontinued, his or her purchase right will be exercised automatically at the end of each purchase period at
the applicable purchase price.
Purchase Price
The purchase price per share at which shares of our common stock are sold on each purchase date during an offeri
f
ng period
will not be less than the lower of (i) 85% of the fair market value of a share of our common stock on the first day of the offeri
f
ng period
or (ii) 85% of the fair market value of a share of our common stock on the purchase date.
As of the Record Date, the closing price of our common stock as reported on the Nasdaq Global Select Market was $115.60
per share.
Paymen
a
t of Purchase Price; Payr
a
oll Deductions
The purchase of shares during an offeri
f
ng period generally will be funded by a participant’s payroll deductions accumulated
during the offeri
f
ng period. A participant may change his or her rate of contributions, as determined by the Plan Administrator in the
offeri
f
ng. All contributions made for a participant are credited to his or her account under the Amended ESPP and deposited with our
general funds.
37
Purchase Limits
In connection with each offeri
f
ng made under the Amended ESPP, the Plan Administrator may specify (i) a maximum number
of shares of our common stock that may be purchased by any participant pursuant to such offeri
f
ng, (ii) a maximum number of shares
of our common stock that may be purchased by any participant on any purchase date pursuant to such offeri
f
ng, (iii) a maximum
aggregate number of shares of our common stock that may be purchased by all participants pursuant to such offeri
f
ng, and/or (iv) a
maximum aggregate number of shares of our common stock that may be purchased by all participants on any purchase date pursuant
to such offeri
f
ng. If the aggregate purchase of shares of our common stock issuable upon exercise of purchase rights granted under
such offeri
f
ng would exceed any such maximum aggregate number, then the Plan Administrator will make a pro rata allocation of
availabl
a e shares in a uniform and equitabl
a e manner.
Withdrawal
Participants may withdraw from a given offeri
f
ng by delivering a withdrawal form to us and terminating their contributions.
Such withdrawal may be elected at any time prior to the end of an offeri
f
ng, except as otherwise provided by the Plan Administrator.
Upon such withdrawal, we will distribute to the employee his or her accumulated but unused contributions without interest, and such
employee’s right to participate in that offeri
f
ng will terminate. However, an employee’s withdrawal from an offeri
f
ng does not affe
f ct
such employee’s eligibility to participate in subs
u
equent offeri
f
ngs under the Amended ESPP.
Termination of Employ
m
ment
A participant’s rights under any offeri
f
ng under the Amended ESPP will terminate immediately if the participant either (i) is no
longer employed by us or any of our parent or subs
u
idiary companies (subject to any post-employment participation period required by
law) or (ii) is otherwise no longer eligible to participate. In such event, we will distribute to the participant his or her accumulated but
unused contributions without interest.
Restrictions on Transfer
s
Rights granted under the Amended ESPP are not transfer
f able except by will, by the laws of descent and distribution, or if
permitted by us, by a beneficiary de
r
signation. During a participant’s lifet
f ime, such rights may only be exercised by the participant.
Changes in Capi
a talization
In the event of certain changes in our capi
a talization, the Plan Administrator will appropriately adju
d st: (i) the class(es) and
maximum number of securities subj
u ect to the Amended ESPP; (ii) the class(es) and number of securities subj
u ect to, and the purchase
price applicable to outstanding purchase rights; and (iii) the class(es) and number of securities that are the subj
u ect of any purchase
limits under each ongoing offeri
f
ng.
Effe
f ct of Certain Corporate Transactions
In the event of a corporate transaction (as defined in the Amended ESPP and described below), (i) any surviving or acquiring
corporation (or its parent company) may assume or continue outstanding purchase rights granted under the Amended ESPP or may
subs
u
titute similar rights (including a right to acquire the same consideration paid to the stockholders in the corporate transaction) for
such outstanding purchase rights, or (ii) if any surviving or acquiring corporation (or its parent company) does not assume or continue
such outstanding purchase rights or does not subs
u
titute similar rights for such outstanding purchase rights, then the participants’
accumulated contributions will be used to purchase shares of our common stock within ten business days prior to the corporate
transaction under such purchase rights, and such purchase rights will terminate immediately afte
f r such purchase.
For purpos
r
es of the Amended ESPP, a corporate transaction generally will be deemed to occur in the event of the
consummation of:f (i) a sale or other disposition of all or subs
u
tantially all of our consolidated assets; (ii) a sale or other disposition of at
least 90% of our outstanding securities; (iii) a merger, consolidation or similar transaction following which we are not the surviving
corporation; or (iv) a merger, consolidation or similar transaction following which we are the surviving corporation but the shares of
our common stock outstanding immediately prior to such transaction are converted or exchanged into other property by virtue of
t
such
transaction.
Duration, Amendment and Termination
The Plan Administrator may amend or terminate the Amended ESPP at any time. However, except in regard to certain
capitalization adju
d stments, any such amendment must be approved by our stockholders if such approval is required by applicable law
or listing requirements.
Any outstanding purchase rights granted before an amendment or termination of the Amended ESPP will not be materially
impaired by any such amendment or termination, except (i) with the consent of the employee to whom such purchase rights were
granted, (ii) as necessary to comply with applicable laws, listing requirements or governmental regulations (including Section 423 of
the Internal Revenue Code), or (iii) as necessary to obtain or maintain favorable tax, listing or regulatory treatment.
38
Notwithstanding anything in the Amended ESPP or any offeri
f
ng to the contrary, the Plan Administrator will be entitled to: (i)
establ
a ish the exchange ratio applicable to amounts withheld in a currency other than U.S. dollars; (ii) permit contributions in excess of
the amount designated by a participant in order to adju
d st for mistakes in the processing of properly completed contribution elections;
(iii) establ
a ish reasonable waiting and adju
d stment periods and/or accounting and crediting procedur
d
es to ensure that amounts applied
toward the purchase of our common stock for each participant properly correspond with amounts withheld from the participant’s
contributions; (iv) amend any outstanding purchase rights or clarify
f any ambiguities regarding the terms of any offeri
f
ng to enable such
purchase rights to qualify under and/or comply with Section 423 of the Internal Revenue Code; and (v) establ
a ish other limitations or
procedur
d
es as the Plan Administrator determines in its sole discretion advisabl
a e that are consistent with the Amended ESPP. Any such
actions by the Plan Administrator will not be considered to alter or impair any purchase rights granted under an offeri
f
ng as they are
part of the initial terms of each offeri
f
ng and the purchase rights granted under each offeri
f
ng.
Federal Income Tax Information
The following is a summary of
r
the principal United States federal income taxation consequences to participants and us with
respect to participation in the Amended ESPP. This summary
r is not intended to be exhaustive and does not discuss the income tax
laws of any local, state or foreign jurisdiction in which a participant may reside. The information is based upon current federal income
tax rules and therefor
f
e is subj
u ect to change when those rules change. Because the tax consequences to any participant may depend on
his or her particular situation, each participant should consult the participant’s tax adviser regarding the federal, state, local, and other
tax consequences of the grant or exercise of a purchase right or the sale or other disposition of common stock acquired under the
Amended ESPP. The Amended ESPP is not qualified under the provisions of Section 401(a) of the Internal Revenue Code and is not
subj
u ect to any of the provisions of ERISA.
Rights granted under the Amended ESPP are intended to qualify for favorable federal income tax treatment associated with
rights granted under an employee stock purchase plan which qualifies under the provisions of Section 423 of the Internal Revenue
Code.
A participant will be taxed on amounts withheld for the purchase of shares of our common stock as if such amounts were
actua
t
lly received. Otherwise, no income will be taxable to a participant as a result of the granting or exercise of a purchase right until a
sale or other disposition of the acquired shares. The taxation upon such sale or other disposition will depend upon the holding period
of the acquired shares.
If the shares are sold or otherwise disposed of more than two years afte
f r the beginning of the offeri
f
ng period and more than
one year afte
f r the shares are transfer
f red to the participant, then the lesser of the following will be treated as ordinary income: (i) the
excess of the fair market value of the shares at the time of such sale or other disposition over the purchase price; or (ii) the excess of
the fair market value of the shares as of the beginning of the offeri
f
ng period over the purchase price (determined as of the beginning of
the offeri
f
ng period). Any further gain or any loss will be taxed as a long-term capital gain or loss.
If the shares are sold or otherwise disposed of before the expiration of either of the holding periods described above, then the
excess of the fair market value of the shares on the purchase date over the purchase price will be treated as ordinary income at the time
of such sale or other disposition. The balance of any gain will be treated as capital gain. Even if the shares are later sold or otherwise
disposed of for less than its fair market value on the purchase date, the same amount of ordinary income is attributed to the participant,
and a capital loss is recognized equal to the difference between the sales price and the fair market value of the shares on such purchase
date. Any capital gain or loss will be short-term or long-term, depending on how long the shares have been held.
There are no federal income tax consequences to us by reason of the grant or exercise of rights under the Amended ESPP. We
are entitled to a deduction to the extent amounts are taxed as ordinary income to a participant for shares sold or otherwise disposed of
before the expiration of the holding periods described above (subje
b ct to the requirement of reasonableness and the satisfact
f
ion of tax
reporting obligations).
New Plan Benefits under Amended ESPP
Participation in the Amended ESPP is voluntary
r and each eligible employee will make his or her own decision regarding
whether and to what extent to participate in the Amended ESPP. In addition, the Board of Directors and the Compensation Committee
have not granted any purchase rights under the Amended ESPP that are subj
u ect to stockholder approval of this Proposal Four.
Accordingly, the benefits or amounts that will be received by or allocated to our executive offi
f cers and other employees under the
Amended ESPP are not determinable. Our non-employee directors will not be eligible to participate in the Amended ESPP.
39
Plan Benefits under ESPP
The fol
f lowing tabl
a e sets for
f
th, for
f
each of the individuals and various groups indicated, the total number of shares of our
common stock that have been purchased under the ESPP as of the Record Date.
Name
Position
Number of
Shares
Kyle W. Gano, Ph.D.
Chief Executive Offi
f cer
1,850
Kevin C. Gorman, Ph.D.
Former Chief Executive Offic
f er
—
Matthew C. Abernethy
Chief Financial Offic
f er
701
Eric Benevich
Chief Commercial Officer
1,806
Jude Onyia, Ph.D.
Chief Scientific
f
Offi
f cer
934
Eiry W. Roberts, M.D.
Chief Medical Offi
f cer
1,185
All current executive officers as a group
9,832
All current directors who are not executive officers as a group
—
Each nominee for election as a director:
Kyle W. Gano, Ph.D.
1,850
Richard F. Pops
—
Shalini Sharp
—
Stephen A. Sherwin, M.D.
—
Each associate of any executive officers, current directors or director nominees
—
Each other person who received or is to receive 5% of purchase rights
—
All current employees, including all current offi
f cers who are not executive
offi
f cers, as a group
521,283
Registration with the SEC
If this Proposal Four is approved by our stockholders, we will file
f
a Registration Statement on Form S-8 with the SEC with
respect to the shares of our common stock to be registered pursuant to the Amended ESPP, as soon as reasonably practicable
following stockholder appr
a
oval.
Vote Required
At the Annual Meeting, the stockholders are being asked to approve
a
an amendment and restatement of the Company’s 2018
Employee Stock Purchase Plan. The affirm
f
ative vote of the holders of a majority of the shares represented in person or by proxy at the
Annual Meeting and entitled to vote on the item will be required to approve
a
the amendment and restatement of the Company’s 2018
Employee Stock Purchase Plan. The Board of Directors unanimously recommends voting “FOR” the approval of an amendment
and restatement of the Company’s 2018 Employee Stock Purchase Plan.
40
EQUITY COMPENSATION PLANS
The fol
f lowing tabl
a e sets for
f
th information regarding all of the Company’s equity compensation plans as of December 31,
2024:
Plan Category
Number of
Securities to be
Issued upon
Exercise of
Outstanding
Options, Warrants
and Rights
(a)
Weighted Average
Exercise Price of
Outstanding
Options, Warrants
and Rights
(b) (3)
Number of Securities
Remaining Available
for Future Issuance
Under Equity
Compensation Plans
(Excluding Securities
Reflected in Column a)
(c)
Equity compensation plans approved by security holders (1) .........................
12,367,484
$88.40
10,964,021
Equity compensation plans not approved by security holders (2)...................
—
—
55,182
Total.................................................................................................................
12,367,484
$88.40
11,019,203
(1)
The number of securities remaining availabl
a e for
f
future issuance under equity compensation plans approved by security holders as of December 31, 2024 are
from the 2020 Plan and the Neurocrine Biosciences, Inc. 2018 Employee Stock Purchase Plan (the "ESPP"). The shares availabl
a e for
f
issuance under the 2020
Plan may be issued in the for
f
m of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit
awards, performance awards, and other awards, subj
u ect to limitations set for
f
th in the 2020 Plan. The ESPP had 346,870 shares remaining availabl
a e for
f
future
issuance, which are included under column (c).
(2)
Consists of stock options and restricted stock unit awards that were issued to certain employees under the Neurocrine Biosciences, Inc. Inducement Plan,
which was not approved by security holders. These stock option grants have a four
f
-year vesting period and the restricted stock unit awards generally have
vesting periods of three to four ye
f
ars.
(3)
The weighted average exercise price excludes restricted stock unit awards, which have no exercise price.
41
PROPOSAL FIVE: RATIFICATION OF APPOINTMENT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
General
The Audit Committee has selected Ernst & Young LLP to audit the financial statements of the Company for the current fiscal
year ending December 31, 2025. Ernst & Young LLP has audited the Company’s financial statements since 1992. Representatives of
Ernst & Young LLP are expected to be present at the Annual Meeting, will have the opportunity to make a statement if they so desire,
and are expected to be availabl
a e to respond to appropriate questions.
Stockholders are not required to ratify the selection of Ernst & Young LLP as the Company’s independent registered public
accounting firm. However, the Audit Committee is subm
u
itting the selection of Ernst & Young LLP to the stockholders for ratification
as a matter of good corporate practice. If the stockholders fail to ratify
f the selection, the Audit Committee will reconsider whether or
not to retain that firm. Even if the selection is ratified, the Audit Committee in their discretion may direct the selection of a different
independent registered public accounting firm at any time during the year if they determine that such a change would be in the best
interests of the Company and its stockholders.
Vote Required
The affirm
f
ative vote of the holders of a majority of the shares represented in person or by proxy at the Annual Meeting and
entitled to vote on the item will be required to approve and ratify
f the Audit Committee’s selection of Ernst & Young LLP. The Board
of Directors unanimously recommends voting “FOR” approval and ratification of such selection. In the event of a negative vote
on such ratification, the Audit Committee will reconsider its selection.
42
EXECUTIVE OFFICERS
The table below sets for
f
th information regarding our executive officers and other management team members as of the Record
Date. In April 2025, we announced that Sanjay Keswani, M.D., would assume the role of Chief Medical Offi
f cer, effective June 2,
2025. Dr. Keswani will succeed Dr. Roberts who agreed to remain with the Company in a strategic advisory role following her
succession by Dr. Keswani.
Name
Age
Position
Kyle W. Gano, Ph.D.....................................................................
52
Chief Executive Offic
f er and Director
Matthew C. Abernethy .................................................................
45
Chief Financial Offi
f cer
Eric Benevich ...............................................................................
59
Chief Commercial Offic
f er
David W. Boyer............................................................................
46
Chief Corporate Affairs Officer
Julie S. Cooke...............................................................................
59
Chief Human Resources Offi
f cer
Ingrid Delaet.................................................................................
59
Chief Regulatory O
r
fficer
Darin M. Lippoldt.........................................................................
59
Chief Legal Offi
f cer and Corporate Secretary
Jude Onyia, Ph.D..........................................................................
61
Chief Scientific Officer
Eiry W. Roberts, M.D...................................................................
61
Chief Medical Offi
f cer
See above
a
for biographical infor
f
mation concerning Kyle W. Gano, Ph.D.
Matthew C. Abernethy was appoint
a
ed Chief Financial Offi
f cer in November 2017 and is responsible for leading corporate
finance activities, commercial supply chain operations, information technology, investor relations, faci
f
lities, and European operations
at Neurocrine Biosciences. Mr. Abernethy has over 15 years of biotech and medical device experience in finance and investor
relations. He joined Neurocrine Biosciences from Zimmer Biomet, where he held various positions from February 2
r
009 to November
2017, including most recently, Vice President, Investor Relations and Treasurer and Vice President of Finance for
f
the Americas and
Global Product Engines. He began his career with KPMG LLP and became a certified public accountant (inactive). Mr. Abernethy
earned his B.S. in Accounting and Business Administration fro
f
m Grace College and an MBA from the University of Chicago.
Eric Benevich was appoint
a
ed Chief Commercial Officer in May 2015 and is responsible for all aspects of commercial
development, marketing and sales of the Neurocrine Biosciences product portfol
f io. Mr. Benevich has over 30 years of commercial
experience in the pharmaceutical industry a
r
nd previously served in various positions of increasing responsibility at AstraZeneca,
Amgen, Peninsula Pharmaceuticals and Avanir Pharmaceuticals in the sales and marketing of drugs such as Prilosec®, Epogen®,
Enbrel®,
and Neudexta®. Mr. Benevich has a BBA in International Business fro
f
m Washington State University.
David W. Boyer was appoint
a
ed Chief Corpor
r
ate Affai
f rs Offi
f cer in September 2019 and is responsible for patient advocacy and
engagement, corpor
r
ate communications, government relations, and public policy at Neurocrine Biosciences. Mr. Boyer brings nearly
20 years of experience in public affa
f irs, specializing in the life s
f
ciences and biopharmaceutical sectors. He joins Neurocrine
Biosciences afte
f r nine years with the BGR Group, where he served as a Principal and the Head of the Health & Lifesci
f
ences Practice,
leading the firm’s healthcare advocacy, policy and strategy development, and strategic consulting team. During his tenure at the BGR
Group, Mr. Boyer led public policy, advocacy, and strategic communications initiatives for a wide range of healthcare clients. Prior to
joining the BGR Group, Mr. Boyer served as Special Assistant to the President for
f
Legislative Affairs under President George W.
Bush, Assistant Commissioner for
f
Legislation at the U.S. Food and Drug Administration, and Special Assistant to the Secretary a
r
t the
U.S. Department of Health and Human Services. In addition to his public service, Mr. Boyer held senior advocacy positions at the
Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufact
f
ur
t
ers of America (PhRMA). Mr. Boyer
holds a B.A. in Government from Georgetown University.
Julie S. Cooke was appoint
a
ed Chief Human Resources Offi
f cer in September 2017. She joined Neurocrine Biosciences from
the Sanford Burnham Prebys Medical Research Institute where she served as Senior Vice President for
f
Human Resources and was a
member of the executive management team. Previously, Ms. Cooke held multiple positions at Life Technologies, including being the
human resource partner to the Chief Operating Officer, Division Presidents and Global Function Leads. Prior to Life T
f
echnologies,
she ran human resources and was a member of the executive management team at SGX Pharmaceuticals. Ms. Cooke began her career
at PepsiCo., The Pepsi Bottling Group, and Gateway, where she held positions of increasing responsibility in human resources. She
holds a Bachelor of Arts in Economics fro
f
m Colorado College.
Ingrid Delaet, P
t
h.
P
D. was appoint
a
ed Vice President, Regulatory A
r
ffairs in 2021, and Chief Regulatory O
r
fficer in October
2022. She is responsible for leading the regulatory a
r
ffairs, quality assurance, medical writing, and program management teams. Dr.
Delaet has more than 25 years of drug development experience in several therapeut
a
ic areas, including immunology, hepatology,
cardiovascular, and metabol
a
ic diseases. Prior to joining Neurocrine Biosciences, she served as Senior Vice President, Regulatory
r
Affa
f irs at Intercept Pharmaceuticals, which she joined in 2016. Between 1997 and 2016, Dr. Delaet held various positions of
increasing responsibility at Bristol-Myers Squibb in the United States, fir
f st in Clinical Research and Development and then in Global
Regulatory A
r
ffairs, where she served as Therapeutic Area Lead for Immunology. Prior to Bristol-Myers Squibb, she held positions in
clinical research at CellPro, Inc. and Wyeth-Ayerst Research. She received her Ph.D. in Immunology and her M.Sc. in Pharmaceutical
Sciences from The Free University of Brus
r
sels, Belgium.
43
Darin
i
M. Lippo
i
ldt was appointed Chief Legal Offi
f cer and Corporate Secretary
r in October 2014 and has oversight of all legal,
intellectua
t
l property, and compliance matters. Mr. Lippoldt is also serving as Chair of the Biotechnology Innovation Organization
(BIO) General Counsels’ Committee for 2023-2024. Prior to joining Neurocrine Biosciences, Mr. Lippoldt served as Executive Vice
President, General Counsel, Chief Compliance Offi
f cer and Corporate Secretary of
r
Volcano Corporation, a company he joined in 2010.
Prior to Volcano, Mr. Lippoldt served as Associate General Counsel at Amylin Pharmaceuticals, Inc. He previously practiced
corporate and securities law with the law firms of Fulbright & Jaworski LLP and Matthews and Branscomb, P.C. Mr. Lippoldt
received a B.B.A. in Finance, an M.A. in International Relations and a J.D. from St. Mary’s University.
Jude Onyi
n a, Ph.D. was appointed Chief Scientific
f
Offi
f cer in November 2021 and leads the drug discovery and non-clinical
development teams responsible for bolstering and advancing the company’s pipeline of therapeutic candidates. Additionally, in
Februa
r
ry 2023, Dr. Onyia joined Voyager Therapeutics, Inc.'s board of directors. A scientist with more than 25 years of experience in
the pharmaceutical industry,
r
Dr. Onyia is the former Vice President of Biotechnology Discovery Research at Eli Lilly and Company.
At Lilly, Dr. Onyia contributed to the discovery and/or advancement of more than 60 clinical candidates across multiple therapeutic
areas, which led to seven approved medicines. He also was responsible for more than 50 pre-candidate programs across multiple
therapeutic areas. Dr. Onyia holds a B.S. in Forest Biology from the State University of New York (SUNY) College of Environmental
Science and Forestry, as well as a Ph.D. in Cell and Molecular Biology from the SUNY He
U
alth Science Center, both at Syracuse NY.
Eiry W.
i
Roberts, M.D. was appointed Chief Medical Offi
f cer in January 2018 and is responsible for all clinical development
and medical affa
f irs activities at Neurocrine Biosciences. Dr. Roberts has over 25 years of research and development experience in the
pharmaceutical industry
r across all phases of drug deve
r
lopment from research through commercialization in multiple therapeutic areas,
including neuroscience, inflammation, oncology and metabol
a
ic diseases. She joined Neurocrine Biosciences from Eli Lilly and
Company where she had worked since May 1991. During her tenure at Lilly, Dr. Roberts held various positions of increasing
responsibility, including Vice President, Clinical Pharmacology/Managing Director of Chorus, a position she held from October 2014
until December 2017, and Vice President of Research and Development, BioMedicines Business Unit. Dr. Roberts is a physician who
trained in pharmacology and medicine in the United Kingdom, qualifying
f
from the University of London in 1987. Her post-gradua
d
te
clinical training was in clinical pharmacology and cardiology at St. Bartholomew’s Hospital and the Royal London Hospital.
Dr. Roberts also serves as a director of Amicus Therapeutics, a clinical-stage biopharmaceutical company focused on rare diseases.
44
COMPENSATION DISCUSSION AND ANALYSIS
This Compensation Discussion and Analysis describes Neurocrine Biosciences’ executive officer compensation program for
2024. It provides qualitative information on the factors relevant to these decisions and the manner in which compensation is awarded
to the fol
f lowing individuals who are our Named Executive Officers (“NEOs”) for 2024:
•
Kyle W. Gano, Ph.D., Chief Executive Officer (1)
•
Kevin C. Gorman, Ph.D., Former Chief Executive Offic
f er
•
Matthew C. Abernethy, Chief Financial Offi
f cer
•
Eric Benevich, Chief Commercial Offi
f cer
•
Jude Onyia, Ph.D., Chief Scientific Officer
•
Eiry W. Roberts, M.D., Chief Medical Offi
f cer
(1)
In May 2024, the Board appointed Dr. Gano, who previously served as our Chief Business Development and Strategy Offi
f cer, to succeed Dr.
Gorman as our CEO effective October 11, 2024. Dr. Gorman retired as our CEO effective October 11, 2024, and he continues to serve as a
member of the Board.
Executive Summary
Busine
i
ss Overview
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for
people with great needs, but few options. We are dedicated to discovering and developing life-chan
f
ging treatments for
f
patients with
under-addressed neurological, neuroendocrine, and neuropsychiatric disorders.
Our portfol
f io of products includes U.S. Food and Drug Administration ("FDA") approve
a
d treatments for
f
tardive dyskinesia,
chorea associated with Huntington's disease, classic congenital adrenal hyperplasia ("CAH"), and endometriosis and uterine fibroids in
collabor
a
ation with AbbVie Inc. ("AbbVie").
We launched INGREZZA® (valbenazine) in the U.S. as the fir
f st FDA-approved drug for
f
the treatment of tardive dyskinesia in
May 2017 and for
f
the treatment of chorea associated with Huntington's disease in August 2023 and launched CRENESSITYTM
(crinecerfont) in the U.S. as a fir
f st-in-class FDA-approve
a
d treatment of CAH in December 2024.
In addition to our marketed products:
•
We have a diversified portfol
f io of multiple compounds in mid- to late-phase development across our core therapeutic
areas and an expanding early-phase pipeline that includes a range of modalities including small molecules, peptides,
proteins, antibodies, and gene therapy.
•
Our partner Mitsubi
u shi Tanabe Pharma Corpo
r
ration ("MTPC") launched DYSVAL® (valbenazine) in Japan for the
treatment of tardive dyskinesia in June 2022 and subsequently in other select Asian markets, where it is marketed as
REMLEAS® (valbenazine). We receive royalties at tiered percentage rates on MTPC net sales of valbenazine.
•
Our partner AbbVie launched ORILISSA® (elagolix tabl
a ets) in the U.S. for
f
the treatment of moderate to severe pain
associated with endometriosis in August 2018 and ORIAHNN® (elagolix, estradiol and norethindrone acetate capsules
and elagolix capsul
a
es) in the U.S. for the treatment of heavy menstrual bleeding due
d
to uterine fib
f roids in June 2020. We
receive royalties at tiered percentage rates on AbbVie net sales of elagolix.
2024 Busine
i
ss Highl
g
ig
l hts
g
We delivered a strong performance in 2024, as demonstrated by the fol
f lowing achievements and developments:
•
INGREZZA net product sales for 2024 increased $477.5 million, or 26.0%, to $2.3 billion, reflecting strong underlying
patient demand and improved gross-to-net dynamics.
•
In December 2024, we received FDA approval for
f
CRENESSITY capsules and oral solution as an adjunctive treatment
of CAH and launched CRENESSITY in the U.S. as a first-in-class FDA-approved treatment of CAH. We estimate that
CAH affects appr
a
oximately 30,000 people in the U.S.
•
Kevin Gorman, Ph.D., retired as Chief Executive Offi
f cer (CEO) effe
f ctive October 11, 2024. Kyle Gano, Ph.D., formerly
Neurocrine’s Chief Business Development and Strategy Offi
f cer, succeeded Dr. Gorman in the CEO role and also joined
the Company’s Board of Directors at that time. Dr. Gorman continues to serve on the Company’s Board.
•
Received notification fro
f
m the Centers for
f
Medicare and Medicaid Services that INGREZZA qualified for
f
the Specified
Small Manufac
f
turer Exception pertaining to the Part D redesign of the Inflatio
f
n Reduc
d
tion Act.
•
Settled the convertible senior notes due
d
May 15, 2024 (the "2024 Notes") in ful
f l in cash upon
u
maturity.
45
•
Deployed expanded INGREZZA psychiatry and long-term care sales teams to better serve patients by accelerating the
number of people who are diagnosed and treated for tardive dyskinesia and chorea associated with Huntington's disease
with INGREZZA.
•
Repurchased and retired an initial delivery of 2.0
r
million shares of the Company’s common stock pursuant to previously
announced $300.0 million accelerated share repurchase (ASR) program. The program was completed in Februa
r
ry 2025,
at which time we received an additional 0.3 million shares upon settlement.
Select Pipe
i
line Highl
g
ig
l hts
g
•
Announced the initiation of the Phase 3 program for osavampator (formerly NBI-1065845), a potential first-in-class
alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in
development for patients with inadequate response to treatment of major depressive disorder (MDD).
•
Announced amendment to strategic collabor
a
ation with Takeda Pharmaceutical Company Limited (Takeda) to develop
and commercialize osavampator. Under the amended agreement, we will retain exclusive rights for all indications to
develop and commercialize osavampator in all territories worldwide except Japan,
a
where Takeda will have exclusive
rights. Under the terms of the updated agreement, each company is responsible for development costs in their respective
region, and both companies are eligible to receive royalty payments.
•
Announced the initiation of the Phase 1 clinical study
t
to evaluate the safety, tolerabi
a lity, pharmacokinetics, and
pharmacodynamics of investigational compound NBI-921355 in healthy adul
d t participants. NBI-921355 is an
investigational, selective inhibitor of voltage-gated sodium channels Nav1.2 and Nav1.6 and in development for the
potential treatment of certain types of epilepsy.
•
Announced positive topline data for the Phase 2 study of
t
NBI-1117568, a first-in-class, orally active, highly selective
investigational M4 agonist, in development as a potential treatment for schizophrenia.
•
Announced positive topline data for the Phase 2 SAVITRI™study.
t
This randomized, double-blind, placebo-controlled
dose-finding study
t
assessed the effi
f cacy and safety of osavampator in adul
d t subj
u ects with MDD.
•
Initiated Phase 2 study of
t
NBI-1070770 in adul
d ts with MDD. NBI-1070770 is a novel, selective, and orally active,
negative allosteric modulator (NAM) of the NR2B subuni
u
t-containing N-methyl-D-aspartate (NMDA NR2B) receptor.
•
Initiated Phase 1 study of
t
NBI-1117567 in healthy adul
d t participants. NBI-1117567 is an investigational, oral, M1/M4
(M1 prefer
f ring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric conditions.
•
Initiated Phase 1 study of
t
NBI-1076968 in healthy adul
d t participants. NBI-1076968 is an investigational, oral, M4
subtype
u
-selective muscarinic antagonist for the potential treatment of movement disorders.
•
Received approval from the FDA for INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation
of INGREZZA capsul
a
es, and subs
u
equently launched new sprinkle formulation of INGREZZA capsules for the treatment
of adul
d ts with tardive dyskinesia and chorea associated with Huntington’s disease.
2024 Compensation Program High
i
ligh
i
ts
Consistent with our goal of attracting, motivating and retaining a high-caliber executive team, our executive offi
f cer
compensation program is designed to pay for performance. A summary of key
r
compensation decisions and compensation related
outcomes aligned with this philosophy are highlighted below for 2024.
•
Pay for Perfor
f
mance / At-Risk Pay - Our executive compensation program is designed so that a significant portion of pay is
variable or “at risk” and the realized value of compensation is linked with Company performance and value delivered to
stockholders. For 2024, the percentage of pay that is “at risk” for our CEO and NEOs (excluding Dr. Gorman who retired as
CEO effe
f ctive October 11, 2024) is approximately 74% and 71%, respectively, helping us align pay with performance (refer
f
to "Pay for Performance / At-Risk Pay" below).
•
Base Salary
r Adju
d stme
t
ntst - Salary increases for 2024 were generally due to Company performance in 2023 and maintaining
competitive market positioning relative to market data. Merit-based increases for NEOs ranging from 4% – 7% were
approved for 2024. In connection with his promotion to CEO, Dr. Gano's salary increased from $645,116 to $900,000,
effe
f ctive as of October 11, 2024.
•
Annual Cash Incentives - Our annual cash award opportunity is based on corporate performance compared to pre-establ
a ished
corporate goals and the individual performance of each executive offi
f cer. Corporate goals are selected to directly align with
our specific strategic goals that we believe will create long-term stockholder value. For 2024, we achieved our corporate
goals at an overall level of 115% and we paid an annual cash incentive award to our CEO at 115% of target and to our other
NEOs at 115% - 150% of target.
•
Long-Term Equity Awards: Equity Mix - A significant portion of our CEO’s and other NEOs' compensation is delivered in
the form of long-term equity awards comprised of a mix of stock options, PRSUs and RSUs. In 2024, the target equity award
mix for each of Drs. Gano and Gorman was approximately 50% stock options, 30% PRSUs and 20% RSUs and the target
equity award mix for our other NEOs was approximately 45-55% stock options, 15-35% PRSUs and 20-25% RSUs.
•
PRSU Payo
a
utst Linked
k
to Perfor
f
mance - The performance conditions for PRSUs granted to our NEOs in 2022 with a
performance period ending on December 31, 2024 were only partially achieved, resulting in a payout of 40% of target for
these PRSUs. The Compensation Committee did not take any actions to mitigate the negative impact on payouts for these
awards consistent with our pay-for-performance philosophy.
46
Compensation Com
C
mittee Actio
t ns in Connection with
i
Say-
a on-Pay
P
Vote
The Compensation Committee of the Board of Directors is committed to ensuring that our executive officer compensation
program is effe
f ctive and aligned with our stockholders’ interests and concerns. Accordingly, critical components of our Compensation
Committee’s process continue to be (1) reviewing emerging compensation “best practices”, with a focus
f
toward companies of similar
size, as measured by market capitalization and revenues, (2) soliciting advice from our Compensation Committee’s independent
compensation consultant and (3) listening and responding to feedba
d
ck from our stockholders via our annual say-on-pay vote and
through our stockholder outreach effort
f
s.
We seek a say-on-pay advisory vote fro
f
m our stockholders regarding our executive officer compensation program on an
annual basis. Each year, the Compensation Committee considers the results of the advisory vote as it completes its annual review of
each pay element and the compensation provided to our NEOs and other executive officers.
2024 Say-on-Pay Voting Results
In 2024, we received appr
a
oximately
94% of votes cast in support of our
2024 executive officer compensation
program.
Over the last ten years, we have received approximately 97% (on average) of votes cast in
suppor
u
t of our executive compensation programs. Given the significant level of stockholder
suppor
u
t, the Compensation Committee concluded that:
executive offi
f cer compensation program continues to align executive offic
f er pay with
stockholder interests;
our executive offi
f cer compensation program provides competitive pay that encourages
retention and effe
f ctively incentivizes performance of talented NEOs and executive
offi
f cers;
no significant changes to the structur
t
e of our programs were necessary for 2024; and
the Compensation Committee will continue to consider the outcome of our say-on-pay
votes and our stockholders’ views when making future compensation decisions for the
NEOs and executive offi
f cers.
During 2024, we continued our stockholder engagement effort
f
s in order to solicit fee
f
dback on a variety of topics, including
board, governance, and executive compensation practices. We contacted a number of our largest stockholders and spoke with all
stockholders that wanted to provide us with feedba
d
ck. Specifically, we reached out to 19 of our largest stockholders (representing
approximately 46% of the outstanding shares of our common stock). While the engagements are primarily conducted by management,
Board members (including Compensation Committee members) are also availabl
a e to participate, when appropriate. Overall,
stockholders have expressed strong suppor
u
t for our boa
f
rd, governance, and executive compensation practices. We are pleased with our
say-on-pay advisory vote results and stockholder feed
f
ba
d
ck, and we will continue to engage with our stockholders to ensure alignment
between our executive officer compensation program and our stockholders’ interests.
Pay f
a
or
f
Perfor
f
ma
r
nce / At-R
t
isk Pay
P
Our executive officer compensation program is designed to reward achievement of the specific strategic goals that we believe
will advance our business strategy and create long-term value for
f
our stockholders. Consistent with our goal of attracting, motivating
and retaining a high-caliber executive team, our executive officer compensation program is designed to pay for performance. We
utilize compensation elements that meaningful
f ly align our NEOs’ interests with those of our stockholders to create long-term value.
As such, a significant portion of our CEO’s and other executive officers’ compensation is “at-risk,” performance-based compensation,
in the for
f
m of long-term equity awards that have performance-based vesting criteria or have value directly dependent on the
Company’s stock price (or in the case of stock options, only have value if the Company's stock price increases), and annual cash
incentives that are only earned if we achieve pre-establ
a ished corporate goals.
With respect to long-term equity awards, the Compensation Committee annually considers the appropriate mix of equity
awards. The Compensation Committee believes that combining performance-based vesting equity awards with time-based vesting
equity awards appropriately promotes a focus on de
f
livering sustainable long-term value to our stockholders, while also suppor
u
ting the
long-term retention of our executive officers.
47
The graphi
a
cs below illustrate the primary e
r
lements of compensation mix for our CEO (Dr. Gano) and the aggregate 2024
compensation mix for the other NEOs as a group (excluding Dr. Gorman who retired as CEO effective October 11, 2024). The
percentages in the chart below reflect the actua
t
l base salary e
r
arned, cash incentives paid, and the grant date fair value of equity awards
granted, in each case as reported in our 2024 Summary Compensation Table.
CEO 2024 Compensation Mix
All Other NEOs 2024 Compensation Mix
48
Compensation Philosophy and Objectives
Compensation Phi
P
lo
i soph
o
y.
h
We believe that in order to create value for
f
our stockholders, it is critical to attract, motivate and
retain key executive offic
f er talent by providing competitive compensation packages. Accordingly, we design our executive offic
f er
compensation program to:
ATTRACT, DEVELOP & RETAIN
executive officers with the skills and expertise
to execute our business plans within the
highly competitive life sciences industry
MOTIVATE & REWARD
executives fairly over time for actions
consistent with creating long-term stockholder
value
MAXIMIZE
stockholder value via an appropriate blend of
short-term and long-term incentives
Our compensation philosophy for executive offi
f cers provides that cash compensation should be struc
r
tured such that at least
one-third of each executive officer’s target total cash compensation, consisting of base salary a
r
nd target cash incentives, is at risk and
dependent upon the Company’s achievement of specific corpo
r
rate goals that drive stockholder value. Starting in 2020, 50% of our
CEO’s target total cash compensation is at risk under our annual cash incentive plan. Long-term equity compensation for
f
executive
offi
f cers is generally a combination of performance-based and time-based vesting equity awards, and it is designed to motivate
executive officers to increase long-term stockholder value and to reward and retain key employees.
Stro
t
ng Executive Compe
C
nsatio
t n Gov
G
ernance Pra
P
ctic
t es. The Compensation Committee regularly reviews best practices in
governance and executive compensation. The fol
f lowing chart summarizes executive compensation practices that the Compensation
Committee believes (i) drive Company performance and (ii) serve our stockholders’ long-term interests.
WHAT WE DO
WHAT WE DON'T DO
Heavily weight our executive offic
f er compensation toward
“at risk,” performance-based compensation
Balance short-term and long-term incentive compensation
Use multi-year vesting for
f
all executive officer equity
awards
Grant performance-based equity awards annually in the form
f
of PRSUs
Have an incentive compensation recoupment or clawback
policy
Structur
t
e our executive offi
f cer compensation program to
minimize inappropriate risk-taking and encourage
appropriate risk-taking
Cap a
a
nnual cash incentives at a maximum payout amount
Select peer companies that we compete with for executive
offi
f cer talent, have a similar business and are of similar size
as us, and review their pay practices
Utilize an independent compensation consulting fir
f m to
facilitate pay assessments and review best practices
Have meaningful
f
equity ownership guidelines for executive
offi
f cers and the Board of Directors
Hold annual say-on-pay advisory vote
× Provide guaranteed bonuses or base salary increases
× Allow for
f
the repricing of stock options without stockholder
approval
× Pay dividends or dividend equivalents on unearned shares
× Permit hedging or other for
f
ms of speculative transactions by
employees or directors
× Permit pledging by employees or directors
× Provide single-trigger change in control benefits
f
× Include gross-ups in executive employment agreements or
change-in-control arrangements
× Provide excessive perquisites to our executive officers
× Provide retirement or pension benefit
f s to our executive
offi
f cers that are not availabl
a e to employees generally
Compensation Program Changes to be Effe
f ctiv
t e in 2025. We anticipate that our 2025 executive compensation program,
which will be fully disclosed in next year’s Compensation Discussion and Analysis, will include several changes that we believe will
enhance our performance-based compensation program and further tie executive compensation to the creation of long-term
stockholder value. In 2024, the target equity award mix for our CEO was approximately 30% PRSUs, 20% RSUs and 50% stock
options, and the target equity award mix for our other NEOs (excluding Dr. Gorman) was approximately 15-35% PRSUs, 20-25%
RSUs and 45-55% stock options. In 2025, it is expected that the target equity award mix for all NEOs (including Dr. Gano) will be
approximately 30% PRSUs, 20% RSUs and 50% stock options. Additionally, on February 7, 2025, the Compensation Committee
approved and adopted an Executive Severance Plan, pursuant to which executive offi
f cers now participate, including our NEOs. In
connection with the adoption of the Executive Severance Plan, we simultaneously entered into amended and restated employment
agreements with each of our executive offi
f cers, including our NEOs. The Executive Severance Plan and amended employment
agreements for our executive offi
f cers incorporate “best practices” relating to severance payments and more closely align with market
and peer practices. The Compensation Committee believes these changes will further improve the alignment between executive
compensation and the long-term interests of stockholders. For further information regarding the Executive Severance Plan and the
amended and restated employment agreements, please see the sections entitled "Executive Severance Plan" and "Amendment and
Restatement of Employment Arrangements" below.
Overall Compensation Determination Process
The implementation of the compensation philosophy is carried out under the supe
u
rvision of the Compensation Committee. The
Compensation Committee uses the services of an independent compensation consultant who is retained by, and reports directly to, the
Compensation Committee. Management, under guidelines and procedur
d
es approved by the Compensation Committee, determines the
compensation of our non-executive offi
f cer employees.
Role of the Compensation Committee. The Compensation Committee takes into consideration a peer group, survey data and
advice from an independent compensation consultant when setting the compensation philosophy and compensation structur
t
e for the
Company. The Compensation Committee’s complete roles and responsibilities are set forth in a written charter, which was adopted by
the Board of Directors and is availabl
a e at http://w
/
ww.neurocrine.com/investors/co
/
rporate-governance/./ Some of the significant roles
and responsibilities of the Compensation Committee include reviewing, revising, and approving:
•
the compensation philosophy of the Company;
•
the corporate goals and objectives relating to the compensation of the Company’s employees, including executive
offi
f cers, and evaluating the performance of the Company, and its executive offi
f cers, in light of these corporate goals
and objectives;
•
compensation for all executive offi
f cers, including perquisite benefits, if any;
•
all promotions to executive offi
f cer positions and the hiring of all new executive offi
f cers, including employment
agreements;
•
recommendations to the full Board of Directors regarding all director compensation by taking into consideration peer
group data and advice from an independent compensation consultant;
•
guidelines for salaries, merit salary increases, cash incentive payments, stock-based grants and performance-based stock
grants for all non-executive offi
f cer employees of the Company;
•
equity and incentive plans, including amendments or modifications to such equity and incentive plans;
•
equity ownership guidelines for executive offi
f cers and directors;
•
the Compensation Discussion and Analysis for inclusion in any of the Company's annual reports on Form 10-K,
registration statements, proxy statements or information statements; and
•
the Compensation Committee report on executive compensation to be included in the Company's annual proxy
statement in accordance with applicable SEC rules and regulations.
In addition, the Compensation Committee also has the following oversight responsibilities:
•
overseeing the development, implementation and effe
f ctiveness of the Company’s policies and strategies with respect to
human capital and talent management;
•
administering the Company’s equity and incentive plans and employee benefit plans;
•
overseeing the implementation of clawback policies allowing the Company to recoup certain compensation paid to
employees;
•
reviewing and taking into consideration stockholder feedba
d
ck regarding compensation matters, including our annual
say-on-pay vote;
•
retaining independent compensation consultants and advisors when appropriate to advise the Compensation Committee
on compensation policies and plans; and
•
complying with requirements establ
a ished by the SEC, assessing the risks arising from the Company’s compensation
policies and taking any actions required as a result thereof.
50
In the early part of each year, the Compensation Committee deliberates and makes decisions regarding the base salary, target
cash incentives and long-term equity award components of compensation to be awarded to our executive offi
f cers, including our CEO,
for the new fiscal year, as well as performance-based compensation payouts for the prior fiscal year. In setting compensation for our
other NEOs, the Compensation Committee solicits the input of our CEO, who recommends to the Compensation Committee the base
salary, target cash incentives and long-term equity award components of compensation to be awarded to our NEOs for the new fiscal
year, as well as performance-based compensation payouts for the prior fiscal year. The Compensation Committee remains solely
responsible for making the final decisions on compensation for all of our NEOs. Our NEOs, including our CEO, are not present during
discussions of their respective compensation packages nor do they participate in approving any portion of their own or other NEO
compensation packages.
The Compensation Committee considers a variety of factors, as described below, which may vary from year to year, to set the
compensation of our NEOs at levels that the Compensation Committee considers to be competitive and appropriate for each NEO,
using the Compensation Committee’s profes
f
sional experience and judgment:
Company performance
Market data from the independent compensation consultant
Individual performance
Retention risk
Independent compensation consultant recommendations
CEO’s recommendations (other than for himself), based on direct knowledge of NEO performance and his extensive
industry
r experience
Internal pay equity among individuals and positions
Criticality and scope of job function
Total targeted and historical compensation
Any other factors the Compensation Committee determines appropriate
In addition, during the first quarter of the year, Company-wide performance goals for the then current year are typically
finalized by the Compensation Committee and the Board of Directors, and progress toward these goals is reviewed at meetings
throughout the year. Later in the year, the Compensation Committee reviews the Company’s compensation philosophy, policies and
procedur
d
es. The Compensation Committee meetings in the fourth quarter of the year generally focus on Company goal achievement,
selection of the peer group for the following year and executive offic
f er performance.The Compensation Committee may make
executive compensation decisions at additional times during the year for new hires, promotions or other special circumstances as our
Compensation Committee determines appropriate.
Compensation Consulta
l nt. The Compensation Committee uses the services of an independent compensation consultant who is
retained by, and reports directly to, the Compensation Committee to provide the Compensation Committee with an additional external
perspective with respect to its evaluation of relevant market and industry pr
r
actices. The Compensation Committee engaged the
services of Frederic W. Cook & Co., Inc. (“FW Cook”) as its independent compensation consultant to assist the Compensation
Committee with evaluating our executive and director compensation programs and to make recommendations for our 2024
compensation programs, including updating the Compensation Committee on new developments in areas that fall within the
Compensation Committee's oversight. FW Cook serves solely at the pleasure of the Compensation Committee and their fees are
approved by the Compensation Committee. FW Cook conducted analyses and provided advice on, among other things, the appropriate
peer group, executive offi
f cer compensation and compensation trends in the lifef sciences industry.
r
In weighing its recommendations for executive offi
f cer compensation for 2024, the Compensation Committee directed FW
Cook to advise the Compensation Committee on both best practices and peer practices when designing and modifying our executive
offi
f cer compensation program in order to achieve our objectives. As part of its duties, FW Cook provided the Compensation
Committee with the following services with respect to 2024 compensation decisions:
•
carried out a comprehensive review of our peer group for use in making 2024 executive offi
f cer compensation decisions;
•
provided compensation data for the peer group and relevant executive offi
f cer pay survey data and an analysis of the
compensation of the Company’s executive offi
f cers as compared to this market data;
•
provided compensation data, relevant pay survey data and other analysis and recommendations with respect to the
compensation package for Dr. Gano in connection with his promotion to CEO, including severance benefits;
•
provided a competitive assessment of,f and comparison to, incentive design and executive offi
f cer pay program structur
t
e
based on peer group data;
•
conducted a comprehensive pay for performance assessment;
•
provided recommendations regarding the annual cash incentive and long-term equity incentive program design for 2024;
•
assisted the Compensation Committee with the design of 2024 pay programs consistent with the Company’s business
strategy and pay philosophy;
•
provided background information and data for 2024 adju
d stments to the Company’s executive offi
f cer compensation
program consistent with good governance practices and the Company’s objectives; and
•
prepared an analysis of the Board of Directors’ 2024 compensation program.
51
The Compensation Committee annually assesses whether the work of its compensation consultant has raised any conflic
f
t of
interest, taking into consideration the following factors: (i) the provision of other services, if any, to the Company by the compensation
consultant; (ii) the amount of fees the Company paid to the compensation consultant as a percentage of the firm’
f
s total revenue;
(iii) the compensation consultant’s policies and procedur
d
es that are designed to prevent conflicts
f
of interest; (iv) any business or
personal relationship of the compensation consultant or the individual compensation advisors employed by the firm with an executive
offi
f cer of the Company; (v) any business or personal relationship of the individual compensation advisors with any member of the
Compensation Committee; and (vi) any stock of the Company owned by the compensation consultant or the individual compensation
advisors employed by the firm. The Compensation Committee has determined, based on its analysis of the above
a
factors, that there
was no conflic
f
t of interest with respect to FW Cook providing services to the Compensation Committee.
Competitiv
t
e Assessment of C
o
ompe
C
nsatio
t n—Pe
—
er Group a
u
nd Market Data
2024 Peer Group. In October 2023, when developing a proposed list of our peer group companies to be used in connection
with making compensation decisions for 2024, FW Cook selected commercial biopharmaceutical companies with revenues generally
between $900 million and $9.0 billion, market capitalization generally between $3.2 billion and $32.4 billion, and employee
headcount generally between 675 and 6,750, which FW Cook recommended as a reasonable range in relation to our then-current
revenue, market capitalization and headcount.
Based on these criteria, FW Cook recommended, and our Compensation Committee approve
a
d in October 2023, the fol
f lowing
peer group to be used in connection with making compensation decisions for 2024:
ACADIA Pharmaceuticals, Inc.
Alkermes plc
Alnylam Pharmaceuticals, Inc.
argenx SE
BeiGene, Ltd.
BioMarin Pharmaceuticals, Inc.
Exelixis, Inc.
Horizon Therapeutics plc
Incyte Corpo
r
ration
Ionis Pharmaceuticals, Inc.
Jazz Pharmaceuticals plc
Karuna Therapeutics, Inc.
Organon & Co.
Sarepta Therapeut
a
ics, Inc.
Ultragenyx Pharmaceutical Inc
United Therapeut
a
ics Corpor
r
ation
The 2024 peer group reflects the fol
f lowing changes fro
f
m our 2023 peer group: (i) the removal of Biohaven Ltd. and Seagen
Inc. due to acquisitions, (ii) the removal of Mirati Therapeut
a
ics, Inc., as its market capitalization and revenue fell below the targeted
range, and (iii) the addition of argenx SE, Karuna Therapeutics, Inc., and Organon & Co., each of which generally met the criteria set
forth above
a
. At the time of approval of our 2024 peer group (which occurred in October 2023), our Company was approximately in
the 54th percentile of the peer group for market capitalization and in the 57th percentile of the peer group for revenue.
2024 Market
k
Data. In late 2023, FW Cook completed an assessment of executive officer compensation based on the 2024 peer
group to inform the Compensation Committee’s determinations of executive officer compensation for 2024.
f
The data for
f
this
assessment was compiled fro
f
m multiple sources, including: (i) the 2024 peer group companies’ publicly disclosed information, or
public peer data; and (ii) survey data from the Radford Global Compensation Database for pe
f
er companies and biotechnology and
pharmaceutical companies that had annual revenue between $500
illi
million and $3.0 bi
nd $3.0 b llion. The components of this data were based on
the availabi
a lity of sufficient comparative data for
f
an executive officer’s position. The public peer data and survey data, collectively
referred to in this Proxy Statement together as market data, were reviewed by the Compensation Committee, with the assistance of FW
Cook, and used as one reference point, in addition to other factors, in setting our executive officers’ compensation for 2024.
f
Use of 2
o
024 Market
k
Data. The Compensation Committee generally reviews target total direct compensation, comprising both
target cash compensation and equity compensation, against the market data described above pr
a
imarily to ensure that our executive
offi
f cer compensation program as a whole is positioned competitively to attract and retain the highest caliber executive officers and
that the total direct compensation opportunity for the executive officer group is aligned with our corporate objectives and strategic
needs. The Compensation Committee does not have a specific target compensation level for the NEOs; rather, the Compensation
Committee reviews a range of market data reference points with respect to target total direct compensation, target total cash
compensation (including both base salary a
r
nd the target annual cash incentive) and equity compensation (valued based on an
approximation of grant date fair value). In making compensation determinations, the Compensation Committee considers the market
data, along with the other factors described above under “Overall Compensation Determination Process.”
52
Components of Executive Compensation
The Compensation Committee considers each executive offi
f cer’s performance, contributions to Company goals,
responsibilities, experience, qualifications, and where in the competitive range the executive officer’s compensation compares to the
Company’s peer group when determining the appropriate compensation for
f
each executive officer. The Compensation Committee
considers each component of compensation independently and each component in the context of each executive officer’s total
compensation. Compensation for our NEOs currently consists of three key elements that are designed to reward performance in a
simple and straightforward manner: base salaries, annual performance-based cash incentives and long-term equity awards, which
generally include RSUs and stock options, which both vest based on continued service over time, as well as PRSUs, which vest upon
achievement of key corpor
r
ate goals that we believe will create stockholder value. The tabl
a e below summarizes the purpos
r
e and key
characteristics of each Compensation Element, with those associated with at-risk pay shown in pink font.
f
Compensation Element
Purpose of This Element
Key Characteristics
Base Salary
Designed to compensate competitively at levels
necessary to attract and retain qualified
executive officers in the life s
f
ciences industry;
r
generally based on the scope of each executive
offi
f cer’s responsibilities, as well as his/her
qualifications, breadth of experience,
performance record and depth of applicable
functional expertise; establ
a ished and adju
d sted to
be appropriate as compared to the appl
a
icable
market data, enabl
a ing the Company to attract,
motivate, reward and retain highly skilled
executive officers; gives executive officers a
degree of certainty in light of having a majority
of their compensation at risk.
Fixed cash compensation where year-to-year
adju
d stments to each executive officer’s base
salary are based upon sustained superior
performance, changes in the general level of
base salaries of persons in comparable positions
within our industry,
r
and any average merit
salary increase for
f
such year for all employees
of the Company establ
a ished by the
Compensation Committee, as well as other
factors the Compensation Committee judges to
be pertinent dur
d
ing an assessment period.
In making base salary decisions, the
Compensation Committee exercises its
judgment to determine the appropriate weight to
be given to each of these fact
f
ors. Although
adju
d stments may also be made during the year
for special circumstances, no mid-year
adju
d stments have been made in the past five
f
years, except for
f
adju
d stments associated with
promotions.
Annual Cash Incentives
Motivates executive officers to achieve our
short-term strategic plan and milestones that are
designed to drive long-term growth and
performance while providing flexibility to
respond to opportunities and changing market
conditions.
Annual cash award opportunity based on
corporate performance compared to pre-
establ
a ished corporate goals with pre-establ
a ished
target and maximum payout opportunities for
f
each executive officer.
The cash incentive program, including
corporate goals and target payouts, are reviewed
and approve
a
d by the Compensation Committee
annually and may include individual
performance targets for
f
each executive officer.
The corporate goals are prepared in an
interactive process between management and
the Compensation Committee based on the
Company’s business plan and budget for
f
the
year. Cash incentive payments are linked to the
attainment of overall corporate goals and the
individual performance of each executive
offi
f cer, or other factors the Compensation
Committee determines appropriate.
Long-Term Equity Incentives (RSUs)
Motivates executive officers to achieve our
business objectives by tying compensation to
the performance of our common stock over the
long term; creates an ownership culture;
motivates our executive officers to remain with
the Company by mitigating swings in incentive
values during periods when market volatility
impacts our stock price; directly motivates an
executive officer to maximize long-term
stockholder value and serve as an effe
f ctive tool
for incentivizing and retaining those executive
offi
f cers who are most responsible for
influencing stockholder value.
RSUs generally vest on an annual basis, ratably
over four ye
f
ars subject to executive officer’s
continued service; the ultimate value realized
varies with our common stock price.
53
Long-Term Equity Incentives
(Stock Options)
Motivates executive officers to achieve our
business objectives by tying incentives to the
appreciation of our common stock over the
long-term and creates an ownership culture.
Stock options with an exercise price equal to the
fair market value on the date of grant generally
vest monthly over four ye
f
ars subject to
executive offi
f cer’s continued service; the
ultimate realizable value, if any, depends on the
appreciation of our common stock price from
f
the date of grant. The Compensation Committee
views stock options as performance-based
compensation, as stock options provide a return
t
to our executive officers only if the market price
of our common shares appr
a
eciates over the
stock option term.
Long-Term Equity Incentives (PRSUs)
Creates a strong link to the Company’s long-
term performance, creates an ownership culture
and closely aligns the interests of our executive
offi
f cers with those of our stockholders because
the value that the grants deliver is directly
dependent on attainment of performance metrics
and our stock price.
PRSUs only vest upon
u
achievement of
objectively measurable performance metrics
tied to our business strategy that focus
f
executive
offi
f cers on achieving these long-term Company
performance metrics and increasing stockholder
value.
Other Compensation
Provides benefit
f s that promote employee health
and welfare, which assists in attracting and
retaining our executive officers; certain
additional benefit
f s refle
f ct market standards and
are reasonable and necessary to attract and/or
retain each of our executive officers and allow
the executive officers to realize the full benefit
of the other elements of compensation we
provide.
Executive officers are eligible to participate in
the Company’s employee benefit
f
plans on the
same terms as all other ful
f l-time employees.
These plans include medical, dental and life
insurance and eligibility to participate in the
Company’s employee stock purchase plan.
Additional benefit
f s include disabi
a lity insurance
premiums, an annual physical examination and
financial planning services.
The terms of the Company’s 401(k) Savings
Plan (the “401(k) Plan”) provide for executive
offi
f cer and broad-based employee participation
on the same general terms. Under the 401(k)
Plan, all Company employees are eligible to
receive basic matching contributions from the
Company that vest annually over three years
from date of hire.
Severance and Change in Control
Benefits
Serves our retention objectives by helping our
executive officers maintain continued foc
f
us and
dedication to their responsibilities to maximize
stockholder value, including in the event of a
transaction that could result in a change in
control of the Company.
Provides protection in the event of a termination
of employment under specified circumstances,
including following a change in control of the
Company as described below under “Potential
Payments Upon Termination or Change-in-
Control.”
Compensation components for
f
executive
offi
f cers in the event of a termination by the
Company without cause or termination by the
executive offi
f cer due to construc
r
tive
termination alone or in connection with a
change in control include cash and equity
payments and benefit
f s and requires a signed
release agreement by the executive officer. In
February 2025, the Board approved an
Executive Severance Plan. For more
information on the benefits provided under this
plan, please refer to the section entitled
"Executive Severance Plan" below.
No executive officer is entitled to excise tax
gross-up payments in connection with a change
in control. Prior to his retirement as CEO, Dr.
Gorman was eligible for a change in control tax
gross-up pursuant to his 2007 employment
agreement, however, these provisions are no
longer appl
a
icable effe
f ctive as of October 11,
2024, and we do not intend to enter into any
new agreements containing such gross-up
entitlements.
54
2024 Named Executive Offi
f cer Compensation Decisions
2024 Base Salaries
In Februa
r
ry 2024, our Compensation Committee approved the 2024 base salaries for the NEOs as set for
f
th in the table below.
In making these 2024 decisions, the Compensation Committee considered the Company’s performance in 2023, market data for each
individual NEO’s position, as well as the individual’s historical salary l
r
evels, our then-current budget for
f
employee salary a
r
djustments,
anticipated role and responsibilities for
f
the coming year, along with the other factors described in the section entitled “Overall
Compensation Determination Process” above. At the conclusion of its review, the Compensation Committee determined that the
increases reflected in the table below were appr
a
opriate due to (i) the Company’s performance in 2023, (ii) maintaining competitive
positioning relative to the market data, (iii) retention of our NEOs and (iv) our NEOs’ experience, job criticality and performance.
Named Executive Offi
f cer
2024
Base Salary
%
Change
from 2023 Base
Salary
Kyle W. Gano, Ph.D., Chief Executive Officer
$645,116
7.0%
Kevin C. Gorman, Ph.D., Former Chief Executive Officer
$993,300
5.0%
Matthew C. Abernethy, Chief Financial Offi
f cer
$684,824
6.0%
Eric Benevich, Chief Commercial Officer
$636,848
6.0%
Jude Onyia, Ph.D., Chief Scientific Offi
f cer
$676,545
6.0%
Eiry W. Roberts, M.D., Chief Medical Offi
f cer
$686,761
4.0%
In October 2024, in connection with Dr. Gano’s promotion to CEO, the Compensation Committee approve
a
d an increase in his
annual base salary to $
r
900,000, effe
f ctive as of October 11, 2024. The Compensation Committee determined this level of base
compensation was appropriate for Dr. Gano in his promoted role, based on market data for pe
f
er company CEOs, Dr. Gano’s
experience and his anticipated role and responsibilities.
2024 Annual Cas
C
h Inc
I
entives
In Februa
r
ry 2024, the Compensation Committee approve
a
d the 2024 target bonus opportunities, expressed as a percentage of an
NEO’s base salary,
r
shown in the tabl
a e below. Upon his promotion to CEO in October 2024, Dr. Gano’s target bonus opportunity
increased from 50% of base salary to 100% of base salary, with his 2024 target bonus opportunity being pro-rated based on his base
salary and target bonus opportunity in effe
f ct prior to and following his promotion. No changes were made to the target bonus
opportunities of our other NEOs, as the Compensation Committee determined that such opportunities remained market competitive.
Executive Offi
f cer
2024
Target Bonus
(% of Base Salary)
Chief Executive Officer
100%
All Other Executive Officers
50%
In Februa
r
ry 2024, the Compensation Committee approve
a
d the corporate goals for our 2024 annual cash incentive plan. The
most significant and impactful goals and achievements are summarized in the table below. Our corporate goals are directly aligned
with our specific strategic goals that we believe will create long-term stockholder value, including achieving a net revenue target from
sales of INGREZZA, ensuring commercial readiness for
f
the launch of CRENESSITY™(crinecerfont), advancing and expanding our
clinical pipeline, and achieving certain other corpor
r
ate and financial goals. The Compensation Committee did not assign specific
relative weightings to the corpor
r
ate goals for 2024 in order to enable a holistic assessment of complementary goals that collectively
reflect achievement of our 2024 performance objectives and build the founda
f
tion for
f
long-term success. The maximum bonus payout
for each NEO was cappe
a
d at 150% of their target bonus opportunity.
During meetings conducted throughout the year and culminating in January 2025, the Compensation Committee engaged in a
robust dialogue with management, the Board Chair and other Board members (including at Board meetings), and its independent
compensation consultant to evaluate the accomplishments and performance of the Company relative to the 2024 corporate goals. The
Compensation Committee discussed the relative importance of each of these goals and ultimately determined that the fol
f lowing goals
were the most impactful to the creation of long-term stockholder value: (i) the INGREZZA net sales goal; (ii) subm
u
ission of the
crinecerfont NDAs to the FDA and ensuring commercial launch readiness of CRENESSITY in the four
f
th quarter of 2024; and (iii) the
advancement of our clinical pipeline, including reporting top-line results in four Phase 2 studi
t
es during 2024. The Compensation
Committee fur
f
ther determined that the Company exceeded the high-end of the range for the INGREZZA net sales goal; successful
f ly
subm
u
itted the crinecerfont NDAs to the FDA and completed foundational activities to ensure commercial launch readiness of
CRENESSITY; over achieved the most critical goals associated with the advancement of the Company's clinical pipeline, and
achieved other important goals. After these discussions, the Compensation Committee determined our 2024 corporate goal
achievement at 115%.
55
Commercial
Activities
Achieve INGREZZA net sales in 2024 between
$2.15B and $2.25B
Achieved INGREZZA net sales of $2.3B
Achieved -
Exceeded High
End of Range
Crinecerfont
f
Activities
Subm
u
it New Drug Applications (NDAs) for
crinecerfont to the FDA by June 30, 2024
Subm
u
itted NDAs for crinecerfont in April 2024
Achieved
Complete key launch readiness activities to support
launch of CRENESSITY by December 31, 2024
Completed founda
f
tional activities, hired
commercial team, and initiated disease state
educ
d
ation platfor
f
m by December 31, 2024
Over Achieved
Advance and Expand
Clinical Pipeline
Phase 3 Portfolio:
Achieved in
Part
• Achieve enrollment target in one Phase 3 study
t
• Met enrollment target in one Phase 3 Study
t
• Complete enrollment in one Phase 3 stud
t
y
Phase 2 Proof-of-
f
Concept Studies:
Over
Achieved*
• Report top-line data in four
f
Phase 2 stud
t
ies
• Reported top-line data on four
f
Phase 2 stud
t
ies
• Complete enrollment in one Phase 2 stud
t
y
• Completed enrollment in one Phase 2 study
t
• Achieve enrollment target in one Phase 2 study
t
• Achieved enrollment target in one Phase 2 study
t
Phase 1 Studies and Development Candidates:
Over Achieved
in Part**
• Initiate one Phase 1 study
t
• Submitted two clinical trial appl
a
ications for
Phase 1 studi
t
es during 2024; first patient
enrollment to occur in 2025
• Identify f
f
our ne
f
w development candidates,
including one biologic or gene therapy
a
• Identified fiv
f e new development candidates,
including at least one biologic
Financial/Operational
• Meet 2024 annual budget for
f
non-GAAP net
income
• Met 2024 annual budget for non-
f
GAAP net
income
Achieved
• Settle the 2024 Notes
• Settled the 2024 Notes in ful
f l upon
u
maturity
• Implement enterprise resource planning (ERP)
system by March 31, 2024
• Successful
f ly implemented a new company-wide
ERP system in Q1 2024 to streamline business,
operational, and fin
f ancial processes
General Business and
People
• Increase manager accountability through
structur
t
ed feedba
d
ck mechanisms
• Implemented processes and procedur
d
es to
solicit, track and analyze manager feed
f
ba
d
ck for
continuous improvement
Achieved
• Build a talent pipeline of program leaders that
spans biologics to small molecules
• Hired program leaders in both our biologics and
small molecule programs
Legal
Continue to maintain company culture of integrity,
ethics and compliance
Enhanced compliance training and related
communication, including targeted programs in the
UK and Europe
Achieved
Overall Achievement:
115%
Business Area /
Initiative
Target
Achievements / Relevant Developments
Overall
Achievement
*
This goal was deemed "Over Achieved" as we reported positive top-line data in three of the four
f
Phase 2 studi
t
es.
**
Although we did not initiate a Phase 1 study prior to December 31 ,2024, the Compensation Committee considered identification of fiv
f e new
development candidates, including at least one biologic, to be the most impactful to the Company and the long-term benefit of stockholders
and this specific goal was deemed to be “Over Achieved”
56
Notwithstanding the Compensation Committee’s determination of our 2024 corporate goal achievement at 115%, the
Compensation Committee had discretion to eliminate any NEO’s bonus or to reduce or increase the amount of any NEO’s bonus
payout amount. However, our CEO's bonus payment cannot be increased above the corporate goal achievement level for
f
the
Company. In January 2025, the Compensation Committee determined whether to exercise its discretion to increase or decrease the
bonus payout amount for each NEO after considering their individual performance contributing to achievement of our corporate goals.
Following such review, the individuals listed below were awarded an increased bonus payout amount in recognition of their
outstanding performance:
•
Mr. Abernethy, in recognition of his role in the Company accomplishing its financial and operational goals for 2024,
including achieving the 2024 annual budget for
f
non-GAAP net income and the successful
f
implementation of a new
company-wide ERP system to streamline business, operational, and fin
f ancial processes;
•
Dr. Onyia, in recognition of his role in the Company exceeding its development program goals for 2024, including the
identification of fiv
f e new development candidates, including a biologic; and
•
Dr. Roberts, in recognition of her role in the Company advancing and expanding its clinical development programs dur
d
ing
2024, including the generation of positive top-line data from three Phase 2 clinical studi
t
es.
The Compensation Committee also utilized its discretion to award Dr. Gorman a bonus payout amount equal to (x) our 2024
corporate goal achievement of 115% multiplied by (y) Dr. Gorman’s ful
f l annual target bonus (100% of his annualized base salary for
2024), as a result of the Company's achievement of its 2024 corporate goals and Dr. Gorman's effort
f
s in fac
f
ilitating a successful
f
CEO
transition. Afte
f r making these determinations, the Compensation Committee approved the bonus payout amounts set forth in the table
a
below.
2024 Target Bonus
2024 Actual Bonus Paid
Named Executive Offi
f cer
% of Base
Salary
$
% of Target
Bonus
$
Kyle W. Gano, Ph.D., Chief Executive Officer (1)
100%
$466,919
115%
$536,906
Kevin C. Gorman, Ph.D., Former Chief Executive Officer
100%
$993,300
115%
$1,141,950
Matthew C. Abernethy, Chief Financial Offi
f cer
50%
$342,412
132%
$452,840
Eric Benevich, Chief Commercial Officer
50%
$318,424
115%
$366,188
Jude Onyia, Ph.D., Chief Scientific Offi
f cer
50%
$338,273
150%
$505,717
Eiry W. Roberts, M.D., Chief Medical Offi
f cer
50%
$343,381
150%
$513,354
(1)
Dr. Gano's total bonus was prorated based on his base salary a
r
nd target bonus opportunity in effe
f ct prior to and following his promotion to CEO in October
2024.
2024 Long-T
g
er
T
m E
r
quity A
t
wards
Annual Equity Award Grants a
t
nd Mix.
i
In the fir
f st quarter of 2024, the Compensation Committee granted long-term equity
awards to our NEOs in the for
f
m of stock options, RSUs and PRSUs after determining that these three types of equity awards
continued to provide the appr
a
opriate balance of long-term and performance-based incentives for our executive officers. The
Compensation Committee generally maintained the overall equity award mix provided to the NEOs in the prior year, but with an
approximate 5% increase in the amount of RSUs granted as a percentage of the total long-term equity award. This increase in RSUs
reflects a slight adju
d stment toward providing more stable, predictable equity compensation that aligns with market data and enhances
retention while still tying compensation to the performance of our common stock over the long term. For our CEO, the Compensation
Committee allocated approximately 50% of the aggregate value of long-term equity awards in the for
f
m of stock options, 30% of such
value in the form of PRSUs and approximately 20% of such value in the form of RSUs. For each of the other NEOs, the
Compensation Committee generally allocated approximately 45-55% of the aggregate value of their long-term equity awards in the
form of stock options, 15-35% of such value in the form of PRSUs and 20-25% of such value in the form of RSUs, primarily based on
each NEO’s expected impact on the achievement of the performance metrics underlying the PRSUs. At the time of the annual equity
grant, Dr. Gano was serving in his role as Chief Business Development and Strategy Offi
f cer.
Promotion Equity Award Grants i
t
n Conne
C
ction with C
t
EO Ap
C
point
p
me
t
nt. In connection with Dr. Gano's promotion to CEO, the
Compensation Committee approved promotion long-term equity awards on November 1, 2024 having an aggregate target grant date
value of $1,500,000 to establ
a ish a total targeted equity vehicle mix of approximately 50% stock options, 30% performance-based
restricted stock units, and 20% restricted stock units. The Compensation Committee determined these promotion long-term equity
awards were appropriate for Dr. Gano in his promoted role, based on market data for pe
f
er company CEOs, Dr. Gano’s experience and
his anticipated role and responsibilities.
57
Equity Awards Grants i
t
n Conne
C
ction with C
t
hi
C ef Medical Offic
O
er Transition. In July 2023, Dr. Roberts notifie
f d the Company
of her decision to retire fro
f
m her position as Chief Medical Officer and agreed to remain in her position until her replacement had been
on-boarded which was originally expected to occur in late 2024 or early 2025. As a result of this anticipated transition, Dr. Robert's
annual long-term equity award granted in Februa
r
ry 2024 was reduc
d
ed by approximately 35% compared to the prior year. After
subs
u
equent discussions, both the Company and Dr. Roberts determined it would be beneficia
f
l to extend the timeline for he
f
r retirement
beyond early 2025. In recognition of this revised timeframe, the Compensation Committee approve
a
d a one-time, off-cycle equity grant
to Dr. Roberts in December 2024 which was designed to restore Dr. Robert's overall long-term equity awards for 2024 to a level
commensurate with her role as Chief Medical Offi
f cer and aligned with market data and the Company's pay practices. The equity
grants consisted of: (i) stock options with a target grant value of approxi
a
mately $1,750,000, with 25% of the shares underlying the
option vesting on February 1
r
3, 2025 and an additional 1/48th of the shares underlying the option vesting each month thereafter
f
beginning on March 13, 2025, such that the option shall fully vest on February 13, 2028; and (ii) RSUs with a target grant value of
approximately $750,000, 25% of which will vest on February 13, 2025, and an additional 25% on each February 13th thereafte
f r,
culminating in ful
f l vesting on Februa
r
ry 13, 2028. All terms and conditions of these additional equity grants were consistent with the
annual long-term equity awards granted in the first quarter of 2024 to our NEOs.
In April 2025, we announced that Sanjay Keswani, M.D., would assume the role of Chief Medical Offi
f cer, effective June 2,
2025. Dr. Keswani will succeed Dr. Roberts who agreed to remain with the Company in a strategic advisory role following her
succession by Dr. Keswani.
Size
i
of 2024 Equity Awards. In determining the size of the total equity compensation opportunity in 2024, the Compensation
Committee:
•
aimed to have the aggregate target award value result in target total direct compensation at a level that is competitive in the
marketpl
t aces in which we compete;
•
maintained a meaningful por
f
tion of total direct compensation in the form of long-term performance equity awards which
only vest upon
u
achievement of the specific, objective criteria described below, which if achieved, the Compensation
Committee believes will drive long-term differentiated value relative to our peers and maximize long-term stockholder
value; and
•
considered the recommendations of the CEO for the other NEOs.
The fol
f lowing tabl
a e summarizes the annual 2024 long-term equity awards for the NEOs:
Stock Options
RSUs
PRSUs
Named Executive Offi
f cer
$*
# of Shares
$*
# of Shares
$*
# of Shares
(Target)
Total ($*)
Kyle Gano, Ph.D., CEO (1)
$ 3,550,000
58,402
$ 1,500,000
11,421
$ 2,200,000
16,233
$ 7,250,000
Kevin Gorman, Ph.D., Former CEO
$ 7,000,000
112,644
$ 3,000,000
22,415
$ 4,000,000
28,686
$14,000,000
Matthew Abernethy, CFO
$ 2,800,000
45,058
$ 1,200,000
8,966
$ 1,400,000
10,040
$ 5,400,000
Eric Benevich, Chief Commercial Officer
$ 2,450,000
39,426
$ 1,050,000
7,846
$ 1,750,000
12,550
$ 5,250,000
Jude Onyia, Ph.D., Chief Scientific Offi
f cer
$ 3,360,000
54,069
$ 1,440,000
10,760
$ 1,000,000
7,172
$ 5,800,000
Eiry Roberts, M.D., Chief Medical Offi
f cer (2)
$ 3,150,000
50,299
$ 1,350,000
9,970
$ 1,000,000
7,172
$ 5,500,000
*
Represents the target grant date fai
f r value of the awards appr
a
oved by the Compensation Committee. The Compensation Committee appr
a
oved the PRSU award
values in Februa
r
ry 2024, but the PRSUs were granted in March 2024 following Compensation Committee appr
a
oval of performance metrics and vesting
requirements for
f
these awards. See the Summary Compensation Table and the Grants of Plan-Based Awards Table included in this Proxy Statement for
f
the
actua
t
l grant date fair value of such awards.
(1)
Includes the following equity awards granted in connection with Dr. Gano's promotion to CEO effe
f ctive in October 2024: (i) stock options with a target grant
value of appr
a
oximately $750,000 that vest in equal monthly installments over a four-year period; (ii) RSUs with a target grant value of appr
a
oximately
$300,000 that vest in equal annual installments over a four-year period; and (iii) PRSUs with a target grant value of appr
a
oximately $450,000 that vest in
accordance with the terms of the PRSU awards granted to Neurocrine Biosciences’ executive officers in March 2024.
(2)
Includes the following equity awards granted to Dr. Roberts in December 2024 as a result of the Company and Dr. Roberts mutua
t
lly agreeing to extend the
timeline for he
f
r retirement (discussed in fur
f
ther detail above): (i) stock options with a target grant value of appr
a
oximately $1,750,000, with 25% of the shares
underlying the option vesting on February 1
r
3, 2025 and an additional 1/48th of the shares underlying the option vesting each month thereafte
f r beginning on
March 13, 2025, such that the option shall fully vest on Februa
r
ry 13, 2028; (ii) RSUs with a target grant value of appr
a
oximately $750,000, 25% of which will
vest on Februa
r
ry 13, 2025, and an additional 25% on each Februa
r
ry 13th thereafte
f r, culminating in ful
f l vesting on February 1
r
3, 2028.
2024 Equity Award Ves
V
ting Criteria. The Compensation Committee determined that the annual equity grants made in February
r
and March of 2024 vest as follows: (i) the stock options vest in equal monthly installments over a four-year period; (ii) the RSUs vest
in equal annual installments over a four-year period; and (iii) the PRSUs vest on the date, or dates, that the Compensation Committee
determines achievement of two u d
nde lrlying pe
ying performance metrics, each of whihi h
ch must occu b
r by the end of a hthree-year performance
pe iri d
od ending on
ding on December 31, 2026.
58
The metrics underlying the PRSUs target certain revenue diversification achievements and business development objectives
that we believe will drive stockholder value within the three-year performance period ending on December 31, 2026. The actual
t
number of earned units subj
u ect to the PRSUs will be determined based on the level of achievement of such metrics, with minimum,
target, and maximum levels specified in the Grants of Plan-Based Awards During the Fiscal Year Ended December 31, 2024 tabl
a e.
The Compensation Committee set the specific performance targets underlying each performance metric at challenging levels that the
Compensation Committee determined would require subs
u
tantial effort to be achieved. We believe disclosing the specific performance
targets while the performance period is ongoing could cause competitive harm, as providing this information could provide
competitors with insights into our strategy and clinical development programs that would be harmful
f
to us. However, we will disclose
the specific performance targets in 2027 following the Compensation Committee’s determination of performance and certification.
2022 PRSUs:
U
Perfor
f
ma
r
nce and Payo
a
ut
In January 2022, the Company granted PRSUs to the NEOs that would vest on hth d
e date,
d
or dates, hthat hth C
e
ompensation
Co
i
mmitte d
e deter i
min d
ed
h
achievement of two separate performance
i
metrics, each within the three-year performance period ending on
December 31, 2024 (the “2022 PRSUs”).
The fir
f st performance metric underlying the 2022 PRSUs, with a relative weighting of 40%, was based on the Company
receiving FDA appr
a
oval of INGREZZA for the treatment of adul
d ts with chorea associated with Huntington's disease (the “INGREZZA
HD Metric”). As previously disclosed, in August 2023, the Compensation Committee certified that the Company had received FDA
approval of INGREZZA for the treatment of adul
d ts with chorea associated with Huntington's disease and that the INGREZZA HD
Metric was achieved at the target performance level. Accordingly, each NEO earned 100% of the target number of PRSUs associated
with the INGREZZA HD Metric in August 2023.
The second performance metric underlying the 2022 PRSUs, with a relative weighting of 60%, was based on the number of
Phase 3 clinical trials initiated by the Company dur
d
ing the performance period, excluding the fol
f lowing programs: valbenazine for
f
dyskinesia in cerebral palsy, valbenazine as an adju
d nctive treatment for schizophrenia, and crinecerfont for the treatment of CAH (the
"Clinical Trial Metric"). The specific performance targets underlying the Clinical Trial Metric, as well as the payout levels at
minimum, target, ups
u
ide, and maximum achievement for the Clinical Trial Metric, are set forth in the tabl
a e below. If the Company
failed to initiate any new Phase 3 clinical trial dur
d
ing the performance period, then no portion of the underlying RSUs associated with
the Clinical Trial Metric would vest.
Achievement
Level
Perfor
f
mance Targets
Payout Level
(as a % of target with respect to the
Clinical Trial Metric)
Minimum
Company initiates one new Phase 3 clinical trial dur
d
ing the performance period
67%
Target
Company initiates two new Phase 3 clinical trials during the performance period
100%
Upside
Company initiates three new Phase 3 clinical trials during the performance period
133%
Maximum
Company initiates four or
f
more new Phase 3 clinical trials during the
performance period
183%
The Company did not initiate any new Phase 3 clinical trials during the three-year performance period ending on December 31,
2024. Accordingly, each NEO for
f
feited all PRSUs associated with the Clinical Trial Metric.
401(k)
(
Retirement Benefits
f
The Company’s matching contribution to the 401(k) Plan for 2024 was 100% of eligible participant contributions, subject to
applicable federal limits. Our NEOs are eligible for these benefits on the same basis as our other employees. The Company made no
additional discretionary contributions to the 401(k) Plan in 2024.
Other Features of our Executive Compensation Program
Severance and Chang
C
e in C
i
on
C
trol Benefi
e ts
i
We provide severance benefit
f s to our NEOs upon certain types of involuntary t
r
ermination events, including terminations in
connection with a change in control of our Company. Historically and dur
d
ing 2024, these benefits
f
were set for
f
th in each NEO’s
employment agreement with the Company. In October 2024, we entered into an amended and restated employment agreement with
Dr. Gano in connection with his promotion to CEO, which contained the updated terms of his employment as our CEO and updated
severance benefits
f
. The Compensation Committee adopted Dr. Gano’s upda
u
ted severance benefits, after a review of market data
provided by FW Cook, to incorporate “best practices” relating to severance payments and more closely align with market data. For
example, for severance benefits paid upon an involuntary t
r
ermination in connection with a change in control, we increased the
“change in control determination period” from six to 12 months following a change in control, we eliminated the automatic cashout
treatment for equity awards and replaced it with a “double trigger” vesting acceleration provision, and we eliminated cash payments
upon a death or disability termination.
59
In early 2025, the Compensation Committee determined it was appropr
a
iate to revise the severance benefits for other executive
offi
f cers, including the NEOs (excluding Dr. Gorman), to align with the updated struc
r
ture approved for
f
Dr. Gano. Accordingly, the
Compensation Committee adopted the Executive Severance Plan to reflect the severance benefits for all NEOs (other than Dr.
Gorman), which supersedes and replaces the severance benefits provided under individual employment agreements. The Executive
Severance Plan refle
f cts Dr. Gano’s severance benefits set for
f
th in his upda
u
ted employment agreement entered into in October 2024. A
more detailed description of the terms and benefits
f
provided under these employment agreements and the Executive Severance Plan is
described in the section of this Proxy Statement entitled “Agreements with Named Executive Officer Effe
f ctive During Fiscal Year
2024”, “Executive Severance Plan” and “Amendment and Restatement of Employment Agreements” below.
As a result of Dr. Gorman’s retirement in October 2024, Dr. Gorman ceased to be an employee of the Company but continues
to provide service to the Company as a non-employee member of the Board of Directors. Dr. Gorman did not receive any severance
payments under his employment agreement or otherwise as a result of his retirement. Dr. Gorman’s employment agreement (and
severance benefits th
f
ereunder) terminated as of October 11, 2024. Because Dr. Gorman’s service on the Board of Directors is
recognized as "continuous service" under the Company's equity incentive plans, Dr. Gorman's outstanding equity awards will remain
outstanding and continue to vest in accordance with their terms. In addition, since becoming a non-employee member of the Board of
Directors on October 12, 2024, Dr. Gorman has been eligible to receive the cash and equity compensation under our non-employee
director compensation program, described below under the section of this Proxy Statement entitled “Directors Compensation
Summary”.
Offi
f cer Equity Ownership Guidelines
Since 2014, we have maintained equity ownership guidelines for
f
our executive officers. The Compensation Committee
amended these guidelines in November 2018 to increase the guideline for our
f
CEO fro
f
m three to six times his base salary. The equity
ownership guidelines are designed to fur
f
ther align the interests of the executive officers with those of our stockholders by ensuring
that our executive offic
f ers have a meaningful
f
financial stake in the Company’s long-term success. The equity ownership guidelines
establ
a ish a minimum equity ownership level by position, with such values determined based on the value of our common stock owned
by such persons as of certain measurement dates. When creating our equity ownership guidelines, the Compensation Committee
adopted the view that the in-the-money value of vested stock options are of equivalent ownership value to the value of such stock
options had they been exercised for shares of our common stock. Accordingly, all shares directly or beneficially owned by the
executive officer, including the net exercisabl
a e value of outstanding vested stock options (where the market price of our common stock
exceeds the strike price of such option) are included in determining the value of equity owned under our equity ownership guidelines.
Unvested RSUs or PRSUs are excluded for pur
f
pos
r
es of determining the value of equity owned under our equity ownership guidelines.
The equity ownership requirements are as follows:
Chief Executive Officer
6 times base salary
All other executive officers
1 times base salary
New executive officers are granted a fiv
f e-year period to reach the equity ownership requirements set forth in the guidelines
and are expected to make annual progress toward the equity ownership requirements dur
d
ing this fiv
f e-year period. When an executive
offi
f cer does not meet the equity ownership requirements set forth in the guidelines, he/she is restricted fro
f
m selling any held shares
until such requirements are met. Additionally, should an executive officer who does not meet the equity ownership requirements
choose to exercise a stock option or vest in any RSUs or PRSUs, he or she is required to retain all shares acquired through those
transactions, aside from any shares necessary to fulfill such transaction related tax obligations, until full compliance with the equity
ownership guidelines is attained.
Annual compliance with the equity ownership guidelines is assessed dur
d
ing the fourth quarter of each year. As of March 24,
2025, each of our executive officers was in compliance with the equity ownership guidelines.
Equity Trading Policies and Procedures
The Company has adopted insider trading policies and procedur
d
es governing the purchase, sale and/or other dispositions of the
Company’s securities by its directors, offi
f cers, employees and consultants that are reasonably designed to promote compliance with
insider trading laws, rul
r es and regulations, and any listing standards appl
a
icable to the Company. It is also the Company’s intent to
comply with applicable laws and regulations relating to insider trading. In addition, the Company's policies prohibit direct or indirect
participation by directors, offi
f cers and other employees of the Company in transactions involving trading activities in Company
common stock which by their aggressive or speculative natur
t
e may give rise to an appearance of impropriety. Such prohibited
activities would include the purchase of put or call options, or the writing of such options as well as short sales, hedging transactions
such as “cashless” collars, forward sales, equity swaps and other related arrangement which may indirectly involve short-sale and any
other transactions designed for pr
f
ofit
f
from short-term movement in the Company’s stock price. In addition, no offi
f cer, director or
employee of the Company may margin, or make any offe
f r to margin, any Company common stock, including without limitation,
borrowing against such stock, at any time. Under the policies, a contribution of the Company’s securities to an exchange fund not
designed to hedge any decrease in the market value of Neurocrine's equity securities is not considered a for
f
m of hedging; however,
60
such contribution by an employee or director remains subj
u ect to the other provisions of the Company’s insider trading policy,
including provisions regarding quarterly trading blackout periods and pre-clearance requirements.
To the Company’s knowledge, there were no transactions involving hedging, pledging or margining Company common stock
during 2024, nor were there any such transactions as of the Record Date.
The Company also requires directors and executive offi
f cers to complete all equity related open-market purchase and sale
transactions via a 10b5-1 plan. The 10b5-1 plans typically cover, among other transactions, direct sales and purchases of Company
stock, as well as same-day-sales related to option exercises and sales of stock for tax payments upon the vesting of RSUs. All 10b5-1
plans are required to have a waiting period from the election date to the date of the first transaction. Additionally, Company policy
restricts the executive offi
f cers from amending a 10b5-1 trading plan.
Equity Grant Practices
All equity awards granted to our NEOs are approved by the Compensation Committee on or prior to the date of grant. While
the Compensation Committee does not have a formal policy or obligation to grant equity awards to NEOs on specific dates, the
Compensation Committee’s typical practice is to review the Company’s performance results and our NEOs’ individual performances
following the end of each fiscal year, as well as the then-outstanding equity awards held by our NEOs, and then, based on those
reviews, approve annual equity awards (including stock options) to our NEOs shortly following our annual release of financial results
for the prior fiscal year. Additionally, our Compensation Committee approves the granting of equity awards in connection with the
commencement of employment or promotion of our NEOs, and from time to time as otherwise determined appropriate by our
Compensation Committee. The Compensation Committee does not grant equity awards in anticipation of the release of material
nonpublic information (“MNPI”) and we do not time the release of MNPI based on equity award grant dates or for the purposes of
affe
f cting the value of executive compensation. For additional information regarding the timing of our equity awards and stock options
as required by Item 402(x) of Regulation S-K, please see the section below entitled “Policies and Practices Related to the Grant of
Certain Equity Awards Close in Time to the Release of Material Nonpublic Information”.
Compensation Recoupment Policy
In October 2023, the Compensation Committee adopted a compensation recoupment policy, as required by SEC rules and
Nasdaq listing standards, that provides for recoupment of certain cash and equity-based incentive compensation paid to current and
former executive offi
f cers of the Company in the event of an accounting restatement of the Company’s financial statements. The policy
applies to all incentive compensation that is received by a covered offi
f cer on or afte
f r October 2, 2023.
Our prior compensation recoupment policy, which still applies to incentive compensation that is received by a covered offi
f cer
prior to October 2, 2023, provides that, in the event (i) we are required to prepare an accounting restatement for any fiscal quarter or
year due to our material noncompliance with any financial reporting requirement and (ii) it is determined that misconduct contributed
to the noncompliance that resulted in the obligation to restate our financial statements, we may take action to recover from any offi
f cer
whose misconduct contributed to the noncompliance which resulted in the obligation to restate our financial statements, the incentive
compensation, including cash and equity, that was paid or vested to such offi
f cer during the twelve-month period preceding the
restatement obligation.
Our compensa ition recoupment
l
poli i
icies are d
ad i
mi inist
d
ered by
by hthe Compensa ition Co
i
mmittee.
Tax and Accounting Considerations
Internal Revenue Code Sectio
t n 162(m)
(
Under Section 162(m) of the Internal Revenue Code (“Section 162(m)”), compensation paid to each of the Company’s
“covered employees” that exceeds $1 million per taxable year is generally non-deductible unless the compensation qualifies for certain
grandfat
f hered exceptions (including the “performance-based compensation” exception) for certain compensation paid pursuant to a
written binding contract in effe
f ct on November 2, 2017 and not materially modified on or afte
f r such date.
In light of the repeal of the performance-based compensation exemption under Section 162(m), the Compensation Committee
may authorize compensation that is not deductible if it is determined to be appropriate and in the best interests of the Company and
our stockholders.
Accountin
t
g Consider
d
atio
t ns
The Company accounts for equity compensation paid to our employees under the FASB ASC Topic 718, which requires us to
estimate and record an expense over the service period of the equity award. Our cash compensation is recorded as an expense at the
time the obligation is incurred. The accounting impact of our compensation programs are one of many factors that the Compensation
Committee considers in determining the structur
t
e and size of our executive offi
f cer compensation programs.
61
Risk Analysis of Our Compensation Program
Our Compensation Committee has reviewed our compensation policies as generally applicable to our employees and believes
that our policies do not encourage excessive or inappropriate risk taking and that the level of risk that they do encourage is not
reasonably likely to have a material adverse effe
f ct on the Company. As part of its assessment, the Compensation Committee
considered, among other factors, the allocation of compensation among base salary and short- and long-term compensation, our
approach to establ
a ishing Company-wide and individual financial, operational and other performance targets, our bonus structur
t
e of
payouts at multiple levels of performance (including maximum payout caps and payments for performance below target levels) and
the nature of our key performance metrics. We believe these practices encourage our employees to focus on sustained, long-term
Company growth, which we believe will ultimately contribute to the creation of stockholder value.
62
EXECUTIVE COMPENSATION AND OTHER INFORMATION
The fol
f lowing tabl
a es set for
f
th the compensation paid by the Company for 2022, 2023
f
and 2024 to the NEOs named below.
Summary Compensation Table
Name and Principal Position (1)
Year
Salary
($) (2)
Bonus
($) (2)
Option
Awards
($) (3)
Stock
Awards
($) (4)
All
Other
Compensation
($) (5)
Total ($)
Kyle W. Gano, Ph.D..........................
2022
$550,605
$332,428
$2,775,053
$1,725,086
$38,485
$5,421,657
Chief Executive Officer
2023
$5,990,215
$602,912
$331,602
$3,187,536
$1,812,563
$55,602
2024
$8,535,422
$698,217
$536,906
$3,549,970
$3,700,106
$50,223
Kevin C. Gorman, Ph.D.....................
2022
$860,000
$989,000
$4,875,106
$5,125,079
$53,342
$11,902,527
Former Chief Executive Offi
f cer
2023
$946,000
$1,040,600
$6,678,790
$7,021,386
$64,036
$15,750,812
2024
$779,357
$1,141,950
$6,999,698
$7,000,139
$97,493
$16,018,637
Matthew C. Abernethy
..........
$618,240
$373,262
$2,310,061
$1,570,128
$52,632
$4,924,323
2022
Chief Financial Offi
f cer
$646,061
$355,335
$3,187,536
$1,812,563
$56,387
$6,057,882
2023
20
$684,824
$452,840
$2,799,904
$2,599,987
$57,646
$6,595,201
24
Eric Benevich (6)...............................
Chief Commercial Officer
2024
$636,848
$366,188
$2,449,932
$2,800,081
$53,115
$6,306,164
Jude Onyia, Ph.D...............................
$575,000
$330,625
$225,008
$1,275,146
$55,520
$2,461,299
2022
Chief Scientific Offi
f cer
$638,250
$351,038
$3,375,024
$2,625,124
$233,780
$7,223,216
2023
20
$676,545
$505,717
$3,359,848
$2,440,182
$53,559
$7,035,851
24
Eiry W. Roberts, M.D........................
2022
$631,912
$345,182
$2,625,057
$2,075,144
$57,986
$5,735,281
Chief Medical Offi
f cer
2023
$660,348
$399,511
$2,625,024
$2,125,112
$63,852
$5,873,847
2024
$686,761
$513,354
$3,150,017
$2,350,087
$64,099
$6,764,318
(1)
The titles and capacities set forth in the tabl
a e above
a
are as of December 31, 2024.
(2)
Salary a
r
nd bonus figures represent amounts earned dur
d
ing each respective fis
f cal year, regardless of whether part or all of such amounts were paid in
subs
u
equent fiscal year(s). Bonuses are awarded pursuant to a bonus program.
(3)
The amounts shown are the ful
f l grant date fair value in accordance with Accounting Standards Codification 718-10, Compensation—Stock Compensation
(ASC 718). The assumptions used to calculate the grant date fair value of option awards are set for
f
th under Note 7 of the Notes to the Consolidated Financial
Statements included in the Company’s Annual Report on Form 10-K for
f
the year ended December 31, 2024 filed with the SEC on Februa
r
ry 10, 2025. The
grant date fai
f r values of option awards for 2024
f
(other than the option awards granted to Dr. Gano in November 2024 in connection with his promotion to
CEO and Dr. Roberts in December 2024 in connection with the extended timeline for he
f
r retirement) are based on per share Black-Scholes values of $62.14.
The grant date fair value of Dr. Gano's option award granted in November 2024 and Dr. Robert's option award granted in December 2024 is based on a per
share Black-Scholes value of $56.21 and $63.02, respectively.
(4)
Stock awards consist of RSUs and PRSUs and may be subject to deferred delivery a
r
rrangements. The amounts shown are the ful
f l grant date fair value in
accordance with Accounting Standards Codification 718-10, Compensation—Stock Compensation (ASC 718). The assumptions used to calculate the grant
date fair value of stock awards are set forth under Note 7 of the Notes to the Consolidated Financial Statements included in the Company’s Annual Report on
Form 10-K for
f
the year ended December 31, 2024 filed with the SEC on Februa
r
ry 10, 2025. The fai
f r values of RSUs granted in 2024 are based on the
Company’s closing market price per share on the grant date, which was $133.84 for all 2024 RSU grants (other than the RSUs granted to Dr. Gano in
November 2024 in connection with his promotion to CEO and to Dr. Roberts in December 2024 in connection with the extended timeline for he
f
r retirement,
for which the Company's closing market price per share on such grant dates was $122.21 and $136.69, respectively). The fair values of PRSUs granted in
2024 are based on the Company's closing market price per share on the grant date, which was $139.44 for 2024 PRSU grants, except for
f
the PRSU granted to
Dr. Gano in November 2024 in connection with his promotion to CEO, which was $122.21. The PRSU values included in the tabl
a e above
a
are based on the
target number of shares subject to the PRSU awards. If the highest level of performance metrics are achieved, the PRSU values based on the maximum
number of shares issuable to each NEO for 2024
f
are as fol
f lows: Dr. Gano – $2,750,000, Dr. Gorman – $5,000,000, Mr. Abernethy – $1,750,000, Mr.
Benevich – $2,187,500, Dr. Onyia – $1,250,000, and Dr. Roberts – $1,250,000.
(5)
Includes all other compensation as described in the table below.
(6)
Mr. Benevich was not a named executive officer during fis
f cal years 2022 and 2023.
63
All O
l
ther Compensation Tabl
T
e f
l
or 2024
f
Name
Year
401(k)
Employer
Match
Insurance
Premiums (1)
Other
Total
Other
Kyle W. Gano, Ph.D................................................
2024
$20,700
$29,523
—
$50,223
Kevin C. Gorman, Ph.D. (2) .................................
2024
$18,244
$30,299
$48,950
$97,493
Matthew C. Abernethy (3)
.................................
2024
$20,700
$35,346
$1,600
$57,646
Eric Benevich .........................................................
2024
$20,700
$32,415
—
$53,115
Jude Onyia, Ph.D.....................................................
2024
$20,700
$32,859
—
$53,559
Eiry W. Roberts, M.D. (4)
.................................
$1,600
$64,099
2024
$20,700
$41,799
(1)
The amounts in this column represent the costs for medical insurance for
f
Company-wide plans, as well as disabi
a lity insurance premiums.
(2)
For 2024, amounts in the column "Other" for
f
Dr. Gorman includes: (a) $3,364 in non-taxable benefits
f
related to spousal travel to attend business func
f
tions, (b)
$13,207 in fees for Dr. Gorman's service as a non-employee director of the Company from October 11, 2024 through December 31, 2024, and (c) $32,379 for
commemorative gifts in connection with Dr. Gorman's retirement as CEO and in recognition for ove
f
r 30 years of service to the Company.
(3)
For 2024, the amount in the column "Other" for Mr. Abernethy represents employer contributions to a health savings account.
(4)
For 2024, the amount in the column "Other" for Dr. Roberts represents employer contributions to a health savings account.
Grants of Plan-Based Awards During 2024
The fol
f lowing tabl
a e sets for
f
th certain information regarding plan based awards granted by the Company during 2024 to the
NEOs below:
Estimated Future Payouts Under PRSU
Awards (1)
All Other
Stock Awards:
Number of
Shares of
Stock or Units
(#)(2)
All Other
Option Awards:
Number of
Securities
Underlying
Options (#)(2)
Exercise
Price of
Option
Awards
($/Sh)(2)
Grant Date
Fair
Value (3)
Name
Approval
Date
Grant
Date
Minimum(
#)
Target
(#)
Maximum
(#)
Kyle W. Gano, Ph.D..........
2/2/
2/13/2024
2024
8,966
$1,200,009
3/18/
3/18/2024
2024
(1
1
)
0,040
15,688
12,550
$1,749,972
2/2/2024
2/13/2024
45,058
$2,799,904
$133.84
10/10/2024
11/1/2024
2,455
$300,026
10/10/2024
11/1/2024 (1)
2,946
3,683
11,205
$450,099
10/10/2024
11/1/2024
13,344
$122.21
$750,066
Kevin C. Gorman, Ph.D. ...
2/2/2024
2/13/2024
22,415
$3,000,024
3/18/2024
3/18/2024 (1)
22,949
28,686
35,858
$4,000,115
2/2/2024
2/13/2024
112,644
$133.84 $6,999,698
Matthew C. Abernethy.
2/2/2024
2/13/2024
8,966
$1,200,009
3/18/2024
3/18/2024 (1)
8
10,040
12,550
,032
$1,399,978
2/2/2024
2/13/2024
$2,799,904
45,058
$133.84
Eric Benevich
2/2/2024
2/13/2024
7,846
$1,050,109
3/18/2024
3/18/2024 (1)
10,040
12,550
15,688
$1,749,972
2/2/2024
2/13/2024
39,426
$133.84 $2,449,932
Jude Onyia, Ph.D.
2/2/2024
2/13/2024
10,760
$1,440,118
3/18/2024
3/18/2024 (1)
5,737
7,172
8,965
$1,000,064
2/2/2024
2/13/2024
54,069
$133.84 $3,359,848
Eiry W. Roberts, M.D.
2/2/2024
2/13/2024
4,483
$600,005
3/18/2024
3/18/2024 (1)
5,737
7,172
8,965
$1,000,064
2/2/2024
2/13/2024
22,529
$133.84 $1,399,952
12/17/2024
12/17/2024
5,487
$750,018
12/17/2024
12/17/2024
27,770
$136.69 $1,750,065
(1)
Represents the number of shares that may be earned under the PRSUs granted to NEOs in 2024 under the Company’s Amended 2020 Plan. The PRSUs will
vest on the date, or dates, that the Compensation Committee determines achievement of two underlying performance metrics, each of which must occur before
f
December 31, 2026. Such metrics relate to certain revenue diversification achievements and business development objectives which we believe will drive
stockholder value within the 36-month performance period commencing on January 1, 2024 and ending on December 31, 2026. The actua
t
l number of units
subj
u ect to the PRSUs will be determined based on the level of achievement of such metrics, with minimum, target, and maximum levels specified.
64
(2)
Option awards granted have an exercise price equal to the closing market price of the Company’s common stock on the date of grant. Except for the option
award granted to Dr. Roberts in December 2024, all option awards are time-based awards, which vest monthly, on a pro-rata basis, over four years and have
an option term of ten years. Except for the RSU granted to Dr. Roberts in December 2024, all RSUs vest annually, on a pro-rata basis, over a four-year period.
As discussed above, the Compensation Committee approved a one-time, off-c
f
ycle equity award to Dr. Roberts in December 2024 in connection with the
extended timeline for her retirement. The option award granted to Dr. Roberts in December 2024 is a time-based award, with 25% of the shares underlying the
option vesting on Februa
r
ry 13, 2025 and an additional 1/48th of the shares underlying the option vesting each month thereafte
f r beginning on March 13, 2025,
such that the option shall fully vest on Februa
r
ry 13, 2028. With respect to RSU award granted to Dr. Roberts in December 2024, 25% of the RSU will vest on
Februa
r
ry 13, 2025, and an additional 25% of the RSU will vest on each Februa
r
ry 13th thereafte
f r, culminating in full vesting on Februa
r
ry 13, 2028.
(3)
Refle
f cts the grant date per share Black-Scholes value of $62.14, $56.21, and $63.02 for option awards granted on Februa
r
ry 13, 2024, November 1, 2024, and
December 17, 2024, respectively. The grant date per share value of $133.84, $122.21 and $136.69 for RSUs granted on Februa
r
ry 13, 2024, November 1,
2024, and December 17, 2024, respectively, and $139.44 and $122.21 for PRSUs which were granted on March 18, 2024 and November 1, 2024, all of which
were calculated in accordance with ASC 718.
Agreements with Named Executive Offi
f cers Effe
f ctive During Fiscal Year 2024
On Februa
r
ry 7, 2025, we entered into amended and restated employment agreements (the "Amended Employment
Agreements") with each of our executive offi
f cers, including Dr. Gano, Mr. Abernethy, Mr. Benevich, Dr. Onyia, and Dr. Roberts. The
Amended Employment Agreements amend and restate the employment agreements summarized below that we previously entered into
with our executive offi
f cers and which were in effe
f ct during the 2024 fiscal year. For further information regarding these Amended
Employment Agreements, please see the section entitled “Amendment and Restatement of Employment Arrangements” below.
Kyle W. Gano, Ph.D. On November 12, 2014, we entered into an employment agreement with Dr. Gano with respect to his
employment, compensation and benefits as Chief Business Development Offi
f cer. This employment agreement provided: (i) that Dr.
Gano would serve as the Company’s Chief Business Development Offi
f cer commencing on November 12, 2014 at an initial annual
salary of $310,000, subj
u ect to annual adju
d stment by the Board of Directors (Dr. Gano’s annual base salary for 2024 prior to his
promotion to CEO was $645,116); (ii) that the agreement would terminated upon death, disabi
a lity, termination by the Company with
or without cause, construc
r
tive termination or voluntary
r resignation; (iii) Dr. Gano would be eligible for a discretionary annual bonus
as determined by the Board of Directors, based upon achieving certain performance criteria; and (iv) Dr. Gano would be eligible to
receive equity awards with the number of shares, vesting terms, and exercise price as determined by the Board of Directors.
In connection with Dr. Gano's appointment to serve as CEO, on October 11, 2024, we entered into an Amended and Restated
Employment Agreement with Dr. Gano (the “2024 Gano Agreement”). The 2024 Gano Agreement provided: (i) that Dr. Gano would
be entitled to receive an annual base salary of $900,000 per year, (ii) Dr. Gano would be eligible to receive an annual cash incentive
bonus with an initial target bonus amount equal to 100% of his base pay earned for the applicable year; (iii) Dr. Gano would be
eligible to receive equity awards with the number of shares, vesting terms, and exercise price as determined by the Compensation
Committee; and (iv) Dr. Gano would receive the following equity grants in connection with his promotion: (a) stock options with a
target grant value of approximately $750,000 that vest in equal monthly installments over a four-year period (the “Promotion Option
Grant”); (ii) RSUs with a target grant value of approximately $300,000 that vest in equal annual installments over a four-year period
(the “Promotion RSU Grant”); and (iii) PRSUs with a target grant value of approximately $450,000 that vest in accordance with the
terms of the PRSUs granted to our executive offi
f cers in March 2024 (the “Promotion PRSU Grant” and, together with the Promotion
Option Grant and the Promotion RSU Grant, the “Promotion Equity Grants”). The Promotion Equity Grants were automatically
granted to Dr. Gano on November 11, 2024, the date that was two business days following the filing of our first quarterly report on
Form 10-Q following the effe
f ctive date of the 2024 Gano Agreement.
Kevin
i
C. Gorman, Ph.D. Prior to his retirement as CEO of the Company effe
f ctive October 11, 2024, Dr. Gorman's
employment contract provided that: (i) Dr. Gorman would serve as the Company’s Executive Vice President and Chief Operating
Offi
f cer commencing on August 1, 2007 at an initial annual salary of $400,000, subj
u ect to annual adju
d stment by the Board of Directors
(subsequent to entering into this employment contract, Dr. Gorman became Chief Executive Offi
f cer and his annual base salary for
2024 was $993,300); (ii) the agreement would terminate upon death, disabi
a lity, termination by the Company with or without cause,
construc
r
tive termination or voluntary
r resignation; (iii) Dr. Gorman would be eligible for a discretionary annual bonus as determined
by the Board of Directors, based upon achieving certain performance criteria; and (iv) each year starting in 2007 and continuing for
the term of the agreement, Dr. Gorman was eligible to receive equity awards with the number of shares, vesting terms, and exercise
price as shall be determined by the Board of Directors. Dr. Gorman's employment contract terminated upon his retirement effe
f ctive
October 11, 2024.
Matthew C. Abernethy.
h
On November 29, 2017, we entered into an employment agreement with Mr. Abernethy with respect
to his employment, compensation and benefits as Chief Financial Offi
f cer. Mr. Abernethy's employment agreement provided: (i) for an
initial annual base salary of $420,000 per year, which was his base salary for 2018, subj
u ect to future adju
d stments (Mr. Abernethy’s
annual base salary for 2024 was $684,824); (ii) that the agreement would terminate upon death, disabi
a lity, termination by the
Company with or without cause, construc
r
tive termination or voluntary
r resignation; (iii) Mr. Abernethy would be eligible to receive an
annual incentive bonus with an initial target bonus amount equal to 50% of his base pay earned for the applicable year; (iv) Mr.
Abernethy would be eligible to receive equity awards with the number of shares, vesting terms, and exercise price as determined by
the Compensation Committee; (v) for a one-time cash inducement advance in the amount of $180,000, which was deemed earned in
2020 as Mr. Abernethy completed two full years of employment with the Company; and (vi) for relocation benefits, including a one-
time cash relocation advance in the amount of $140,000.
65
Eric Benevich. On May 26, 2015, we entered into an employment agreement with Mr. Benevich with respect to his
employment, compensation and benefits as Chief Commercial Offi
f cer. Mr. Benevich's employment agreement provided: (i) for an
initial annual base salary of $365,000 per year, which was his base salary for 2015, subj
u ect to future adju
d stments (Mr. Benevich's
annual base salary for 2024 was $636,848); (ii) that the agreement would terminate upon death, disabi
a lity, termination by the
Company with or without cause, construc
r
tive termination or voluntary
r resignation; (iii) Mr. Benevich would be eligible to receive an
annual incentive bonus with an initial target bonus amount equal to 50% of his base pay earned for the applicable year; and (iv) Mr.
Benevich would be eligible to receive equity awards with the number of shares, vesting terms, and exercise price as determined by the
Compensation Committee.
Jude Onyi
n a, Ph.D. On November 29, 2021, we entered into an employment agreement with Dr. Onyia with respect to his
employment, compensation and benefits as Chief Scientific
f
Offi
f cer. Dr. Onyia's employment agreement provided: (i) for an initial
annual base salary of $575,000, subj
u ect to future adju
d stments (Dr. Onyia's annual base salary for 2024 was $676,545); (ii) that the
agreement would terminate upon death, disabi
a lity, termination by the Company with or without cause, construc
r
tive termination or
voluntary
r resignation; (iii) Dr. Onyia would be eligible to receive an annual incentive bonus with an initial target bonus amount equal
to 50% of his base pay earned for the applicable year; (iv) Dr. Onyia would eligible to receive equity awards with the number of
shares, vesting terms, and exercise price as set forth in the employment agreement and as be determined by the Compensation
Committee; and (v) for a one-time cash inducement advance in the amount of $175,000, which was deemed earned in November 2023
when Dr. Onyia completed two full years of employment with the Company.
Eiry W.
i
Roberts, M.D. On January 8, 2018, we entered into an employment agreement with Dr. Roberts with respect to her
employment, compensation and benefits as Chief Medical Offi
f cer. Dr. Roberts' employment agreement provided: (i) for an initial
annual salary of $520,000, subj
u ect to annual adju
d stment by the Board of Directors (Dr. Roberts’ annual base salary for 2024 was
$686,761); (ii) that the agreement would terminate upon death, disabi
a lity, termination by the Company with or without cause,
construc
r
tive termination or voluntary
r resignation; (iii) Dr. Roberts would be eligible to receive annual incentive bonus with an initial
target bonus amount equal to 50% of her base pay earned for the applicable year; (iv) Dr. Roberts is eligible to receive equity awards
with the number of shares, vesting terms, and exercise price as shall be determined by the Compensation Committee; (v) for a one-
time cash inducement advance in the amount of $225,000, which was deemed earned in early 2021 when Dr. Roberts completed two
full years of employment with the Company; and (vi) for relocation benefits, including a one-time cash relocation advance in the
amount of $220,000.
The foregoing is only a brief description of certain terms of each of the employment agreements, does not purport to be
complete, and is qualifie
f d in its entirety by reference to the full text of the employment agreements, copies of which are filed as
exhibits to our Annual Reports on Form 10-K or Quarterly Reports on Form 10-Q, as appropriate.
Executive Severance Plan
On Februa
r
ry 7, 2025, the Compensation Committee approved and adopted an Executive Severance Plan (the "Severance
Plan"), pursuant to which executive offi
f cers are eligible to participate, including Dr. Gano, Mr. Abernethy, Mr. Benevich, Dr. Onyia,
and Dr. Roberts (each, a "Covered Employee", and collectively, the "Covered Employees"). Pursuant to the Severance Plan, the
Covered Employees are eligible to receive the severance benefits described below, contingent upon the respective Covered
Employee’s execution of a general release of claims in favor of the Company as further described in the Severance Plan. The
severance benefits provided pursuant to the Severance Plan supe
u
rsede any severance benefits to which the Covered Employees were
previously entitled, including pursuant to their respective employment agreements.
The Severance Plan provides that, upon (a) a termination of a Covered Employee’s employment without “cause” (as defined in
the Severance Plan) and other than due to death or “disability” (as defined in the Severance Plan) or (b) the Covered Employee’s
“resignation for good reason” (as defined in the Severance Plan), in each case outside of the time period beginning with the date on
which a “change in control” (as defined in the Severance Plan) occurs and ending 12 months following the change in control, or the
“change in control determination period,” the Covered Employee will be entitled to receive: (1) cash severance equal to the product of
(x) the sum of (i) the Covered Employee’s annual base salary and (ii) the Covered Employee’s target annual incentive bonus for the
year of termination, multiplied by (y) 1 (or 1.5 for Dr. Gano); (2) a cash payment equal to the Covered Employee’s pro rata annual
incentive bonus for the year of termination based on actua
t
l achievement of the applicable performance goals for such year; (3)
payment of premiums for continued coverage under the Company’s group health plans for up to 12 months (or 18 months for Dr.
Gano); (4) accelerated vesting of the Covered Employee’s outstanding time-vesting equity awards to the extent such awards were
scheduled to vest under their terms based on the Covered Employee’s continued service over the 12-month period (or 15-month period
for Dr. Gano) following the date of termination; and (5) vesting of the Covered Employee’s outstanding performance-vesting equity
awards to the extent the Compensation Committee determines, in its sole discretion, that the applicable performance goals for such
awards have been met as of the date of termination.
66
In addition, the Severance Plan provides that, upon (a) a termination of a Covered Employee’s employment without “cause”
and other than due to death or “disability” or (b) the Covered Employee’s “resignation for good reason, in each case within the change
in control determination period, the Covered Employee will be entitled to receive, in lieu of the benefits described above: (1) a cash
payment equal to the product of (x) the sum of (i) the Covered Employee’s annual base salary and (ii) the Covered Employee’s target
annual incentive bonus for the year of termination, multiplied by (y) 1.5 (or 2 for Dr. Gano); (2) a cash payment equal to the Covered
Employee’s pro rata target annual incentive bonus for the year of termination; (3) payment of premiums for continued coverage under
the Company’s group health plans for up to 18 months (or 24 months for Dr. Gano); and (4) full vesting acceleration of the Covered
Employee’s outstanding equity awards, with performance-vesting equity awards vesting at the greater of (x) the target level of
performance or (y) the actua
t
l level of performance measured in accordance with the applicable performance goals as of the date of
termination, as determined by the Compensation Committee in its sole discretion.
The Severance Plan further provides that, upon the termination of a Covered Employee’s employment due to his or her death
or “disability” (as defined in the Severance Plan), the Covered Employee will be entitled to receive full vesting acceleration of the
Covered Employee’s outstanding equity awards, with performance-vesting equity awards vesting at the greater of (x) the target level
of performance or (y) the actual level of performance measured in accordance with the applicable performance goals as of the date of
termination, as determined by the Compensation Committee in its sole discretion.
The foregoing description of the Severance Plan does not purport to be complete and is qualified in its entirety by reference to
the full text of the Severance Plan, a copy of which is filed as an exhibit to our Annual Report on Form 10-K for the period ended
December 31, 2024.
Amendment and Restatement of Employment Arrangements
In connection with the adoption of the Severance Plan, and upon the approval by the Compensation Committee, on Februa
r
ry 7,
2025, we entered into amended and restated employment agreements (the Amended Employment Agreements) with each of our
executive offi
f cers, including Dr. Gano, Mr. Abernethy, Mr. Benevich, Dr. Onyia, and Dr. Roberts. The Amended Employment
Agreements amend and restate the employment agreements that we previously entered into with our executive offi
f cers. Provisions that
were amended include, among other things:
•
Each Amended Employment Agreement provides that the executive offi
f cer is eligible for severance benefits under the terms
and conditions of the Severance Plan and that such benefits supe
u
rsede the severance benefits set forth in his or her prior
employment agreement.
•
Pursuant to their respective Amended Employment Agreements, Dr. Gano, Mr. Abernethy, Mr. Benevich, Dr. Onyia, and Dr.
Roberts will receive an annual base salary of $920,000, $725,913, $668,690, $720,520 and $731,400, respectively, and will
continue to be eligible to receive an annual cash incentive bonus with a target bonus amount equal to 50% (or 100% for Dr.
Gano) of his or her base pay earned for the applicable year.
•
Each Amended Employment Agreement provides that compensation provided thereunder, under the Severance Plan, or
otherwise awarded or paid to the executive offi
f cer in connection with his or her employment with the Company will be
subj
u ect to recoupment in accordance with the following, as applicable: (i) the Neurocrine Biosciences, Inc. Policy for
Recoupment of Incentive Compensation, as may be amended from time to time (covering incentive compensation that is
received by a covered offi
f cer prior to October 2, 2023); (ii) the Neurocrine Biosciences, Inc. Incentive Compensation
Recoupment Policy, as may be amended from time to time (covering incentive compensation that is received by a covered
offi
f cer on or afte
f r October 2, 2023); (iii) any clawback policy that we are required to adopt pursuant to the listing standards of
any national securities exchange or association on which our securities are listed or as is otherwise required by the Dodd-
Frank Wall Street Reform and Consumer Protection Act or other applicable law; and (iv) any other clawback policy that we
adopt.
The foregoing is only a brief description of certain terms of the Amended Employment Agreements, does not purport to be
complete, and is qualifie
f d in its entirety by reference to the full text of the Amended Employment Agreements, copies of which are
filed as exhibits to the Annual Report on Form 10-K for the period ended December 31, 2024.
67
Outstanding Equity Awards at Fiscal Year-End. The fol
f lowing tabl
a e sets for
f
th the outstanding equity awards held by the NEOs as
of December 31, 2024:
Outstanding Equity Awards Table
Option Awards
Stock Awards
Name
Award
Grant and
Commencement
of Vesting Date
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Equity
Incentive
Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
Option
Exercise
Price ($)
Option
Expiration
Date
Number
of
Shares
or Units
of
Stock
That
Have
Not
Vested (#) (3)
Market
Value of
Shares
or Units
of Stock
That
Have Not
Vested ($)
Equity
Incentive
Plan Awards:
Number of
Unearned
Shares, Units
or Other
Rights That
Have Not
Vested (#)
Equity
Incentive
Plan
Awards:
Market or
Payout
Value of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested ($)
Kyle W. Gano, Ph.D..........
2/3/2015
65,000
—
—
$32.99
2/3/2025 (2)
—
—
—
—
2/5/2016
36,400
—
—
$35.99
2/5/2026 (2)
—
—
—
—
2/6/2017
60,000
—
—
$43.24
2/6/2027 (2)
—
—
—
—
2/5/2018
30,400
—
—
$81.49
2/5/2028 (2)
—
—
—
—
2/7/2019
66,673
—
—
$81.05
2/7/2029 (2)
—
—
—
—
2/6/2020
76,683
—
—
$102.90
2/6/2030 (2
—
)
—
—
—
2/8/2021
47,005
2,044
—
$117.63
2/8/2031 (2
1
)
253,890
,860
—
—
1/31/2022
58,129
21,591
—
$79.02
1/31/2032 (2
5
)
799,071
,854
6,075 (4)
829,238
2/13/2023
29,237
34,552
—
$103.52
2/13/2033 (2
7
)
1,050,777
,698
—
—
5/19/2023
—
—
—
—
—
—
7,974 (5)
1,088,451
2/13/2024
9,387
35,671
—
$
2/13/2034
133.84
(2
8
)
1,223,859
,966
—
—
3/18/2024
—
—
—
—
—
1
—
2,550 (6
1
)
,713,075
11/1/2024
278
13,066
$
—
11/1/2034
122.21
(2)
2,455
335,108
3,683 (6)
502,729
Kevin C. Gorman, Ph.D.
2/3/2015
146,105
—
—
$32.99
2/3/2025 (2)
—
—
—
—
2/5/2016
106,322
—
—
$35.99
2/5/2026 (2)
—
—
—
—
2/6/2017
205,088
—
—
$43.24
2/6/2027 (2)
—
—
—
—
2/5/2018
104,200
—
—
$81.49
2/5/2028 (2)
—
—
—
—
2/7/2019
133,345
—
—
$81.05
2/7/2029 (2)
—
—
—
—
2/6/2020
145,698
—
—
$102.90
2/6/2030 (2)
—
—
—
—
2/8/2021
109,119
4,744
—
$117.63
2/8/2031 (2)
4,318
589,407
—
—
1/31/2022
102,119
37,930
—
$79.02
1/31/2032 (2)
10,283
1,403,630
26,576 (4)
3,627,624
2/13/2023
61,259
72,397
—
$103.52
2/13/2033 (2)
16,130
2,201,745
—
—
5/19/2023
—
—
—
—
—
—
50,979 (5)
6,958,634
2/13/2024
23,468
89,176
—
$133.84
2/13/2034 (2)
22,415
3,059,648
—
—
3/18/2024
—
—
—
—
—
—
28,686 (6)
3,915,639
Matthew C. Aberne
r
thy
2/7/2019
83,341
—
—
$81.05
2/7/2029 (2)
—
—
—
—
2/6/2020
61,347
—
—
2/6/2030
$102.90
(2)
—
—
—
—
2/
47,005
8/2021
2,044
$
—
117.63
2/8/2031 (2
1
)
,860
253,890
—
—
1/
48,389
17,973
31/2022
$
—
79.02
1/31/2032 (2
4
)
,873
665,165
6,075 (4)
829,237
2/
29,237
34,552
13/2023
$
—
103.52
2/13/2033 (2
7
)
,698
1,050,777
—
—
5/19/2023
—
—
—
—
—
—
7,974 (5)
1,088,451
2/13/2024
9,387
35,671
2/13/2034
$133.84
(2
8
)
,966
1,223,859
—
3/18/2024
—
—
—
—
—
—
10,040 (6
1
)
,370,460
Eric Benevich
2/5/2016
12,830
—
—
$35.99
2/5/2026 (2)
—
—
—
—
2/6/2017
3,194
—
—
$43.24
2/6/2027 (2)
—
—
—
—
2/5/2018
27,519
—
—
$81.49
2/5/2028 (2)
—
—
—
—
2/7/2019
1,233
—
—
$81.05
2/7/2029 (2)
—
—
—
—
2/6/2020
61,347
—
—
$102.90
2/6/2030 (2)
—
—
—
—
2/8/2021
47,005
2,044
—
$117.63
2/8/2031 (2)
1,860
253,890
—
—
1/31/2022
18,225
16,922
—
$79.02
1/31/2032 (2)
4,588
626,262
4,556 (4)
621,894
2/13/2023
23,733
28,049
—
$103.52
2/13/2033 (2)
6,249
852,989
—
—
5/19/2023
—
—
—
—
—
13,290 (5)
1,814,085
2/13/2024
8,214
31,212
—
$133.84
2/13/2034 (2)
7,846
1,070,979
—
3/18/2024
—
—
—
—
—
—
12,550 (6)
1,713,075
Jude Onyia, Ph.D.
11/29/2021
92,630
27,539
—
$
11/29/2031
84.74
(1)
4
604,149
,426
—
—
1/31/2022
4,713
1,751
—
$
1/31/2032
79.02
(2)
4
64,974
76
9,112 (4
1
)
,243,788
2/13/2023
30,956
36,585
—
$
2/13/2033
103.52
(2)
8
1,112,612
,151
—
—
5/19/2023
—
—
—
—
—
1
—
5,948 (5
2
)
,176,902
2/13/2024
11,264
42,805
—
$
2/13/2034
133.84
(2)
10,760
1,468,740
—
—
3/18/2024
—
—
—
—
—
7
—
,172 (6
9
)
78,978
68
Eiry W. Roberts, M.D
2/7/2019
39,440
—
—
$81.05
2/7/2029 (2)
—
—
—
—
2/6/2020
52,707
—
—
$102.90
2/6/2030 (2)
—
—
—
—
2/8/2021
47,005
2,044
—
$117.63
2/8/2031 (2)
1,860
253,890
—
—
1/31/2022
40,846
20,424
—
$79.02
1/31/2032 (2)
5,538
755,937
9,112 (4)
1,243,788
2/13/2023
24,077
28,455
—
$103.52
2/13/2033 (2)
6,340
865,410
—
—
5/19/2023
—
—
—
—
—
—
13,290 (5)
1,814,085
2/13/2024
4,694
17,835
—
$133.84
2/13/2034 (2)
4,483
611,930
—
—
3/18/2024
—
—
—
—
—
—
7,172 (6)
978,978
12/17/2024
—
27,770
—
$136.69
12/17/2034 (2)
5,487
748,976
—
—
(1)
Vests monthly over four ye
f
ars, subj
u ect to an initial one-year “cliff.”
f
(2)
Vests monthly over four ye
f
ars.
(3)
Vests annually over four ye
f
ars.
(4)
Consists of PRSUs. Represents the target number of shares that may be earned under the PRSUs granted to NEOs in 2022 under the Company’s 2020 Plan.
The PRSUs will vest on the date, or dates, that the Compensation Committee determines achievement of two underlying performance metrics, each of which
must occur by December 31, 2024. Such metrics relate to the advancement of certain clinical programs which we believe will drive stockholder value within
the 36-month performance period commencing on January 1, 2022 and ending on December 31, 2024. The actua
t
l number of units subj
u ect to the PRSUs will
be determined based on the level of achievement of such metrics, with minimum, target and maximum levels specified.
(5)
Consists of PRSUs. Represents the target number of shares that may be earned under the PRSUs granted to NEOs in 2023 under the Company’s 2020 Plan.
The PRSUs will vest on the date, or dates, that the Compensation Committee determines achievement of two underlying performance metrics, each of which
must occur by December 31, 2025. Such metrics relate to regulatory m
r
ilestones and the advancement of certain clinical programs which we believe will drive
stockholder value within the 36-month performance period commencing on January 1, 2023 and ending on December 31, 2025. The actua
t
l number of units
subj
u ect to the PRSUs will be determined based on the level of achievement of such metrics, with minimum, target and maximum levels specified.
(6)
Consists of PRSUs. Represents the target number of shares that may be earned under the PRSUs granted to NEOs in 2024 under the Company’s 2020 Plan.
The PRSUs will vest on the date, or dates, that the Compensation Committee determines achievement of two underlying performance metrics, each of which
must occur by December 31, 2026. Such metrics relate to revenue diversification achievements and business development objectives which we believe will
drive stockholder value within the 36-month performance period commencing on January 1, 2024 and ending on December 31, 2026. The actua
t
l number of
units subj
u ect to the PRSUs will be determined based on the level of achievement of such metrics, with minimum, target and maximum levels specified.
Option Exercises and Stock Vested During the Year. The fol
f lowing tabl
a e sets for
f
th the options exercised and stock awards that
vested during 2024 along with their respective values at December 31, 2024 for the NEOs:
Option Exercises and Stock Vested Table
Option Awards (1)
Stock Awards (2)
Name
Number of
Shares
Acquired on
Exercise (#)
Value
Realized on
Exercise ($) (3)
Number of
Shares
Acquired on
Vesting (#)
Value
Realized on
Vesting ($) (4)
Kyle W. Gano, Ph.D. .................................................................................
75,000
$8,390,944
10,389
$1,436,591
Kevin C. Gorman, Ph.D.............................................................................
172,948
$19,521,374
20,605
$2,843,395
Matthew C. Abernethy...............................................................................
45,000
$3,081,819
9,292
$1,281,327
Eric Benevich.............................................................................................
169,818
$11,495,943
8,667
$1,196,835
Jude Onyia, Ph.D. ......................................................................................
—
—
7,380
$957,764
Eiry W. Roberts, M.D................................................................................
7,345
$323,687
8,867
$1,223,641
(1)
Infor
f
mation relates to stock option exercises during 2024.
(2)
Infor
f
mation relates to RSUs that vested during 2024.
(3)
Calculated by multiplying the number of shares acquired upon
u
exercise of stock options by the differe
f
nce between the exercise price and the market price of
the Company’s common stock at the time of exercise.
(4)
Calculated by multiplying the number of shares acquired upon ve
u
sting of RSUs by the average price of shares sold for purpos
r
es of satisfying federal an
f
d state
income tax liabi
a lities.
69
Potential Payments Upon Termination or Change-in-Control. The tables below set for
f
th the potential severance benefits
f
payable
to the NEOs (excluding Dr. Gorman) in the event of a termination prior to or following a change in control, assuming such event
occurred on December 31, 2024. As a result of Dr. Gorman’s retirement in October 2024, Dr. Gorman ceased to be an employee of the
Company and did not receive any severance payments under his employment agreement or otherwise as a result of his retirement. Dr.
Gorman’s employment agreement (and severance benefit
f s thereunder) terminated as of October 11, 2024.
Potential Payment Upon Termination Table*
Name
Salary (1)
Bonus (2)
Accrued
Compensation (3)
Stock
Awards (4)
Medical (5)
Total
Kyle W. Gano, Ph.D.............................
$2,700,000
$900,000
$129,807
$4,483,036
$44,298
$8,257,141
Matthew C. Abernethy .........................
$684,824
$342,412
$98,772
$2,790,620
$35,352
$3,951,980
Eric Benevich. ......................................
$636,848
$318,424
$91,854
$2,508,611
$32,424
$3,588,161
Jude Onyia, Ph.D..................................
$676,545
$338,273
$81,315
$3,485,856
$32,868
$4,614,857
Eiry W. Roberts, M.D...........................
$686,761
$343,381
$99,051
$2,830,789
$41,808
$4,001,790
*
Refle
f cts a termination without cause or due to a construc
r
tive termination, or deemed termination, prior to a change in control.
(1)
Based on salary as of December 31, 2024.
(2)
Based on bonus targets established by the Board of Directors for 2024.
f
(3)
Accrue
r
d compensation is comprised of vacation pay earned and unpaid as of December 31, 2024.
(4)
The amounts in this column represent the intrinsic value of ‘in-the money’ unvested options and RSUs (but excluding unvested PRSUs) as of December 31,
2024 that would vest in accordance with the executive officers’ employment agreements. Values were derived using the closing price of the Company’s
common stock on December 31, 2024 of $136.50.
(5)
Medical is comprised primarily of health insurance premiums for the period specified in each executive officer’s employment contract.
Potential Payment Upon Change-in-Control Table*
Name
Salary (1)
Bonus (2)
Accrued
Compensation (3)
Stock
Awards (4)
Medical (5)
Total (6)
Kyle W. Gano, Ph.D.............................
$3,600,000
$900,000
$129,807
$10,496,941
$59,064
$15,185,812
Matthew C. Abernethy .........................
$1,027,236
$513,618
$98,772
$8,787,907
$53,028
$10,480,561
Eric Benevich .......................................
$955,272
$477,636
$91,854
$8,972,500
$48,636
$10,545,898
Jude Onyia, Ph.D..................................
$1,014,818
$507,409
$81,315
$10,496,643
$49,302
$12,149,487
Eiry W. Roberts, M.D...........................
$1,030,142
$515,071
$99,051
$9,471,422
$62,712
$11,178,398
*
Refle
f cts benefits to
f
be provided upon
u
a termination without cause, or due
d
to a construc
r
tive termination, within a specified time following a change-in-control.
(1)
Based on salary as of December 31, 2024.
(2)
Based on bonus targets established by the Board of Directors for 2024.
f
(3)
Accrue
r
d compensation is comprised of vacation pay earned and unpaid as of December 31, 2024.
(4)
The amounts in this column represent the intrinsic value of ‘in-the money’ unvested options, PRSUs, and RSUs as of December 31, 2024 that would vest in
accordance with the executive officers’ employment agreements. Values were derived using the closing price of the Company’s common stock on
December 31, 2024 of $136.50. See the discussion that follows these tables for
f
a description of the applicable vesting provisions. Unvested PRSUs are
presented assuming they are paid out at target.
(5)
Medical is comprised primarily of health insurance premiums for the period specified in each executive officer’s employment contract.
(6)
The totals shown here do not take into account the appl
a
ication of any “best-afte
f r-tax” provision that may appl
a
y if an executive officer’s payments would
otherwise be subject to the excise tax provisions of Section 280G of the Internal Revenue Code.
70
Potential Payment Upon Termination by Disability Table*
Name
Salary (1)
Bonus (2)
Accrued
Compensation (3)
Stock
Awards (4)
Medical (5)
Total
Kyle W. Gano, Ph.D.............................
—
—
$129,807
$10,496,941
—
$10,626,748
Matthew C. Abernethy.........................
$684,824
$342,412
$98,772
$2,790,620
$35,352
$3,951,980
Eric Benevich.......................................
$636,848
$318,424
$91,854
$2,508,611
$32,424
$3,588,161
Jude Onyia, Ph.D..................................
$676,545
$338,273
$81,315
$3,485,856
$32,868
$4,614,857
Eiry W. Roberts, M.D. .........................
$686,761
$343,381
$99,051
$2,830,789
$41,808
$4,001,790
*
Refle
f cts a termination due
d
to disabi
a lity.
(1)
Based on salary as of December 31, 2024.
(2)
Based on bonus targets established by the Board of Directors for 2024.
f
(3)
Accrue
r
d compensation is comprised of vacation pay earned and unpaid as of December 31, 2024.
(4)
The amounts in this column represent the intrinsic value of ‘in-the money’ unvested options and RSUs (and PRSUs with respect to Dr. Gano) as of
December 31, 2024 that would vest in accordance with the executive officers’ employment agreements. Values were derived using the closing price of the
Company’s common stock on December 31, 2024 of $136.50. For Dr. Gano, unvested PRSUs are presented assuming they are paid out at target.
(5)
Medical is comprised primarily of health insurance premiums for the period specified in each executive officer’s employment contract.
Potential Payment Upon Termination by Death Table*
Name
Bonus (1)
Accrued
Compensation (2)
Stock
Awards (3)
Total
Kyle W. Gano, Ph.D.....................................................................................
—
$129,807
$10,496,941
$10,626,748
Matthew C. Abernethy .................................................................................
$342,412
$98,772
$2,790,620
$3,231,804
Eric Benevich ...............................................................................................
$318,424
$91,854
$2,508,611
$2,918,889
Jude Onyia, Ph.D..........................................................................................
$338,273
$81,315
$3,485,856
$3,905,444
Eiry W. Roberts, M.D...................................................................................
$343,381
$99,051
$2,830,789
$3,273,221
*
Refle
f cts a termination due
d
to death.
(1)
Based on bonus targets established by the Board of Directors for 2024.
f
(2)
Accrue
r
d compensation is comprised of vacation pay earned and unpaid as of December 31, 2024.
(3)
The amounts in this column represent the intrinsic value of ‘in-the money’ unvested options and RSUs (and PRSUs with respect to Dr. Gano) as of
December 31, 2024 that would vest in accordance with the executive officers’ employment agreements. Values were derived using the closing price of the
Company’s common stock on December 31, 2024 of $136.50. For Dr. Gano, unvested PRSUs are presented assuming they are paid out at target.
As discussed above unde
a
r the heading "Executive Severance Plan", on February 7, 2025, the Compensation Committee
approved and adopted the Severance Plan, pursuant to which executive officers now participate, including our NEOs. The following is
a description of the arrangements in effect during fis
f cal year 2024 within each NEO's employment agreement that would have entitled
them to potential payments upon
u
a termination without cause or resignation due
d
to a construc
r
tive termination or, in the case of Dr.
Gano, "resignation for good
f
reason" (including following a change-in-control), or upon di
u
sabi
a lity or death. For our NEOs, resignation
due to construc
r
tive termination (or resignation for good
f
reason, with respect to Dr. Gano) may include an executive’s resignation
following one or more of the fol
f lowing material adverse changes in the nature of such executive’s employment, as specified in their
employment agreement, which is not cured fol
f lowing notific
f ation of:
•
a significant reduction in the executive or the executive supervisor’s duties or responsibilities,
•
a material reduction in base salary,
•
material relocation, or
•
material breach of the executive’s employment agreement.
71
Dr.r Gano. Pursuant of the terms of his amended and restated employment agreement in effe
f ct as of December 31, 2024, Dr.
Gano was entitled to certain severance benefits upon his “involuntary
r termination”. Upon (a) a termination of Dr. Gano’s employment
without “cause” (as defined in the 2024 Gano Agreement) and other than due to death or “disability” (as defined in the 2024 Gano
Agreement) or (b) Dr. Gano’s “resignation for good reason” (as defined in the 2024 Gano Agreement), in each case outside of the time
period beginning with the date on which a “change in control” (as defined in the 2024 Gano Agreement) occurs and ending 12 months
following the change in control, or the “change in control determination period,” Dr. Gano would be entitled to receive: (1) cash
severance equal to the product of (x) the sum of (i) Dr. Gano’s annual base salary and (ii) Dr. Gano’s target annual incentive bonus for
the year of termination, multiplied by (y) 1.5; (2) a cash payment equal to Dr. Gano’s pro rata annual incentive bonus for the year of
termination based on actual achievement of the applicable performance goals for such year; (3) payment of premiums for continued
coverage under the Company's group health plans for up to 18 months; (4) accelerated vesting of Dr. Gano’s outstanding time-vesting
equity awards to the extent such awards were scheduled to vest under their terms based on Dr. Gano’s continued service over the 15-
month period following the date of termination; and (5) vesting of Dr. Gano’s outstanding performance-vesting equity awards to the
extent the Compensation Committee determines, in its sole discretion, that the applicable performance goals for such awards have
been met as of the date of termination. Upon (a) a termination of Dr. Gano’s employment without “cause” and other than due to death
or “disability” or (b) Dr. Gano’s “resignation for good reason,” in each case within the change in control determination period, Dr.
Gano would be entitled to receive: (1) a cash payment equal to the product of (x) the sum of (i) Dr. Gano’s annual base salary and (ii)
Dr. Gano’s target annual incentive bonus for the year of termination, multiplied by (y) 2; (2) a cash payment equal to Dr. Gano’s pro
rata target annual incentive bonus for the year of termination; (3) payment of premiums for continued coverage under the Company's
group health plans for up to 24 months; and (4) full vesting acceleration of Dr. Gano’s outstanding equity awards, with performance-
vesting equity awards vesting at the greater of (x) the target level of performance or (y) the actua
t
l level of performance measured in
accordance with the applicable performance goals as of the date of termination, as determined by the Compensation Committee in its
sole discretion. Upon the termination of Dr. Gano’s employment due to his death or “disability” (as defined in the 2024 Gano
Agreement), Dr. Gano would be entitled to receive full vesting acceleration of his outstanding equity awards, with performance-
vesting equity awards vesting at the greater of (x) the target level of performance or (y) the actua
t
l level of performance measured in
accordance with the applicable performance goals as of the date of termination, as determined by the Compensation Committee in its
sole discretion. If any severance payment or benefit received from the Company by Dr. Gano would constitute a “parachute payment”
within the meaning of Section 280G of the Internal Revenue Code and subj
u ect to the excise tax imposed by Section 4999 of the
Internal Revenue Code, then such payments or benefits would be reduced to either (1) the largest portion of the payment that would
result in no portion of the payment being subj
u ect to such excise tax or (y) the largest portion, up to and including the total, of the
payment, whichever amount, afte
f r taking into account all applicable federal, state and local employment taxes, income taxes, and the
excise tax, results in Dr. Gano's receipt, on an afte
f r-tax basis, of the greater economic benefit notwithstanding that all or some portion
of the payment may be subj
u ect to such excise tax.
Dr.r Gorman. Dr. Gorman retired as CEO effe
f ctive October 11, 2024. Accordingly, as of December 31, 2024, Dr. Gorman is
no longer entitled to receive any severance or other benefits pursuant to the terms of his prior employment agreement. The
Compensation Committee did utilize its discretion to award Dr. Gorman a bonus payout amount equal to 100% of his annualized base
salary for 2024 multiplied by corporate goal achievement at 115%, in recognition of his strong leadership as CEO through the first
three quarters of 2024 and his effort
f
s in facilitating a successful
f
CEO transition. Dr. Gorman continues to serve as a member of our
Board of Directors and his service as a Director is recognized as "continuous service" under the Company's equity incentive plans,
such that Dr. Gorman's outstanding equity awards continue to vest in accordance with their terms. Additionally, certain of Dr.
Gorman's previously granted stock options provide for full vesting upon the date Dr. Gorman's continuous service terminates as result
of his retirement. Pursuant to the terms of the applicable stock option agreements, “retirement” means a termination of continuous
service upon or afte
f r an employee has reached age 60 with at least five years of continuous service, provided that the employee
complies with any other requirements in the Company’s then-current policy regarding retirement.
Mr. Abernethy.
h
Pursuant of the terms of his employment agreement in effe
f ct as of December 31, 2024, Mr. Abernethy was
entitled to 1.0 times the amount of his annual base salary and target annual bonus to be paid equally over 12 months, an acceleration of
unvested shares that would have vested over the 12 continuous months afte
f r the date of termination, and payment of COBRA benefits
to continue then-current coverage for a period of 12 months following termination in the event that the Company terminates his
employment without cause, or he resigns due to a construc
r
tive termination. In the event of such termination within six months afte
f r the
consummation of a change in control, Mr. Abernethy was entitled to 1.5 times the amount of his annual base salary and annual target
bonus to be paid in one lump sum, a cash amount equal to the value of all unvested stock awards and all vested and outstanding stock
awards, and payment of COBRA
R
benefits to continue then-current coverage for a period of 18 months following termination;
provided, however, in the event such payment to Mr. Abernethy afte
f r a change in control is subj
u ect to a “best-afte
f r-tax” provision. The
best-after-tax provision provides that if the change in control payment due to Mr. Abernethy would be subj
u ect to the excise tax
provisions of Section 280G of the Internal Revenue Code, the Company may reduce the change in control payments to Mr. Abernethy
if,f afte
f r all applicable taxes, the final payments would be larger than if the change in control payments were not reduced and therefor
f
subj
u ect to an excise tax. In the event of termination due to disabi
a lity, Mr. Abernethy was entitled to 12 months of base salary paid
semi-monthly over 12 months, a lump sum amount equal to his target annual bonus multiplied by a fraction the numerator of which is
the number of full months of employment by Mr. Abernethy in the fiscal year and the denominator of which is 12, an acceleration of
unvested shares that would have vested over the 12 continuous months afte
f r the date of termination, and payment of COBRA benefits
to continue then-current coverage for a period of 12 months following termination. In the event of a termination due to
Mr. Abernethy’s death, his beneficiaries or estate, would have been entitled to an acceleration of unvested shares that would have
vested over the 12 continuous months afte
f r the date of termination, a lump sum amount equal to his target annual bonus multiplied by
a fraction the numerator of which is the number of full months of employment by Mr. Abernethy in the fiscal year and the
denominator of which is 12 and any accrued
r
and unpaid compensation on the date of termination.
72
Mr. Benevich. Pursuant of the terms of his employment agreement in effe
f ct as of December 31, 2024, Mr. Benevich was
entitled to 1.0 times the amount of his annual base salary and target annual bonus to be paid equally over 12 months, an acceleration of
unvested shares that would have vested over the 12 continuous months afte
f r the date of termination, and payment of COBRA benefits
to continue then-current coverage for a period of 12 months following termination in the event that the Company terminates his
employment without cause, or he resigns due to a construc
r
tive termination. In the event of such termination within six months afte
f r the
consummation of a change in control, Mr. Benevich was entitled to 1.5 times the amount of his annual base salary and annual target
bonus to be paid in one lump sum, a cash amount equal to the value of all unvested stock awards and all vested and outstanding stock
awards, and payment of COBRA
R
benefits to continue then-current coverage for a period of 18 months following termination;
provided, however, in the event such payment to Mr. Benevich afte
f r a change in control is subj
u ect to a “best-afte
f r-tax” provision. The
best-after-tax provision provides that if the change in control payment due to Mr. Benevich would be subj
u ect to the excise tax
provisions of Section 280G of the Internal Revenue Code, the Company may reduce the change in control payments to Mr. Benevich
if,f afte
f r all applicable taxes, the final payments would be larger than if the change in control payments were not reduced and therefor
f
subj
u ect to an excise tax. In the event of termination due to disabi
a lity, Mr. Benevich was entitled to 12 months of base salary paid semi-
monthly over 12 months, a lump sum amount equal to his target annual bonus multiplied by a fraction the numerator of which is the
number of full months of employment by Mr. Benevich in the fiscal year and the denominator of which is 12, an acceleration of
unvested shares that would have vested over the 12 continuous months afte
f r the date of termination, and payment of COBRA benefits
to continue then-current coverage for a period of 12 months following termination. In the event of a termination due to Mr. Benevich’s
death, his beneficiaries or estate, would have been entitled to an acceleration of unvested shares that would have vested over the 12
continuous months afte
f r the date of termination, a lump sum amount equal to his target annual bonus multiplied by a fraction the
numerator of which is the number of full months of employment by Mr. Benevich in the fiscal year and the denominator of which is
12 and any accrued
r
and unpaid compensation on the date of termination.
Dr.r Onyi
n a. Pursuant of the terms of his employment agreement in effe
f ct as of December 31, 2024, Dr. Onyia was entitled to
1.0 times the amount of his annual base salary and target annual bonus to be paid equally over 12 months, an acceleration of unvested
shares that would have vested over the 12 continuous months afte
f r the date of termination, and payment of COBRA benefits to
continue then-current coverage for a period of 12 months following termination in the event that the Company terminates his
employment without cause, or he resigns due to a construc
r
tive termination. In the event of such termination within six months afte
f r the
consummation of a change in control, Dr. Onyia was entitled to 1.5 times the amount of his annual base salary and annual target bonus
to be paid in one lump sum, a cash amount equal to the value of all unvested stock awards and all vested and outstanding stock
awards, and payment of COBRA
R
benefits to continue then-current coverage for a period of 18 months following termination;
provided, however, in the event such payment to Dr. Onyia afte
f r a change in control is subj
u ect to a “best-afte
f r-tax” provision. The
best-after-tax provision provides that if the change in control payment due to Dr. Onyia would be subj
u ect to the excise tax provisions
of Section 280G of the Internal Revenue Code, the Company may reduce the change in control payments to Dr. Onyia if,f afte
f r all
applicable taxes, the final payments would be larger than if the change in control payments were not reduced and therefor
f
subj
u ect to an
excise tax. In the event of termination due to disabi
a lity, Dr. Onyia is entitled to 12 months of base salary paid semi-monthly over 12
months, a lump sum amount equal to his target annual bonus multiplied by a fraction the numerator of which is the number of full
months of employment by Dr. Onyia in the fiscal year and the denominator of which is 12, an acceleration of unvested shares that
would have vested over the 12 continuous months afte
f r the date of termination, and payment of COBRA benefits to continue then-
current coverage for a period of 12 months following termination. In the event of a termination due to Dr. Onyia’s death, his
beneficiaries or estate, would have been entitled to an acceleration of unvested shares that would have vested over the 12 continuous
months afte
f r the date of termination, a lump sum amount equal to his target annual bonus multiplied by a fraction the numerator of
which is the number of full months of employment by Dr. Onyia in the fiscal year and the denominator of which is 12 and any accrued
r
and unpaid compensation on the date of termination.
Dr.r Roberts. Pursuant of the terms of her employment agreement in effe
f ct as of December 31, 2024, Dr. Roberts was entitled
to 1.0 times the amount of her annual base salary and target annual bonus to be paid equally over 12 months, an acceleration of
unvested shares that would have vested over the 12 continuous months afte
f r the date of termination, and payment of COBRA benefits
to continue then-current coverage for a period of 12 months following termination in the event that the Company terminates her
employment without cause, or she resigns due to a construc
r
tive termination. In the event of such termination within six months afte
f r
the consummation of a change in control, Dr. Roberts was entitled to 1.5 times the amount of her annual base salary and annual target
bonus to be paid in one lump sum, a cash amount equal to the value of all unvested stock awards and all vested and outstanding stock
awards, and payment of COBRA
R
benefits to continue then-current coverage for a period of 18 months following termination;
provided, however, in the event such payment to Dr. Roberts afte
f r a change in control is subj
u ect to a “best-afte
f r-tax” provision. The
best-after-tax provision provides that if the change in control payment due to Dr. Roberts would be subj
u ect to the excise tax provisions
of Section 280G of the Internal Revenue Code, the Company may reduce the change in control payments to Dr. Roberts if,f afte
f r all
applicable taxes, the final payments would be larger than if the change in control payments were not reduced and therefor
f
subj
u ect to an
excise tax. In the event of termination due to disabi
a lity, Dr. Roberts is entitled to 12 months of base salary paid semi-monthly over
12 months, a lump sum amount equal to her target annual bonus multiplied by a fraction the numerator of which is the number of full
months of employment by Dr. Roberts in the fiscal year and the denominator of which is 12, an acceleration of unvested shares that
would have vested over the 12 continuous months afte
f r the date of termination, and payment of COBRA benefits to continue then-
current coverage for a period of 12 months following termination. In the event of a termination due to Dr. Roberts’s death, her
beneficiaries or estate, would have been entitled to an acceleration of unvested shares that would have vested over the 12 continuous
months afte
f r the date of termination, a lump sum amount equal to her target annual bonus multiplied by a fraction the numerator of
which is the number of full months of employment by Dr. Roberts in the fiscal year and the denominator of which is 12 and any
accrued
r
and unpaid compensation on the date of termination.
73
CEO PAY RATIO
Under SEC rules, we are required to calculate and disclose the annual total compensation of our median employee, as well as
the ratio of the annual total compensation of our median employee as compared to the annual total compensation of our CEO, Dr.
Gano, who was CEO at the time we identified our median employee (the “CEO Pay Ratio”). To identify our
f
median employee, we
used the following methodology:
•
To determine our total population of employees, we included all full-time and part-time employees as of December 31,
2024.
•
To identify our median employee from our employee population, we calculated the aggregate amount of each
employee’s 2024 base salary (using a reasonable estimate of the hours worked and overtime actua
t
lly paid during 2024
for hourly employees and actua
t
l salary paid for our remaining employees) and bonuses attributable to 2024 performance
and the grant date fair value of equity awards granted in fiscal 2024 using the same methodology we use for estimating
the value of the equity awards granted to our NEOs and reported in our Summary Compensation Tabl
a e.
•
In making this determination, we annualized the base salary and target bonus compensation of employees who were
employed by us for less than the entire fiscal year.
Afte
f r identifying our
f
median employee, we then calculated compensation for such median employee using the same
methodology used to calculate compensation for our NEOs as reported in the 2024 Summary Compensation Tabl
a e. For 2024, the
median of the annual total compensation of our employees (other than our CEO) was $265,089.
Neurocrine had two individuals serve as CEO during 2024. For purposes of calculating the CEO Pay Ratio, we annualized the
salary and bonus of our current CEO, Dr. Gano, who began serving in the role in October 2024, and we included all other components
of his compensation in the same amounts as disclosed in the Summary Compensation Tabl
a e. Dr. Gano’s annualized base salary was
$900,000 (representing his 2024 base salary as CEO), and his annualized bonus was $1,035,000 (representing the value of Dr. Gano’s
2024 bonus assuming his 2024 target bonus opportunity and 2024 base salary as CEO and applying his actua
t
l 2024 bonus payout
percentage of 115% of target). Accordingly, Dr. Gano's total compensation for the purposes of this calculation was $9,235,299. Based
on this information, the ratio of the annual total compensation of our CEO to the median of the annual total compensation of all
employees was approximately 35 to 1.
The CEO Pay Ratio above represents our reasonable estimate calculated in a manner consistent with SEC rules and applicable
guidance. SEC rules and guidance provide significant flexibility in how companies identify
f the median employee, and each company
may use a different methodology and make different assumptions particular to that company. As a result, and as explained by the SEC
when it adopted these rules, in considering the pay ratio disclosure, stockholders should keep in mind that the rule was not designed to
facilitate comparisons of pay ratios among different companies, even companies within the same industry, but
r
rather to allow
stockholders to better understand and assess each particular company’s compensation practices and pay ratio disclosures. Neither the
Compensation Committee nor our management used our CEO Pay Ratio measure in making compensation decisions.
In addition to the information above, in order to reflect our employee compensation practices, we have also calculated the
annual base salary of our median employee while taking only annual base salary into account, as well as the ratio of the base salary of
our CEO as compared to the annual base salary of such median employee. In calculating the annual base salary of our median
employee, we used the applicable methodology listed above. For fiscal 2024, the median of the annual base salary of our employees
(other than Dr. Gano ) was $170,000, and the annualized base salary of our CEO, effe
f ctive as of October 11, 2024, was $900,000.
Based on this information, the ratio of the annualized base salary of our CEO to the median of the annual base salary of all employees
(other than the CEO) was approximately 5 to 1. Neither the Compensation Committee nor our management used this ratio to make
compensation decisions.
74
ITEM 402(v) PAY VERSUS PERFORMANCE
The disclosure included in this section is prescribed by SEC rul
r es and does not necessarily align with how the Company or the
Compensation Committee view the link between the Company’s performance and NEO pay and the Compensation Committee does
not utilize CAP (as defined below) as the basis for
f
making compensation decisions. For additional information about our pay-for-
performance philosophy and how we align executive compensation with Company performance, refer to the Compensation Discussion
and Analysis.
Required Tabular Disclosure of Pay Versus Perfor
f
mance
The fol
f lowing tabl
a e reports the compensation of our current and former Principal Executive Officer ("PEO") or CEO and the
average compensation of the other non-PEO named executive officers ("Non-PEO NEOs") as reported in the Summary Compensation
Tabl
a e ("SCT") for the past five fiscal years, as well as Compensation Actua
t
lly Paid ("CAP") as calculated under new SEC Pay-
Versus-Performance ("PVP") disclosure requirements and certain performance measures required by the rules. The disclosure covers
the fiv
f e most-recent fis
f cal years.
Value of Initial Fixed $100
Investment Based On:
Year
Summary
Compensation
Table Total
for Former
PEO ($)(1)
Compensation
Actually Paid
to Former
PEO ($)(2)
Summary
Compensation
Table Total
for Current
PEO ($)(3)
Compensation
Actually Paid
to Current
PEO ($)(4)
Average
Summary
Compensation
Table Total
for Non-PEO
NEOs ($)(5)
Average
Compensation
Actually Paid
to Non-PEO
NEOs ($)(6)
Total
Shareholder
Return ($)(7)
Peer Group
Total
Shareholder
Return ($)(7)
GAAP
Net
Income
(millions)
($)(8)
Net
Product
Sales
(millions)
($)(9)
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(
2024
$16,018,637
$16,741,241
$8,535,422
$7,083,275
$6,675,384
$6,488,850
$126.99
$118.20
$341.3
$2,330.6
2023
$15,750,812
$12,335,515
—
—
$6,286,290
$5,262,182
$122.58
$118.87
$249.7
$1,860.6
2022
$11,902,527
$21,886,517
—
—
$5,200,614
$11,398,982
$111.46
$111.66
$154.5
$1,440.9
2021
$14,081,412
$4,496,176
—
—
$6,429,791
$3,012,565
$79.48
$125.33
$89.6
$1,090.1
2020
$13,880,632
$8,176,596
—
—
$6,522,476
$4,030,852
$89.45
$126.13
$407.3
$994.1
( )
( )
(1)
The dollar amounts reported in column (b) are the amounts of total compensation reported for
f
Kevin C. Gorman, Ph.D. (Former PEO) for each corresponding
year in the “Total” column of the Summary Compensation Table.
(2)
The dollar amounts reported in column (c) represent the amount of CAP for
f
Dr. Gorman, as computed in accordance with Item 402(v) of Regulation S-K. The
dollar amounts do not reflect the actua
t
l amount of compensation earned by or paid to Dr. Gorman during the applicable year. In accordance with the
requirements of Item 402(v) of Regulation S-K, the following adju
d stments were made to Dr. Gorman’s total reported compensation for 2024
f
to determine the
CAP:
2024
Total Compensation for
f
Covered Fiscal Year ("FY") from Summary Compensation Table
$ 16,018,637
Deduct: Amounts Reported in "Stock Awards" & "Option Awards" Columns
13,999,837
Add: Year End Fair Value of Equity Awards Granted During the Covered FY that Remain
Outstanding and Unvested as of Last Day of the Covered FY
8,140,851
Add: Change in Fair Value fro
f
m the end of the Prior FY to the end of the Covered FY
5,193,013
Add: Fair Value as of Vesting Date of Equity Awards Granted and Vested in the Covered FY
1,367,672
Add: Change in Fair Value as of the Vesting Date of Equity Awards Granted in Prior FY that
Vested in the Covered FY
20,905
Add: Fair Value at the End of the Prior FY of Equity Awards that Failed to Meet Vesting
Conditions in the Covered FY
—
Add: Value of Dividends or other Earnings Paid on Stock or Option Awards not Otherwise
Reflected in Fair Value or Total Compensation
—
Compensation Actua
t
lly Paid (as defin
f ed by SEC rul
r e)
$ 16,741,241
(3)
The dollar amounts reported in column (d) are the amounts of total compensation reported for
f
Kyle W. Gano, Ph.D. (Current PEO) for each corresponding
year in the “Total” column of the Summary Compensation Table. Dr. Gano, formerly Neurocrine Biosciences' Chief Business Development and Strategy
Offi
f cer, succeeded Dr. Gorman as the Company’s CEO, effective October 11, 2024.
(4)
The dollar amounts reported in column (e) represent the amount of CAP for
f
Dr. Gano, as computed in accordance with Item 402(v) of Regulation S-K. The
dollar amounts do not reflect the actua
t
l amount of compensation earned by or paid to Dr. Gano during the applicable year. In accordance with the
requirements of Item 402(v) of Regulation S-K, the following adju
d stments were made to Dr. Gano’s total reported compensation for 2024
f
to determine the
CAP:
75
2024
Total Compensation for
f
Covered Fiscal Year ("FY") from Summary Compensation Table
$ 8,535,422
Deduct: Amounts Reported in "Stock Awards" & "Option Awards" Columns
7,250,076
Add: Year End Fair Value of Equity Awards Granted During the Covered FY that Remain
Outstanding and Unvested as of Last Day of the Covered FY
4,402,908
Add: Change in Fair Value fro
f
m the end of the Prior FY to the end of the Covered FY
814,206
Add: Fair Value as of Vesting Date of Equity Awards Granted and Vested in the Covered FY
563,101
Add: Change in Fair Value as of the Vesting Date of Equity Awards Granted in Prior FY that
Vested in the Covered FY
17,714
Add: Fair Value at the End of the Prior FY of Equity Awards that Failed to Meet Vesting
Conditions in the Covered FY
—
Add: Value of Dividends or other Earnings Paid on Stock or Option Awards not Otherwise
Reflected in Fair Value or Total Compensation
—
Compensation Actua
t
lly Paid (as defin
f ed by SEC rul
r e)
$ 7,083,275
(5)
The dollar amounts reported in column (f) represent the average of the amounts reported for
f
the Company’s Non-PEO NEOs as a group in the “Total” column
of the Summary Compensation Table in each applicable year. The names of each of the Non-PEO NEOs included for pur
f
pos
r
es of calculating the average
amounts in each applicable year are as fol
f lows: (i) for 2024, Matthew C. Abernethy, Eric Benevich, Jude Onyia, Ph.D., and Eiry W. R
r
oberts, M.D.; (ii) for
2023, Matthew C. Abernethy, Kyle W. Gano, Ph.D., Darin M. Lippoldt, and Eiry W. Roberts, M.D.; (iii) for 2022, Matthew C. Abernethy, Eric Benevich,
Jude Onyia, Ph.D., and Eiry W. R
r
oberts, M.D.; (iv) for 2021,
f
Matthew C. Abernethy, Eric Benevich, Kyl
K e W. Gano, Ph.D., and Eiry W. R
r
oberts, M.D; and
(v) for 2020,
f
Matthew C. Abernethy, Eric Benevich, Kyl
K e W. Gano, Ph.D., and Eiry W. R
r
oberts, M.D.
(6)
The dollar amounts reported in column (g) represent the average amount of CAP to the Non-PEO NEOs, as computed in accordance with Item 402(v) of
Regulation S-K. The dollar amounts do not reflect the actua
t
l average amount of compensation earned by or paid to the NEOs as a group (excluding the
PEO(s)) dur
d
ing the applicable year. In accordance with the requirements of Item 402(v) of Regulation S-K, the following adju
d stments were made to average
total reported compensation for
f
the Non-PEO NEOs for
f
each year to determine the CAP, using the same methodology described above in Notes 2 and 4:
2024
Total Compensation for
f
Covered FY fro
f
m Summary Compensation Table
$ 6,675,384
Deduct: Amounts Reported in "Stock Awards" & "Option Awards" Columns
5,487,510
Add: Year End Fair Value of Equity Awards Granted During the Covered FY that Remain
Outstanding and Unvested as of Last Day of the Covered FY
3,534,335
Add: Change in Fair Value fro
f
m the end of the Prior FY to the end of the Covered FY
1,286,100
Add: Fair Value as of Vesting Date of Equity Awards Granted and Vested in the Covered FY
488,933
Add: Change in Fair Value as of the Vesting Date of Equity Awards Granted in Prior FY that
Vested in the Covered FY
(8,392)
Add: Fair Value at the End of the Prior FY of Equity Awards that Failed to Meet Vesting
Conditions in the Covered FY
—
Add: Value of Dividends or other Earnings Paid on Stock or Option Awards not Otherwise
Reflected in Fair Value or Total Compensation
—
Compensation Actua
t
lly Paid (as defin
f ed by SEC rul
r e)
$ 6,488,850
(7)
The dollar amounts refle
f ct the cumulative Total Shareholder Retur
t
n (TSR) of our common stock (column (h)) and the Peer Group (column (i)) for
f
the
measurement periods beginning on December 31, 2019 and ending on December 31 of each of 2024, 2023, 2022 and 2021, respectively, calculated in
accordance with Item 201(e) of Regulation S-K. “Peer Group” represents the NASDAQ Biotechnology Index, which the Company has identified as its peer
group for purpos
r
es of Item 402(v) and which is used by the Company for purpos
r
es of compliance with Item 201(e) of Regulation S-K.
(8)
The dollar amounts reported in column (j)
(
represent net income reflected in the Company’s audited fin
f ancial statements for the applicable fiscal year.
(9)
As required by Item 402(v) of Regulation S-K, we have determined that Net Product Sales is the Company-Selected Measure. Dollar amounts reported for
f
INGREZZA net product sales, which represent nearly all of the Company's total net product sales, are reflected in the Company's audited fin
f ancial statements
for the applicable fiscal year.
The assumptions used in calculating the fair value of the equity awards did not differ in any material respect from the
assumptions used to calculate the grant date fai
f r value of the awards as reported in the Summary Compensation Table, except that the
fair value calculations of (i) the unvested options used an estimated term between 1.44 years and 6.76 years in fis
f cal 2024, as
compared to an estimated term of 6.0 to 6.5 years used to calculate the grant date fair value of such awards, and (ii) the PRSUs
assumed payout multipliers at current expectations, which range from 0% to 150% across differe
f
nt grant years and metrics, in each
case as compared to the grant date fai
f r value calculations which assumed a payout at target.
Required Tabular Disclosure of Most Important Perfor
f
mance Measures
The most important financial performance measures used by the company to link CAP to the company’s NEOs for
f
the most
recently completed fis
f cal year to the company’s performance are set forth below. For further information regarding these performance
metrics and their func
f
tion in our executive compensation program, please see “Compensation Discussion and Analysis”.
•
Net Product Sales
•
Non-GAAP Net Income
•
Pipeline Progression
•
Regulatory A
r
dvancement
Required Disclosure of the Relationship Between Compensation Actually Paid and Financial Perfor
f
mance Measures
As required by Item 402(v) of Regulation S-K, we are providing the fol
f lowing graphs to illustrate the relationship between
the pay and performance figures that are included in the pay versus performance tabul
a
ar disclosure above. In addition, the fir
f st graph
below fur
f
ther illustrates the relationship between Company total shareholder retur
t
n and that of the Peer Group. As noted above, CAP
for purpos
r
es of the tabular disclosure and the following graphs were calculated in accordance with SEC rul
r es and do not fully
represent the actual final amount of compensation earned by or actua
t
lly paid to our NEOs during the applicable fiscal years.
76
CAP ($000)
TSR Value
Compensation Actually Paid versus TSR Performance
$—
$—
$—
$—
$7,083
$8,177
$4,496
$21,887
$12,336
$16,741
$4,031
$3,013
$11,399
$5,262
$6,489
$89
$79
$111
$123
$127
$126
$125
$112
$119
$118
Current PEO Compensation Actually Paid
Former PEO Compensation Actually Paid
Average Non-PEO NEOs Compensation Actually Paid
Total Shareholder Return
Peer Group Total Shareholder Return
2020
2021
2022
2023
2024
—
5,000
10,000
15,000
20,000
—
40
80
120
160
CAP ($000)
Net Income ($000)
Compensation Actually Paid versus Net Income
$—
$—
$—
$—
$7,083
$8,177
$4,496
$21,887
$12,336
$16,741
$4,031
$3,013
$11,399
$5,262
$6,489
$407,300
$89,600
$154,500
$249,700
$341,300
Current PEO Compensation Actually Paid
Former PEO Compensation Actually Paid
Average Non-PEO NEOs Compensation Actually Paid
Net Income
2020
2021
2022
2023
2024
—
5,000
10,000
15,000
20,000
25,000
—
90,000
180,000
270,000
360,000
450,000
77
CAP ($000)
Net Product Sales ($000)
Compensation Actually Paid versus Net Product Sales
$—
$—
$—
$—
$7,083
$8,177
$4,496
$21,887
$12,336
$16,741
$4,031
$3,013
$11,399
$5,262
$6,489
$994,100
$1,090,100
$1,440,900
$1,860,600
$2,330,600
Current PEO Compensation Actually Paid
Former PEO Compensation Actually Paid
Average Non-PEO NEOs Compensation Actually Paid
Net Product Sales
2020
2021
2022
2023
2024
—
5,000
10,000
15,000
20,000
25,000
500,000
1,000,000
1,500,000
2,000,000
2,500,000
All information provided
d
above under the “Ite
I m 402(v)
(
Pay
a Versus Perfor
f
mance” heading will not be deemed to be incorporated by
refe
e rence into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as
amended, whethe
t
r made befo
e re or afte
f r the date hereof and irrespective of any general incorporation language in any such filing,
except to the extent the Company specific
i
ally incorporates such information by refe
e rence.
Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic
Information
The Compensation Committee has a practice of generally granting stock options on a predetermined grant date, or in some
cases on regularly scheduled Compensation Committee meetings when they determine appropriate. Annual equity awards, including
stock options, are typically granted shortly following the Company’s release of the financial results for the prior fiscal year through the
filing of a Current Report on Form 8-K and accompanying earnings release and earnings call. However, the grant date for PRSUs may
be delayed pending final determination of all performance terms necessary to constitute an effe
f ctive grant under financial accounting
rules. Additionally, our Compensation Committee generally approves the granting of equity awards, including stock options, in
connection with the commencement of employment or promotion of our NEOs, and from time to time as otherwise determined
appropriate by our Compensation Committee. Our eligible non-employee directors receive automatic grants of initial and annual RSUs
and/or stock options at the time of a director’s initial appointment or election to the Board of Directors and as of the date of each
annual meeting of our stockholders, in accordance with our director compensation policy as further described under the section
entitled “Director Compensation Summary” below. The Company does not otherwise maintain any written policies on the timing of
awards of stock options, stock appreciation rights, or similar instruments with option-like featur
t
es or other equity awards.
The Company does not grant equity awards in anticipation of the release of material nonpublic information (“MNPI”) and we
do not time the release of MNPI based on equity award grant dates or for the purposes of affe
f cting the value of executive
compensation.
78
DIRECTORS COMPENSATION SUMMARY
Non-Employee Director Compensation Philosophy
Our non-employee director compensation philosophy is based on the following guiding principles:
•
Aligning the long-term interests of stockholders and directors; and
•
Compensating directors appropriately and adequately for their time, effort
f
and experience.
The elements of director compensation consist of annual cash retainers and equity awards, as well as customary
r and usual
expense reimbursement in attending Board or committee meetings. In an effort
f
to align the long-term interests of our stockholders and
non-employee directors, the mix of cash and equity compensation has historically been, and is currently, weighted more heavily to
equity.
The Board and the Company’s stockholders have approved certain annual limits on compensation to be paid to the Company’s
non-employee directors. Our 2020 Plan provides that the aggregate value of all compensation granted or paid by us to any individual
for service as a non-employee director with respect to any period commencing on the date of the annual stockholders meeting for a
particular year and ending on the date of the annual stockholders meeting for the next subs
u
equent year (such period, the “annual
period”), including awards granted under our 2020 Plan and cash fees paid to such non-employee director, will not exceed $1,250,000
in total value. In addition, the aggregate value of any equity award(s) granted by us to any individual for service as a non-employee
director upon or in connection with his or her initial election or appointment to the Board of Directors will not exceed $2,000,000 in
total value (such that the aggregate compensation granted or paid by us to any individual for service as a non-employee director with
respect to an annual period in which such individual is first appointed or elected to the Board of Directors will not exceed $3,250,000
in total value).
In March 2025, the Board approved lowering these annual limits on compensation to be paid to the Company's non-employee
directors in connection with the adoption of the 2025 Plan. The 2025 Plan proposed for approval in Proposal Three of this Proxy
Statement provides that the aggregate value of all compensation granted or paid by us to any individual for service as a non-employee
director with respect to an annual period, including awards granted under our 2025 Plan and cash fees paid to such non-employee
director, will not exceed $750,000 in total value. In addition, the aggregate value of any equity award(s) granted by us to any
individual for service as a non-employee director upon or in connection with his or her initial election or appointment to the Board of
Directors will not exceed $1,500,000 in total value (such that the aggregate compensation granted or paid by us to any individual for
service as a non-employee director with respect to an annual period in which such individual is first appointed or elected to the Board
of Directors will not exceed $2,250,000 in total value). For purpos
r
es of these limitations, the value of any equity awards is calculated
based on the grant date fair value of such awards for financial reporting purposes.
Our Compensation Committee regularly assesses, on at least an annual basis, our non-employee director compensation
program in consultation with its independent compensation consultant, who provides analysis and input on recent developments,
prevailing market practices, and recommends any changes to the program to our Board, who ultimately approves non-employee
director compensation.
The fiscal 2024 compensation for the Company’s non-employee directors was recommended by the Compensation Committee
to the Board following the review of a report from FW Cook, its independent compensation consultant, which contained an analysis of
prevailing market practices regarding levels and types of non-employee director compensation, including the non-employee director
compensation practices of our peer group, which is described in the “Compensation Discussion and Analysis” section of this Proxy
Statement, and a comparative assessment of our non-employee director compensation to such peers and market practices.
In formulating its recommendations to the Board for fiscal 2024, the Compensation Committee did not engage in
benchmarking or targeting compensation to a specific level of the peer group data provided by FW Cook, but rather used the peer data
as a reference point in making non-employee director compensation recommendations. For 2024, the Compensation Committee
determined that each non-employee director may elect to receive the full value of his or her annual award in the form of (i) restricted
stock units, (ii) nonstatutory stock options, or (iii) 50% restricted stock units and 50% nonstatutory stock options. It is the
Compensation Committee’s view that offeri
f
ng both stock options and restricted stock units provides a total compensation package that
enables us to retain and attract highly skilled and qualifie
f d non-employee directors. Ultimately, the Board set fiscal 2024 non-
employee director compensation in the forms and amounts it determined to be appropriate using its profes
f
sional experience and
judgment, afte
f r careful
f
review of the FW Cook analysis and the Compensation Committee’s recommendations. Our director
compensation for fiscal 2024 is described below.
79
Non-Employee Director Compensation for 2024
For fis
f cal 2024, directors who are not employees of the Company earned a $60,000 annual cash retainer. The Company
provided the Chair of the Board, William H. Rastetter, an additional $35,000, making his total annual cash retainer $95,000. In
addition to the cash compensation set forth above
a
, the Chair of the Audit Committee earned an additional $25,000 annual cash
retainer, the Chair of the Compensation Committee earned an additional $20,000 annual cash retainer, the Chair of the Nominating /
Corporate Governance Committee earned an additional $18,000 annual cash retainer, and the Chair of the Science and Medical
Technology Committee earned an additional $20,000 annual cash retainer. Each other director who was a member of the Audit
Committee, the Compensation Committee, the Nominating / Corporate Governance Committee, or the Science and Medical
Technology Committee earned an additional annual cash retainer of $12,000, $12,000, $9,000, and $10,000, respectively, for each
Committee on which she or he served. Non-employee directors are also reimbursed for
f
expenses incurred in connection with
performing their duties as directors of the Company.
For fis
f cal 2024, the Board maintained the existing director annual equity award levels and on the date of the 2024 Annual
Meeting of Stockholders, each continuing non-employee director received an annual equity award with an approximate grant date
value of $400,000. Each non-employee director had the ability to elect to receive the ful
f l value of his or her annual award in the form
f
of (i) restricted stock units, (ii) nonstatutory stock options, or (iii) 50% restricted stock units and 50% nonstatutory stock options. The
restricted stock units granted to non-employee directors vest in ful
f l on the one-year anniversary o
r
f the date of grant. The options
granted to non-employee directors have exercise prices equal to the closing price of the Company’s common stock on the date of the
grant, are subject to a ten-year term, and vest in ful
f l on the one-year anniversary o
r
f the date of grant. Additionally, newly-appoint
a
ed
members of our Board of Directors received an initial equity award with an approximate grant value of $800,000 on their date of
appointment. This initial equity award is comprised 100% of nonstatutory stock options, vests monthly over three years, and has a ten-
year term.
The fol
f lowing tabl
a e sets for
f
th the compensation earned for
f
the fis
f cal year ended December 31, 2024 by the directors of the
Company named below:
Director Compensation Table
Name (1)
Fees Earned
or Paid in
Cash (2)
Option
Awards (3)
Stock
Awards (4)
Total
William H. Rastetter, Ph.D. (5)
.................................................................
$101,250
—
$400,025
$501,275
Gary A. Lyons (6) .................................................................................................
$70,000
$200,003
$200,082
$470,085
Johanna Mercier (7)
.................................................................................
$69,000
$200,003
$200,082
$469,085
George J. Morrow (8)
.................................................................................
$81,000
—
$400,025
$481,025
Leslie V. Norwalk (9)
.................................................................................
$78,000
$200,003
$200,082
$478,085
Christine A. Poon (10)
.................................................................................
$81,541
$200,003
200,082
$481,626
Richard F. Pops (11)
.................................................................................
$89,069
—
$400,025
$489,094
Shalini Sharp (12) .................................................................................................
$99,000
$200,003
$200,082
$499,085
Stephen A. Sherwin, M.D. (13)
.................................................................
$94,140
—
$400,025
$494,165
(1)
As discussed above
a
in the Compensation Discussion and Analysis, Dr. Gano succeeded Dr. Gorman in the CEO role and also joined the Company’s Board of
Directors effective October 11, 2024. Additionally, Dr. Gorman continues to serve as a Director. As compensation infor
f
mation for
f
Drs. Gano and Gorman is
included within the Summary Compensation Table above, these amounts are not separately provided in the Director Summary Compensation Table. Dr. Gano
did not receive any compensation for hi
f
s service on the Board of Directors. Dr. Gorman became eligible for, and started receiving compensation for
f
, his
service on the Board of Directors under our non-employee director compensation policy, effe
f ctive as of October 12, 2024 when he ceased employment with
us.
(2)
Amounts in this column refle
f ct compensation earned in 2024.
(3)
The amounts shown represent the ful
f l grant date fair value of option awards granted in 2024 as determined pursuant to ASC 718. The assumptions used to
calculate the value of such awards are set forth under Note 7 of the Notes to the Consolidated Financial Statements included in the Company’s Annual Report
on Form 10-K for
f
the year ended December 31, 2024. All option awards were granted on the date of our 2024 annual meeting of stockholders; the gr
t
ant date
fair values of all option awards are based on a per share Black-Scholes value of $67.07.
(4)
The amounts shown represent the ful
f l grant date fair value of RSU awards granted in 2024 as determined pursuant to ASC 718.
(5)
As of December 31, 2024, Dr. Rastetter had outstanding options to purchase 127,154 shares of common stock and 2,869 outstanding RSUs.
(6)
As of December 31, 2024, Mr. Lyons had outstanding options to purchase 84,347 shares of common stock and 1,435 outstanding RSUs.
(7)
As of December 31, 2024, Ms. Mercier had outstanding options to purchase 43,009 shares of common stock and 1,435 outstanding RSUs.
(8)
As of December 31, 2024, Mr. Morrow had outstanding options to purchase 77,075 shares of common stock and 2,869 outstanding RSUs.
(9)
As of December 31, 2024, Ms. Norwalk had outstanding options to purchase 38,847 shares of common stock and 1,435 outstanding RSUs.
(10)
As of December 31, 2024, Ms. Poon had outstanding options to purchase 19,357 shares of common stock and 1,435 outstanding RSUs..
(11)
As of December 31, 2024, Mr. Pops had outstanding options to purchase 77,075 shares of common stock and 2,869 outstanding RSUs.
(12)
As of December 31, 2024, Ms. Sharp h
r
ad outstanding options to purchase 40,829 shares of common stock and 1,435 outstanding RSUs.
(13)
As of December 31, 2024, Dr. Sherwin had outstanding options to purchase 62,075 shares of common stock and 2,869 outstanding RSUs.
80
Non-Employee Director Compensation for 2025
In 2025, upon the recommendation of the Compensation Committee and based on a review of our peer group companies and
analysis performed by FW Cook, the Board increased the annual retainer for the non-executive Board Chair by $5,000 to a total of
$40,000 annually. The Board maintained all equity compensation and all other annual cash retainers for non-employee directors at the
2024 levels.
Non-Employee Director Equity Ownership Guidelines
The Board of Directors has adopted equity ownership guidelines for our non-employee directors, which are designed to further
align the interests of the non-employee directors with those of our stockholders by ensuring that our non-employee directors have a
significant financial stake in the Company’s long-term success. The equity ownership guidelines establ
a ish a minimum equity
ownership equal to three times the cash retainer paid to the non-employee director, with such values determined based on the value of
our common stock owned by such persons as of certain measurement dates. All shares directly or beneficially owned by the non-
employee director, including the net exercisabl
a e value of outstanding vested stock options (where the market price of our common
stock exceeds the strike price of such option) are included in determining the value of equity owned under our equity ownership
guidelines. New non-employee directors are granted a five-year period to reach the equity ownership requirements set forth in the
guidelines and are expected to make annual progress toward the equity ownership requirements during this five-year period. When a
non-employee director does not meet the equity ownership requirements set forth in the guidelines, he/she is restricted from selling
any held shares until such requirements are met. Additionally, should non-employee director who does not meet the equity ownership
requirements choose to exercise a stock option or vest in any RSUs, he or she is required to retain all shares acquired through those
transactions, aside from any shares necessary to fulfill such transaction related tax obligations, until full compliance with the equity
ownership guidelines is attained.
Annual compliance with the equity ownership guidelines is assessed each year. As of March 24, 2025, each of our non-
employee directors was in compliance with the equity ownership guidelines.
Additional Information
Executive offi
f cers of the Company serve at the discretion of the Board of Directors. There are no family relationships among
any of the directors, executive offi
f cers or key employees of the Company. None of our directors or executive offi
f cers has been
involved in any of the legal proceedings specified in Item 401(f) of Regulation S-K in the past 10 years.
RELATED PERSON TRANSACT
R
IONS
Review, Approval or Ratification of Related Person Transactions
In accordance with the Company’s Audit Committee Charter, the Company’s Audit Committee is responsible for reviewing
and approving the terms and conditions of all related person transactions. In connection with its review, approval or ratification of
related person transactions, the Company’s Audit Committee takes into account all relevant availabl
a e facts and circumstances in
determining whether such transaction is in the best interests of the Company and its stockholders. Any transaction that would
disqualify
f a director from meeting the “independent director” standard as defined under the Nasdaq Stock Market rules requires
review by the Company’s Audit Committee prior to entering into such transaction. For all other related person transactions, the
Company reviews all agreements and payments for related person transactions and based on this review, a report is made to the
Company’s Audit Committee quarterly disclosing all related person transactions during that quarter, if any. All related person
transactions shall be disclosed in the Company’s applicable filings with the SEC as required under SEC rules.
There were no related person transactions during fiscal 2024.
OTHER MATTERS
As of the date of this Proxy Statement, the Company knows of no other matters to be subm
u
itted to the stockholders at the
Annual Meeting. If any other matters properly come before the Annual Meeting, it is the intention of the persons named in the proxy
to vote the shares they represent as the Board of Directors may recommend.
ADDITIONAL INFORMATION
“Householding” of Proxy Materials.
l
The SEC has adopted rules that permit companies and intermediaries such as brokers to
satisfy delivery
r requirements for proxy statements with respect to two or more stockholders sharing the same address by delivering a
single set of proxy materials addressed to those stockholders. This process, which is commonly referred to as “householding,”
potentially provides extra convenience for stockholders and cost savings for companies. The Company, as well as certain brokers,
household proxy materials, unless contrary instructions have been received from the affe
f cted stockholders. Once you have received
notice from your broker or us that they or we will be householding materials to your address, householding will continue until you are
notified otherwise or until you revoke your consent. If,f at any time, you no longer wish to participate in householding and would
prefer to receive a separate set of proxy materials, please notify your broke
f
r if your shares are held in a brokerage account or us if you
81
hold registered shares. If you hold registered shares, you may direct your written request to the Company’s Corporate Secretary
r at
6027 Edgewood Bend Court, San Diego, Califor
f
nia 92130, or contact the Company’s Corporate Secretary
r at 858-617-7600.
Adva
d
nce Notice Procedures. To be considered for inclusion in next year’s proxy materials, a stockholder must subm
u
it his, her
or its proposal or director nomination in writing by December 10, 2025 which is the date that is 120 days prior to the first anniversary
r
of the mailing date of this Proxy Statement, to the Company’s Corporate Secretary
r at 6027 Edgewood Bend Court, San Diego,
Californi
f
a 92130. Any proposal must comply with the requirements as to form and subs
u
tance establ
a ished by the SEC for such proposal
to be included in our Proxy Statement. Stockholders are also advised to review our bylaws, which contain additional requirements for
advance notice of stockholder proposals and director nominations.
In addition, our bylaws contain “proxy access” provisions that permit a stockholder or group of stockholders to include
director candidates that they intend to nominate in our annual meeting proxy statement and on our proxy card, provided that the
stockholder ownership, notice and other requirements set forth in our bylaws are satisfied. To be timely for our 2026 Annual Meeting
of Stockholders, the required notice under the proxy access provisions of our bylaws must be received by the Company’s Corporate
Secretary
r at 6027 Edgewood Bend Court, San Diego, Californi
f
a 92130 not earlier than November 10, 2025 and not later than the close
of business on December 10, 2025. However, if our 2026 Annual Meeting of Stockholders is held more than 30 days prior to or more
than 60 days afte
f r the anniversary of
r
the Annual Meeting, then notice under the proxy access provisions must be received no earlier
than the close of business on the 150th day prior to the 2026 Annual Meeting of Stockholders and not later than the close of business
on the later of the 120th day prior to such annual meeting or the 10th day following the day on which public announcement of the date
of such annual meeting is first made.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Proxy Statement and other materials we are sending you or that are availabl
a e on our website in connection with the
Annual Meeting contain “for
f
ward-looking statements” as defined under federal securities laws. Many of these statements can be
identified by the use of terminology such as “believes,” “expects,” “intends,” “anticipates,” “plans,” “may,” “will,” “proje
o cts,”
“continues,” “estimates,” “potential,” “opportunity” or the negative versions of these terms and other similar expressions. These
forward-looking statements may be found in the sections of this Proxy Statement titled “Proxy Summary,” “Compensation Discussion
and Analysis,” and other sections of this Proxy Statement. These forward-looking statements are based on our current expectations and
assumptions, and are subj
u ect to risks and uncertainties that could cause our actua
t
l results or experience and the timing of events to
differ significantly from the forward-looking statements. Factors that could cause or contribute to these differences include those
discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on
Februa
r
ry 10, 2025 under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
and elsewhere in the Annual Report. You should carefully consider that information before voting.
You should not place undue reliance on these statements, which speak only as of the date that they were made. These
cautionary statements should be considered in connection with any written or oral forward-looking statements that we may make in
the future. We do not undertake any obligation to release publicly any revisions to these forward-looking statements to reflect later
events or circumstances or to reflect the occurrence of unanticipated events.
82
Appendix A
Neurocrine Biosciences, Inc.
2025 Equity Incentive Plan
Adopted by the Compensation Committee: March 14, 2025
Approved by the Stockholders: _____, 2025
1.
General.
(a)
Relationship to Prior Plans. The Plan is the successor to the 2020 Plan. As of the Effe
f ctive Date: (i) no additional
awards may be granted under the 2020 Plan; and (ii) all Prior Plan Awards will remain subj
u ect to the terms of the applicable Prior Plan
(except that any Prior Plans’ Returning Shares will become availabl
a e for issuance pursuant to Awards granted under this Plan). All
Awards granted under this Plan will be subj
u ect to the terms of this Plan.
(b)
Plan Purpose. The Company, by means of the Plan, seeks to secure and retain the services of Employees, Directors
and Consultants, to provide incentives for such persons to exert maximum effort
f
s for the success of the Company and any Affi
f liate,
and to provide a means by which such persons may be given an opportunity to benefit from increases in value of the Common Stock
through the granting of Awards.
(c)
Available Awards. The Plan provides for the grant of the following Awards: (i) Incentive Stock Options;
(ii) Nonstatutory Stock Options; (iii) SARs; (iv) Restricted Stock Awards; (v) RSU Awards; (vi) Performance Awards; and (vii) Other
Awards.
(d)
Adoption Date. The Plan will come into existence on the Adoption Date. No Award may be granted under the Plan
prior to the Adoption Date. Any Award granted prior to the Effe
f ctive Date is contingent upon timely receipt of stockholder approval to
the extent required under applicable tax, securities and regulatory rules, and satisfaction of any other compliance requirements.
2.
Shares Subject to the Plan.
(a)
Share Reserve.
(i)
Subj
u ect to Section 2(a)(iii), any adju
d stment in accordance with Section 2(b), and any adju
d stment as
necessary to implement any Capi
a talization Adju
d stment, the aggregate number of shares of Common Stock that may be issued pursuant
to Awards (the “Share Reserve”) will not exceed: (A) the sum of (i) 7,800,000 new shares and (ii) the Prior Plans’ Returning Shares,
if any, as such shares become availabl
a e for issuance under this Plan from time to time; minus (B) one share for each share of Common
Stock subj
u ect to an Appreciation Award granted under the 2020 Plan afte
f r March 24, 2025 and prior to the Effe
f ctive Date and 2.43
shares for each share of Common Stock subj
u ect to a Full Value Award granted under the 2020 Plan afte
f r March 24, 2025 and prior to
the Effe
f ctive Date.
(ii)
Subj
u ect to Section 2(b), the Share Reserve will be reduced by: (A) one share for each share of Common
Stock issued pursuant to an Appreciation Award granted under the Plan; and (B) 2.43 shares for each share of Common Stock issued
pursuant to a Full Value Award granted under the Plan.
(iii)
Subj
u ect to Section 2(b), the Share Reserve will be increased by: (A) one share for each Prior Plans’
Returning Share or 2025 Plan Returning Share (as defined in Section 2(b)(ii)) subj
u ect to an Appreciation Award; and (B) 2.43 shares
for each Prior Plans’ Returning Share or 2025 Plan Returning Share subj
u ect to a Full Value Award.
(iv)
For clarity, the Share Reserve is a limit on the number of shares of Common Stock that may be issued
pursuant to the Plan. Accordingly, this Section 2(a) does not limit the granting of Awards, except that the Company will keep availabl
a e
at all times the number of shares of Common Stock reasonably required to satisfy its obligations to issue shares pursuant to such
Awards. Shares may be issued in connection with a merger or acquisition as permitted by, as applicable, Nasdaq Listing Rule 5635(c),
NYSE Listed Company Manual Section 303A.08, NYSE American Company Guide Section 711 or other applicable rule, and such
issuance will not reduce the number of shares availabl
a e for issuance under the Plan.
(b)
Share Reserve Operation.
(i)
No Reduction to Share Reserve. The Share Reserve will not be reduced by any of the following shares of
Common Stock and such shares will remain availabl
a e for issuance under the Plan: (A) any shares subj
u ect to an Award that are not
issued because such Award or any portion thereof expires or otherwise terminates without all of the shares covered by such Award
having been issued; and (B) any shares subj
u ect to an Award that are not issued because such Award or any portion thereof is settled in
cash.
(ii)
Shares Available for Subsequent Issuance. The following shares of Common Stock (collectively, the
“2025 Plan
l
Returning Shares”) will become availabl
a e again for issuance under the Plan: (A) any shares issued pursuant to an Award
that are forfeited back to or repurchased by the Company because of the failure to meet a contingency or condition required for the
vesting of such shares; and (B) any shares that are reacquired or withheld (or not issued) by the Company to satisfy a tax withholding
obligation in connection with a Full Value Award granted under the Plan.
(iii)
Shares Not Available for Subsequent Issuance. The following shares of Common Stock will not revert to
the Share Reserve or become availabl
a e again for issuance under the Plan: (A) any shares that are reacquired or withheld (or not issued)
by the Company to satisfy
f
the exercise, strike or purchase price of an Award or a Prior Plan Award (including any shares subj
u ect to
such award that are not delivered because such award is exercised through a reduction of shares subj
u ect to such award (i.e., “net
exercised”)); (B) any shares that are reacquired or withheld (or not issued) by the Company to satisfy a tax withholding obligation in
connection with an Appreciation Award granted under the Plan or a Prior Plan; (C) any shares repurchased by the Company on the
open market with the proceeds of the exercise, strike or purchase price of an Award or a Prior Plan Award; and (D) in the event that a
Stock Appreciation Right granted under the Plan or a stock appreciation right granted under a Prior Plan is settled in shares of
Common Stock, the gross number of shares of Common Stock subj
u ect to such award.
3.
Eligibility and Limitations.
(a)
Eligible Award Recipients. Subj
u ect to the terms of the Plan, Employees, Directors and Consultants are eligible to
receive Awards.
(b)
Specific Award Limitations.
(i)
Limitations on Incentive Stock Option Recipients. Incentive Stock Options may be granted only to
employees of the Company or a “parent corporation” or “subsidiary corporation” thereof (as such terms are defined in Sections 424(e)
and (f) of the Code).
(ii)
Incentive Stock Option $100,000 Limitation. To the extent that the aggregate Fair Market Value
(determined at the time of grant) with respect to which Incentive Stock Options are exercisabl
a e for the first time by any Participant
during any calendar year (under all plans of the Company and any Affi
f liates) exceeds $100,000 (or such other limit establ
a ished in the
Code) or otherwise does not comply with the rules governing Incentive Stock Options, the Options or portions thereof that exceed
such limit (according to the order in which they were granted) or otherwise do not comply with such rules will be treated as
Nonstatutory Stock Options, notwithstanding any contrary provision of the applicable Option Agreement(s).
(iii)
Limitations on Incentive Stock Options Granted to Ten Percent Stockholders. A Ten Percent
Stockholder may not be granted an Incentive Stock Option unless (1) the exercise price of such Option is at least 110% of the Fair
Market Value on the date of grant of such Option and (2) such Option is not exercisabl
a e afte
f r the expiration of five years from the date
of grant of such Option.
(iv)
Limitations on Nonstatutory Stock Options and SARs. Nonstatutory Stock Options and SARs may not
be granted to Employees, Directors and Consultants who are providing Continuous Service only to any “parent” of the Company (as
such term is defined in Rule 405) unless the stock underlying such Awards is treated as “service recipient stock” under Section 409A
because such Awards are granted pursuant to a corporate transaction (such as a spin offf transaction) or unless such Awards otherwise
comply with the distribution requirements of Section 409A.
(c)
Aggregate Incentive Stock Option Limit. Notwithstanding anything to the contrary in Section 2(a) and subj
u ect to
any adju
d stment as necessary to implement any Capi
a talization Adju
d stment, the aggregate maximum number of shares of Common
Stock that may be issued pursuant to the exercise of Incentive Stock Options is 7,800,000 shares.
(d)
Non-Employee Director Compensation Limit. The aggregate value of all compensation granted or paid, as
applicable, by the Company to any individual for service as a Non-Employee Director with respect to any period commencing on the
date of the Annual Meeting for a particular year and ending on the date immediately prior to the date of the Annual Meeting for the
next subs
u
equent year (the “An
“
nual Period”)
d , including Awards granted and cash fees paid by the Company to such Non-Employee
Director, will not exceed $750,000 in total value. In addition, the aggregate value of any equity award(s) granted under the Plan or
otherwise by the Company to any individual for service as a Non-Employee Director upon or in connection with his or her initial
election or appointment to the Board will not exceed $1,500,000 in total value; for the avoidance of doubt, the aggregate compensation
granted or paid, as appl
a
icable, by the Company to any individual for service as a Non-Employee Director with respect to an Annual
Period in
h
which su h
ch indi id
dividual is fifirst ap
i
point d
ed or l
d
elected to hthe Board
i
willll not exce d
ed hthe sum of hthe two pr
d
eceding lili i
mita itions in
hi
this Sectio
(
n 3(d)
d).
h
The value of any eq iui yty awards, for purposes of hthe li i
i
limitatio
d
ns desc irib d
bed i
hi
in this Sectio
(d)
n 3(d),
i
willll be calc lul
d
ated
ba
based on hthe grant date fair value of su h
ch eq iui yty awards f
fi
for financi l
ial repor iting purposes.
A-2
4.
Options and Stock Appreciation Rights.
Each Option and SAR will have such terms and conditions as determined by the Board. Each Option will be designated in
writing as an Incentive Stock Option or Nonstatutory Stock Option at the time of grant; provided
d
, how
d
ever, that if an Option is not so
designated, then such Option will be a Nonstatutory Stock Option, and the shares purchased upon exercise of each type of Option will
be separately accounted for. Each SAR will be denominated in shares of Common Stock equivalents. The terms and conditions of
separate Options and SARs need not be identical; provided
d
, how
d
ever, that each Option Agreement and SAR Agreement will conform
(through incorporation of the provisions hereof by reference in the Award Agreement or otherwise) to the subs
u
tance of each of the
following provisions:
(a)
Term. Subj
u ect to Section 3(b) regarding Ten Percent Stockholders, no Option or SAR will be exercisabl
a e afte
f r the
expiration of ten years from the date of grant of such Award or such shorter period specified in the Award Agreement.
(b)
Exercise or Strike Price. Subj
u ect to Section 3(b) regarding Ten Percent Stockholders, the exercise or strike price of
each Option or SAR will not be less than 100% of the Fair Market Value on the date of grant of such Award. Notwithstanding the
foregoing, an Option or SAR may be granted with an exercise or strike price lower than 100% of the Fair Market Value on the date of
grant of such Award if such Award is granted pursuant to an assumption of or subs
u
titution for another option or stock appreciation
right pursuant to a Transaction and in a manner consistent with the provisions of Section 409A and, if applicable, Section 424(a) of the
Code.
(c)
Exercise Procedure and Payment of Exercise Price for Options. In order to exercise an Option, the Participant
must provide notice of exercise to the Plan Administrator in accordance with the procedur
d
es specified in the Option Agreement or
otherwise provided by the Company. The Board has the authority to grant Options that do not permit all of the following methods of
payment (or otherwise restrict the ability to use certain methods) and to grant Options that require the consent of the Company to
utilize a particular method of payment. The exercise price of an Option may be paid, to the extent permitted by Applicable Law and as
determined by the Board, by one or more of the following methods of payment to the extent set forth in the Option Agreement:
(i)
by cash (including electronic funds transfer
f s), check, bank draftf or money order payable to the Company;
(ii)
pursuant to a “cashless exercise” program developed under Regulation T as promulgated by the Federal
Reserve Board that, prior to the issuance of the Common Stock subj
u ect to the Option, results in either the receipt of cash (or check) by
the Company or the receipt of irrevocable instructions to pay the exercise price to the Company from the sales proceeds;
(iii)
by delivery to the Company (either by actual delivery or attestation) of shares of Common Stock that are
already owned by the Participant free and clear of any liens, claims, encumbrances or security interests, with a Fair Market Value on
the date of exercise that is necessary to satisfy the exercise price, provided that any amount of the exercise price not satisfied by such
delivery
r is paid by the Participant in cash or other permitted form of payment;
(iv)
if the Option is a Nonstatutory Stock Option, by a “net exercise” arrangement pursuant to which the
Company will reduce the number of shares of Common Stock issuable upon exercise by the whole number of shares with a Fair
Market Value on the date of exercise that is necessary to satisfy
f
the exercise price, provided that (1) such shares used to pay the
exercise price will not be exercisabl
a e thereafte
f r and (2) any amount of the exercise price not satisfied by such net exercise is paid by
the Participant in cash or other permitted form of payment; or
(v)
in any other form of consideration that may be acceptabl
a e to the Board and permissible under Applicable
Law.
(d)
Exercise Procedure and Payment of Appreciation Distribution for SARs. In order to exercise a SAR, the
Participant must provide notice of exercise to the Plan Administrator in accordance with the procedur
d
es specified in the SAR
Agreement or otherwise provided by the Company. The appreciation distribution payable to a Participant upon the exercise of a SAR
will not be greater than an amount equal to the excess of (i) the aggregate Fair Market Value on the date of exercise of a number of
shares of Common Stock equal to the number of Common Stock equivalents that are vested and being exercised under such SAR, over
(ii) the strike price of such SAR. Such appreciation distribution may be paid to the Participant in the form of Common Stock or cash
(or any combination of Common Stock and cash) or in any other form of payment, as determined by the Board and specified in the
SAR Agreement.
(e)
Transferability. The Board may impose such limitations on the transferab
f
ility of an Option or SAR as it
determines. In the absence of any such determination by the Board, the restrictions set forth in this Section 4(e) on the transferab
f
ility
of Options and SARs will apply. Notwithstanding the foregoing or anything in the Plan or an Award Agreement to the contrary, no
Option or SAR may be transfer
f red to any third-party financial institution for value without prior stockholder approval.
(i)
Restrictions on Transfer.
f
An Option or SAR will not be transfer
f able, except by will or by the laws of
descent and distribution (and pursuant to Sections 4(e)(ii) and 4(e)(iii) below), and will be exercisabl
a e during the lifetime of the
Participant only by the Participant; provided
d
, how
d
ever, that the Company may permit transfer
f
of an Option or SAR in a manner that is
not prohibited by applicable tax and securities laws upon the Participant’s request, provided the Participant and transferee
f
enter into
any transfer an
f
d other agreements required by the Company.
A-3
(ii)
Domestic Relations Orders. The Company may permit an Option or SAR to be transfer
f red pursuant to the
terms of a domestic relations order, offi
f cial marital settlement agreement or other divorce or separation instrument as permitted by
Treasury
r
Regulations Section 1.421-1(b)(2). If an Option is an Incentive Stock Option, such Option may be deemed to be a
Nonstatutory Stock Option as a result of such transfer.
f
(iii)
Beneficiary Designation. Subj
u ect to the approval of the Company, a Participant may, by delivering written
notice to the Company, in a form approved by the Company (or the designated broker), designate a third party who, upon the death of
the Participant, will thereafter be entitled to exercise the Option or SAR and receive the Common Stock or other consideration
resulting from such exercise. In the absence of such a designation, upon the death of the Participant, the executor or administrator of
the Participant’s estate will be entitled to exercise the Option or SAR and receive the Common Stock or other consideration resulting
from such exercise. However, the Company may prohibit designation of a beneficiary
r at any time, including due to any conclusion by
the Company that such designation would be inconsistent with Applicable Law.
(f)
Vesting. The Board may impose such restrictions on or conditions to the vesting and/or exercisabi
a lity of an Option
or SAR as determined by the Board. Except as otherwise provided in the Award Agreement or other written agreement between a
Participant and the Company or an Affi
f liate, vesting of Options and SARs will cease upon termination of the Participant’s Continuous
Service.
(g)
Termination of Continuous Service for Cause. Except as explicitly otherwise provided in the Award Agreement
or other written agreement between a Participant and the Company or an Affi
f liate, if a Participant’s Continuous Service is terminated
for Cause, the Participant’s Options and SARs will terminate and be forfeited immediately upon such termination of Continuous
Service, the Participant will be prohibited from exercising any portion (including any vested portion) of such Awards on and afte
f r the
date of such termination of Continuous Service, and the Participant will have no further right, title or interest in the forfeited Award,
the shares of Common Stock subj
u ect to the forfeited Award, or any consideration in respect of the forfeited Award.
(h)
Post-Termination Exercise Period Following Termination of Continuous Service for Reasons Other than for
Cause. Except as otherwise provided in the Award Agreement, other written agreement between a Participant and the Company or an
Affi
f liate or as otherwise determined by the Board, subj
u ect to Section 4(i), if a Participant’s Continuous Service terminates for any
reason other than for Cause, the Participant may exercise his or her Option or SAR to the extent vested, but only within the following
period of time or, if applicable, such other period of time provided in the Award Agreement, other written agreement between a
Participant and the Company or an Affi
f liate or as otherwise determined by the Board; provided
d
, how
d
ever, that in no event may such
Award be exercised afte
f r the expiration of its maximum term as set forth in the Award Agreement:
(i)
three months following the date of such termination if such termination is a termination without Cause
(other than any termination due to the Participant’s Disabi
a lity or death);
(ii)
12 months following the date of such termination if such termination is due to the Participant’s Disabi
a lity;
(iii)
18 months following the date of such termination if such termination is due to the Participant’s death; or
(iv)
18 months following the date of the Participant’s death if such death occurs following the date of such
termination but during the period such Award is otherwise exercisabl
a e (as provided in (i) or (ii) above).
Following the date of such termination or death, as applicable, to the extent the Participant does not exercise such Award within the
applicable Post-Termination Exercise Period (or, if earlier, prior to the expiration of the maximum term of such Award), such
unexercised portion of the Award will terminate, and the Participant will have no further right, title or interest in the terminated
Award, the shares of Common Stock subj
u ect to the terminated Award, or any consideration in respect of the terminated Award.
(i)
Restrictions on Exercise; Extension of Exercisability. A Participant may not exercise an Option or SAR at any
time that the issuance of shares of Common Stock upon such exercise would violate Applicable Law. Except as otherwise provided in
the Award Agreement, other written agreement between a Participant and the Company or an Affi
f liate or as otherwise determined by
the Board, if a Participant’s Continuous Service terminates for any reason other than for Cause and, at any time during the applicable
Post-Termination Exercise Period: (i) the exercise of the Participant’s Option or SAR would be prohibited solely because the issuance
of shares of Common Stock upon such exercise would violate Applicable Law; or (ii) the immediate sale of any shares of Common
Stock issued upon such exercise would violate the Company’s Trading Policy, then the applicable Post-Termination Exercise Period
will be extended to the last day of the calendar month that commences following the date the Award would otherwise expire, with an
additional extension of the exercise period to the last day of the next calendar month to apply if any of the foregoing restrictions apply
at any time during such extended exercise period, generally without limitation as to the maximum permitted number of extensions;
provided
d
, how
d
ever, that in no event may such Award be exercised afte
f r the expiration of its maximum term (as set forth in the Award
Agreement).
A-4
(j)
Non-Exempt Employees. No Option or SAR, whether or not vested, granted to an Employee who is a non-exempt
employee for purpos
r
es of the Fair Labor
a
Standards Act of 1938, as amended, will be first exercisabl
a e for any shares of Common Stock
until at least six months following the date of grant of such Award. Notwithstanding the foregoing, in accordance with the provisions
of the Worker Economic Opportunity Act, any vested portion of such Award may be exercised earlier than six months following the
date of grant of such Award in the event of (i) such Participant’s death or Disabi
a lity, (ii) a Transaction in which such Award is not
assumed, continued or subs
u
tituted, (iii) a Change in Control, or (iv) such Participant’s retirement (as such term may be defined in the
Award Agreement or another applicable agreement or, in the absence of any such definition, in accordance with the Company’s then-
current employment policies and guidelines). This Section 4(j)
(
is intended to operate so that any income derived by a non-exempt
employee in connection with the exercise or vesting of an Option or SAR will be exempt from his or her regular rate of pay. To the
extent permitted and/or required for compliance with the Worker Economic Opportunity Act to ensure that any income derived by a
non-exempt employee in connection with the exercise, vesting or issuance of any shares under any other Award will be exempt from
the employee’s regular rate of pay, the provisions of this Section 4(j)
(
will apply to all Awards and are hereby incorporated by
reference into such Award Agreements.
(k)
Whole Shares. Options and SARs may be exercised only with respect to whole shares of Common Stock or their
equivalents.
5.
Awards Other Than Options and Stock Appreciation Rights.
(a)
Restricted Stock Awards and RSU Awards. Each Restricted Stock Award and RSU Award will have such terms
and conditions as determined by the Board. The terms and conditions of separate Restricted Stock Awards and RSU Awards need not
be identical; provided
d
, how
d
ever, that each Restricted Stock Award Agreement and RSU Award Agreement will conform (through
incorporation of the provisions hereof by reference in the Award Agreement or otherwise) to the subs
u
tance of each of the following
provisions:
(i)
Form of Award.
(1)
Restricted Stock Awards. To the extent consistent with the Company’s Bylaws, at the Board’s
election, shares of Common Stock subj
u ect to a Restricted Stock Award may be (i) held in book entry
r
form subj
u ect to the Company’s
instructions until such shares become vested or any other restrictions laps
a
e, or (ii) evidenced by a certificate, which certificate will be
held in such form and manner as determined by the Board. Unless otherwise determined by the Board, a Participant will have voting
and other rights as a stockholder of the Company with respect to any shares subj
u ect to a Restricted Stock Award.
(2)
RSU Awards. A RSU Award represents a Participant’s right to be issued on a futur
t
e date the
number of shares of Common Stock that is equal to the number of restricted stock units subj
u ect to the RSU Award. As a holder of a
RSU Award, a Participant is an unsecured creditor of the Company with respect to the Company’s unfunded obligation, if any, to
issue shares of Common Stock in settlement of such Award and nothing contained in the Plan or any RSU Award Agreement, and no
action taken pursuant to its provisions, will create or be construe
r
d to create a trus
r
t of any kind or a fiduciary relationship between a
Participant and the Company or an Affi
f liate or any other person. A Participant will not have voting or any other rights as a stockholder
of the Company with respect to a RSU Award (unless and until shares are actua
t
lly issued in settlement of a vested RSU Award).
(ii)
Consideration.
(1)
Restricted Stock Awards. A Restricted Stock Award may be granted in consideration for
(A) cash (including electronic funds transfer
f s), check, bank draftf or money order payable to the Company, (B) past services to the
Company or an Affi
f liate, or (C) any other form of consideration (including future services) as the Board may determine and
permissible under Applicable Law.
(2)
RSU Awards. Unless otherwise determined by the Board at the time of grant, a RSU Award will
be granted in consideration for the Participant’s services to the Company or an Affi
f liate, such that the Participant will not be required
to make any payment to the Company (other than such services) with respect to the grant or vesting of the RSU Award, or the issuance
of any shares of Common Stock pursuant to the RSU Award. If, at the time of grant, the Board determines that any consideration must
be paid by the Participant (in a form other than the Participant’s services to the Company or an Affi
f liate) upon the issuance of any
shares of Common Stock in settlement of the RSU Award, such consideration may be paid in any form of consideration as the Board
may determine and permissible under Applicable Law.
(iii)
Vesting. The Board may impose such restrictions on or conditions to the vesting of a Restricted Stock
Award or RSU Award as determined by the Board. Except as otherwise provided in the Award Agreement or other written agreement
between a Participant and the Company or an Affi
f liate, vesting of Restricted Stock Awards and RSU Awards will cease upon
termination of the Participant’s Continuous Service.
A-5
(iv)
Termination of Continuous Service. Except as otherwise provided in the Award Agreement or other
written agreement between a Participant and the Company or an Affi
f liate, if a Participant’s Continuous Service terminates for any
reason, (1) the Company may receive through a forfeitur
t
e condition or a repurchase right any or all of the shares of Common Stock
held by the Participant under his or her Restricted Stock Award that have not vested as of the date of such termination under the terms
set forth in the Restricted Stock Award Agreement, and (2) any portion of the Participant’s RSU Award that has not vested as of the
date of such termination will be forfeited upon such termination and the Participant will have no further right, title or interest in the
RSU Award, the shares of Common Stock issuable pursuant to the RSU Award, or any consideration in respect of the RSU Award.
(v)
Settlement of RSU Awards. A RSU Award may be settled by the issuance of shares of Common Stock or
cash (or any combination thereof) or in any other form of payment, as determined by the Board and specified in the RSU Award
Agreement. The Board may determine to impose such restrictions or conditions that delay such delivery
r to a date following the vesting
of the RSU Award.
(b)
Perfor
f
mance Awards. With respect to any Performance Award, the length of any Performance Period, the
Performance Goals to be achieved during the Performance Period, the other terms and conditions of such Award, and the measure of
whether and to what degree such Performance Goals have been attained will be determined by the Board. In addition, to the extent
permitted by Applicable Law and set forth in the applicable Award Agreement, the Board may determine that cash or other property
may be used in payment of Performance Awards. Perfor
f
mance Awards that are settled in cash or other property are not required to be
valued in whole or in part by reference to, or otherwise based on, the Common Stock.
(c)
Other Awards. Other forms of Awards valued in whole or in part by reference to, or otherwise based on, Common
Stock, including the appr
a
eciation in value thereof, may be granted either alone or in addition to Awards provided for under Section 4
and the preceding provisions of this Section 5. Subj
u ect to the provisions of the Plan, the Board will have sole and complete discretion
to determine the persons to whom and the time or times at which such Other Awards will be granted, the number of shares of
Common Stock (or the cash equivalent thereof) to be granted pursuant to such Other Awards, and all other terms and conditions of
such Other Awards.
6.
Adju
d
stments upon Changes in Common Stock; Other Corporate Events.
(a)
Capitalization Adju
d
stments. In the event of a Capi
a talization Adju
d stment, the Board will appropriately and
proportionately adju
d st: (i) the class(es) and maximum number of shares of Common Stock subj
u ect to the Plan pursuant to Section 2(a);
(ii) the class(es) and maximum number of shares of Common Stock that may be issued pursuant to the exercise of Incentive Stock
Options pursuant to Section 3(c); and (iii) the class(es) and number of shares of Common Stock and the exercise, strike or purchase
price of Common Stock subj
u ect to outstanding Awards. The Board will make such adju
d stments, and its determination will be final,
binding and conclusive. Notwithstanding the foregoing, no fractional shares or rights for fractional shares of Common Stock will be
created in order to implement any Capi
a talization Adju
d stment. The Board will determine an appropriate equivalent benefit, if any, for
any fractional shares or rights to fractional shares that may be created by the adju
d stments referred to in the preceding provisions of this
Section 6(a).
(b)
Dissolution or Liquidation. Except as otherwise provided in the Award Agreement or other written agreement
between a Participant and the Company or an Affi
f liate, in the event of a dissolution or liquidation of the Company, all outstanding
Awards (other than Awards consisting of vested and outstanding shares of Common Stock not subj
u ect to a forfeiture condition or the
Company’s right of repurchase) will terminate immediately prior to the completion of such dissolution or liquidation, and the shares of
Common Stock subj
u ect to a forfeiture condition or the Company’s right of repurchase may be reacquired or repurchased by the
Company notwithstanding the fact that the holder of such Award is providing Continuous Service.
(c)
Transaction. In the event of a Transaction, the provisions of this Section 6(c) will apply to each outstanding Award
unless otherwise provided in the instrument evidencing the Award, in any other written agreement between a Participant and the
Company or an Affi
f liate, or in any director compensation policy of the Company.
(i)
Awards May Be Assumed. In the event of a Transaction, the Acquiring Entity may assume or continue
any or all outstanding Awards or may subs
u
titute similar awards for any or all outstanding Awards (including but not limited to, awards
to acquire the same consideration paid to the stockholders of the Company pursuant to the Transaction), and any reacquisition or
repurchase rights held by the Company in respect of Common Stock issued pursuant to outstanding Awards may be assigned by the
Company to the Acquiring Entity. For clarity, in the event of a Transaction, the Acquiring Entity may choose to assume or continue
only a portion of an outstanding Award, to subs
u
titute a similar award for only a portion of an outstanding Award, or to assume or
continue, or subs
u
titute similar awards for, the outstanding Awards held by some, but not all, Participants. The terms of any
assumption, continuation or subs
u
titution will be set by the Board.
(ii)
Awards Held by Current Participants. In the event of a Transaction in which the Acquiring Entity does
not assume or continue outstanding Awards or subs
u
titute similar awards for outstanding Awards, then with respect to any such Awards
that have not been assumed, continued or subs
u
tituted and that are held by Participants whose Continuous Service has not terminated
prior to the effe
f ctive time of the Transaction (referred to as the “Current Particip
t
ants”), the vesting (and exercisabi
a lity, if applicable)
of such Awards will be accelerated in full (and with respect to any such Awards that are subj
u ect to performance-based vesting
conditions or requirements, vesting will be deemed to be satisfie
f d at the greater of (x) the target level of performance or (y) the actua
t
l
level of performance measured in accordance with the applicable performance goals as of the date of the Transaction) to a date prior to
the effe
f ctive time of such Transaction (contingent upon the effe
f ctiveness of the Transaction) as the Board determines (or, if the Board
A-6
does not determine such a date, to the date that is 15 days prior to the effe
f ctive time of the Transaction), and such Awards will
terminate if not exercised (if applicable) at or prior to the effe
f ctive time of the Transaction, and any reacquisition or repurchase rights
held by the Company with respect to such Awards will laps
a
e (contingent upon the effe
f ctiveness of the Transaction). With respect to
the vesting of Awards that will accelerate upon the occurrence of a Transaction pursuant to this Section 6(c)(ii) and are settled in the
form of a cash payment, such cash payment will be made no later than 30 days following the occurrence of the Transaction.
(iii)
Awards Held by Participants other than Current Participants. In the event of a Transaction in which
the Acquiring Entity does not assume or continue outstanding Awards or subs
u
titute similar awards for outstanding Awards, then with
respect to any such Awards that have not been assumed, continued or subs
u
tituted and that are held by Participants other than Current
Participants, such Awards will terminate if not exercised (if applicable) at or prior to the effe
f ctive time of the Transaction; provided
d
,d
however, that any reacquisition or repurchase rights held by the Company with respect to such Awards will not terminate and may
continue to be exercised notwithstanding the Transaction.
(iv)
Payment for Awards in Lieu of Exercise. Notwithstanding the foregoing, in the event any outstanding
Award held by a Participant will terminate if not exercised at or prior to the effe
f ctive time of a Transaction, the Board may provide
that the Participant may not exercise such Award but instead will receive a payment, in such form as may be determined by the Board,
equal in value, at the effective time, to the excess, if any, of (1) the value of the property the Participant would have received upon the
exercise of such Award, over (2) any exercise price payable by the Participant in connection with such exercise. For clarity, such
payment may be zero if the value of such property is equal to or less than the exercise price. Payments under this provision may be
delayed to the same extent that payment of consideration to the holders of Common Stock in connection with the Transaction is
delayed as a result of escrows, earn outs, holdbacks or any other contingencies.
(d)
Involuntary Termination Upon or Following a Transaction. Except as otherwise provided in the Award
Agreement, in any other written agreement between a Participant and the Company or an Affi
f liate, in any severance plan of the
Company governing the Participant’s Awards under the Plan, or in any director compensation policy of the Company, in the event that
an Employee or Director’s Continuous Service is involuntarily terminated without Cause (including any such termination due to such
Employee or Director’s death or Disabi
a lity) upon or within 12 months following the effe
f ctive time of a Transaction, the vesting (and
exercisabi
a lity, if applicable) of any Assumed Awards (as defined in this Section 6(d)) held by such Employee or Director as of the date
of such termination will be accelerated in full (and with respect to any such Awards that are subj
u ect to performance-based vesting
conditions or requirements, vesting will be deemed to be satisfie
f d at the greater of (x) the target level of performance or (y) the actua
t
l
level of perfor
f
mance measured in accordance with the applicable performance goals as of the date of such termination), effe
f ctive as of
the date of such termination. For purpos
r
es of this Section 6(d), an “As
“
sumed Award”
d means any outstanding Award that was assumed
or continued, or any outstanding similar award that was granted in subs
u
titution for an Award, in each case by the Acquiring Entity in
connection with the appl
a
icable Transaction.
(e)
Parachute Payments. Except as otherwise provided in the Award Agreement or other written agreement between a
Participant and the Company or an Affi
f liate or in any severance plan of the Company that applies to the Participant, if any payment or
benefit (including payments or benefits pursuant to this Plan or otherwise) that the Participant would or may receive from the
Company or otherwise (“Pa
“
yment
a
”)
t
would (i) constitute a “parachute payment” within the meaning of Section 280G of the Code and
(ii) but for this sentence, be subj
u ect to the excise tax imposed by Section 4999 of the Code (the “Ex
“
cise
i
Tax”), then such Payment will
be equal to the Reduced Amount. The “Re
“
duced Amount”t will be either (x) the largest portion of the Payment that would result in no
portion of the Payment being subj
u ect to the Excise Tax or (y) the largest portion, up to and including the total, of the Payment,
whichever amount, afte
f r taking into account all applicable federal, state and local employment taxes, income taxes, and the Excise Tax
(all computed at the highest applicable marginal rate), results in the Participant’s receipt, on an afte
f r-tax basis, of the greater economic
benefit notwithstanding that all or some portion of the Payment may be subj
u ect to the Excise Tax. If a reduction in payments or
benefits constituting “parachute payments” is necessary so that the Payment equals the Reduced Amount, the Participant will have no
rights to any additional payments and/or benefits, and reduction shall occur in the manner that results in the greatest economic benefit
for the Participant. If more than one method of reduction will result in the same economic benefit, the items so reduced will be
reduced pro rata.
In the event it is subs
u
equently determined by the Internal Revenue Service that some portion of the Reduced Amount as
determined pursuant to clause (x) in the preceding paragraph is subj
u ect to the Excise Tax, the Participant agrees to promptly return to
the Company a sufficient amount of the Payment so that no portion of the Reduced Amount is subj
u ect to the Excise Tax. For the
avoidance of doubt, if the Reduced Amount is determined pursuant to clause (y) in the preceding paragraph, the Participant will have
no obligation to return any portion of the Payment pursuant to the preceding sentence.
The foregoing calculations will be determined by the independent registered public accounting firm engaged by the Company
for general audit purposes as of the day prior to the effe
f ctive date of the event described in Section 280G(b)(2)(A)(i) of the Code or
such nationally recognized independent registered public accounting firm chosen by the Company. The Company will bear all
expenses with respect to the determinations by such independent registered public accounting firm required to be made hereunder.
Any good faith determinations of the independent registered public accounting firm made hereunder will be final, binding and
conclusive upon the Company and the Participant.
(f)
Appointment of Stockholder Representative. As a condition to the receipt of an Award, a Participant will be
deemed to have agreed that the Award will be subj
u ect to the terms of any agreement governing a Transaction involving the Company,
including, without limitation, a provision for the appointment of a stockholder representative that is authorized to act on the
Participant’s behalf with respect to any escrow, indemnities and any contingent consideration.
A-7
(g)
No Restriction on Right to Undertake Transactions. The grant of any Award and the issuance of shares of
Common Stock pursuant to any Award does not affe
f ct or restrict in any way the right or power of the Company or the stockholders of
the Company to make or authorize any adju
d stment, recapi
a talization, reorganization or other change in the Company’s capi
a tal structure
or its business, any merger or consolidation of the Company, any issue of stock or of options, rights or options to purchase stock or of
bonds, debentures, preferred or prior preference stocks whose rights are supe
u
rior to or affe
f ct the Common Stock or the rights thereof
or which are convertible into or exchangeable for Common Stock, or the dissolution or liquidation of the Company, or any sale or
transfer
f
of all or any part of its assets or business, or any other corporate act or proceeding, whether of a similar character or otherwise.
7.
Administration.
(a)
Administration by Board. The Board will administer the Plan unless and until the Board delegates administration
of the Plan to a Committee or Committees, as provided in Section 7(c).
(b)
Powers of Board. The Board will have the power, subj
u ect to, and within the limitations of, the express provisions of
the Plan:
(i)
To determine from time to time: (1) which of the persons eligible under the Plan will be granted Awards;
(2) when and how each Award will be granted; (3) what type or combination of types of Award will be granted; (4) the provisions of
each Award (which need not be identical), including the time or times when a person will be permitted to receive an issuance of
Common Stock or other payment pursuant to an Award; (5) the number of shares of Common Stock or cash equivalent with respect to
which an Award will be granted to each such person; and (6) the Fair Market Value applicable to an Award.
(ii)
To construe
r
and interpret the Plan and Awards granted under it, and to establ
a ish, amend and revoke rules
and regulations for its administration. The Board, in the exercise of this power, may correct any defect, omission or inconsistency in
the Plan or in any Award Agreement, in a manner and to the extent it deems necessary or expedient to make the Plan or Awards fully
effe
f ctive.
(iii)
To settle all controversies regarding the Plan and Awards granted under it.
(iv)
To accelerate the time at which an Award may first be exercised or the time during which an Award or any
part thereof will vest, notwithstanding the provisions in the Award Agreement stating the time at which it may first be exercised or the
time during which it will vest.
(v)
To prohibit the exercise of any Option, SAR or other exercisabl
a e Award during a period of up to 30 days
prior to the consummation of any pending stock dividend, stock split, combination or exchange of shares, merger, consolidation or
other distribution (other than normal cash dividends) of Company assets to stockholders, or any other change affe
f cting the shares of
Common Stock or the share price of the Common Stock, including any Transaction, for reasons of administrative convenience.
(vi)
To suspend or terminate the Plan at any time. Except as otherwise provided in the Plan (including
Section 7(b)(ix)) or an Award Agreement, suspension or termination of the Plan will not Materially Impair a Participant’s rights under
any Award granted while the Plan is in effe
f ct unless (1) the Company requests the consent of the affe
f cted Participant, and (2) such
Participant consents in writing.
(vii)
To amend the Plan in any respect the Board deems necessary or advisabl
a e; provided
d
, how
d
ever, that
stockholder approval will be required for any such amendment to the extent required by Applicable Law. Except as otherwise
provided in the Plan (including Section 7(b)(ix)) or an Award Agreement, a Participant’s rights under any Award granted before any
amendment of the Plan will not be Materially Impaired by any such amendment unless (1) the Company requests the consent of the
affected Participant, and (2) such Participant consents in writing.
(viii)
To subm
u
it any amendment to the Plan for stockholder approval.
(ix)
To approve forms of Award Agreements for use under the Plan and to amend the terms of any one or more
Awards, including, but not limited to, amendments to provide terms more favorable to the Participant than previously provided in the
Award Agreement, subj
u ect to any specified limits in the Plan that are not subj
u ect to Board discretion; provided
d
, how
d
ever, that except as
otherwise provided in the Plan (including this Section 7(b)(ix)) or an Award Agreement, a Participant’s rights under any Award will
not be Materially Impaired by any such amendment unless (1) the Company requests the consent of the affe
f cted Participant, and
(2) such Participant consents in writing.
(x)
Generally, to exercise such powers and to perform such acts as the Board deems necessary or expedient to
promote the best interests of the Company and that are not in conflict
f
with the provisions of the Plan or Awards.
(xi)
To adopt such procedur
d
es and sub-pl
u
ans as are necessary or appropriate to permit and facilitate
participation in the Plan by, or take advantage of specific ta
f
x treatment for Awards granted to, Employees, Directors or Consultants
who are foreign nationals or employed outside the United States (provided that Board approval will not be necessary for immaterial
modifications to the Plan or any Award Agreement to ensure or facilitate compliance with the laws of the relevant foreign
jurisdiction).
A-8
(c)
Delegation to Committee.
(i)
General. The Board may delegate some or all of the administration of the Plan to a Committee or
Committees. If administration of the Plan is delegated to a Committee, the Committee will have, in connection with the administration
of the Plan, the powers theretofor
f
e possessed by the Board that have been delegated to the Committee, including the power to delegate
to another Committee or a subcom
u
mittee of the Committee any of the administrative powers the Committee is authorized to exercise
(and references in this Plan to the Board will thereafte
f r be to the Committee or subcom
u
mittee, as applicable), subj
u ect, however, to such
resolutions, not inconsistent with the provisions of the Plan, as may be adopted from time to time by the Board. Each Committee may
retain the authority to concurrently administer the Plan with any Committee or subcom
u
mittee to which it has delegated its authority
hereunder and may, at any time, revest in such Committee some or all of the powers previously delegated. The Board may retain the
authority to concurrently administer the Plan with any Committee and may, at any time, revest in the Board some or all of the powers
previously delegated.
(ii)
Rule 16b-3 Compliance. To the extent an Award is intended to qualify for the exemption from Section
16(b) of the Exchange Act that is availabl
a e under Rule 16b-3 of the Exchange Act, the Award will be granted by the Board or a
Committee that consists solely of two or more non-employee directors, as determined under Rule 16b-3(b)(3) of the Exchange Act,
and thereafte
f r any action establ
a ishing or modifying the terms of the Award will be approved by the Board or a Committee meeting
such requirements to the extent necessary for such exemption to remain availabl
a e.
(d)
Effect of Board’s Decision. All determinations, interpretations and construc
r
tions made by the Board or any
Committee in good faith will not be subj
u ect to review by any person and will be final, binding and conclusive on all persons.
(e)
Cancellation and Re-Grant of Awards. Except in connection with a Transaction, as provided in Section 6(a)
relating to Capi
a talization Adju
d stments, or unless the stockholders of the Company have approved such an action within 12 months
prior to such an event, neither the Board nor any Committee will have the authority to: (i) reduce the exercise or strike price of any
outstanding Option or SAR; or (ii) cancel any outstanding Option or SAR that has an exercise or strike price greater than the then-
current Fair Market Value in exchange for cash or other Awards under the Plan.
(f)
Delegation to an Offi
f cer. The Board or any Committee may delegate to one or more Offi
f cers the authority to do
one or both of the following: (i) designate Employees who are not Offi
f cers to be recipients of Options and SARs (and, to the extent
permitted by Applicable Law, other types of Awards) and, to the extent permitted by Applicable Law, the terms thereof; and
(ii) determine the number of shares of Common Stock to be subj
u ect to such Awards granted to such Employees; provided
d
, how
d
ever,
that the resolutions or charter adopted by the Board or any Committee evidencing such delegation will specify the total number of
shares of Common Stock that may be subj
u ect to the Awards granted by such Offi
f cer and that such Offi
f cer may not grant an Award to
himself or herself. Any such Awards will be granted on the applicable form of Award Agreement most recently approved for use by
the Board or the Committee, unless otherwise provided in the resolutions approving the delegation authority. Notwithstanding
anything to the contrary herein, neither the Board nor any Committee may delegate to an Offi
f cer who is acting solely in the capacity of
an Offi
f cer (and not also as a Director) the authority to determine the Fair Market Value.
8.
Tax Withholding.
(a)
Withholding Authorization. As a condition to acceptance of any Award, a Participant authorizes withholding from
payroll and any other amounts payable to such Participant, and otherwise agrees to make adequate provision for, any sums required to
satisfy any U.S. federal, state, local and/or foreign tax or social insurance contribution withholding obligations of the Company or an
Affi
f liate, if any, which arise in connection with the exercise, vesting or settlement of such Award, as applicable. Accordingly, a
Participant may not be able to exercise an Award even though the Award is vested, and the Company will have no obligation to issue
shares of Common Stock subj
u ect to an Award, unless and until such withholding obligations are satisfied.
(b)
Satisfaction of Withholding Obligations. To the extent permitted by the terms of an Award Agreement, the
Company may, in its sole discretion, satisfy any U.S. federal, state, local and/or foreign tax or social insurance contribution
withholding obligations relating to an Award by any of the following means or by a combination of such means: (i) causing the
Participant to tender a cash payment (which may be in the form of a check, electronic wire transfer
f
or other method permitted by the
Company); (ii) withholding shares of Common Stock from the shares of Common Stock issued or otherwise issuable to the Participant
in connection with the Award; (iii) withholding cash from an Award settled in cash; (iv) withholding payment from any amounts
otherwise payable to the Participant; (v) by allowing a Participant to effe
f ctua
t
te a “cashless exercise” pursuant to a program developed
under Regulation T as promulgated by the Federal Reserve Board; or (vi) by such other method as may be set forth in the Award
Agreement or otherwise approved by the Board.
(c)
No Obligation to Notify or Minimize Taxes; No Liability to Claims. Except as required by Applicable Law, the
Company has no duty or obligation to any Participant to advise such Participant as to the time or manner of exercising an Award.
Furthermore, the Company has no duty or obligation to warn or otherwise advise such Participant of a pending termination or
expiration of an Award or a possible period in which the Award may not be exercised. The Company has no duty or obligation to
minimize the tax consequences of an Award to any Participant and will not be liabl
a e to any Participant for any adverse tax
consequences to such Participant in connection with an Award. As a condition to accepting an Award, each Participant (i) agrees to
not make any claim against the Company, or any of its Offi
f cers, Directors, Employees or Affi
f liates related to tax liabilities arising
from such Award or other Company compensation and (ii) acknowledges that such Participant was advised to consult with his or her
own personal tax, financial and other legal advisors regarding the tax consequences of the Award and has either done so or knowingly
A-9
and voluntarily declined to do so. Additionally, each Participant acknowledges that any Option or SAR is exempt from Section 409A
only if the exercise or strike price of such Option or SAR is at least equal to the “fair market value” of the Common Stock on the date
of grant of such Option or SAR as determined by the Internal Revenue Service and there is no other impermissible deferral of
compensation associated with the Award. Additionally, as a condition to accepting an Option or SAR, each Participant agrees to not
make any claim against the Company, or any of its Offi
f cers, Directors, Employees or Affi
f liates in the event that the Internal Revenue
Service asserts that the exercise or strike price of such Option or SAR is less than the “fair market value” of the Common Stock on the
date of grant of such Option or SAR as subs
u
equently determined by the Internal Revenue Service.
(d)
Withholding Indemnific
f ation. As a condition to accepting an Award, in the event that the amount of the
Company’s and/or its Affi
f liate’s withholding obligations in connection with such Award was greater than the amount actua
t
lly
withheld by the Company and/or its Affi
f liates, each Participant agrees to indemnify
f
and hold the Company and/or its Affi
f liates
harmless from any failure by the Company and/or its Affi
f liates to withhold the proper amount.
9.
Miscellaneous.
(a)
Dividends and Dividend Equivalents.
(i)
Dividends or dividend equivalents may not be paid or credited to Options or SARs.
(ii)
With respect to any Award other than an Option or SAR, dividends or dividend equivalents may be paid or
credited, as applicable, with respect to any shares of Common Stock subj
u ect to such Award, as determined by the Board and specified
in the applicable Award Agreement; provided
d
, how
d
ever, that (i) no dividends or dividend equivalents may be paid with respect to any
such shares before the date such shares have vested under the terms of such Award Agreement, (ii) any dividends or dividend
equivalents that are credited with respect to any such shares will be subj
u ect to all of the terms and conditions applicable to such shares
under the terms of such Award Agreement (including, but not limited to, any vesting conditions), and (iii) any dividends or dividend
equivalents that are credited with respect to any such shares will be forfeited to the Company on the date, if any, such shares are
forfeited to or repurchased by the Company due to a failure to meet any vesting conditions under the terms of such Award Agreement.
(b)
Source of Shares. The stock issuable under the Plan will be shares of authorized but unissued or reacquired
Common Stock, including shares repurchased by the Company on the open market or otherwise.
(c)
Use of Proceeds from Sales of Common Stock. Proceeds from the sale of shares of Common Stock pursuant to
Awards will constitute general funds of the Company.
(d)
Corporate Action Constituting Grant of Awards. Corporate action constitut
t ing a grant by the Company of an
Award to any Participant will be deemed completed as of the date of such corporate action, unless otherwise determined by the Board,
regardless of when the instrument, certificate, or letter evidencing the Award is communicated to, or actua
t
lly received or accepted by,
the Participant. In the event that the corporate records (e.g., Board consents, resolutions or minutes) documenting the corporate action
approving the grant contain terms (e.g., exercise price, vesting schedule or number of shares) that are inconsistent with those in the
Award Agreement or related grant documents as a result of a clerical error in the Award Agreement or related grant documents, the
corporate records will control and the Participant will have no legally binding right to the incorrect term in the Award Agreement or
related grant documents.
(e)
Stockholder Rights. No Participant will be deemed to be the holder of, or to have any of the rights of a holder with
respect to, any shares of Common Stock subj
u ect to an Award unless and until (i) such Participant has satisfied all requirements for
exercise of the Award pursuant to its terms, if applicable, and (ii) the issuance of the Common Stock subj
u ect to such Award is
reflected in the records of the Company.
(f)
No Employment or Other Service Rights. Nothing in the Plan, any Award Agreement or any other instrument
executed thereunder or in connection with any Award granted pursuant thereto will confer
f
upon any Participant any right to continue
to serve the Company or an Affi
f liate in the capacity in effe
f ct at the time the Award was granted or affe
f ct the right of the Company or
an Affi
f liate to terminate at will and without regard to any future vesting opportunity that a Participant may have with respect to any
Award (i) the employment of an Employee with or without notice and with or without cause, (ii) the service of a Consultant pursuant
to the terms of such Consultant’s agreement with the Company or an Affi
f liate, or (iii) the service of a Director pursuant to the Bylaws
of the Company or an Affi
f liate, and any applicable provisions of the corporate law of the state or foreign jurisdiction in which the
Company or the Affi
f liate is incorporated, as the case may be. Further, nothing in the Plan, any Award Agreement or any other
instrument executed thereunder or in connection with any Award will constitute any promise or commitment by the Company or an
Affi
f liate regarding the fact or nature of future positions, future work assignments, future compensation or any other term or condition
of employment or service or confer an
f
y right or benefit under the Award or the Plan unless such right or benefit has specifically
accrued unde
r
r the terms of the Award Agreement and/or Plan.
(g)
Change in Time Commitment. In the event a Participant’s regular level of time commitment in the performance of
his or her services for the Company or any Affi
f liate is reduced (for example, and without limitation, if the Participant is an Employee
and has a change in status
t
from a full-time Employee to a part-time Employee or takes an extended leave of absence) afte
f r the date of
grant of any Award to the Participant, the Board may determine, to the extent permitted by Applicable Law, to (i) make a
corresponding reduction in the number of shares or cash amount subj
u ect to any portion of such Award that is scheduled to vest or
A-10
become payable afte
f r the date of such change in time commitment, and (ii) in lieu of or in combination with such a reduction, extend
the vesting or payment schedule applicable to such Award. In the event of any such reduction, the Participant will have no right with
respect to any portion of the Award that is so reduced or extended.
(h)
Execution of Additional Documents. As a condition to accepting an Award, the Participant agrees to execute any
additional documents or instruments necessary or desirabl
a e, as determined in the Plan Administrator’s sole discretion, to carry out the
purpos
r
es or intent of the Award, or facilitate compliance with securities and/or other regulatory requirements, in each case at the Plan
Administrator’s request.
(i)
Electronic Delivery and Participation. Any reference herein or in an Award Agreement to a “written” agreement
or document will include any agreement or document delivered electronically, filed publicly at www.sec.gov (or any successor
website thereto) or posted on the Company’s intranet (or other shared electronic medium controlled by the Company to which the
Participant has access). By accepting any Award, the Participant consents to receive documents by electronic delivery and to
participate in the Plan through any on-line electronic system establ
a ished and maintained by the Plan Administrator or another third
party selected by the Plan Administrator. The form of delivery of any Common Stock (e.g., a stock certificate or electronic entry
r
evidencing such shares) will be determined by the Company.
(j)
Clawback/R
k
ecovery. All Awards granted under the Plan will be subj
u ect to recoupment in accordance with the
following, as applicable: (i) the Neurocrine Biosciences, Inc. Policy for Recoupment of Incentive Compensation; (ii) the Neurocrine
Biosciences, Inc. Incentive Compensation Recoupment Policy; (iii) any clawback policy that the Company is required to adopt
pursuant to the listing standards of any national securities exchange or association on which the Company’s securities are listed or as
is otherwise required by the Dodd-Frank Wall Street Reform and Consumer Protection Act or other Applicable Law; and (iv) any
other clawback policy that the Company adopts. In addition, the Board may impose such other clawback, recovery or recoupment
provisions in an Award Agreement as the Board determines necessary or appropriate, including but not limited to a reacquisition right
in respect of previously acquired shares of Common Stock or other cash or property upon the occurrence of Cause. No recovery of
compensation under such a clawback policy will be an event giving rise to a Participant’s right to voluntary
r
terminate employment
upon a “resignation for good reason,” or for a “construc
r
tive termination” or any similar term under any plan of or agreement with the
Company.
(k)
Securities Law Compliance. A Participant will not be issued any shares in respect of an Award unless either (i) the
shares are registered under the Securities Act or (ii) the Company has determined that such issuance would be exempt from the
registration requirements of the Securities Act. Each Award also must comply with other Applicable Law governing the Award, and a
Participant will not receive such shares if the Company determines that such receipt would not be in material compliance with
Applicable Law.
(l)
Transfer or Assignment of Awards; Issued Shares. Except as expressly provided in the Plan or an Award
Agreement, Awards may not be transfer
f red or assigned by the Participant. Afte
f r the vested shares subj
u ect to an Award have been
issued, or in the case of Restricted Stock and similar awards, afte
f r the issued shares have vested, the holder of such shares is free to
assign, hypothecate, donate, encumber or otherwise dispose of any interest in such shares provided that any such actions are in
compliance with the provisions herein, the terms of the Trading Policy and Applicable Law.
(m)
Effe
f ct on Other Employee Benefit Plans. The value of any Award, as determined upon grant, vesting or
settlement, will not be included as compensation, earnings, salaries, or other similar terms used when calculating any Participant’s
benefits under any employee benefit plan sponsored by the Company or any Affi
f liate, except as such plan otherwise expressly
provides. The Company expressly reserves its rights to amend, modify, or terminate any of the Company’s or any Affi
f liate’s employee
benefit plans.
(n)
Deferra
f
ls. To the extent permitted by Applicable Law, the Board may determine that the delivery of
r
Common Stock
or the payment of cash, upon the exercise, vesting or settlement of all or a portion of any Award may be deferred and may also
establ
a ish programs and procedur
d
es for deferral elections to be made by Participants. Deferrals by will be made in accordance with the
requirements of Section 409A.
(o)
Section 409A. Unless otherwise expressly provided for in an Award Agreement, the Plan and each Award
Agreement will be interpr
r
eted to the greatest extent possible in a manner that makes the Plan and the Awards granted hereunder
exempt from Section 409A, and, to the extent not so exempt, in compliance with the requirements of Section 409A. If the Company
determines that any Award granted hereunder is not exempt from and is therefor
f
e subj
u ect to Section 409A, the Award Agreement
evidencing such Award will incorporate the terms and conditions necessary to avoid the consequences specified in Section 409A(a)(1)
of the Code, and to the extent an Award Agreement is silent on terms necessary for compliance, such terms are hereby incorporated by
reference into the Award Agreement. Notwithstanding anything to the contrary in this Plan (and unless the Award Agreement
specifically provides otherwise), if the shares of Common Stock are publicly traded, and if a Participant holding an Award that
constitut
t es “deferred compensation” under Section 409A is a “specified employee” for purposes of Section 409A, no distribution or
payment of any amount that is due because of a “separation from service” (as defined in Section 409A without regard to alternative
definitions thereunder) will be issued or paid before the date that is six months and one day following the date of such Participant’s
“separation from service” or, if earlier, the date of the Participant’s death, unless such distribution or payment may be made in a
manner that complies with Section 409A, and any amounts so deferred will be paid in a lump sum on the day afte
f r such six month
period elapses, with the balance paid thereafte
f r on the original schedule.
A-11
(p)
Choice of Law. This Plan and any controversy arising out of or relating to this Plan will be governed by, and
construed
r
in accordance with, the internal laws of the State of Californi
f
a, without regard to conflict
f
of law principles that would result
in any application of any law other than the law of the State of Californi
f
a.
(q)
Compliance with Law. The Company will seek to obtain from each regulatory
r
commission or agency, as may be
deemed to be necessary, having jurisdiction over the Plan such authority as may be required to grant Awards and to issue and sell
shares of Common Stock upon exercise or vesting of the Awards; provided
d
, how
d
ever, that this undertaking will not require the
Company to register under the Securities Act the Plan, any Award or any Common Stock issued or issuable pursuant to any such
Award. If, afte
f r reasonable effort
f
s and at a reasonable cost, the Company is unable to obtain from any such regulatory commission or
agency the authority that counsel for the Company deems necessary or advisabl
a e for the lawful
f
issuance and sale of Common Stock
under the Plan, the Company will be relieved from any liabi
a lity for failure to issue and sell Common Stock upon exercise or vesting of
such Awards unless and until such authority is obtained. A Participant is not eligible for the grant of an Award or the subs
u
equent
issuance of Common Stock pursuant to the Award if such grant or issuance would be in violation of any Applicable Law.
10.
Severability.
If all or any part of the Plan or any Award Agreement is declared by any court or governmental authority to be unlawful or
invalid, such unlawfulness or invalidity will not invalidate any portion of the Plan or such Award Agreement not declared to be
unlawful or invalid. Any Section of the Plan or any Award Agreement (or part of such a Section) so declared to be unlawful
f
or invalid
will, if possible, be construed
r
in a manner which will give effe
f ct to the terms of such Section or part of a Section to the fullest extent
possible while remaining lawful
f
and valid.
11.
Suspension or Termination of the Plan.
The Board may suspend or terminate the Plan at any time. No Incentive Stock Options may be granted afte
f r the tenth
anniversary of
r
the earlier of:f (i) the Adoption Date; or (ii) the Effe
f ctive Date. No Awards may be granted under the Plan while the
Plan is suspended or afte
f r it is terminated.
12.
Definitions.
As used in the Plan, the following definitions apply to the capitalized terms indicated below:
(a)
“2020 Plan
l
” means the Neurocrine Biosciences, Inc. 2020 Equity Incentive Plan.
(b)
“Ac
“
quiring Entity” means the surviving or acquiring corporation (or the surviving or acquiring corporation’s parent
company) in connection with a Transaction.
(c)
“Ad
“
opt
d
io
t n Date” means the date the Plan is first approved by the Compensation Committee.
(d)
“Af
“
fi
f li
i ate” means, at the time of determination, any “parent” or “subsidiary” of the Company as such terms are
defined in Rule 405 promulgated under the Securities Act. The Board may determine the time or times at which “parent” or
“subsidiary” status
t
is determined within the foregoing definition.
(e)
“An
“
nual Meeting
t
” means the first meeting of the Company’s stockholders held each calendar year at which
Directors are selected.
(f)
“Ap
“
pl
p ic
l ablel Law” means any applicable securities, federal, state, foreign, material local or municipal or other law,
statut
t e, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, listing rule, regulation, judicial decision,
ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effe
f ct by or under the authority of any
Governmental Body (including under the authority of any applicable self-re
f
gulating organization such as the Nasdaq Stock Market,
New York Stock Exchange, or the Financial Industry
r Regulatory
r Authority).
(g)
“Ap
“
pr
p
eciation Award”
d
means (i) a stock option or stock appreciation right granted under a Prior Plan or (ii) an
Option or SAR, in each case with respect to which the exercise or strike price is at least 100% of the Fair Market Value of the
Common Stock subj
u ect to the stock option or stock appreciation right, or Option or SAR, as applicable, on the date of grant.
(h)
“Awa
“
rd”
d means any right to receive Common Stock, cash or other property granted under the Plan (including an
Incentive Stock Option, a Nonstatutory Stock Option, a SAR, a Restricted Stock Award, a RSU Award, a Performance Award or any
Other Award).
(i)
“Awa
“
rd Agreement”t means a written agreement between the Company and a Participant evidencing the terms and
conditions of an Award. The Award Agreement generally consists of the Grant Notice and the agreement containing the written
summary of the general terms and conditions applicable to the Award and which is provided to a Participant along with the Grant
Notice.
A-12
(j)
“Board”
d means the Board of Directors of the Company (or its designee). Any decision or determination made by the
Board will be a decision or determination that is made in the sole discretion of the Board (or its designee), and such decision or
determination will be final and binding on all Participants.
(k)
“Capi
a ta
i liza
i
tion Adju
d
stme
t
nt”t
means any change that is made in, or other events that occur with respect to, the
Common Stock subj
u ect to the Plan or subj
u ect to any Award afte
f r the Adoption Date without the receipt of consideration by the
Company through merger, consolidation, reorganization, recapi
a talization, reincorporation, stock dividend, dividend in property other
than cash, large nonrecurring cash dividend, stock split, reverse stock split, liquidating dividend, combination of shares, exchange of
shares, change in corporate structur
t
e or any similar equity restructur
t
ing transaction, as that term is used in Statement of Financial
Accounting Standards Board Accounting Standards Codification Topic 718 (or any successor thereto). Notwithstanding the foregoing,
the conversion of any convertible securities of the Company will not be treated as a Capi
a talization Adju
d stment.
(l)
“Cause” has the meaning ascribed to such term in any written agreement between the Participant and the Company
or an Affi
f liate defining such term and, in the absence of such agreement, such term means, with respect to a Participant, the
occurrence of any of the following events: (i) such Participant’s commission of any crime involving fraud, dishonesty or moral
turpitude; (ii) such Participant’s attempted commission of, or participation in, a fraud or act of dishonesty against the Company or an
Affi
f liate that results in (or might have reasonably resulted in) material harm to the business of the Company or an Affi
f liate; (iii) such
Participant’s intentional, material violation of any contract or agreement between such Participant and the Company or an Affi
f liate, or
of any statutory duty
t
such Participant owes to the Company or an Affi
f liate; or (iv) such Participant’s conduct that constitut
t es gross
insubordina
u
tion, incompetence or habitual neglect of duties and that results in (or might have reasonably resulted in) material harm to
the business of the Company or an Affi
f liate; provided
d
, how
d
ever, that the action or conduct described in clauses (iii) and (iv) above will
constitut
t e “Cause” only if such action or conduct continues afte
f r the Company has provided such Participant with written notice
thereof and not less than five business days to cure the same. The determination that a termination of the Participant’s Continuous
Service is either for Cause or without Cause will be made by the Board with respect to Participants who are Offi
f cers and by the Chief
Executive Offi
f cer of the Company with respect to Participants who are not Offi
f cers. Any determination by the Company that the
Continuous Service of a Participant was terminated with or without Cause for the purposes of outstanding Awards held by such
Participant will have no effe
f ct upon any determination of the rights or obligations of the Company or such Participant for any other
purpos
r
e.
(m)
“Change in Control
t
”l or “Change of Control
t
”l means the occurrence, in a single transaction or in a series of related
transactions, of any one or more of the following events; provided
d
, how
d
ever, to the extent necessary to avoid adverse personal income
tax consequences to the Participant in connection with an Award, such transaction also constitutes a Section 409A Change in Control:
(i)
any Exchange Act Person becomes the Owner, directly or indirectly, of securities of the Company
representing more than 50% of the combined voting power of the Company’s then outstanding securities other than by virtue of
t
a
merger, consolidation or similar transaction. Notwithstanding the foregoing, a Change in Control will not be deemed to occur (A) on
account of the acquisition of securities of the Company directly from the Company, (B) on account of the acquisition of securities of
the Company by an investor, any affi
f liate thereof or any other Exchange Act Person that acquires the Company’s securities in a
transaction or series of related transactions the primary purpose of which is to obtain financing for the Company through the issuance
of equity securities, or (C) solely because the level of Ownership held by any Exchange Act Person (the “Subje
b ct Person”) exceeds
the designated percentage threshold of the outstanding voting securities as a result of a repurchase or other acquisition of voting
securities by the Company reducing the number of shares outstanding, provided that if a Change in Control would occur (but for the
operation of this sentence) as a result of the acquisition of voting securities by the Company, and afte
f r such share acquisition, the
Subj
u ect Person becomes the Owner of any additional voting securities that, assuming the repurchase or other acquisition had not
occurred, increases the percentage of the then outstanding voting securities Owned by the Subj
u ect Person over the designated
percentage threshold, then a Change in Control will be deemed to occur;
(ii)
there is consummated a merger, consolidation or similar transaction involving (directly or indirectly) the
Company and, immediately afte
f r the consummation of such merger, consolidation or similar transaction, the stockholders of the
Company immediately prior thereto do not Own, directly or indirectly, either (A) outstanding voting securities representing more than
50% of the combined outstanding voting power of the surviving Entity in such merger, consolidation or similar transaction or
(B) more than 50% of the combined outstanding voting power of the parent of the surviving Entity in such merger, consolidation or
similar transaction, in each case in subs
u
tantially the same proportions as their Ownership of the outstanding voting securities of the
Company immediately prior to such transaction;
(iii)
the stockholders of the Company approve a plan of complete dissolution or liquidation of the Company, or
a complete dissolution or liquidation of the Company shall otherwise occur, except for a liquidation into a parent corporation;
(iv)
there is consummated a sale, lease, exclusive license or other disposition of all or subs
u
tantially all of the
consolidated assets of the Company and its Subs
u
idiaries, other than a sale, lease, license or other disposition of all or subs
u
tantially all
of the consolidated assets of the Company and its Subs
u
idiaries to an Entity, more than 50% of the combined voting power of the
voting securities of which are Owned by stockholders of the Company in subs
u
tantially the same proportions as their Ownership of the
outstanding voting securities of the Company immediately prior to such sale, lease, license or other disposition; or
(v)
individuals who, on the date the Plan is adopted by the Compensation Committee, are members of the
Board (the “In
“
cumbent Board”) cease
d
for any reason to constitute at least a majority of the members of the Board; provided
d
, how
d
ever,
that if the appointment or election (or nomination for election) of any new Board member was approved or recommended by a
A-13
majority vote of the members of the Incumbent Board then still in offi
f ce, such new member will, for purposes of this Plan, be
considered as a member of the Incumbent Board.
Notwithstanding the foregoing or any other provision of this Plan, (A) the term Change in Control will not include a sale of
assets, merger or other transaction effe
f cted exclusively for the purpose of changing the domicile of the Company, and (B) the
definition of Change in Control (or any analogous term) in an individual written agreement between the Company or any Affi
f liate and
the Participant will supe
u
rsede the foregoing definition with respect to Awards subj
u ect to such agreement; provided
d
, how
d
ever, that (1) if
no definition of Change in Control (or any analogous term) is set forth in such an individual written agreement, the foregoing
definition will apply; and (2) no Change in Control (or any analogous term) will be deemed to occur with respect to Awards subj
u ect to
such an individual written agreement without a requirement that the Change in Control (or any analogous term) actua
t
lly occur.
(n)
“Code” means the Internal Revenue Code of 1986, as amended, including any applicable regulations and guidance
thereunder.
(o)
“Committee” means the Compensation Committee and any other committee of Directors to whom authority has
been delegated by the Board or Compensation Committee in accordance with the Plan.
(p)
“Common Stock
t
” means the common stock of the Company.
(q)
“Company
n ” means Neurocrine Biosciences, Inc., a Delaware corporation.
(r)
“Compensation Committee
t
” means the Compensation Committee of the Board.
(s)
“Consulta
l nt”t means any person, including an advisor, who is (i) engaged by the Company or an Affi
f liate to render
consulting or advisory services and is compensated for such services, or (ii) serving as a member of the board of directors of an
Affi
f liate and is compensated for such services. However, service solely as a Director, or payment of a fee for such service, will not
cause a Director to be considered a “Consultant” for purposes of the Plan. Notwithstanding the foregoing, a person is treated as a
Consultant under this Plan only if a Form S-8 Registration Statement under the Securities Act is availabl
a e to register either the offer
f
or
the sale of the Company’s securities to such person.
(t)
“Contin
t
uous Service” means that the Participant’s service with the Company or an Affi
f liate, whether as an
Employee, Director or Consultant, is not interrupt
u ed or terminated. A change in the capacity in which the Participant renders service to
the Company or an Affi
f liate as an Employee, Director or Consultant or a change in the Entity for which the Participant renders such
service, provided that there is no interrupt
u ion or termination of the Participant’s service with the Company or an Affi
f liate, will not
terminate a Participant’s Continuous Service; provided
d
, how
d
ever, that if the Entity for which a Participant is rendering services ceases
to qualify
f as an Affi
f liate, as determined by the Board, such Participant’s Continuous Service will be considered to have terminated on
the date such Entity ceases to qualify
f
as an Affi
f liate. For example, a change in status
t
from an Employee of the Company to a
Consultant of an Affi
f liate or to a Director will not constitut
t e an interrupt
u ion of Continuous Service. To the extent permitted by law, the
Board or a duly authorized Offi
f cer, in that party’s sole discretion, may determine whether Continuous Service will be considered
interrupt
u ed in the case of (i) any leave of absence, including sick leave, military leave or any other personal leave, or (ii) transfer
f s
between the Company, an Affi
f liate, or their successors. A leave of absence will be treated as Continuous Service for purposes of
vesting in an Award only to such extent as may be provided in the Company’s leave of absence policy, in the written terms of any
leave of absence agreement or policy applicable to the Participant or as otherwise approved by the Board (or a duly authorized
Offi
f cer) or required by Applicable Law. In addition, to the extent required for exemption from or compliance with Section 409A, the
determination of whether there has been a termination of Continuous Service will be made, and such term will be construed,
r
in a
manner that is consistent with the definition of “separation from service” as defined under Treasury Regulation Section 1.409A-1(h)
(without regard to any alternative definition thereunder).
(u)
“Corporatet Transaction
t
” means the consummation, in a single transaction or in a series of related transactions, of
any one or more of the following events:
(i)
a sale or other disposition of all or subs
u
tantially all, as determined by the Board, of the consolidated assets
of the Company and its Subs
u
idiaries;
(ii)
a sale or other disposition of more than 50% of the outstanding securities of the Company;
(iii)
a merger, consolidation or similar transaction following which the Company is not the surviving
corporation; or
(iv)
a merger, consolidation or similar transaction following which the Company is the surviving corporation
but the shares of Common Stock outstanding immediately preceding the merger, consolidation or similar transaction are converted or
exchanged by virtue of
t
the merger, consolidation or similar transaction into other property, whether in the form of securities, cash or
otherwise.
A-14
(v)
“determine” or “determined”
d
means as determined by the Board or the Committee (or its designee) in its sole
discretion.
(w)
“Di
“
re
i
ctor
t
” means a member of the Board of Directors of the Company.
(x)
“Di
“
sa
i
bility
i
” means, with respect to a Participant, such Participant is unable to engage in any subs
u
tantial gainful
activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has
lasted or can be expected to last for a continuous period of not less than 12 months, as provided in Section 22(e)(3) of the Code, and
will be determined by the Board on the basis of such medical evidence as the Board deems warranted under the circumstances.
(y)
“Ef
“
fe
f ctiv
t e Date” means the date of the Annual Meeting in 2025, provided this Plan is approved by the Company’s
stockholders at such meeting.
(z)
“Em
“
ploy
m
ee” means any person employed by the Company or an Affi
f liate. However, service solely as a Director, or
payment of a fee for such services, will not cause a Director to be considered an “Employee” for purposes of the Plan.
(aa)
“Em
“
ploy
m
er” means the Company or the Affi
f liate of the Company that employs the Participant.
(bb)
“En
“
tity” means a corporation, partnership, limited liability company or other entity.
(cc)
“Ex
“
change Act”t
means the Securities Exchange Act of 1934, as amended, and the rules and regulations
promulgated thereunder.
(dd)
“Ex
“
change Act Person” means any natural person, Entity or “group” (within the meaning of Section 13(d) or 14(d)
of the Exchange Act), except that “Exchange Act Person” will not include (i) the Company or any Subs
u
idiary, (ii) any employee
benefit plan of the Company or any Subs
u
idiary or any trus
r
tee or other fiduciary holding securities under an employee benefit plan of
the Company or any Subs
u
idiary, (iii) an underwriter temporarily holding securities pursuant to a registered public offeri
f
ng of such
securities, (iv) an Entity Owned, directly or indirectly, by the stockholders of the Company in subs
u
tantially the same proportions as
their Ownership of stock of the Company, or (v) any natural person, Entity or “group” (within the meaning of Section 13(d) or 14(d)
of the Exchange Act) that, as of the Effe
f ctive Date, is the Owner, directly or indirectly, of securities of the Company representing
more than 50% of the combined voting power of the Company’s then outstanding securities.
(ee)
“Fair Market Value” means, as of any date, unless otherwise determined by the Board, the value of the Common
Stock (as determined on a per share or aggregate basis, as applicable) determined as follows:
(i)
If the Common Stock is listed on any establ
a ished stock exchange or traded on any establ
a ished market, the
Fair Market Value will be the closing sales price for such stock as quoted on such exchange or market (or the exchange or market with
the greatest volume of trading in the Common Stock) on the date of determination, as reported in a source the Board deems reliable.
(ii)
If there is no closing sales price for the Common Stock on the date of determination, then the Fair Market
Value will be the closing sales price on the last preceding date for which such quotation exists.
(iii)
In the absence of such exchange or market for the Common Stock, or if otherwise determined by the Board,
the Fair Market Value will be determined by the Board in good faith and in a manner that complies with Sections 409A and 422 of the
Code.
(ff)
“Full Value Award”
d means (i) a stock award granted under a Prior Plan or (ii) an Award, in each case that is not an
Appreciation Award.
(gg)
“Governmental
t
Body” means any: (i) nation, state, commonwealth, province, territory, county, municipality, district
or other jurisdiction of any nature; (ii) federal, state, local, municipal, foreign or other government; (iii) governmental or regulatory
r
body, or quasi-governmental body of any nature (including any governmental division, department, administrative agency or bureau,
commission, authority, instrumentality, offi
f cial, ministry,
r
fund, foundation, center, organization, unit, body or Entity and any court or
other tribunal, and for the avoidance of doubt, any tax authority) or other body exercising similar powers or authority; or (iv) self-
regulatory organization (including the Nasdaq Stock Market, New York Stock Exchange, and the Financial Industry
r
Regulatory
r
Authority).
(hh)
“Grant Notice” means the notice provided to a Participant that he or she has been granted an Award and which
includes the name of the Participant, the type of Award, the date of grant of the Award, number of shares of Common Stock subj
u ect to
the Award or potential cash payment right, (if any), the vesting schedule for the Award (if any) and other key terms applicable to the
Award.
(ii)
“In
“
centiv
t e Stock
t
Option” means an option granted pursuant to Section 4 that is intended to be, and qualifies as, an
“incentive stock option” within the meaning of Section 422 of the Code.
A-15
(jj)
“Ma
“
terially
l
Impair
m
” means that a Participant’s rights under an Award will be materially adversely affe
f cted by a
suspension or termination of the Plan, an amendment of the Plan, or an amendment to the terms of the Award, as applicable. For
purpos
r
es of the Plan, a Participant’s rights under an Award will not be deemed to have been Materially Impaired by any of the
foregoing actions if the Board determines that such action, taken as a whole, does not materially impair the Participant’s rights under
the Award. For example, an amendment to the terms of an Award in order to do any of the following, or that results in any of the
following, will not be deemed to Materially Impair the Participant’s rights under the Award: (i) an imposition of reasonable
restrictions on the minimum number of shares subj
u ect to an Option that may be exercised; (ii) to maintain the qualifie
f d status of
t
the
Award as an Incentive Stock Option under Section 422 of the Code; (iii) a change in the terms of an Incentive Stock Option in a
manner that disqualifies, impairs or otherwise affe
f cts the qualified status of
t
the Award as an Incentive Stock Option under Section 422
of the Code; (iv) to clarify
f the manner of exemption from, or to bring the Award into compliance with or qualify
f it for an exemption
from, Section 409A; or (v) to comply with other Applicable Laws.
(kk)
“No
“
n-Em
-
ploy
m
ee Dire
i
ctor
t
” means a Director who is not an employee of the Company or an Affi
f liate.
(ll)
“No
“
nstatutory Stock
t
Option” means any option granted pursuant to Section 4 that does not qualify as an Incentive
Stock Option.
(mm)
“Offi
f cer” means a person who is an offi
f cer of the Company within the meaning of Section 16 of the Exchange Act.
(nn)
“Option” means an Incentive Stock Option or a Nonstatutory Stock Option to purchase shares of Common Stock
which is granted pursuant to the terms and conditions of Section 4.
(oo)
“Option Agreement”t means a written agreement between the Company and a Participant evidencing the terms and
conditions of an Option grant. The Option Agreement includes the Grant Notice for the Option and the agreement containing the
written summary of the general terms and conditions applicable to the Option and which is provided to a Participant along with the
Grant Notice. Each Option Agreement will be subj
u ect to the terms and conditions of the Plan.
(pp)
“Othe
t
r Award”
d
means an award based in whole or in part by reference to the Common Stock which is granted
pursuant to the terms and conditions of Section 5(c).
(qq)
“Othe
t
r Award Agreement”t means a written agreement between the Company and a Participant evidencing the terms
and conditions of an Other Award grant. Each Other Award Agreement will be subj
u ect to the terms and conditions of the Plan.
(rr)
“Own,” “Owned,” “Owner,” or “Ownership” means that a person or Entity will be deemed to “Own,” to have
“Owned,” to be the “Owner” of, or
f
to have acquired “Ownership” of securities if such person or Entity, directly or indirectly, through
any contract, arrangement, understanding, relationship or otherwise, has or shares voting power, which includes the power to vote or
to direct the voting, with respect to such securities.
(ss)
“Pa
“
rticip
t
ant”t means an Employee, Director or Consultant to whom an Award is granted pursuant to the Plan or, if
applicable, such other person who holds an outstanding Award.
(tt)
“Pe
“
rfor
f
ma
r
nce Award”
d means an Award that may vest or may be exercised, or that may become earned and paid,
contingent upon the attainment during a Performance Period of certain Performance Goals and which is granted pursuant to the terms
and conditions of Section 5(b) and such terms as approved by the Board.
(uu)
“Pe
“
rfor
f
ma
r
nce Criteria” means the one or more criteria that the Board will select for purposes of establ
a ishing the
Performance Goals for a Performance Period. The Performance Criteria that will be used to establ
a ish such Performance Goals may be
based on any one of, or
f
co bi
mbination of,f
hthe follllo i
wi g
ng, as determin d
ed by
by hthe Board: ( )
(1) earnings
nings (i(including
ding earnings pe
nings per h
share and net
earnings
nings, in iei hther case before or afte
f r any or lall of:f interest, taxes, depr
i
eciation and amor itization, legal se l
ttlements
h
or other income
(expens )e), or st
k
ock-based compensa itio
h
n, other non-cash expenses and
h
changes in deferred revenue) ( )
); (2)
l
total st
kh ld
ockholder return;
( )
(3) return on eq iui yty or aver g
age st
kh ld
ockholder’s eq iui yty; ( )
(4) return on assets, investment, or capi l
ital employed;
ployed; ( )
(5) stock price; (6) ma g
rgin
(i(including gr
ding gross ma g
rgin) ( )
); (7) income (b
(befor
f
e or afte
f r taxe )s); (8) opera iting income; ( )
(9) opera iting income afte
f r taxes; (10) pre-tax profit;
f
(1 )
1) opera iting cash flflow; (1 )
2) sales, prescri i
iptions, or revenue ta g
rgets; (1 )
3) increases in re
d
venue or product revenue; (14) expenses and
cost reduc itio
g
n goals; (1 )
5) improvement in or at i
tainme
f
nt of wo k
rking ca ipi
a tal l
l levels; (1 )
6) economic value
d
add d
ded (or an eq iuivalent
i
metric); (1 )
7) ma k
rket h
share; (1 )
8) cash flflow; (1 )
9) cash flflow per h
share; (2 )
0) cash b
h burn; (2 )
1) h
share price performance; (2 ) d b
2) debt reduc ition;
(2 )
3) i
l
implementation or co
l
mple ition of proj
n of projects or processes (i(including,
ding,
i
wi hthout li i
i
limitatio
di
n, discove y
ry of a pr
l
e-cli i
inic lal dr g
ug
r
ca did
ndidate,
recomme d
nda ition of a dr g
ug
r
candididate to enter
l
a clinic lal
i
trial, lcli i
inic lal
i l i i i i
trial initiation,
lcli i
inic lal
i l
trial enrollllment and d
d dates,
lclinic lal
i l
trial
results, regul
gulat
y
ory fifililing subm
u
is isions, regul
gulat
y
ory fifililing acceptances, regul
gulat
y
ory or
d
ad iviso y
ry co
i
mmittee interactions, regul
gulatory
r
approvals, presen
i
tation of st di
udi
t
es and la
h
f
unch of commerci l
ial
lplans, co
li
mpliance
g
programs or
d
educ
d
ation campaigigns); (2 )
4) customer
sa itisfaction; (2 )
5) st
kh ld
ockholders’ eq iui yty; (2 )
6) capital ex
di
penditures; (2 ) d b
7) debt levels; (2 )
8) fifinancings; (2 )
9) opera iti g
ng profit
f
or net
opera iting profit;
f
(30) grow
0) grow hth of ne i
t income or opera iti g
ng income; (3 ) bi
1) billi
llings; (3 )
2) employe
ployee hihi iri g
ng; (3 )
3) fu d
nds from opera itions;
(34) budge
4) budget ma
g
nagement; (3 )
5) strategigic partnershihips or transactions (i(including
ding acq iui isi itions, joint
joint ventures or lilicen isi g
ng transactions);
(3 )
6) eng g
gagement of hthought
ought le d
aders and pa itient d
advocacy g
y groups; (3 )
7) enhancement of i
ll
intellectua
t
l property portf lol
f io, fifilili g
ng of patent
ap lplications and gr
d gran iting of patents; (3 )
8) litig
litigation preparation and ma
g
nagement; and (3 )
9) any othe
y other measure of performance sele
d
cted
by
by hthe Board.
A-16
(vv)
“Pe
“
rfor
f
ma
r
nce Goals” means, for a Perfor
f
mance Period, the one or more goals establ
a ished by the Board for the
Performance Period based upon the Performance Criteria. Performance Goals may be based on a Company-wide basis, with respect to
one or more business units, divisions, Affi
f liates, or business segments, and in either absolute terms or relative to the perform
f
ance of
one or more comparable companies or the performance of one or more relevant indices. The Board is authorized to make appropriate
adju
d stments in the method of calculating the attainment of Performance Goals for a Performance Period as follows: (1) to exclude
restructur
t
ing and/or other nonrecurring charges; (2) to exclude exchange rate effe
f cts, as applicable, for non-U.S. dollar denominated
Performance Goals; (3) to exclude the effe
f cts of changes to generally accepted accounting principles; (4) to exclude the effe
f cts of any
statutory
t
adju
d stments to corporate tax rates; (5) to exclude the effe
f cts of items that are “unusual” in nature or occur “infre
f quently” as
determined under generally accepted accounting principles; (6) to exclude the dilutive effe
f cts of acquisitions or joint ventures; (7) to
assume that any business divested by the Company achieved performance objectives at targeted levels during the balance of a
Performance Period following such divestiture; (8) to exclude the effe
f ct of any change in the outstanding shares of common stock of
the Company by reason of any stock dividend or split, stock repurchase, reorganization, recapitalization, merger, consolidation, spin-
off,
f
combination or exchange of shares or other similar corporate change, or any distributions to common stockholders other than
regular cash dividends; (9) to exclude the effe
f cts of stock based compensation and the award of bonuses under the Company’s bonus
plans; (10) to exclude costs incurred in connection with potential acquisitions or divestitures that are required to be expensed under
generally accepted accounting principles; (11) to exclude the goodwill and intangible asset impairment charges that are required to be
recorded under generally accepted accounting principles; (12) to exclude the effe
f cts of the timing of acceptance for review and/or
approval of subm
u
issions to the U.S. Food and Drug
r
Administration or any other regulatory body; and (13) to make other appropriate
adju
d stments selected by the Board. In addition, the Board retains the discretion to define the manner of calculating the Performance
Criteria it selects to use for a Performance Period and to reduce or eliminate the compensation or economic benefit due upon the
attainment of any Performance Goal. Partial attainment of any Performance Goal may result in payment or vesting corresponding to
the degree of attainment as specified in the applicable Award Agreement or the written terms of a Performance Award.
(ww)
“Pe
“
rfor
f
ma
r
nce Period”
d means the period of time selected by the Board over which the attainment of one or more
Performance Goals will be measured for the purpos
r
e of determining a Participant’s right to vesting or exercise of, or any payment
under, an Award. Performance Periods may be of varying and overlapping duration, at the sole discretion of the Board.
(xx)
“Pl
“
an
l
” means this Neurocrine Biosciences, Inc. 2025 Equity Incentive Plan.
(yy)
“Pl
“
an
l
Admin
d
istrator” means the person, persons, and/or third-party administrator designated by the Company to
administer the day to day operations of the Plan and the Company’s other equity incentive programs.
(zz)
“Po
“
st-T
t
er
T
min
r
atio
t n Exercise
i
Period”
d means the period following termination of a Participant’s Continuous Service
within which an Option or SAR is exercisabl
a e, as specifie
f d in Section 4(h).
(aaa)
“Pr
“
ior Plans
l
” means the 2020 Plan and the Neurocrine Biosciences, Inc. 2011 Equity Incentive Plan and each is a
“Pr
“
ior Plan
l
”.
(bbb)
“Pr
“
ior Plan
l
Award”
d means an award granted under a Prior Plan that is outstanding as of the Effe
f ctive Date.
(ccc)
“Pr
“
ior Plan
l
s’ Returning Shares” means: (i) any shares of Common Stock subj
u ect to a Prior Plan Award that afte
f r
March 24, 2025 are not issued because such Prior Plan Award or any portion thereof expires or otherwise terminates without all of the
shares covered by such Prior Plan Award having been issued; (ii) any shares of Common Stock subj
u ect to a Prior Plan Award that afte
f r
March 24, 2025 are not issued because such Prior Plan Award or any portion thereof is settled in cash; (iii) any shares of Common
Stock issued pursuant to a Prior Plan Award that afte
f r March 24, 2025 are forfeited back to or repurchased by the Company because of
the failure to meet a contingency or condition required for the vesting of such shares; and (iv) any shares of Common Stock that afte
f r
March 24, 2025 are reacquired or withheld (or not issued) by the Company to satisfy a tax withholding obligation in connection with a
Full Value Award granted under a Prior Plan.
(ddd)
“Pr
“
ospe
s
ctus” means the document containing the Plan information specified in Section 10(a) of the Securities Act.
(eee)
“Re
“
stricted
t
Stock
t
Award”
d means an Award of shares of Common Stock which is granted pursuant to the terms and
conditions of Section 5(a).
(fff)
“Re
“
stricted
t
Stock
t
Award Agreement”t
means a written agreement between the Company and a Participant
evidencing the terms and conditions of a Restricted Stock Award grant. The Restricted Stock Award Agreement includes the Grant
Notice for the Restricted Stock Award and the agreement containing the written summary of the general terms and conditions
applicable to the Restricted Stock Award and which is provided to a Participant along with the Grant Notice. Each Restricted Stock
Award Agreement will be subj
u ect to the terms and conditions of the Plan.
(ggg)
“RS
“
U Award”
d means an Award of restricted stock units representing the right to receive an issuance of shares of
Common Stock which is granted pursuant to the terms and conditions of Section 5(a).
(hhh)
“RS
“
U Award Agreement”t means a written agreement between the Company and a Participant evidencing the terms
and conditions of a RSU Award grant. The RSU Award Agreement includes the Grant Notice for the RSU Award and the agreement
A-17
containing the written summary of
r
the general terms and conditions applicable to the RSU Award and which is provided to a
Participant along with the Grant Notice. Each RSU Award Agreement will be subj
u ect to the terms and conditions of the Plan.
(iii)
“Ru
“
le 16b-3” means Rule 16b-3 promulgated under the Exchange Act or any successor to Rule 16b-3, as in effe
f ct
from time to time.
(jjj)
“Ru
“
le 405” means Rule 405 promulgated under the Securities Act.
(kkk)
“Sectio
t n 409A” means Section 409A of the Code and the regulations and other guidance thereunder.
(lll)
“Sectio
t n 409A Change in Control
t
”l means a change in the ownership or effe
f ctive control of the Company, or in the
ownership of a subs
u
tantial portion of the Company’s assets, as provided in Section 409A(a)(2)(A)(v) of the Code and Treasury
Regulations Section 1.409A-3(i)(5) (without regard to any alternative definition thereunder).
(mmm) “Securiti
i es Act”t
means the Securities Act of 1933, as amended, and the rules and regulations promulgated
thereunder.
(nnn)
“SAR” or “Stock
t
Appr
p
eciation Right
i
”t means a right to receive the appreciation on Common Stock which is granted
pursuant to the terms and conditions of Section 4.
(ooo)
“SAR Agreement”t
means a written agreement between the Company and a Participant evidencing the terms and
conditions of a SAR grant. The SAR Agreement includes the Grant Notice for the SAR and the agreement containing the written
summary of the general terms and conditions applicable to the SAR and which is provided to a Participant along with the Grant
Notice. Each SAR Agreement will be subj
u ect to the terms and conditions of the Plan.
(ppp)
“Subsidiary
r ” means, with respect to the Company, (i) any corporation of which more than 50% of the outstanding
capital stock having ordinary voting power to elect a majority of the board of directors of such corporation (irrespective of whether, at
the time, stock of any other class or classes of such corporation will have or might have voting power by reason of the happening of
any contingency) is at the time, directly or indirectly, Owned by the Company, and (ii) any partnership, limited liabi
a lity company or
other entity in which the Company has a direct or indirect interest (whether in the form of voting or participation in profits or capital
contribution) of more than 50%.
(qqq)
“Ten Percent Stockholder
t
” means a person who Owns (or is deemed to Own pursuant to Section 424(d) of the
Code) stock possessing more than 10% of the total combined voting power of all classes of stock of the Company or any Affi
f liate.
(rrr)
“Trading
i
Policy” means the Company’s policy permitting certain individuals to sell Company shares only during
certain “window” periods and/or otherwise restricts the ability of certain individuals to transfer
f
or encumber Company shares, as in
effe
f ct from time to time.
(sss)
“Transaction
t
” means a Corporate Transaction or a Change in Control.
A-18
Appendix B
Neurocrine Biosciences, Inc.
2018 Employee Stock Purchase Plan
Adopted by the Board of Directors: February 6, 2018
Approved by the Stockholders: May 24, 2018
Amended and Restated by the Compensation Committee: March 14, 2022
Approved by the Stockholders: May 18, 2022
Amended and Restated by the Compensation Committee: March 14, 2025
Approved by the Stockholders: _____, 2025
1.
General; Purpose.
(a)
The Plan provides a means by which Eligible Employees of the Company and certain designated Related
Corporations may be given an opportunity to purchase shares of Common Stock. The Plan permits the Company to grant a series of
Purchase Rights to Eligible Employees under an Employee Stock Purchase Plan.
(b)
The Company, by means of the Plan, seeks to retain the services of such Employees, to secure and retain the
services of new Employees and to provide incentives for such persons to exert maximum effort
f
s for the success of the Company and
its Related Corporations.
2.
Administration.
(a)
The Board will administer the Plan. The Board may delegate administration of the Plan to a Committee or
Committees, as provided in Section 2(c).
(b)
The Board will have the power, subj
u ect to, and within the limitations of, the express provisions of the Plan:
(i)
To determine when and how Purchase Rights will be granted and the provisions of each Offeri
f
ng (which
need not be identical).
(ii)
To designate from time to time which Related Corporations will be eligible to participate in the Plan.
(iii)
To construe
r
and interpret the Plan and Purchase Rights, and to establ
a ish, amend and revoke rules and
regulations for the administration of the Plan. The Board, in the exercise of this power, may correct any defect, omission or
inconsistency in the Plan, in a manner and to the extent it deems necessary or expedient to make the Plan fully effe
f ctive.
(iv)
To settle all controversies regarding the Plan and Purchase Rights.
(v)
To amend the Plan at any time as provided in Section 12.
(vi)
To suspend or terminate the Plan at any time as provided in Section 12.
(vii)
Generally, to exercise such powers and to perfor
f
m such acts as it deems necessary or expedient to promote
the best interests of the Company and its Related Corporations and to carry out the intent that the Plan be treated as an Employee
Stock Purchase Plan.
(viii)
To adopt such procedur
d
es and sub-pl
u
ans as are necessary or appropriate to permit participation in the Plan
by Employees who are foreign nationals or employed outside the United States.
(c)
The Board may delegate some or all of the administration of the Plan to a Committee or Committees. If
administration is delegated to a Committee, the Committee will have, in connection with the administration of the Plan, the powers
theretofore possessed by the Board that have been delegated to the Committee, including the power to delegate to a subcom
u
mittee any
of the administrative powers the Committee is authorized to exercise (and references to the Board in this Plan and in any applicable
Offeri
f
ng Document will thereafter be to the Committee or subc
u
ommittee), subj
u ect, however, to such resolutions, not inconsistent with
the provisions of the Plan, as may be adopted from time to time by the Board. The Board may retain the authority to concurrently
administer the Plan with the Committee and may, at any time, revest in the Board some or all of the powers previously delegated.
Whether or not the Board has delegated administration of the Plan to a Committee, the Board will have the final power to determine
all questions of policy and expediency that may arise in the administration of the Plan.
(d)
All determinations, interpretations and construc
r
tions made by the Board in good faith will not be subj
u ect to review
by any person and will be final, binding and conclusive on all persons.
B-1
3.
Shares of Common Stock Subject to the Plan.
(a)
Subj
u ect to Section 11(a) relating to Capi
a talization Adju
d stments, the aggregate number of shares of Common Stock
that may be issued under the Plan will not exceed 1,700,000 shares, which number is the sum of (i) three hundred thousand (300,000)
shares that were approved at the Annual Meeting in 2018, (i(ii)i) six hundred thousand (600,000) shares that were approved at the Annual
Meeting in 2022, and (i(iiiii) 800,000 shares that were approved at the Annual Meeting in
.
2025
(b)
If any Purchase Right terminates without having been exercised in full, the shares of Common Stock not purchased
under such Purchase Right will again become availabl
a e for issuance under the Plan.
(c)
The stock issuable under the Plan will be shares of authorized but unissued or reacquired Common Stock, including
shares repurchased by the Company on the open market.
4.
Grant of Purchase Rights; Offe
f ring.
(a)
The Board may from time to time grant or provide for the grant of Purchase Rights to Eligible Employees under an
Offeri
f
ng (consisting of one or more Purchase Periods) on an Offeri
f
ng Date or Offeri
f
ng Dates selected by the Board. Each Offeri
f
ng
will be in such form and will contain such terms and conditions as the Board will deem appropriate and will comply with the
requirement of Section 423(b)(5) of the Code that all Employees granted Purchase Rights will have the same rights and privileges. The
terms and conditions of an Offeri
f
ng will be incorporated by reference into the Plan and treated as part of the Plan. The provisions of
separate Offeri
f
ngs need not be identical, but each Offeri
f
ng will include (through incorporation of the provisions of this Plan by
reference in the document comprising the Offeri
f
ng or otherwise) the period during which the Offeri
f
ng will be effe
f ctive, which period
will not exceed twenty-seven (27) months beginning with the Offeri
f
ng Date, and the subs
u
tance of the provisions contained in Sections
5 through 8, inclusive.
(b)
If a Participant has more than one Purchase Right outstanding under the Plan, unless he or she otherwise indicates in
forms delivered to the Company: (i) each form will apply to all of his or her Purchase Rights under the Plan, and (ii) a Purchase Right
with a lower exercise price (or an earlier-granted Purchase Right, if different Purchase Rights have identical exercise prices) will be
exercised to the fullest possible extent before a Purchase Right with a higher exercise price (or a later-granted Purchase Right if
different Purchase Rights have identical exercise prices) will be exercised.
(c)
The Board will have the discretion to structur
t
e an Offeri
f
ng so that if the Fair Market Value of a share of Common
Stock on the first Trading Day of a new Purchase Period within that Offeri
f
ng is less than or equal to the Fair Market Value of a share
of Common Stock on the Offeri
f
ng Date for that Offeri
f
ng, then (i) that Offeri
f
ng will terminate immediately as of that first Trading Day,
and (ii) the Participants in such terminated Offeri
f
ng will be automatically enrolled in a new Offeri
f
ng beginning on the first Trading
Day of such new Purchase Period.
5.
Eligibility.
(a)
Purchase Rights may be granted only to Employees of the Company or, as the Board may designate in accordance
with Section 2(b), to Employees of a Related Corporation. Except as provided in Section 5(b), an Employee will not be eligible to be
granted Purchase Rights unless, on the Offeri
f
ng Date, the Employee has been in the employ of the Company or the Related
Corporation, as the case may be, for such continuous period preceding such Offeri
f
ng Date as the Board may require, but in no event
will the required period of continuous employment be equal to or greater than two (2) years. In addition, the Board may provide that
no Employee will be eligible to be granted Purchase Rights unless, on the Offeri
f
ng Date, such Employee’s customary
r
employment
with the Company or the Related Corporation is more than twenty (20) hours per week and more than five (5) months per calendar
year or such other criteria as the Board may determine consistent with Section 423 of the Code.
(b)
The Board may provide that each person who, during the course of an Offeri
f
ng, first becomes an Eligible Employee
will, on a date or dates specifie
f d in the Offeri
f
ng which coincides with the day on which such person becomes an Eligible Employee or
which occurs thereafter, receive a Purchase Right under that Offeri
f
ng, which Purchase Right will thereafte
f r be deemed to be a part of
that Offeri
f
ng. Such Purchase Right will have the same characteristics as any Purchase Rights originally granted under that Offe
f ring, as
described herein, except that:
(i)
the date on which such Purchase Right is granted will be the “Offering Date” of such Purchase Right for all
purpos
r
es, including determination of the exercise price of such Purchase Right;
(ii)
the period of the Offeri
f
ng with respect to such Purchase Right will begin on its Offeri
f
ng Date and end
coincident with the end of such Offeri
f
ng; and
(iii)
the Board may provide that if such person first becomes an Eligible Employee within a specified period of
time before the end of the Offeri
f
ng, he or she will not receive any Purchase Right under that Offeri
f
ng.
B-2
(c)
No Employee will be eligible for the grant of any Purchase Rights if,f immediately afte
f r any such Purchase Rights
are granted, such Employee owns stock possessing five percent (5%) or more of the total combined voting power or value of all
classes of stock of the Company or of any Related Corporation. For purposes of this Section 5(c), the rules of Section 424(d) of the
Code will apply in determining the stock ownership of any Employee, and stock which such Employee may purchase under all
outstanding Purchase Rights and options will be treated as stock owned by such Employee.
(d)
As specifie
f d by Section 423(b)(8) of the Code, an Eligible Employee may be granted Purchase Rights only if such
Purchase Rights, together with any other rights granted under all Employee Stock Purchase Plans of the Company and any Related
Corporations, do not permit such Eligible Employee’s rights to purchase stock of the Company or any Related Corporation to accrue
r
at a rate which exceeds twenty-five thousand dollars ($25,000) of Fair Market Value of such stock (determined at the time such rights
are granted, and which, with respect to the Plan, will be determined as of their respective Offeri
f
ng Dates) for each calendar year in
which such rights are outstanding at any time.
(e)
Offi
f cers of the Company and any designated Related Corporation, if they are otherwise Eligible Employees, will be
eligible to participate in Offer
f
ings under the Plan. Notwithstanding the foregoing, the Board may provide in an Offeri
f
ng that
Employees who are highly compensated Employees within the meaning of Section 423(b)(4)(D) of the Code will not be eligible to
participate.
6.
Purchase Rights; Purchase Price.
(a)
On each Offeri
f
ng Date, each Eligible Employee, pursuant to an Offeri
f
ng made under the Plan, will be granted a
Purchase Right to purchase up to that number of shares of Common Stock purchasable either with a percentage or with a maximum
dollar amount, as designated by the Board, but in either case not exceeding fifteen percent (15%) of such Employee’s earnings (as
defined by the Board in each Offeri
f
ng) during the period that begins on the Offeri
f
ng Date (or such later date as the Board determines
for a particular Offeri
f
ng) and ends on the date stated in the Offeri
f
ng, which date will be no later than the end of the Offeri
f
ng.
(b)
The Board will establ
a ish one (1) or more Purchase Dates during an Offeri
f
ng on which Purchase Rights granted
pursuant to that Offeri
f
ng will be exercised and shares of Common Stock will be purchased in accordance with such Offeri
f
ng.
(c)
In connection with each Offeri
f
ng made under the Plan, the Board may specify (i) a maximum number of shares of
Common Stock that may be purchased by any Participant pursuant to such Offeri
f
ng, (ii) a maximum number of shares of Common
Stock that may be purchased by any Participant on any Purchase Date pursuant to such Offeri
f
ng, (iii) a maximum aggregate number of
shares of Common Stock that may be purchased by all Participants pursuant to such Offeri
f
ng, and/or (iv) a maximum aggregate
number of shares of Common Stock that may be purchased by all Participants on any Purchase Date pursuant to such Offeri
f
ng. If the
aggregate purchase of shares of Common Stock issuable upon exercise of Purchase Rights granted under such Offeri
f
ng would exceed
any such maximum aggregate number, then, in the absence of any Board action otherwise, a pro rata (based on each Participant’s
accumulated Contributions) allocation of the shares of Common Stock availabl
a e will be made in as nearly a uniform manner as will be
practicable and equitabl
a e.
(d)
The purchase price of shares of Common Stock acquired pursuant to Purchase Rights will be not less than the lesser
of:f
(i)
an amount equal to eighty-five percent (85%) of the Fair Market Value of the shares of Common Stock on
the Offeri
f
ng Date; or
(ii)
an amount equal to eighty-five percent (85%) of the Fair Market Value of the shares of Common Stock on
the applicable Purchase Date.
7.
Participation; Withdrawal; Termination.
(a)
An Eligible Employee may elect to authorize payroll deductions as the means of making Contributions by
completing and delivering to the Company, within the time specified in the Offeri
f
ng, an enrollment form provided by the Company.
The enrollment form will specify
f
the amount of Contributions not to exceed the maximum amount specified by the Board. Each
Participant’s Contributions will be credited to a bookkeeping account for such Participant under the Plan and will be deposited with
the general funds of the Company except where applicable law requires that Contributions be deposited with a third party. To the
extent provided in the Offeri
f
ng, a Participant may begin such Contributions on or afte
f r the Offeri
f
ng Date. To the extent provided in the
Offeri
f
ng, a Participant may thereafte
f r decrease (including to zero) or increase his or her Contributions. To the extent specifically
provided in the Offeri
f
ng, in addition to or instead of making Contributions by payroll deductions, a Participant may make
Contributions through payment by cash or check prior to a Purchase Date.
(b)
During an Offeri
f
ng, a Participant may cease making Contributions and withdraw from the Offeri
f
ng by delivering to
the Company a withdrawal form provided by the Company. The Company may impose a deadline before a Purchase Date for
withdrawing. Upon such withdrawal, such Participant’s Purchase Right in that Offeri
f
ng will immediately terminate and the Company
will distribute to such Participant all of his or her accumulated but unused Contributions without interest. A Participant’s withdrawal
from an Offeri
f
ng will have no effe
f ct upon his or her eligibility to participate in any other Offeri
f
ngs under the Plan, but such Participant
will be required to deliver a new enrollment form to participate in subs
u
equent Offeri
f
ngs.
B-3
(c)
Purchase Rights granted pursuant to any Offeri
f
ng under the Plan will terminate immediately if the Participant either
(i) is no longer an Employee for any reason or for no reason (subject to any post-employment participation period required by law) or
(ii) is otherwise no longer eligible to participate. The Company will distribute to such individual all of his or her accumulated but
unused Contributions without interest.
(d)
Purchase Rights will not be transferab
f
le by a Participant except by will, by the laws of descent and distribution, or, if
permitted by the Company, by a beneficiary de
r
signation as described in Section 10. During a Participant’s lifet
f ime, Purchase Rights
will be exercisabl
a e only by such Participant.
(e)
Unless otherwise specifie
f d in an Offeri
f
ng, the Company will have no obligation to pay interest on Contributions.
8.
Exercise of Purchase Rights.
(a)
On each Purchase Date, each Participant’s accumulated Contributions will be applied to the purchase of shares of
Common Stock, up to the maximum number of shares of Common Stock permitted by the Plan and the applicable Offeri
f
ng, at the
purchase price specified in the Offeri
f
ng. No fractional shares will be issued upon the exercise of Purchase Rights unless specifically
provided for in the Offeri
f
ng.
(b)
Unless otherwise provided in the Offeri
f
ng, if any amount of accumulated Contributions remains in a Participant’s
account afte
f r the purchase of shares of Common Stock and such remaining amount is less than the amount required to purchase one
share of Common Stock on the final Purchase Date of an Offeri
f
ng, then such remaining amount will be held in such Participant’s
account for the purchase of shares of Common Stock under the next Offeri
f
ng under the Plan, unless such Participant withdraws from
or is not eligible to participate in such next Offeri
f
ng, in which case such amount will be distributed to such Participant afte
f r the final
Purchase Date without interest. If the amount of Contributions remaining in a Participant’s account afte
f r the purchase of shares of
Common Stock is at least equal to the amount required to purchase one (1) whole share of Common Stock on the final Purchase Date
of an Offeri
f
ng, then such remaining amount will be distributed in full to such Participant afte
f r the final Purchase Date of such Offeri
f
ng
without interest.
(c)
No Purchase Rights may be exercised to any extent unless the shares of Common Stock to be issued upon such
exercise under the Plan are covered by an effe
f ctive registration statement pursuant to the Securities Act and the Plan is in material
compliance with all applicable federal, state, foreign and other securities and other laws applicable to the Plan. If, on a Purchase Date,
the shares of Common Stock are not so registered or the Plan is not in such compliance, no Purchase Rights will be exercised on such
Purchase Date, and the Purchase Date will be delayed until the shares of Common Stock are subj
u ect to such an effe
f ctive registration
statement and the Plan is in such compliance, except that the Purchase Date will not be delayed more than twelve (12) months and the
Purchase Date will in no event be more than twenty-seven (27) months from the Offeri
f
ng Date. If, on the Purchase Date, as delayed to
the maximum extent permissible, the shares of Common Stock are not so registered or the Plan is not in such compliance, no Purchase
Rights will be exercised and all accumulated but unused Contributions will be distributed to the Participants without interest.
9.
Covenants of the Company.
The Company will seek to obtain from each federal, state, foreign or other regulatory commission or agency having
jurisdiction over the Plan such authority as may be required to grant Purchase Rights and issue and sell shares of Common Stock
thereunder. If, afte
f r commercially reasonable effort
f
s, the Company is unable to obtain the authority that counsel for the Company
deems necessary for the grant of Purchase Rights or the lawful
f
issuance and sale of Common Stock under the Plan, and at a
commercially reasonable cost, the Company will be relieved from any liabi
a lity for failure to grant Purchase Rights and/or to issue and
sell Common Stock upon exercise of such Purchase Rights.
10.
Designation of Beneficiary.
(a)
The Company may, but is not obligated to, permit a Participant to subm
u
it a form designating a beneficiary
r who will
receive any shares of Common Stock and/or Contributions from the Participant’s account under the Plan if the Participant dies before
such shares and/or Contributions are delivered to the Participant. The Company may, but is not obligated to, permit the Participant to
change such designation of beneficiary.
r
Any such designation and/or change must be on a form approved by the Company.
(b)
If a Participant dies, and in the absence of a valid beneficiary
r
designation, the Company will deliver any shares of
Common Stock and/or Contributions to the executor or administrator of the estate of the Participant. If no executor or administrator
has been appointed (to the knowledge of the Company), the Company, in its sole discretion, may deliver such shares of Common
Stock and/or Contributions to the Participant’s spouse, dependents or relatives, or if no spouse, dependent or relative is known to the
Company, then to such other person as the Company may designate.
B-4
11.
Adju
d
stments upon Changes in Common Stock; Corporate Transactions.
(a)
In the event of a Capi
a talization Adju
d stment, the Board will appropriately and proportionately adju
d st: (i) the class(es)
and maximum number of securities subj
u ect to the Plan pursuant to Section 3(a); (ii) the class(es) and number of securities subj
u ect to,
and the purchase price applicable to outstanding Offeri
f
ngs and Purchase Rights; and (iii) the class(es) and number of securities that are
the subj
u ect of the purchase limits under each ongoing Offeri
f
ng. The Board will make these adju
d stments, and its determination will be
final, binding and conclusive.
(b)
In the event of a Corporate Transaction, (i) any surviving or acquiring corporation (or its parent company) may
assume or continue outstanding Purchase Rights or may subs
u
titut
t e similar rights (including a right to acquire the same consideration
paid to the stockholders in the Corporate Transaction) for outstanding Purchase Rights, or (ii) if any surviving or acquiring corporation
(or its parent company) does not assume or continue outstanding Purchase Rights or does not subs
u
titute similar rights for outstanding
Purchase Rights, then the Participants’ accumulated Contributions will be used to purchase shares of Common Stock within ten (10)
business days prior to the Corporate Transaction under such Purchase Rights, and such Purchase Rights will terminate immediately
afte
f r such purchase.
12.
Amendment, Suspension or Termination of the Plan.
(a)
The Board may amend the Plan at any time in any respect the Board deems necessary or advisabl
a e. However, except
as provided in Section 11(a) relating to Capi
a talization Adju
d stments, stockholder approval will be required for any amendment of the
Plan for which stockholder approval is required by applicable law or listing requirements.
(b)
The Board may suspend or terminate the Plan at any time. No Purchase Rights may be granted under the Plan while
the Plan is suspended or afte
f r it is terminated.
(c)
Any benefits, privileges, entitlements and obligations under any outstanding Purchase Rights granted before an
amendment, suspension or termination of the Plan will not be materially impaired by any such amendment, suspension or termination
except (i) with the consent of the person to whom such Purchase Rights were granted, (ii) as necessary to comply with any laws,
listing requirements, or governmental regulations (including, without limitation, the provisions of Section 423 of the Code and the
regulations and other interpretive guidance issued thereunder relating to Employee Stock Purchase Plans) including, without
limitation, any such regulations or other guidance that may be issued or amended afte
f r the Adoption Date, or (iii) as necessary to
obtain or maintain favorable tax, listing, or regulatory treatment. To be clear, the Board may amend outstanding Purchase Rights
without a Participant’s consent if such amendment is necessary to ensure that the Purchase Right and/or the Plan complies with the
requirements of Section 423 of the Code.
Notwithstanding anything in the Plan or any Offeri
f
ng Document to the contrary, the Board will be entitled to: (i) establ
a ish the
exchange ratio applicable to amounts withheld in a currency other than U.S. dollars; (ii) permit Contributions in excess of the amount
designated by a Participant in order to adju
d st for mistakes in the Company’s processing of properly completed Contribution elections;
(iii) establ
a ish reasonable waiting and adju
d stment periods and/or accounting and crediting procedur
d
es to ensure that amounts applied
toward the purchase of Common Stock for each Participant properly correspond with amounts withheld from the Participant’s
Contributions; (iv) amend any outstanding Purchase Rights or clarify
f
any ambiguities regarding the terms of any Offeri
f
ng to enable
the Purchase Rights to qualify under and/or comply with Section 423 of the Code; and (v) establ
a ish other limitations or procedur
d
es as
the Board determines in its sole discretion advisabl
a e that are consistent with the Plan. The actions of the Board pursuant to this
paragraph will not be considered to alter or impair any Purchase Rights granted under an Offeri
f
ng as they are part of the initial terms
of each Offeri
f
ng and the Purchase Rights granted under each Offeri
f
ng.
13.
Effe
f ctive Date of Plan.
The Plan will become effe
f ctive on the Effe
f ctive Date. No Purchase Rights will be exercised unless and until the Plan has
been approved by the stockholders of the Company, which approval must be within 12 months before or afte
f r the date the Plan is
adopted (or if required under Section 12(a), materially amended) by the Board.
14.
Miscellaneous Provisions.
(a)
Proceeds from the sale of shares of Common Stock pursuant to Purchase Rights will constitute general funds of the
Company.
(b)
A Participant will not be deemed to be the holder of, or to have any of the rights of a holder with respect to, shares
of Common Stock subj
u ect to Purchase Rights unless and until the Participant’s shares of Common Stock acquired upon exercise of
Purchase Rights are recorded in the books of the Company (or its transfer agen
f
t).
(c)
The Plan and Offeri
f
ng do not constitut
t e an employment contract. Nothing in the Plan or in the Offeri
f
ng will in any
way alter the at will nature of a Participant’s employment or be deemed to create in any way whatsoever any obligation on the part of
any Participant to continue in the employ of the Company or a Related Corporation, or on the part of the Company or a Related
Corporation to continue the employment of a Participant.
B-5
(d)
The provisions of the Plan will be governed by the laws of the State of Delaware without resort to that state’s
conflicts
f
of laws rules.
15.
Definitions.
As used in the Plan, the following definitions will apply to the capi
a talized terms indicated below:
(a)
“Ad
“
opt
d
io
t n Date” means Februa
r
ry 6, 2018, which is the date the Plan was adopted by the Board.
(b)
“An
“
nual Meeting
t
” means the first meeting of the Company’s stockholders held each calendar year at which
Directors are selected.
(c)
“Board”
d means the Board of Directors of the Company.
(d)
“Capi
a ta
i liza
i
tion Adju
d
stme
t
nt”t
means any change that is made in, or other events that occur with respect to, the
Common Stock subj
u ect to the Plan or subj
u ect to any Purchase Right afte
f r the Adoption Date without the receipt of consideration by the
Company through merger, consolidation, reorganization, recapi
a talization, reincorporation, stock dividend, dividend in property other
than cash, large nonrecurring cash dividend, stock split, reverse stock split, liquidating dividend, combination of shares, exchange of
shares, change in corporate structur
t
e or other similar equity restructur
t
ing transaction, as that term is used in Statement of Financial
Accounting Standards Board Accounting Standards Codification Topic 718 (or any successor thereto). Notwithstanding the foregoing,
the conversion of any convertible securities of the Company will not be treated as a Capi
a talization Adju
d stment.
(e)
“Code” means the Internal Revenue Code of 1986, as amended, including any applicable regulations and guidance
thereunder.
(f)
“Committee” means a committee of one (1) or more members of the Board to whom authority has been delegated by
the Board in accordance with Section 2(c).
(g)
“Common Stock
t
” means the common stock of the Company.
(h)
“Company
n ” means Neurocrine Biosciences, Inc., a Delaware corporation.
(i)
“Contri
t butions” means the payroll deductions and other additional payments specifically provided for in the
Offeri
f
ng that a Participant contributes to fund the exercise of a Purchase Right. A Participant may make additional payments into his
or her account if specifically provided for in the Offeri
f
ng, and then only if the Participant has not already had the maximum permitted
amount withheld during the Offeri
f
ng through payroll deductions.
(j)
“Corporatet Transaction
t
” means the consummation, in a single transaction or in a series of related transactions, of
any one or more of the following events:
(i)
a sale or other disposition of all or subs
u
tantially all, as determined by the Board in its sole discretion, of the
consolidated assets of the Company and its Subs
u
idiaries;
(ii)
a sale or other disposition of at least ninety percent (90%) of the outstanding securities of the Company;
(iii)
a merger, consolidation or similar transaction following which the Company is not the surviving
corporation; or
(iv)
a merger, consolidation or similar transaction following which the Company is the surviving corporation
but the shares of Common Stock outstanding immediately preceding the merger, consolidation or similar transaction are converted or
exchanged by virtue of
t
the merger, consolidation or similar transaction into other property, whether in the form of securities, cash or
otherwise.
(k)
“Di
“
re
i
ctor
t
” means a member of the Board.
(l)
“Ef
“
fe
f ctiv
t e Date” means the effe
f ctive date of this Plan document, which is the date of the Annual Meeting in 2018,
provided that this Plan is approved by the Company’s stockholders at such meeting.
(m)
“El
“
ig
l ible Employ
m
ee” means an Employee who meets the requirements set forth in the document(s) governing the
Offeri
f
ng for eligibility to participate in the Offeri
f
ng, provided that such Employee also meets the requirements for eligibility to
participate set forth in the Plan.
B-6
(n)
“Em
“
ploy
m
ee” means any person, including an Offi
f cer or Director, who is “employed” for purposes of Section
423(b)(4) of the Code by the Company or a Related Corporation. However, service solely as a Director, or payment of a fee for such
services, will not cause a Director to be considered an “Employee” for purposes of the Plan.
(o)
“Em
“
ploy
m
ee Stock
t
Purchase Plan
l
” means a plan that grants Purchase Rights intended to be options issued under an
“employee stock purchase plan,” as that term is defined in Section 423(b) of the Code.
(p)
“Ex
“
change Act”t
means the Securities Exchange Act of 1934, as amended, and the rules and regulations
promulgated thereunder.
(q)
“Fair Market Value” means, as of any date, the value of the Common Stock determined as follows:
(i)
If the Common Stock is listed on any establ
a ished stock exchange or traded on any establ
a ished market, the
Fair Market Value of a share of Common Stock will be, unless otherwise determined by the Board, the closing sales price for such
stock as quoted on such exchange or market (or the exchange or market with the greatest volume of trading in the Common Stock) on
the date of determination, as reported in a source the Board deems reliabl
a e.
(ii)
Unless otherwise provided by the Board, if there is no closing sales price for the Common Stock on the date
of determination, then the Fair Market Value will be the closing sales price on the last preceding date for which such quotation exists.
(iii)
In the absence of such markets for the Common Stock, the Fair Market Value will be determined by the
Board in good faith in compliance with applicable laws and in a manner that complies with Section 409A of the Code.
(r)
“Offe
f ring
i
” means the grant to Eligible Employees of Purchase Rights, with the exercise of those Purchase Rights
automatically occurring at the end of one or more Purchase Periods. The terms and conditions of an Offeri
f
ng will generally be set
forth in the “Offe
f ring
i
Document”t approved by the Board for that Offeri
f
ng.
(s)
“Offe
f ring
i
Date” means a date selected by the Board for an Offeri
f
ng to commence.
(t)
“Offi
f cer” means a person who is an offi
f cer of the Company or a Related Corporation within the meaning of Section
16 of the Exchange Act.
(u)
“Pa
“
rticip
t
ant”t means an Eligible Employee who holds an outstanding Purchase Right.
(v)
“Pl
“
an
l
” means this Neurocrine Biosciences, Inc. 2018 Employee Stock Purchase Plan.
(w)
“Pu
“
rchase Date” means one or more dates during an Offeri
f
ng selected by the Board on which Purchase Rights will
be exercised and on which purchases of shares of Common Stock will be carried out in accordance with such Offeri
f
ng.
(x)
“Pu
“
rchase Period”
d means a period of time specified within an Offeri
f
ng, generally beginning on the Offeri
f
ng Date or
on the first Trading Day following a Purchase Date and ending on a Purchase Date. An Offeri
f
ng may consist of one or more Purchase
Periods.
(y)
“Pu
“
rchase Right
i
”t means an option to purchase shares of Common Stock granted pursuant to the Plan.
(z)
“Re
“
lated Corporation
t
” means any “parent corporation” or “subsidiary corporation” of the Company whether now or
subs
u
equently establ
a ished, as those terms are defined in Sections 424(e) and (f), respectively, of the Code.
(aa)
“Securiti
i es Act”t means the Securities Act of 1933, as amended.
(bb)
“Subsidiary
r ” means, with respect to the Company, (i) any corporation of which more than fifty percent (50%) of the
outstanding capi
a tal stock having ordinary voting power to elect a majority of the board of directors of such corporation (irrespective of
whether, at the time, stock of any other class or classes of such corporation will have or might have voting power by reason of the
happening of any contingency) is at the time, directly or indirectly, Owned by the Company, and (ii) any partnership, limited liabi
a lity
company or other entity in which the Company has a direct or indirect interest (whether in the form of voting or participation in profits
f
or capital contribution) of more than fifty percent (50%). For purposes of the foregoing clause (i), the Company will be deemed to
“Own” or have “Owned” such securities if the Company, directly or indirectly, through any contract, arrangement, understanding,
relationship or otherwise, has or shares voting power, which includes the power to vote or to direct the voting, with respect to such
securities.
(cc)
“Trading
i
Day” means any day on which the exchange(s) or market(s) on which shares of Common Stock are listed
(including, but not limited to, the NYSE, the Nasdaq Global Select Market, the Nasdaq Global Market, the Nasdaq Capi
a tal Market or
any successors thereto) is open for trading.
B-7
[THIS PAGE INTENTIONALLY LEFT BLANK]
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☑
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2024
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________to__________
Commission file number 0-22705
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
Delaware
33-0525145
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
6027 Edgewood Bend Court, San Diego, California
92130
(Address of principal executive offices)
(Zip Code)
(858) 617-7600
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Common Stock, $0.001 par value
NBIX
Nasdaq Global Select Market
(Title of each class)
(Trading Symbol)
(Name of each exchange on which registered)
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☑
No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐
No ☑
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days. Yes ☑
No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑
No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange
Act.
Large accelerated filer
☑
Accelerated filer
☐
Non-accelerated filer
☐
Smaller reporting company
☐
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
Yes ☑
No ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the
correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the
registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐
No ☑
The aggregate market value of registrant’s common stock held by non-affiliates of the registrant, computed by reference to the closing price as of the last business day of
the registrant’s most recently completed second fiscal quarter, June 30, 2024, was $10.5 billion.
As of February 5, 2025, 99,703,527 shares of the registrant’s common stock were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive proxy statement relating to the registrant’s annual meeting of stockholders to be filed pursuant to Regulation 14A within 120 days
following the end of the registrant’s fiscal year ended December 31, 2024 are incorporated by reference into Part III of this Form 10-K.
TABLE OF CONTENTS
Page
PART I
Item 1.
Business
4
Item 1A.
Risk Factors
19
Item 1B.
Unresolved Staff C
f
omments
47
Item 1C.
Cybersecurity
47
Item 2.
Properties
49
Item 3.
Legal Proceedings
49
Item 4.
Mine Safety Disclosures
49
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities
50
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
52
Item 7A.
Quantitative and Qualitative Disclosures about Market Risk
61
Item 8.
Financial Statements and Suppl
u
ementary Data
62
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
93
Item 9A.
Controls and Procedures
93
Item 9B.
Other Infor
f
mation
96
Item 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
98
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
99
Item 11.
Executive Compensation
99
Item 12.
Security Ownership of Certain Beneficia
f
l Owners and Management and Related Stockholder
Matters
99
Item 13.
Certain Relationships and Related Transactions, and Director Independence
99
Item 14.
Principal Accounting Fees and Services
99
PART IV
Item 15.
Exhibits, Financial Statement Schedul
d es
100
NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, the
INGREZZA Logo, CRENESSITY, the CRENESSITY Logo, and other Neurocrine Biosciences trademarks are the
property of Neurocrine Biosciences, Inc. ALKINDI, EFMODY, and other Neurocrine UK Limited trademarks are
the property of Neurocrine UK Limited, a Neurocrine Biosciences company. Any other brand names or trademarks
appearing in this Annual Report that are not the property of Neurocrine Biosciences, Inc. are the property of their
respective holders.
2
PART I
Forward-Looking Statements
This Annual Report on Form 10-K and the information incorporated herein by reference contain forward-looking
statements that involve a number of risks and uncertainties. Although our forward-looking statements reflect the
good faith judgment of our management, these statements can only be based on facts and factors currently known by
us. Consequently, these forward-looking statements are inherently subject to risks and uncertainties, and actual
results and outcomes may differ materially from results and outcomes discussed in the forward-looking statements.
Forward-looking statements can be identified by the use of forward-looking words such as “believes,” “expects,”
“hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” “pro
forma,” or “anticipates,” or other similar words (including their use in the negative), or by discussions of future
matters such as the development of new products, technology enhancements, possible changes in legislation and
other statements that are not historical. These statements include but are not limited to statements under the captions
“Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and
“Business,” as well as other sections in this report. You should be aware that the occurrence of any of the events
discussed under the heading in Part I titled “Item 1A. Risk Factors” and elsewhere in this report could substantially
harm our business, results of operations and financial condition and that if any of these events occurs, the trading
price of our common stock could decline and you could lose all or a part of the value of your shares of our common
stock.
The cautionary statements made in this report are intended to be applicable to all related forward-looking statements
wherever they may appear in this report. We urge you not to place undue reliance on these forward-looking
statements, which speak only as of the date of this report. Except as required by law, we assume no obligation to
update our forward-looking statements, even if new information becomes available in the future.
3
Item 1. Business
Overview
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve
suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing
treatments for patients with under-addressed neuropsychiatric, neurological, and neuroendocrine disorders.
Our portfolio of products includes U.S. Food and Drug Administration (FDA) approved treatments for tardive
dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia (CAH), and
endometriosis and uterine fibroids in collaboration with AbbVie Inc. (AbbVie). In addition, we have a diversified
portfolio of multiple compounds in mid- to late-phase development across our core therapeutic areas and an
expanding early-phase pipeline that includes a range of modalities including small molecules, peptides, proteins,
antibodies, and gene therapy.
We launched INGREZZA® (valbenazine) in the U.S. as the first FDA-approved drug for the treatment of tardive
dyskinesia in May 2017 and for the treatment of chorea associated with Huntington's disease in August 2023 and
launched CRENESSITYTM (crinecerfont) in the U.S. as a first-in-class FDA-approved treatment of CAH in
December 2024.
We estimate that tardive dyskinesia affects approximately 800,000 people in the U.S., that approximately 90% of the
40,000 people in the U.S. affected by Huntington’s disease will develop chorea, and that CAH affects approximately
30,000 people in the U.S. Key elements of our commercial strategy include maximizing the opportunities in
INGREZZA and CRENESSITY through consistent and effective commercial execution, continued development of
valbenazine as the best-in-class treatment for new patient populations, and to lead the evolving understanding of
VMAT2 biology and its role in disease. INGREZZA net product sales totaled $2.3 billion for 2024, $1.8 billion for
2023, and $1.4 billion for 2022 and accounted for substantially all of our total net product sales during each of these
years.
Our partner Mitsubishi Tanabe Pharma Corporation (MTPC) launched DYSVAL® (valbenazine) in Japan for the
treatment of tardive dyskinesia in June 2022 and subsequently in other select Asian markets, where it is marketed as
REMLEAS® (valbenazine). We receive royalties at tiered percentage rates on MTPC net sales of valbenazine.
Our partner AbbVie launched ORILISSA® (elagolix tablets) in the U.S. for the treatment of endometriosis in August
2018 and ORIAHNN® (elagolix, estradiol and norethindrone acetate capsules and elagolix capsules) in the U.S. for
the treatment of heavy menstrual bleeding due to uterine fibroids in June 2020. We receive royalties at tiered
percentage rates on AbbVie net sales of elagolix.
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Commercial Products
Product
Indication
Major Markets
Tardive Dyskinesia
U.S., Japan, Select
Asian Markets (1)
Chorea Associated with Huntington’s Disease
Classic Congenital Adrenal Hyperplasia
U.S.
Endometriosis
U.S. (4)
Uterine Fibroids
U.S. (4)
Adrenal Insufficiency
U.S., United
Kingdom, EU4 (2) (3)
Classic Congenital Adrenal Hyperplasia
United Kingdom,
EU4 (3)
(1) INGREZZA is marketed as DYSVAL® (valbenazine) in Japan and REMLEAS® (valbenazine) in other select
Asian markets, where MTPC retains commercialization rights.
(2) ALKINDI is marketed as ALKINDI SPRINKLE® (hydrocortisone) in the U.S., where Eton Pharmaceuticals,
Inc. retains commercialization rights.
(3) The EU4 market is made up of the following countries: Germany, France, Italy, and Spain.
(4) AbbVie retains global commercialization rights to elagolix.
Commercial Operations
Our specialty sales force consists of approximately 600 experienced sales professionals located in the U.S. and is
divided into four dedicated sales teams focused on psychiatry, neurology, long-term care, and rare diseases.
We sell INGREZZA in the U.S. principally to a limited network of specialty pharmacy providers, wholesale
distributors, and specialty distributors. In addition, we sell CRENESSITY in the U.S. to a specialty pharmacy
provider.
Manufacturing and Supply
We currently rely on, and intend to continue to rely on, third-party manufacturers for the production of INGREZZA,
CRENESSITY, and our product candidates. Raw materials, active pharmaceutical ingredients (API), and other
supplies required for the production of INGREZZA, CRENESSITY, and our product candidates are sourced from
various third-party manufacturers and suppliers in quantities adequate to meet our needs. Continuing adequate
supply of such raw materials and API is assured through long-term commercial supply and manufacturing
agreements with multiple manufacturers and a continued focus on the expansion and diversification of our third-
party manufacturing relationships.
We believe our outsourced manufacturing strategy enables us to direct our financial resources to the maximization
of our opportunity with INGREZZA and CRENESSITY, investment in our internal research and development
programs, and expansion of our clinical pipeline through business development opportunities.
Our third-party manufacturers, suppliers and service providers may be subject to routine current Good
Manufacturing Practice (cGMP) inspections by the FDA or comparable agencies in other jurisdictions. We depend
on our third-party partners and our quality system oversight of them for continued compliance with cGMP
requirements and applicable foreign standards.
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Clinical Development Programs
The following chart summarizes our clinical development programs
_________________________
Small Molecule
* Initiating Phase 1 clinical study in the first quarter of 2025
Neuropsychiatry
Valbenazine
Valbenazine is a highly selective VMAT2 inhibitor. VMAT2 is a protein concentrated in the human brain that is
essential for the transmission of nerve impulses between neurons. VMAT2 is primarily responsible for packaging
and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in neurons. Specifically,
dopamine enables neurotransmission among nerve cells that are involved in voluntary and involuntary motor
control.
We have ongoing the JourneyTM study, a Phase 3 randomized, double-blind, placebo-controlled clinical study to
evaluate the efficacy, safety, and tolerability of valbenazine when administered orally once daily as adjunctive
treatment in adolescents and adults with schizophrenia who have had an inadequate response to antipsychotics.
Schizophrenia is a serious and complex syndrome with heterogeneous symptoms. The World Health Organization
estimates that the disorder impacts more than 20 million people worldwide. Annual associated costs for
schizophrenia are estimated to be more than $150 billion in the U.S. As one of the leading causes of disability
worldwide, it often results in significant emotional and functional burden for those who experience symptoms, as
well as their family and friends. This chronic and disabling mental health condition is thought to result from a
complex interplay of genetic and environmental risk factors. Traditional treatment approaches for schizophrenia rely
on the use of antipsychotic medications that can lead to considerable short- and long-term health impacts.
Osavampator (formerly NBI-1065845)
Osavampator is a potential first-in-class alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA)
positive allosteric modulator (PAM) in development for patients with inadequate response to treatment of major
depressive disorder. We originally acquired the global rights to osavampator in June 2020 as a 50:50 profit-share
product from Takeda. In January 2025, we agreed with Takeda to convert from sharing operating profits and losses
with respect to the development and commercialization of osavampator to a royalty-bearing license. Pursuant to the
license, we have exclusive rights to develop and commercialize osavampator for all indications in all territories
worldwide, excluding Japan.
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In April 2024, we announced positive top-line data from the Phase 2 SAVITRI™study of osavampator in adults
with major depressive disorder. The Phase 2 dose-finding study met its primary and key secondary endpoints,
demonstrating that once-daily, oral administration of NBI-1065845 produced a statistically significant change from
baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at both Day 28 (primary,
p=0.0159) and Day 56 (secondary, p=0.0016).
We have an ongoing Phase 3, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy
and safety of osavampator in adults with major depressive disorder. Major depressive disorder is a mental health
disorder characterized by a persistently depressed mood, loss of interest, lack of enjoyment in daily activities, poor
concentration, and decreased energy. Major depressive disorder is one of the leading causes of disability.
Approximately 21 million people in the U.S. live with major depressive disorder. It is estimated that roughly one-
third of people living with major depressive disorder do not respond to available antidepressants.
NBI-1117568
NBI-1117568 is a first-in-class, orally active, highly selective investigational M4 agonist in development as a
potential treatment for schizophrenia. As a selective M4 orthosteric agonist, NBI-1117568 offers the potential for a
novel mechanism with an improved safety profile without the need of combination therapy to minimize off-target
pharmacology-related side effects, while also not being dependent on the presence of acetylcholine for efficacy.
Muscarinic receptors are central to brain function and validated as drug targets in psychosis and cognitive disorders.
We acquired the global rights to NBI-1117568, excluding in Japan, from Nxera in 2021.
In August 2024, we announced positive top-line data from the Phase 2 clinical study of NBI-1117568 in adults with
schizophrenia. The Phase 2 dose-finding study met its primary endpoint for the once-daily 20 mg dose,
demonstrating a clinically meaningful and statistically significant reduction from baseline in the Positive and
Negative Syndrome Scale (PANSS) total score at Week 6 (p=0.011 and effect size of 0.61). The once-daily 20 mg
dose also demonstrated statistically significant improvement for additional endpoints, including improvement in the
Clinical Global Impression of Severity (CGI-S) scale, Marder Factor Score – Positive Symptom Change, and
Marder Factor Score - Negative Symptom Change. We expect to advance NBI-1117568 into Phase 3 development
in the first half of 2025.
NBI-1070770
NBI-1070770 is a novel, selective, and orally active, negative allosteric modulator (NAM) of the NR2B subunit-
containing N-methyl-D-aspartate (NMDA NR2B) receptor in development as a potential treatment for major
depressive disorder. We acquired the global rights to NBI-1070770 from Takeda in 2020.
We have an ongoing Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate
the efficacy, safety, and tolerability of NBI-1070770 in adults with major depressive disorder.
Other Early-Stage Neuropsychiatry Programs
We have ongoing Phase 1 first-in-human clinical studies to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of investigational compounds NBI-1117570, NBI-1117567, NBI-1117569, and NBI-1065890 in
healthy adult participants.
NBI-1117570, NBI-1117567 (M1 preferring), and NBI-1117569 (M4 preferring) are investigational, oral,
muscarinic M1/M4 agonists being developed for the potential treatment of certain neuropsychiatric and neurological
conditions. We acquired the global rights NBI-1117570, NBI-1117567, and NBI-1117569 from Nxera in 2021.
NBI-1065890 is an investigational, oral, selective VMAT2 inhibitor for the potential treatment of certain
neuropsychiatric and neurological conditions. NBI-1065890 was discovered and is being developed internally at
Neurocrine Biosciences.
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Neurology
Valbenazine
We have an ongoing Phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy,
safety, and tolerability of valbenazine for the treatment of dyskinetic cerebral palsy in pediatrics and adults.
Dyskinetic cerebral palsy is a non-progressive, permanent disorder marked by involuntary movement and is a result
of damage to the fetal or infant brain’s basal ganglia. The basal ganglia are responsible for submitting messages to
the body to help coordinate and control movements. When damaged, voluntary movements are compromised,
resulting in involuntary and abnormal movements. It affects development and movement and has long term effects
on patients’ quality of life. The long-term outlook for patients with dyskinetic cerebral palsy will depend upon the
severity of the brain damage and how well the treatment works. Dyskinetic cerebral palsy affects up to 15% of the
estimated 500,000 to 1 million people affected by cerebral palsy in the U.S.
NBI-1076986
NBI-1076986 is an investigational, oral, muscarinic M4 selective acetylcholine antagonist for the potential treatment
of certain movement disorders. NBI-1076986 was discovered and is being developed internally at Neurocrine
Biosciences.
We have an ongoing Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of investigational compound NBI-1076986 in healthy adult participants.
Intellectual Property
We actively seek to protect our products, product candidates, and related inventions and improvements that we
consider important to our business. We own a portfolio of U.S. and ex-U.S. patents and patent applications, and have
also licensed rights to a number of U.S. and ex-U.S. patents and patent applications. Our owned and licensed patents
and patent applications cover or relate to our products and product candidates, including certain formulations, uses
to treat particular conditions, methods of administration, drug delivery technologies and delivery profiles, and
methods of manufacturing.
Below is a description of the U.S. and ex-U.S. patents to INGREZZA and CRENESSITY:
•
INGREZZA, our highly selective VMAT2 inhibitor approved in the U.S. for the treatment of tardive
dyskinesia and of chorea associated with Huntington’s disease, is covered by 22 issued, FDA Orange
Book-listed U.S. patents which are set to expire between 2027 and 2040. Patent term extension
corresponding to regulatory approval delay of 552 days has been received for U.S. Patent No. 8,039,627,
which now expires in 2031 and covers valbenazine, the active pharmaceutical ingredient contained in
INGREZZA. In 2023, we entered into settlement agreements resolving all patent litigation brought by us
against the companies that filed ANDAs seeking approval to market generic versions of INGREZZA, and
all cases have been dismissed. Pursuant to the terms of the respective settlement agreements, such
companies have the right to sell generic versions of INGREZZA in the U.S. beginning March 1, 2038, or
earlier under certain circumstances.
•
CRENESSITY, a CRF1 receptor antagonist approved in the U.S. for the treatment of CAH in adults and
children, is covered by U.S. patents among other patents set to expire between 2035 and 2041 (not
including any potential patent term extensions), and pending patent applications, which, if issued, could
expire at least as late as 2045.
We also own, or have licensed rights to, patents covering our other products and earlier stage product candidates. In
addition to the potential patent term extensions referenced above, the products and product candidates in our
pipeline may be subject to additional terms of exclusivity that we may obtain by future patent issuances.
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Separately, the U.S., the EU, and Japan each provide data and marketing exclusivity for new medicinal compounds.
If this protection is available, no competitor may use the original applicant’s data as the basis of a generic marketing
application during the period of data and marketing exclusivity, which is measured from the date of marketing
approval by the FDA or corresponding foreign regulatory authority. This period of exclusivity is generally five years
in the U.S., six years in Japan and eight years in the EU, with marketing exclusivity lasting an additional two years
in the EU, except that for biologics, the period of exclusivity in the U.S. is 12 years under the Biologics Price
Competition and Innovation Act. In addition, if granted orphan drug designation, certain of our product candidates,
including, for example, crinecerfont, may also be eligible for marketing exclusivity in the U.S. for seven years and
EU for 10 years.
Refer to Part I, Item 1A. Risk Factors for a discussion of the challenges we may face in obtaining or maintaining
patent and/or trade secret protection and Note 15 to the consolidated financial statements for a description of our
legal proceedings related to intellectual property matters.
Competition
The biotechnology and pharmaceutical industries are subject to rapid and intense technological change. We face, and
will continue to face, competition in the development and marketing of our products and product candidates from
academic institutions, government agencies, research institutions and biotechnology and pharmaceutical companies.
Competition may also arise from, among other things, other drug development technologies, methods of preventing
or reducing the incidence of disease, including vaccines, and new small molecule or other classes of therapeutic
agents. Such developments by others (including the development of generic equivalents) may render our product
candidates or technologies obsolete or noncompetitive.
•
INGREZZA competes with AUSTEDO® (deutetrabenazine), marketed by Teva Pharmaceuticals Industries,
for the treatment of tardive dyskinesia in adults and chorea associated with Huntington's disease. A once-
daily dosing of AUSTEDO (AUSTEDO XR) was introduced in February 2023. Additionally, there are a
number of commercially available medicines used to treat tardive dyskinesia off-label, such as
XENAZINE® (tetrabenazine) and generic equivalents, and various antipsychotic medications (e.g.,
clozapine), anticholinergics, benzodiazepines (off-label), and botulinum toxin. In addition, there are several
programs in clinical development by other companies targeting Huntington's disease.
•
CRENESSITY competes with high dose corticosteroid monotherapy which is the current standard of care
to both correct the endogenous cortisol deficiency as well as reduce the excessive adrenocorticotropic
hormone levels for patients with CAH. In the U.S. alone, there are more than two dozen companies
manufacturing steroid-based products. In addition, there are several programs in clinical development by
other companies targeting CAH.
•
Our investigational treatments for potential use in schizophrenia and depression may in the future compete
with several development-stage programs being pursued by other companies. In addition, there are a
number of different anti-psychotic and anti-depressant medications currently used in these patient
populations.
•
Our investigational treatments for potential use in neurology, neuroendocrinology and neuropsychiatry may
in the future compete with numerous approved products and development-stage programs being pursued by
several other companies.
Collaboration and License Agreements
Refer to Note 2 to the consolidated financial statements for more information on our significant collaboration and
license agreements.
Government Regulation
Our business activities are subject to extensive regulation by the U.S. and other countries. Regulation by government
authorities in the U.S. and foreign countries is a significant factor in the development, manufacture, distribution,
tracking, marketing and sale of our proposed products and in our ongoing research and product development
activities. All of our products in development will require regulatory approval by government agencies prior to
commercialization. The process of obtaining these approvals and the subsequent compliance with appropriate
federal and state statutes and regulations require the expenditure of substantial time and financial resources.
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In addition, federal and state healthcare laws, and equivalent supranational and foreign laws, restrict business
practices in the pharmaceutical industry. These laws include, without limitation, federal, state and foreign fraud and
abuse laws, false claims laws, data privacy and security laws, as well as transparency laws and industry codes of
conduct regarding payments or other items of value provided to healthcare providers. We have a comprehensive
compliance program designed to ensure our business practices remain compliant.
The U.S. federal Anti-Kickback Statute and equivalent foreign laws makes it illegal for any person or entity to
knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that is intended to
induce the referral of business, including the purchase, order, lease of any good, facility, item or service for which
payment may be made under programs such as a federal healthcare program, such as Medicare or Medicaid in the
U.S.
Federal and equivalent foreign civil and criminal false claims laws and the federal civil monetary penalties law and
equivalent foreign laws, which prohibit among other things, any person or entity from knowingly presenting, or
causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims
for items or services, including drugs, that are false or fraudulent or not provided as claimed and knowingly making,
or causing to be made, a false record or to avoid or decrease an obligation to pay money to the federal government.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) created additional federal criminal
statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to
defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in
connection with the delivery of or payment for healthcare benefits, items or services and equivalent foreign laws.
We may be subject to HIPAA, as amended by the Health Information Technology for Economic and Clinical Health
Act of 2009 (HITECH) and their privacy and security regulations, which impose certain obligations, including the
adoption of administrative, physical and technical safeguards to protect individually identifiable health information
on covered entities subject to HIPAA (i.e., health plans, healthcare clearinghouses and certain healthcare providers)
and their business associates that perform certain services for or on their behalf involving the use or disclosure of
individually identifiable health information as well as their covered subcontractors.
The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and
medical supplies to report annually to the Centers for Medicare & Medicaid Services (CMS) information related to
payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists,
podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners)
and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and
their immediate family members.
Also, many states have similar healthcare statutes or regulations that may be broader in scope and may apply
regardless of payor. Additionally, to the extent that our product is sold in a foreign country, we may be subject to
similar foreign laws.
The U.S. Foreign Corrupt Practices Act (FCPA) prohibits corporations and individuals from engaging in certain
activities to obtain or retain business or to influence a person working in an official capacity. It is illegal to pay, offer
to pay or authorize the payment of anything of value to any foreign government official, government staff member,
political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person
working in an official capacity. The FCPA also imposes accounting standards and requirements on publicly traded
U.S. corporations and their foreign affiliates, which are intended to prevent the diversion of corporate funds to the
payment of bribes and other improper payments. Similar laws exist in other countries, such as the United Kingdom
(UK) or in EU member states, that restrict improper payments to public and private parties. Many countries have
laws prohibiting these types of payments within the respective country. In addition to these anti-corruption laws, we
are subject to import and export control laws, tariffs, trade barriers, economic sanctions, and regulatory limitations
on our ability to operate in certain foreign markets.
Failure to comply with these laws, where applicable, can result in significant penalties, including the imposition of
significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, imprisonment,
possible exclusion from participation in Medicare, Medicaid and other federal and equivalent foreign healthcare
programs, and additional reporting requirements and regulatory oversight, any of which could adversely affect our
ability to operate our business and our results of operations.
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Development and Marketing Approval for Products
Preclinical studies generally are conducted in laboratory animals to evaluate the potential safety and efficacy of a
product. Drug developers submit the results of preclinical studies to the FDA as a part of an investigational new drug
application (IND) and to equivalent foreign authorities before clinical trials can begin in humans. Typically, clinical
evaluation involves a time consuming and costly multi-phase process.
Phase 1
Clinical trials are conducted with a small number of subjects to determine the early safety profile,
maximum tolerated dose and pharmacokinetic properties of the product in human volunteers or in
patients with the target disease.
Phase 2
Clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine
preliminary efficacy, optimal dosages and expanded evidence of safety.
Phase 3
Larger, multi-center, comparative clinical trials are conducted with patients afflicted with a specific
disease in order to determine safety and efficacy as primary support for regulatory approval by the FDA,
the European Commission, or equivalent foreign authorities, to market a product candidate for a specific
disease.
The FDA closely monitors the progress of each of the three phases of clinical trials that are conducted in the U.S.
and may, at its discretion, re-evaluate, alter, suspend or terminate the testing based upon the data accumulated to that
point and the FDA’s assessment of the risk/benefit ratio to the patient. Institutional Review Boards, Institutional
Ethics Committees and Data Safety Monitoring Boards also closely monitor the conduct of our trials and may also
place holds on our clinical trials or recommend that we voluntarily do so. Clinical trials conducted in foreign
countries are also subject to oversight by regulatory authorities in those countries.
Once Phase 3 trials are completed, drug developers submit the results of preclinical studies and clinical trials to the
FDA in the form of a new drug application (NDA) for approval to commence commercial sales. In most cases, the
submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act
(PDUFA), the FDA has a goal of 10 months from the date of filing of a standard NDA for a new molecular entity to
review and act on the submission. The FDA generally has a six-month review goal of priority NDAs.
In addition, under the Pediatric Research Equity Act of 2003 as amended and reauthorized, certain applications or
supplements to an application must contain data that are adequate to assess the safety and effectiveness of the drug
for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for
each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at
the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the
product for use in adults or full or partial waivers from the pediatric data requirements.
The FDA also may require submission of a risk evaluation and mitigation strategy to ensure that the benefits of the
drug outweigh its risks. The risk evaluation and mitigation strategy could include medication guides, physician
communication plans, assessment plans and/or additional elements to assure safe use, such as restricted distribution
methods, patient registries, or other risk minimization tools.
The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting
them for filing, to determine whether they are sufficiently complete to permit substantive review. The FDA may
request additional information rather than accept an application for filing. Once the submission is accepted for filing,
the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things,
whether the drug is safe and effective for its intended use and whether the facility in which it is manufactured,
processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity.
The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of
independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a
recommendation as to whether the application should be approved and under what conditions. The FDA is not
bound by the recommendations of an advisory committee, but it considers such recommendations carefully when
making decisions.
Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is
manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and
facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product
within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical
trial sites to assure compliance with Good Clinical Practice (GCP) requirements.
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After evaluating the NDA and all related information, including the advisory committee recommendation, if any,
and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval
letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of
specific conditions that must be met in order to secure final approval of the application and may require additional
clinical or preclinical testing in order for FDA to reconsider the application. Even with submission of this additional
information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval
letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for
specific indications.
Even if the FDA approves a product, it may limit the approved indications for use of the product, require that
contraindications, warnings or precautions be included in the product labeling, require that post-approval studies,
including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and
surveillance programs to monitor the product after commercialization, or impose other conditions, including
distribution and use restrictions or other risk management mechanisms under a risk evaluation and mitigation
strategy, which can materially affect the potential market and profitability of the product. The FDA may prevent or
limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After
approval, some types of changes to the approved product, such as adding new indications, manufacturing changes
and additional labeling claims, are subject to further testing requirements and FDA review and approval.
We will also have to complete an approval process similar to that in the U.S. in order to commercialize our product
candidates in each foreign country. The approval procedure and the time required for approval vary from country to
country and may involve additional testing. Foreign approvals may not be granted on a timely basis, or at all. In
addition, regulatory approval of prices is required in most countries other than the U.S., except for a certain limited
number of drugs sold to certain Medicare beneficiaries beginning in 2023. The resulting prices may not be sufficient
to generate an acceptable return to us or our corporate collaborators.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or
condition, which is a disease or condition that affects fewer than 200,000 individuals in the U.S., or if it affects more
than 200,000, there is no reasonable expectation that sales of the drug in the U.S. will be sufficient to offset the costs
of developing and making the drug available in the U.S. Orphan drug designation must be requested before
submitting an NDA. Orphan drug designation does not convey any advantage in or shorten the duration of the
regulatory review and approval process.
If the FDA approves a sponsor’s marketing application for a designated orphan drug for use in the rare disease or
condition for which it was designated, the sponsor is eligible for a seven-year period of marketing exclusivity,
during which the FDA may not approve another sponsor’s marketing application for a drug with the same active
moiety and intended for the same use or indication as the approved orphan drug, except in limited circumstances,
such as if a subsequent sponsor demonstrates its product is clinically superior. During a sponsor’s orphan drug
exclusivity period, competitors, however, may receive approval for drugs with different active moieties for the same
indication as the approved orphan drug, or for drugs with the same active moiety as the approved orphan drug, but
for different indications. Orphan drug exclusivity could block the approval of one of our products for seven years if
a competitor obtains approval for a drug with the same active moiety intended for the same indication before we do,
unless we are able to demonstrate that grounds for withdrawal of the orphan drug exclusivity exist, or that our
product is clinically superior. Further, if a designated orphan drug receives marketing approval for an indication
broader than the rare disease or condition for which it received orphan drug designation, it may not be entitled to
exclusivity.
Post-Approval Requirements
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by
the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product
sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After
approval, most changes to the approved product, such as adding new indications or other labeling claims are subject
to prior FDA review and approval. There also are continuing, annual program user fee requirements for any
marketed products, as well as new application fees for supplemental applications with clinical data.
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The FDA may impose a number of post-approval requirements as a condition of approval of an NDA. For example,
the FDA may require post-marketing testing, including Phase 4 clinical trials, and surveillance to further assess and
monitor the product’s safety and effectiveness after commercialization.
In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs
are required to register their establishments with the FDA and state agencies and are subject to periodic
unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements. Changes to
the manufacturing process are strictly regulated and often require prior FDA approval before being implemented.
FDA regulations also require investigation and correction of any deviations from cGMP requirements and impose
reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may
decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production
and quality control to maintain cGMP compliance.
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and
standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously
unknown problems with a product, including adverse events of unanticipated severity or frequency, or with
manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to
the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess
new safety risks; or imposition of distribution or other restrictions. Other potential consequences include, among
other things:
•
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the
market or product recalls;
•
fines, warning letters or holds on post-approval clinical trials;
•
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or
revocation of product approvals;
•
product seizure or detention, or refusal to permit the import or export of products; or
•
injunctions or the imposition of civil or criminal penalties.
The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market.
Drugs may be promoted only for the approved indication(s) and in accordance with the provisions of the approved
label. However, companies may share truthful and not misleading information that is otherwise consistent with a
product’s FDA approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting
pre-approval promotion of investigational drugs, as well as the promotion of off-label uses of approved drugs, and a
company may be subject to significant liability. Physicians may prescribe legally available products for uses that are
not described in the product’s labeling and that differ from those tested by us and approved by the FDA. The FDA
does not regulate behavior of physicians in their choice of treatments. The FDA does, however, restrict
manufacturer’s communications on the subject of off-label use of their products.
Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we
obtain regulatory approval. In the U.S. and other countries, sales of any products for which we receive regulatory
approval will depend, in part, on the extent to which third-party payors provide coverage and establish adequate
reimbursement levels for such drug products.
In the U.S., third-party payors include federal and state healthcare programs, government authorities, private
managed care providers, private health insurers and other organizations. No uniform policy for coverage and
reimbursement exists in the U.S., and coverage and reimbursement can differ significantly from payor to payor.
Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own
reimbursement rates, but also have their own methods and approval process apart from Medicare determinations. As
a result, the coverage determination process is often a time-consuming and costly process that will require us to
provide scientific and clinical support for the use of our drug products to each payor separately, with no assurance
that coverage and adequate reimbursement will be obtained in the first instance or applied consistently.
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Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-
effectiveness of drug products and medical services, in addition to questioning their safety, efficacy and clinical
appropriateness. Such payors may limit coverage to specific drug products on an approved list, also known as a
formulary, which might not include all of the FDA-approved drugs for a particular indication. We may need to
conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness
of our products, in addition to the costs required to obtain the FDA approvals. Nonetheless, our products or product
candidates, including INGREZZA, may not be considered medically necessary or cost-effective.
Moreover, the process for determining whether a third-party payor will provide coverage for a drug product may be
separate from the process for setting the price of a drug product or for establishing the reimbursement rate that such
a payor will pay for the drug product. A payor’s decision to provide coverage for a drug product does not imply that
an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug
product does not assure that other payors will also provide coverage for the drug product. Adequate third-party
payor reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate
return on our investment in product development.
The marketability of any product or product candidates for which we or our collaborators receive regulatory
approval for commercial sale may suffer if third-party payors fail to provide coverage and adequate reimbursement.
In addition, emphasis on managed care in the U.S. has increased and we expect will continue to increase the pressure
on pharmaceutical pricing. Coverage policies and third-party payor reimbursement rates may change at any time.
Even if favorable coverage and reimbursement status is attained for one or more products for which we receive
regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Healthcare Reform Measures
The U.S. and some foreign jurisdictions have enacted a number of legislative and regulatory proposals to change the
healthcare system in ways that could affect our ability to sell our products profitably. In the U.S., the pharmaceutical
industry and the cost of prescription drugs has been a continuous focus of these efforts and has been significantly
affected by major legislative initiatives.
Most recently, in August 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law, which, among other
things, (1) directs the Secretary of the U.S. Department of Health and Human Services (HHS) to negotiate the price
of certain high-expenditure, single-source drugs and biologics covered under Medicare, (2) redesigns the Medicare
Part D prescription drug benefit to lower patient out-of-pocket costs and increase manufacturer liability and (3)
requires drug manufacturers to pay rebates on drugs whose prices increase greater than the rate of inflation. The IRA
also extends enhanced subsidies for individuals purchasing health insurance coverage in the ACA marketplaces
through plan year 2025 and eliminated the “donut hole” under the Medicare Part D program in 2025 by significantly
lowering the beneficiary maximum out-of-pocket cost to $2,000 through a newly established manufacturer discount
program. These provisions took effect progressively starting in 2023. On August 15, 2024, HHS announced the
negotiated prices of the first 10 drugs that were subject to price negotiations, although the Medicare drug price
negotiation program is currently subject to legal challenges. On January 17, 2025, HHS announced its selection of
fifteen additional drugs covered under Part D for negotiation in 2025 (for initial price applicability year 2027).
Certain high-expenditure Part B and Part D drugs/biologics will be selected for negotiation in 2026 (for initial price
applicability year 2028) and annually thereafter. AUSTEDO and AUSTEDO XR, marketed by Teva
Pharmaceuticals Industries, have been selected for the Medicare drug negotiation program in 2025 (for initial price
applicability year 2027). If the negotiation program results in a decrease in the price of AUSTEDO or AUSTEDO
XR, it may result in increased competitive pressure on INGREZZA. The overall impact of any potential negotiated
priced reduction of AUSTEDO or AUSTEDO XR on INGREZZA revenues is inherently uncertain and difficult to
predict.
While the Medicare drug negotiation program targets high-expenditure drugs/biologics that have been on the market
for several years without generic or biosimilar competition, we were notified in January 2025 that INGREZZA
qualifies for the small biotech exception, which provides an exemption from selection for price negotiation until
2027 (for initial price applicability year 2029, pursuant to which negotiated pricing would go into effect, if selected).
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Additionally, on January 1, 2025, the Centers for Medicare & Medicaid Services (CMS) implemented those
provisions of the IRA establishing a new Medicare Part D manufacturer discount program. Under this discount
program and subject to certain exceptions, manufacturers must give a 10 percent discount on Part D program drugs
in the initial coverage phase, and a 20 percent discount on Part D drugs when the beneficiary enters the catastrophic
coverage phase (the phase after the patient incurs costs above the initial phase out-of-pocket threshold, which is
$2,000). However, the IRA allows the 10 and 20 percent discounts to be phased in over a multi-year period for
“specified manufacturers” and “specified small manufacturers”. During this phase-in period, such manufacturers
would pay a lower percentage discount on Medicare Part D program drugs. In April 2024, the Company was notified
by CMS that it qualified as a “specified small manufacturer” and will receive the discount phase-in discussed above
for INGREZZA. INGREZZA is reimbursed under Medicare Part D, and increased discounts could impact
INGREZZA revenues, while also having an industry-wide impact on the cost of other Part D program drugs such as
AUSTEDO and AUSTEDO XR. The overall impact on INGREZZA revenues is inherently uncertain and difficult to
predict and we are still evaluating the potential impact of this discount program and our designation as a “specified
small manufacturer.”
Our designation as a “specified small manufacturer” under the new Medicare Part D manufacturer discount program
and INGREZZA’s qualification for the small biotech exception for purposes of the Medicare drug price negotiation
program are subject to various requirements and there is no assurance that we will continue to qualify for these
exemptions in the future. The loss or potential loss of these exemptions, including as a result of a third party
acquiring us, could have an adverse impact on our business.
The most significant prior revisions to federal law governing the pharmaceutical industry and prescription drug
pricing were enacted through the March 2010 Patient Protection and Affordable Care Act, as amended by the Health
Care and Education Reconciliation Act (collectively, the ACA). This law was intended to broaden access to health
insurance by reducing the number of uninsured persons, reducing or constraining the growth of healthcare spending,
enhancing remedies against fraud and abuse, adding transparency requirements for the healthcare and health
insurance industries, imposing taxes and fees on the health industry and imposing additional health policy reforms.
We expect that these health reform measures may result in more rigorous coverage criteria and lower reimbursement
for prescription drugs, as well as result in additional downward pressure on any price that we receive for any
approved product. Any reduction in reimbursement from Medicare or other government-funded programs may result
in a similar reduction in payments from private third-party payors.
Other significant legislative changes impacting the pharmaceutical industry and prescription drug pricing have been
adopted since the ACA was enacted. These changes include, among others, aggregate reductions to Medicare
payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013
and, due to subsequent legislative amendments, including the Investment and Jobs Act, will remain in effect through
2032.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to examine
and/or control pharmaceutical and biological product pricing, including price or patient reimbursement constraints,
discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in
some cases, designed to encourage importation from other countries and bulk purchasing. For example, on January
5, 2024, the FDA approved Florida’s Section 804 Importation Program (SIP) proposal to import certain drugs from
Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which
drugs will be chosen, and whether it will be subject to legal challenges in the U.S. or Canada. Other states have also
submitted SIP proposals that are pending review by the FDA. Any such approved importation plans, when
implemented, may result in lower drug prices for products covered by those programs. Further, certain states
through legislation have created a state prescription drug affordability board (PDAB) to help control costs of drugs
for that state. The functions of the PDABs vary by state, and may include among others, negotiating the price the
state pays for certain drugs, recommending or setting upper limits on drug prices, performing drug affordability
reviews, and advising state lawmakers on additional ways to reduce the state’s drug spending. It is possible that the
actions taken by the PDABs may result in lower prices for certain drug products sold in their states.
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Proposed Healthcare Reform Measures
The U.S. and some foreign jurisdictions are considering a number of legislative and regulatory proposals to change
the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and
payors in the U.S. and elsewhere, there is significant interest in promoting changes in healthcare systems with the
stated goals of containing healthcare costs, improving quality or expanding access. In the U.S., the pharmaceutical
industry has been a particular focus of these efforts and may be significantly affected by major legislative initiatives.
We are currently unable to predict what other additional legislation or regulation, if any, relating to the healthcare
industry may be enacted in the future or what effect recently enacted federal legislation or any such additional
legislation or regulation would have on our business, particularly in light of the recent U.S. Presidential and
Congressional elections.
Regulation and Procedures Governing Approval of Medicinal Products in the EU
To market any product outside of the U.S., a company must also comply with numerous and varying regulatory
requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other
things, clinical trials, marketing authorization, commercial sales and distribution of products. Whether or not it
obtains FDA approval for a product, an applicant will need to obtain the necessary approvals by the comparable
foreign regulatory authorities before it can initiate clinical trials or marketing of the product in those countries or
jurisdictions. Specifically, the process governing approval of medicinal products in the EU generally aligns with the
requirements in the U.S. It entails satisfactory completion of pharmaceutical development, nonclinical studies and
adequate and well-controlled clinical trials to establish the safety and efficacy of the medicinal product for each
proposed indication.
The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement
may vary from country to country. In all cases, the clinical trials must be conducted in accordance with GCP and the
applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
Medicines used in clinical trials must be manufactured in accordance with cGMP and in a GMP licensed facility,
which can be subject to GMP inspections.
Clinical Trials in the EU
In the EU, the Clinical Trials Regulation (EU) No 536/2014 (CTR) entered into application on January 31, 2022 and
became effective for all clinical trials on January 31, 2025, repealing and replacing the former Clinical Trials
Directive 2001/20 (CTD). The regulation introduces a streamlined application procedure via a single entry point, the
“EU portal”, the Clinical Trials Information System (CTIS); a single set of documents to be prepared and submitted
for the application as well as simplified reporting procedures for clinical trial sponsors. A harmonized procedure for
the assessment of applications for clinical trials has been introduced and is divided into two parts.
Marketing Authorizations
In the EU, medicinal products can only be commercialized after a related marketing authorization (MA) has been
granted. To obtain an MA for a product in the EU, an applicant must submit a marketing authorization application
(MAA) either under a centralized procedure administered by the EMA or one of the procedures administered by the
competent authorities of EU Member States (decentralized procedure, national procedure or mutual recognition
procedure). An MA may be granted only to an applicant established in the EU.
The centralized procedure provides for the grant of a single MA by the European Commission that is valid
throughout the European Economic Area (which is comprised of the 27 EU Member States plus Norway, Iceland
and Liechtenstein). Pursuant to Regulation (EC) No 726/2004, the centralized procedure is compulsory for specific
products, including for (i) medicinal products derived from biotechnological processes, (ii) products designated as
orphan medicinal products, (iii) advanced therapy medicinal products (ATMPs), and (iv) products with a new active
substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases, diabetes, auto-immune and
other immune dysfunctions and viral diseases. For products with a new active substance indicated for the treatment
of other diseases and products that are highly innovative or for which a centralized process is in the interest of
patients, authorization through the centralized procedure is optional on related approval.
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Accelerated assessment may be granted by the EMA’s Committee for Medicinal Products for Human Use (CHMP)
in exceptional cases, when a medicinal product targeting an unmet medical need is expected to be of major interest
from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation. If the CHMP
accepts a request for accelerated assessment, the time limit of 210 days will be reduced to 150 days (excluding clock
stops). The CHMP can, however, revert to the standard time limit for the centralized procedure if it considers that it
is no longer appropriate to conduct an accelerated assessment.
An MA has, in principle, an initial validity of five years. The MA may be renewed after five years on the basis of a
re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the EU Member State in
which the original MA was granted. The European Commission or the competent authorities of the EU Member
States may decide on justified grounds relating to pharmacovigilance, to proceed with one further five-year renewal
period for the MA. Once subsequently definitively renewed, the MA shall be valid for an unlimited period. Any
authorization which is not followed by the actual placing of the medicinal product on the EU market (for a
centralized MA) or on the market of the authorizing EU Member State within three years after authorization ceases
to be valid (the so-called sunset clause).
Upon receiving an MA, innovative medicinal products are generally entitled to receive eight years of data
exclusivity and 10 years of market exclusivity. Data exclusivity, if granted, prevents regulatory authorities in the EU
from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from
the date of authorization of the innovative product, after which a generic or biosimilar MAA can be submitted, and
the innovator’s data may be referenced. The market exclusivity period prevents a successful generic or biosimilar
applicant from commercializing its product in the EU until 10 years have elapsed from the initial MA of the
reference product in the EU. The overall ten-year period may, occasionally, be extended for a further year to a
maximum of 11 years if, during the first eight years of those ten years, the MA holder obtains an authorization for
one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held
to bring a significant clinical benefit in comparison with existing therapies.
Orphan Designation and related Exclusivity in the EU
In the EU, Regulation (EC) No. 141/2000 provides that a medicinal product can be designated as an orphan
medicinal product by the European Commission if its sponsor can establish that: (i) the product is intended for the
diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions; (ii) either (a) such
conditions affect not more than five in 10,000 persons in the EU when the application is made, or (b) the product
without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the
necessary investment in developing the medicinal product; and (iii) there exists no satisfactory authorized method of
diagnosis, prevention, or treatment of the condition that has been authorized in the EU, or even if such method
exists, the product will be of significant benefit to those affected by that condition.
Upon grant of a marketing authorization, orphan medicinal products are entitled to a ten-year period of market
exclusivity for the approved therapeutic indication, which means that the EMA cannot accept another marketing
authorization application or accept an application to extend for a similar product and the European Commission
cannot grant a marketing authorization for the same indication for a period of ten years. The period of market
exclusivity is extended by two years for orphan medicinal products that have also complied with an agreed PIP. The
period of market exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established
that the product no longer meets the criteria on the basis of which it received orphan medicinal product destination.
Post-Authorization Obligations in the EU
Where an MA is granted in relation to a medicinal product in the EU, the holder of the MA is required to comply
with a range of regulatory requirements applicable to the manufacturing, marketing, promotion and sale of medicinal
products. Similar to the U.S., both MA holders and manufacturers of medicinal products are subject to
comprehensive regulatory oversight by the EMA, the European Commission and/or the competent regulatory
authorities of the individual EU Member States. The holder of an MA must establish and maintain a
pharmacovigilance system and appoint an individual qualified person for pharmacovigilance who is responsible for
oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and
submission of periodic safety update reports (PSURs).
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In the EU, the advertising and promotion of medicinal products are subject to both EU and EU Member States’ laws
governing promotion of medicinal products, interactions with physicians and other healthcare professionals,
misleading and comparative advertising and unfair commercial practices. General requirements for advertising and
promotion of medicinal products, such as direct-to-consumer advertising of prescription medicinal products are
established in EU law. However, the details are governed by regulations in individual EU Member States and can
differ from one country to another.
Brexit and the Regulatory Framework in the UK
The UK’s withdrawal from the EU on January 31, 2020, commonly referred to as Brexit, has changed the regulatory
relationship between the UK and the EU. The Medicines and Healthcare products Regulatory Agency (MHRA) is
now the UK’s standalone regulator for medicinal products and medical devices. Great Britain (England, Scotland
and Wales) is now a third country to the EU. Northern Ireland continues to follow the EU regulatory rules.
The UK regulatory framework in relation to clinical trials is governed by the Medicines for Human Use (Clinical
Trials) Regulations 2004, as amended, which is derived from the CTD, as implemented into UK national law
through secondary legislation. In October 2023, the MHRA announced a new Notification Scheme for clinical trials
which enables a more streamlined and risk-proportionate approach to initial clinical trial applications for Phase 4
and low-risk Phase 3 clinical trial applications.
Marketing authorizations in the UK are governed by the Human Medicines Regulations (SI 2012/1916), as
amended. This legislation includes procedures to prioritize access to new medicines that will benefit patients,
including a 150-day assessment route, a rolling review procedure and the International Recognition Procedures
(IRP) which entered into application on January 1, 2024. Since January 1, 2024, the MHRA may rely on the IRP
when reviewing certain types of marketing authorization applications. There is no pre-marketing authorization
orphan designation for medicinal products in the UK. Instead, the MHRA reviews applications for orphan
designation in parallel to the corresponding marketing authorization application. The criteria are essentially the same
as those in the EU but have been tailored for the market.
Human Capital
Our Employees
We have grown to a team of approximately 1,800 employees as of December 31, 2024, primarily employed in the
U.S. Our highly qualified and experienced team, which includes scientists, physicians, and professionals across
sales, marketing, manufacturing, regulatory, finance, and other essential functions are critical to our success. We
also leverage temporary workers to provide flexibility for our business needs. During 2024, we added more than 400
new employees to our team.
We expect to add additional employees in 2025 with a focus on expanding our research and development
organization. We continually evaluate our business needs and opportunities and balance in-house with external
expertise and capacity. Currently, we rely on third-party contract manufacturers.
Our Culture
The success of our human capital management investments is evidenced by our low employee turnover, a number
which is regularly reviewed by our Board of Directors as part of their oversight of our human capital strategy. In
recognition of our efforts, in 2024, we were ranked #7 in Fortune Best Workplaces in BiopharmaTM and named
Company of the Year: Specialty Pharma/Biotech in the PM360 Trailblazer Awards.
Employee Engagement, Talent Development & Benefits
We believe that our future success largely depends upon our continued ability to attract and retain highly skilled
employees. We provide our employees with competitive salaries and bonuses, opportunities for equity ownership,
development programs that enable continued learning and growth and a robust employment package that promotes
well-being across all aspects of their lives, including healthcare, retirement planning and paid time off. As part of
our promotion and retention efforts, we also invest in ongoing leadership development programs as well as offer
tuition reimbursement. In addition, we regularly conduct employee surveys to gauge employee engagement and
identify areas of focus.
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Diversity & Inclusion
Much of our success is rooted in the diversity of our teams and our commitment to inclusion. We value diversity at
all levels and continue to focus on extending our diversity and inclusion initiatives across our entire workforce. We
believe that our business benefits from the different perspectives a diverse workforce brings, and we pride ourselves
on having a strong, inclusive and positive culture based on our shared mission and values.
Corporate Information
We were originally incorporated in California in January 1992 and reincorporated in Delaware in May 1996. Our
principal executive offices are located at 6027 Edgewood Bend Court, San Diego, California 92130. Our telephone
number is (858) 617-7600.
Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as
amended, are available free of charge on our website at www.neurocrine.com, as soon as reasonably practicable after
such reports are available on the Securities and Exchange Commission (SEC) website at www.sec.gov. Additionally,
copies of our Annual Report will be made available, free of charge, upon written request. Information found on, or
accessible through, our website is not a part of, and is not incorporated into, this Annual Report on Form 10-K.
Item 1A. Risk Factors
The following information sets forth risk factors that could cause our actual results to differ materially from those
contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may
make from time to time. If any of the following risks actually occur, our business, operating results, prospects or
financial condition could be harmed. Additional risks not presently known to us, or that we currently deem
immaterial, may also affect our business operations.
Summary Risk Factors
We face risks and uncertainties related to our business, many of which are beyond our control. In particular, risks
associated with our business include:
•
We may not be able to continue to successfully commercialize INGREZZA or any of our product
candidates if they are approved in the future.
•
We may not be able to successfully launch CRENESSITY.
•
If physicians and patients do not continue to accept INGREZZA or do not accept CRENESSITY, or our
sales and marketing efforts are not effective, we may not generate sufficient revenue.
•
We face intense competition, and if we are unable to compete effectively, the demand for our products may
be reduced.
•
Government and third-party payors may impose sales and pharmaceutical pricing controls on our products,
or limit coverage and/or reimbursement for our products or impose policies and/or make decisions
regarding the status of our products that could limit our product revenues and delay sustained profitability.
•
Because the development of our product candidates is subject to a substantial degree of technological
uncertainty, we may not succeed in developing any of our product candidates.
•
Our clinical trials may be delayed for safety or other reasons, or fail to demonstrate the safety and efficacy
of our product candidates, which could prevent or significantly delay their regulatory approval.
•
Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the
Inflation Reduction Act of 2022, could adversely affect our business.
•
We have increased the size of our organization and will need to continue to increase the size of our
organization. We may encounter difficulties with managing our growth, which could adversely affect our
results of operations.
•
We are transforming our research and development strategies to include the development of biologics,
which requires substantial investment, including in personnel and facilities. We may encounter difficulties
as we expand and may fail to successfully develop or commercialize our biologic product candidates,
which could adversely affect our results of operations.
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•
If we are unable to retain and recruit qualified scientists and other employees or if any of our key senior
executives discontinues his or her employment with us, it may delay our development efforts or impact our
commercialization of INGREZZA, CRENESSITY, or any product candidate approved by the FDA in the
future.
•
Use of our approved products or those of our collaborators could be associated with side effects or adverse
events.
•
We currently depend on a limited number of third-party suppliers. The loss of these suppliers, or delays or
problems in the supply of INGREZZA, CRENESSITY, or our product candidates, could materially and
adversely affect our ability to successfully develop or commercialize INGREZZA, CRENESSITY, or any
of our product candidates.
•
We currently have no manufacturing capabilities. If third-party manufacturers of INGREZZA,
CRENESSITY, or any of our product candidates fail to devote sufficient time and resources to our
concerns, or if their performance is substandard, our ability to commercialize existing products, conduct
clinical trials and develop new products could be impaired and our costs may rise.
•
We depend on our current collaborators for the development and commercialization of several of our
products and product candidates and may need to enter into future collaborations to develop and
commercialize certain of our product candidates.
•
We license some of our core technologies and drug candidates from third parties. If we default on any of
our obligations under those licenses, or violate the terms of these licenses, we could lose our rights to those
technologies and drug candidates or be forced to pay damages.
•
If we are unable to protect our intellectual property, our competitors could develop and market products
based on our discoveries, which may reduce demand for our products.
•
Our customers are concentrated and therefore the loss of a significant customer may harm our business.
•
We may need additional capital in the future. If we cannot raise additional funding, we may be unable to
fund our business plan and our future research, development, commercial and manufacturing efforts.
•
We expect to increase our expenses for the foreseeable future, and we may not be able to sustain growth
and profitability.
Risks Related to Our Company
We may not be able to continue to successfully commercialize INGREZZA or any of our product candidates if
they are approved in the future.
We launched INGREZZA in the U.S. as the first FDA-approved drug for the treatment of tardive dyskinesia in May
2017 and for the treatment of chorea associated with Huntington's disease in August 2023. Our ability to produce
INGREZZA revenues consistent with expectations ultimately depends on our ability to continue to successfully
commercialize INGREZZA and secure and maintain adequate third-party reimbursement. Our experience in
marketing and selling pharmaceutical products began with INGREZZA’s approval in 2017, when we hired our sales
force and established our distribution and reimbursement capabilities, all of which are necessary to successfully
commercialize our current and future products. We have continued to invest in our commercial infrastructure and
distribution capabilities, including the recent expansion of our psychiatry and long-term care sales teams for
INGREZZA in September 2024. While our team members and consultants have experience marketing and selling
pharmaceutical products, we may face difficulties related to managing the rapid growth of our personnel and
infrastructure, and there can be no guarantee that we will be able to maintain the personnel, systems, arrangements
and capabilities necessary to continue to successfully commercialize INGREZZA or any product candidate approved
by the FDA, or equivalent foreign authorities, in the future.
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We may not be able to successfully launch CRENESSITY.
In December 2024, we announced FDA approval and launched CRENESSITY capsules and oral solution as an
adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of
age and older with classic CAH. We have also established our commercial team and hired our U.S. sales force for
CRENESSITY. The successful commercial launch of CRENESSITY depends on the extent to which patients and
physicians accept and adopt CRENESSITY as a treatment for CAH, and we do not know whether our expectations
or estimates in this regard, or those of investors or securities analysts, will be accurate. Physicians may not prescribe
CRENESSITY and patients may be unwilling to use CRENESSITY. In addition, patients may be unwilling to use
CRENESSITY if reimbursement is not provided or reimbursement is inadequate to cover a significant portion of the
cost to the patient. CRENESSITY is a first-in-class therapy for children and adults with classic CAH and will
therefore require us to expend substantial time and resources to educate physicians and other healthcare providers
about the benefits of CRENESSITY. If we are unable to provide our sales force with effective materials, including
medical and sales literature to help them inform and educate potential customers about the benefits of
CRENESSITY, our efforts to commercialize CRENESSITY may not be successful. Further, any negative publicity
related to CRENESSITY, or negative development for CRENESSITY in our post-marketing commitments or in
regulatory processes in other jurisdictions, may adversely impact the potential of CRENESSITY and our
commercial results. If the commercialization of CRENESSITY and future sales are less successful than anticipated
by us or our investors or securities analysts, our stock price could decline and our business may be harmed.
If physicians and patients do not continue to accept INGREZZA or do not accept CRENESSITY, or our sales and
marketing efforts are not effective, we may not generate sufficient revenue.
The commercial success of INGREZZA and CRENESSITY will depend upon the acceptance of these products as
safe and effective by the medical community and patients.
The market acceptance of INGREZZA and CRENESSITY could be affected by a number of factors, including:
•
the timing of receipt of marketing approvals for additional indications;
•
the safety and efficacy of the products;
•
the pricing of these products;
•
the availability of healthcare payor coverage and adequate reimbursement for the products;
•
public perception regarding of these products;
•
the success of existing competitor products addressing our target markets or the emergence of equivalent or
superior products; and
•
the cost-effectiveness of the products.
If the medical community, patients and payors do not continue to accept our products as being safe, effective,
superior and/or cost effective, we may not generate sufficient revenue.
We face intense competition, and if we are unable to compete effectively, the demand for our products may be
reduced.
The biotechnology and pharmaceutical industries are subject to rapid and intense technological change. We face, and
will continue to face, competition in the development and marketing of our products and product candidates from
academic institutions, government agencies, research institutions and biotechnology and pharmaceutical companies.
Competition may also arise from, among other things:
•
other drug development technologies;
•
methods of preventing or reducing the incidence of disease, including vaccines; and
•
new small molecule or other classes of therapeutic agents.
Developments by others (including the development of generic equivalents) may render our product candidates or
technologies obsolete or noncompetitive.
21
We are commercializing and performing research on or developing products for the treatment of several disorders,
including tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia,
uterine fibroids, endometriosis, pain, Parkinson’s disease, schizophrenia, epilepsy, and other neurology,
neuroendocrinology, and neuropsychiatry-related diseases and disorders, and there are a number of competitors to
our products and product candidates. If one or more of our competitors’ products or programs are successful
(including the development of generic equivalents), the market for our products may be reduced or eliminated.
•
INGREZZA competes with AUSTEDO® (deutetrabenazine), marketed by Teva Pharmaceuticals Industries,
for the treatment of tardive dyskinesia in adults and chorea associated with Huntington's disease. A once-
daily dosing of AUSTEDO (AUSTEDO XR) was introduced in February 2023. Additionally, there are a
number of commercially available medicines used to treat tardive dyskinesia off-label, such as
XENAZINE® (tetrabenazine) and generic equivalents, and various antipsychotic medications (e.g.,
clozapine), anticholinergics, benzodiazepines (off-label), and botulinum toxin. In addition, there are several
programs in clinical development by other companies targeting Huntington's disease.
•
CRENESSITY competes with high dose corticosteroid monotherapy which is the current standard of care
to both correct the endogenous cortisol deficiency as well as reduce the excessive adrenocorticotropic
hormone levels for patients with CAH. In the U.S. alone, there are more than two dozen companies
manufacturing steroid-based products. In addition, there are several programs in clinical development by
other companies targeting CAH.
•
Our investigational treatments for potential use in schizophrenia and depression may in the future compete
with several development-stage programs being pursued by other companies. In addition, there are a
number of different anti-psychotic and anti-depressant medications currently used in these patient
populations.
•
Our investigational treatments for potential use in neurology, neuroendocrinology and neuropsychiatry may
in the future compete with numerous approved products and development-stage programs being pursued by
several other companies.
Compared to us, many of our competitors and potential competitors have substantially greater:
•
capital resources;
•
sales and marketing experience;
•
research and development resources, including personnel and technology;
•
regulatory experience;
•
preclinical study and clinical testing experience;
•
manufacturing, marketing and distribution experience; and
•
production facilities.
Moreover, increased competition in certain disorders or therapies may make it more difficult for us to recruit or
enroll patients in our clinical trials for similar disorders or therapies.
Government and third-party payors may impose sales and pharmaceutical pricing controls on our products or
limit coverage and/or reimbursement for our products or impose policies and/or make decisions regarding the
status of our products that could limit our product revenues and delay sustained profitability.
Our ability to continue to commercialize INGREZZA and successfully launch and commercialize CRENESSITY
will depend in part on the extent to which coverage and adequate reimbursement for these products and related
treatments will be available. The continuing efforts of government and third-party payors to contain or reduce the
costs of healthcare and the price of prescription drugs through various means may impact our revenues. These
payors’ efforts could decrease the price that we receive for any products we may develop and sell in the future.
22
Assuming we obtain coverage for a given product by a third-party payor, the resulting reimbursement rates may not
be adequate or may require co-payments that patients find unacceptably high. Patients who are prescribed
medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party
payors to reimburse all or part of the costs associated with their prescription drugs. Patients are unlikely to use our
products unless coverage is provided and reimbursement is adequate to cover all or a significant portion of the out-
of-pocket cost of our products. Coverage decisions may depend upon clinical and economic standards that disfavor
new drug products when more established or lower cost therapeutic alternatives are already available or
subsequently become available regardless of whether they are approved by the FDA for that particular use.
Coverage decisions by payors for our competitors' products may also impact coverage for our products.
Government authorities and other third-party payors are developing increasingly sophisticated methods of
controlling healthcare costs, such as by limiting coverage and the amount of reimbursement for particular
medications. Further, no uniform policy requirement for coverage and reimbursement for drug products exists
among third-party payors in the U.S. Therefore, coverage and reimbursement for drug products can differ
significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and
costly process that will require us to provide scientific and clinical support for the use of our products to each payor
separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in
the first instance. In addition, communications from government officials, media outlets, and others regarding
healthcare costs and pharmaceutical pricing could have a negative impact on our stock price, even if such
communications do not ultimately impact coverage or reimbursement decisions for our products.
There may also be significant delays in obtaining coverage and reimbursement for newly approved drugs or
indications, and coverage may be more limited than the purposes for which the drug is approved by the FDA or
comparable foreign regulatory authorities. Moreover, eligibility for coverage and reimbursement does not imply that
a drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,
sale and distribution. In addition, we could also be subject to amendments in our rebate agreements with
pharmaceutical benefit managers that require us to pay larger rebate amounts or modify our formulary position,
which could have a material adverse effect on our business. Even if favorable coverage and reimbursement status is
attained for one or more products for which we receive regulatory approval, less favorable coverage policies and
reimbursement rates may be implemented in the future. For example, government authorities could make a decision
that adversely impacts the status of one of our products, which could impact the eligibility and/or the amount of
government reimbursement for that product.
As a pharmaceutical manufacturer, we are subject to various federal statutes and regulations requiring the reporting
of price data and the subsequent provision of concessions to certain purchasers/payors, including state Medicaid
programs. Federal agencies issue guidance to manufacturers related to the interpretation of laws and regulations, and
this guidance has changed and may change or be updated over time. In interpreting these laws, regulations and
guidance, manufacturers may make reasonable assumptions to fill gaps, and these reasonable assumptions may need
to be updated upon issuance of additional agency guidance.
If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may be
unable to successfully commercialize INGREZZA, CRENESSITY, or any of our product candidates for which we
obtain marketing approval in the future. Our inability to promptly obtain coverage and profitable reimbursement
rates from both government-funded and private payors for any approved products that we develop could have a
material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our
overall financial condition. Further, a majority of our current revenue is derived from federal healthcare program
payors, including Medicare and Medicaid. Thus, changes in government reimbursement policies, government
negotiation of the price of any of products, reductions in payments and/or our suspension or exclusion from
participation in federal healthcare programs could have a material adverse effect on our business.
Further, the use of physician telehealth services has continued to increase, fueled by an unprecedented expansion of
coverage and reimbursement for telehealth services across public and private insurers. The limitations that telehealth
places on the ability to conduct a thorough physical examination may impact the ability of providers to screen for
tardive dyskinesia or chorea associated with Huntington’s disease, leading to fewer patients being diagnosed and/or
treated.
23
Outside the U.S., reimbursement and healthcare payment systems vary significantly by country, and many countries
have instituted price ceilings on specific products and therapies. The EU provides options for EU Member States to
restrict the range of medicinal products for which their national health insurance systems provide reimbursement and
to control the prices of medicinal products for human use. An EU Member State may approve a specific price for the
medicinal product, it may refuse to reimburse a product at the price set by the manufacturer or it may instead adopt a
system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.
To obtain reimbursement for our products in some European countries, including some EU Member States, we may
be required to compile additional data comparing the cost-effectiveness of our products to other available therapies.
The Health Technology Assessment (HTA) of medicinal products is becoming an increasingly common part of the
pricing and reimbursement procedures in some EU Member States, including those representing the larger markets.
The extent to which pricing and reimbursement decisions are influenced by the HTA of the specific medicinal
product currently varies between EU Member States. If we are unable to obtain favorable pricing and reimbursement
status in EU Member States for product candidates that we may successfully develop and for which we may obtain
regulatory approval, any anticipated revenue from and growth prospects for those products in the EU could be
negatively affected.
Legislators, policymakers, and payors may continue to propose and implement cost-containing measures to keep
healthcare costs down. These measures could include limitations on the prices we would be able to charge for
product candidates that we may successfully develop and for which we may obtain regulatory approval or the level
of reimbursement available for these products from governmental authorities or third-party payors. Further, an
increasing number of countries use prices for medicinal products established in other countries as “reference prices”
to help determine the price of the product in their own territory. Consequently, a downward trend in prices of
medicinal products in some countries could contribute to similar downward trends elsewhere, including in the U.S.
Because the development of our product candidates is subject to a substantial degree of technological
uncertainty, we may not succeed in developing any of our product candidates.
Only a small number of research and development programs ultimately result in commercially successful drugs.
Potential products that appear to be promising at early stages of development may not reach the market for a number
of reasons. These reasons include the possibilities that the potential products may:
•
be found ineffective or cause harmful side effects during preclinical studies or clinical trials;
•
fail to receive necessary regulatory approvals on a timely basis or at all;
•
be precluded from commercialization by proprietary rights of third parties;
•
be difficult to manufacture on a large scale; or
•
be uneconomical to commercialize or fail to achieve market acceptance.
If any of our product candidates encounters any of these potential problems, we may never successfully market that
product candidate.
Our clinical trials may be delayed for safety or other reasons, or fail to demonstrate the safety and efficacy of our
product candidates, which could prevent or significantly delay their regulatory approval.
Before obtaining regulatory approval for the sale of any of our potential products, we must subject these product
candidates to extensive preclinical and clinical testing to demonstrate their safety and efficacy for humans. Clinical
trials are expensive, time consuming and may take years to complete and the outcomes are uncertain.
In connection with the clinical trials of our product candidates, we face the risks that:
•
the FDA or similar foreign regulatory authority may not allow an IND or foreign equivalent filings required
to initiate human clinical studies for our drug candidates or the FDA or similar foreign regulatory
authorities may require additional preclinical studies as a condition of the initiation of Phase 1 clinical
studies, or additional clinical studies for progression from Phase 1 to Phase 2, or Phase 2 to Phase 3, or for
NDA approval;
•
the product candidate may not prove to be effective or as effective as other competing product candidates;
•
we may discover that a product candidate may cause harmful side effects or results of required toxicology
or other studies may not be acceptable to the FDA or similar foreign regulatory authorities;
24
•
clinical trial results may not replicate the results of previous trials;
•
we or the FDA or similar foreign regulatory authorities may suspend or vary the trials;
•
the results may not be statistically significant;
•
clinical site initiation or patient recruitment and enrollment may be slower or more difficult than expected;
•
the FDA or similar foreign regulatory authorities may not accept the data from any trial or trial site outside
of the U.S.;
•
a study is compromised due to patients dropping out and not completing the trials;
•
unforeseen disruptions or delays may occur, caused by man-made or natural disasters, public health
pandemics or epidemics, armed conflicts, trade restrictions or other business interruptions; and
•
regulatory requirements may change.
These risks and uncertainties impact all of our clinical programs and any of the clinical, regulatory or operational
events described above could change our planned clinical and regulatory activities. Geopolitical tensions could also
affect our ability to obtain supplies of our investigational products, which could cause delays or otherwise disrupt
our clinical trials and research and development efforts. Some of our suppliers and research collaborators are located
in China, exposing us to the possibility of supply disruption in the event of changes to the laws, rules, regulations,
and policies of the governments of the U.S. or China. Any such changes to laws or the adoption of tariffs or other
restrictions could impact our ability to contract with certain Chinese biotechnology companies, cause delays, or have
other adverse effects on the development of certain of our research programs.
In addition, late-stage clinical trials are often conducted with patients having the most advanced stages of disease.
During the course of treatment, these patients can die or suffer other adverse medical effects for reasons that may not
be related to the pharmaceutical agent being tested but which can nevertheless adversely affect clinical trial conduct,
completion and results. Any failure or substantial delay in completing clinical trials for our product candidates may
severely harm our business.
Even if the clinical trials are successfully completed, we cannot guarantee that the FDA or similar foreign regulatory
authorities will interpret the results as we do, and more trials could be required before we submit our product
candidates for approval. The FDA and similar foreign regulatory authorities have substantial discretion in the
approval process and may either refuse to accept an application for substantive review or may form the opinion after
review of an application that the application is insufficient to allow approval of a product candidate. To the extent
that the FDA or similar foreign regulatory authorities do not accept our application for review or approve our
application, we may be required to expend significant additional resources, which may not be available to us, to
conduct additional trials in support of potential approval of our product candidates. Depending on the extent of these
additional trials or any other studies that might be required, approval of any applications that we submit may be
significantly delayed. It is also possible that any such additional studies, if performed and completed, may not be
considered sufficient by the FDA or similar foreign regulatory authorities and we may be forced to delay or abandon
our applications for approval.
We have increased the size of our organization and will need to continue to increase the size of our organization.
We may encounter difficulties with managing our growth, which could adversely affect our results of operations.
Since 2017, our number of full-time employees has grown from approximately 200 to 1,800 as of December 31,
2024. Although we have substantially increased the size of our organization, we may need to add additional
qualified personnel and resources, especially with the recent increase in the size of our sales force. Our current
infrastructure may be inadequate to support our development and commercialization efforts and expected growth.
Future growth will impose significant added responsibilities on our organization, including the need to identify,
recruit, maintain and integrate additional employees and implement and expand managerial, operational and
financial systems and may be costly and take time away from running other aspects of our business, including
development and commercialization of our product candidates. For example, we implemented a new company-wide
enterprise resource planning (ERP) system in 2024 to streamline certain existing business, operational, and financial
processes. This project has required and may continue to require investment of capital and human resources, the re-
engineering of processes of our business, and the attention of many employees who would otherwise be focused on
other aspects of our business. Any deficiencies in the design of the ERP system could adversely affect the
effectiveness of our internal control over financial reporting or our ability to accurately maintain our books and
25
records, provide accurate, timely and reliable reports on our financial and operating results, or otherwise operate our
business. Any of these consequences could have an adverse effect on our results of operations and financial
condition.
Our future financial performance and our ability to commercialize INGREZZA, CRENESSITY, or any of our
product candidates that receive regulatory approval in the future, will partially depend on our ability to manage any
future growth effectively. In particular, as we commercialize INGREZZA and CRENESSITY, we will need to
support the training and ongoing activities of our sales force and will likely need to continue to expand the size of
our employee base for managerial, operational, financial and other resources. To that end, we must be able to
successfully:
•
manage our development efforts effectively;
•
integrate additional management, administrative and manufacturing personnel;
•
further develop our marketing and sales organization;
•
compensate our employees on adequate terms in an increasingly competitive, inflationary market;
•
attract and retain personnel; and
•
maintain sufficient administrative, accounting and management information systems and controls.
We may not be able to accomplish these tasks or successfully manage our operations and, accordingly, may not
achieve our research, development and commercialization goals. Our failure to accomplish any of these goals could
harm our financial results and prospects.
We are transforming our research and development strategies to include the development of biologics, which
requires substantial investment, including in personnel and facilities. We may encounter difficulties as we expand
and may fail to successfully develop or commercialize our biologic product candidates, which could adversely
affect our results of operations.
We are transforming our research and development strategies to include the development of biologics, including
peptides, antibodies and gene therapies. As a company, we do not have experience successfully developing and
commercializing biologics and our current infrastructure may be inadequate to support the expected growth and
transformation of processes, personnel, and technologies required for these new programs. We have hired employees
with expertise in these modalities, but we will need to hire additional qualified personnel and expand our
management, administrative, and manufacturing functions to support the research and development organization. If
we are unable to identify, recruit and integrate additional employees with the requisite skills, or effectively manage
our transformation activities, the development of our biologic product candidates may not be successful, or be
delayed or paused indefinitely. Additionally, the manufacture of biologics is more complex than the manufacture of
small molecule therapies. We may encounter delays in production and delivery of our biologic product candidates
by our third-party manufacturers or other vendors, which would result in corresponding delays to our development
and commercialization of such biologic candidates. In addition, the regulatory requirements in the United States and
in other countries governing biologics are evolving and the FDA or comparable foreign regulatory authorities may
change the requirements, or identify different regulatory pathways, for approval for any of our biologic candidates.
As a result, we may be required to change our regulatory strategy or to modify our applications for regulatory
approval, which could delay and impair our ability to complete the preclinical and clinical development and
manufacture of, and obtain regulatory approval for, our biologic candidates. We have made, and expect to continue
making, substantial investments in our research and development personnel and facilities, as well in external
innovation to support our expansion into the development of our biologics. If any of these risks occur and we fail to
successfully develop or commercialize our biologic product candidates, we may not realize a return on our
investments which could have an adverse effect on our results of operations and financial condition.
26
If we are unable to retain and recruit qualified scientists and other employees or if any of our key senior
executives discontinues his or her employment with us, it may delay our development efforts or impact our
commercialization of INGREZZA, CRENESSITY, or any product candidate approved by the FDA in the future.
We are highly dependent on the principal members of our management, commercial and scientific staff. The loss of
any of these people could impede the achievement of our objectives, including the successful commercialization of
INGREZZA, the launch of CRENESSITY, or the commercialization of any product candidate approved by the FDA
in the future. Furthermore, recruiting and retaining qualified scientific personnel to perform research and
development work in the future, along with personnel with experience marketing and selling pharmaceutical
products, is critical to our success. We may be unable to attract and retain personnel on acceptable terms given the
competition among biotechnology, pharmaceutical and healthcare companies, universities and non-profit research
institutions for experienced scientists and individuals with experience marketing and selling pharmaceutical
products. We may face particular retention challenges in light of the recent rapid growth in our personnel and
infrastructure and the perceived impact of those changes upon our corporate culture. In addition, we rely on a
significant number of consultants to assist us in formulating our research and development strategy and our
commercialization strategy. Our consultants may have commitments to, or advisory or consulting agreements with,
other entities that may limit their availability to us.
On October 11, 2024, Kevin Gorman, Ph.D., retired as the Company's President and Chief Executive Officer and
Kyle Gano, Ph.D., formerly our Chief Business Development and Strategy Officer, succeeded Dr. Gorman in the
CEO role. Dr. Gano also joined our Board of Directors effective as of October 11, 2024. Dr. Gorman founded
Neurocrine in 1992 and has held numerous positions across the Company, including Chief Operating Officer, Chief
Business Officer, and Senior Vice President of Business Development, before being appointed CEO in 2008. Dr.
Gano was appointed Neurocrine’s Chief Business Development Officer in 2011, and Chief Business Development
and Strategy Officer in 2020, and is responsible for all of Neurocrine’s business and corporate development
activities. Our Board of Directors worked closely with Dr. Gorman on succession planning and believes Dr. Gano
and the senior leadership team are well-positioned to continue to execute our strategy. Although Dr. Gorman will
continue to serve on our Board of Directors and provide strategic direction to the Company, this leadership transition
may be viewed negatively by investors, our strategic partners, or other stakeholders. Further, if the transition is not
managed effectively, it could disrupt our operations and impact our financial condition and results.
Use of our approved products or those of our collaborators could be associated with side effects or adverse events.
As with most pharmaceutical products, use of our approved products or those of our collaborators could be
associated with side effects or adverse events which can vary in severity (from minor adverse reactions to death) and
frequency (infrequent or prevalent). Side effects or adverse events associated with the use of our products or those of
our collaborators may be observed at any time, including after a product is commercialized, and reports of any such
side effects or adverse events may negatively impact demand for our or our collaborators’ products or affect our or
our collaborators’ ability to maintain regulatory approval for such products. Side effects or other safety issues
associated with the use of our approved products or those of our collaborators could require us or our collaborators
to modify or halt commercialization of these products or expose us to product liability lawsuits which will harm our
business. We or our collaborators may be required by regulatory agencies to conduct additional studies regarding the
safety and efficacy of our products which we have not planned or anticipated. Furthermore, there can be no
assurance that we or our collaborators will resolve any issues related to any product related adverse events to the
satisfaction of the FDA or any regulatory agency in a timely manner or ever, which could harm our business,
prospects and financial condition.
27
We currently depend on a limited number of third-party suppliers. The loss of these suppliers, or delays or
problems in the supply of INGREZZA, CRENESSITY, or our product candidates, could materially and adversely
affect our ability to successfully develop or commercialize INGREZZA, CRENESSITY, or any of our product
candidates.
The manufacture of pharmaceutical products requires significant expertise and capital investment, including the
development of process controls required to consistently produce the active pharmaceutical ingredients (API), the
finished drug product and packaging in sufficient quantities while meeting detailed product specifications on a
repeated basis. Manufacturers of pharmaceutical products may encounter difficulties in production, such as
difficulties with production costs and yields, process controls and validation, quality control and quality assurance,
including testing of stability, impurities and impurity levels and other product specifications by validated test
methods, compliance with strictly enforced U.S., state and non-U.S. regulations, and disruptions or delays caused by
man-made or natural disasters, public health pandemics or epidemics, armed conflicts, trade restrictions, or other
business interruptions. We depend on a limited number of suppliers for the production (including API) of
INGREZZA, CRENESSITY and our product candidates and for the packaging of INGREZZA and CRENESSITY.
If our third-party suppliers for INGREZZA, CRENESSITY, or any of our product candidates encounter these or any
other manufacturing, quality or compliance difficulties, our ability to successfully develop or commercialize
INGREZZA, CRENESSITY, or any of our product candidates could be materially and adversely affected.
In addition, if our suppliers fail or refuse to supply us with INGREZZA, CRENESSITY, or any of our product
candidates, or their APIs for any reason, or terminate our supply agreements or do not perform as agreed, it would
take a significant amount of time and expense to qualify a new supplier. The FDA and similar foreign regulatory
authorities must approve manufacturers of the active and inactive pharmaceutical ingredients and certain packaging
materials used in pharmaceutical products. The loss of a supplier could require us to obtain regulatory clearance and
to incur validation and other costs associated with the transfer of the API or product manufacturing processes. If
there are delays in qualifying new suppliers or facilities or if a new supplier is unable to meet FDA or a similar
foreign regulatory authority’s requirements for approval, there could be a shortage of INGREZZA, CRENESSITY,
or any of our product candidates, which could materially and adversely affect our ability to successfully develop or
commercialize INGREZZA, CRENESSITY, or any of our product candidates.
We currently have no manufacturing capabilities. If third-party manufacturers of INGREZZA, CRENESSITY,
or any of our product candidates fail to devote sufficient time and resources to our concerns, or if their
performance is substandard, our ability to commercialize existing products, conduct clinical trials and develop
new products could be impaired and our costs may rise.
We have in the past utilized, and intend to continue to utilize, third-party manufacturers to produce the drug
compounds we use in our clinical trials and for the commercialization of our products. We have limited experience
in manufacturing products for commercial purposes and do not currently have any manufacturing facilities.
Establishing internal commercial manufacturing capabilities would require significant time and resources, and we
may not be able to timely or successfully establish such capabilities. Consequently, we depend on, and will continue
to depend on, several contract manufacturers for all production of products for development and commercial
purposes, including INGREZZA and CRENESSITY. If we are unable to obtain or retain third-party manufacturers,
we will not be able to develop or commercialize our products, including INGREZZA and CRENESSITY. The
manufacture of our products for clinical trials and commercial purposes is subject to specific FDA and equivalent
foreign regulations, including current Good Manufacturing Practice regulations. Our third-party manufacturers
might not comply with FDA or equivalent foreign regulations relating to manufacturing our products for clinical
trials and commercial purposes or other regulatory requirements now or in the future. Our reliance on contract
manufacturers also exposes us to the following risks:
•
contract manufacturers may encounter difficulties in achieving volume production, quality control or
quality assurance, and also may experience shortages in qualified personnel or materials and ingredients
necessary to conduct their operations. As a result, our contract manufacturers might not be able to meet our
clinical schedules or adequately manufacture our products in commercial quantities when required;
28
•
switching manufacturers may be difficult because the number of potential manufacturers is limited. It may
be difficult or impossible for us to find a replacement manufacturer quickly on acceptable terms, or at all;
•
our contract manufacturers may not perform as agreed or may not remain in the contract manufacturing
business for the time required to successfully produce, store or distribute our products; and
•
drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the U.S. Drug
Enforcement Administration, equivalent foreign regulatory authorities, and other agencies to ensure strict
compliance with cGMP and other government regulations and corresponding foreign standards. Any delay,
interruption, or other issue that arises in the manufacture of our products or product candidates as a result of
a failure of a third-party manufacturer to pass regulatory inspections or maintain cGMP compliance could
significantly impair our ability to develop, obtain approval for, or successfully commercialize our products.
Our current dependence upon third parties for the manufacture of our products may reduce our profit margin, if any,
on the sale of INGREZZA, CRENESSITY, or our future products and our ability to develop and deliver products on
a timely and competitive basis.
We depend on our current collaborators for the development and commercialization of several of our products
and product candidates and may need to enter into future collaborations to develop and commercialize certain of
our product candidates.
We depend on our current collaborators for the development and commercialization of several of our products and
product candidates and may need to enter into future collaborations to develop and commercialize certain of our
product candidates. For example, we depend on AbbVie for the manufacture and commercialization of ORILISSA
and ORIAHNN and for the continued development of elagolix. We collaborate with MTPC for the
commercialization of DYSVAL in Japan and for the continued development and commercialization of valbenazine
for movement disorders in other select Asian markets. Some of our other collaborators include Nxera Pharma UK
Limited (formerly Sosei Heptares), Takeda Pharmaceutical Company Limited, Voyager Therapeutics, Inc., and
Xenon Pharmaceuticals, Inc.
Our current and future collaborations and licenses could subject us to a number of risks, including:
•
strategic collaborators may sell, transfer or divest assets or programs related to our partnered product or
product candidates;
•
we may be required to undertake the expenditure of substantial operational, financial and management
resources;
•
we may be required to assume substantial actual or contingent liabilities;
•
we may not be able to control the amount and timing of resources that our strategic collaborators devote to
the development or commercialization of our products or product candidates;
•
we may not be able to influence our strategic collaborator’s decisions regarding the development and
collaboration of our partnered product and product candidates, and as a result, our collaboration partners
may not pursue or prioritize the development and commercialization of those partnered products and
product candidates in a manner that is in our best interest;
•
strategic collaborators may select indications or design clinical trials in a way that may be less successful
than if we were doing so;
•
strategic collaborators may not conduct collaborative activities in a timely manner, provide insufficient
funding, terminate a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or
require a new version of a product candidate for clinical testing;
•
strategic collaborators may not pursue further development and commercialization of products resulting
from the strategic collaboration arrangement or may elect to discontinue research and development
programs;
•
disagreements or disputes may arise between us and our strategic collaborators that result in delays or in
costly litigation or arbitration that diverts management’s attention and consumes resources;
•
strategic collaborators may experience financial difficulties;
29
•
strategic collaborators may not properly maintain, enforce or defend our intellectual property rights or may
use our proprietary information in a manner that could jeopardize or invalidate our proprietary information
or expose us to potential litigation;
•
we or strategic collaborators could terminate the arrangement (in whole or in part) or allow it to expire,
which would delay the development and commercialization, result in disagreements or disputes or may
increase the cost of developing and commercializing our products or product candidates;
•
strategic collaborators could develop, either alone or with others, products or product candidates that may
compete with ours; and
•
our strategic collaborator’s decisions regarding the development and commercialization of a partnered
product or product candidate within their territory(ies) could negatively impact us in the territories where
we have development and commercialization rights for such product or product candidate.
If any of these issues arise, it may delay and/or negatively impact the development and commercialization of drug
candidates and, ultimately, our generation of product revenues.
We license some of our core technologies and drug candidates from third parties. If we default on any of our
obligations under those licenses, or violate the terms of these licenses, we could lose our rights to those
technologies and drug candidates or be forced to pay damages.
We are dependent on licenses from third parties for some of our key technologies. These licenses typically subject
us to various commercialization, reporting and other obligations. If we fail to comply with these obligations, we
could lose important rights. If we were to default on our obligations under any of our licenses, we could lose some
or all of our rights to develop, market and sell products covered by these licenses. In addition, several of our
collaboration and license agreements allow our licensors to terminate such agreements if we challenge the validity or
enforceability of certain intellectual property rights or if we commit a material breach in whole or in part of the
agreement and do not cure such breach within the agreed upon cure period. In addition, if we were to violate any of
the terms of our licenses, we could become subject to damages. Likewise, if we were to lose our rights under a
license to use proprietary research tools, it could adversely affect our existing collaborations or adversely affect our
ability to form new collaborations. We also face the risk that our licensors could, for a number of reasons, lose
patent protection or lose their rights to the technologies we have licensed, thereby impairing or extinguishing our
rights under our licenses with them.
Our customers are concentrated and therefore the loss of a significant customer may harm our business.
We have entered into agreements for the distribution of INGREZZA with a limited number of specialty pharmacy
providers and distributors. Four of these customers represented approximately 93% of our total product sales for
2024 and approximately 98% of our accounts receivable balance as of December 31, 2024. In addition,
CRENESSITY is distributed by one specialty pharmacy provider. If any of our significant customers becomes
subject to bankruptcy, is unable to pay us for our products or wants to terminate their relationship with us, or if we
otherwise lose any of these significant customers, our revenue, results of operations and cash flows would be
adversely affected. Also, we may need to enter into agreements with additional distributors or specialty pharmacy
providers, and there is no guarantee that we will be able to do so on commercially reasonable terms or at all. Even if
we replace the loss of a significant customer, we cannot predict with certainty that such transition would not result in
a decline in our revenue, results of operations and cash flows.
We may need additional capital in the future. If we cannot raise additional funding, we may be unable to fund
our business plan and our future research, development, commercial and manufacturing efforts.
Our future funding requirements will depend on many factors and we may need to raise additional capital to fund
our business plan and our future research, development, commercial and manufacturing efforts.
Our future capital requirements will depend on many factors, including:
•
the commercial success of INGREZZA and CRENESSITY;
•
the cost of commercialization activities and arrangements, including advertising campaigns;
•
continued scientific progress in our R&D and clinical development programs;
•
the magnitude and complexity of our research and development programs;
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•
progress with preclinical testing and clinical trials;
•
the time and costs involved in obtaining regulatory approvals;
•
the cost involved in filing and pursuing patent applications, enforcing patent claims, or engaging in
interference proceedings or other patent litigation;
•
costs associated with securing adequate coverage and reimbursement for our products;
•
competing technological and market developments;
•
developments related to any future litigation;
•
the cost of manufacturing our product candidates;
•
the impact of pandemics or epidemics on our business; and
•
the cost of any strategic alliances, collaborations, product in-licensing, or acquisitions.
We may seek additional funding through public or private sales of our securities, including equity securities. In
addition, we have previously financed capital purchases and may continue to pursue opportunities to obtain debt
financing in the future. Additional equity or debt financing might not be available on reasonable terms, if at all. Any
additional equity financings will be dilutive to our stockholders and any debt financings may involve operating
covenants that restrict our business.
We expect to increase our expenses for the foreseeable future, and we may not be able to sustain growth and
profitability.
We received FDA approval for INGREZZA for tardive dyskinesia in April 2017 and for chorea associated with
Huntington's disease in August 2023. We received FDA approval for CRENESSITY capsules and oral solution as an
adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of
age and older with classic CAH in December 2024. Our partner AbbVie received FDA approval for ORILISSA for
endometriosis in July 2018 and for ORIAHNN for uterine fibroids in May 2020. Additionally, our partner MTPC
received Japanese Ministry of Health, Labour, and Welfare approval for DYSVAL for the treatment of tardive
dyskinesia in March 2022. However, we have not yet obtained regulatory approvals for any other product
candidates. Even if we continue to succeed in commercializing INGREZZA, or are successful in commercializing
CRENESSITY or any of our product candidates, we may not be able to sustain profitability. We also expect to
continue to incur significant operating and capital expenditures as we:
•
commercialize INGREZZA for tardive dyskinesia and chorea associated with Huntington's disease;
•
commercially launch CRENESSITY as an adjunctive treatment to glucocorticoid replacement to control
androgens in adult and pediatric patients four years of age and older with classic CAH;
•
seek regulatory approvals for our product candidates or for additional indications for our current products;
•
develop, formulate, manufacture and commercialize our product candidates;
•
in-license or acquire new product development opportunities;
•
implement additional internal systems and infrastructure; and
•
hire additional clinical, scientific, sales, marketing and administrative personnel.
We expect to increase our expenses and other investments in the coming years as we fund our operations and capital
expenditures. Thus, our future operating results and profitability may fluctuate from period to period due to the
factors described above, and we will need to generate significant revenues to achieve and maintain profitability and
positive cash flow on a sustained basis. We may not be able to generate these revenues, and we may never achieve
profitability on a sustained basis in the future. In addition, there is no guarantee that our prioritization determinations
regarding our R&D and clinical development programs, including the acceleration or discontinuation of certain
programs and product candidates, will generate their expected benefits and/or meet investor expectations. Our
prioritization decisions may also adversely affect other internal programs and initiatives as well as our ability to
recruit and retain skilled and motivated personnel. Our failure to maintain or increase profitability on a sustained
basis could negatively impact the market price of our common stock.
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The independent clinical investigators and contract research organizations that we rely upon to conduct our
clinical trials may not be diligent, careful or timely, or may make mistakes in the conduct of our trials.
We depend on independent clinical investigators and CROs to conduct our clinical trials under their agreements with
us. The investigators are not our employees, and we cannot control the amount or timing of resources that they
devote to our programs. If our independent investigators fail to devote sufficient time and resources to our drug
development programs, or if their performance is substandard, or not in compliance with GCPs, it may delay or
prevent the approval of our regulatory applications and our introduction of new treatments. The CROs we contract
with for execution of our clinical trials play a significant role in the conduct of the trials and the subsequent
collection and analysis of data. Failure of the CROs to meet their obligations could adversely affect clinical
development of our products. Moreover, these independent investigators and CROs may also have relationships with
other commercial entities, some of which may compete with us. If independent investigators and CROs assist our
competitors at our expense, it could harm our competitive position.
We are subject to ongoing obligations and continued regulatory review for INGREZZA and CRENESSITY.
Additionally, our product candidates, if approved, could be subject to labeling and other post-marketing
requirements and restrictions.
Regulatory approvals for any of our product candidates may be subject to limitations on the approved indicated uses
for which the product may be marketed or to the conditions of approval, or contain requirements for potentially
costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of
the product candidate. For INGREZZA, CRENESSITY, and any product candidate that the FDA or a comparable
foreign regulatory authority approves, the manufacturing processes, labeling, packaging, distribution, adverse event
reporting, storage, advertising, promotion and recordkeeping for the product is subject to extensive and ongoing
regulatory requirements. These requirements include submissions of safety and other post-marketing information
and reports, registration, as well as continued compliance with GCPs for any clinical trials that we conduct post-
approval. In addition, advertising and promotional materials for approved products must comply with FDA
regulations and those of foreign regulatory authorities and may be subject to other potentially applicable federal and
state laws.
Failure to comply with these ongoing regulatory requirements, or later discovery of previously unknown problems
with a product, including adverse events of unanticipated severity or frequency, or with our third-party
manufacturers or manufacturing processes, may result in, among other things:
•
restrictions on the marketing or manufacturing of the product, changes in the product’s label, withdrawal of
the product from the market, or voluntary or mandatory product recalls;
•
fines, warning or untitled letters or holds on clinical trials;
•
refusal by the FDA or similar foreign regulatory authorities to approve pending applications or supplements
to approved applications filed by us, or suspension or revocation of product license approvals;
•
adverse inspection findings, enforcement actions, or other activities that temporarily delay manufacture and
distribution of our products;
•
product seizure or detention, or refusal to permit the import or export of products; and
•
product injunctions or the imposition of civil or criminal penalties.
The occurrence of any of these events may adversely affect our business, prospects and ability to achieve or sustain
profitability on a sustained basis.
The U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding
Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable
interpretations of ambiguous federal statutes. The Loper decision could result in additional legal challenges to
regulations and guidance issued by federal agencies, including the FDA, on which we rely. Any such legal
challenges, if successful, could have a material impact on our business. Additionally, the Loper decision may result
in increased regulatory uncertainty, inconsistent judicial interpretations, and other impacts to the agency rulemaking
process, any of which could adversely impact our business and operations. We cannot predict the likelihood, nature
or extent of government regulation that may arise from future legislation or administrative action or as a result of
legal challenges, either in the United States or abroad. If we are slow or unable to adapt to changes in existing
requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory
compliance, our business could be materially harmed.
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If the market opportunities for our products and product candidates are smaller than we believe they are, our
expected revenues may be adversely affected, and our business may suffer.
Certain of the diseases that INGREZZA, CRENESSITY, and our product candidates are being developed to address
are in underserved and underdiagnosed populations. Our projections of both the number of people who have these
diseases, as well as the subset of people with these diseases who will seek treatment utilizing our products or product
candidates, may not be accurate. If our estimates of the prevalence or number of patients potentially on therapy
prove to be inaccurate, the market opportunities for INGREZZA, CRENESSITY, and our product candidates may be
smaller than we believe they are, our prospects for generating expected revenue may be adversely affected and our
business may suffer.
Because our operating results may vary significantly in future periods, our stock price may decline.
Our quarterly revenues, expenses and operating results have fluctuated in the past and are likely to fluctuate
significantly in the future. Our financial results are unpredictable and may fluctuate, for among other reasons, due to
seasonality and timing of customer purchases and commercial sales of INGREZZA and CRENESSITY, royalties
from out-licensed products, the impact of Medicare Part D coverage, including redesign of the Part D benefit
enacted as part of the Inflation Reduction Act, our achievement of product development objectives and milestones,
clinical trial enrollment and expenses, research and development expenses and the timing and nature of contract
manufacturing, contract research payments, fluctuations in our effective tax rate, disruptions caused by man-made or
natural disasters, public health pandemics or epidemics, armed conflicts, trade restrictions, or other business
interruptions. Because a majority of our costs are predetermined on an annual basis, due in part to our significant
research and development costs, small declines in revenue could disproportionately affect financial results in a
quarter. Thus, our future operating results and profitability may fluctuate from period to period, and even if we
become profitable on a quarterly or annual basis, we may not be able to sustain or increase our profitability.
Moreover, as our company and our market capitalization have grown, our financial performance has become
increasingly subject to quarterly and annual comparisons with the expectations of securities analysts or investors.
The failure of our financial results to meet these expectations, either in a single quarterly or annual period over a
sustained period time, could cause our stock price to decline.
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse
effect on our business, cash flows, financial condition or results of operations.
New tax laws or regulations could be enacted at any time, and existing tax laws or regulations could be interpreted,
modified or applied in a manner that is adverse to us or our customers, which could adversely affect our business
and financial condition. For example, the Tax Cuts and Jobs Act of 2017, the Coronavirus Aid, Relief, and
Economic Security Act and the Inflation Reduction Act enacted many significant changes to the U.S. tax laws.
Among other changes, the Tax Cuts and Jobs Act eliminated the option to deduct research and development
expenses for tax purposes in the year incurred and requires taxpayers to capitalize and subsequently amortize such
expenses over five years for research activities conducted in the U.S. and over 15 years for research activities
conducted outside the U.S. If the requirement to amortize research and development expenditures is not repealed or
otherwise modified, it will continue to have an adverse effect on our tax liability. Furthermore, our tax obligations
and effective tax rate in the jurisdictions in which we conduct business could increase as a result of international tax
developments, including the implementation of the Organization for Economic Co-operation and Development’s
(OECD) Base Erosion and Profit Shifting “Two-Pillar” framework, which involves the reallocation of taxing rights
in respect of certain multinational enterprises above a fixed profit margin to the jurisdictions in which they carry on
business (referred to as Pillar One) and the imposition of a minimum effective corporate tax rate (referred to as Pillar
Two). Certain countries in which we conduct business have enacted, or are in the process of enacting, core
provisions of the Pillar Two rules. We continue to evaluate and assess the potential impact of these new rules,
including on our effective tax rate, and our eligibility to qualify for transition and safe harbor. Any changes in tax
laws, including any new tax legislation or initiatives, could not only significantly increase our tax provision, cash tax
liabilities, and effective tax rate, but could also have a material impact on the value of our deferred tax assets, result
in significant one-time charges and ongoing compliance costs, and increase our future tax expense.
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Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued
amounts.
We have a multinational tax structure and are subject to income tax in the U.S. and various foreign jurisdictions,
including the United Kingdom and Switzerland. Our effective tax rate is influenced by many factors including
changes in our operating structure, changes in the mix of our earnings among countries, our allocation of profits and
losses among our subsidiaries, our intercompany transfer pricing agreements and rules relating to transfer pricing,
our inability to secure or sustain acceptable agreements with tax authorities, the impact of stock-based
compensation, the availability of U.S. research and development tax credits, the results of examinations and audits
of our tax filings, changes in accounting for income taxes, and future changes in tax laws and regulations in the U.S.
and foreign countries. Significant judgment is required in determining our tax liabilities including management’s
judgment for uncertain tax positions. The Internal Revenue Service, other domestic taxing authorities, or foreign
taxing authorities may disagree with our interpretation of tax laws as applied to our operations. Our reported
effective tax rate and after-tax cash flows may be materially and adversely affected by tax assessments in excess of
amounts accrued for our financial statements. This could cause us to experience an effective tax rate significantly
different from previous periods or our current expectations.
The price of our common stock is volatile.
The market prices for securities of biotechnology and pharmaceutical companies historically have been highly
volatile, and the market for these securities has from time to time experienced significant price and volume
fluctuations that are unrelated to the operating performance of particular companies. For example, the applicability
of the Medicare drug price negotiation provisions in the Inflation Reduction Act negatively affected investor
sentiment and resulted in significant volatility. Furthermore, especially as we and our market capitalization have
grown, the price of our common stock has been increasingly affected by quarterly and annual comparisons with the
valuations and recommendations of the analysts who cover our business. If our results do not meet these analysts’
forecasts, the expectations of our investors or the financial guidance we provide to investors in any period, which is
based on assumptions that may be incorrect or that may change from quarter to quarter, the market price of our
common stock could decline. Over the course of the last 12 months, the price of our common stock has ranged from
approximately $111 per share to approximately $158 per share.
The market price of our common stock may fluctuate in response to many factors, including:
•
sales of INGREZZA and CRENESSITY;
•
failure of CRENESSITY to achieve commercial success;
•
the results of our clinical trials;
•
reports of safety issues related to INGREZZA or CRENESSITY;
•
any delay in filing an IND, NDA, marketing authorization application (MAA), or other regulatory
submission for any of our product candidates and any adverse development or perceived adverse
development with respect to the applicable regulatory agency's review of that IND, NDA, MAA, or other
regulatory submission;
•
developments concerning new and existing collaboration agreements;
•
announcements of technological innovations or new therapeutic products by us or others, including our
competitors;
•
general economic and market conditions, including economic and market conditions affecting the
biotechnology industry;
•
developments in patent or other proprietary rights;
•
developments related to the FDA, CMS and foreign regulatory agencies;
•
government regulation, including the Inflation Reduction Act;
•
future sales of our common stock by us or our stockholders;
•
any trading activity pursuant to a share repurchase program;
•
comments by securities analysts;
•
additions or departures of key personnel;
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•
fluctuations in our operating results;
•
potential litigation matters;
•
government and third-party payor coverage and reimbursement;
•
failure of any of our product candidates to achieve commercial success even if approved;
•
disruptions caused by man-made or natural disasters, public health pandemics or epidemics, armed
conflicts, trade restrictions, or other business interruptions; and
•
public concern as to the safety of our drugs.
In addition, we are a member of the S&P MidCap 400 index. If we cease to be represented in the S&P MidCap 400
index, or other indexes or indexed products, as a result of our market capitalization falling below the threshold for
inclusion in the index, certain institutional shareholders may, due to their internal policies and investment guidelines,
be required to sell their shareholdings. Such sales may result in further negative pressure on our stock price and,
when combined with reduced trading volume and liquidity, could adversely affect the value of your investment and
your ability to sell your shares.
There can be no assurance that any share repurchases will enhance long-term stockholder value.
In October 2024, our Board of Directors authorized a share repurchase program to repurchase up to $300 million of
our common stock and we subsequently entered into an accelerated share repurchase (ASR) transaction to
repurchase the entirety of this authorized amount. The purchase period for this ASR transaction ended in February
2025 and an aggregate of 2.3 million shares were delivered to us at an average repurchase price of $131.83 per
share. We can provide no assurance that this or future share repurchases will enhance long-term stockholder value,
and it may not prove to be the best use of our cash. If our Board of Directors authorizes any additional stock
repurchase programs it could affect the trading price of our stock and increase volatility.
Compliance with changing regulation of corporate governance and public disclosure may result in additional
expenses.
Changing laws, regulations and standards relating to corporate governance and public disclosure, including the
Dodd-Frank Wall Street Reform and Consumer Protection Act, new SEC regulations and Nasdaq rules, are creating
uncertainty for companies such as ours. These laws, regulations and standards are subject to varying interpretations
in some cases due to their lack of specificity, and as a result, their application in practice may evolve over time as
new guidance is provided by regulatory and governing bodies, which could result in continuing uncertainty
regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance
practices. We are committed to maintaining high standards of corporate governance and public disclosure. As a
result, our efforts to comply with evolving laws, regulations and standards have resulted in, and are likely to
continue to result in, increased selling, general and administrative expenses and management time related to
compliance activities. If we fail to comply with these laws, regulations and standards, our reputation may be harmed
and we might be subject to sanctions or investigation by regulatory authorities, such as the SEC. Any such action
could adversely affect our financial results and the market price of our common stock.
Increasing use of social media could give rise to liability and result in harm to our business.
Our employees are increasingly utilizing social media tools and our website as a means of communication. Despite
our efforts to monitor social media communications, there is risk that the unauthorized use of social media by our
employees to communicate about our products or business, or any inadvertent disclosure of material, nonpublic
information through these means, may result in violations of applicable laws and regulations, which may give rise to
liability and result in harm to our business. In addition, there is also risk of inappropriate disclosure of sensitive
information, which could result in significant legal and financial exposure and reputational damages that could
potentially have a material adverse impact on our business, financial condition and results of operations.
Furthermore, negative posts or comments about us or our products on social media could seriously damage our
reputation, brand image and goodwill.
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We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of
their former employers.
As is commonplace in the biotechnology industry, we employ individuals who were previously employed at other
biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims
against us are currently pending, we may be subject to claims that these employees or we have inadvertently or
otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may
be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation
could result in substantial costs and be a distraction to management.
Risks Related to Our Industry
Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the Inflation
Reduction Act of 2022, could adversely affect our business.
The business and financial condition of pharmaceutical and biotechnology companies are affected by the efforts of
government and third-party payors to contain or reduce the costs of healthcare and to lower drug prices. In the U.S.,
comprehensive drug pricing legislation enacted by the Federal government implements, for the first time,
government control over the pricing of certain prescription pharmaceuticals. Moreover, in some foreign
jurisdictions, pricing of prescription pharmaceuticals is also subject to government control. Additionally, other
federal and state laws impose obligations on manufacturers of pharmaceutical products, among others, related to
disclosure of new drug products introduced to the market and increases in drug prices above a specified threshold.
For example, the Inflation Reduction Act of 2022, or the IRA, provides for, among other things: (1) the Secretary of
the HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under
Medicare; (2) the redesign of the Medicare Part D prescription drug benefit to lower patient out-of-pocket costs and
increase manufacturer liability; and (3) drug manufacturers to pay rebates on drugs whose prices increase greater
than the rate of inflation. The IRA also extends enhanced subsidies for individuals purchasing health insurance
coverage in the ACA marketplaces through plan year 2025 and in 2025, eliminated the “donut hole” under the
Medicare Part D program and creates a new, permanent cap on beneficiary out-of-pocket spending for Part D drugs,
in addition to a newly established manufacturer discount program. The IRA permits HHS to implement many of
these provisions through guidance, as opposed to regulation, for the initial years. HHS has issued and updated and
will continue to issue and update guidance as these programs are implemented. These provisions took effect
progressively beginning in 2023. On August 15, 2024, HHS announced the negotiated prices of the first 10 drugs
that were subject to price negotiations, although the Medicare drug price negotiation program is currently subject to
legal challenges. On January 17, 2025, HHS announced its selection of fifteen additional drugs covered under Part D
for negotiation in 2025 (for initial price applicability year 2027). Certain high-expenditure Part B and Part D drugs/
biologics will be selected for negotiation in 2026 (for initial price applicability year 2028) and annually thereafter.
While the Medicare drug price negotiation program targets high-expenditure drugs/biologics that have been on the
market for several years without generic or biosimilar competition, we were notified in January 2025 that
INGREZZA qualifies for the small biotech exception, which provides an exemption from selection until 2027 (for
initial price applicability year 2029, pursuant to which negotiated pricing would go into effect, if selected).
Additionally, on January 1, 2025, the Centers for Medicare & Medicaid Services (CMS) implemented those
provisions of the IRA establishing a new Medicare Part D manufacturer discount program. Under this discount
program and subject to certain exceptions, manufacturers must give a 10 percent discount on Part D program drugs
in the initial coverage phase, and a 20 percent discount on Part D drugs when the beneficiary enters the catastrophic
coverage phase (the phase after the patient incurs costs above the initial phase out-of-pocket threshold, which is
$2,000). However, the IRA allows the 10 and 20 percent discounts to be phased in over a multi-year period for
“specified manufacturers” and “specified small manufacturers”. During this phase-in period, such manufacturers
would pay a lower percentage discount on Medicare Part D program drugs. In April 2024, the Company was notified
by CMS that it qualified as a “specified small manufacturer” and will receive the discount phase-in discussed above
for INGREZZA. INGREZZA is reimbursed under Medicare Part D, and increased discounts could impact
INGREZZA revenues, while also having an industry-wide impact on the cost of other Part D program drugs such as
AUSTEDO and AUSTEDO XR, marketed by Teva Pharmaceuticals Industries. The overall impact on INGREZZA
revenues is inherently uncertain and difficult to predict and we are still evaluating the potential impact of this
discount program and our designation as a “specified small manufacturer.”
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Our designation as a “specified small manufacturer” under the new Medicare Part D manufacturer discount program
and INGREZZA’s qualification for the small biotech exception for purposes of the Medicare drug price negotiation
program are subject to various requirements and there is no assurance that we will continue to qualify for these
exemptions in the future. The loss or potential loss of these exemptions, including as a result of a third party
acquiring us, could have an adverse impact on our business.
Prior to the IRA’s enactment, the most significant recent federal legislation impacting the pharmaceutical industry
occurred in March 2010, when the ACA was signed into law. The ACA was intended to broaden access to health
insurance and reduce the number of uninsured individuals, reduce or constrain the growth of healthcare spending,
enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance
industries, impose taxes and fees on the health industry and impose additional health policy reforms.
Other legislative changes have been adopted since the ACA was enacted. These changes include aggregate
reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of
2011, which began in 2013 and, due to subsequent legislative amendments to the statute, including the Infrastructure
Investment and Jobs Act and Consolidated Appropriations Act of 2023, will remain in effect until 2032. The
American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several
providers, including hospitals and cancer treatment centers, increased the statute of limitations period for the
government to recover overpayments to providers from three to five years.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control
pharmaceutical and biological product pricing, price or patient reimbursement constraints, discounts, restrictions on
certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to
encourage importation from other countries and bulk purchasing. For example, on January 5, 2024, the FDA
approved Florida’s SIP proposal to import certain drugs from Canada for specific state healthcare programs. It is
unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject
to legal challenges in the U.S. or Canada. Other states have also submitted SIP proposals that are pending review by
the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products
covered by those programs. Further, certain states through legislation have created a state PDAB to help control
costs of drugs for that state. The functions of the PDABs vary by state, and may include among other things,
recommending or setting upper limits on the price the state pays for certain drugs, performing drug affordability
reviews, and advising state lawmakers on additional ways to reduce the state’s drug spending. It is possible that the
actions taken by the PDABs may result in lower prices for certain drug products sold in their states.
The implementation of these cost containment measures may prevent us from being able to generate revenue, attain
sustained profitability or commercialize our drugs, particularly since the majority of our current revenue is derived
from federal healthcare programs, including Medicare and Medicaid.
If we are unable to protect our intellectual property, our competitors could develop and market products based on
our discoveries, which may reduce demand for our products.
Our success will depend on our ability to, among other things:
•
obtain patent protection for our products;
•
preserve our trade secrets;
•
prevent third parties from infringing upon our proprietary rights; and
•
operate without infringing upon the proprietary rights of others, both in the U.S. and internationally.
Because of the substantial length of time and expense associated with bringing new products through the
development and regulatory approval processes in order to reach the marketplace, the pharmaceutical industry places
considerable importance on obtaining patent and trade secret protection for new technologies, products and
processes. Accordingly, we intend to seek patent protection for our proprietary technology and compounds.
However, we face the risk that we may not obtain any of these patents and that the breadth of claims we obtain, if
any, may not provide adequate protection of our proprietary technology or compounds. Additionally, if our
employees, commercial collaborators or consultants use generative artificial intelligence (AI) technologies to
develop our proprietary technology and compounds, it may impact our ability to obtain or successfully defend
certain intellectual property rights.
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We also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological
innovation to develop and maintain our competitive position, which we seek to protect, in part, through
confidentiality agreements with our commercial collaborators, employees and consultants. We also have invention
or patent assignment agreements with our employees and some, but not all, of our commercial collaborators and
consultants. However, if our employees, commercial collaborators or consultants breach these agreements, we may
not have adequate remedies for any such breach, and our trade secrets may otherwise become known or
independently discovered by our competitors.
In addition, although we own a number of patents, the issuance of a patent is not conclusive as to its validity or
enforceability, and third parties may challenge the validity or enforceability of our patents. We cannot assure you
how much protection, if any, will be given to our patents if we attempt to enforce them and they are challenged in
court or in other proceedings. It is possible that a competitor may successfully challenge our patents or that
challenges will result in limitations of their coverage. Moreover, competitors may infringe our patents or
successfully avoid them through design innovation. In addition, potential competitors have in the past and may in
the future file an abbreviated new drug application (ANDA) with the FDA seeking approval to market a generic
version of our products, or our competitors’ products, before the expiration of the patents covering our products or
our competitors’ products, as applicable. To prevent infringement or unauthorized use, we have in the past and may
in the future need to file infringement claims, which are expensive and time-consuming. In addition, in an
infringement proceeding a court may decide that a patent of ours or a patent of a competitor is not valid or is
unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our
patents do not cover its technology. Derivation proceedings declared by the U.S. Patent and Trademark Office may
be necessary to determine the priority of inventions with respect to our patent applications (or those of our licensors)
or a patent of a competitor. Litigation or derivation proceedings may fail and, even if successful, may result in
substantial costs and be a distraction to management. Litigation or derivation proceedings, including proceedings of
a competitor, may also result in a competitor entering the marketplace faster than expected. We cannot assure you
that we will be able to prevent misappropriation of our proprietary rights, particularly in countries where the laws
may not protect such rights as fully as in the U.S.
Proposed healthcare reform, drug pricing measures and other prospective legislative initiatives could adversely
affect our business.
We expect that there will continue to be a number of federal and state proposals to implement additional government
controls over the pricing of prescription pharmaceuticals. Increasing emphasis on reducing the cost of healthcare in
the U.S. will continue to put pressure on the pricing and reimbursement of prescription pharmaceuticals.
In addition, certain jurisdictions outside of the U.S., including the EU, have instituted price ceilings on specific
products and therapies, as described further in the risk factor titled “Government and third-party payors may impose
sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products
or impose policies and/or make decisions regarding the status of our products that could limit our product revenues
and delay sustained profitability.”
We are currently unable to predict what other additional legislation or regulation, if any, relating to the healthcare
industry may be enacted in the future or what effect recently enacted federal or equivalent foreign legislation or any
such additional legislation or regulation would have on our business, particularly in light of the recent U.S.
Presidential and Congressional elections. The pendency or approval of such proposals or reforms could result in a
decrease in our stock price or limit our ability to raise capital or to enter into collaboration agreements for the further
development and commercialization of our programs and products.
38
Any relationships with healthcare professionals, principal investigators, consultants, customers (actual and
potential) and third-party payors in connection with our current and future business activities are and will
continue to be subject, directly or indirectly, to federal and state healthcare laws. If we are unable to comply, or
have not fully complied, with such laws, we could face penalties, contractual damages, reputational harm,
diminished profits and future earnings and curtailment or restructuring of our operations.
Our business operations and activities may be directly, or indirectly, subject to various federal and state healthcare
laws, including without limitation, fraud and abuse laws, false claims laws, data privacy and security laws, as well as
transparency laws regarding payments or other items of value provided to healthcare providers. These laws may
restrict or prohibit a wide range of business activities, including, but not limited to, research, manufacturing,
distribution, pricing, discounting, marketing and promotion, sales commission, customer incentive programs and
other business arrangements. These laws may impact, among other things, our current activities with principal
investigators and research subjects, as well as current and future sales, marketing, patient co-payment assistance and
education programs.
Such laws include:
•
the federal Anti-Kickback Statute which prohibits, among other things, persons and entities from
knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in
cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase,
order or recommendation of, any good or service, for which payment may be made under a federal
healthcare program such as Medicare and Medicaid;
•
the federal civil and criminal false claims laws, including the federal civil False Claims Act, and Civil
Monetary Penalties Laws, which impose criminal and civil penalties against individuals or entities for,
among other things, knowingly presenting, or causing to be presented, to the federal government, claims for
payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation
to pay money to the federal government;
•
HIPAA, which imposes criminal and civil liability for, among other things, executing a scheme to defraud
any healthcare benefit program or making false statements relating to healthcare matters;
•
HIPAA, as amended by HITECH and its implementing regulations, which also imposes obligations,
including mandatory contractual terms, on covered entities, including certain healthcare providers, health
plans and healthcare clearinghouses, as well as their business associates and their covered subcontractors,
with respect to safeguarding the privacy, security and transmission of individually identifiable health
information;
•
the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices,
biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s
Health Insurance Program, with specific exceptions, to report annually to CMS information related to
payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists,
podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse
practitioners) and teaching hospitals, and applicable manufacturers and applicable group purchasing
organizations to report annually to CMS ownership and investment interests held by physicians and their
immediate family members; and
•
analogous state, local and foreign laws and regulations, such as state anti-kickback and false claims laws,
which may apply to sales or marketing arrangements and claims involving healthcare items or services
reimbursed by non-governmental third party payors, including private insurers; state laws that require
pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines
and the relevant compliance guidance promulgated by the federal government; state laws that require drug
manufacturers to report information related to payments and other transfers of value to physicians and other
healthcare providers or marketing expenditures or drug pricing; state laws that require disclosure of price
increases above certain identified thresholds as well as of new commercial launches in the state; state laws
that create Prescription Drug Price Affordability Boards to review or attempt to cap drug spending; state
and local laws that require the registration of pharmaceutical sales representatives; state and local “drug
take back” laws and regulations; and state and foreign laws governing the privacy and security of health
39
information in some circumstances, many of which differ from each other in significant ways and often are
not preempted by HIPAA, thus complicating compliance efforts.
Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve
substantial costs. While our interactions with healthcare professionals, including our speaker programs and other
arrangements have been structured to comply with these laws and related guidance, it is possible that governmental
and enforcement authorities will conclude that our business practices, business practices of our vendors or
consultants, or a rogue employee’s activities, may not comply with current or future statutes, regulations or case law
interpreting applicable fraud and abuse or other healthcare laws. For example, we maintain a patient assistance
program to help eligible patients afford our products. These and other types of programs have become the subject of
governmental scrutiny, and numerous organizations, including pharmaceutical manufacturers, have been subject to
litigation, enforcement actions and settlements related to their patient assistance programs. If our operations or
activities or those of our vendors are found to be in violation of any of the laws described above or any other
applicable governmental regulations, we may be subject to, without limitation, significant civil, criminal and
administrative penalties, damages, monetary fines, disgorgement, possible exclusion from participation in Medicare,
Medicaid and other federal healthcare programs, additional reporting requirements and oversight if we become
subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these
laws, contractual damages, reputational harm, diminished profits and future earnings and curtailment or restructuring
of our operations, any of which could adversely affect our ability to operate.
Any sales of our product once commercialized outside the U.S. will also likely subject us to foreign equivalents of
the healthcare laws mentioned above, among other foreign laws. Additionally, because of our U.S. and international
operations, we are also subject to anti-corruption laws and regulations, in the United States and internationally,
including but not limited the U.S. Foreign Corrupt Practices (FCPA), the U.K. Bribery Act 2010, and other
applicable anti-bribery and corruption laws. Anti-corruption laws are interpreted broadly and prohibit corporations
and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an
official capacity. It is illegal to pay, offer to pay or authorize the payment of anything of value to any foreign
government official, government staff member, political party, or political candidate in an attempt to obtain or retain
business or to otherwise influence a person working in an official capacity. The FCPA also imposes accounting
standards and requirements on publicly traded U.S. corporations and their foreign affiliates, which are intended to
prevent the diversion of corporate funds to the payment of bribes and other improper payments. Recent years have
seen substantial increase in the global enforcement of anti-corruption laws. Our operations outside the United States
could increase the risk of such violations. Our business is also heavily regulated and involves significant interaction
with foreign officials. In many countries outside the U.S., independent clinical investigators conducting our clinical
trials and prescribers of our products are employed by government entities, and purchasers themselves can be
government entities. As such, our interactions with such investigators, prescribers and purchasers may be subject to
regulation under the FCPA, as well as other similar under anti-corruption laws and/or regulations enacted by other
countries. Failure to comply with these laws, where applicable, can result in significant penalties, including the
imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement,
imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal and equivalent foreign
healthcare programs, and additional reporting requirements and regulatory oversight, any of which could adversely
affect our ability to operate our business and our results of operations.
We could face liability if a regulatory authority determines that we are promoting INGREZZA, CRENESSITY, or
any of our product candidates that receives regulatory approval, for “off-label” uses.
A company may not promote “off-label” uses for its drug products. An off-label use is the use of a product for an
indication that is not described in the product’s FDA-approved label in the U.S. or for uses in other jurisdictions that
differ from those approved by the applicable regulatory agencies. Physicians, on the other hand, may prescribe
products for off-label uses. Although the FDA and other regulatory agencies do not regulate a physician’s choice of
drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications
from companies or their sales force with respect to off-label uses of products for which marketing clearance has not
been issued. However, companies may share truthful and not misleading information that is otherwise consistent
with a product’s FDA approved labeling. A company that is found to have promoted off-label use of its product may
be subject to significant liability, including civil and criminal sanctions.
40
If the FDA or any other governmental agency, including equivalent foreign authorities, initiates an enforcement
action against us, or if we are the subject of a qui tam suit brought by a private plaintiff o
f
n behalf of the government,
and it is determined that we violated prohibitions relating to the promotion of products for unapproved uses, we
could be subject to subs
u
tantial civil or criminal fines or damage awards and other sanctions such as consent decrees
and corpor
r
ate integrity agreements pursuant to which our activities would be subject to ongoing scrutiny and
monitoring to ensure compliance with applicable laws and regulations. Any such fines, awards or other sanctions
would have an adverse effe
f ct on our revenue, business, financial prospects and reputation.
If our inf
i
or
f
matio
r
n tech
t
nology
o
system
t
s, those thi
t
rd
i
parties upon which we rely, or our dat
d a i
t
s or w
i
ere
compromised, w
d
e could expe
x
rience adverse
r
impacts resulting
i
from such compromise, includin
d
g, but not limited
to, int
i
er
t
rupt
u io
t ns to our ope
o
rations such as our clinic
l
al trials, c
s
laims that we breached our dat
d a p
t
rotection
t
obligatio
t ns, h
s
arm t
r
o o
t
ur repu
e
tation, regu
e
latory investigat
i
io
t ns or actions, l
s itig
l
atio
t n, fine
i
s and penalties, and a loss
l
of custom
t
ers or s
r
ales.
l
We are increasingly dependent on information technology systems and infrastructur
t
e, including mobile technologies
and technology systems and infrastructur
t
e of third parties upon
u
whom we rely, including CROs and other vendors,
to operate our business. In the ordinary c
r
ourse of our business, we and the third parties upon
u
which we rely, collect,
receive, store, process, generate, disclose, make accessible, protect, dispose of, transmit, use, safeguard, share and
transfer
f , or collectively, process, confid
f ential and sensitive electronic information on our networks and in our data
centers. This infor
f
mation includes, among other things, de-identified or pseudonymous sensitive personal data
(including health data), our intellectua
t
l property and proprietary information, the confid
f ential information of our
collabor
a
ators and licensees, and the personal data of our employees. It is important to our operations and business
strategy that this electronic infor
f
mation remains secure and is perceived to be secure.
The size and complexity of our information technology systems, and those of third-party vendors with whom we
contract, and the volume of data we retain, make such systems potentially vulnerabl
a e to a variety of evolving threats,
including but not limited to social-engineering attacks (including through deep fakes, which may be increasingly
more difficult to identify as fake, and phishing attacks), malicious code, malware (such as malicious code, adware,
and command and control (C2)), denial-of-service attacks, credential harvesting, personnel misconduct or error,
ransomware attacks, supply-
u
chain attacks, software bugs, server malfunctions, softw
f
are or hardware fai
f lures, loss of
data or other infor
f
mation technology assets, attacks enhanced or facilitated by AI, telecommunications failures, and
other similar threats.
Cyber-attacks, malicious internet-based activity, online and offl
f ine fra
f ud, and other similar activities threaten the
confid
f entiality, integrity, and availabi
a lity of our sensitive information and information technology systems, and
those of the third parties upon which we rely. Such threats continue to rise, are increasingly diffi
f cult to detect, and
come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized
criminal threat actors, personnel (such as through theft o
f
r misuse), sophisticated nation states, and nation-state-
suppor
u
ted actors (also referred to as APTs). Some actors now engage and are expected to continue to engage in
cyber-attacks, including without limitation nation-state actors for geopol
f
itical reasons and in conjunction with
military conflic
f
ts and defen
f
se activities. During times of war and other major conflicts
f
, we and the third parties upon
u
which we rely may be vulnerabl
a e to a heightened risk of these attacks, including retaliatory cyber-attacks, which
could materially disrupt our
u
systems and operations, as well as our ability to conduct clinical trials.
Ransomware attacks are also becoming increasingly prevalent and severe, and can lead to significant interrupt
u ions in
our operations (including our ability to conduct clinical trials), loss of sensitive data (including related to our clinical
trials) and income, reputational harm, and diversion of funds. To alleviate the fin
f ancial, operational and reputational
impact of a ransomware attack, it may be preferabl
a e to make extortion payments, but we may be unwilling or unable
to do so (including, for example, if appl
a
icable laws or regulations prohibit such payments). Similarly, suppl
u
y chain
attacks have increased in frequency and severity, and we cannot guarantee that third parties in our suppl
u
y chain have
not been compromised or that they do not contain exploitabl
a e defects, vulnerabi
a lities, or bugs that could result in a
breach of or disrupt
r
ion to our information technology systems and infrastructur
t
e or the information technology
systems and infrastructur
t
e of third parties that support our operations.
Remote work has increased risks to our information technology systems and data, as certain of our employees work
from home, utilizing network connections, computers and devices outside our premises, including at home, while in
transit or in public locations.
41
Additionally, natural disasters, public health pandemics or epidemics, terrorism, war and geopolitical conflicts, and
telecommunication and electrical failures may result in damage to or the interruption or impairment of key business
processes, or the loss or corruption of confidential information, including intellectual property, proprietary business
information and personal data.
Future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity
risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or
integrated entities’ systems and technologies. Furthermore, we may discover security issues that were not found
during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our
information technology environment and security program.
As cyber threats continue to evolve, we may be required to expend significant additional resources to continue to
modify or enhance our protective measures or to investigate and remediate any information security vulnerabilities
or modify our business activities (including our clinical trial activities) to try to protect against security incidents.
We take steps designed to detect, mitigate, and remediate vulnerabilities in our information security systems (such as
our hardware and/or software, including that of third parties upon which we rely). We may not, however, detect and
remediate all such vulnerabilities including on a timely basis. Further, we may experience delays in developing and
deploying remedial measures and patches designed to address identified vulnerabilities. Vulnerabilities could be
exploited and result in a security incident.
We rely on third-party service providers and technologies to operate critical business systems to process sensitive
information in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities,
encryption and authentication technology, employee email and other functions. We also rely on third-party service
providers to provide other products, services, parts, or otherwise to operate our business, including clinical trial sites
and investigators, contractors, manufacturers, suppliers and consultants. Our ability to monitor these third parties’
information security practices is limited, and these third parties may not have adequate information security
measures in place. If our third-party service providers or CROs experience a security incident or other interruption,
we could experience adverse consequences. In addition, supply-chain attacks have increased in frequency and
severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’
supply chains have not been compromised or otherwise subject to a security incident. While we may be entitled to
damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any
award may be insufficient to cover our damages, or we may be unable to recover such award.
Although to our knowledge we, or the third parties upon who we rely, have not experienced a security incident or
disruption to date that is material to us, we and our vendors have been, either directly or indirectly, the target of
cybersecurity incidents and expect them to continue. While we have implemented security measures designed to
protect our data security and information technology systems, such measures may not prevent such events.
Furthermore, while we have implemented certain redundancies designed to avoid interruptions to our operations, not
all potential events can be anticipated and interruptions to our operations could lead to decreased productivity.
If we (or a third party upon whom we rely) experience a security incident, ransomware attack or are perceived to
have experienced a security incident, we may experience material adverse consequences. Such material
consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits and
inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information
(including personal data); litigation (including class claims); indemnification obligations; negative publicity;
reputational harm (including but not limited to damage to our patient, partner, or employee relationships); monetary
fund diversions; diversion of management’s attention; interruptions in our operations (including availability of data,
loss of connectivity to our network or internet); financial loss (including decreased productivity resulting from
interruptions in our operations); and other similar harms. Similarly, the loss of clinical trial data from completed or
ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase
our costs to recover or reproduce the data. In addition, theft of our intellectual property or proprietary business
information could require substantial expenditures to remedy. Applicable data privacy and security obligations may
also require us to notify relevant stakeholders, including affected individuals, customers, regulators, and investors,
of security incidents. Such disclosures are costly, and the disclosure or the failure to comply with such requirements
could lead to adverse consequences.
42
Our contracts, with for example third parties or CROs, may not contain limitations of liability, and even where they
do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities,
damages, or claims related to our data privacy and security obligations. We also cannot be sure that our insurance
coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and
security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or
that such coverage will pay future claims.
In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about
us from public sources, data brokers, or other means that reveals competitively sensitive details about our
organization and could be used to undermine our competitive advantage or market position. Additionally, our
sensitive information could be leaked, disclosed, or revealed as a result of or in connection with our employees’,
personnel’s, or vendors’ potential use of generative AI technologies.
If we fail to obtain or maintain orphan drug designation or other regulatory exclusivity for some of our product
candidates, our competitive position would be harmed.
In addition to any patent protection, we rely on forms of regulatory exclusivity to protect our products such as
orphan drug designation. A product candidate that receives orphan drug designation can benefit from a streamlined
regulatory process as well as potential commercial benefits following approval. Currently, this designation provides
market exclusivity in the U.S. for seven years and EU for 10 years if a product is the first such product approved for
such orphan indication. This market exclusivity does not, however, pertain to indications other than those for which
the drug was specifically designated in the approval, nor does it prevent other types of drugs from receiving orphan
designations or approvals in these same indications. Further, even after an orphan drug is approved, the FDA can
subsequently approve the same drug for the same condition if the FDA concludes that the product is clinically
superior to the orphan product or a market shortage occurs.
In the EU, orphan exclusivity may be reduced to six years if the drug no longer satisfies the original designation
criteria or can be lost altogether if the marketing authorization holder consents to a second orphan drug application
or cannot supply enough drug, or when a second applicant demonstrates its drug is “clinically superior” to the
original orphan drug.
If we do not have adequate patent protection for our products, then the relative importance of obtaining regulatory
exclusivity is even greater. We may not be successful obtaining orphan drug designations for any indications and,
even if we succeed, such product candidates with such orphan drug designations may fail to achieve FDA approval.
Even if a product candidate with orphan drug designation may receive marketing approval from the FDA, it may fail
to result in or maintain orphan drug exclusivity upon approval, which would harm our competitive position.
Changes in the FDA, other government agencies or comparable foreign regulatory authorities could hinder their
ability to hire and retain key leadership and other personnel, prevent new products and services from being
developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal
business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA or comparable foreign regulatory authorities to review and approve new products can be
affected by a variety of factors, including government budget and funding levels, ability to hire and retain key
personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times
at the FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies
or comparable foreign regulatory authorities on which our operations may rely, including those that fund research
and development activities, is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA, other government agencies or comparable foreign regulatory authorities may also slow the
time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would
adversely affect our business. For example, over the last several years, the U.S. government has shut down several
times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical
activities. If a prolonged government shutdown occurs, including as a result of reaching the debt ceiling, it could
significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could
have a material adverse effect on our business. Further, government shutdowns could impact our ability to access the
public markets and obtain additional capital in the future.
43
The technologies we use in our research as well as the drug targets we select may infringe the patents or violate
the proprietary rights of third parties.
We cannot assure you that third parties will not assert patent or other intellectual property infringement claims
against us or our collaborators with respect to technologies used in potential products. If a patent infringement suit
were brought against us or our collaborators, we or our collaborators could be forced to stop or delay developing,
manufacturing or selling potential products that are claimed to infringe a third party’s intellectual property unless
that party grants us or our collaborators rights to use its intellectual property. In such cases, we could be required to
obtain licenses to patents or proprietary rights of others in order to continue to commercialize our products.
However, we may not be able to obtain any licenses required under any patents or proprietary rights of third parties
on acceptable terms, or at all. Even if our collaborators or we were able to obtain rights to the third party’s
intellectual property, these rights may be non-exclusive, thereby giving our competitors access to the same
intellectual property. Ultimately, we may be unable to commercialize some of our potential products or may have to
cease some of our business operations as a result of patent infringement claims, which could severely harm our
business.
Our business operations may subject us to disputes, claims and lawsuits, which may be costly and time-
consuming and could materially and adversely impact our financial position and results of operations.
From time to time, we may become involved in disputes, claims and lawsuits relating to our business operations. In
particular, we may face claims related to the safety of our products, intellectual property matters, employment
matters, tax matters, commercial disputes, competition, sales and marketing practices, environmental matters,
personal injury, insurance coverage and acquisition or divestiture-related matters. Any dispute, claim or lawsuit may
divert management’s attention away from our business, we may incur significant expenses in addressing or
defending any dispute, claim or lawsuit, and we may be required to pay damage awards or settlements or become
subject to equitable remedies that could adversely affect our operations and financial results.
Litigation related to these disputes may be costly and time-consuming and could materially and adversely impact our
financial position and results of operations if resolved against us. In addition, the uncertainty associated with
litigation could lead to increased volatility in our stock price.
Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors
may engage in misconduct or other improper activities, including non-compliance with regulatory standards and
requirements.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees and independent
contractors, such as principal investigators, consultants, commercial partners and vendors, or by employees of our
commercial partners could include failures to comply with FDA regulations, to provide accurate information to the
FDA, to comply with manufacturing standards we have established, to comply with federal and state healthcare
fraud and abuse laws, to report financial information or data accurately, to maintain the confidentiality of our trade
secrets or the trade secrets of our commercial partners, or to disclose unauthorized activities to us. In particular,
sales, marketing and other business arrangements in the healthcare industry are subject to extensive laws intended to
prevent fraud, kickbacks, self-dealing and other abusive practices. Employee and independent contractor misconduct
could also involve the improper use of individually identifiable information, including, without limitation,
information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to
our reputation. Any action against our employees, independent contractors, principal investigators, consultants,
commercial partners or vendors for violations of these laws could result in significant civil, criminal and
administrative penalties, fines and imprisonment.
44
We face potential product liability exposure far in excess of our insurance coverage.
The use of any of our potential products in clinical trials, and the sale of any approved products, including
INGREZZA and CRENESSITY, may expose us to liability claims. These claims might be made directly by
consumers, healthcare providers, pharmaceutical companies or others selling our products. We have product liability
insurance coverage for both our clinical trials as well as related to the sale of INGREZZA and CRENESSITY in
amounts consistent with customary industry practices. However, our insurance may not reimburse us or may not be
sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming
increasingly expensive, and we may not be able to maintain insurance coverage at a reasonable cost or in sufficient
amounts to protect us against losses due to liability from any current or future clinical trials or approved products. A
successful product liability claim, or series of claims, brought against us would decrease our cash reserves and could
cause our stock price to fall. Furthermore, regardless of the eventual outcome of a product liability claim, any
product liability claim against us may decrease demand for our approved products, including INGREZZA and
CRENESSITY, damage our reputation, result in regulatory investigations that could require costly recalls or product
modifications, cause clinical trial participants to withdrawal, result in costs to defend the related litigation, decrease
our revenue, and divert management’s attention from managing our business.
Our activities involve hazardous materials, and we may be liable for any resulting contamination or injuries.
Our research activities involve the controlled use of hazardous materials. We cannot eliminate the risk of accidental
contamination or injury from these materials. If an accident occurs, a court may hold us liable for any resulting
damages, which may harm our results of operations and cause us to use a substantial portion of our cash reserves,
which would force us to seek additional financing.
We are subject to stringent and changing obligations related to data privacy and information security. Our actual
or perceived failure to comply with such obligations could have a material adverse effect on our reputation,
business, financial condition or results of operations.
In the ordinary course of our business, we process confidential and sensitive information, including personal data,
proprietary and confidential business data, trade secrets, intellectual property, data we collect about clinical trial
participants in connection with clinical trials, and sensitive third-party data, on our networks and in our data centers.
We are subject to numerous federal, state, local and foreign laws, orders, codes, regulations and regulatory guidance
regarding privacy, data protection, information security and the processing of personal information (including
clinical trial data), the number and scope of which are expanding, changing, subject to differing applications and
interpretations, and may be inconsistent among jurisdictions. Our data processing activities may also subject us to
other data privacy and security obligations, such as industry standards, external and internal privacy and security
policies, contracts and other obligations that govern the processing of data by us and by third parties on our behalf.
Laws regarding privacy, data protection, information security and the processing of personal data are becoming
increasingly common in the U.S. at both the federal and state level. Additionally, in the past few years, numerous
U.S. states—including California, Virginia, Colorado, Connecticut, and Utah—have enacted comprehensive privacy
laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy
notices and affording residents with certain rights concerning their personal data. As applicable, such rights may
include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing
activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may
impact our business and ability to provide our products and services. Certain states also impose stricter requirements
for processing certain personal data, including sensitive information, such as conducting data privacy impact
assessments. These state laws allow for statutory fines for noncompliance. For example, the California Consumer
Privacy Act, as amended by the California Privacy Rights Act of 2020 (collectively, CCPA), requires businesses to
provide specific disclosures in privacy notices, and honor requests of California residents to exercise certain privacy
rights. The CCPA allows for fines for noncompliance (up to $7,500 per intentional violation). Although some U.S.
comprehensive privacy laws and the CCPA exempt some data processed in the context of clinical trials, these laws
may increase compliance costs and potential liability with respect to other personal data we may maintain about
California residents. Other states have also enacted data privacy laws and we expect more jurisdictions to pass
similar laws in the future. These developments may further complicate compliance efforts, and may increase legal
risk and compliance costs for us and the third parties upon whom we rely.
45
Additionally, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and
transmission of individually identifiable health information.
Laws in Europe regarding privacy, data protection, information security and the processing of personal data have
also been significantly reformed and continue to undergo reform. For example, the EU’s General Data Protection
Regulation (EU GDPR) and the UK’s GDPR (UK GDPR) (collectively, GDPR) impose strict requirements for
processing the personal data of individuals located, respectively, within the European Economic Area (EEA) and the
UK, and the Swiss Federal Act on Data Protection similarly applies to the collection and processing of personal data,
including health-related information, in Switzerland. The GDPR provides for enhanced data protection obligations
for processors and controllers of personal data, including, for example, obligations relating to: processing health and
other sensitive data; obtaining consent of individuals; providing notice to individuals regarding data processing
activities; responding to data subject requests; taking certain measures when engaging third-party processors;
notifying data subjects and regulators of data breaches; and implementing safeguards to protect the security and
confidentiality of personal data. The GDPR impose substantial fines for breaches of data protection requirements.
For example, under the GDPR, such fines can be up to four percent of global revenue or 20 million euros under the
EU GDPR / 17.5 million pounds sterling under the UK GDPR, whichever is greater in either case, and also allow for
private litigation related to processing of personal data brought by classes of data subjects or consumer protection
organizations authorized at law to represent their interests. The GDPR and other changes in laws or regulations
associated with the enhanced protection of certain types of sensitive data, such as EU regulations governing clinical
trial data and other healthcare data, could require us to change our business practices or lead to government
enforcement actions, private litigation or significant penalties against us and could have a material adverse effect on
our business, financial condition or results of operations.
We may be subject to additional foreign data laws. For example, in Canada, the Personal Information Protection and
Electronic Documents Act (PIPEDA) and various related provincial laws, as well as Canada’s Anti-Spam
Legislation (CASL), may apply to our operations. As another example, the General Data Protection Law, Lei Geral
de Proteção de Dados Pessoais (LGPD) (Law No. 13,709/2018), may apply to our operations. The LGPD broadly
regulates processing personal data of individuals in Brazil and imposes compliance obligations and penalties
comparable to those of the EU GDPR. We also target customers in Asia and may be subject to new and emerging
data privacy regimes in Asia, including Japan’s Act on the Protection of Personal Information and Singapore’s
Personal Data Protection Act.
In the ordinary course of business, we may transfer personal data from Europe and other jurisdictions to the U.S. or
other countries. Certain jurisdictions have enacted data localization laws and cross-border personal data transfers
laws. For example, countries in the EEA and the UK have significantly restricted the transfer of personal data to the
U.S. and other countries, whose privacy laws it generally believes are inadequate. Although there are currently
various mechanisms that may be used to transfer personal data from the EEA and UK to the U.S. in compliance with
law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum,
and the EU-U.S. Data Privacy Framework and the UK extension thereto (which allows for transfers for to relevant
U.S.-based organizations who self-certify compliance and participate in the Framework), these mechanisms are
subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully
transfer personal data to the U.S. If we cannot implement a valid compliance mechanism for cross-border personal
data transfers or if the requirements for a legally-compliant transfer are too onerous, we may face increased exposure
to regulatory actions, substantial fines and injunctions against processing or transferring personal data from Europe
or elsewhere. The inability to import personal data to the U.S. may significantly and negatively impact our business
operations, including by limiting our ability to conduct clinical trial activities in Europe and elsewhere; limiting our
ability to collaborate with parties subject to European and other data protection laws or requiring us to increase our
personal data processing capabilities in Europe and/or elsewhere at significant expense. Other jurisdictions may
adopt or have already adopted similarly stringent interpretations of their data localization and cross-border data
transfer laws. Additionally, companies that transfer personal data out of the EEA and UK to other jurisdictions,
particularly to the U.S., are subject to increased scrutiny from regulators, individual litigants, and activist groups.
Some European regulators have ordered certain companies to suspend or permanently cease certain transfers out of
Europe for allegedly violating the GDPR’s cross-border data transfer limitations.
46
Our employees and personnel are permitted to use generative AI technologies to perform some of their work, and
the disclosure and use of personal information data in generative AI technologies is subject to various privacy laws
and other privacy obligations. Governments have passed and are likely to pass additional laws regulating generative
AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and
consumer lawsuits. Furthermore, any use of generative AI to develop our proprietary technology and compounds
may also impact our ability to obtain or successfully defend certain intellectual property rights. If we are unable to
use generative AI, it could make our business less efficient and result in competitive disadvantages.
In addition to data privacy and security laws, we may contractually be subject to industry standards adopted by
industry groups and, we are, or may become subject to such obligations in the future. We are also bound by
contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not
be successful. We publish privacy policies, marketing materials and other statements regarding data privacy and
security. Regulators in the U.S. are increasingly scrutinizing these statements, and if these policies, materials or
statements are found to be deficient, lacking in transparency, deceptive, unfair, misleading, or misrepresentative of
our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences.
Our obligations related to data privacy and security (and consumers’ data privacy expectations) are quickly changing
in an increasingly stringent fashion and creating uncertainty. These obligations may be subject to differing
applications and interpretations, which may be inconsistent among jurisdictions or in conflict. Preparing for and
complying with these obligations requires us to devote significant resources (including, without limitation, financial
and time-related resources). These obligations may necessitate changes to our information technologies, systems and
practices and those of any third parties that process personal data on our behalf. In addition, these obligations may
even require us to change our business model.
Although we endeavor to comply with all applicable data privacy and security obligations, we may at times fail (or
be perceived to have failed) to do so. Moreover, despite our efforts, our personnel or third-parties upon whom we
rely may fail to comply such obligations that impacts our compliance posture. If we fail, or are perceived to have
failed, to address or comply with data privacy and security obligations, we could face significant consequences.
These consequences may include, but are not limited to, government enforcement actions, litigation (including class
claims), additional reporting requirements and/or oversight, bans on processing personal data, imprisonment of
company officials, and orders to destroy or not use personal data. In particular, plaintiffs have become increasingly
more active in bringing privacy-related claims against companies, including class claims and mass arbitration
demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable,
carry the potential for monumental statutory damages, depending on the volume of data and the number of
violations. Any of these events could have a material adverse effect on our reputation, business, financial condition
or results of operations.
Item 1B. Unresolved Staff Comments
None.
Item 1C. Cybersecurity
Risk Management and Strategy
We rely on information technology and data to operate our business and develop, market, and deliver our therapies
to our customers. We have implemented and maintain various information security processes designed to identify,
assess and manage material risks from cybersecurity threats to critical computer networks, third party hosted
services, communications systems, hardware, lab equipment, software, and our critical data includes confidential,
personal, proprietary, and sensitive data (collectively “Information Assets”). Accordingly, we maintain certain risk
assessment processes intended to identify cybersecurity threats, determine their likelihood of occurring, and assess
potential material impact to our business. Based on our assessment, we implement and maintain risk management
processes designed to protect the confidentiality, integrity, and availability of our Information Assets and mitigate
harm to our business.
The Company’s general risk management program is designed to manage identified material risks, which would
include material cybersecurity risks.
47
We engage in processes designed to identify such threats by, among other things, monitoring the threat environment
using manual and automated tools, subscribing to reports and services that identify cybersecurity threats, analyzing
reports of threats and actors, conducting scans of the threat environment, evaluating our and our industry’s risk
profile, evaluating threats reported to us, coordinating with law enforcement concerning threats, conducting threat
assessments for internal and external threats, and conducting vulnerability assessments to identify vulnerabilities.
We rely on a multidisciplinary team (including from our information security function, management, and third party
service providers, as described further below) to assess how identified cybersecurity threats could impact our
business. These assessments may leverage, among other processes, industry tools and metrics designed to assist in
the assessment of risks from such cybersecurity threats.
Depending on the environment, we implement and maintain various technical, physical and organizational measures
designed to manage and mitigate material risks from cybersecurity threats to our Information Assets. The
cybersecurity risk management and mitigation measures we implement for certain of our Information Assets
include: policies and procedures designed to address cybersecurity threats, including an incident response plan,
vulnerability management policy, and disaster recovery/business continuity plans; incident detection and response
tools; internal and/or external audits to assess our exposure to cybersecurity threats, environment, compliance with
risk mitigation procedures, and effectiveness of relevant controls; documented risk assessments; implementation of
security standards/certifications; credit and background checks on our and/or third parties’ personnel; encryption of
data; network security controls; threat modeling; data segregation; physical and electronic access controls; physical
security; asset management, tracking and disposal; systems monitoring; vendor risk management program;
employee security training; penetration testing; red/blue team exercises; cyber insurance; dedicated cybersecurity
staff/officer.
We work with third parties from time to time that assist us from time to time to identify, assess, and manage
cybersecurity risks, including professional services firms, threat intelligence service providers, cybersecurity
consultants, cybersecurity software providers, managed cybersecurity service providers, and penetration testing.
To operate our business, we utilize certain third-party service providers to perform a variety of functions, such as
outsourced business critical functions, clinical research, professional services, SaaS platforms, managed services,
property management, cloud-based infrastructure, data center facilities, content delivery, encryption and
authentication technology, corporate productivity services, and other functions. We have certain vendor
management processes designed to help to manage cybersecurity risks associated with our use of certain of these
providers. Depending on the nature of the services provided, the sensitivity and quantity of information processed,
and the identity of the service provider, our vendor management process may include reviewing the cybersecurity
practices of such provider, contractually imposing obligations on the provider related to the services they provide
and/or the information they process, conducting security assessments, conducting on-site inspections, requiring their
completion of written questionnaires regarding their services and data handling practices, and conducting periodic
re-assessments during their engagement.
For a description of the risks from cybersecurity threats that may materially affect us and how they may do so, refer
to Part I, Item 1A. Risk Factors for additional information about cybersecurity-related risks.
Governance
Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company
management, including a Chief Information Officer, who reports to the CFO. Management is also responsible for
hiring appropriate personnel, integrating cybersecurity considerations into the company’s overall risk management
strategy, and for communicating key priorities to employees, as well as for approving budgets, helping prepare for
cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-
related reports. Our cybersecurity incident response and vulnerability management processes involve management,
who participates in our disclosure controls and procedures.
Our cybersecurity incident response and vulnerability management processes are designed to escalate certain
cybersecurity incidents and vulnerabilities to members of management depending on the circumstances, including
work with the company’s incident response team to help the company mitigate and remediate cybersecurity
incidents of which they are notified. In addition, the company’s incident response processes include reporting to the
Audit committee of the board of directors for certain cybersecurity incidents.
48
Management is involved with the Company’s efforts to prevent, detect, and mitigate cybersecurity incidents by
overseeing preparation of cybersecurity policies and procedures, testing of incident response plans, engagement of
vendors to conduct penetration tests. Management participates in cybersecurity incident response efforts by being a
member of the incident response team and helping direct the company’s response to cybersecurity incidents.
Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight
function. The board of directors’ audit committee is responsible for overseeing the company’s cybersecurity risk
management processes, including oversight and mitigation of risks from cybersecurity threats. The audit committee
also has access to various reports, summaries or presentations related to cybersecurity threats, risk, and mitigation.
Item 2. Properties
The following table presents information on our leased facilities.
Location
Use
Square Feet
Expiration Date
Pacific Highlands Ranch in San Diego, California
Corporate Headquarters, Office and Laboratory
535,000
October 31, 2036
Carmel Valley in San Diego, California
Office and Laboratory
229,000
(1)
July 31, 2031
Carmel Valley in San Diego, California
Office
45,000
(2)
April 30, 2029
_________________________
(1) This property is associated with our former corporate headquarters. 73,000 square feet is subleased by multiple
companies for general office space through the remaining term of the lease and we are actively marketing an
additional 141,000 square feet for sublease.
(2) This property is associated with our former corporate headquarters. We are actively marketing this property for
sublease.
Item 3. Legal Proceedings
For a description of our legal proceedings, refer to Note 15 to the consolidated financial statements, which is
incorporated herein by reference.
Item 4. Mine Safety Disclosures
None.
49
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
Our common stock is traded on the Nasdaq Global Select Market under the symbol “NBIX”.
As of February 5, 2025, there were 39 stockholders of record of our common stock. We have not paid any cash
dividends on our common stock since inception and do not anticipate paying cash dividends in the foreseeable
future.
Recent Sales of Unregistered Securities
There were no unregistered sales of our equity securities during 2024.
Issuer Purchases of Equity Securities
In October 2024, our Board of Directors authorized a share repurchase program to repurchase up to $300.0 million
of the Company’s common stock. Through the end of the fourth quarter of 2024, we have repurchased shares of the
Company’s common stock having a value of $240.5 million under this program. The number of shares and average
price paid per share for shares repurchased in each month of the fourth quarter of 2024 are set forth in the table
below:
Period
Total Number of
Shares
Repurchased
Average Price
Paid
Per Share
Total Number of
Shares Purchased as
Part of Publicly
Announced Program (1)
Dollar Value of
Shares that May Yet
Be Purchased
Under the Program (1)
October 2024
—
$
—
—
$
300,000,000
November 2024 (1)
1,995,510
$
120.53
1,995,510
$
59,481,180
December 2024
—
$
—
—
$
59,481,180
1,995,510
$
120.53
1,995,510
_________________________
(1) In November 2024, we paid $300.0 million under an accelerated share repurchase (ASR) transaction and received an initial
delivery of 2.0 million shares. The ASR transaction terminated in February 2025, at which time we became contractually
entitled to receive an additional 0.3 million shares upon settlement. Refer to Note 6 to the consolidated financial statements.
50
STOCK PERFORMANCE GRAPH AND CUMULATIVE TOTAL RETURN*
The following graph presents the cumulative total stockholder return assuming the investment of $100 on
December 31, 2019 (and the reinvestment of dividends thereafter) in each of (i) Neurocrine Biosciences, Inc.’s
common stock, (ii) the Nasdaq Composite Index and (iii) the Nasdaq Biotechnology Index. The comparisons in the
graph below are based upon historical data and are not indicative of, or intended to forecast, future performance of
our common stock or Indexes.
Neurocrine Biosciences, Inc.
Nasdaq Composite
Nasdaq Biotechnology
12/2019
12/2020
12/2021
12/2022
12/2023
12/2024
50
75
100
125
150
175
200
225
* The material in this section is not “soliciting material”, is not deemed “filed” with the Securities and Exchange
Commission and is not to be incorporated by reference into any of our SEC filings whether made before or after the
date hereof and irrespective of any general incorporation language in any such SEC filing except to the extent we
specifically incorporate this section by reference.
51
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of
Operations
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations section
contains forward-looking statements pertaining to, among other things, the commercialization of our product and
product candidates, the expected continuation of our collaborative agreements, the progress, timing, results or
implications of clinical trials and other development activities, our plans and timing with respect to seeking
regulatory approvals, the period of time that our existing capital resources will meet our funding requirements, and
our financial results of operations. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of various risks and uncertainties, including those set forth in this Annual
Report on Form 10-K under the heading “Item 1A. Risk Factors.” See “Forward-Looking Statements” in Part I of
this Annual Report on Form 10-K.
Overview
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve
suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing
treatments for patients with under-addressed neuropsychiatric, neurological, and neuroendocrine disorders.
Our portfolio of products includes U.S. Food and Drug Administration (FDA) approved treatments for tardive
dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia (CAH), and
endometriosis and uterine fibroids in collaboration with AbbVie Inc. (AbbVie). In addition, we have a diversified
portfolio of multiple compounds in mid- to late-phase development across our core therapeutic areas and an
expanding early-phase pipeline that includes a range of modalities including small molecules, peptides, proteins,
antibodies, and gene therapy.
We launched INGREZZA® (valbenazine) in the U.S. as the first FDA-approved drug for the treatment of tardive
dyskinesia in May 2017 and for the treatment of chorea associated with Huntington's disease in August 2023 and
launched CRENESSITYTM (crinecerfont) in the U.S. as a first-in-class FDA-approved treatment of CAH in
December 2024.
We estimate that tardive dyskinesia affects approximately 800,000 people in the U.S., that approximately 90% of the
40,000 people in the U.S. affected by Huntington’s disease will develop chorea, and that CAH affects approximately
30,000 people in the U.S. Key elements of our commercial strategy include maximizing the opportunities in
INGREZZA and CRENESSITY through consistent and effective commercial execution, continued development of
valbenazine as the best-in-class treatment for new patient populations, and to lead the evolving understanding of
VMAT2 biology and its role in disease. INGREZZA net product sales totaled $2.3 billion for 2024, $1.8 billion for
2023, and $1.4 billion for 2022 and accounted for substantially all of our total net product sales during each of these
years.
Our partner Mitsubishi Tanabe Pharma Corporation (MTPC) launched DYSVAL® (valbenazine) in Japan for the
treatment of tardive dyskinesia in June 2022 and subsequently in other select Asian markets, where it is marketed as
REMLEAS® (valbenazine). We receive royalties at tiered percentage rates on MTPC net sales of valbenazine.
Our partner AbbVie launched ORILISSA® (elagolix tablets) in the U.S. for the treatment of endometriosis in August
2018 and ORIAHNN® (elagolix, estradiol and norethindrone acetate capsules and elagolix capsules) in the U.S. for
the treatment of heavy menstrual bleeding due to uterine fibroids in June 2020. We receive royalties at tiered
percentage rates on AbbVie net sales of elagolix.
Business Highlights
• INGREZZA net product sales for 2024 increased $477.5 million, or 26.0%, to $2.3 billion, reflecting strong
underlying patient demand and improved gross-to-net dynamics.
• In December 2024, we received FDA approval for CRENESSITY capsules and oral solution as an adjunctive
treatment of CAH and launched CRENESSITY in the U.S. as a first-in-class FDA-approved treatment of CAH.
We estimate that CAH affects approximately 30,000 people in the U.S.
52
• Kevin Gorman, Ph.D., retired as Chief Executive Officer (CEO) effective October 11, 2024. Kyle Gano, Ph.D.,
formerly Neurocrine’s Chief Business Development and Strategy Officer, succeeded Dr. Gorman in the CEO role
and also joined the Company’s Board of Directors at that time. Dr. Gorman continues to serve on the Company’s
Board.
• Received notification from the Centers for Medicare and Medicaid Services that INGREZZA qualified for the
Specified Small Manufacturer Exception pertaining to the Part D redesign of the Inflation Reduction Act.
• Settled the convertible senior notes due May 15, 2024 (the 2024 Notes) in full in cash upon maturity.
• Deployed expanded INGREZZA psychiatry and long-term care sales teams to better serve patients by accelerating
the number of people who are diagnosed and treated for tardive dyskinesia and chorea associated with
Huntington's disease with INGREZZA.
• Repurchased and retired an initial delivery of 2.0 million shares of the Company’s common stock pursuant to
previously announced $300.0 million accelerated share repurchase (ASR) program. The program was completed
in February 2025, at which time we became contractually entitled to receive an additional 0.3 million shares upon
settlement.
Pipeline Highlights
• Announced the initiation of the Phase 3 program for osavampator (formerly NBI-1065845), a potential first-in-
class alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM)
in development for patients with inadequate response to treatment of major depressive disorder (MDD).
• Announced amendment to strategic collaboration with Takeda Pharmaceutical Company Limited (Takeda) to
develop and commercialize osavampator. Under the amended agreement, we will retain exclusive rights for all
indications to develop and commercialize osavampator in all territories worldwide except Japan, where Takeda
will have exclusive rights. Under the terms of the updated agreement, each company is responsible for
development costs in their respective region, and both companies are eligible to receive royalty payments.
• Announced the initiation of the Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of investigational compound NBI-921355 in healthy adult participants. NBI-921355 is an
investigational, selective inhibitor of voltage-gated sodium channels Nav1.2 and Nav1.6 and in development for
the potential treatment of certain types of epilepsy.
• Presented subgroup analyses and data from the KINECT®-HD study showing the impact of INGREZZA capsules
on emotional health and psychiatric stability in patients with chorea associated with Huntington's disease. The
subgroup analysis showed consistent efficacy in reducing chorea compared to placebo across all identified
subgroups, categorized by demographics and baseline assessment scores. A separate data analysis showed
improvements in some aspects of emotional health with no worsening of psychiatric symptoms.
• Presented data from more than 300 patients diagnosed with tardive dyskinesia and treated with INGREZZA
capsules. These data showed significant improvements in functional, social, emotional, and health-related quality
of life measures in Phase 3 and 4 studies and improvements in functional, social, independence, emotional, and
physical aspects of patients' lives and antipsychotic adherence in real-world practice.
• Announced positive topline data for the Phase 2 study of NBI-1117568, a first-in-class, orally active, highly
selective investigational M4 agonist, in development as a potential treatment for schizophrenia. The successful
completion of the Phase 2 study triggered a $35.0 million milestone payment to Nxera Pharma UK Limited
(Nxera) in 2024. We expect to advance NBI-1117568 into Phase 3 development in the first half of 2025, which
would trigger an additional $15.0 million milestone payment to Nxera upon initiation of the Phase 3 study.
• Announced positive topline data for the Phase 2 SAVITRI™study. This randomized, double-blind, placebo-
controlled dose-finding study assessed the efficacy and safety of osavampator in adult subjects with MDD.
• At the Endocrine Society Annual Meeting (ENDO 2024), presented new Phase 3 clinical study data from the
CAHtalyst™registrational studies of crinecerfont in pediatric and adult patients with CAH. In parallel, announced
that the primary study results from the CAHtalyst™registrational studies of crinecerfont in pediatric and adult
patients with CAH have been published in The New England Journal of Medicine.
• Initiated Phase 2 study of NBI-1070770 in adults with MDD. NBI-1070770 is a novel, selective, and orally active,
negative allosteric modulator (NAM) of the NR2B subunit-containing N-methyl-D-aspartate (NMDA NR2B)
receptor.
53
• Initiated Phase 1 study of NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/
M4 (M1 preferring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric
conditions.
• Initiated Phase 1 study of NBI-1076968 in healthy adult participants. NBI-1076968 is an investigational, oral, M4
subtype-selective muscarinic antagonist for the potential treatment of movement disorders.
• Received approval from the FDA for INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules
formulation of INGREZZA capsules, and subsequently launched new sprinkle formulation of INGREZZA
capsules for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease.
• Presented KINECT®-HD2 interim data at the 2024 MDS International Congress of Parkinson’s Disease and
Movement Disorders demonstrating robust and sustained improvements in chorea associated with Huntington’s
disease through week 104 irrespective of antipsychotic use.
• Announced the ERUDITE™Phase 2 study of luvadaxistat (NBI-1065844) in cognitive impairment associated
with schizophrenia (CIAS) did not meet its primary endpoint. In addition, we provided Takeda with written notice
of termination of the license agreement to develop and commercialize luvadaxistat and NBI-1065846. The
termination is anticipated to be effective in April 2025.
• Provided Idorsia Pharmaceuticals Ltd. with written notice of termination of the license agreement to develop and
commercialize NBI-827104. The termination became effective in January 2025.
Results of Operations
Revenues
Net Product Sales
Year Ended December 31,
(in millions)
2024
2023
2022
INGREZZA
$
2,313.5
$
1,836.0
$
1,427.8
Other
17.1
24.6
13.1
Total net product sales
$
2,330.6
$
1,860.6
$
1,440.9
For 2024 compared to 2023, the increase primarily reflected increased INGREZZA net product sales driven by
strong underlying patient demand and improved gross-to-net dynamics.
For 2023 compared to 2022, the increase primarily reflected increased INGREZZA net product sales on higher
prescription demand and increased commercial activities, including continued investment in our branded direct-to-
consumer INGREZZA advertising campaign and benefit from the expansion of our sales force completed in April
2022.
Collaboration Revenues by Category
Year Ended December 31,
(in millions)
2024
2023
2022
Royalty revenue
$
18.6
$
21.2
$
22.3
Milestones
—
—
20.0
Collaboration and other
6.1
5.3
5.5
Total collaboration revenues
$
24.7
$
26.5
$
47.8
Total collaboration revenues for all periods presented primarily reflected royalty revenue earned on AbbVie net sales
of elagolix and MTPC net sales of valbenazine.
For 2023 compared to 2022, the decrease reflected the achievement of a $20.0 million milestone in 2022 in
connection with MTPC's first commercial sale of DYSVAL in Japan.
54
Operating Expenses
Cost of Revenues
Year Ended December 31,
(in millions)
2024
2023
2022
Cost of revenues
$
34.0
$
39.7
$
23.2
For 2024 compared to 2023, the decrease primarily reflected the impact of decreased ONGENTYS® (opicapone) net
product sales and lower ONGENTYS inventory reserves in connection with the termination of our license
agreement with BIAL, which became effective in December 2023, partially offset by the impact of increased
INGREZZA net product sales.
For 2023 compared to 2022, the increase primarily reflected increased INGREZZA and other net product sales,
increased amortization costs related to intangible assets, increased reserves for ONGENTYS inventory obsolescence
in connection with the termination of our license agreement with BIAL, and increased manufacturing costs in
connection with our supply of valbenazine drug product under our collaboration with MTPC.
Research and Development
We support our drug discovery and development efforts through the commitment of significant resources to
discovery, research and development programs, and business development opportunities. Costs are reflected in the
applicable development stage based upon the program status when incurred. Therefore, the same program could be
reflected in different development stages in the same reporting period. For several of our programs, the research and
development activities are part of our collaborative arrangements.
Year Ended December 31,
(in millions)
2024
2023
2022
Late stage
$
101.8
$
106.1
$
68.7
Early stage
96.1
107.4
81.1
Research and discovery
145.6
96.5
63.7
Milestones
71.7
0.8
42.7
Payroll and benefits
236.7
206.7
163.8
Facilities and other
79.2
47.5
43.8
Research and development
$
731.1
$
565.0
$
463.8
Late Stage. Late stage consists of costs incurred for product candidates in Phase 2 registrational studies and all
subsequent activities.
For 2024 compared to 2023, the decrease primarily reflected the successful completions of the Phase 3 programs for
crinecerfont in CAH and Phase 2 program for EFMODY in CAH, partially offset by increased investments in
advancing Phase 3 programs for osavampator in MDD and NBI-1117568 in schizophrenia.
For 2023 compared to 2022, the increase primarily reflected increased investments in the Phase 3 programs for
crinecerfont in CAH and valbenazine in schizophrenia and Phase 2 program for EFMODY in CAH.
Early Stage. Early stage consists of costs incurred for product candidates after the approval of an investigational new
drug application by the applicable regulatory agency through Phase 2 non-registrational studies.
For 2024 compared to 2023, the decrease primarily reflected lower spend on certain early-stage programs in
epilepsy and psychiatry, including the successful completions of the Phase 2 programs for osavampator in MDD and
NBI-1117568 in schizophrenia, partially offset by increased investments in the Phase 2 program for NBI-1070770 in
MDD and certain early-stage muscarinic programs.
For 2023 compared to 2022, the increase primarily reflected increased investments in certain early-stage programs in
psychiatry, partially offset by lower spend on early-stage programs in epilepsy.
55
Research and Discovery. Research and discovery consists of costs incurred prior to the approval of an
investigational new drug application by the applicable regulatory agency.
For 2024 compared to 2023, the increase reflected increased investments in gene therapy and other preclinical
development programs.
For 2023 compared to 2022, the increase reflected increased investments in preclinical development programs,
including muscarinic agonists, gene therapy, and second generation VMAT2 inhibitors.
Milestones. Milestones consists of costs incurred in connection with the achievement of development milestones
under our collaborative arrangements.
For 2024 compared to 2023, the increase reflected increased expense recognized in connection with development
milestones achieved under our collaborations with Nxera, Takeda, and Voyager Therapeutics, Inc. (Voyager).
For 2023 compared to 2022, the decrease primarily reflected decreased expense recognized in connection with
development milestones achieved under our collaborations with Nxera, Xenon Pharmaceuticals Inc. (Xenon), and
Takeda.
Payroll and Benefits. Payroll and benefits consists of costs incurred for salaries and wages, payroll taxes, benefits
and stock-based compensation associated with employees involved in research and development activities. Stock-
based compensation may fluctuate from period to period based on factors that are not within our control, such as our
stock price on the dates stock-based grants are issued.
For 2024 compared to 2023, the increase primarily reflected higher headcount.
For 2023 compared to 2022, the increase primarily reflected higher headcount and increased non-cash stock-based
compensation expense primarily driven by a charge related to a change in equity grant agreement terms in 2023.
Facilities and Other. Facilities and other consists of indirect costs incurred for the benefit of multiple programs,
including depreciation, information technology, and other facility-based expenses, such as rent expense.
For 2024 compared to 2023, the increase primarily reflected increased facility-based expenses related to our new
campus facility.
Acquired In-Process Research and Development (IPR&D)
Year Ended December 31,
(in millions)
2024
2023
2022
Acquired in-process research and development
$
12.5
$
143.9
$
—
For 2024, IPR&D expense primarily reflected the payment of a $6.0 million upfront fee pursuant to our
collaboration with Biocytogen Pharmaceuticals (Beijing) Co., Ltd.
For 2023, IPR&D expense reflected the payment of a $143.9 million upfront fee pursuant to the expansion of our
collaboration with Voyager.
Selling, General, and Administrative (SG&A)
Year Ended December 31,
(in millions)
2024
2023
2022
Selling, general, and administrative
$
1,007.2
$
887.6
$
752.7
For 2024 compared to 2023, the increase primarily reflected continued investment in our commercial organization,
including the recent expansion of our psychiatry and long-term care sales team in September 2024, pre-launch
CRENESSITY activities, increased facility expenses related to our new campus facility, and impairment charges of
$14.0 million associated with leased office space that has been vacated as we continue to occupy our new campus
facility.
For 2023 compared to 2022, the increase primarily reflected increased investment in our commercial initiatives,
including our branded direct-to-consumer INGREZZA advertising campaign and deployment of our expanded
salesforce completed in April 2022, and increased payroll and benefits expenses on higher headcount and increased
non-cash stock-based compensation expense primarily driven by a charge related to a change in equity grant
agreement terms in 2023.
56
Other (Expense) Income, Net
Year Ended December 31,
(in millions)
2024
2023
2022
Unrealized (loss) gain on equity investments
$
(37.1) $
28.4
$
30.8
Charges associated with convertible senior notes
(138.4)
—
(70.0)
Investment income and other, net
91.0
52.8
4.1
Total other (expense) income, net
$
(84.5) $
81.2
$
(35.1)
For 2024 compared to 2023, the increase in total other expense, net, primarily reflected $138.4 million of expense
recognized in connection with conversions of the 2024 Notes upon maturity in May 2024 and periodic fluctuations
in the fair values of our equity investments, partially offset by increased interest income on our debt security
investments.
For 2023 compared to 2022, the increase in total other income, net, primarily reflected increased interest income on
our debt security investments and decreased debt extinguishment charges in connection with the repurchase of the
2024 Notes in 2022.
Provision for Income Taxes
Year Ended December 31,
(in millions)
2024
2023
2022
Provision for income taxes
$
144.7
$
82.4
$
59.4
For 2024 and 2023, the effective tax rate varied from the federal and state statutory rates primarily due to credits
generated for research activities, certain nondeductible expenses, excess tax benefits related to stock-based
compensation, and losses incurred in foreign jurisdictions for which no tax benefit was recorded as management
cannot conclude that it is more likely than not that the tax benefit of such losses will be realized in the future.
Additionally, in 2024, we incurred a loss on the extinguishment of debt that was nondeductible for tax purposes.
For 2022, the effective tax rate varied from the federal and state statutory rates primarily due to credits generated for
research activities and certain nondeductible expenses, including the premium paid on the repurchase of the 2024
Notes in 2022.
Net Income
Year Ended December 31,
(in millions)
2024
2023
2022
Net income
$
341.3
$
249.7
$
154.5
For 2024 compared to 2023, the increase primarily reflected increased INGREZZA net product sales and decreased
total payments for upfront fees and development milestones achieved in connection with our collaborations, partially
offset by $138.4 million of expense recognized in connection with conversions of the 2024 Notes upon maturity in
May 2024, periodic fluctuations in the fair values of our equity investments, and continued investments in our
commercial organization, including pre-launch CRENESSITY activities, and expanded pre-clinical and clinical
portfolios.
For 2023 compared to 2022, the increase primarily reflected increased INGREZZA net product sales, increased
interest income on our debt security investments, and decreased debt extinguishment charges in connection with the
repurchase of the 2024 Notes in 2022, partially offset by increased total payments for upfront fees and development
milestones achieved in connection with our collaborations and increased investments in our commercial initiatives
and expanded clinical portfolio.
57
Liquidity and Capital Resources
Sources of Liquidity
We believe that our existing capital resources, funds generated by anticipated INGREZZA net product sales, and
investment income will be sufficient to satisfy our current and projected funding requirements for at least the next 12
months. However, we cannot guarantee that our existing capital resources and anticipated revenues will be sufficient
to conduct and complete all of our research and development programs or commercialization activities as planned.
We may seek to access the public or private equity markets whenever conditions are favorable or pursue
opportunities to obtain debt financing in the future. We may also seek additional funding through strategic alliances
or other financing mechanisms. However, we cannot provide assurance that adequate funding will be available on
terms acceptable to us, if at all.
Information Regarding Our Financial Condition
December 31,
(in millions)
2024
2023
Total cash, cash equivalents and marketable securities
$
1,815.6
$
1,719.1
Working Capital:
Total current assets
$
1,724.7
$
1,607.0
Less total current liabilities
507.7
654.8
Total working capital
$
1,217.0
$
952.2
Information Regarding Our Cash Flows
Year Ended December 31,
(in millions)
2024
2023
2022
Cash flows from operating activities
$
595.4
$
389.9
$
339.4
Cash flows from investing activities
(126.8)
(467.1)
(177.1)
Cash flows from financing activities
(486.7)
65.3
(234.3)
Effect of exchange rate changes on cash and cash equivalents
—
0.3
(1.3)
Change in cash, cash equivalents and restricted cash
$
(18.1) $
(11.6) $
(73.3)
Cash Flows from Operating Activities
For 2024 compared to 2023, the increase primarily reflected increased INGREZZA net product sales and decreased
total payments for upfront fees and development milestones achieved in connection with our collaborations, partially
offset by increased payments for income taxes and continued investments in our commercial organization, including
pre-launch CRENESSITY activities, and expanded pre-clinical and clinical portfolios.
For 2023 compared to 2022, the increase primarily reflected increased INGREZZA net product sales, partially offset
by increased total payments for upfront fees and development milestones achieved in connection with our
collaborations and increased investment in our commercial initiatives and expanded clinical portfolio.
Cash Flows from Investing Activities
Periodic fluctuations for all periods presented reflected timing differences related to our purchases, sales, and
maturities of debt security investments and changes in our portfolio-mix.
For 2023, cash flows from investing activities also reflected a $31.3 million equity investment in Voyager.
For 2022, cash flows from investing activities also reflected the acquisition of Diurnal Group plc for $42.7 million in
cash (net of cash acquired) and a $7.7 million equity investment in Xenon.
58
Cash Flows from Financing Activities
Cash flows from financing activities for all periods presented reflected proceeds from issuances of our common
stock.
For 2024 compared to 2023, cash flows from financing activities also reflected a $300.0 million payment to a third-
party financial institution to repurchase shares of the Company’s common stock under a share repurchase program
that was authorized by our Board of Directors in October 2024 and the settlement of the 2024 Notes in full for
$308.8 million in cash.
For 2023 compared to 2022, cash flows from financing activities also reflected the repurchase of $210.8 million
aggregate principal amount of the 2024 Notes for an aggregate repurchase price of $279.0 million in cash.
Material Cash Requirements
In the pharmaceutical industry, it can take a significant amount of time and capital resources to successfully
complete all stages of research and development and commercialize a product candidate, which ultimate length of
time and spend required cannot be accurately estimated as it varies substantially according to the type, complexity,
novelty and intended use of a product candidate.
The funding necessary to execute our business strategies is subject to numerous uncertainties and we may be
required to make substantial expenditures if unforeseen difficulties arise in certain areas of our business. In
particular, our future capital requirements will depend on many factors, including:
•
the commercial success of INGREZZA and CRENESSITY;
•
continued scientific progress in our research and clinical development programs;
•
the magnitude and complexity of our research and development programs;
•
progress with preclinical testing and clinical trials;
•
the time and costs involved in obtaining regulatory approvals;
•
the costs involved in filing and pursuing patent applications, enforcing patent claims, or engaging in
interference proceedings or other patent litigation;
•
costs associated with securing adequate coverage and reimbursement for our products;
•
competing technological and market developments;
•
developments related to any future litigation;
•
the cost of commercialization activities and arrangements, including our advertising campaigns; and
•
the cost of manufacturing our product candidates.
In addition to the foregoing factors, we have significant future capital requirements, including:
External Business Developments
In addition to our independent efforts to develop and market products, we may enter into collaboration and license
agreements or acquire businesses from time-to-time to enhance our drug development and commercial capabilities.
With respect to our existing collaboration and license agreements, we may be required to make potential future
payments of up to $17.7 billion upon the achievement of certain milestones.
Refer to Note 2 to the consolidated financial statements for more information on our significant collaboration and
license agreements.
59
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon financial statements
that we have prepared in accordance with accounting principles generally accepted in the United States of America
(GAAP). The preparation of these financial statements requires management to make estimates and judgments that
affect the reported amounts of assets, liabilities and expenses, and related disclosures. On an on-going basis, we
evaluate these estimates, including those related to revenue recognition. Estimates are based on historical
experience, information received from third parties and on various other assumptions that are believed to be
reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions. Historically, revisions to our estimates have not resulted in a
material change to the financial statements.
The items in our financial statements requiring significant estimates and judgments are as follows:
Reserves for Government Rebates
We recognize revenues from product sales of INGREZZA net of reserves established for applicable discounts and
allowances that are offered within contracts with our customers, payors, and other third parties. Such reserves
include estimates for government rebates that we are obligated to pay for discounts including under the Medicaid
Drug Rebate Program and Medicare Part D. The liability for such rebates consists of invoices received for claims
from prior quarters that remain unpaid, or for which an invoice has not been received, and estimated rebates for the
current applicable reporting period. Such estimates require us to project the magnitude of our sales that will be
subject to such rebates and are based on actual historical rebates by state, estimated payor mix, state and federal
regulations, and relevant contractual terms, as supplemented by management’s judgement. There is a significant
time-lag in our receiving rebate notices from each state (generally, several months or longer after a sale is
recognized). To date, actual government rebates have not differed materially from our estimates.
Income Taxes
Our income tax provision is computed under the asset and liability method. Significant estimates are required in
determining our income tax provision. Some of these estimates are based on interpretations of existing tax laws or
regulations. We recognize deferred tax assets and liabilities for the expected future tax consequences of events that
have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities
are determined on the basis of the difference between the tax basis of assets and liabilities and their respective
financial reporting amounts (temporary differences) at enacted tax rates in effect for the years in which the
differences are expected to reverse. A valuation allowance is established for deferred tax assets for which it is more
likely than not that some portion or all of the deferred tax assets, including net operating losses and tax credits, will
not be realized. We periodically re-assess the need for a valuation allowance against our deferred tax assets based on
various factors including our historical earnings experience by taxing jurisdiction, and forecasts of future operating
results and utilization of net operating losses and tax credits prior to their expiration. Significant judgment is
required in making this assessment and, to the extent that a reversal of any portion of our valuation allowance
against our deferred tax assets is deemed appropriate, a tax benefit will be recognized against our income tax
provision in the period of such reversal.
Additional Information
Refer to Note 1 to the consolidated financial statements for information on accounting pronouncements that have
impacted or are expected to materially impact our consolidated financial condition, results of operations, or cash
flows.
60
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
We maintain a diversified investment portfolio consisting of low-risk, investment-grade debt securities with
maturities of up to three years, including investments in commercial paper, securities of government-sponsored
entities and corporate bonds that are subject to interest rate risk. The primary objective of our investment activities is
to preserve principal and maintain liquidity. If a 1% unfavorable change in interest rates were to have occurred on
December 31, 2024, it would not have had a material effect on the fair value of our investment portfolio as of that
date.
61
Item 8. Financial Statements and Supplementary Data
NEUROCRINE BIOSCIENCES, INC.
INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS
Page
g
Report of Independent Registered Publ
u ic Accounting Firm (PCAOB ID: 42)
63
Consolidated Balance Sheets
65
Consolidated Statements of Income and Comprehensive Income
66
Consolidated Statements of Stockholders’ Equity
67
Consolidated Statements of Cash Flows
68
Notes to the Consolidated Financial Statements
69
62
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Neurocrine Biosciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Neurocrine Biosciences, Inc. (the Company) as
of December 31, 2024 and 2023, the related consolidated statements of income and comprehensive income,
stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2024, and the
related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated
financial statements present fairly, in all material respects, the financial position of the Company at December 31,
2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended
December 31, 2024, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2024, based on
criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (2013 framework), and our report dated February 10, 2025 expressed
an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an
opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with
the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial statements are free of material
misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of
material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and
disclosures in the financial statements. Our audits also included evaluating the accounting principles used and
significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial
statements that was communicated or required to be communicated to the audit committee and that: (1) relates to
accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective or complex judgments. The communication of the critical audit matter does not alter in any way our
opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical
audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which
it relates.
63
Reserves for government rebates related to product sales
Description of
the Matter
The Company sells product to specialty pharmacies and specialty distributors in the U.S.
(collectively, “customers”). As described in Note 1 to the consolidated financial statements, the
Company recognizes revenues for sales of INGREZZA to its customers after deducting
management’s estimates of reserves, including drug coverage gap rebates, it will provide under
government rebate programs (“government rebates”). Estimated government rebates are
presented within accounts payable and accrued liabilities on the consolidated balance sheet.
Auditing the estimates of government rebates was complex and judgmental due to the level of
uncertainty involved in management’s assumptions used in the measurement process. In
particular, management was required to estimate the portion of product that is expected to be
subject to a government rebate and the applicable contractual government rebate percentage by
payor type underlying the revenue and the applicable rebate amount applicable for the payor
type.
How We
Addressed the
Matter in Our
Audit
We tested the Company’s internal controls over management’s process for estimating the
portion of product that is expected to be subject to a government rebate for product that remains
in the distribution channel at December 31, 2024. This included controls over management’s
review of significant assumptions and other inputs into the estimation of government rebates
including the accuracy of data used in the calculation.
To test management’s estimate of government rebate reserves our audit procedures included,
among others, evaluating the methodologies used, testing the significant assumptions discussed
above and testing the completeness and accuracy of the underlying data used by the Company
in its analyses. Specifically, we compared the significant assumptions to third-party reports used
by the Company to estimate product remaining in the distribution channel at December 31,
2024. In addition, we compared the underlying government rebate percentages used in the
Company’s analyses to those published by the applicable government entity. We assessed the
historical accuracy of management’s rebate estimates, tested payments of rebates and performed
a sensitivity analysis of significant assumptions to evaluate the changes in the rebate allowance
that would result from changes in the assumptions.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 1992.
San Diego, California
February 10, 2025
64
NEUROCRINE BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
December 31,
(in millions, except per share data)
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
233.0
$
251.1
Available-for-sale debt securities
843.1
780.5
Accounts receivable
479.1
439.3
Inventory
57.4
38.3
Other current assets
112.1
97.8
Total current assets
1,724.7
1,607.0
Deferred tax assets
485.7
362.6
Available-for-sale debt securities
739.5
687.5
Right-of-use assets
509.4
276.5
Equity investments
124.8
161.9
Property and equipment, net
82.6
70.8
Intangible assets, net
36.5
35.5
Other noncurrent assets
15.5
49.6
Total assets
$
3,718.7
$
3,251.4
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable and accrued liabilities
$
461.6
$
448.8
Convertible senior notes
—
170.1
Other current liabilities
46.1
35.9
Total current liabilities
507.7
654.8
Noncurrent operating lease liabilities
455.1
258.3
Other noncurrent liabilities
166.2
106.3
Total liabilities
1,129.0
1,019.4
Stockholders’ equity:
Preferred stock, $0.001 par value; 5.0 shares authorized; no shares issued and outstanding
—
—
Common stock, $0.001 par value; 220.0 shares authorized; 99.4 and 98.7 shares issued and
outstanding, respectively
0.1
0.1
Additional paid-in capital
2,554.6
2,382.0
Accumulated other comprehensive income
5.8
7.0
Retained earnings (accumulated deficit)
29.2
(157.1)
Total stockholders’ equity
2,589.7
2,232.0
Total liabilities and stockholders’ equity
$
3,718.7
$
3,251.4
See accompanying notes to consolidated financial statements.
65
NEUROCRINE BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS INCOME
AND COMPREHENSIVE INCOME
Year Ended December 31,
(in millions, except per share data)
2024
2023
2022
Revenues:
Net product sales
$
2,330.6
$
1,860.6
$
1,440.9
Collaboration revenue
24.7
26.5
47.8
Total revenues
2,355.3
1,887.1
1,488.7
Operating expenses:
Cost of revenues
34.0
39.7
23.2
Research and development
731.1
565.0
463.8
Acquired in-process research and development
12.5
143.9
—
Selling, general, and administrative
1,007.2
887.6
752.7
Total operating expenses
1,784.8
1,636.2
1,239.7
Operating income
570.5
250.9
249.0
Other (expense) income:
Unrealized (loss) gain on equity investments
(37.1)
28.4
30.8
Charges associated with convertible senior notes
(138.4)
—
(70.0)
Interest income and other, net
91.0
52.8
4.1
Total other (expense) income, net
(84.5)
81.2
(35.1)
Income before provision for income taxes
486.0
332.1
213.9
Provision for income taxes
144.7
82.4
59.4
Net income
341.3
249.7
154.5
Foreign currency translation adjustments, net of tax
(1.1)
2.4
2.9
Unrealized gain (loss) on available-for-sale debt securities, net of tax
(0.1)
12.5
(9.1)
Comprehensive income
$
340.1
$
264.6
$
148.3
Earnings per share, basic
$
3.40
$
2.56
$
1.61
Earnings per share, diluted
$
3.29
$
2.47
$
1.56
Weighted average common shares outstanding, basic
100.4
97.7
95.8
Weighted average common shares outstanding, diluted
103.7
101.0
98.9
See accompanying notes to consolidated financial statements.
66
NEUROCRINE BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Common Stock
Additional
Paid-In Capital
Accumulated
Other
Comprehensive
Income (Loss)
Retained
Earnings
(Accumulated
Deficit)
Total
Stockholders’
Equity
(in millions)
Shares
$
Balances at December 31, 2021
94.9
$
0.1
$
2,011.4
$
(1.7) $
(635.8) $
1,374.0
Net income
—
—
—
—
154.5
154.5
Other comprehensive loss, net of tax
—
—
—
(6.2)
—
(6.2)
Cumulative-effect adjustment due to
adoption of ASU 2020-06
—
—
(106.8)
—
74.5
(32.3)
Stock-based compensation expense
—
—
173.1
—
—
173.1
Issuances of common stock under stock
plans
1.6
—
44.7
—
—
44.7
Balances at December 31, 2022
96.5
$
0.1
$
2,122.4
$
(7.9) $
(406.8) $
1,707.8
Net income
—
—
—
—
249.7
249.7
Other comprehensive income, net of tax
—
—
—
14.9
—
14.9
Stock-based compensation expense
—
—
194.3
—
—
194.3
Issuances of common stock under stock
plans
2.2
—
65.3
—
—
65.3
Balances at December 31, 2023
98.7
$
0.1
$
2,382.0
$
7.0
$
(157.1) $
2,232.0
Net income
—
—
—
—
341.3
341.3
Other comprehensive income, net of tax
—
—
—
(1.2)
—
(1.2)
Stock-based compensation expense
—
—
195.5
—
—
195.5
Issuances of common stock under stock
plans
2.7
—
122.1
—
—
122.1
Repurchases of common stock under
accelerated buyback agreements
(2.0)
—
(145.0)
—
(155.0)
(300.0)
Balances at December 31, 2024
99.4
$
0.1
$
2,554.6
$
5.8
$
29.2
$
2,589.7
See accompanying notes to consolidated financial statements.
67
NEUROCRINE BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended December 31,
(in millions)
2024
2023
2022
Cash flows from operating activities:
Net income
$
341.3
$
249.7
$
154.5
Adjustments to reconcile net income to net cash from operating activities:
Stock-based compensation expense
195.5
194.3
173.1
Charges associated with convertible senior notes
138.4
—
70.0
Depreciation
23.5
17.8
15.1
(Accretion) amortization of (discount) premium on investments, net
(26.2)
(18.3)
3.7
Amortization of intangible assets
3.6
3.5
0.5
Changes in fair values of equity investments
37.1
(28.4)
(30.8)
Deferred income taxes
(123.1)
(56.7)
19.1
Other
24.5
(0.2)
1.6
Changes in operating assets and liabilities:
Accounts receivable
(39.8)
(89.3)
(162.2)
Inventory
(19.1)
5.4
(2.6)
Accounts payable and accrued liabilities
29.0
64.3
114.6
Other assets and liabilities, net
10.7
47.8
(17.2)
Cash flows from operating activities
595.4
389.9
339.4
Cash flows from investing activities:
Purchases of available-for-sale debt securities
(1,056.1)
(1,379.9)
(621.2)
Sales and maturities of available-for-sale debt securities
967.5
972.4
511.0
Acquisition of business, net of cash acquired
—
—
(42.7)
Purchases of equity investments
—
(31.3)
(7.7)
Capital expenditures
(38.2)
(28.3)
(16.5)
Cash flows from investing activities
(126.8)
(467.1)
(177.1)
Cash flows from financing activities:
Issuances of common stock under benefit plans
122.1
65.3
44.7
Repurchases of common stock under accelerated buyback agreements
(300.0)
—
—
Payments associated with convertible senior notes
(308.8)
—
(279.0)
Cash flows from financing activities
(486.7)
65.3
(234.3)
Effect of exchange rate changes on cash and cash equivalents
—
0.3
(1.3)
Change in cash and cash equivalents and restricted cash
(18.1)
(11.6)
(73.3)
Cash, cash equivalents and restricted cash at beginning of period
259.1
270.7
344.0
Cash, cash equivalents and restricted cash at end of period
$
241.0
$
259.1
$
270.7
Supplemental Disclosure:
Accrued capital expenditures
$
2.2
$
2.5
$
0.7
Right-of-use assets acquired through operating leases
$
271.6
$
200.8
$
—
Cash paid for interest
$
1.6
$
3.8
$
6.6
Cash paid for income taxes
$
217.5
$
51.5
$
14.4
See accompanying notes to consolidated financial statements.
68
NEUROCRINE BIOSCIENCES, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. Business Overview and Summary of Significant Accounting Policies
Nature of Operations
Neurocrine Biosciences, Inc. and its subsidiaries (Neurocrine Biosciences, the Company, we, our, or us) is a
neuroscience-focused global biopharmaceutical company focused on discovering, developing, and delivering
innovative therapies to help ease the burden of debilitating disorders and diseases.
Use of Estimates
The consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (GAAP), which requires us to make estimates and assumptions that affect
the amounts reported in the consolidated financial statements. Actual results could differ from those estimates.
Basis of Consolidation
The consolidated financial statements include the accounts of Neurocrine Biosciences as well as our wholly owned
subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.
Revenue Recognition
We recognize revenue when the customer obtains control of promised goods or services in an amount that reflects
the consideration which we expect to receive in exchange for such goods or services. Revenue is recognized using a
five-step model: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii)
determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and
(v) recognize revenues when (or as) we satisfy the performance obligation.
Product Revenue
We sell INGREZZA® (valbenazine) in the U.S. primarily to specialty pharmacy providers and distributors and
CRENESSITYTM (crinecerfont) in the U.S. to a specialty pharmacy provider. Net product sales of INGREZZA
totaled $2.3 billion for 2024, $1.8 billion for 2023, and $1.4 billion for 2022 and accounted for substantially all of
our total net product sales during each of these years.
Product revenue is recorded net of reserves for variable consideration, including discounts and allowances offered
within contracts with our customers, payors, and other third parties. These reserves, classified as reductions of
accounts receivable or liabilities, are based on estimates and include the following categories:
•
Product discounts represent estimated obligations for trade term discounts and other incentives offered to
our customers. We accrue for product discounts based on actual historical discounts, including the timing
of customer payments.
•
Distributor and other fees represent fees for inventory management, data, and distribution services and are
generally recorded as a reduction of revenue or expensed as selling, general, and administrative to the
extent we can demonstrate a separable benefit and fair value for these services.
•
Government rebates represent estimated obligations to government agencies under the Medicaid Drug
Rebate Program and Medicare Part D and are recorded as a reduction of revenue in the period the related
revenue is recognized. We accrue for government rebates based on estimated claims for the current quarter,
estimated claims for prior quarters for which an invoice has not been received, and claims for prior quarters
for which an invoice has been received but not paid.
•
Chargebacks represent estimated obligations to our customers for differences between list and contract
prices. We accrue for chargebacks as a reduction of revenue based on estimated contractual discounts on
product inventory levels on-hand in our distribution channel.
•
Payor and pharmacy rebates represent estimated obligations to payors and pharmacies for contract
discounts on product sales and are recorded as a reduction of revenue in the period the related revenue is
recognized. We accrue for payor and pharmacy rebates based on actual historical rebates, contractual rebate
percentages, sales made through the payor channel, and purchases made by pharmacies.
69
•
Copay assistance represents financial assistance to qualified patients with prescription drug copay
requirements. We accrue for copay assistance as a reduction of revenue based on estimated claims and the
cost per claim we expect to receive in connection with inventory that exists in the distribution channel at
period end.
•
Product returns represent estimated obligations for return rights offered to our customers due to shipment
errors and damaged product and are recorded as a reduction of revenue in the period the related revenue is
recognized. We accrue for product returns based on actual historical returns, benchmarking data, and
industry experience.
Collaboration Revenues
We have entered into collaboration and license agreements under which we out-license certain rights to our product
candidates to third parties. For arrangements that include sales-based royalties, and under which the license is
deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the
related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated
has been satisfied (or partially satisfied). Each quarterly period, sales-based royalties are recorded based on
estimated quarterly net sales of the associated collaboration products. Differences between actual results and
estimated amounts are adjusted for in the period in which they become known, which typically follows the quarterly
period in which the estimate was made. To date, actual royalties received have not differed materially from our
estimates.
Cash Equivalents
We consider all highly liquid investments that are readily convertible into cash without penalty and have an original
maturity of three months or less at the time of purchase to be cash equivalents.
Accounts Receivable
Accounts receivable are recorded net of customer allowances for prompt payment discounts, chargebacks, and any
allowance for credit losses. Our estimate for the allowance for credit losses, which has not been significant to date, is
determined based on existing contractual payment terms, actual payment patterns of our customers, and individual
customer circumstances.
Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws,
coverage and reimbursement, economic pressures or uncertainty associated with local or global economic
recessions, or other customer-specific factors.
Debt Securities
Debt securities consist of investments in certificates of deposit, corporate debt securities, and securities of
government-sponsored entities. We classify debt securities as available-for-sale. Available-for-sale debt securities
are recorded at fair value, with unrealized gains and losses included in other comprehensive income or loss, net of
tax. We exclude accrued interest from both the fair value and amortized cost basis of debt securities. A debt security
is placed on nonaccrual status at the time any principal or interest payments become 90 days delinquent. Interest
accrued but not received for a debt security placed on nonaccrual status is reversed against interest income.
Interest income includes amortization (accretion) of purchase premiums (discounts). Premiums (discounts) on debt
securities are amortized (accreted) using the effective interest rate method. Gains and losses on sales of debt
securities are recorded on the trade date in investment income and other, net, and determined using the specific
identification method.
70
Allowance for Credit Losses
For available-for-sale debt securities in an unrealized loss position, we first assess whether we intend to sell, or it is
more likely than not that we will be required to sell, the security before recovery of its amortized cost basis. If either
of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to
fair value through earnings. For available-for-sale debt securities that do not meet the aforementioned criteria, we
evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment,
we consider the extent to which fair value is less than amortized cost, any changes in interest rates, and any changes
to the rating of the security by a rating agency, among other factors. If this assessment indicates that a credit loss
exists, the present value of cash flows expected to be collected from the security is compared to the amortized cost
basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis,
a credit loss exists and an allowance for credit losses is recorded, limited by the amount that the fair value is less
than the amortized cost basis. Any impairment that has not been recorded through an allowance for credit losses is
recognized in other comprehensive income or loss, as applicable.
Accrued interest receivables on available-for-sale debt securities were $14.4 million and $11.2 million, respectively,
as of December 31, 2024 and 2023. We do not measure an allowance for credit losses for accrued interest
receivables. For the purposes of identifying and measuring an impairment, accrued interest is excluded from both the
fair value and amortized cost basis of the debt security. Uncollectible accrued interest receivables associated with an
impaired debt security are reversed against interest income upon identification of the impairment. No accrued
interest receivables were written off during 2024, 2023, or 2022.
Concentration of Credit Risk
Financial instruments that potentially subject us to concentrations of credit risk include cash and cash equivalents,
investments in debt securities, and accounts receivable.
To minimize the risks related to cash and cash equivalents and investments in debt securities, we have established
guidelines related to credit ratings and maturities intended to safeguard principal balances and maintain liquidity.
Our investment portfolio is maintained in accordance with our investment policy, which defines allowable
investments, specifies credit quality standards, and limits the credit exposure of any single issuer.
To minimize the risks related to accounts receivable, which are typically unsecured, we monitor the financial
performance and creditworthiness of our customers so that we can properly assess and respond to changes in their
credit profiles.
The following table presents the percent of total gross product sales and total accounts receivable for each of our
customers who individually accounted for 10% or more of total gross product sales and/or 10% or more of total
accounts receivable.
Percent of
Percent of
Total Gross Product Revenues
Accounts Receivable
Year Ended December 31,
December 31,
(in millions)
2024
2023
2022
2024
2023
Customer A
43 %
36 %
14 %
41 %
46 %
Customer B
28 %
28 %
29 %
37 %
32 %
Customer C
13 %
15 %
18 %
11 %
12 %
Customer D
< 10 %
12 %
29 %
< 10 %
< 10 %
Equity Investments
We account for certain equity investments subject to the equity method of accounting, or through which we have the
ability to exercise significant influence (but not control) over the operating and financial policies of an investee,
under the fair value option. In assessing whether we exercise significant influence, we consider the nature and
magnitude of such an investment, the voting and protective rights we hold, any participation in the governance of the
investee and other relevant factors, such as the presence of a collaborative or other business relationship. Such
investments in publicly traded companies are currently classified within Level 1 of the fair value hierarchy and
carried at fair value, with any changes in the fair value of such investments recognized in earnings.
71
Fair Value of Financial Instruments
We record cash equivalents, debt securities available-for-sale and equity security investments at fair value based on
a fair value hierarchy that distinguishes between assumptions based on market data (observable inputs) and our own
assumptions (unobservable inputs). The fair value hierarchy consists of the following three levels:
Level 1 – Quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2 – Quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets
or liabilities in markets that are not active or inputs that are observable, either directly or indirectly, for substantially
the full term of the asset or liability.
Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions that market participants
would use in pricing the asset or liability when there is little, if any, market activity for the asset or liability at the
measurement date.
Investments in debt securities available-for-sale are classified as Level 2 and carried at fair value. We estimate the
fair value of debt securities available-for-sale by utilizing third-party pricing services. These pricing services utilize
industry standard valuation models, including both income and market-based approaches, for which all significant
inputs are observable, either directly or indirectly, to estimate fair value. Such inputs include market pricing based
on real-time trade data for similar instruments, issuer credit spreads, benchmark yields, broker/dealer quotes and
other observable inputs. We validate valuations obtained from third-party pricing services by understanding the
models used, obtaining market values from other pricing sources and analyzing data in certain instances.
We deem transfers between levels of the fair value hierarchy to have occurred at the end of the reporting period
during which the event or change in circumstances that caused the transfer occurred.
Inventory
Inventory is valued at the lower of cost or net realizable value. We determine the cost of inventory using the
standard-cost method, which approximates actual cost based on the first-in, first-out method. We perform an
assessment of the recoverability of our inventory on a quarterly basis and write down any excess and obsolete
inventory to its net realizable value in the period in which the impairment is first identified. When future
commercialization is considered probable and the future economic benefit is expected to be realized, based on
management’s judgment, we capitalize pre-launch inventory costs prior to regulatory approval.
Prior to U.S. Food and Drug Administration (FDA) approval of CRENESSITY in December 2024, all costs related
to its manufacturing were expensed as research and development (R&D) in the period incurred. As a result, our
physical inventory as of December 31, 2024 included active pharmaceutical product with no cost basis. Costs related
to the manufacturing of bulk drug product, finished bottling, and other labeling activities that occurred post-FDA
approval are included in the inventory value as of December 31, 2024.
Leases
We determine if an arrangement is a lease at contract inception. Right-of-use (ROU) assets represent our right to use
an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments
arising from the lease. ROU assets and operating lease liabilities are recognized at the commencement date based on
the present value of lease payments over the lease term. When determining the lease term, we include options to
extend or terminate the lease when it is reasonably certain that such options will be exercised.
As none of our operating leases provide an implicit rate, we use our incremental borrowing rate based on the
information available at commencement date in determining the present value of lease payments. Our incremental
borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease.
The lease payments used to determine our ROU assets may include prepaid or accrued lease payments and any lease
incentives received and are recognized in ROU assets on our consolidated balance sheets.
Our lease agreements may include both lease and non-lease components, which we account for as a single lease
component when the payments are fixed. Variable payments included in lease agreements are expensed as incurred.
Our operating leases are reflected in ROU assets, noncurrent operating lease liabilities, and other current liabilities
on our consolidated balance sheets. Lease expense for minimum lease payments is recognized on a straight-line
basis over the lease term.
72
Impairment of ROU Assets
ROU assets are reviewed for impairment when indicators of impairment are present. ROU assets are tested for
impairment individually or as part of an asset group if the cash flows related to the ROU asset are not independent
from the cash flows of other assets and liabilities. An asset group is the unit of accounting for long-lived assets to be
held and used, which represents the lowest level for which identifiable cash flows are largely independent of the
cash flows of other groups of assets and liabilities.
Corporate ROU assets that are actively being marketed for sublease in connection with excess leased capacity are
tested for impairment individually when the cash flows related to the ROU asset are determined to be independent
from the cash flows of other assets and liabilities. Corporate ROU assets are otherwise tested for impairment on a
consolidated level with consideration given to all cash flows of the company as corporate functions do not generate
cash flows and are funded by revenue-producing activities at lower levels of the entity.
Property and Equipment
Property and equipment are stated at cost and depreciated over the estimated useful lives of the assets using the
straight-line method. Equipment is depreciated over an average estimated useful life of 3 to 7 years. Leasehold
improvements are depreciated over the shorter of their estimated useful lives or the remaining lease term.
Depreciation expense was $23.5 million for 2024, $17.8 million for 2023, and $15.1 million for 2022.
Goodwill, Intangible Assets, and Other Long-Lived Assets
Assets acquired, including intangible assets and in-process research and development (IPR&D) and liabilities
assumed are measured at fair value as of the acquisition date. Goodwill, which has an indefinite useful life,
represents the excess of cost over fair value of the net assets acquired. Intangible assets acquired in a business
combination that are used for IPR&D activities are considered indefinite lived until the completion or abandonment
of the associated research and development efforts. Upon reaching the end of the relevant research and development
project (i.e., upon commercialization), the IPR&D asset is amortized over its estimated useful life. If the relevant
research and development project is abandoned, the IPR&D asset is expensed in the period of abandonment.
Goodwill and IPR&D are not amortized; however, they are reviewed for impairment at least annually, as of October
1, and more frequently if an event occurs indicating the potential for impairment. Goodwill and IPR&D are
considered to be impaired if the carrying value of the reporting unit or IPR&D asset exceeds its respective fair value.
We perform our goodwill impairment analysis at the reporting unit level, which aligns with our reporting structure
and availability of discrete financial information. During the goodwill impairment review, we assess qualitative
factors to determine whether it is more likely than not that the fair value of the reporting unit is less than the carrying
amount, including goodwill. The qualitative factors include, but are not limited to, macroeconomic conditions,
industry and market considerations, and our overall financial performance. If, after assessing the totality of these
qualitative factors, we determine that it is not more likely than not that the fair value of the reporting unit is less than
the carrying amount, then no additional assessment is deemed necessary. Otherwise, we proceed to compare the
estimated fair value of the reporting unit with the carrying value, including goodwill. If the carrying amount of the
reporting unit exceed the fair value, we record an impairment loss based on the difference. We may elect to bypass
the qualitative assessment in a period and proceed to perform the quantitative goodwill impairment test.
Our identifiable intangible assets with a finite life are typically comprised of acquired product rights. The cost of
identifiable intangible assets with finite lives is generally amortized on a straight-line basis over the assets’
respective estimated useful lives.
We perform regular reviews to determine if any event has occurred that may indicate that intangible assets with
finite useful lives and other long-lived assets are potentially impaired. If indicators of impairment exist, an
impairment test is performed to assess the recoverability of the affected assets by determining whether the carrying
amount of such assets exceeds the undiscounted expected future cash flows. If the affected assets are not
recoverable, we estimate the fair value of the assets and record an impairment loss if the carrying value of the assets
exceeds the fair value. Factors that may indicate potential impairment include a significant decline in our stock price
and market capitalization compared to the net book value, significant changes in the ability of a particular asset to
generate positive cash flows for our strategic business objectives, and the pattern of utilization of a particular asset.
73
Share Repurchases
Shares repurchased pursuant to our share repurchase program are immediately retired upon purchase. Repurchased
common stock is reflected as a reduction of stockholders' equity by reducing our common stock for the par value of
the shares repurchased and reducing our capital surplus for the excess of the repurchase price over the par value. The
excess over the par value of the shares repurchased is recorded as a reduction to retained earnings to the extent
available, with any remainder recorded as a reduction to additional paid-in capital.
Cost of Revenues
Cost of revenues includes third-party manufacturing, transportation, freight, and indirect overhead costs primarily
for the manufacture and distribution of INGREZZA drug product sold, manufacturing costs in connection with our
supply of valbenazine drug product under our collaboration with Mitsubishi Tanabe Pharma Corporation, royalties
on net sales of CRENESSITY and elagolix, amortization of intangible assets, and adjustments for excess and
obsolete inventory to the extent management determines that the cost cannot be recovered based on estimates about
future demand.
Research and Development
R&D expenses primarily consist of preclinical and clinical trial costs, payroll and benefits costs, including stock-
based compensation associated with employees involved in R&D activities, certain facility-based costs, and certain
costs associated with our collaborative arrangements. All such costs are expensed as R&D when incurred.
Collaborations and Other Arrangements
We enter into collaborative agreements with third parties to develop and commercialize drug candidates.
Collaborative activities may include joint R&D and commercialization of new products. We generally receive
certain licensing rights under these arrangements. These collaborations often require upfront payments and may
include additional milestone, R&D cost sharing, royalty, or profit share payments, contingent upon the occurrence of
certain future events linked to the success of the asset in development and commercialization. Upfront payments
associated with collaborative arrangements are generally expensed as IPR&D. Amounts paid or payable to the
partner in connection with the achievement of development milestones prior to regulatory approval are expensed as
R&D when such milestones are achieved. Regulatory and commercial milestone payments made to the partner
subsequent to regulatory approval are capitalized as intangible assets and amortized to cost of revenues over the
estimated useful life of the related asset. Royalties are expensed as cost of revenues when incurred.
Asset Acquisitions
We account for acquisitions of assets (or groups of assets) that do not meet the definition of a business using the cost
accumulation method, whereby the cost of the acquisition, including certain transaction costs, is allocated to the
assets (or group of assets) acquired on the basis of their relative fair value(s) on the measurement date. No goodwill
is recognized in an asset acquisition. Intangible assets acquired in an asset acquisition for use in R&D activities
which have no alternative future use are expensed as IPR&D on the acquisition date. Amounts paid to acquire such
assets are classified as operating cash outflows on the consolidated statements of cash flows. Future costs to develop
these assets are expensed as R&D when incurred.
Advertising
Costs associated with advertising are expensed as incurred and are included in selling, general, and administrative on
the consolidated statements of income. Advertising expenses were $191.0 million for 2024, $159.9 million for 2023,
and $149.7 million for 2022.
Stock-Based Compensation
We grant stock options to purchase our common stock to eligible employees and directors and also grant certain
employees restricted stock units (RSUs) and performance-based restricted stock units (PRSUs). Additionally, we
allow employees to participate in an employee stock purchase plan (ESPP).
74
We estimate the fair value of stock options and shares to be issued under the ESPP using the Black-Scholes option-
pricing model on the date of grant. RSUs are valued based on the closing price of our common stock on the date of
grant. The fair value of equity instruments expected to vest is recognized and amortized on a straight-line basis over
the requisite service period of the award, which is generally three to four years; however, certain provisions in our
equity compensation plans provide for shorter vesting periods under certain circumstances. The fair value of shares
to be issued under the ESPP is recognized and amortized on a straight-line basis over the purchase period, which is
generally six months. PRSUs vest upon the achievement of certain predefined company-specific performance-based
criteria. Expense related to PRSUs is generally recognized ratably over the expected performance period once the
predefined performance-based criteria for vesting becomes probable.
Income Taxes
Our income tax provision is computed under the asset and liability method. Significant estimates are required in
determining our income tax provision. Some of these estimates are based on interpretations of existing tax laws or
regulations. We recognize deferred tax assets and liabilities for the expected future tax consequences of events that
have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities
are determined on the basis of the difference between the tax basis of assets and liabilities and their respective
financial reporting amounts (temporary differences) at enacted tax rates in effect for the years in which the
differences are expected to reverse. A valuation allowance is established for deferred tax assets for which it is more
likely than not that some portion or all of the deferred tax assets, including net operating losses and tax credits, will
not be realized. We periodically re-assess the need for a valuation allowance against our deferred tax assets based on
various factors including our historical earnings experience by taxing jurisdiction, and forecasts of future operating
results and utilization of net operating losses and tax credits prior to their expiration. Significant judgment is
required in making this assessment and, to the extent that a reversal of any portion of our valuation allowance
against our deferred tax assets is deemed appropriate, a tax benefit will be recognized against our income tax
provision in the period of such reversal.
We recognize tax benefits from uncertain tax positions only if it is more likely than not that the tax position will be
sustained upon examination by the tax authorities based on the technical merits of the position. An adverse
resolution of one or more of these uncertain tax positions in any period could have a material impact on the results
of operations for that period.
Earnings Per Share
Basic earnings per share are computed using the weighted average number of common shares outstanding during the
period. Diluted earnings per share are computed using the treasury stock and if-converted methods and reflect the
weighted average number of common and potentially dilutive shares outstanding during the period, excluding those
which effect would be anti-dilutive. PRSUs for which the performance condition has not been achieved are excluded
from the calculation of diluted earnings per share.
Recently Adopted Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU)
2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public
entities to disclose information about their reportable segments’ significant expenses and other segment items on an
interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure
requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC
280 on an interim and annual basis. ASU 2023-07 is effective for annual reporting periods beginning after December
15, 2023, and for interim reporting periods beginning January 1, 2025. We adopted ASU 2023-07 for our annual
reporting period beginning on January 1, 2024. The adoption of ASU 2023-07 had no significant impact on our
financial statement disclosures.
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax
Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate
reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for
annual reporting periods beginning after December 15, 2024, with early adoption permitted. We are currently
evaluating the impact that adoption of ASU 2023-09 will have on our financial statement disclosures.
75
In November 2024, the FASB issued ASU 2024-03, Income Statement–Reporting Comprehensive Income–Expense
Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires
public entities to disclose specified information about certain costs and expenses on an interim and annual basis.
ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting
periods beginning after December 15, 2027, with early adoption permitted. We are currently evaluating the impact
that adoption of ASU 2024-03 will have on our financial statement disclosures.
2. Collaboration and License Agreements
Nxera Pharma UK Limited, or Nxera.
In 2021, we entered into a collaboration and license agreement with Nxera (formerly Sosei Heptares) to develop and
commercialize certain compounds containing sub-type selective muscarinic M1, M4, or dual M1/M4 receptor
agonists, which we have the exclusive rights to develop, manufacture and commercialize worldwide, excluding in
Japan, where Nxera retains the rights to develop, manufacture, and commercialize all compounds comprised of M1
receptor agonists, subject to certain exceptions. With respect to such rights retained by Nxera, we retain the rights to
opt in to profit sharing arrangements, pursuant to which we and Nxera will equally share in the operating profits and
losses for such compounds in Japan. Subject to specified conditions, we may elect to exercise such opt-in rights with
respect to each such compound either before initiation of the first proof of concept Phase 2 clinical trial for such
compound or following our receipt from Nxera of the top-line data from such clinical trial for such compound. We
are responsible for all development, manufacturing, and commercialization costs of any collaboration product.
In connection with the FDA's acceptance of our investigational new drug application for NBI-1117568 for the
treatment of schizophrenia in 2022, we expensed a milestone payment of $30.0 million to Nxera as R&D in 2022.
In connection with the successful completions of a long-term toxicity program for NBI-1117568 and a Phase 2
clinical study for NBI-1117568 in schizophrenia in 2024, we expensed milestone payments totaling $50.0 million to
Nxera as R&D in 2024. We expect to advance NBI-1117568 into Phase 3 development in the first half of 2025,
which would trigger a milestone of $15.0 million payable to Nxera upon initiation of the Phase 3 clinical study.
Under the terms of the agreement, Nxera may be entitled to receive potential future payments of up to $2.5 billion
upon the achievement of certain event-based milestones and would be entitled to receive royalties on the future net
sales of any collaboration product.
Unless earlier terminated, the agreement will continue on a licensed product-by-licensed product and country-by-
country basis until the date on which the royalty term for such licensed product has expired in such country. On a
licensed product-by-licensed product and country-by-country basis, royalty payments would commence on the first
commercial sale of a licensed product and terminate on the later of (i) the expiration of the last patent covering such
licensed product in such country, (ii) a number of years from the first commercial sale of such licensed product in
such country and (iii) the expiration of regulatory exclusivity for such licensed product in such country.
We may terminate the agreement in its entirety or with respect to one or more targets upon 180 days’ written notice
to Heptares during the research collaboration term and upon 90 days’ written notice to Nxera following the
expiration of the research collaboration term. Following the expiration of the research collaboration term, Nxera
may terminate the agreement on a target-by-target basis in the event that we do not conduct any material
development activities outside of Japan with respect to a certain compound or licensed product within the applicable
target class for a continuous period of not less than 365 days and do not commence any such activities within 120
days of receiving written notice. Either party may terminate the agreement, subject to specified conditions, (i) in the
event of material breach by the other party, subject to a cure period, (ii) if the other party challenges the validity or
enforceability of certain intellectual property rights, subject to a cure period, or (iii) if the other party becomes
insolvent or takes certain actions related to insolvency.
76
Takeda Pharmaceutical Company Limited, or Takeda.
In 2020, we entered into an exclusive license agreement with Takeda (the 2020 Takeda Agreement) , pursuant to
which we acquired the exclusive rights to develop and commercialize certain early to mid-stage psychiatry
compounds, including luvadaxistat, NBI-1070770, osavampator (formerly NBI-1065845), NBI-1065846, and three
non-clinical stage compounds. Pursuant to the 2020 Takeda Agreement, osavampator was designated as a profit-
share product, meaning we and Takeda would equally share in the operating profits and losses. Takeda also retained
the right to opt-out of the profit-sharing arrangement, pursuant to which Takeda would be entitled to receive
potential future payments upon the achievement of certain event-based milestones with respect to osavampator and
receive royalties on the future net sales of osavampator (in lieu of equally sharing in the operating profits and
losses).
In 2024, we provided Takeda with written notice of termination of the license under the 2020 Takeda Agreement to
develop and commercialize luvadaxistat and NBI-1065846. The termination is anticipated to be effective in April
2025. In January 2025, we and Takeda amended and restated the exclusive license agreement (the Restated Takeda
Agreement) to, among other things, reflect the conversion from sharing operating profits and losses with respect to
the development and commercialization of osavampator to a royalty-bearing license, the return of rights to
osavampator in Japan to Takeda, and our previous termination of DAAO inhibitors under the 2020 Takeda
Agreement, including luvadaxistat, and GPR139 agonists, including NBI-1065846.
Under the Restated Takeda Agreement, we will retain exclusive rights to develop and commercialize osavampator
for all indications in all territories worldwide except Japan, where Takeda will reacquire exclusive development and
commercialization rights. In addition, each party is responsible for development costs for osavampator in its
respective territory, and each party is eligible to receive royalty payments based on the other party’s net sales of
osavampator in the other party’s territory. Pursuant to the Restated Takeda Agreement and upon the successful
development and commercialization of osavampator, we expect tiered based royalties payable to Takeda to be in the
mid-to-upper teens in the U.S. and low double-digits outside of the U.S. on a blended basis as a percentage of net
sales. Additionally, we are entitled to receive royalties from Takeda on the future net sales of osavampator in Japan.
In connection with the approval of our clinical trial application for NBI-1070770 for the treatment of major
depressive disorder in 2022, we expensed a milestone payment of $5.0 million to Takeda as R&D in 2022.
In connection with the initiation of a Phase 2 clinical study for NBI-1070770 in major depressive disorder in 2024,
we expensed a milestone payment of $7.5 million to Takeda as R&D in 2024.
Takeda may be entitled to receive potential future payments upon the achievement of certain event-based
milestones. As of December 31, 2024, the aggregate amount of these potential future payments was up to $1.9
billion, excluding the effects of the Restated Takeda Agreement and any pending terminations. Takeda is also
entitled to receive royalties on the future net sales of any royalty-bearing product. In January 2025, we advanced
osavampator into Phase 3 development to evaluate the efficacy and safety of osavampator in adults with major
depressive disorder. The initiation of the Phase 3 study, as defined, will trigger a $35.0 million milestone payable to
Takeda. No expense was recognized in connection with this milestone in 2024.
Unless earlier terminated, the Restated Takeda Agreement will continue on a licensed product-by-licensed product
and country-by-country basis until the date on which, (i) for any royalty-bearing product, the royalty term has
expired in such country; and (ii) for any profit-share product, for so long as we continue to develop, manufacture, or
commercialize such licensed product. On a licensed product-by-licensed product and country-by-country basis,
royalty payments would commence on the first commercial sale of a royalty-bearing product and terminate on the
later of (i) the expiration of the last patent covering such royalty-bearing product in such country, (ii) a number of
years from the first commercial sale of such royalty-bearing product in such country and (iii) the expiration of
regulatory exclusivity for such royalty-bearing product in such country.
77
We may terminate the Restated Takeda Agreement in its entirety or in one or more (but not all) of the United States,
Japan, the European Union and the United Kingdom, or, collectively, the major markets, upon six months’ written
notice to Takeda (i) with respect to all licensed products prior to the first commercial sale of the first licensed
product for which first commercial sale occurs, or (ii) with respect to all licensed products in one or more given
target classes, as defined in the Restated Takeda Agreement, prior to the first commercial sale of the first licensed
product in such target class for which first commercial sale occurs. We may terminate the Restated Takeda
Agreement in its entirety or in one or more (but not all) of the major markets upon 12 months’ written notice to
Takeda (i) with respect to all licensed products following the first commercial sale of the first licensed product for
which first commercial sale occurs, or (ii) with respect to all licensed products in one or more given target classes
following the first commercial sale of the first licensed product in such target class for which first commercial sale
occurs. Takeda may terminate the Restated Takeda Agreement, subject to specified conditions, (i) if we challenge
the validity or enforceability of certain Takeda intellectual property rights or (ii) on a target class-by-target class
basis, in the event that we do not conduct any material development or commercialization activities with respect to
any licensed product within such target class for a specified continuous period. Subject to a cure period, either party
may terminate the Restated Takeda Agreement in the event of any material breach, solely with respect to the target
class of a licensed product to which such material breach relates, or in its entirety in the event of any material breach
that relates to all licensed products, or if either party challenges the validity or enforceability of certain intellectual
property rights.
Idorsia Pharmaceuticals Ltd., or Idorsia.
In 2020, we entered into a collaboration and license agreement with Idorsia, pursuant to which we acquired the
exclusive rights to develop and commercialize NBI-827104, a potent, selective, orally active and brain penetrating
T-type calcium channel blocker in clinical development for the treatment of a rare pediatric epilepsy and other
potential indications, including essential tremor. We are responsible for all manufacturing, development, and
commercialization costs of any collaboration product. In the fourth quarter of 2024, we provided Idorsia with written
notice of termination of the license agreement to develop and commercialize NBI-827104. The termination became
effective in January 2025.
Xenon Pharmaceuticals Inc., or Xenon.
In 2019, we entered into a collaboration and license agreement with Xenon to identify, research and develop sodium
channel inhibitors, including NBI-921352 and three preclinical candidates, which compounds we have the exclusive
rights to develop and commercialize. We are responsible for all development and manufacturing costs of any
collaboration product, subject to certain exceptions.
In connection with the achievement of a development milestone in 2022, we paid Xenon $15.0 million, including a
purchase of 0.3 million shares (at $31.855 per share) of Xenon common stock (the 2022 Xenon Shares). The 2022
Xenon Shares were recorded at a fair value of $7.7 million after considering Xenon’s stock price on the
measurement date. The remaining $7.3 million of the milestone payment was expensed as R&D in 2022.
Under the terms of the agreement, Xenon may be entitled to receive potential future payments of up to $1.7 billion
upon the achievement of certain event-based milestones and is entitled to receive royalties on the future net sales of
any collaboration product. Xenon retains the right to elect to co-develop one product in a major indication, pursuant
to which Xenon would receive a mid-single digit percentage increase in royalties earned on the future net sales of
such product in the United States and we and Xenon would equally share in the development costs of such product
in the applicable indication, except where such development costs relate solely to the regulatory approval of such
product outside the United States.
Unless earlier terminated, the agreement will continue on a licensed product-by-licensed product and country-by-
country basis until the expiration of the royalty term for such product in such country. Upon the expiration of the
royalty term for a particular licensed product and country, the license obtained by us with respect to such product
and country will become fully paid, royalty free, perpetual and irrevocable. We may terminate the agreement upon
90 days’ written notice to Xenon, provided that such unilateral termination will not be effective for certain products
until we have used commercially reasonable efforts to complete certain specified clinical studies. Either party may
terminate the agreement in the event of a material breach in whole or in part, subject to specified conditions.
78
Voyager Therapeutics, Inc., or Voyager.
2019 Voyager Agreement
In 2019, we entered into a collaboration and license agreement with Voyager (the 2019 Voyager Agreement),
pursuant to which we retain certain rights to develop and commercialize the Friedreich’s ataxia (FA) program and
two undisclosed programs. We are responsible for all development and commercialization costs of any collaboration
product under the 2019 Voyager Agreement, subject to certain co-development and co-commercialization rights
retained by Voyager.
In connection with the 2019 Voyager Agreement, we purchased 4.2 million shares (at $11.9625 per share) of
Voyager common stock (the 2019 Voyager Shares), which are subject to certain transfer, beneficial ownership, and
voting restrictions for a period of up to three years from the effective date of the 2023 Voyager Agreement (defined
below). The 2019 Voyager Shares were recorded at a fair value of $54.7 million after considering Voyager’s stock
price and certain transfer restrictions that were applicable to the shares on the measurement date.
In connection with the selection of a development candidate under the FA program pursuant to our collaboration
with Voyager, we expensed a milestone payment of $5.0 million to Voyager as R&D in 2024.
Under the terms of the 2019 Voyager Agreement, Voyager may be entitled to receive potential future payments of
up to $1.3 billion upon the achievement of certain event-based milestones and is entitled to receive royalties on the
future net sales of any collaboration product, subject to certain co-development and co-commercialization rights
retained by Voyager.
Unless terminated earlier, the 2019 Voyager Agreement will continue in effect until the expiration of the last to
expire royalty term with respect to any collaboration product under the agreement or the last expiration or
termination of any exercised co-development and co-commercialization rights by Voyager as provided for in the
2019 Voyager Agreement. We may terminate the 2019 Voyager Agreement upon 180 days’ written notice to
Voyager prior to the first commercial sale of any collaboration product under the 2019 Voyager Agreement or upon
one year after the date of notice if such notice is provided after the first commercial sale of any collaboration product
under the 2019 Voyager Agreement.
2023 Voyager Agreement
In 2023, we entered into a collaboration and license agreement with Voyager which we amended in April 2024 (as
amended, the 2023 Voyager Agreement), pursuant to which we acquired the global rights to the gene therapy
products directed to the gene that encodes glucosylceramidase beta 1 (GBA1) for the treatment of Parkinson's
disease and other diseases associated with GBA1 (the GBA1 Program), and three gene therapy programs directed to
rare central nervous system (CNS) targets, each enabled by Voyager's next-generation TRACERTM capsids. With
respect to collaboration products subject to the GBA1 Program, we are responsible for all development and
commercialization costs of any such products, including in the U.S., where Voyager retains certain co-development
and co-commercialization rights. Voyager may elect to exercise such rights, pursuant to which we and Voyager
would equally share in the operating profits and losses of such products in the U.S. (in lieu of Voyager being entitled
to receive potential future payments of certain event-based milestones upon their achievement in the U.S. and
receive royalties on the future net sales of such products in the U.S.), following Voyager’s receipt of the top-line
data from a first clinical trial Parkinson’s disease. However, if we and Voyager elect to focus on an indication other
than Parkinson’s disease prior to Voyager’s receipt of top-line data from a first clinical trial for Parkinson’s disease,
then Voyager may elect to exercise such co-development and co-commercialization rights after the later of: (i)
Voyager’s receipt of top-line data from the first clinical trial of a product that is the subject of the GBA1 Program or
(ii) the date we and Voyager decide not to pursue Parkinson’s disease as an indication for development under the
GBA1 Program. Irrespective of Voyager’s election to exercise such rights, Voyager may be entitled to receive
potential future payments upon the achievement of certain event-based milestones outside the U.S. and would be
entitled to receive royalties on the future net sales of any such product outside the U.S. With respect to collaboration
products subject to the three gene therapy programs directed to rare CNS targets, we are responsible for all
development and commercialization costs for any such products.
79
In connection with the 2023 Voyager Agreement, we paid Voyager $175.0 million upfront, including a purchase of
4.4 million shares (at $8.88 per share) of Voyager common stock (the 2023 Voyager Shares), which are subject to
certain transfer, beneficial ownership, and voting restrictions for a period of up to three years from the effective date
of the 2023 Voyager Agreement. We accounted for the transaction as an asset acquisition as the set of acquired
assets did not constitute a business. In addition, as part of the collaboration, Jude Onyia, Ph.D., Chief Scientific
Officer of Neurocrine Biosciences, was appointed to Voyager's board of directors. Dr. Onyia (or another individual
designated by us) will be nominated for election to Voyager's board of directors annually for a maximum duration of
10 years from the effective date of the 2023 Voyager Agreement. As a result, our equity investment in Voyager
became subject to the equity method of accounting, and Voyager became a related party, following our purchase of
the 2023 Voyager Shares, after which, together with the 2019 Voyager Shares, we owned approximately 19.9% of
the voting stock of Voyager. We elected the fair value option to account for our equity investment in Voyager as we
believe it creates greater transparency regarding the investment's fair value at future reporting dates. The 2023
Voyager Shares were recorded at a fair value of $31.3 million after considering Voyager’s stock price on the
measurement date. The remaining $143.9 million of the purchase price, which includes certain transaction-related
costs, was expensed as in-process research and development in the first quarter of 2023 as the license had no
foreseeable alternative future use.
In connection with the selection of two development candidates under the GBA1 program pursuant to our
collaboration with Voyager, we expensed milestone payments totaling $6.0 million to Voyager as R&D in 2024.
Under the terms of the 2023 Voyager Agreement, Voyager may be entitled to receive potential future payments of
up to $6.1 billion upon the achievement of certain event-based milestones and is entitled to receive royalties on the
future net sales of any collaboration product, subject to certain co-development and co-commercialization rights
retained by Voyager.
Unless terminated earlier, the 2023 Voyager Agreement will continue in effect until the expiration of the last to
expire royalty term with respect to any collaboration product under the 2023 Voyager Agreement or the last
expiration or termination of any exercised co-development and co-commercialization rights by Voyager as provided
for in the 2023 Voyager Agreement. We may terminate the 2023 Voyager Agreement upon 180 days’ written notice
to Voyager prior to the first commercial sale of any collaboration product under the 2023 Voyager Agreement or
upon one year after the date of notice if such notice is provided after the first commercial sale of any collaboration
product under the 2023 Voyager Agreement.
Sanofi S.A., or Sanofi.
In 2014, we entered into a license agreement with Sanofi, pursuant to which we acquired the global rights to develop
and commercialize certain corticotropin-releasing factor type 1 receptor (CRF1) antagonists, including crinecerfont.
We are responsible for all manufacturing, development, and commercialization costs of any licensed product.
In connection with FDA approval of CRENESSITY capsules and oral solution as an adjunctive treatment of classic
congenital adrenal hyperplasia (CAH) in December 2024, we paid a $5.0 million milestone to Sanofi in January
2025, which we accrued to other current liabilities and recorded within intangible assets, net on the consolidated
balance sheet as of December 31, 2024.
Under the terms of the agreement, Sanofi may be entitled to receive potential future payments of up to $10.0 million
upon the achievement of certain event-based milestones and is entitled to receive royalties at tiered percentage rates
ranging from 3.0% to 5.0% on our future net sales of CRENESSITY in the U.S. for the longer of 16 years or the life
of the related patent rights.
Mitsubishi Tanabe Pharma Corporation, or MTPC.
In 2015, we out-licensed the rights to valbenazine in Japan and other select Asian markets to MTPC. In 2020, we
entered into a commercial supply agreement with MTPC, pursuant to which we supply MTPC with valbenazine
drug product for commercial use in such markets. MTPC is responsible for all development, manufacturing and
commercialization costs of valbenazine in such markets.
MTPC launched DYSVAL® (valbenazine) in Japan for the treatment of tardive dyskinesia in June 2022 and
subsequently in other select Asian markets, where it is marketed as REMLEAS® (valbenazine). We receive royalties
at tiered percentage rates on MTPC net sales of valbenazine.
80
In connection with MTPC's first commercial sale of DYSVAL in Japan, we received a milestone payment of $20.0
million in 2022. ASC 606 provides a royalty exception for a sales-based or usage-based royalty promised in
exchange for a license of intellectual property. Under the royalty exception, the milestone would be recognized as
revenue only when the later of (1) the subsequent sale or usage occurs or (2) the performance obligation to which
some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). As
the milestone related to a license of intellectual property and was contingent upon MTPC’s first commercial sale of
DYSVAL in Japan, the milestone was recognized as revenue in 2022.
Under the terms of our license agreement with MTPC, we may be entitled to receive potential future payments of up
to $30.0 million upon the achievement of certain sales-based milestones and are entitled to receive royalties at tiered
percentage rates on future MTPC net sales of valbenazine for the longer of 10 years or the life of the related patent
rights. MTPC may terminate the agreement upon 180 days’ written notice to us. In such event, all out-licensed
product rights would revert to us.
AbbVie Inc., or AbbVie.
In 2010, we out-licensed the global rights to elagolix to AbbVie. AbbVie is responsible for all development and
commercialization costs of elagolix.
AbbVie launched ORILISSA® (elagolix tablets) in the U.S. for the treatment of moderate to severe pain associated
with endometriosis in August 2018 and ORIAHNN® (elagolix, estradiol and norethindrone acetate capsules and
elagolix capsules) in the U.S. for the treatment of heavy menstrual bleeding due to uterine fibroids in June 2020. We
receive royalties at tiered percentage rates on AbbVie net sales of elagolix and recognized elagolix royalty revenue
of $13.5 million for 2024, $16.7 million for 2023, and $21.2 million for 2022.
Under the terms of our license agreement with AbbVie, we may be entitled to receive potential future payments of
up to $366.0 million upon the achievement of certain event-based milestones and are entitled to receive royalties at
tiered percentage rates on future AbbVie net sales of elagolix for the longer of 10 years or the life of the related
patent rights. AbbVie may terminate the agreement upon 180 days’ written notice to us. In such event, all out-
licensed product rights would revert to us.
3. Available-for-Sale Debt Securities
The following table presents a summary of available-for-sale debt securities, aggregated by major security type and
contractual maturity.
December 31,
2024
December 31,
2023
(in millions)
Contractual
Maturity
Amortized
Cost
Unrealized
Gain
Unrealized
Loss
Fair
Value
Amortized
Cost
Unrealized
Gain
Unrealized
Loss
Fair
Value
Commercial paper
0 to 1 years
$
37.1
$
—
$
—
$
37.1
$
53.5
$
—
$
—
$
53.5
Corporate debt securities
0 to 1 years
527.0
0.6
(0.1)
527.5
382.1
0.1
(1.0)
381.2
Securities of government-
sponsored entities
0 to 1 years
278.2
0.3
—
278.5
346.1
0.2
(0.5)
345.8
$
842.3
$
0.9
$
(0.1) $
843.1
$
781.7
$
0.3
$
(1.5) $
780.5
Corporate debt securities
1 to 3 years
$
584.4
$
2.0
$
(1.0) $
585.4
$
483.5
$
2.9
$
(0.4) $
486.0
Securities of government-
sponsored entities
1 to 3 years
154.4
0.3
(0.6)
154.1
201.1
0.5
(0.1)
201.5
$
738.8
$
2.3
$
(1.6) $
739.5
$
684.6
$
3.4
$
(0.5) $
687.5
Unrealized losses on available-for-sale debt securities were primarily due to changes in interest rates. These
investments are of high credit quality, and we do not intend to sell these investments and it is not more likely than
not that we will be required to sell these investments before recovery of their amortized cost basis. No allowance for
credit losses was recognized as of December 31, 2024 or December 31, 2023.
81
The following table presents available-for-sale debt securities that were in an unrealized loss position as of
December 31, 2024, aggregated by major security type and length of time in a continuous loss position.
Less Than 12 Months
12 Months or Longer
Total
(in millions)
Fair
Value
Unrealized
Loss
Fair
Value
Unrealized
Loss
Fair
Value
Unrealized
Loss
Corporate debt securities
$
334.9
$
(1.1) $
—
$
—
$
334.9
$
(1.1)
Securities of government-sponsored
entities
$
123.8
$
(0.6) $
—
$
—
$
123.8
$
(0.6)
The following table presents available-for-sale debt securities that were in an unrealized loss position as of
December 31, 2023, aggregated by major security type and length of time in a continuous loss position.
Less Than 12 Months
12 Months or Longer
Total
(in millions)
Fair
Value
Unrealized
Loss
Fair
Value
Unrealized
Loss
Fair
Value
Unrealized
Loss
Corporate debt securities
$
265.1
$
(0.4) $
183.8
$
(1.0) $
448.9
$
(1.4)
Securities of government-sponsored
entities
$
214.6
$
(0.2) $
16.7
$
(0.4) $
231.3
$
(0.6)
4. Fair Value Measurements
The following table presents a summary of certain financial assets, which were measured at fair value on a recurring
basis.
December 31,
2024
December 31,
2023
Fair
Value
Leveling
Fair
Value
Leveling
(in millions)
Level 1
Level 2
Level 1
Level 2
Cash and cash equivalents
$
233.0
$
233.0
$
—
$
251.1
$
251.1
$
—
Available-for-sale debt securities
1,582.6
—
1,582.6
1,468.0
—
1,468.0
Equity investments
124.8
124.8
—
161.9
161.9
—
$
1,940.4
$
357.8
$
1,582.6
$
1,881.0
$
413.0
$
1,468.0
5. Earnings Per Share
Earnings per share were calculated as follows:
Year Ended December 31,
(in millions, except per share data)
2024
2023
2022
Net income - basic and diluted
$
341.3
$
249.7
$
154.5
Weighted-average common shares outstanding:
Basic
100.4
97.7
95.8
Effect of dilutive securities
3.3
3.3
3.1
Diluted
103.7
101.0
98.9
Earnings per share:
Basic
$
3.40
$
2.56
$
1.61
Diluted
$
3.29
$
2.47
$
1.56
Shares which have been excluded from diluted per share amounts because their effect would have been anti-dilutive
were 2.4 million for 2024, 4.7 million for 2023, and 4.6 million for 2022.
6. Stockholders’ Equity
Share Repurchases
During 2024, we entered into an accelerated share repurchase (ASR) transaction with a third-party financial
institution to repurchase an aggregate of $300.0 million of shares of the Company’s common stock.
The transaction was accounted for as a treasury stock transaction and a forward stock purchase contract, which was
considered indexed to the Company’s own stock and classified as an equity instrument.
82
At inception, we paid the financial institution $300.0 million using cash on hand and took initial delivery of
2.0 million shares, which resulted in an immediate reduction of the outstanding shares used to calculate the
weighted-average common shares for both basic and diluted earnings per share. The fair market value of the
2.0 million initial shares received was $240.5 million, with the par value of the initial shares received recorded as a
reduction to common stock, the excess of the fair market value over the par value of the initial shares received
recorded as a reduction to retained earnings to the extent available, and the remainder recorded as a reduction to
additional paid-in capital. The remaining $59.5 million of the repurchase price was recorded to additional paid-in
capital.
The ASR transaction terminated in February 2025, at which time we became contractually entitled to receive an
additional 0.3 million shares upon settlement.
7. Stock-Based Compensation
2020 Equity Incentive Plan
In May 2022, 2023, and 2024, our stockholders approved amendments of the 2020 Equity Incentive Plan (as so
amended, the Amended 2020 Plan). The Amended 2020 Plan provides for the grant of stock options, stock
appreciation rights, restricted stock awards, restricted stock unit awards, performance awards, and other awards. As
of December 31, 2024, 10.6 million shares of common stock remain available for future grant under the Amended
2020 Plan.
Under the terms of the Amended 2020 Plan, the number of shares of common stock available for issuance will be:
(i) reduced by (a) one share for each share issued pursuant to an appreciation award (as defined in the Amended
2020 Plan) granted under the Amended 2020 Plan and (b) 2.13 shares for each share issued pursuant to a full value
award (as defined in the Amended 2020 Plan) granted under the Amended 2020 Plan on or after May 18, 2022; and
(ii) increased by (a) one share for each share subject to an appreciation award that becomes available again for
issuance under the terms of the Amended 2020 Plan and (b) 2.13 shares for each share subject to a full value award
that becomes available again for issuance under the terms of the Amended 2020 Plan on or after May 18, 2022.
2011 Equity Incentive Plan
In May 2011, we adopted the 2011 Equity Incentive Plan (the 2011 Plan). The 2011 Plan was a stockholder-
approved plan pursuant to which outstanding awards have been made, but from which no further awards can or will
be made.
2018 Employee Stock Purchase Plan
In May 2021, our stockholders approved an amendment and restatement of the 2018 Employee Stock Purchase Plan
(as so amended and restated, the Amended 2018 ESPP). As of December 31, 2024, 0.3 million shares of common
stock remain available for future issuance under the Amended 2018 ESPP.
Stock-Based Compensation Expense
The effect of stock-based compensation expense on the consolidated statements of income and comprehensive
income by line-item follows:
Year Ended December 31,
(in millions)
2024
2023
2022
Selling, general, and administrative
$
126.7
$
126.3
$
115.4
Research and development
68.8
68.0
57.7
Total stock-based compensation expense
$
195.5
$
194.3
$
173.1
Stock-based compensation expense by award-type follows:
Year Ended December 31,
(in millions)
2024
2023
2022
Stock options
$
80.7
$
91.6
$
62.6
RSUs
97.7
93.4
86.4
PRSUs
11.5
4.6
20.1
ESPP
5.6
4.7
4.0
Total stock-based compensation expense
$
195.5
$
194.3
$
173.1
83
As of December 31, 2024, unrecognized stock-based compensation expense by award-type and the weighted-
average period over which such expense is expected to be recognized, as applicable, was as follows:
(dollars in millions)
Unrecognized
Expense
Weighted-Average
Recognition Period
Stock options
$
92.7
2.2 years
RSUs
$
187.5
2.3 years
PRSUs
$
30.7
Stock Options
Typically, stock options have a 10-year term and vest over a three to four-year period. The exercise price of stock
options granted is equal to the closing price of our common stock on the date of grant. We estimate the fair value of
stock options using the Black-Scholes option-pricing model on the date of grant. The Black-Scholes option-pricing
model incorporates various and highly sensitive assumptions including expected volatility, term and interest rates.
The weighted-average grant-date fair values of stock options granted were $55.74 for 2024, $45.19 for 2023, and
$32.05 for 2022.
The fair value of each stock option granted was estimated on the date of grant using the Black-Scholes option-
pricing valuation model with the following weighted-average assumptions:
Year Ended December 31,
2024
2023
2022
Risk-free interest rate
4.3 %
3.9 %
1.8 %
Expected volatility of common stock
37.2 %
40.8 %
42.6 %
Dividend yield
0.0 %
0.0 %
0.0 %
Expected option term
5.5 years
5.5 years
5.0 years
The weighted-average valuation assumptions were determined as follows:
•
The expected volatility of common stock is estimated based on the historical volatility of our common
stock over the most recent period commensurate with the estimated expected term of our stock options.
•
The expected option term is estimated based on historical experience as well as the status of the employee.
For example, directors and officers have a longer expected option term than all other employees.
•
The risk-free interest rate for periods within the contractual life of a stock option is based upon observed
interest rates appropriate for the expected term of our employee stock options.
•
We have not historically declared or paid dividends and do not intend to do so in the foreseeable future.
The following table presents summary of activity related to stock options.
(in millions, except weighted average data)
Number of
Stock Options
Weighted
Average
Exercise Price
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic Value
Outstanding at December 31, 2023
10.0
$
84.46
Granted
1.5
$
133.93
Exercised
(1.7) $
65.22
Canceled
(0.2) $
108.84
Outstanding at December 31, 2024
9.6
$
95.48
6.2 years
$
394.0
Exercisable at December 31, 2024
6.8
$
88.40
5.3 years
$
327.7
The total intrinsic value of stock options exercised was $122.5 million for 2024, $39.9 million for 2023, and $39.7
million for 2022. Cash received from stock option exercises was $110.8 million for 2024, $55.5 million for 2023,
and $37.0 million for 2022.
Restricted Stock Units
RSUs typically vest over a four-year period and may be subject to a deferred delivery arrangement at the election of
eligible employees. The fair value of RSUs is based on the closing sale price of our common stock on the date of
issuance. The total fair value of RSUs that vested was $116.7 million for 2024, $101.0 million for 2023, and $72.4
million for 2022.
84
The following table presents a summary of activity related to RSUs.
(in millions, except weighted average data)
Number of
RSUs
Weighted-Average
Grant Date
Fair Value
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic Value
Unvested at December 31, 2023
2.4
$
97.32
Granted
1.1
$
132.74
Released
(0.9) $
97.91
Canceled
(0.2) $
108.56
Unvested at December 31, 2024
2.4
$
111.90
1.2 years
$
329.2
Performance-Based Restricted Stock Units
PRSUs vest based on the achievement of certain predefined Company-specific performance criteria. Any unvested
PRSUs will expire if it is determined the related performance criteria has not been met during the applicable three to
four-year performance period. The fair value of PRSUs is estimated based on the closing sale price of our common
stock on the date of grant. The fair value of PRSUs that vested was $34.4 million during 2023. No PRSUs vested
during 2024 or 2022.
The following table presents a summary of activity related to PRSUs.
(in millions, except weighted average data)
Number of
PRSUs
Weighted-Average
Grant Date
Fair Value
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic Value
Unvested at December 31, 2023
0.3
$
89.23
Granted
0.1
$
138.90
Unvested at December 31, 2024
0.4
$
105.11
1.4 years
$
49.9
Employee Stock Purchase Plan
Under the Amended 2018 ESPP, eligible employees may purchase shares of our common stock at a discount semi-
annually based on a percentage of their annual compensation. The discounted purchase price is equal to the lower of
85% of (i) the market value per share of the common stock on the first day of the offering period or (ii) the market
value per share of common stock on the purchase date.
8. Income Taxes
The following table presents income from continuing operations before provision for income taxes for domestic and
international operations.
Year Ended December 31,
(in millions)
2024
2023
2022
U.S.
$
597.5
$
409.2
$
218.0
Foreign
(111.5)
(77.1)
(4.1)
Income before provision for income taxes
$
486.0
$
332.1
$
213.9
The following table presents the components of income tax expense for continuing operations.
Year Ended December 31,
(in millions)
2024
2023
2022
Current:
Federal
$
215.2
$
115.0
$
17.1
State
52.5
28.1
20.3
Current income taxes
267.7
143.1
37.4
Deferred:
Federal
(104.9)
(45.2)
27.5
State
(18.1)
(15.5)
(5.5)
Deferred income taxes
(123.0)
(60.7)
22.0
Provision for income taxes
$
144.7
$
82.4
$
59.4
85
The provision for income taxes on earnings subject to income taxes differs from the statutory federal rate due to the
following:
Year Ended December 31,
(in millions)
2024
2023
2022
Federal income taxes at 21%
$
102.1
$
69.7
$
44.9
State income tax, net of federal benefit
34.6
17.5
11.8
Branded prescription drug fee
7.5
8.7
6.5
Loss on extinguishment of convertible senior notes
29.1
—
12.0
Stock-based compensation expense
(20.4)
(3.9)
(2.5)
Officer compensation
3.3
9.6
9.2
Foreign rate differential
7.2
3.4
(0.2)
Change in tax rate
(0.6)
(5.5)
(1.1)
Research credits
(49.2)
(42.2)
(29.9)
Change in valuation allowance
23.9
22.0
7.4
Other
7.2
3.1
1.3
Provision for income taxes
$
144.7
$
82.4
$
59.4
The following table presents the significant components of our deferred tax assets.
December 31,
(in millions)
2024
2023
Deferred tax assets:
Net operating losses
$
50.5
$
36.5
Research and development credits
62.8
55.3
Capitalized research and development
255.7
178.7
Stock-based compensation expense
61.4
52.7
Operating lease assets
122.7
72.0
Intangible assets
121.4
110.0
Other
51.7
37.2
Total deferred tax assets
726.2
542.4
Deferred tax liabilities:
Operating lease liabilities
(112.8)
(66.3)
Other
(15.5)
(24.6)
Total deferred tax liabilities
(128.3)
(90.9)
Net of deferred tax assets and liabilities
597.9
451.5
Valuation allowance
(112.2)
(88.9)
Net deferred tax assets
$
485.7
$
362.6
As of December 31, 2024 and 2023, we recorded a valuation allowance of $112.2 million and $88.9 million,
respectively, against our gross deferred tax asset balance.
As of each reporting date, management considers new evidence, both positive and negative, that could affect its
assessment of the future realizability of our deferred tax assets. As of December 31, 2024, management determined
there was sufficient positive evidence to conclude that it is more likely than not deferred tax assets of $485.7 million
are realizable. The recorded valuation allowance of $112.2 million consisted primarily of state and foreign net
operating loss carryforwards and state credit carryforwards for which management cannot conclude it is more likely
than not to be realized.
As of December 31, 2024, we had state and foreign income tax net operating loss carryforwards of $279.5 million
and $237.5 million, respectively. We had no federal income tax operating loss carryforwards as of December 31,
2024. California net operating losses will begin to expire in 2031 unless previously utilized and the net operating
losses related to other states will begin to expire in 2037. Swiss net operating losses will begin to expire in 2030
unless previously utilized. UK net operating losses will carry forward indefinitely.
86
As of December 31, 2024, we had state R&D tax credit carryforwards of $97.1 million. California R&D tax credits
carry forward indefinitely, while R&D tax credits related to other states will begin to expire in 2034 unless
previously utilized.
Additionally, the future utilization of our net operating loss and R&D tax credit carryforwards to offset future
taxable income may be subject to an annual limitation, pursuant to Internal Revenue Code Sections 382 and 383, as
a result of ownership changes that could occur in the future. No ownership changes have occurred through
December 31, 2024.
The impact of an uncertain income tax position on the income tax return must be recognized at the largest amount
that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax
position will not be recognized if it has less than a 50% likelihood of being sustained.
We recognize interest and penalties related to income tax matters in income tax expense. We had accruals for
interest related to income tax matters of $10.9 million as of December 31, 2024 and $3.1 million as of December 31,
2023. We had accruals for penalties related to income tax matters of $2.2 million as of December 31, 2024 and
2023.
We are subject to taxation in the U.S. and various state and foreign jurisdictions. Our tax years for 2002 for federal,
2000 for California, 2015 for other significant state jurisdictions, and 2019 and forward for foreign jurisdictions are
subject to examination by tax authorities due to the carryforward of unutilized net operating losses and R&D tax
credits.
The following table presents a summary of activity related to unrecognized tax benefits.
Year Ended December 31,
(in millions)
2024
2023
2022
Balance at January 1
$
121.0
$
84.5
$
64.6
Increase related to prior year tax positions
4.0
3.4
4.7
Increase related to current year tax positions
54.8
36.7
15.2
Decrease related to prior year tax positions
—
(3.6)
—
Balance at December 31
$
179.8
$
121.0
$
84.5
As of December 31, 2024, we had $141.9 million of unrecognized tax benefits that, if recognized and realized,
would affect the effective tax rate, subject to changes in the valuation allowance. We do not expect a significant
change in our unrecognized tax benefits in the next 12 months.
9. Leases
Our operating leases have terms that expire beginning 2025 through 2036 and consist of office space and research
and development laboratories, including our corporate headquarters. Certain of these lease agreements contain
clauses for renewal at our option. As we were not reasonably certain to exercise any of these renewal options at
commencement of the associated leases, no such options were recognized as part of our ROU assets or operating
lease liabilities.
The following table presents supplemental operating lease information for operating leases that have commenced.
Year Ended December 31,
(in millions, except weighted average data)
2024
2023
2022
Operating lease cost
$
43.6
$
17.1
$
16.3
Sublease income
(2.0)
(0.7)
—
Net operating lease cost
$
41.6
$
16.4
$
16.3
Cash paid for amounts included in the measurement of operating lease liabilities
$
33.1
$
17.9
$
16.9
December 31,
2024
December 31,
2023
Weighted average remaining lease term
10.8 years
10.8 years
Weighted average discount rate
4.9 %
5.1 %
Restricted cash related to letters of credit issued in lieu of cash security deposits
$
7.8
$
7.8
87
The following table presents approximate future non-cancelable minimum lease payments under operating leases
and sublease income as of December 31, 2024.
(in millions)
Operating
Leases (1)
Sublease
Income
Year ending December 31, 2025
$
41.8
$
(3.5)
Year ending December 31, 2026
58.2
(3.5)
Year ending December 31, 2027
59.1
(3.5)
Year ending December 31, 2028
60.6
(3.5)
Year ending December 31, 2029
60.7
(3.5)
Thereafter
373.9
(5.3)
Total operating lease payments (sublease income)
654.3
$
(22.8)
Less accreted interest
158.6
Total operating lease liabilities
495.7
Less current operating lease liabilities included in other current liabilities
40.6
Noncurrent operating lease liabilities
$
455.1
New Campus Facility
On February 8, 2022, we entered into a lease agreement for a four-building campus facility to be constructed in San
Diego, California, including a six-year option for the construction of a fifth building. This campus facility,
comprised of office space and research and development laboratories, now serves as our new corporate
headquarters.
The construction of the new campus facility was phased. In connection with the completion of the first phase of
construction relating to office space, we recognized ROU assets of $199.0 million and operating lease liabilities of
$189.8 million in December 2023. In connection with the completion of the second phase of construction relating to
laboratory space, we recognized ROU assets of $258.9 million and operating lease liabilities of $211.7 million in
October 2024.
As we continue to occupy our new campus facility, certain of our existing leased properties will be marketed for
sublease when we determine there is excess leased capacity. Certain of these subleases contain both lease and non-
lease components. Sublease income is recognized as an offset to operating expense on a straight-line basis over the
lease term. Income related to non-lease components is recognized in operating expenses as a reduction to costs we
incur in relation to the primary lease.
Impairment of ROU Assets
During 2024, we reassessed the asset groupings for corporate ROU assets that are actively being marketed for
sublease in connection with leased office space that has been vacated as we continue to occupy our new campus
facility. For asset groups where impairment was triggered, we used discounted cash flow models (an income
approach) with Level 3 inputs to estimate the fair values of the asset groups and recognized corresponding
impairment charges totaling $14.0 million in 2024, of which $11.3 million and $2.7 million, respectively, was
related to the ROU assets and tenant improvements associated with the underlying leased properties. The significant
assumptions used in the discounted cash flows models included projected sublease income over the remaining lease
term, expected downtime prior to the commencement of executed or future subleases, and discount rates that
reflected a market participant's assumptions in valuing the asset groups.
10. Convertible Senior Notes
On May 2, 2017, we completed a private placement of $517.5 million in aggregate principal amount of 2.25% fixed-
rate convertible senior notes due May 15, 2024 (the 2024 Notes) and entered into the 2017 Indenture with respect to
the 2024 Notes. Interest on the 2024 Notes was due semi-annually on May 15 and November 15 of each year.
In 2020, we repurchased $136.2 million in aggregate principal amount of the 2024 Notes for an aggregate
repurchase price of $186.9 million in cash. In 2022, we repurchased $210.8 million in aggregate principal amount of
the 2024 Notes for an aggregate repurchase price of $279.0 million in cash, which resulted in the recognition of a
$70.0 million loss on extinguishment.
88
On or after January 15, 2024, holders of the 2024 Notes had the ability to convert the 2024 Notes at any time until
the close of business on the scheduled trading day immediately preceding May 15, 2024. In January 2024, we
provided notice to the holders of the 2024 Notes electing to settle all conversions of the 2024 Notes which occur on
or after January 15, 2024 in cash. Consequently, the embedded conversion option of the 2024 Notes (the conversion
feature) required bifurcation and separate accounting from the 2024 Notes as it no longer qualified for the equity
scope exception under ASC 815, Derivatives and Hedging. Upon bifurcation of the conversion feature, we recorded
a derivative liability at a fair value of $126.6 million (Level 3) and a corresponding debt discount that was accreted
over the remaining term of the 2024 Notes using the straight-line method. Subsequent changes in the fair value of
the derivative liability and accretion of the associated debt discount were recorded in other income (expense), net on
the consolidated statements of income.
During 2024, holders of the 2024 Notes converted $169.8 million in aggregate principal amount of the 2024 Notes
for $308.2 million in cash, reflecting a conversion premium of $138.4 million calculated based on the per share
volume-weighted average price (VWAP) for each of the 30 consecutive trading days during the observation period
(as more fully described in the 2017 Indenture). The 2024 Notes were settled in full upon maturity on May 15, 2024.
The following table presents a summary of charges recognized in connection with the bifurcation of the conversion
feature of the 2024 Notes and conversions of the 2024 Notes by holders during 2024.
(in millions)
Amount
Accretion of debt discount associated with derivative liability
$
126.6
Change in fair value of derivative liability
9.6
Loss on extinguishment of convertible senior notes
2.2
Charges associated with convertible senior notes
$
138.4
11. Goodwill and Intangible Assets
The following table presents the changes in the carrying amount of goodwill. Goodwill is included in other
noncurrent assets in the consolidated balance sheets.
(in millions)
Amount
Balance as of December 31, 2022
$
5.4
Foreign currency translation adjustments
0.4
Balance as of December 31, 2023
5.8
Foreign currency translation adjustments
(0.1)
Balance as of December 31, 2024
$
5.7
The following table presents information relating to our recognized intangible assets.
December 31,
2024
December 31,
2023
(dollars in millions)
Gross
Carrying
Amount
Accumulated
Amortization
Net
Carrying
Amount
Gross
Carrying
Amount
Accumulated
Amortization
Net
Carrying
Amount
Developed product rights (1)
$
40.5
$
7.7
$
32.8
$
35.9
$
4.0
$
31.9
Acquired IPR&D
$
3.7
$
—
3.7
$
3.6
$
—
3.6
Total intangible assets, net
$
36.5
$
35.5
_________________________
(1) Developed product rights have a useful life of 10 to 16 years.
(2) Acquired IPR&D is considered indefinite lived until the completion or abandonment of the associated research
and development efforts.
89
The following table presents approximate future annual amortization expense for our finite-lived intangible assets as
of December 31, 2024.
(in millions)
Amount
Year ending December 31, 2025
$
3.9
Year ending December 31, 2026
$
3.9
Year ending December 31, 2027
$
3.9
Year ending December 31, 2028
$
3.9
Year ending December 31, 2029
$
3.9
Thereafter
$
13.3
12. Other Balance Sheet Details
Inventory consisted of the following:
December 31,
(in millions)
2024
2023
Raw materials
$
33.7
$
21.5
Work in process
10.9
9.7
Finished goods
12.8
12.3
57.4
43.5
Less inventory reserves
—
(5.2)
Total inventory
$
57.4
$
38.3
Property and equipment, net, consisted of the following:
December 31,
(in millions)
2024
2023
Tenant improvements
$
35.9
$
38.1
Scientific equipment
95.7
79.6
Computer equipment
38.9
25.2
Furniture and fixtures
18.6
10.9
189.1
153.8
Less accumulated depreciation
(106.5)
(83.0)
Total property and equipment, net
$
82.6
$
70.8
Accounts payable and accrued liabilities consisted of the following:
December 31,
(in millions)
2024
2023
Sales rebates and reserves
$
144.2
$
139.3
Accrued employee related costs
107.5
86.2
Accrued development costs
50.8
44.3
Current branded prescription drug fee
49.2
45.7
Accounts payable and other accrued liabilities
110.0
133.3
Total accounts payable and accrued liabilities
$
461.6
$
448.8
Other noncurrent liabilities consisted of the following:
December 31,
(in millions)
2024
2023
Noncurrent income taxes payable
$
160.7
$
96.0
Other noncurrent liabilities
5.5
10.3
Total other noncurrent liabilities
$
166.2
$
106.3
90
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the
consolidated balance sheets that sum to the total of the same such amounts shown on the consolidated statements of
cash flows.
December 31,
(in millions)
2024
2023
Cash and cash equivalents
$
233.0
$
251.1
Restricted cash included in other noncurrent assets
8.0
8.0
Total cash, cash equivalents, and restricted cash
$
241.0
$
259.1
13. Retirement Plan
We have a 401(k) defined contribution savings plan for the benefit of all qualifying employees and permits
voluntary contributions by employees up to 60% of base salary limited by the IRS-imposed maximum. Employer
contributions were $15.5 million for 2024, $12.5 million for 2023, and $10.3 million for 2022.
14. Segment Reporting and Disaggregation of Relevant Expense Captions
Neurocrine Biosciences operates as a single global business segment dedicated to the research and development,
commercialization, and sale of pharmaceuticals primarily in the U.S. for the treatment of neurological,
neuroendocrine, and neuropsychiatric disorders. Net product sales from external customers attributed to foreign
countries, intra-entity sales, and long-lived assets located outside the U.S. were not significant for 2024, 2023, or
2022. The accounting policies of the segment are the same as those described in the summary of significant
accounting policies.
The determination of a single business segment is consistent with the consolidated financial information regularly
reviewed by the Chief Executive Officer as chief operating decision maker (CODM) in assessing segment
performance and deciding how to allocate resources on a consolidated basis.
The CODM assesses performance for the segment and decides how to allocate resources based on net income that
also is reported on the consolidated statements of income as consolidated net income. The CODM uses net income
to monitor budget and forecast versus actual results in assessing segment performance and to evaluate income
generated from segment assets in deciding how to allocate resources. The measure of segment assets is reported on
the consolidated balance sheets as total consolidated assets.
91
The following table presents information about reported segment revenues, segment profit, and significant segment
expenses.
Year Ended December 31,
(in millions)
2024
2023
2022
Revenues
$
2,355.3
$
1,887.1
$
1,488.7
Less:
Cost of revenues
34.0
39.7
23.2
Research and development:
External research and development
343.5
310.0
213.5
Payroll and benefits
236.7
206.7
163.8
Milestones
71.7
0.8
42.7
Other research and development (1)
79.2
47.5
43.8
Total research and development
731.1
565.0
463.8
Acquired in-process research and development
12.5
143.9
—
Selling, general, and administrative
1,007.2
887.6
752.7
Unrealized loss (gain) on equity investments
37.1
(28.4)
(30.8)
Charges associated with convertible senior notes
138.4
—
70.0
Interest income and other, net
(91.0)
(52.8)
(4.1)
Provision for income taxes
144.7
82.4
59.4
Net income
$
341.3
$
249.7
$
154.5
_________________________
(1) Other research and development consists of indirect costs incurred for the benefit of multiple research and
development programs, including depreciation, information technology, and other facility-based expenses, such
as rent expense.
15. Legal Proceedings
In January 2025, we filed suit in the United States District Court for the District of Delaware against Spruce
Biosciences, Inc. (Spruce), seeking to invalidate one of Spruce’s patents. In addition, we have initiated (1)
administrative proceedings against other Spruce patents in the U.S. Patent Office, and (2) both judicial and
administrative proceedings against Spruce patents in other jurisdictions.
From time to time, we may also become subject to other legal proceedings or claims arising in the ordinary course of
our business. We currently believe that none of the claims or actions pending against us is likely to have,
individually or in the aggregate, a material adverse effect on our business, financial condition or results of
operations. Given the unpredictability inherent in litigation, however, we cannot predict the outcome of these
matters.
92
Item 9. Changes and Disagreements with Accountants on Accounting and Financial
Disclosure
Not applicable.
Item 9A. Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed
in our Exchange Act reports is recorded, processed, summarized and reported within the timelines specified in the
SEC’s rules and forms, and that such information is accumulated and communicated to our management, including
our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any
controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of
achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily
was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation
of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures as of the end of the year covered by this report.
Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures were effective at the reasonable assurance level.
93
Management’s Report on Internal Control Over Financial Reporting
Internal control over financial reporting refers to the process designed by, or under the supervision of, our Chief
Executive Officer and Chief Financial Officer, and effected by our board of directors, management and other
personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles, and includes
those policies and procedures that:
(1) Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions
and dispositions of our assets;
(2) Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting principles, and that our receipts and
expenditures are being made only in accordance with authorization of our management and directors; and
(3) Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or
disposition of our assets that could have a material effect on the financial statements.
Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting
objectives because of its inherent limitations. Internal control over financial reporting is a process that involves
human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human
failures. Internal control over financial reporting also can be circumvented by collusion or improper management
override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on
a timely basis by internal control over financial reporting. However, these inherent limitations are known features of
the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not
eliminate, this risk. Management is responsible for establishing and maintaining adequate internal control over
financial reporting for the company.
Management has used the framework set forth in the report entitled Internal Control-Integrated Framework
(2013 framework) published by the Committee of Sponsoring Organizations of the Treadway Commission
(2013 framework), known as COSO, to evaluate the effectiveness of our internal control over financial reporting.
Based on this assessment, management has concluded that our internal control over financial reporting was effective
as of December 31, 2024. Ernst & Young, LLP, our independent registered public accounting firm, has issued an
attestation report on our internal control over financial reporting as of December 31, 2024, which is included herein.
There has been no change in our internal control over financial reporting during our most recent fiscal quarter that
has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
94
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Neurocrine Biosciences, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Neurocrine Biosciences, Inc.’s internal control over financial reporting as of December 31, 2024,
based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Neurocrine
Biosciences, Inc. (the Company) maintained, in all material respects, effective internal control over financial
reporting as of December 31, 2024, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related
consolidated statements of income and comprehensive income, stockholders’ equity and cash flows for each of the
three years in the period ended December 31, 2024, and the related notes and our report dated February 10, 2025
expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and
for its assessment of the effectiveness of internal control over financial reporting included in the accompanying
Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on
the Company’s internal control over financial reporting based on our audit. We are a public accounting firm
registered with the PCAOB and are required to be independent with respect to the Company in accordance with the
U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and
the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting
was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a
material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on
the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We
believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles. A company’s internal control over financial reporting
includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable
assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company are being made
only in accordance with authorizations of management and directors of the company; and (3) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
/s/ Ernst & Young LLP
San Diego, California
February 10, 2025
95
Item 9B. Other Information
During the period from October 1, 2024, to December 31, 2024, our executive officers and directors adopted or
terminated contracts, instructions or written plans for the purchase or sale of our securities as noted below:
Name and Title
Action
Date
Trading Arrangement
Total Shares
Authorized
to be Sold***
Expiration
Date
Rule 10b5-1*
Non-Rule 10b5-1**
Stephen A. Sherwin, M.D.
Adoption
11/7/2024
X
13,831
5/7/2025
Director
Jude Onyia, Ph.D.
Adoption
11/18/2024
X
89,090
12/31/2025
Chief Scientific Officer
David W. Boyer
Termination
12/11/2024
X
18,571
2/15/2025
Chief Corporate Affairs Officer
______________
* Intended to satisfy the affirmative defense of Rule 10b5-1(c)
** Not intended to satisfy the affirmative defense of Rule 10b5-1(c)
*** Represents the maximum number of shares that may be sold pursuant to the 10b5-1 arrangement. The number of shares sold
is dependent on the satisfaction of certain conditions as set forth in the written plan and the satisfaction of applicable vesting
conditions of equity awards.
Executive Severance Plan
On February 7, 2025, the compensation committee of our board of directors (the Compensation Committee)
approved and adopted an Executive Severance Plan (the Severance Plan), pursuant to which executive officers are
eligible to participate, including Kyle W. Gano, Ph.D., our President and Chief Executive Officer, Matthew C.
Abernethy, our Chief Financial Officer, Eric Benevich, our Chief Commercial Officer, Jude Onyia, Ph.D., our Chief
Scientific Officer, and Eiry W. Roberts, M.D., our Chief Medical Officer (each, a Covered Employee, and
collectively, the Covered Employees). Pursuant to the Severance Plan, the Covered Employees are eligible to
receive the severance benefits described below, contingent upon the respective Covered Employee’s execution of a
general release of claims in favor of the Company as further described in the Severance Plan. The severance benefits
provided pursuant to the Severance Plan supersede any severance benefits to which the Covered Employees were
previously entitled, including pursuant to their respective employment agreements.
The Severance Plan provides that, upon (a) a termination of a Covered Employee’s employment without “cause” (as
defined in the Severance Plan) and other than due to death or “disability” (as defined in the Severance Plan) or (b)
the Covered Employee’s “resignation for good reason” (as defined in the Severance Plan), in each case outside of
the time period beginning with the date on which a “change in control” (as defined in the Severance Plan) occurs
and ending 12 months following the change in control, or the “change in control determination period,” the Covered
Employee will be entitled to receive: (1) cash severance equal to the product of (x) the sum of (i) the Covered
Employee’s annual base salary and (ii) the Covered Employee’s target annual incentive bonus for the year of
termination, multiplied by (y) 1 (or 1.5 for Dr. Gano); (2) a cash payment equal to the Covered Employee’s pro rata
annual incentive bonus for the year of termination based on actual achievement of the applicable performance goals
for such year; (3) payment of premiums for continued coverage under the Company’s group health plans for up to
12 months (or 18 months for Dr. Gano); (4) accelerated vesting of the Covered Employee’s outstanding time-vesting
equity awards to the extent such awards were scheduled to vest under their terms based on the Covered Employee’s
continued service over the 12-month period (or 15-month period for Dr. Gano) following the date of termination;
and (5) vesting of the Covered Employee’s outstanding performance-vesting equity awards to the extent the
Compensation Committee determines, in its sole discretion, that the applicable performance goals for such awards
have been met as of the date of termination.
96
In addition, the Severance Plan provides that, upon (a) a termination of a Covered Employee’s employment without
“cause” and other than due to death or “disability” or (b) the Covered Employee’s “resignation for good reason, in
each case within the change in control determination period, the Covered Employee will be entitled to receive, in
lieu of the benefits described above: (1) a cash payment equal to the product of (x) the sum of (i) the Covered
Employee’s annual base salary and (ii) the Covered Employee’s target annual incentive bonus for the year of
termination, multiplied by (y) 1.5 (or 2 for Dr. Gano); (2) a cash payment equal to the Covered Employee’s pro rata
target annual incentive bonus for the year of termination; (3) payment of premiums for continued coverage under the
Company’s group health plans for up to 18 months (or 24 months for Dr. Gano); and (4) full vesting acceleration of
the Covered Employee’s outstanding equity awards, with performance-vesting equity awards vesting at the greater
of (x) the target level of performance or (y) the actual level of performance measured in accordance with the
applicable performance goals as of the date of termination, as determined by the Compensation Committee in its
sole discretion.
The Severance Plan further provides that, upon the termination of a Covered Employee’s employment due to his or
her death or “disability” (as defined in the Severance Plan), the Covered Employee will be entitled to receive full
vesting acceleration of the Covered Employee’s outstanding equity awards, with performance-vesting equity awards
vesting at the greater of (x) the target level of performance or (y) the actual level of performance measured in
accordance with the applicable performance goals as of the date of termination, as determined by the Compensation
Committee in its sole discretion.
The foregoing description of the Severance Plan does not purport to be complete and is qualified in its entirety by
reference to the full text of the Severance Plan, a copy of which is filed as Exhibit 10.26 to this Annual Report on
Form 10-K.
Amendment and Restatement of Employment Arrangements
In connection with the adoption of the Severance Plan, and upon the approval by the Compensation Committee, on
February 7, 2025, we entered into amended and restated employment agreements (the Amended Employment
Agreements) with each of our executive officers, including Dr. Gano, Mr. Abernethy, Mr. Benevich, Dr. Onyia, and
Dr. Roberts. The Amended Employment Agreements amend and restate the employment agreements that we
previously entered into with our executive officers. Provisions that were amended in include, among other things:
•
Each Amended Employment Agreement provides that the executive officer is eligible for severance
benefits under the terms and conditions of the Severance Plan and that such benefits supersede the
severance benefits set forth in his or her prior employment agreement.
•
Pursuant to their respective Amended Employment Agreements, Dr. Gano, Mr. Abernethy, Mr. Benevich,
Dr. Onyia, and Dr. Roberts will receive an annual base salary of $920,000, $725,913, $668,690, $720,520
and $731,400, respectively, and will continue to be eligible to receive an annual cash incentive bonus with
a target bonus amount equal to 50% (or 100% for Dr. Gano) of his or her base pay earned for the applicable
year.
•
Each Amended Employment Agreement provides that compensation provided thereunder, under the
Severance Plan, or otherwise awarded or paid to the executive officer in connection with his or her
employment with the Company will be subject to recoupment in accordance with the following, as
applicable: (i) the Neurocrine Biosciences, Inc. Policy for Recoupment of Incentive Compensation, as may
be amended from time to time (covering incentive compensation that is received by a covered officer prior
to October 2, 2023); (ii) the Neurocrine Biosciences, Inc. Incentive Compensation Recoupment Policy, as
may be amended from time to time (covering incentive compensation that is received by a covered officer
on or after October 2, 2023); (iii) any clawback policy that we are required to adopt pursuant to the listing
standards of any national securities exchange or association on which our securities are listed or as is
otherwise required by the Dodd-Frank Wall Street Reform and Consumer Protection Act or other
applicable law; and (iv) any other clawback policy that we adopt.
The foregoing is only a brief description of certain terms of the Amended Employment Agreements, does not
purport to be complete, and is qualified in its entirety by reference to the full text of the Amended Employment
Agreements, copies of which are filed as Exhibits 10.31 through 10.35 to this Annual Report on Form 10-K.
97
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
98
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Information required by this item will be contained in our Definitive Proxy Statement for our 2025 Annual Meeting
of Stockholders, to be filed pursuant to Regulation 14A with the SEC within 120 days of December 31, 2024. Such
information is incorporated herein by reference.
We have adopted a code of ethics that applies to our Chief Executive Officer, Chief Financial Officer, and to all of
our other officers, directors, employees and agents. The code of ethics is available at the Corporate Governance
section of the Investors page on our website at www.neurocrine.com. We intend to disclose future amendments to,
or waivers from, certain provisions of our code of ethics on the above website within four business days following
the date of such amendment or waiver. Information found on, or accessible through, our website is not part of, and is
not incorporated into, this Annual Report on Form 10-K.
Item 11. Executive Compensation
Information required by this item will be contained in our Definitive Proxy Statement for our 2025 Annual Meeting
of Stockholders, to be filed pursuant to Regulation 14A with the SEC within 120 days of December 31, 2024. Such
information is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
Information required by this item will be contained in our Definitive Proxy Statement for our 2025 Annual Meeting
of Stockholders, to be filed pursuant to Regulation 14A with the SEC within 120 days of December 31, 2024. Such
information is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Information required by this item will be contained in our Definitive Proxy Statement for our 2025 Annual Meeting
of Stockholders, to be filed pursuant to Regulation 14A with the SEC within 120 days of December 31, 2024. Such
information is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services
Information required by this item will be contained in our Definitive Proxy Statement for our 2025 Annual Meeting
of Stockholders, to be filed pursuant to Regulation 14A with the SEC within 120 days of December 31, 2024. Such
information is incorporated herein by reference.
99
PART IV
Item 15. Exhibits, Financial Statement Schedules
(a) Documents filed as part of this report.
1. List of Financial Statements. The fol
f lowing are included in Item 8 of this report:
Report of Independent Registered Publ
u ic Accounting Firm
Consolidated Balance Sheets as of December 31, 2024 and 2023
Consolidated Statements of Income and Comprehensive Income for the years ended December 31, 2024, 2023, and
2022
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024, 2023, and 2022
Consolidated Statements of Cash Flows for
f
the years ended December 31, 2024, 2023, and 2022
Notes to the Consolidated Financial Statements
2. List of all Financial Statement schedul
d es. All schedules are omitted because they are not applicable, or the
required infor
f
mation is shown in the Financial Statements or notes thereto.
3. List of Exhibits required by Item 601 of Regulation S-K. See part (b) below.
(b) Exhibits. The fol
f lowing exhibits are fil
f ed as part of, o
f
r incorporated by reference into, this report:
Exhibit
3.1
Description:
Certificate of Incorpor
r
ation, as amended
Reference:
Incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
November 5, 2018
3.2
Description:
Bylaws, as amended
Reference:
Incorporated by reference to Exhibit 3.2 of the Company's Quarterly Report on Form 10-Q fil
f ed on
October 30, 2024
4.1
Description:
Form of Common Stock Certificate
Reference:
Incorporated by reference to the Company’s Registration Statement on Form S-1 (Registration No.
333-03172)
4.2
Description:
Indenture, dated as of May 2, 2017, by and between the Company and U.S. Bank National
Association, as Trus
r
tee
Reference:
Incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed on May
2, 2017
4.3
Description:
First Supplemental Indenture, dated as of December 22, 2021, by and between the Company and
U.S. Bank National Association, as Trus
r
tee
Reference:
Incorporated by reference to Exhibit 4.3 of the Company’s Annual Report on Form 10-K file
f
d on
February 11, 2022
4.4
Description:
Form of Note representing the Company’s 2.25% Convertible Notes due 2024
d
Reference:
Incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K filed on
May 2, 2017
4.5
Description:
Description of Common Stock of the Company
Reference:
Incorporated by reference to Exhibit 4.4 of the Company’s Annual Report on Form 10-K file
f
d on
February 7, 2020
19.1
Description:
Neurocrine Biosciences, Inc. Insider Trading Policy
21.1
Description:
Subs
u
idiaries of the Company
23.1
Description:
Consent of Independent Registered Publ
u ic Accounting Firm
31.1
Description:
Certification of Chief Executive Officer pursuant to Rul
R es 13a-14 and 15d-14 promulgated under the
Securities Exchange Act of 1934
31.2
Description:
Certification of Chief Financial Officer pursuant to Rul
R es 13a-14 and 15d-14 promulgated under the
Securities Exchange Act of 1934
100
32**
Description:
Certifications of Chief Executive Offic
f er and Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbane
r
s-Oxley Act of 2002
97+
Description:
Neurocrine Biosciences, Inc. Clawback Policy
Reference:
Incorporated by reference to Exhibit 97 of the Company’s Annual Report on Form 10-K file
f
d on
February 9, 2024
101.INS
Description:
Inline XBRL Instance Document. – the instance document does not appear in the Interactive Data
File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH
Description:
Inline XBRL Taxonomy Extension Schema Document.
101.CAL
Description:
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Description:
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Description:
Inline XBRL Taxonomy Extension Labe
a
l Linkbase Document.
101.PRE
Description:
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Description:
Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension
information contained in Exhibit 101)
Collaboration and License Agre
g
ements
g
:
10.1*
Description:
Collabor
a
ation Agreement dated June 15, 2010, by and between Abbott International Luxembourg
S.a.r.l. and the Company as amended on August 31, 2011
Reference:
Incorporated by reference to Exhibit 10.1 of the Company's Quarterly Report on Form 10-Q file
f
d on
May 5, 2021
10.2*
Description:
First Amendment to Collabor
a
ation and License Agreement Dated August 31, 2011 between the
Company and Abbott International Luxemburg S.a.r.l.
Reference:
Incorporated by reference to Exhibit 10.2 of the Company's Quarterly Report on Form 10-Q file
f
d on
May 5, 2021
10.3*
Description:
Collabor
a
ation and License Agreement dated March 31, 2015 between Mitsubishi Tanabe Pharma
Corporation and the Company
Reference:
Incorporated by reference to Exhibit 10.3 of the Company's Quarterly Report on Form 10-Q file
f
d on
May 5, 2021
10.4*
Description:
Collabor
a
ation and License Agreement dated January 28, 2019 between Voyager Therapeut
a
ics, Inc.
and the Company
10.5
Description:
Stock Purchase Agreement dated January 28, 2019 between Voyager Therapeut
a
ics, Inc. and the
Company
Reference:
Incorporated by reference to Exhibit 10.6 of the Company’s Annual Report on Form 10-K file
f
d on
February 7, 2019
10.6
Description:
Amendment No. 1 to Collabor
a
ation and License Agreement dated June 14, 2019 between Voyager
Therapeutics, Inc. and the Company
Reference:
Incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
July 29, 2019
10.7*
Description:
Exclusive License Agreement dated June 12, 2020 between Takeda Pharmaceutical Company
Limited and the Company
Reference:
Incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q file
f
d on
August 3, 2020
10.8*
Description:
Collabor
a
ation and License Agreement dated November 22, 2021 between Heptares Therape
a
utics
Limited and the Company
Reference:
Incorporated by reference to Exhibit 10.10 of the Company’s Annual Report on Form 10-K file
f
d on
February 11, 2022
10.9*
Description:
Collabor
a
ation and License Agreement dated January 8, 2023 between Voyager Therape
a
utics, Inc. and
the Company
Reference:
Incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q file
f
d on
May 3, 2023
10.10*
Description:
First Amendment to the Collabor
a
ation and License Agreement, effe
f ctive April 3, 2024, between the
Company and Voyager Therapeut
a
ics, Inc.
Reference:
Incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q file
f
d on
August 1, 2024
101
10.11
Description:
Stock Purchase Agreement dated January 8, 2023 between Voyager Therape
a
utics, Inc. and the
Company
Reference:
Incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q file
f
d on
May 3, 2023
10.12
Description:
Amended and Restated Investor Agreement dated January 8, 2023 between Voyager Therape
a
utics,
Inc. and the Company
Reference:
Incorporated by reference to Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q file
f
d on
May 3, 2023
Equity Plans and Related Agreements
q
y
g
:
10.13+
Description:
Neurocrine Biosciences, Inc. 2011 Equity Incentive Plan, as amended
Reference:
Incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
October 30, 2024
10.14+
Description:
Form of Stock Option Grant Notice and Option Agreement for
f
use under the Neurocrine Biosciences,
Inc. 2011 Equity Incentive Plan, and Form of Restricted Stock Unit Grant Notice and Restricted
Stock Unit Agreement for use under the Neurocrine Biosciences, Inc. 2011 Equity Incentive Plan
Reference:
Incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K filed on
June 1, 2015
10.15+
Description:
Form of Stock Option Grant Notice and Option Agreement for
f
use under the Neurocrine Biosciences,
Inc. 2011 Equity Incentive Plan, as amended
Reference:
Incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q file
f
d on
October 30, 2024
10.16+
Description:
Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement for
f
grants on or afte
f r February 1
r
3, 2024 made under the Neurocrine Biosciences, Inc. 2020 Equity
Incentive Plan
Reference:
Incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
May 1, 2024
10.17+
Description:
Form of Stock Option Grant Notice and Option Agreement for grants made to Kevin Gorman on or
afte
f r February 1
r
3, 2024 made under the Neurocrine Biosciences, Inc. 2020 Equity Incentive Plan
Reference:
Incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q file
f
d on
May 1, 2024
10.18+
Description:
Neurocrine Biosciences, Inc. Inducement Plan, as amended
Reference:
Incorporated by reference to Exhibit 10.17 of the Company’s Annual Report on Form 10-K file
f
d on
February 13, 2018
10.19+
Description:
Form of Stock Option Grant Notice and Option Agreement for
f
use under the Neurocrine Biosciences,
Inc. Inducement Plan, and Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement for us
f
e under the Neurocrine Biosciences, Inc. Inducement Plan
Reference:
Incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
July 29, 2015
10.20+
Description:
Neurocrine Biosciences, Inc. 2018 Employee Stock Purchase Plan, as amended and restated
Reference:
Incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q file
f
d on
August 4, 2022
10.21+
Description:
Form of Stock Option Grant Notice and Option Agreement for use under the Neurocrine Biosciences,
Inc. 2020 Equity Incentive Plan, and Form of Restricted Stock Unit Award Grant Notice and
Restricted Stock Unit Award Agreement for
f
use under the Neurocrine Biosciences, Inc. 2020 Equity
Incentive Plan
Reference:
Incorporated by reference to Exhibit 10.17 of the Company’s Annual Report on Form 10-K file
f
d on
February 11, 2022
10.22+
Description:
Neurocrine Biosciences, Inc. 2020 Equity Incentive Plan, as amended and restated
Reference:
Incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q file
f
d on
October 30, 2024
10.23+
Description:
Neurocrine Biosciences, Inc. 2011 Equity Incentive Plan, as amended
Reference:
Incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
October 30, 2024
102
10.24+
Description:
Neurocrine Biosciences, Inc. 2020 Equity Incentive Plan, as amended and restated
Reference:
Incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q file
f
d on
October 30, 2024
10.25+
Description:
Form of Stock Option Grant Notice and Option Agreement for
f
use under the Neurocrine Biosciences,
Inc. 2011 Equity Incentive Plan, as amended
Reference:
Incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q file
f
d on
October 30, 2024
Agre
g
ements with Offic
f
ers a
r
nd Directors
g
fff
:
10.26+
Description:
Neurocrine Biosciences, Inc. Executive Severance Plan effe
f ctive February 7, 2
r
025
10.27+
Description:
Form of Indemnity Agreement entered into between the Company and its offi
f cers and directors
Reference:
Incorpo
r
rated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
November 1, 2017
10.28+
Description:
Amended and Restated Employment Agreement effective August 1, 2007 between the Company and
Kevin C. Gorman, Ph.D.
Reference:
Incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q file
f
d on
August 3, 2007
10.29+
Description:
Form of Amendment to Employment Agreement for executive officers, effe
f ctive as of December 15,
2010
Reference:
Incorporated by reference to Exhibit 10.32 of the Company’s Annual Report on Form 10-K file
f
d on
February 11, 2008
10.30+
Description:
Amended and Restated Employment Agreement effective October 11, 2024 between the Company
and Kyl
K e W. Gano, Ph.D.
10.31+
Description:
Amended and Restated Employment Agreement effective February 7, 2
r
025 between the Company
and Kyl
K e W. Gano, Ph.D.
10.32+
Description:
Amended and Restated Employment Agreement effective February 7, 2
r
025 between the Company
and Matthew C. Abernethy
10.33+
Description:
Amended and Restated Employment Agreement effective February 7, 2
r
025 between the Company
and Eric Benevich
10.34+
Description:
Amended and Restated Employment Agreement effective February 7, 2
r
025 between the Company
and Jude Onyia
10.35+
Description:
Amended and Restated Employment Agreement effective February 7, 2
r
025 between the Company
and Eiry W. R
r
oberts
Agre
g
ements Related to Real Prope
o
rty
g
p
y:
10.36
Description:
Amended and Restated Lease dated November 1, 2011 between the Company and Kilroy Realty,
L.P.
Reference:
Incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K filed on
January 18, 2012
10.37
Description:
First Amendment to Amended and Restated Lease between the Company and Kilroy Realty, L.P.,
dated June 5, 2017
Reference:
Incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
August 3, 2017
10.38
Description:
Second Amendment to Amended and Restated Lease between the Company and Kilroy Realty, L.P.,
dated October 12, 2017
Reference:
Incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q file
f
d on
November 1, 2017
10.39
Description:
Third Amendment to Amended and Restated Lease between the Company and Kilroy Realty, L.P.
dated August 7, 2019
Reference:
Incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
November 4, 2019
10.40
Description:
Commercial Lease dated February 8, 2022, by and between the Company and Gemdale Aperture
Phase I, LLC
Reference:
Incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q file
f
d on
May 4, 2022
103
+
Management contract or compensatory plan or arrangement.
*
Certain information in this exhibit has been omitted pursuant to Item 601 of Regulation S-K.
**
These certifications are being furnished solely to accompany this annual report pursuant to 18 U.S.C.
Section 1350 and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and
are not to be incorporated by reference into any filing of Neurocrine Biosciences, Inc., whether made before
or after the date hereof, regardless of any general incorporation language in such filing.
Except as specifically noted above, the Company’s Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K have a Commission File Number of 000-22705.
(c) Financial Statement Schedules. See Item 15(a)(2) above.
104
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
NEUROCRINE BIOSCIENCES, INC.
(Registrant)
By:
/s/ Kyle W. Gano
Kyle W. Gano
Chief Executive Officer
Date: February 10, 2025
By:
/s/ Matthew C. Abernethy
Matthew C. Abernethy
Chief Financial Officer
Date: February 10, 2025
105
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and
appoints Kyle W. Gano and Matthew C. Abernethy, and each of them, as his or her true and lawful attorneys-in-fact
and agents, with full power of substitution for him or her, and in his or her name in any and all capacities, to sign
any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other
documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-
fact and agents, and each of them, full power of authority to do and perform each and every act and thing requisite
and necessary to be done therewith, as fully to all intents and purposes as he or she might or could do in person,
hereby ratifying and confirming all that said attorneys-in-fact and agents, and any of them, his or her substitute or
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following
persons on behalf of the Registrant and in the capacities indicated as of February 10, 2025:
Signature
Title
/s/ Kyle W. Gano
Chief Executive Officer and Director
Kyle W. Gano, Ph.D.
(Principal Executive Officer)
/s/ Matthew C. Abernethy
Chief Financial Officer
Matthew C. Abernethy
(Principal Financial and Accounting Officer)
/s/ William H. Rastetter
Chairman of the Board of Directors
William H. Rastetter, Ph.D.
/s/ Kevin C. Gorman
Director
Kevin C. Gorman, Ph.D.
/s/ Gary A. Lyons
Director
Gary A. Lyons
/s/ Johanna Mercier
Director
Johanna Mercier
/s/ George J. Morrow
Director
George J. Morrow
/s/ Leslie V. Norwalk
Director
Leslie V. Norwalk
/s/ Christine A. Poon
Director
Christine A. Poon
/s/ Richard F. Pops
Director
Richard F. Pops
/s/ Shalini Sharp
Director
Shalini Sharp
/s/ Stephen A. Sherwin
Director
Stephen A. Sherwin, M.D.
106
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Neurocrine Biosciences
Corporate Information
CORPORATE MANAGEMENT
Kyle W. Gano, Ph.D.
ʶ˛˜˘˙ʸ˫˘˖˨˧˜˩˘˂˙Ѓ˖˘˥
Matthew C. Abernethy
ʶ˛˜˘˙ʹ˜ˡ˔ˡ˖˜˔˟˂˙Ѓ˖˘˥
Eric Benevich
ʶ˛˜˘˙ʶˢˠˠ˘˥˖˜˔˟˂˙Ѓ˖˘˥
David W. Boyer
ʶ˛˜˘˙ʶˢ˥ˣˢ˥˔˧˘ʴ˙˙˔˜˥˦˂˙Ѓ˖˘˥
Julie S. Cooke
ʶ˛˜˘˙ʻ˨ˠ˔ˡ˅˘˦ˢ˨˥˖˘˦˂˙Ѓ˖˘˥
Ingrid Delaet, Ph.D.
ʶ˛˜˘˙˅˘˚˨˟˔˧ˢ˥ˬ˂˙Ѓ˖˘˥
Darin M. Lippoldt, J.D.
ʶ˛˜˘˙ʿ˘˚˔˟˂˙Ѓ˖˘˥
Jude Onyia, Ph.D.
ʶ˛˜˘˙ˆ˖˜˘ˡ˧˜Ѓ˖˂˙Ѓ˖˘˥
Eiry W. Roberts, M.D.
ʶ˛˜˘˙ˀ˘˗˜˖˔˟˂˙Ѓ˖˘˥
BOARD OF DIRECTORS
Kyle W. Gano, Ph.D.
ʶ˛˜˘˙ʸ˫˘˖˨˧˜˩˘˂˙Ѓ˖˘˥
William H. Rastetter, Ph.D.
Chairman of the Board,
Neurocrine Biosciences, Inc.
and Fate Therapeutics
Kevin C. Gorman, Ph.D.
ʹˢ˥ˠ˘˥ʶ˛˜˘˙ʸ˫˘˖˨˧˜˩˘˂˙Ѓ˖˘˥ʟ
Neurocrine Biosciences, Inc.
Gary A. Lyons
Former President and Chief
ʸ˫˘˖˨˧˜˩˘˂˙Ѓ˖˘˥ʟˁ˘˨˥ˢ˖˥˜ˡ˘
Biosciences, Inc.
Johanna Mercier
ʶ˛˜˘˙ʶˢˠˠ˘˥˖˜˔˟˂˙Ѓ˖˘˥ʟ
Gilead Sciences
George J. Morrow
Former Executive Vice President,
Global Commercial Operations,
Amgen Inc.
Leslie V. Norwalk
Former Acting Administrator
for the Centers for Medicare &
Medicaid Services
Christine A. Poon
Former Vice Chair and Worldwide
Chair of Pharmaceuticals at
Johnson & Johnson
Richard F. Pops
Chairman of the Board
˔ˡ˗ʶ˛˜˘˙ʸ˫˘˖˨˧˜˩˘˂˙Ѓ˖˘˥ʟ
Alkermes plc
Shalini Sharp
ʹˢ˥ˠ˘˥ʶ˛˜˘˙ʹ˜ˡ˔ˡ˖˜˔˟˂˙Ѓ˖˘˥˔ˡ˗
Executive Vice President
of Ultragenyx
Stephen A. Sherwin, M.D.
Former Chairman of the Board
˔ˡ˗ʶ˛˜˘˙ʸ˫˘˖˨˧˜˩˘˂˙Ѓ˖˘˥ʟ
Cell Genesys, Inc.
STOCKHOLDER INFORMATION
Transfer Agent
Equiniti Trust Company
Corporate Counsel
Cooley LLP
Auditors
Ernst & Young LLP
Neurocrine Biosciences is
a leading neuroscience-
focused, biopharmaceutical
company with a simple
purpose: to relieve suffering
for people with great needs.
We are dedicated to discovering and
developing life-changing treatments
for patients with under-addressed
neurological, neuroendocrine and
neuropsychiatric disorders. The
company’s diverse portfolio includes
U.S. FDA-approved treatments for
tardive dyskinesia, chorea associated
with Huntington’s disease, classic
congenital adrenal hyperplasia,
˘ˡ˗ˢˠ˘˧˥˜ˢ˦˜˦ʝ˔ˡ˗˨˧˘˥˜ˡ˘Ѓ˕˥ˢ˜˗˦ʝʟ
as well as a robust pipeline including
multiple compounds in mid- to late-
phase clinical development across
our core therapeutic areas. For three
decades, we have applied our unique
insight into neuroscience and the
interconnections between brain
and body systems to treat complex
conditions. We relentlessly pursue
medicines to ease the burden of
debilitating diseases and disorders,
because you deserve brave science.
For more information, visit
neurocrine.com, and follow the
company on LinkedIn, X and Facebook.
*in collaboration with AbbVie
6027 EDGEWOOD BEND COURT
SAN DIEGO, CA 92130
(858) 617-7600
WWW.NEUROCRINE.COM