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Halozyme Therapeutics

halo · NASDAQ Healthcare
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Ticker halo
Exchange NASDAQ
Sector Healthcare
Industry Biotechnology
Employees 201-500
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FY2023 Annual Report · Halozyme Therapeutics
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2023   
Annual Report

We  are  proud  of  the  many  milestones  and 
accomplishments  that  we  achieved  as  an 
organization  and  with  our  partners  throughout 
the  year.  These  accomplishments  supported 
another year of record growth while also serving 
as a strong foundation for our future growth.

800,000 

patient lives touched
by ENHANZE®

>

40 million devices supplied

7

partner commercial products 
global markets
in up to  

100

• 

In 2023, we increased the total number of 
ENHANZE® commercial partner products from 5 to 
7, with the approval of argenx’s VYVGART® Hytrulo 
for generalized myasthenia gravis in the U.S. and 
EU and the approval of Roche’s Tecentriq SC in 
Great Britain for multiple cancer types.

•  We had multiple, positive phase 3 data readouts, 
supporting regulatory submissions for approval of 
the ENHANZE® subcutaneous (SC) formulations 
for argenx’s VYVGART® Hytrulo for chronic 
inflammatory demyelinating polyneuropathy 
(CIDP), Roche’s ocrelizumab SC for multiple 
sclerosis and Bristol Myers Squibb’s nivolumab SC 
for cancer.

•  We added a new ENHANZE® partner, Acumen 
Pharmaceuticals, for the potential use of 
ENHANZE® for ACU193, Acumen’s clinical stage 
monoclonal antibody candidate to target 
Amyloid-β Oligomers for the treatment of early 
Alzheimer’s disease.

•  We achieved an important milestone for our 
new high-volume auto-injector, successfully 
demonstrating the feasibility of administering 
a subcutaneous injection of 10 mLs of a 
representative biologic, immunoglobulin 10% with 
ENHANZE®, in approximately 30 seconds using our 
high volume auto-injector.

Dear Fellow  
Shareholders:

As I reflect on the achievements of the past 
year, I am proud of the growth and progress 
accomplished during 2023. 

It has been a year of many successes and 
significant impact as we made progress with 
our commitment to advance new solutions  
for patients.   

At the heart of our vision is an unyielding 
dedication to the patients we serve. Today, 
many breakthrough therapies require the 
patient’s life to fit the treatment. Our vision is 
that breakthrough treatments fit the patient’s 
life.

Each member of our team is driven by a 
shared mission to alleviate the burden of 
treatment and enhance outcomes for those 
battling illnesses. 

In 2023, our reach expanded significantly. Our 
ENHANZE® drug delivery technology has now 
touched the lives of over 800,000 patients 
across more than 100 global markets. And our 
auto-injector technology has been used in 
more than 40 million devices. 

• 

In our proprietary commercial portfolio, XYOSTED®, 
the first and only weekly auto-injector for subcuta-
neous (SC) delivery of testosterone replacement 
therapy, achieved $100 million in sales in 2023.  

Based on this exciting progress, we project to grow the 
number of new product launches of products delivered 
subcutaneously with ENHANZE® from 7 exiting 2023 to 10 
by end of 2025, with potential launches of ocrelizumab 
SC in 2024 and nivolumab SC and amivantamab SC in 
2025. 

We also advanced our broad ENHANZE® development 
pipeline in 2023, which can add additional new royalty 
revenue opportunity beginning as early as 2027.

We currently have seven Wave 4 products in develop-
ment, of which two products are in phase 3, and one 
product is in phase 2. 

•  Bristol Myers Squibb’s nivolumab plus relatlimab for 
melanoma continues to advance in phase 3 devel-
opment.

•  We are pleased that Takeda’s TAK-881 for primary 

immune deficiency advanced into phase 3.

• 

In addition, ViiV initiated a phase 2 study for N6LS 
for an HIV treatment.

ROBUST CAPITAL ALLOCATION  
STRATEGY
As we continue to generate significant cash, we main-
tain a three-pillar capital allocation strategy with a 
focus on driving growth and value for shareholders. This 
strategy is comprised of three core objectives:

• 

Invest to maximize revenue growth and durability. 
We continue to invest in ENHANZE® and auto-injector 
innovation to maximize revenue growth and durability.

•  Return capital to shareholders. In 2023, we de-

ployed $400 million to shareholders through share 
repurchases and have returned a total of $1.3 bil-
lion to shareholders in share buybacks over the past 
five years. We are excited to share that we have 
Board approval for a new $750 million program that 
was announced in February 2024 and reflects our 
confidence in the sustained and durable growth of 
the company.

• 

Identify opportunities for external growth. We con-
sistently evaluate opportunities to accelerate and 
extend revenue.

STRONG FINANCIAL GROWTH AND OUTLOOK
We continued our strong growth trajectory in 2023, delivering a 26% year-over-year increase in total revenue to $829 
million, and reaching a record $448 million in royalty revenue, which represents a 24% year-over-year increase. We 
reported adjusted EBITDA of $426 million and non-GAAP diluted earnings per share reached $2.77. 

As we look ahead to 2024, we are poised for another record year, driven by the momentum of our recent successes. 
We recently reiterated our 2024 financial guidance for total revenue of $915 million to $985 million, representing year-
over-year growth of 10% to 19%, adjusted EBITDA of $535 million to $585 million, representing year-over-year growth 
of 26% to 37% and non-GAAP diluted earnings per share of $3.55 to $3.90, representing year-over-year growth of 28% 
to 41%.

We were also delighted to recently share our longer-term guidance that projects total revenue hitting more than 
$1.5 billion in 2027 and royalty revenue reaching approximately $1 billion in 2027 and 2028.

Revenue Projections

$915M - $985M
Total

$1,565M - $1,690M
Total

$829M
Total

$448M
Royalty

10%-19%
YoY

12%-17%
YoY

$500M-$525M
Royalty

+14%
CAGR

+18%
CAGR

$829M
Total

$448M
Royalty

$1,000M-
$1,050M
Royalty

Revenue 2023-2024

Revenue 2023-2028

CAGR calculated from 2023 actual to 2028 midpoint

FOCUS ON CONTINUOUS IMPROVEMENT
At Halozyme, we believe operating responsibly and efficiently is vital to creating long-term value for our company 
and stakeholders. In early 2023, we launched a new continuous improvement initiative, engaging every employee in 
bringing forth new ideas to increase our operating effectiveness and efficiency. 

Our stakeholders are considered in every aspect of our business. We are focused on delivering on the key metrics 
and goals we established to advance our strategy. As part of this focus, we continue to evolve and strengthen our 
Environmental, Social and Governance (ESG) program as well as executing our commitment to transparency. Nota-
ble ESG highlights from 2023 include: 

• 

• 

Supporting employees’ continuous growth and development through dedicated learning time and an extensive 
in-person and online curriculum.

Serving our various communities, including hosting our inaugural Dedicated Service Time benefiting organizations 
such as Boys and Girls Club, Habitat for Humanity, Ronald McDonald House and Bikes for Goodness Sakes. In 
addition, we supported St. Jude Children’s Research Hospital at the enterprise-level.

•  Demonstrating our commitment to governance and board refreshment, we welcomed Barbara Duncan to the 

board and, after 8 years of strong service, thanked Jim Daly for his many contributions.

As a testament to our commitment to sustainability, in 2023 we were named by Barron’s as one of the 100 Most Sus-
tainable Companies. We were also recently named as one of America’s Greenest Companies by Newsweek.

As we lead the way in drug delivery innovation, I am immensely proud of the strides we have made and the impact 
we have had on patients’ lives. We are excited to build upon our progress, driving value creation for all our stake-
holders.

Thank you for your ongoing support and partnership as we continue this journey together.

Best Regards,

Helen Torley

Forward Looking Statements:   Statements set forth in this letter to shareholders include forward-looking statements including, 
without limitation, statements concerning the Company’s expected future financial performance (including the Compa-
ny’s 2024 financial guidance and long-term revenue projections), plans to repurchase shares under its share repurchase 
program and to potentially expand the Company’s platform through acquisitions, expectations concerning the Company’s 
and its partners’ development programs and potential approvals and commercial launches of partnered products. These 
forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” 
“will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “contin-
ue,” and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially 
from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these 
forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, 
unexpected delays in the execution of the Company’s share repurchase program or platform expansion, unexpected 
results or delays in the development, regulatory review or commercialization of the Company’s partnered or proprietary 
products. These and other factors that may result in differences are discussed in greater detail in the Company’s most 
recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission.  The Company undertakes no 
obligation to update or revise any forward-looking statements or any other information contained herein.

Note:  This letter to shareholders contains product names, trademarks and registered trademarks that are the property of 
their respective owners.

Note Regarding Use Non-GAAP Financial Measures: In addition to disclosing financial measures prepared in accordance with U.S. generally 
accepted accounting principles (GAAP), this letter to shareholders contains certain non-GAAP financial measures. The Company reports 
EBITDA, Adjusted EBITDA and non-GAAP diluted earnings per share and expectations of those measures in addition to, and not as a substitute 
for, or superior to, financial measures calculated in accordance with GAAP. The Company uses Non-GAAP financial information in assessing 
what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establish-
ing portions of our performance-based incentive compensation programs. Reconciliations between GAAP and non-GAAP financial measures 
are included in this letter to shareholders. The Company does not provide reconciliations for forward-looking adjusted measures to GAAP due 
to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that 
could be made for changes in contingent liabilities, share based compensation expense and the effects of any discrete income tax items.

GAAP to Non-GAAP Reconciliation: EBITDA and Adjusted EBITDA

($ in thousands) 

GAAP to Non-GAAP Reconciliation: Net Income and Diluted EPS

($ in thousands)

1. 

2. 

3. 

4. 

1. 

2. 

3. 

4. 

5. 

6. 

Amount relates to fair value gain on contingent liability due to the due 
to the termination of the TLANDO license agreement in September 
2023 (“TLANDO Termination”).

Amount relates to inventory write-off due to TLANDO Termination and 
amortization of the inventory step-up associated with purchase ac-
counting for the prior year Antares acquisition.

Amounts represent incremental costs including legal fees, accounting 
fees and advisory fees incurred for the prior year Antares acquisition.

Amount represents severance cost and acceleration of unvested equi-
ty awards as part of the Antares merger agreement.

Amount represents incremental costs including legal fees, accounting 
fees and advisory fees incurred for the prior year Antares acquisition.  

Amount represents severance cost and acceleration of unvested equi-
ty awards as part of the Antares merger agreement.  

Amounts relate to amortization of the inventory step-up associated with 
purchase accounting for the Antares acquisition. 

Amount represents a realized loss from the sale of our marketable secu-
rities to finance the prior year acquisition of Antares.  

Amounts relate to a fair value gain on contingent liability, inventory 
write-off and impairment of TLANDO product rights intangible assets due 
to the TLANDO Termination.  

Adjustments relate to taxes for the reconciling items, as well as excess 
benefits or tax deficiencies from stock-based compensation, and the 
quarterly impact of other discrete items.

Dollar amounts, as presented, are rounded. Consequently, totals may not add up.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K

(Mark One)

☒ ANNUAL  REPORT  PURSUANT  TO  SECTION  13  OR  15(d)  OF  THE  SECURITIES  EXCHANGE  ACT  OF 

1934

For the fiscal year ended December 31, 2023 
OR

☐ 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 001-32335 

_________________________
HALOZYME THERAPEUTICS, INC. 
(Exact name of registrant as specified in its charter)
___________________________

Delaware
(State or other jurisdiction of incorporation or organization)

88-0488686
(I.R.S. Employer Identification No.)

12390 El Camino Real
San Diego
California
(Address of principal executive offices)

92130
(Zip Code)

(858) 794-8889 
(Registrant’s telephone number, including area code)

Title of Each Class

Securities registered under Section 12(b) of the Act:
Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 Par Value

HALO

The NASDAQ Stock Market, LLC

Securities registered under Section 12(g) of the Act:
None

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 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  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.  ☒

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 the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2023 
was approximately $3.5 billion based on the closing price on the NASDAQ Global Select Market reported for such date. Shares of 
common stock held by each officer and director and by each person who is known to own 10% or more of the outstanding common 
stock have been excluded in that such persons may be deemed to be affiliates of the registrant. This determination of affiliate status is 
not necessarily a conclusive determination for other purposes.

The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 126,824,800 as of February 12, 
2024.

DOCUMENTS INCORPORATED BY REFERENCE

Portions  of  the  registrant’s  definitive  Proxy  Statement  to  be  filed  subsequent  to  the  date  hereof  with  the  Securities  and  Exchange 
Commission pursuant to Regulation 14A in connection with the registrant’s 2024 Annual Meeting of Stockholders are incorporated by 
reference into Part III of this Annual Report on Form 10-K.

 
 
 
HALOZYME THERAPEUTICS, INC.
TABLE OF CONTENTS

Summary of Risk Factors   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART I

Business        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk Factors       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unresolved Staff Comments      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cybersecurity      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Properties    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Legal Proceedings     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mine Safety Disclosures    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART II
Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity 
Securities      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Reserved)     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Management’s Discussion and Analysis of Financial Condition and Results of Operations     . . . . . . . . . . . .
Quantitative and Qualitative Disclosures About Market Risk     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Financial Statements and Supplementary Data   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure    . . . . . . . . . . . .
Controls and Procedures      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other Information     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections    . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART III

Directors, Executive Officers and Corporate Governance        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Executive Compensation      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters    . . .

Certain Relationships and Related Transactions, and Director Independence       . . . . . . . . . . . . . . . . . . . . . . .

Principal Accounting Fees and Services    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Item 1.
Item 1A.
Item 1B.
Item 1C.
Item 2.
Item 3.
Item 4.

Item 5.

Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.

Item 10.

Item 11.

Item 12.

Item 13.

Item 14.

Item 15.

Exhibits, Financial Statement Schedules      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Item 16.     . . Form 10-K Summary    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SIGNATURES     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART IV

Page
3

8
24
41
42
44
44
44

45
47
48
60
60
60
61
63
63

63

64

64

65

65

66

70

71

3

 
 
 
Summary of Risk Factors

Our business is subject to a number of risks and uncertainties, including those described under the heading “Risk Factors” 

in Part I, Item 1A of this Annual Report on Form 10-K. These risks include the following:

Risks Related To Our Business

•

•

•

•

•

•

•

•

•

•

•

•

Failure or delay in receiving and maintaining regulatory approval for our partnered or proprietary product candidates 
would substantially impact our ability to generate revenues or the timing of such revenues.

Use of our partnered or proprietary products and product candidates could be associated with adverse events.

Disruptions  in  the  supply  of  bulk  rHuPH20  or  other  components  by  our  manufacturers  or  vendors  could  delay  or 
suspend  development  or  commercialization  efforts  and  harm  our  business  results  associated  with  operations  and 
collaborations.

Inability  of  third  parties  to  perform  necessary  services  for  our  products,  such  as  distribution,  invoicing  and  storage 
services could impact our business performance.

If we or any party to a key collaboration agreement fail to perform material obligations under such agreement, or if a 
key collaboration agreement is terminated for any reason, our business could suffer.

Any adverse development regarding the rHuPH20 enzyme could substantially impact multiple areas of our business, 
including current and potential ENHANZE collaborations and revenues, as well as any proprietary programs.

Additional applications of our ENHANZE technology or acquiring new technologies may require the use of additional 
resources, result in increased expense and ultimately may not be successful.

Our  partnered  or  proprietary  product  candidates  may  not  receive  regulatory  approvals  or  their  development  may  be 
delayed which may materially adversely affect our business, financial condition and results of operations.

Failure  of  our  third-party  partners  to  supply  certain  proprietary  materials  that  are  essential  components  of  partnered 
products or product candidates could delay development and commercialization efforts and/or harm our collaborations. 

If we or our partners fail to comply with regulatory requirements applicable to promotion, sale and manufacturing of 
approved products, regulatory agencies may act against us or them, which could harm our business.

Failure of our auto-injector and specialty products business to perform could adversely impact our future business and 
operations.

Pandemics or similar public health crises could adversely impact our business and results of operations.

• We may need to raise additional capital in the future and there can be no assurance that we will be able to do so.

•

•

•

•

•

•

•

Failure by us to fulfill obligations under our debt instruments may cause repayment obligations to accelerate.

Conversion  of  our  Convertible  Notes  may  dilute  the  ownership  interest  of  existing  stockholders  or  may  otherwise 
depress the price of our common stock or adversely affect our financial condition and operating results.

If proprietary or partnered product candidates are approved for commercialization but do not gain market acceptance 
resulting in commercial performance below that which was expected or projected, our business may suffer.

Our ability to license our ENHANZE and device technologies depends on the validity of our patents.

Developing,  manufacturing  and  marketing  pharmaceutical  products  for  human  use  involves  significant  product 
liability risks for which we may have insufficient insurance coverage.

Failure  by  our  partners  to  achieve  projected  development  or  clinical  goals  in  the  timeframes  expected  may  delay 
product commercialization, which may adversely affect our business, financial condition, and results of operations.

Future acquisitions could disrupt our business and impact our financial condition.

4

•

Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.

Risks Related To Ownership of Our Common Stock

•

•

•

Our stock price is subject to significant volatility.

Future transactions where we raise capital may negatively affect our stock price.

Anti-takeover provisions in our charter documents, the Indentures and Delaware law may make an acquisition of us 
more difficult.

Risks Related to Our Industry

•

•

Compliance  with  extensive  government  regulations  for  our  and  our  partnered  products  is  expensive  and  time 
consuming  and  may  result  in  delay  or  cancellation  of  our  or  our  partnered  product  sales,  introductions  or 
modifications.

Because some of our and our partnered products and product candidates are considered to be drug/device combination 
products, the approval and post-approval requirements can be more complex.

• We may be subject to various federal and state healthcare laws, which could subject us to government investigation, 

litigation, and other penalties, which could adversely affect our ability to operate.

• We may be required to initiate or defend against legal proceedings related to intellectual property rights, which may 
result in substantial expense, delay and/or cessation of certain development and commercialization of our products.

•

•

•

•

•

Off-label promotion or marketing of products inconsistent with FDA requirements could result in significant liability.

Compliance  with  regulatory  requirements  related  to  controlled  substances  will  require  additional  time  and  expenses 
and may subject us to additional penalties for noncompliance, which could inhibit successful commercialization.

Changes  in  intellectual  property  laws  may  adversely  impact  our  business  because  we  may  lose  the  ability  to  obtain 
patent protection or enforce our intellectual property rights against competitors.

If third-party reimbursement and customer contracts are not available, our proprietary and partnered products may not 
be accepted in the market resulting in commercial performance below that which was expected or projected.

Changes  in  private  and  federal  reimbursement  policies  and  practices  could  lower  pharmaceutical  product  prices  and 
decrease our revenue.

• We face competition and rapid technological change that could result in the development of products by others that are 

competitive with our proprietary and partnered products, including those under development.

General Risks

•

•

•

If we are unable to attract, hire and retain key personnel, our business could be negatively affected.

Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.

Cyberattacks, security breaches or system breakdowns may disrupt our operations and harm our operating results and 
reputation.

5

This Annual Report on Form 10-K contains “forward-looking statements” within the meaning of the “safe harbor” within 
the meaning of the Private Securities Litigation Reform act of 1995, provisions of Section 21E of the Securities Exchange Act of 
1934,  as  amended,  and  Section  27A  of  the  Securities  Act  of  1933,  as  amended.  All  statements,  other  than  statements  of 
historical  fact,  included  herein,  including  without  limitation  those  regarding  our  future  product  development  and  regulatory 
events and goals, product collaborations, our business intentions and financial estimates and anticipated results, are, or may 
be  deemed  to  be,  forward-looking  statements.  Words  such  as  “expect,”  “anticipate,”  “intend,”  “plan,”  “believe,”  “seek,” 
“estimate,”  “think,”  “may,”  “could,”  “will,”  “would,”  “should,”  “continue,”  “potential,”  “likely,”  “opportunity,” 
“project” and similar expressions or variations of such words are intended to identify forward-looking statements, but are not 
the  exclusive  means  of  identifying  forward-looking  statements  in  this  Annual  Report  on  Form  10-K.  Additionally,  statements 
concerning future matters such as the development or regulatory approval of new partner products, enhancements of existing 
products or technologies, timing and success of the launch of new products by us and our partners, third party performance 
under key collaboration agreements, the ability of our bulk drug and device part manufacturers to provide adequate supply for 
our partners, revenue, expense, cash burn levels and our ability to make timely repayments of debt, anticipated amounts and 
timing  of  share  repurchases,  anticipated  profitability  and  expected  trends  and  other  statements  regarding  our  plans  and 
matters that are not historical are forward-looking statements.

Although  forward-looking  statements  in  this  Annual  Report  on  Form  10-K  reflect  the  good  faith  judgment  of  our 
management,  such  statements  can  only  be  based  on  facts  and  factors  currently  known  by  us.  Consequently,  forward-looking 
statements  are  inherently  subject  to  risks  and  uncertainties  and  actual  results  and  outcomes  may  differ  materially  from  the 
results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to 
such differences in results and outcomes include without limitation those discussed under the heading “Risk Factors” in Part I, 
Item  1A,  as  well  as  those  discussed  elsewhere  in  this  Annual  Report  on  Form  10-K.  Readers  are  urged  not  to  place  undue 
reliance  on  these  forward-looking  statements,  which  speak  only  as  of  the  date  of  this  Annual  Report  on  Form  10-K.  We 
undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that 
may arise after the date of this Annual Report on Form 10-K. Readers are urged to carefully review and consider the various 
disclosures made in this Annual Report on Form 10-K, which attempt to advise interested parties of the risks and factors that 
may affect our business, financial condition, results of operations and prospects.

References  to  “Halozyme,”  “the  Company,”  “we,”  “our,”  “ours,”  and  “us”  refer  to  Halozyme  Therapeutics,  Inc.,  its 
wholly  owned  subsidiaries,  Halozyme,  Inc.,  Antares  Pharma  Inc.,  and  Antares  Pharma  Inc.’s  wholly-owned  subsidiaries, 
Antares  Pharma  IPL  AG  and  Antares  Pharma  AG.  References  to  “Notes”  refer  to  the  notes  to  the  consolidated  financial 
statements included herein (refer to Item 8 of Part II).

PART I

7

Item 1.

Business

Overview

Halozyme  Therapeutics,  Inc.  is  a  biopharmaceutical  company  advancing  disruptive  solutions  to  improve  patient 

experiences and outcomes for emerging and established therapies. 

As the innovators of ENHANZE® drug delivery technology (“ENHANZE”) with our proprietary enzyme rHuPH20, our 
commercially-validated solution is used to facilitate the subcutaneous (“SC”) delivery of injected drugs and fluids, with the goal 
of  reducing  the  treatment  burden  for  patients.  We  license  our  technology  to  biopharmaceutical  companies  to  collaboratively 
develop  products  that  combine  ENHANZE  with  our  partners’  proprietary  compounds.  We  also  develop,  manufacture  and 
commercialize,  for  ourselves  or  with  our  partners,  drug-device  combination  products  using  our  advanced  auto-injector 
technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and 
tolerability, and enhanced patient comfort and adherence.

 Our ENHANZE partners’ approved products and product candidates are based on rHuPH20, our patented recombinant 
human hyaluronidase enzyme. rHuPH20 works by breaking down hyaluronan (“HA”), a naturally occurring carbohydrate that 
is  a  major  component  of  the  extracellular  matrix  of  the  SC  space.  This  temporarily  reduces  the  barrier  to  bulk  fluid  flow 
allowing  for  improved  and  more  rapid  SC  delivery  of  high  dose,  high  volume  injectable  biologics,  such  as  monoclonal 
antibodies and other large therapeutic molecules, as well as small molecules and fluids. We refer to the application of rHuPH20 
to facilitate the delivery of other drugs or fluids as ENHANZE. We license the ENHANZE technology to form collaborations 
with  biopharmaceutical  companies  that  develop  or  market  drugs  requiring  or  benefiting  from  injection  via  the  SC  route  of 
administration.  In  the  development  of  proprietary  intravenous  (“IV”)  drugs  combined  with  our  ENHANZE  technology,  data 
have been generated supporting the potential for ENHANZE to reduce patient treatment burden, as a result of shorter duration 
of SC administration with ENHANZE compared to IV administration. ENHANZE may enable fixed-dose SC dosing compared 
to  weight-based  dosing  typically  required  for  IV  administration,  extend  the  dosing  interval  for  drugs  that  are  already 
administered subcutaneously and potentially allow for lower rates of infusion-related reactions. ENHANZE may enable more 
flexible  treatment  options  such  as  home  administration  by  a  healthcare  professional  or  potentially  the  patient  or 
caregiver. Lastly, certain proprietary drugs co-formulated with ENHANZE have been granted additional exclusivity, extending 
the patent life of the product beyond the patent expiry of the proprietary IV drug.

We currently have ENHANZE collaborations and licensing agreements with F. Hoffmann-La Roche, Ltd. and Hoffmann-
La  Roche,  Inc.  (“Roche”),  Takeda  Pharmaceuticals  International  AG  and  Baxalta  US  Inc.  (“Takeda”),  Pfizer  Inc.  (“Pfizer”), 
Janssen Biotech, Inc. (“Janssen”), AbbVie, Inc. (“AbbVie”), Eli Lilly and Company (“Lilly”), Bristol Myers Squibb Company 
(“BMS”),  argenx  BVBA  (“argenx”),  ViiV  Healthcare  (the  global  specialist  HIV  Company  majority  owned  by 
GlaxoSmithKline)  (“ViiV”),  Chugai  Pharmaceutical  Co.,  Ltd  (“Chugai”)  and  Acumen  Pharmaceuticals,  Inc.  (“Acumen”).  In 
addition to receiving upfront licensing fees from our ENHANZE collaborations, we are entitled to receive event and sales-based 
milestone payments, revenues from the sale of bulk rHuPH20 and royalties from commercial sales of approved partner products 
co-formulated with ENHANZE. We currently earn royalties from four of these collaborations, including royalties from sales of 
one  product  from  the  Takeda  collaboration,  four  products  from  the  Roche  collaboration,  one  product  from  the  Janssen 
collaboration and one product from the argenx collaboration.

We  have  commercialized  auto-injector  products  with  several  pharmaceutical  companies  including  Teva  Pharmaceutical 
Industries, Ltd. (“Teva”) and Otter Pharmaceuticals, LLC (“Otter”). We have development programs including auto-injectors 
with Idorsia Pharmaceuticals Ltd. (“Idorsia”).

Our  commercial  portfolio  of  proprietary  products  includes  Hylenex®,  utilizing  rHuPH20,  and  our  specialty  product 

XYOSTED®, utilizing our auto-injector technology.

Our principal offices and research facilities are located at 12390 El Camino Real, San Diego, CA 92130. Our telephone 
number  is  (858)  794-8889  and  our  e-mail  address  is  info@halozyme.com.  Our  website  address  is  www.halozyme.com. 
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. Our periodic and current reports that we filed with the Securities and Exchange Commission (“SEC”) are available 
on our website at www.halozyme.com, free of charge, as soon as reasonably practicable after we have electronically filed such 
material  with,  or  furnished  them  to,  the  SEC,  including  our  annual  reports  on  Form  10-K,  quarterly  reports  on  Form  10-Q, 
current reports on Form 8-K and any amendments to those reports.

8

Our Technology

rHuPH20  can  be  applied  as  a  drug  delivery  platform  to  increase  dispersion  and  absorption  of  other  injected  drugs  and 
fluids,  potentially  reducing  treatment  burden.  For  example,  rHuPH20  has  been  used  to  convert  drugs  that  must  be  delivered 
intravenously  into  SC  injections  or  to  reduce  the  number  of  SC  injections  needed  for  effective  therapy.  When  ENHANZE 
technology  is  applied  subcutaneously,  the  rHuPH20  acts  locally  and  transiently,  with  a  tissue  half-life  of  less  than  30 
minutes.  HA  at  the  local  site  reconstitutes  its  normal  density  within  two  days  and,  therefore,  the  effect  of  rHuPH20  on  the 
architecture of the SC space is temporary. 

 The pressure-assisted auto-injector technology is a form of parenteral drug delivery that continues to gain acceptance and 
demand among the medical and patient community. Encompassing a variety of sizes and designs, our technology operates by 
using pressure to force the drug, in solution or suspension, through the skin and deposits the drug into the SC or intramuscular 
tissue. We have designed disposable, pressure-assisted auto-injector devices to address acute and chronic medical needs, such 
as rheumatoid arthritis and psoriasis, allergic reactions, testosterone deficiency. Our current platforms include the high-volume 
auto-injector, VIBEX®, VIBEX® QuickShot®, and Vai™ auto-injectors and multi-does pen injectors, Our current auto-injectors 
offer a dose capacity ranging from 0.5 mL to 2.25 mL, and our high-volume auto-injector technology extends that dose capacity 
to at least 10mL. They are designed for speed and patient comfort and accommodate for highly viscous drug products. They are 
customizable  for  fill  volumes  and  needle  lengths  to  meet  our  partners’  needs  for  reliability  requirements,  including  for 
emergency use applications.

Our Strategy

We  are  a  leader  in  converting  IV  biologics  to  SC  delivery  and  extending  the  dosing  interval  of  SC  drugs,  using  our 
commercially-validated  ENHANZE  technology.  Our  ENHANZE  technology  also  has  the  potential  for  SC  delivery  of  small 
molecules and other therapeutic modalities including those developed as long-acting injectables and other therapies that might 
benefit from larger dose/larger volume SC delivery. We collaborate with leading pharmaceutical and biotechnology companies 
to  help  them  develop  products  that  combine  our  ENHANZE  technology  with  their  proprietary  compounds.  We  target  large, 
attractive  markets,  where  ENHANZE-enabled  SC  delivery  has  the  potential  to  deliver  competitive  differentiation  and  other 
important  benefits  to  our  partners,  such  as  larger  injection  volumes  administered  rapidly,  extended  dosing  intervals,  and 
reduced  treatment  burden  and  healthcare  costs.  In  addition,  ENHANZE  has  been  demonstrated  to  enable  the  combination  of 
two  therapeutic  antibodies  in  a  single  injection,  as  well  as  the  development  of  new  co-formulation  intellectual  property.  We 
leverage our strategic, technical, regulatory and alliance management skills in support of our partners' efforts to develop new 
SC delivered products. We currently have eleven collaborations with seven currently approved products and additional product 
candidates  in  development  using  our  ENHANZE  technology.  We  intend  to  work  with  our  existing  partners  to  expand  our 
collaborations  to  add  new  targets  and  develop  targets  and  product  candidates  under  the  terms  of  the  operative  collaboration 
agreements. We will also continue our efforts to enter into new collaborations to derive additional revenue from our proprietary 
technology. 

We  also  support  leading  pharmaceutical  companies  by  assisting  in  the  development  of,  and  supplying,  auto-injector 
devices  and  auto-injector  drug  combination  products.  We  leverage  our  engineering,  regulatory  and  manufacturing  skills  to 
support our partners’ plans. We intend to extend the range of auto-injectors available to current and new partners. In 2023, we 
completed a successful Phase I clinical study using a high-volume auto-injector. It is our goal to further extend the number of 
partners  for  the  current  auto-injectors  and  add  new  partners  for  our  high-volume  auto-injector  that  utilizes  our  ENHANZE 
technology.

9

Product and Product Candidates

The  following  table  summarizes  our  marketed  proprietary  products  and  product  candidates  under  development  and  our 

marketed partnered products and product candidates under development with our partners:

10

11

Proprietary Products and Product Candidates

Hylenex Recombinant (hyaluronidase human injection)

We  market  and  sell  Hylenex  recombinant  which  is  a  formulation  of  rHuPH20  that  facilitates  SC  administration  for 
achieving  hydration,  increases  the  dispersion  and  absorption  of  other  injected  drugs  and,  in  SC  urography,  to  improve 
resorption of radiopaque agents. Hylenex recombinant is currently the number one prescribed branded hyaluronidase. 

XYOSTED (testosterone enanthate) Injection

We  market  and  sell  our  proprietary  product  XYOSTED  for  SC  administration  of  testosterone  replacement  therapy 
(“TRT”)  in  adult  males  for  conditions  associated  with  a  deficiency  or  absence  of  endogenous  testosterone  (primary  or 
hypogonadism). XYOSTED is the only Food and Drug Administration (“FDA”)-approved SC testosterone enanthate product 
for  once-weekly,  at-home  self-administration  and  is  approved  and  marketed  in  the  United  States  (“U.S”).  in  three  dosage 
strengths, 50 mg, 75 mg and 100 mg.

ATRS - 1902

We have an ongoing program to develop a proprietary drug device combination product for the endocrinology market, for 
patients who require additional supplemental hydrocortisone, identified as ATRS-1902. The development program uses a novel 
proprietary auto-injector platform to deliver a liquid stable formulation of hydrocortisone.

In June 2021, we submitted an investigational new drug (“IND”) application with the FDA for the initiation of a Phase 1 
clinical study of ATRS-1902 for adrenal crisis rescue. The IND application included the protocol for an initial clinical study to 
compare the pharmacokinetics (“PK”) profile of our novel formulation of hydrocortisone versus Solu-Cortef®, which is an anti-
inflammatory glucocorticoid and is the current standard of care for the management of acute adrenal crises.

In July 2021, the FDA accepted our IND for ATRS-1902 enabling us to initiate our Phase 1 clinical study. The Phase 1 
clinical study, designed to evaluate the safety, tolerability and PK of a liquid stable formulation of hydrocortisone, was initiated 
in September 2021. The study was a cross-over design to establish the PK profile of ATRS-1902 (100 mg) compared to Solu-
Cortef (100 mg), the reference-listed drug, in 32 healthy adults. 

In  January  2022,  we  announced  the  positive  results  from  the  Phase  1  clinical  study  and  were  granted  Fast  Track 
designation by the FDA. The positive results supported the advancement of our ATRS-1902 development program to a pivotal 
study for the treatment of acute adrenal insufficiency, using our Vai novel proprietary rescue pen platform to deliver a liquid 
stable formulation of hydrocortisone. 

Partnered Products

ENHANZE Collaborations

Roche Collaboration

In  December  2006,  we  and  Roche  entered  into  a  collaboration  and  license  agreement  under  which  Roche  obtained  a 
worldwide license to develop and commercialize product combinations of rHuPH20 and up to twelve Roche target compounds 
(the “Roche Collaboration”). Under this agreement, Roche elected a total of eight targets, two of which are exclusive. 

In  September  2013,  Roche  launched  a  SC  formulation  of  Herceptin  (trastuzumab)  (Herceptin®  SC)  in  Europe  for  the 
treatment of patients with HER2-positive breast cancer followed by launches in additional countries. This formulation utilizes 
our  ENHANZE  technology  and  is  administered  in  two  to  five  minutes,  compared  to  30  to  90  minutes  with  the  standard  IV 
form. Herceptin SC has since received approval in Canada, the U.S. (under the brand name Herceptin Hylecta™) and China.

In  June  2020,  the  FDA  approved  the  fixed-dose  combination  of  Perjeta®  (pertuzumab)  and  Herceptin  for  SC  injection 
(Phesgo®)  utilizing  ENHANZE  technology  for  the  treatment  of  patients  with  HER2-positive  breast  cancer.  Phesgo  has  since 
received approval in Europe and China. In September 2023, Chugai Pharmaceuticals Co., Ltd (a Member of the Roche Group) 
announced that it had obtained regulatory approval for Phesgo from the Ministry of Health, Labour and Welfare (“MHLW”) in 
Japan. We will receive royalties for Phesgo sales in Japan as part of our licensing agreement with Roche.

In June 2014, Roche launched MabThera® SC in Europe for the treatment of patients with common forms of non-Hodgkin 
lymphoma (“NHL”), followed by launches in additional countries. This formulation utilizes our ENHANZE technology and is 
administered  in  approximately  five  minutes  compared  to  the  approximate  1.5  to  4  hour  IV  infusion.  In  May  2016,  Roche 
announced that the European Medicines Agency (“EMA”) approved MabThera SC to treat patients with chronic lymphocytic 
leukemia  (“CLL”).  In  June  2017,  the  FDA-approved  Genentech’s  RITUXAN  HYCELA®,  a  combination  of  rituximab  using 
ENHANZE technology (approved and marketed under the MabThera SC brand in countries outside the U.S. and Canada), for 
CLL and two types of NHL, follicular lymphoma and diffuse large B-cell lymphoma. In March 2018, Health Canada approved 

12

a combination of rituximab and ENHANZE (approved and marketed under the brand name RITUXAN® SC) for patients with 
CLL. In November 2022, Roche submitted the independent medical assessment (“IMA”) for MabThera SC to the Center for 
Drug Evaluation (“CDE”) in China.

In September 2017 and October 2018, we entered into agreements with Roche to develop and commercialize additional 
exclusive targets using ENHANZE technology. The upfront license payment may be followed by event-based payments subject 
to Roche’s achievement of specified development, regulatory and sales-based milestones. In addition, Roche will pay royalties 
to us if products under the collaboration are commercialized.

In  December  2018,  Roche  initiated  a  Phase  1b/2  study  in  patients  with  non-small  cell  lung  cancer  (“NSCLC”)  for 
TECENTRIQ® (atezolizumab) using ENHANZE technology, followed by initiation of a Phase 3 study in December 2020. In 
August 2022, Roche announced that the Phase 3 study met its co-primary endpoints showing non-inferior levels of Tecentriq in 
the  blood  PK,  when  injected  subcutaneously,  compared  with  IV  infusion,  in  cancer  immunotherapy-naïve  patients  with 
advanced  or  metastatic  NSCLC  for  whom  prior  platinum  therapy  has  failed.  The  safety  profile  of  the  SC  formulation  was 
consistent with that of IV Tecentriq. In August 2023, Roche announced the approval of Tecentriq SC with ENHANZE by the 
Medicines and Healthcare products Regulatory Agency (“MHRA”) in Great Britain. In January 2024, Roche received European 
Commission (“EC”) marketing authorization for Tecentriq SC for all approved indications of Tecentriq IV. Roche is expecting 
Tecentriq SC approval in the U.S. in September 2024 and is planning to launch soon after. Tecentriq SC enables SC delivery in 
approximately seven minutes, compared with 30-60 minutes for IV infusion. 

 In August 2019, Roche initiated a Phase 1 study evaluating ocrelizumab SC with ENHANZE technology in subjects with 
multiple sclerosis, followed by initiation of a Phase 3 study in April 2022. In July 2023, Roche announced that the Phase III 
OCARINA II trial evaluating ocrelizumab SC with ENHANZE as a twice a year 10-minute SC injection met its primary and 
secondary  endpoints  in  patients  with  relapsing  forms  of  multiple  sclerosis  (“MS”)  or  primary  progressive  MS  (“RMS”  or 
“PPMS”). Subsequently, Roche filed ocrelizumab SC with ENHANZE with regulatory authorities in the EU, United Kingdom 
(“UK”) and the U.S.

In  October  2019,  Roche  nominated  a  new  undisclosed  exclusive  target  to  be  studied  using  ENHANZE  technology.  In 

November 2021, Roche initiated a Phase 1 study with the undisclosed target and ENHANZE.

Takeda Collaboration

In  September  2007,  we  and  Takeda  entered  into  a  collaboration  and  license  agreement  under  which  Takeda  obtained  a 
worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 with GAMMAGARD LIQUID 
(HYQVIA®)  (the  “Takeda  Collaboration”).  HYQVIA  is  indicated  for  the  treatment  of  primary  immunodeficiency  disorders 
associated with defects in the immune system.

In  May  2013,  the  EC  granted  Takeda  marketing  authorization  in  all  EU  Member  States  for  the  use  of  HYQVIA  as 
replacement therapy for adult patients with primary and secondary immunodeficiencies. Takeda launched HYQVIA in the first 
EU country in July 2013 and has continued to launch in additional countries. In May 2016, Takeda announced that HYQVIA 
received a marketing authorization from the EC for a pediatric indication.

In September 2014, HYQVIA was approved by the FDA for treatment of adult patients with primary immunodeficiency 
in the U.S. HYQVIA is the first SC immune globulin (“IG”) treatment approved for adult primary immunodeficiency patients 
with a dosing regimen requiring only one infusion up to once per month (every three to four weeks) and one injection site per 
infusion in most patients, to deliver a full therapeutic dose of IG. 

In  September  2020,  Takeda  announced  that  the  EMA  approved  a  label  update  for  HYQVIA  broadening  its  use  and 
making  it  the  first  and  only  facilitated  SC  immunoglobulin  replacement  therapy  in  adults,  adolescents  and  children  with  an 
expanded range of secondary immunodeficiencies (“SID”).

In  October  2021,  Takeda  initiated  a  Phase  1  single-dose,  single-center,  open-label,  three-arm  study  to  assess  the 
tolerability and safety of immune globulin SC (human), 20% solution with ENHANZE (TAK-881) at various infusion rates in 
healthy  adult  subjects.  In  October  2023,  Takeda  initiated  a  Phase  2/3  study  to  evaluate  PK,  safety,  and  tolerability  of 
subcutaneous  administration  of  TAK-881  in  adult  and  pediatric  participants  with  Primary  Immunodeficiency  Diseases 
(“PIDD”).

13

In July 2022, Takeda announced positive topline results from pivotal Phase 3 trial evaluating HYQVIA, for maintenance 
treatment  of  chronic  inflammatory  demyelinating  polyneuropathy  (“CIDP”).  In  June  2023,  Takeda  announced  positive  full 
results  from  a  pivotal  Phase  3  trial  evaluating  HYQVIA  for  maintenance  treatment  of  CIDP  and  confirmed  regulatory 
applications were under review in the U.S. and EU for HYQVIA use as a maintenance therapy in adults with stable CIDP. In 
January  2024,  Takeda  received  FDA  and  EC  approval  for  HYQVIA  for  the  treatment  of  CIDP  as  maintenance  therapy  to 
prevent the relapse of neuromuscular disability and impairment in adults.

 In April 2023, Takeda announced that the FDA-approved the supplemental Biologics License Application (“sBLA”) to 
expand the use of HYQVIA to treat primary immunodeficiency in children. In February 2024, Takeda submitted a New Drug 
Application  in  Japan  seeking  approval  for  TAK-771,  subcutaneous  10%  human  immunoglobulin  with  ENHANZE,  for 
treatment of primary immunodeficiency.

Pfizer Collaboration

In  December  2012,  we  and  Pfizer  entered  into  a  collaboration  and  license  agreement,  under  which  Pfizer  has  the 
worldwide license to develop and commercialize products combining our rHuPH20 enzyme with Pfizer proprietary biologics in 
primary care and specialty care indications. Pfizer has elected five targets and has returned two targets. 

Janssen Collaboration

In  December  2014,  we  and  Janssen  entered  into  a  collaboration  and  license  agreement,  under  which  Janssen  has  the 
worldwide license to develop and commercialize products combining our rHuPH20 enzyme with Janssen proprietary biologics 
directed to up to five targets. Targets may be selected on an exclusive basis. Janssen elected CD38 and initiated several Phase 3 
studies, Phase 2 studies and Phase 1 studies of DARZALEX® (daratumumab), directed at CD38, using ENHANZE technology 
in patients with amyloidosis, smoldering myeloma and multiple myeloma. 

In  May  2020,  Janssen  launched  the  commercial  sale  of  DARZALEX  FASPRO®  (DARZALEX  utilizing  ENHANZE 
technology)  in  four  regimens  across  five  indications  in  multiple  myeloma  patients,  including  newly  diagnosed,  transplant-
ineligible  patients  as  well  as  relapsed  or  refractory  patients.  As  a  fixed-dose  formulation,  DARZALEX  FASPRO  can  be 
administered over three to five minutes, significantly less time than DARZALEX IV which requires multi-hour infusions. In 
June  2020,  we  announced  that  Janssen  received  European  marketing  authorization  and  launched  the  commercial  sale  of 
DARZALEX SC utilizing ENHANZE in the EU. Subsequent to these approvals, Janssen received several additional regulatory 
approvals for additional indications and patient populations in the U.S., EU, Japan and China. Beginning with the U.S., Janssen 
has  marketing  authorization  for  DARZALEX  FASPRO  in  combination  with  bortezomib,  thalidomide,  and  dexamethasone  in 
newly  diagnosed  multiple  myeloma  patients  who  are  eligible  for  autologous  stem  cell  transplant,  in  combination  with 
bortezomib,  cyclophosphamide  and  dexamethasone  (“D-VCd”)  for  the  treatment  of  adult  patients  with  newly  diagnosed  AL 
amyloidosis, in combination with pomalidomide and dexamethasone (“D-Pd”) for patients with multiple myeloma after first or 
subsequent relapse, and in combination with Kyprolis® (carfilzomib) and dexamethasone for patients with relapsed or refractory 
multiple myeloma who have received one to three prior lines of therapy. In the EU, Janssen has marketing authorization for 
DARZALEX SC in combination with D-VCd in newly diagnosed adult patients with AL amyloidosis and in combination with 
D-Pd in adult patients with relapsed or refractory multiple myeloma. In Japan, Janssen has marketing authorization for the SC 
formulation  of  DARZALEX  (known  as  DARZQURO  in  Japan)  for  the  treatment  of  multiple  myeloma  and  systemic  AL 
amyloidosis.  In  China,  Janssen  has  marketing  authorization  for  DARZALEX  SC  for  the  treatment  of  primary  light  chain 
amyloidosis,  in  combination  with  D-VCd  in  newly  diagnosed  patients.  In  January  2024,  Janssen  announced  submission  of  a 
sBLA  to  the  FDA  seeking  approval  of  a  new  indication  for  DARZALEX  FASPRO  in  combination  with  bortezomib, 
lenalidomide  and  dexamethasone  (“D-VRd”)  for  induction  and  consolidation  treatment  and  with  lenalidomide  (“D-R”)  for 
maintenance  treatment  of  adult  patients  who  are  newly  diagnosed  with  multiple  myeloma  (“NDMM”)  and  are  eligible  for 
autologous stem cell transplant (“ASCT”).

In December 2019, Janssen elected EGFR and cMET as a bispecific antibody (amivantamab) target on an exclusive basis, 
which  is  being  studied  in  solid  tumors.  In  September  2022,  following  a  Phase  1  study,  Janssen  initiated  a  Phase  3  study  of 
lazertinib and amivantamab with ENHANZE in patients with epidermal growth factor receptor (“EGFR”)-mutated advanced or 
metastatic non-small cell lung cancer (PALOMA-3). In November 2022, Janssen initiated a Phase 2 study of amivantamab with 
ENHANZE in multiple regimens in patients with advanced or metastatic solid tumors including EGFR-mutated non-small cell 
lung  cancer  (PALOMA-2).  In  January  2024,  Janssen  noted  its  intention  to  submit  applications  in  the  U.S.  and  EU  seeking 
approval of a SC formulation for amivantamab SC during 2024. 

In  July  2021,  Janssen  elected  the  target  HIV  reverse  transcriptase  limited  to  non-nucleoside  reverse  transcriptase 
inhibitors. In December 2021, Janssen initiated a Phase 1 clinical trial combining rilpivirine and ENHANZE. In 2023, Janssen 
discontinued the rilpivirine program with ENHANZE.

14

AbbVie Collaboration

In June 2015, we and AbbVie entered into a collaboration and license agreement, under which AbbVie has the worldwide 
license to develop and commercialize products combining our rHuPH20 enzyme with AbbVie proprietary biologics directed to 
up to nine targets. Targets may be selected on an exclusive basis. 

Lilly Collaboration

In December 2015, we and Lilly entered into a collaboration and license agreement, under which Lilly has the worldwide 
license  to  develop  and  commercialize  products  combining  our  rHuPH20  enzyme  with  Lilly  proprietary  biologics.  Lilly 
currently has the right to select up to three targets. Targets may be selected on an exclusive basis. Lilly has elected two targets 
on an exclusive basis and one target on a semi-exclusive basis. 

BMS Collaboration

In  September  2017,  we  and  BMS  entered  into  a  collaboration  and  license  agreement,  which  became  effective  in 
November 2017, under which BMS had the worldwide license to develop and commercialize products combining our rHuPH20 
enzyme with BMS products directed at up to eleven targets. Targets may be selected on an exclusive basis or non-exclusive 
basis.  BMS  has  designated  multiple  immuno-oncology  targets  including  programmed  death  1  (“PD-1”)  and  has  an  option  to 
select three additional targets by November 2024. In October 2019, BMS initiated a Phase 1 study of relatlimab, an anti-LAG-3 
antibody, in combination with nivolumab using ENHANZE technology. In May 2021, BMS initiated a Phase 3 of nivolumab 
using  ENHANZE  technology  for  patients  with  advanced  or  metastatic  clear  cell  renal  cell  carcinoma  (CheckMate-67T), 
leveraging data and insights from Phase 1/2 CA209-8KX study in patients with solid tumors. In October 2023, BMS reported 
positive  top-line  data  from  the  Phase  3  CheckMate-67T  trial  evaluating  a  SC  formulation  of  Opdivo  (nivolumab)  with 
ENHANZE in patients with advanced or metastatic clear cell renal cell carcinoma (“ccRCC”) who have received prior systemic 
therapy. The study met its co-primary PK endpoints and a key secondary endpoint.

In June 2022, BMS nominated an undisclosed target, which was returned in January 2024. In March 2023, BMS initiated 
a Phase 3 trial to demonstrate the drug exposure levels of nivolumab and relatlimab fixed-dose combination with ENHANZE is 
not  inferior  to  IV  administration  in  participants  with  previously  untreated  metastatic  or  unresectable  melanoma 
(RELATIVITY-127).

Alexion Collaboration 

In December 2017, we and Alexion entered into a collaboration and license agreement (“CLA”), under which Alexion has 
the  worldwide  license  to  develop  and  commercialize  products  combining  our  rHuPH20  enzyme  with  Alexion’s  portfolio  of 
products  directed  at  up  to  four  exclusive  targets.  Alexion  notified  us  of  a  discontinuation  of  our  CLA,  effective  in  the  first 
quarter of 2024.

argenx Collaboration 

In  February  2019,  we  and  argenx  entered  into  an  agreement  for  the  right  to  develop  and  commercialize  one  exclusive 
target, the human neonatal Fc receptor FcRn, which includes argenx’s lead asset efgartigimod (ARGX-113), and an option to 
select two additional targets using ENHANZE technology. In May 2019, argenx nominated a second target to be studied using 
ENHANZE  technology,  a  human  complement  factor  C2  associated  with  the  product  candidate  ARGX-117,  which  is  being 
developed  to  treat  severe  autoimmune  diseases  in  Multifocal  Motor  Neuropathy  (“MMN”).  In  October  2020,  we  and  argenx 
entered into an agreement to expand the collaboration relationship, adding three targets for a total of up to six targets under the 
collaboration. 

In December 2021, argenx announced the FDA approval of efgartigimod (VYVGARTTM) for the treatment of generalized 
myasthenia  gravis  (“gMG”)  for  the  IV  dosing  regimen.  In  March  2022,  argenx  announced  that  data  from  argenx’s  phase  3 
ADAPT-SC  study  evaluating  SC  efgartigimod  utilizing  ENHANZE  (1000mg  efgartigimod-PH20)  for  the  treatment  of  gMG 
achieved  the  primary  endpoint  of  total  IgG  reduction  from  baseline  at  day  29,  demonstrating  statistical  non-inferiority  to 
VYVGART (efgartigimod alfa-fcab) IV formulation in gMG patients. 

  In  June  2023,  argenx  received  FDA  approval  under  the  brand  name  VYVGART®  Hytrulo  for  the  injection  with 
ENHANZE for SC use of treatment of gMG in adult patients who are anti-acetylcholine receptor (“AChR”) antibody positive. 
In November 2023, argenx received EC approval of VYVGART SC for the treatment of gMG, which also provides the option 
for  patient  self-administration.  In  January  2024,  argenx  received  Japan  approval  for  VYVDURA®  (efgartigimod  alfa  and 
hyaluronidase-qvfc)  co-formulated  with  ENHANZE  for  the  treatment  of  adult  patients  with  gMG  including  options  for  self-
administration. argenx also expects the regulatory decision on approval of VYVGART SC for gMG in China through Zai Lab 
by the end of 2024. 

15

In July 2023, argenx reported positive data from the ADHERE study evaluating VYVGART® Hytrulo with ENHANZE in 
adults with CIDP.  In February 2024, argenx announced that the FDA had accepted for priority review a sBLA for VYVGART 
Hytrulo for the treatment of CIDP. The application has been granted a Prescription Drug User Fee Act (“PDUFA”) action date 
of June 21, 2024. argenx also expects to submit VYVGART SC for CIDP for regulatory approval in Japan, Europe, China and 
Canada  in  2024.  In  September  2023,  Zai  Lab  limited  (argenx  commercial  partner  for  China)  announced  the  CDE  of  the 
National Medical Products Administration (“NMPA”) granted Breakthrough Therapy Designation for efgartigimod SC for the 
treatment of patients with CIDP.

In  November  2023,  argenx  reported  that  the  ADVANCE-SC  study,  evaluating  VYVGART®  Hytrulo  in  adults  with 
primary immune thrombocytopenia (“ITP”) did not meet the primary endpoint of a sustained platelet count response in chronic 
ITP  patients.  In  December  2023,  argenx  reported  that  the  ADDRESS  study,  evaluating  efgartigimod  SC  in  adults  with 
pemphigus  vulgaris  (“PV”)  and  pemphigus  foliaceus  (“PF”)  resulted  in  the  proportion  of  PV  patients  achieving  the  primary 
endpoint of complete remission on a minimal dose of steroids (“CRmin”) was not significantly different between efgartigimod 
SC  and  the  control  arm.  In  both  studies,  patients  treated  with  Efgartigimod  PH20  SC  achieved  the  same  magnitude  of  total 
Immunoglobulin G (“IgG”) reduction as observed in previous clinical trials, reflecting no impact of the route of administration 
on the study results. argenx will not pursue additional development in pemphigus.

argenx is currently conducting a Phase 2 study of ARGX-113 (ALKIVIA) using ENHANZE technology for patients with 
active idiopathic inflammatory myopathy (Myositis) and another study, BALLAD, evaluating ARGX -113 using ENHANZE in 
bullous  pemphigoid.  argenx  intends  to  initiate  a  registrational  trial  of  ARGX-113  using  ENHANZE  technology  for  patients 
with thyroid eye disease in 2024. 

Horizon Collaboration

In  November  2020,  we  and  Horizon  entered  into  a  global  collaboration  and  license  agreement  that  gives  Horizon 
exclusive  access  to  ENHANZE  technology  for  SC  formulation  of  medicines  targeting  IGF-1R.  Horizon  intends  to  use 
ENHANZE  to  develop  a  SC  formulation  of  TEPEZZA®  (teprotumumab-trbw),  indicated  for  the  treatment  of  thyroid  eye 
disease, a serious, progressive and vision-threatening rare autoimmune disease, potentially shortening drug administration time, 
reducing healthcare practitioner time and offering additional flexibility and convenience for patients. In March 2021, Horizon 
completed dosing in a Phase 1 study exploring the SC formulation of TEPEZZA®. The trial was a small, single-dose Phase 1 
PK  trial  which  included  evaluation  of  ENHANZE  technology  for  a  SC  formulation.  In  March  2022,  Horizon  announced  the 
completion of a Phase 1 trial for the TEPEZZA® SC program. In October 2023, Horizon became an affiliated entity of Amgen 
Inc. Horizon noticed a return of the target and discontinuation of our CLA, effective in the second quarter of 2024. 

16

ViiV Healthcare Collaboration

In June 2021, we and ViiV entered into a global collaboration and license agreement that gives ViiV exclusive access to 
our ENHANZE technology for four specific small and large molecule targets for the treatment and prevention of HIV. These 
targets are integrase inhibitors, reverse transcriptase inhibitors limited to nucleoside reverse transcriptase inhibitors (“NRTI”) 
and nucleoside reverse transcriptase translocation inhibitors (“NRTTIs”), capsid inhibitors and broadly neutralising monoclonal 
antibodies (“bNAbs”), that bind to the gp120 CD4 binding site. In December 2021, ViiV initiated enrollment of a Phase 1 study 
to evaluate cabotegravir administered subcutaneously with ENHANZE. In February 2022, ViiV initiated enrollment of a Phase 
1 study to evaluate the safety and PKs of N6LS, a broadly neutralizing antibody, administered subcutaneously with ENHANZE 
technology.  In  June  2022,  ViiV  initiated  enrollment  of  a  Phase  1  single  dose  escalation  study  to  evaluate  PKs,  safety  and 
tolerability  of  long-acting  cabotegravir  administered  subcutaneously  with  ENHANZE  technology.  In  August  2023,  ViiV 
initiated  a  Phase  2b  study  to  evaluate  the  efficacy,  safety,  PKs  and  tolerability  of  VH3810109  (N6LS)  administered 
subcutaneously with rHuPH20 in combination with cabotegravir. In the third quarter of 2023, ViiV initiated a Phase 1 study 
with ENHANZE for an undisclosed program.

Chugai Collaboration 

In  March  2022,  we  and  Chugai  entered  into  a  global  collaboration  and  license  agreement  that  gives  Chugai  exclusive 
access  to  ENHANZE  technology  for  an  undisclosed  target.  Chugai  intends  to  explore  the  potential  use  of  ENHANZE  for  a 
Chugai drug candidate. In May 2022, Chugai initiated a Phase 1 study to evaluate the PKs, pharmacodynamics, and safety of 
targeted antibody administered subcutaneously with ENHANZE.

Acumen Collaboration 

In November 2023, we and Acumen entered into a global collaboration and non-exclusive license agreement that provides 
Acumen  access  to  ENHANZE    for  a  single  target.  Acumen  intends  to  explore  the  potential  use  of  ENHANZE  for  ACU193, 
Acumen’s clinical stage monoclonal antibody candidate to target Amyloid-β Oligomers for the treatment of early Alzheimer’s 
disease.

Device and Other Drug Product Collaborations

Teva License, Development and Supply Agreements

In July 2006, we entered into an exclusive license, development and supply agreement with Teva for an epinephrine auto- 
injector product to be marketed in the U.S. and Canada. We are the exclusive supplier of the device, which we developed, for 
Teva’s  generic  Epinephrine  Injection  USP  products,  indicated  for  emergency  treatment  of  severe  allergic  reactions  including 
those that are life threatening (anaphylaxis) in adults and certain pediatric patients. Teva’s Epinephrine Injection, utilizing our 
patented VIBEX® injection technology, was approved by the FDA as a generic drug product with an AB rating, meaning that it 
is therapeutically equivalent to the branded products EpiPen® and EpiPen Jr® and therefore, subject to state law, substitutable at 
the pharmacy.

In December 2007, we entered into a license, development and supply agreement with Teva under which we developed 
and supply a disposable pen injector for teriparatide. Under the agreement, we received an upfront payment and development 
milestones, and are entitled to receive royalties on net product sales by Teva in territories where commercialized. 

We are the exclusive supplier of the multi-dose pen, which we developed, used in Teva’s generic teriparatide injection 
product. In 2020, Teva launched Teriparatide Injection, the generic version of Eli Lilly’s branded product Forsteo® featuring 
our multi-dose pen platform, for commercial sale in several countries outside of the U.S. In November 2023, Teva announced 
FDA  approval  of  the  generic  version  of  Forteo,  featuring  our  multi-dose  auto-injector  pen  platform  for  the  treatment  of 
osteoporosis among certain women and men.

Pfizer Agreement

In August 2018, we entered into a development agreement with Pfizer to jointly develop a combination drug device rescue 
pen utilizing the QuickShot auto-injector and an undisclosed Pfizer drug. Pfizer has provided the intellectual property rights for 
further  development  of  the  product  to  us  and  has  retained  an  option  to  assist  in  the  marketing,  distribution  and  sale  if  we 
complete development of the product and submit for regulatory approval. We are continuing to evaluate the next steps for this 
program. 

Idorsia Agreement

In November 2019, we entered into a global agreement with Idorsia to develop a novel, drug-device product containing 
selatogrel.  A  new  chemical  entity,  selatogrel  is  being  developed  for  the  treatment  of  a  suspected  acute  myocardial  infarction 
(“AMI”) in adult patients with a history of AMI.

17

In January 2024, Idorsia disclosed that recruitment of their Phase 3 study with selatogrel for acute myocardial infarction 

had reached more than 5,500 patients.

Otter Agreement

In  December  2021,  we  entered  into  a  supply  agreement  with  Otter  to  manufacture  the  VIBEX  auto-injection  system 
device, designed and developed to incorporate a pre-filled syringe for delivery of methotrexate, assemble, package, label and 
supply the final OTREXUP product and related samples to Otter at cost plus mark-up. Otter is responsible for manufacturing, 
formulation and testing of methotrexate and the corresponding pre-filled syringe for assembly with the device manufactured by 
us,  along  with  the  commercialization  and  distribution  of  OTREXUP.  OTREXUP  is  a  SC  methotrexate  injection  for  once 
weekly  self-administration  with  an  easy-to-use,  single  dose,  disposable  auto  injector,  indicated  for  adults  with  severe  active 
rheumatoid  arthritis  (“RA”),  children  with  active  polyarticular  juvenile  idiopathic  arthritis  and  adults  with  severe  recalcitrant 
psoriasis. Further, we entered into a license agreement with Otter in which we granted Otter a worldwide, exclusive, fully paid-
up license to certain patents relating to OTREXUP that may also relate to our other products for Otter to commercialize and 
otherwise exploit OTREXUP in the field as defined in the license agreement.

For a further discussion of the collaboration agreements, refer to Note 2, Summary of Significant Accounting Policies - 

Revenues under Collaborative Agreements.

Patents and Intellectual Proprietary Rights

Patents and other intellectual proprietary rights are essential to our business. Our success will depend in part on our ability 
to  obtain  patent  protection  for  our  inventions,  to  preserve  our  trade  secrets  and  to  operate  without  infringing  the  proprietary 
rights  of  third  parties.  Our  strategy  is  to  actively  pursue  patent  protection  in  the  U.S.  and  certain  foreign  jurisdictions  for 
technology that we believe to be proprietary to us and that offers us a potential competitive advantage. 

Halozyme Patent Portfolio

Our Halozyme patent portfolio includes patents we own solely and, in some cases, jointly with several licensees in the 
U.S., Europe and other countries in the world and we also have numerous pending patent applications. In general, patents have 
a  term  of  20  years  from  the  application  filing  date  or  earlier  claimed  priority  date.  We  continue  to  file  and  prosecute  patent 
applications to strengthen and grow our patent portfolio pertaining to our recombinant human hyaluronidase and other drugs 
and drug delivery devices, which cover primarily compositions of matter, formulations, methods of use and manufacture, and 
devices.  We  have  multiple  patents  and  patent  applications  throughout  the  world  pertaining  to  our  recombinant  human 
hyaluronidase and methods of use and manufacture, including an issued U.S. patent which expires in 2027, an issued European 
patent which expires in 2024, and additional patents that are valid into 2029, which we believe cover the products and product 
candidates under our existing collaborations and Hylenex recombinant. In addition, we have, under prosecution throughout the 
world,  multiple  patent  applications  that  relate  specifically  to  individual  product  candidates  under  development,  and  jointly 
owned patent applications relating to our collaborations with several licensees (including, but not limited to, patent applications 
covering co-formulations and methods of treatment or use that if granted will be valid into the 2040s), the expiration of which 
can only be definitely determined upon maturation into our issued patents. We believe our patent filings represent a barrier to 
entry for potential competitors looking to utilize these hyaluronidases, other drugs and drug delivery devices.

Other Proprietary Rights

In  addition  to  patents,  we  rely  on  trade  secrets,  proprietary  know-how,  regulatory  exclusivities  and  continuing 
technological  innovation  to  protect  our  products  and  technologies.  We  protect  our  trade  secrets,  proprietary  know-how  and 
innovation, in part, by maintaining physical security of our sites and electronic security of our information technology systems 
and  utilizing  confidentiality  and  proprietary  information  agreements.  Our  policy  is  to  require  our  employees,  directors, 
consultants, advisors, partners, outside scientific partners and sponsored researchers, other advisors and other individuals and 
entities to execute confidentiality agreements upon the start of employment, consulting or other contractual relationships with 
us. These agreements provide that all confidential information developed or made known to the individual or entity during the 
course of the relationship is to be kept confidential and not disclosed to third parties except in specific circumstances. In the 
case  of  employees  and  some  other  parties,  the  agreements  provide  that  all  discoveries  and  inventions  conceived  by  the 
individual  will  be  our  exclusive  property.  In  certain  instances,  partners  with  which  we  have  entered  into  development 
agreements  may  have  rights  to  certain  technology  developed  in  connection  with  such  agreements.  Despite  the  use  of  these 
agreements and our efforts to protect our intellectual property, there is a risk of unauthorized use or disclosure of information. 
Furthermore, our trade secrets may otherwise become known to, or underlying technology may be independently developed by, 
our competitors.

We also file trademark applications to protect the names of our products and product candidates. These applications may 
not  mature  to  registration  and  may  be  challenged  by  third  parties.  We  are  pursuing  trademark  protection  in  a  number  of 
different countries around the world.

18

Research and Development Activities

Our research and development expenses consist primarily of costs associated with the product development, quality and 
regulatory  work  required  to  maintain  the  ENHANZE  platform,  expenses  associated  with  testing  of  new  high-volume  auto-
injectors, activities and support for our partners in their development and manufacturing of product candidates performed on 
behalf  of  our  partners,  compensation  and  other  expenses  for  research  and  development  personnel,  supplies  and  materials, 
facility  costs  and  amortization  and  depreciation.  We  charge  all  research  and  development  expenses  to  operations  as  they  are 
incurred. 

Manufacturing

ENHANZE

We do not have our own manufacturing facility for our product and our partners’ products and product candidates, or the 

capability to package our products. We have engaged third parties to manufacture bulk rHuPH20 and Hylenex.

We  have  existing  supply  agreements  with  contract  manufacturing  organizations  Avid  Bioservices,  Inc.  (“Avid”)  and 
Catalent  Indiana  LLC  (“Catalent”)  to  produce  supplies  of  bulk  rHuPH20.  These  manufacturers  each  produce  bulk  rHuPH20 
under  current  Good  Manufacturing  Practices  (“cGMP”)  for  clinical  and  commercial  uses.  Catalent  currently  produces  bulk 
rHuPH20 for use in Hylenex and collaboration products and product candidates. Avid currently produces bulk rHuPH20 for use 
in collaboration products and product candidates. We rely on their ability to successfully manufacture these batches according 
to  product  specifications.  It  is  important  for  our  business  for  Catalent  and  Avid  to  (i)  retain  their  status  as  cGMP-approved 
manufacturing  facilities;  (ii)  successfully  scale  up  bulk  rHuPH20  production;  and/or  (iii)  manufacture  the  bulk  rHuPH20 
required  by  us  and  our  partners  for  use  in  our  proprietary  and  collaboration  products  and  product  candidates.  In  addition  to 
supply obligations, Avid and Catalent also provide support for data and information used in the chemistry, manufacturing and 
controls (“CMC”) sections for FDA and other regulatory filings.

We  have  a  commercial  manufacturing  and  supply  agreement  with  Patheon  Manufacturing  Services,  LLC  (“Patheon”) 

under which Patheon will provide the final fill and finishing steps in the production process of Hylenex recombinant. 

Devices

We  also  use  third  parties  to  manufacture  our  auto-injector  technology  products  and  product  candidates,  including  the 
products and related components we supply to our partners. For our products and product candidates, we verify that they are 
manufactured  in  accordance  with  FDA’s  cGMPs  for  drug  products  and  the  FDA’s  current  Quality  System  Regulations 
(“QSRs”)  for  medical  devices  and  equivalent  provisions  in  the  EU  and  elsewhere,  which  are  required  as  part  of  the  overall 
obligations  necessary,  in  the  EU  for  instance,  to  obtain  a  CE-mark.  We  enter  into  quality  agreements  with  our  third-party 
manufacturers which require compliance with cGMPs, QSRs and foreign equivalents, to the extent applicable. We use third-
party  service  providers  to  assemble  and  package  our  products  and  product  candidates  under  our  direction.  We  monitor  and 
evaluate manufacturers and suppliers to assess compliance with regulatory requirements and our internal quality standards and 
benchmarks. We perform quality reviews of manufacturing for all of our product candidates and products, and quality releases 
for all of our product candidates and products that we sponsor or commercialize.

We  use  third-party  manufacturers  to  manufacture  and  supply  certain  components,  drugs,  final  assembly  and  finished 
product.  Below  is  a  summary  of  our  key  production,  manufacturing,  assembly  and  packaging  arrangements  with  third-party 
manufacturers for products commercialized by us and our partners:

•

•

•

•

•

Phillips-Medisize  Corporation  (“Phillips”),  an  international  outsource  provider  of  design  and  manufacturing 
services,  produces  commercial  quantities  of  components  of  our  QuickShot  auto-injector  device  for  XYOSTED 
and our VIBEX epinephrine auto-injector product with Teva.

ComDel  Innovation,  Inc.  (“ComDel”),  a  domestic  provider  of  integrated  solutions  for  product  development, 
tooling,  and  manufacturing,  produces  commercial  quantities  of  components  for  the  VIBEX  teriparatide  auto-
injector product with Teva and the VIBEX auto-injector device for the OTREXUP product for Otter.

Jabil  Healthcare,  an  international  manufacturing  development  company,  produces  commercial  quantities  of 
components of our VIBEX auto-injector device for the OTREXUP product for Otter and the VIBEX epinephrine 
auto-injector product with Teva.

Fresenius Kabi supplies commercial quantities of pre-filled syringes of testosterone for XYOSTED.

Sharp Corporation (“Sharp”), an international contract packaging company, assembles and packages XYOSTED 
auto-injector products and the OTREXUP auto-injector product for Otter.

In addition, our Minnetonka, Minnesota facility supports our administrative functions, product development and quality 

operations and provides additional assembling and warehousing capabilities.

19

Sales, Marketing and Distribution

We  have  two  teams  of  sales  specialists,  one  that  provide  hospital  and  surgery  center  customers  with  the  information 
needed to obtain formulary approval for, and support utilization of, Hylenex recombinant and one that supports the promotion 
of our testosterone product XYOSTED. Our commercial activities also include marketing and related services and commercial 
support  services  such  as  commercial  operations,  managed  markets  and  commercial  analytics.  We  also  employ  third-party 
vendors, such as advertising agencies, market research firms and suppliers of marketing and other sales support related services 
to assist with our commercial activities.

We sell XYOSTED and Hylenex recombinant in the U.S. to wholesale pharmaceutical distributors, who sell Hylenex to 
hospitals and XYOSTED to other end-user customers. We engage Integrated Commercialization Solutions (“ICS”), a division 
of AmerisourceBergen Specialty Group, a subsidiary of AmerisourceBergen, to act as our exclusive distributor for commercial 
shipment  and  distribution  of  Hylenex  recombinant  to  our  customers  in  the  U.S.  We  also  contract  with  numerous  wholesale 
distributors,  including  Cardinal,  McKesson  Corporation  (“McKesson”)  and  AmerisourceBergen  Corporation  to  distribute 
XYOSTED, to retail pharmacies as well as the Veterans Administration and other governmental agencies.

  In  addition  to  shipping  and  distribution  services,  these  distributors  and  third-party  logistics  providers,  Cardinal  Health 
105, Inc., also known as Specialty Pharmaceutical Services (“Cardinal”), and Knipper Health, Inc. (“Knipper”) provide us with 
other key services related to logistics, warehousing, returns and inventory management, sales reports, contract administration 
and chargebacks processing and accounts receivable management. We also use a division of Cardinal and Knipper for sample 
administration.  In  addition,  we  utilize  these  third  parties  to  perform  various  other  services  for  us  relating  to  regulatory 
monitoring,  including  call  center  management,  adverse  event  reporting,  safety  database  management  and  other  product 
maintenance  services.  In  exchange  for  these  services,  we  pay  fees  to  certain  distributors  based  on  a  percentage  of  wholesale 
acquisition cost. We have also contracted with several specialty pharmacies to support fulfillment of certain prescriptions. In 
addition, we use third parties to perform various other services for us relating to regulatory monitoring, including adverse event 
reporting, safety database management and other product maintenance services.

Competition

The  pharmaceutical  industry  is  characterized  by  rapidly  advancing  technologies,  intense  competition  and  a  strong 
emphasis  on  proprietary  therapeutics.  We  face  competition  from  a  number  of  sources,  some  of  which  may  target  the  same 
indications as our product or product candidates, including large pharmaceutical companies, smaller pharmaceutical companies, 
biotechnology  companies,  academic  institutions,  government  agencies  and  private  and  public  research  institutions,  many  of 
which have greater financial resources, drug development experience, sales and marketing capabilities, including larger, well 
established  sales  forces,  manufacturing  capabilities,  experience  in  obtaining  regulatory  approvals  for  product  candidates  and 
other resources than us. 

ENHANZE

Our ENHANZE technology may face increasing competition from alternate approaches and/or emerging technologies to 
deliver medicines SC. In addition, our partners face competition in the commercialization of the product candidates for which 
the partners seek marketing approval from the FDA and other regulatory authorities.

Hylenex Recombinant

Hylenex  recombinant  is  currently  the  only  FDA-approved  recombinant  human  hyaluronidase  on  the  market.  The 
competitors  for  Hylenex  recombinant  include  Amphastar  Pharmaceuticals,  Inc.’s  product,  Amphadase®,  a  bovine  (bull) 
hyaluronidase.

XYOSTED

In the U.S., there are several different formulations for TRT including intramuscular injection, transdermal patches and gels, 
oral  formulations  and  nasal  gels.  Potential  competition  in  the  U.S.  testosterone  replacement  market  includes  transdermal 
solutions  such  as  AbbVie’s  Androgel®  1%  and  1.62%,  Perrigo’s  generic  Androgel®  Topical  Gel  1.62%,  Eli  Lilly’s  Axiron®, 
Endo’s Testim® and Fortesta® (and the authorized generic) and Verity Pharma’s TLANDO® and Natesto®. Other forms of TRT 
include injectables such as Endo’s Aveed®, Pfizer’s Depo®-Testosterone, and several generic oil testosterone products sold by 
Actavis, Sandoz, Viatris Inc., Teva and others, as well as Testopel® pellets by Endo and JATENZO®, an oral formulation, by 
Tolmar, and Kyzatrex, an oral formulation by Marius Pharmaceuticals.

Devices

We  have  a  wide  range  of  competitors  depending  upon  the  branded  or  generic  marketplace,  the  therapeutic  product 
category,  and  the  product  type,  including  dosage  strengths  and  route  of  administration.  Our  competitors  include  established 
specialty pharmaceutical companies, major brand name and generic manufacturers of pharmaceuticals such as Teva, Viatris, Eli 

20

Lilly  and  Endo,  as  well  as  a  wide  range  of  medical  device  companies  that  sell  a  single  or  limited  number  of  competitive 
products  or  participate  in  only  a  specific  market  segment.  Our  competitors  also  include  third  party  contract  medical  device 
design and development companies such as Scandinavian Health Ltd., Ypsomed AG, West Pharmaceutical and Owen Mumford 
Ltd.  Many  of  our  competitors  have  greater  financial  and  other  resources  than  we  have,  such  as  more  commercial  resources, 
larger research and development staffs and more extensive marketing and manufacturing organizations. Smaller or early stage 
emerging companies may also prove to be significant competitors, particularly through collaborative arrangements with large, 
established companies.

Government Regulations

The  FDA  and  comparable  regulatory  agencies  in  foreign  countries  regulate  the  manufacture  and  sale  of  the 
pharmaceutical  products  that  we  or  our  partners  have  developed  or  that  our  partners  currently  are  developing.  The  FDA  has 
established  guidelines  and  safety  standards  that  are  applicable  to  the  laboratory  and  preclinical  evaluation  and  clinical 
investigation  of  therapeutic  products  and  stringent  regulations  that  govern  the  manufacture  and  sale  of  these  products.  The 
process  of  obtaining  regulatory  approval  for  a  new  therapeutic  product  usually  requires  a  significant  amount  of  time  and 
substantial resources. 

Regulatory obligations continue post-approval and include the reporting of adverse events when a drug is utilized in the 
broader patient population. Promotion and marketing of drugs is also strictly regulated, with penalties imposed for violations of 
FDA regulations, the Lanham Act and other federal and state laws, including the federal anti-kickback statute.

We  currently  intend  to  continue  to  seek,  through  our  partners,  approval  to  market  products  and  product  candidates  in 
foreign  countries,  which  may  have  regulatory  processes  that  differ  materially  from  those  of  the  FDA.  Our  partners  may  rely 
upon independent consultants to seek and gain approvals to market our proposed products in foreign countries or may rely on 
other  pharmaceutical  or  biotechnology  companies  to  license  our  proposed  products.  We  cannot  guarantee  that  approvals  to 
market any of our partners’ products can be obtained in any country. Approval to market a product in any one foreign country 
does not necessarily indicate that approval can be obtained in other countries.

From  time  to  time,  legislation  is  drafted  and  introduced  in  Congress  that  could  significantly  change  the  statutory 
provisions governing the approval, manufacturing and marketing of drug products. In addition, FDA regulations and guidance 
may  be  revised  or  reinterpreted  by  the  agency  or  reviewing  courts  in  ways  that  may  significantly  affect  our  business  and 
development  of  our  partners’  product  candidates  and  any  products  that  we  may  commercialize.  It  is  impossible  to  predict 
whether  additional  legislative  changes  will  be  enacted,  or  FDA  regulations,  guidance  or  interpretations  changed,  or  what  the 
impact of any such changes may be. 

Information about our Executive Officers

Information  concerning  our  executive  officers,  including  their  names,  ages  and  certain  biographical  information  can  be 
found  in  Part  III,  Item  10,  Directors,  Executive  Officers  and  Corporate  Governance.  This  information  is  incorporated  by 
reference into Part I of this report.

21

Human Capital Management

The experience, expertise and dedication of our employees drive the progress and accomplishments of Halozyme. 

As  of  February  12,  2024,  we  had  373  full-time  employees.  None  of  our  employees  are  unionized  and  we  believe  our 

employee relations to be good. 

Recognizing the value of our employees and the contributions they make in achieving our business objectives and overall 
success,  we  focus  on  creating  and  providing  an  inclusive  and  safe  work  environment  where  employees  are  respected  and 
rewarded for their contributions, work together as one team, have opportunities to grow and develop their careers, and support 
the communities in which we work. We also believe this approach to human capital management is essential to attracting and 
retaining  employees  in  the  highly  competitive  biotechnology  and  pharmaceutical  labor  market.  To  achieve  this  supportive 
working environment, our human capital management efforts focus on:

Corporate Values and Ethics

The foundation of our human capital management strategy is contained in our corporate values statement and our Code of 
Conduct  and  Ethics  (the  “Code  of  Conduct”),  both  of  which  provide  uniform  guidance  to  all  our  employees  regarding 
expectations for proper workplace behavior. Our corporate values emphasize respecting and valuing fellow team members and 
acting with integrity and honesty to uphold the highest ethical standards. We believe these values provide an environment in 
which all employees can feel proud and motivated to contribute their valued talents to achieving corporate goals and objectives. 
Our  values  also  emphasize  empowering  employees  and  personal  accountability  as  a  means  to  fulfill  our  commitments  to 
patients, partners, shareholders and each other.

Our  Board  of  Directors  adopted  and  regularly  reviews  the  Code  of  Conduct,  which  applies  to  all  of  our  employees, 
officers and directors. Adherence to the Code of Conduct helps ensure that all employees can feel a part of an organization that 
emphasizes adherence to laws and policies covering the industry in which we work. Our Code of Conduct also emphasizes each 
employee’s accountability for making decisions and taking actions in a highly ethical manner with a focus on honesty, fairness 
and integrity and treating all fellow employees in a respectful and inclusive manner. We have established a reporting hotline 
that  enables  employees  to  file  anonymous  reports  of  any  suspected  violations  of  the  Code  of  Conduct.  We  believe  that 
providing an ethical environment in which to work is vital to our efforts to attract, retain and develop our employees.

Diversity and Inclusion

We seek to build and maintain a diverse team of employees that are passionate about and committed to having a positive 
impact on the lives of patients and their families. We value and celebrate the unique talents, backgrounds and perspectives each 
employee  contributes  to  achieving  our  mission  and  corporate  objectives.  In  support  of  this  philosophy,  we  adopted  the 
Biotechnology  Innovation  Organization’s  principles  on  workforce  development,  diversity  and  inclusion.  Our  diverse  and 
inclusive  culture  is  key  to  attracting,  developing  and  retaining  our  talent  pool  within  the  globally  competitive  biotechnology 
industry. Our dedication to these principles has resulted in a diverse and inclusive employee base consisting of 43% female and 
29% non-white/Caucasian employees as of February 12, 2024.

As an equal opportunity employer, assuring we have and maintain an inclusive work environment is a key focus area for 
management.  We  actively  seek  to  attract  and  retain  employees  who  embody  and  embrace  inclusivity  as  a  core  value.  Our 
recruiting team collaborates with hiring managers to find the best possible candidates with appropriate knowledge, experience 
and technical skills. These candidates are then carefully vetted by a range of internal stakeholders as part of diverse interview 
panels. We evaluate our recruitment and retention efforts based on a variety of metrics, including offer acceptance rate, time-to-
hire, turnover and diversity of our employees.

Professional Development for Employees at All Levels

We  are  firmly  committed  to  employee  development  as  an  essential  driver  of  our  future  growth  and  overall  success  of 
Halozyme. We understand that high performing employees are always seeking a challenge and reaching for ways to broaden, 
deepen and develop their skills and grow professionally. To support our employees, we conduct an individual development plan 
process to give employees the opportunity and accountability to document their career goals and discuss the actions necessary 
to  achieve  those  goals.  We  have  three  internal  training  programs:  (i)  our  senior  leader  development  program  is  focused  on 
advancing  business  acumen  and  leadership  skills,  (ii)  our  management  development  program  is  focused  on  strengthening 
people  management  capabilities,  and  (iii)  our  learning  and  development  curriculum  for  the  entire  organization  is  focused  on 
personal,  professional,  team  and  leadership  development  opportunities  and  grounded  in  our  established  leadership  attributes 
which  identify  the  knowledge,  skills,  abilities  and  behaviors  that  contribute  to  individual  and  organizational  performance.  In 
addition,  everyone  attends  or  participates  in  compliance,  harassment  prevention,  and  safety  training  and  we  offer  education 
assistance  for  college  and  university  courses,  training  seminars  and  educational  conference  attendance  opportunities  to  all 
employees.

22

To  monitor  progress,  we  review  our  succession  plan  for  key  senior  management  positions  as  part  of  our  annual  talent 

review and identify development opportunities to help ensure potential successor readiness.

Employee Engagement

Building  trust  and  a  high  performing  culture  is  a  top  priority  for  us.  We  achieve  this  by  providing  a  platform  for 
employees  to  give  feedback,  collaborate  on  solutions,  and  discuss  how  to  make  changes  to  help  improve  our  experience  at 
work. Over the years, we have regularly conducted employee engagement surveys to better understand what we do well and 
where there are opportunities for improvement. 

Based on the insights gained from past surveys, we have focused on strengthening cross-functional teamwork including 
how teams communicate and how we hold each other accountable. Examples of specific actions we have taken in response to 
employee survey feedback include all-employee trainings on cross-functional teamwork, accountability and building trust and a 
learning series to equip employees to give and receive constructive feedback. Our current focus, based on the latest survey, is to 
continue to enhance manager leadership and coaching capabilities. 

We hold frequent all-employee meetings that serve as an open forum to share progress on strategy and corporate goals as 
well  as  potential  at-risk  areas,  celebrate  achievements,  and  share  best  practices  and  learnings.  These  meetings  also  keep 
employees well-informed, connected and provide them with a setting to ask questions and discuss solutions.

Management  tracks  and  assesses  retention  and  attrition  and  interviews  departing  employees  in  order  to  identify  any 

addressable trends.

Compensation & Benefits

Our compensation and benefits programs, with oversight from the Compensation Committee of our Board of Directors, are 
designed  to  attract,  retain  and  reward  employees  through  competitive  salaries,  annual  bonus  eligibility,  long-term  incentive 
awards,  an  Employee  Stock  Purchase  Plan,  a  401(k)  Plan,  healthcare  and  insurance  benefits,  health  savings  and  flexible 
spending accounts, paid time off, family leave, and employee assistance programs. Each year we conduct surveys to benchmark 
our  salaries  and  benefits  and  confirm  we  are  satisfied  with  the  competitiveness  of  our  total  compensation  offering.  We  also 
provide a variety of peer-to-peer and corporate recognition programs to celebrate and recognize our employees for their hard 
work and contributions.

Employee Health and Safety

We are committed to protecting the health and safety of our employees, visitors, clients, and the public. Health and safety 
practices are integrated into our business processes and align with our Corporate Environmental, Social, Governance program 
(“ESG”)  philosophy  and  requirements.  We  maintain  robust  health  and  safety  management  systems  and  have  established 
procedures that reduce the risk of injury and ensure compliance with applicable laws and regulations. Continuous improvement 
is a key component of our health and safety efforts. We establish objectives and performance targets and periodically review 
results  both  with  our  internal  safety  committee  as  well  as  at  the  Executive  and  Board  level  to  ensure  our  high  standards  are 
maintained.  Our  leadership  team  is  active  and  engaged  in  supporting  our  health  and  safety  program.  Our  employees  are 
empowered and responsible for integrating health and safety into their daily work activities and we have experienced health and 
safety professionals on staff to guide these efforts.

Corporate Citizenship

We  believe  in  supporting  the  community  in  which  we  work  and  provide  our  employees  multiple  opportunities  to 

contribute to the community, including providing company-wide community service days/volunteerism supporting:

•

•

•

•

•

•

Patient advocacy/healthcare;

Health disparities;

STEM education;

Humanitarian services (e.g., food drives, home builds, meal services);

Environment (e.g., lagoon cleanup events, park restoration); and

Children in underserved communities (e.g. school supply drives, holiday adopt-a-family).

23

Item 1A. Risk Factors

Risks Related To Our Business

If our partnered or proprietary product candidates do not receive and maintain regulatory approvals, or if approvals are 
not obtained in a timely manner, such failure or delay would substantially impact our ability to generate revenues.

Approval  from  the  FDA  or  equivalent  health  authorities  is  necessary  to  design,  develop,  test,  manufacture  and  market 
pharmaceutical products and medical devices in the U.S. and the other countries in which we anticipate doing business have 
similar requirements. The process for obtaining FDA and other regulatory approvals is extensive, time-consuming, risky and 
costly, and there is no guarantee that the FDA or other regulatory bodies will approve any applications that may be filed with 
respect to any of our partnered or proprietary product candidates, or that the timing of any such approval will be appropriate for 
the desired product launch schedule for a product candidate. We and our partners may provide guidance as to the timing for the 
filing  and  acceptance  of  such  regulatory  approvals,  but  such  filings  and  approvals  may  not  occur  when  we  or  our  partners 
expect,  or  at  all.  The  FDA  or  other  foreign  regulatory  agency  may  refuse  or  delay  approval  of  our  partnered  or  proprietary 
product candidates for failure to collect sufficient clinical or animal safety data and require additional clinical or animal safety 
studies  which  may  cause  lengthy  delays  and  increased  costs  to  our  or  our  partners’  development  programs.  Any  such  issues 
associated  with  rHuPH20  could  have  an  adverse  impact  on  future  development  of  our  partners’  products  which  include 
rHuPH20, future sales of Hylenex recombinant, or our ability to maintain our existing ENHANZE collaborations or enter into 
new ENHANZE collaborations.

We  and  our  partners  may  not  be  successful  in  obtaining  approvals  for  any  additional  potential  products  in  a  timely 

manner, or at all. 

Refer to the risk factor titled “Our partnered or proprietary product candidates may not receive regulatory approvals or 
their  development  may  be  delayed  for  a  variety  of  reasons,  including  delayed  or  unsuccessful  clinical  trials,  regulatory 
requirements or safety concerns” for additional information relating to the approval of product candidates. 

Additionally,  even  with  respect  to  products  which  have  been  approved  for  commercialization,  in  order  to  continue  to 
manufacture  and  market  pharmaceutical  and  medical  device  products,  we  or  our  partners  must  maintain  our  regulatory 
approvals. If we or any of our partners are unsuccessful in maintaining the required regulatory approvals, our revenues would 
be adversely affected.

Use of our partnered or proprietary products and product candidates could be associated with adverse events or product 
recalls.

As with most pharmaceutical and medical device products, our partnered or proprietary products and product candidates 
could be associated with adverse events which can vary in severity (from minor reactions to death) and frequency (infrequent to 
very common) or product recalls. Adverse events associated with the use of our partnered or proprietary products or product 
candidates may be observed at any time, including in clinical trials or when a product is commercialized, and any such adverse 
events may negatively affect our or our partners’ ability to obtain or maintain regulatory approval or market such products and 
product candidates. Adverse events such as toxicity or other safety issues associated with the use of our partnered or proprietary 
products  and  product  candidates  could  require  us  or  our  partners  to  perform  additional  studies  or  halt  development  or 
commercialization  of  these  products  and  product  candidates  or  expose  us  to  product  liability  lawsuits  which  will  harm  our 
business. For example, we experienced a clinical hold on patient enrollment and dosing in our phase 2 study of PEGPH20 in 
patients  with  PDA  (a  discontinued  program),  which  was  not  resolved  until  we  implemented  steps  to  address  an  observed 
possible difference in TE event rates between the arms of the study. We or our partners may be required by regulatory agencies 
to  conduct  additional  animal  or  human  studies  regarding  the  safety  and  efficacy  of  our  pharmaceutical  products  or  product 
candidates which we have not planned or anticipated. There can be no assurance that we or our partners will resolve any issues 
related to any product or product candidate 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.

To the extent that a product fails to conform to its specifications or comply with the applicable laws or regulations, we or 
our partners may be required to or may decide to voluntarily recall the product or regulatory authorities may request or require 
that we recall a product even if there is no immediate potential harm to a patient. Any recall of our products or their components 
that we supply to our partners could materially adversely affect our business by rendering us unable to sell those products or 
components for some time and by adversely affecting our reputation. Recalls are costly and take time and effort to administer. 
Even if a recall only initially relates to a single product, product batch, or a portion of a batch, recalls may later be expanded to 
additional  products  or  batches  or  we  or  our  partners  may  incur  additional  costs  and  need  to  dedicate  additional  efforts  to 
investigate  and  rule  out  the  potential  for  additional  impacted  products  or  batches.  Moreover,  if  any  of  our  partners  recall  a 
product due to an issue with a product or component that we supplied, they may claim that we are responsible for such issue 
and  may  seek  to  recover  the  costs  related  to  such  recall  or  be  entitled  to  certain  contractual  remedies  from  us.  Recalls  may 
further result in decreased demand for our partnered or proprietary products, could cause our partners or distributors to return 

24

products to us for which we may be required to provide refunds or replacement products, or could result in product shortages. 
Recalls may also require regulatory reporting and prompt regulators to conduct additional inspections of our or our partners’ or 
contractors’ facilities, which could result in findings of noncompliance and regulatory enforcement actions. A recall could also 
result in product liability claims by individuals and third-party payers. In addition, product liability claims or other safety issues 
could  result  in  an  investigation  of  the  safety  or  efficacy  of  our  products,  our  manufacturing  processes  and  facilities,  or  our 
marketing  programs  conducted  by  the  FDA  or  the  authorities  of  the  EU  member  states  and  other  jurisdictions.  Such 
investigations  could  also  potentially  lead  to  a  recall  of  our  products  or  more  serious  enforcement  actions,  limitations  on  the 
indications for which they may be used, or suspension, variation, or withdrawal of approval. Any such regulatory action by the 
FDA, the EMA or the competent authorities of the EU member states could lead to product liability lawsuits as well.

If our contract manufacturers or vendors are unable or unwilling for any reason to manufacture and supply to us bulk 
rHuPH20  or  other  raw  materials,  reagents,  components  or  devices  in  the  quantity  and  quality  required  by  us  or  our 
partners for use in the production of our proprietary or partnered products and product candidates, our and our partners’ 
product development and commercialization efforts could be delayed or stopped and our business results associated with 
operations and our collaborations could be harmed.

We rely on a number of third parties in our supply chain for the supply and manufacture of our partnered and proprietary 
products, and the availability of such products depends upon our ability to procure the raw materials, components, packaging 
materials  and  finished  products  from  these  third  parties,  some  of  which  are  currently  our  single  source  for  the  materials 
necessary  for  certain  of  our  products.  We  have  entered  into  supply  agreements  with  numerous  third-party  suppliers.  For 
example,  we  have  existing  supply  agreements  with  contract  manufacturing  organizations  Avid  Bioservices,  Inc.  (Avid)  and 
Catalent Indiana LLC (Catalent) to produce bulk rHuPH20. These manufacturers each produce bulk rHuPH20 under cGMP for 
use in Hylenex recombinant, and for use in partnered products and product candidates. We rely on their ability to successfully 
manufacture bulk rHuPH20 according to product specifications. In addition to supply obligations, our contract manufacturers 
will also provide support for the chemistry, manufacturing and controls sections for FDA and other regulatory filings. We also 
rely on vendors to supply us with raw materials to produce reagents and other materials for bioanalytical assays used to support 
our partners’ clinical trials. If any of our contract manufacturers or vendors: (i) is unable to retain its status as an FDA approved 
manufacturing  facility;  (ii)  is  unable  to  otherwise  successfully  scale  up  production  to  meet  corporate  or  regulatory  authority 
quality  standards;  (iii)  is  unable  to  procure  the  labor,  raw  materials,  reagents  or  components  necessary  to  produce  our 
proprietary products, including bulk rHuPH20 and Hylenex recombinant, our bioanalytical assays or our partnered products or 
(iv) fails to manufacture and supply our partnered and proprietary products, including bulk rHuPH20 in the quantity and quality 
required  by  us  or  our  partners  for  use  in  Hylenex  and  partnered  products  and  product  candidates  for  any  other  reason,  our 
business  will  be  adversely  affected.  In  addition,  a  significant  change  in  such  parties’  or  other  third-party  manufacturers’ 
business or financial condition could adversely affect their abilities or willingness to fulfill their contractual obligations to us. 
We  have  not  established,  and  may  not  be  able  to  establish,  favorable  arrangements  with  additional  bulk  rHuPH20 
manufacturers and suppliers of the ingredients necessary to manufacture bulk rHuPH20 should the existing manufacturers and 
suppliers become unavailable or in the event that our existing manufacturers and suppliers are unable or unwilling to adequately 
perform  their  responsibilities.  We  have  attempted  to  mitigate  the  impact  of  a  potential  supply  interruption  through  the 
establishment of excess bulk rHuPH20 inventory where possible, but there can be no assurances that this safety stock will be 
maintained or that it will be sufficient to address any delays, interruptions or other problems experienced by any of our contract 
manufacturers. Any delays, interruptions or other problems regarding the ability or willingness of our contract manufacturers to 
supply  bulk  rHuPH20  or  the  ability  or  willingness  of  other  third-party  manufacturers,  to  supply  other  raw  materials  or 
ingredients necessary to produce our other proprietary or partnered products on a timely basis could: (i) cause the delay of our 
partners’ clinical trials or otherwise delay or prevent the regulatory approval of our partners’ product candidates; (ii) delay or 
prevent  the  effective  commercialization  of  proprietary  or  partnered  products  and  product  candidates;  and/or  (iii)  cause  us  to 
breach  contractual  obligations  to  deliver  bulk  rHuPH20  to  our  partners.  Such  delays  could  damage  our  relationship  with  our 
partners, and they could have a material adverse effect on royalties and thus our business and financial condition. Additionally, 
we rely on third parties to manufacture, prepare, fill, finish, package, store and ship our proprietary and partnered products and 
product  candidates  on  our  behalf.  If  the  third  parties  we  identify  fail  to  perform  their  obligations,  the  progress  of  partners’ 
clinical trials could be delayed or even suspended and the commercialization of our partnered or proprietary products could be 
delayed or prevented.

In addition, our Minnetonka, Minnesota facility supports our administrative functions, product development and quality 
operations and provides additional assembly and warehousing capabilities, and therefore is subject to relevant risks comparable 
to those of our third-party manufacturers. For example, we may not be able to begin product manufacturing and production due 
to a number of different reasons including, but not limited to, an ability to obtain necessary supplies and materials, labor and 
expertise.  To  the  extent  we  rely  on  our  ability  to  manufacture  and  ship  any  of  our  proprietary  and  partnered  products,  our 
inability to do so could have a material adverse impact on our business, financial condition and results of operations.

25

We rely on third parties to perform necessary services for our products including services related to the distribution, 
invoicing, rebates and contract administration, co-pay program administration, sample distribution and administration, 
storage and transportation of our products. If anything should impede their ability to meet their commitments this could 
impact our business performance.

Depending on the product, we have retained third-party service providers to perform a variety of functions related to the 
distribution,  invoicing,  rebates  and  contract  administration,  co-pay  program  administration,  sample  distribution  and 
administration,  storage  and  transportation  of  our  products,  key  aspects  of  which  are  out  of  our  direct  control.  We  place 
substantial reliance on these providers as well as other third-party providers that perform services for us, including, depending 
on the product, entrusting our inventories of products to their care and handling. We also may rely on third parties to administer 
our drug price reporting and rebate payments and contracting obligations under federal programs. Despite our reliance on third 
parties,  we  have  responsibilities  for  compliance  with  the  applicable  legal  and  program  requirements.  By  example,  in  certain 
states, we are required to hold licenses to distribute our products in these states and must comply with the associated state laws. 
Moreover, if these third-party service providers fail to meet expected deadlines, or otherwise do not carry out their contractual 
duties  to  us  or  encounter  physical  damage  or  a  natural  disaster  at  their  facilities,  our  ability  to  deliver  products  to  meet 
commercial demand would be significantly impaired. In addition, we may use third parties to perform various other services for 
us  relating  to  regulatory  monitoring,  including  adverse  event  reporting,  safety  database  management  and  other  product 
maintenance services. If our employees or any third-party service providers fail to comply with applicable laws and regulations, 
we and/or they may face regulatory or False Claims Act enforcement actions. Moreover, if the quality or accuracy of the data 
maintained by these service providers is insufficient, our ability to continue to market our products could be jeopardized or we 
and/or  they  could  be  subject  to  regulatory  sanctions.  We  do  not  currently  have  the  internal  capacity  to  perform  all  of  these 
important commercial functions, and we may not be able to maintain commercial arrangements for these services on reasonable 
terms.

If we or any party to a key collaboration agreement fail to perform material obligations under such agreement, or if a key 
collaboration agreement is terminated for any reason, our business could suffer.

We have entered into multiple collaboration agreements under which we may receive significant future payments in the 
form of milestone payments, target designation fees, maintenance fees and royalties. We are heavily dependent on our partners 
to develop and commercialize product candidates subject to our collaborations in order for us to realize any financial benefits, 
including  revenues  from  milestones,  royalties  and  product  sales  from  these  collaborations.  Our  partners  may  not  devote  the 
attention and resources to such efforts that we would ourselves, change their clinical development plans, promotional efforts or 
simultaneously develop and commercialize products in competition to those products we have licensed to them. Any of these 
actions may not be visible to us immediately and could negatively impact our ability to forecast and our ability to achieve the 
benefits  and  revenue  we  receive  from  such  collaboration.  In  addition,  in  the  event  that  a  party  fails  to  perform  under  a  key 
collaboration  agreement,  or  if  a  key  collaboration  agreement  is  terminated,  the  reduction  in  anticipated  revenues  could 
negatively impact our operations. In addition, the termination of a key collaboration agreement by one or more of our partners 
could  have  a  material  adverse  impact  on  our  ability  to  enter  into  additional  collaboration  agreements  with  new  partners  on 
favorable terms, if at all. In certain circumstances, the termination of a key collaboration agreement would require us to revise 
our corporate strategy going forward and may lead us to reevaluate the applications and value of our technology.

Hylenex and our partners’ ENHANZE products and product candidates rely on the rHuPH20 enzyme, and any adverse 
development regarding rHuPH20 could substantially impact multiple areas of our business, including current and 
potential ENHANZE collaborations, as well as any proprietary programs.

rHuPH20  is  a  key  technological  component  of  Hylenex  and  our  ENHANZE  technology  and  most  of  our  ENHANZE 
partnered  products  and  product  candidates,  including  the  current  and  future  products  and  product  candidates  under  our 
ENHANZE collaborations. We derive a substantial portion of our revenues from our ENHANZE collaborations. Therefore, if 
there is an adverse development for rHuPH20 (e.g., an adverse regulatory determination relating to rHuPH20, if we are unable 
to obtain sufficient quantities of rHuPH20, if we are unable to obtain or maintain material proprietary rights to rHuPH20 or if 
we discover negative characteristics of rHuPH20), multiple areas of our business, including current and potential collaborations, 
as  well  as  proprietary  programs  would  be  substantially  impacted.  For  example,  elevated  anti-rHuPH20  antibody  titers  were 
detected in the registration trial for HYQVIA as well as in a former partner’s product in a Phase 2 clinical trial with rHuPH20, 
but  have  not  been  associated,  in  either  case,  with  any  adverse  events.  We  monitor  for  antibodies  to  rHuPH20  in  our 
collaboration and proprietary programs, and although we do not believe at this time that the incidence of non-neutralizing anti-
rHuPH20  antibodies  in  either  the  HYQVIA  program  or  the  former  partner’s  program  will  have  a  significant  impact  on  our 
proprietary product and our partners’ product and product candidates, there can be no assurance that there will not be other such 
occurrences in the foregoing programs or that concerns regarding these antibodies will not also be raised by the FDA or other 
health authorities in the future, which could result in delays or discontinuations of our Hylenex commercialization activities, the 
development  or  commercialization  activities  of  our  ENHANZE  partners,  or  deter  our  entry  into  additional  ENHANZE 
collaborations with third parties. 

26

Our business strategy is focused on growth of our ENHANZE and auto-injector technologies, our commercial products 
and potential growth through acquisition. Currently, ENHANZE is the largest revenue driver and as a result there is a 
risk  for  potential  negative  impact  from  adverse  developments.  Future  expansion  of  our  strategic  focus  to  additional 
applications of our ENHANZE technology or by acquiring new technologies may require the use of additional resources, 
result in increased expense and ultimately may not be successful.

We routinely evaluate our business strategy, and may modify this strategy in the future in light of our assessment of unmet 
medical needs, growth potential, resource requirements, regulatory issues, competition, risks and other factors. As a result of 
these  strategic  evaluations,  we  may  focus  our  resources  and  efforts  on  one  or  a  few  programs  or  fields  and  may  suspend  or 
reduce our efforts on other programs and fields. For example, in the fourth quarter of 2019, we decided to focus our resources 
on  our  ENHANZE  technology  and  our  commercial  product,  Hylenex.  By  focusing  primarily  on  these  areas,  we  increase  the 
potential  impact  on  us  if  one  of  those  partner  programs  does  not  successfully  complete  clinical  trials,  achieve  commercial 
acceptance  or  meet  expectations  regarding  sales  and  revenue.  We  may  also  expand  our  strategic  focus  by  seeking  new 
therapeutics applications of our technology or by acquiring new technologies which may require the use of additional resources, 
increased expense and would require the attention of senior management. For example, in May 2022, we acquired Antares as a 
means to diversify the sources of our revenues. There can be no assurance that our investment in Antares or any such future 
investment of resources in new technologies will ultimately result in additional approved proprietary or partnered products or 
commercial success of new therapeutic applications of our technology.

Our  partnered  or  proprietary  product  candidates  may  not  receive  regulatory  approvals  or  their  development  may  be 
delayed  for  a  variety  of  reasons,  including  delayed  or  unsuccessful  clinical  trials,  regulatory  requirements  or  safety 
concerns.  If  we  or  our  partners  fail  to  obtain,  or  have  delays  in  obtaining,  regulatory  approvals  for  any  product 
candidates, our business, financial condition and results of operations may be materially adversely affected.

Clinical testing of pharmaceutical products is a long, expensive and uncertain process, and the failure or delay of a clinical 
trial can occur at any stage, including the patient enrollment stage. Even if initial results of preclinical and nonclinical studies or 
clinical trial results are promising, our partners may obtain different results in subsequent trials or studies that fail to show the 
desired levels of dose safety and efficacy, or we or our partners may not obtain applicable regulatory approval for our products 
for a variety of other reasons. Preclinical, nonclinical, and clinical trials for proprietary or partnered product candidates could be 
unsuccessful, which would delay or preclude regulatory approval and commercialization of the product candidates. In the U.S. 
and other jurisdictions, regulatory approval can be delayed, limited or not granted for many reasons, including, among others:

•

•

•

•

•

•

•

•

•

•

•

during  the  course  of  clinical  studies,  the  final  data  from  later  Phase  3  studies  may  differ  from  data  observed  in 
early  phase  clinical  trials,  and  clinical  results  may  not  meet  prescribed  endpoints  for  the  studies  or  otherwise 
provide sufficient data to support the efficacy of our partners’ product candidates;

clinical  and  nonclinical  test  results  may  reveal  inferior  pharmacokinetics,  adverse  events  or  unexpected  safety 
issues associated with the use of our partners’ product candidates;

regulatory review may not find that the data from preclinical testing and clinical trials justifies approval;

regulatory authorities may require that we or our partners change our studies or conduct additional studies which 
may significantly delay or make continued pursuit of approval commercially unattractive; 

a  regulatory  agency  may  reject  our  and  our  partners’  trial  data  or  disagree  with  their  interpretations  of  either 
clinical trial data or applicable regulations;

a  regulatory  agency  may  require  additional  safety  monitoring  and  reporting  through  Risk  Evaluation  and 
Mitigation  Strategies  including  conditions  to  assure  safe  use  programs  and  we  or  a  partner  may  decide  to  not 
pursue regulatory approval for a such a product;

a regulatory agency may not approve our manufacturing processes or facilities, or the processes or facilities of our 
partners, our contract manufacturers or our raw material suppliers;

failure  of  our  or  our  partners’  contract  research  organization,  or  CRO,  to  properly  perform  the  clinical  trial  in 
accordance with the written protocol, our contractual obligations with them or applicable regulatory requirements; 

a  regulatory  agency  may  identify  problems  or  other  deficiencies  in  our  existing  manufacturing  processes  or 
facilities,  or  the  existing  processes  or  facilities  of  our  partners,  our  contract  manufacturers  or  our  raw  material 
suppliers; 

a  regulatory  agency  may  change  its  formal  or  informal  approval  requirements  and  policies,  act  contrary  to 
previous guidance, adopt new regulations or raise new issues or concerns late in the approval process; or

a  proprietary  or  partnered  product  candidate  may  be  approved  only  for  indications  that  are  narrow  or  under 
conditions that place the product at a competitive disadvantage, which may limit the sales and marketing activities 
for such product candidate or otherwise adversely impact the commercial potential of a product.

27

If  a  proprietary  or  partnered  product  candidate  is  not  approved  in  a  timely  fashion  or  approval  is  not  obtained  on 
commercially viable terms, or if development of any product candidate is terminated due to difficulties or delays encountered in 
the  regulatory  approval  process,  it  could  have  a  material  adverse  impact  on  our  business,  financial  condition  and  results  of 
operation and we would become more dependent on the development of other proprietary or partnered product candidates and/
or our ability to successfully acquire other technologies. There can be no assurances that any proprietary or partnered product 
candidate will receive regulatory approval in a timely manner, or at all. There can be no assurance that partners will be able to 
gain clarity as to the FDA’s requirements or that the requirements may be satisfied in a commercially feasible way, in which 
case our ability to enter into collaborations with third parties or explore other strategic alternatives to exploit an opportunity will 
be limited or may not be possible.

We  anticipate  that  certain  proprietary  or  partnered  products  will  be  marketed,  and  perhaps  manufactured,  in  foreign 
countries. The process of obtaining regulatory approvals in foreign countries is subject to delay and failure for the reasons set 
forth above, as well as for reasons that vary from jurisdiction to jurisdiction. The approval process varies among countries and 
jurisdictions and can involve additional testing. The time required to obtain approval in foreign countries may differ from that 
required to obtain FDA approval. Foreign regulatory agencies may not provide approvals on a timely basis, if at all. Approval 
by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign 
regulatory authority does not ensure approval by regulatory authorities in other foreign countries or jurisdictions or by the FDA.

Our third-party partners are responsible for providing certain proprietary materials that are essential components of our 
partnered  products  and  product  candidates,  and  any  failure  to  supply  these  materials  could  delay  the  development  and 
commercialization  efforts  for  these  partnered  products  and  product  candidates  and/or  harm  our  collaborations.  Our 
partners  are  also  responsible  for  distributing  and  commercializing  their  products,  and  any  failure  to  successfully 
commercialize their products could materially adversely affect our revenues.

Our  development  and  commercialization  partners  are  responsible  for  providing  certain  proprietary  materials  that  are 
essential components of our partnered products and product candidates. For example, Roche is responsible for producing the 
Herceptin and MabThera required for its subcutaneous products and Takeda is responsible for producing the GAMMAGARD 
LIQUID for its product HYQVIA. If a partner, or any applicable third party service provider of a partner, encounters difficulties 
in the manufacture, storage, delivery, fill, finish or packaging of the partnered product or product candidate or component of 
such product or product candidate, such difficulties could (i) cause the delay of clinical trials or otherwise delay or prevent the 
regulatory approval of partnered product candidates; and/or (ii) delay or prevent the effective commercialization of partnered 
products. Such delays could have a material adverse effect on our business and financial condition. We also rely on our partners 
to commercialize and distribute their products and if they are unsuccessful in commercializing certain products, the resulting 
royalty revenue we would receive may be lower than expected. 

If we or our partners fail to comply with regulatory requirements applicable to promotion, sale and manufacturing of 
approved products, regulatory agencies may take action against us or them, which could harm our business.

Any  approved  products,  along  with  the  manufacturing  processes,  post-approval  clinical  data  requirements,  labeling, 
advertising  and  promotional  activities  for  these  products,  are  subject  to  continual  requirements  and  review  by  the  FDA,  and 
state and foreign regulatory bodies. Regulatory authorities subject a marketed product, its manufacturer and the manufacturing 
facilities to continual review and periodic inspections. We, our partners and our respective contractors, suppliers and vendors, 
will  be  subject  to  ongoing  regulatory  requirements,  including  complying  with  regulations  and  laws  regarding  advertising, 
promotion  and  sales  of  drug  products,  required  submissions  of  safety  and  other  post-market  information  and  reports, 
registration requirements, cGMP regulations (including requirements relating to quality control and quality assurance, as well as 
the corresponding maintenance of records and documentation), and the requirements regarding the distribution of samples to 
physicians  and  recordkeeping  requirements.  Further,  because  some  of  our  proprietary  and  partnered  products  and  product 
candidates  are  drug/device  combination  products,  we  and  our  partners  will  have  to  comply  with  extensive  regulatory 
requirements  than  would  otherwise  be  required  for  products  that  are  not  combination  products.  Regulatory  agencies  may 
change existing requirements or adopt new requirements or policies. We, our partners and our respective contractors, suppliers 
and vendors, may be slow to adapt or may not be able to adapt to these changes or new requirements.

In  particular,  regulatory  requirements  applicable  to  pharmaceutical  products  make  the  substitution  of  suppliers  and 
manufacturers costly and time consuming. We have minimal internal manufacturing capabilities and are, and expect to be in the 
future, substantially dependent on contract manufacturers and suppliers for the manufacture of our products and for their active 
and other ingredients. The disqualification of these manufacturers and suppliers through their failure to comply with regulatory 
requirements could negatively impact our business because the delays and costs in obtaining and qualifying alternate suppliers 
(if such alternative suppliers are available, which we cannot assure) could delay our or our partners’ clinical trials or otherwise 
inhibit  our  or  partners’  ability  to  bring  approved  products  to  market,  which  would  have  a  material  adverse  effect  on  our 
business and financial condition. Likewise, if we, our partners and our respective contractors, suppliers and vendors involved in 
sales  and  promotion  of  our  products  do  not  comply  with  applicable  laws  and  regulations,  for  example  off-label  or  false  or 
misleading promotion, this could materially harm our business and financial condition.

28

Failure to comply with regulatory requirements may result in adverse regulatory actions including but not limited to, any 

of the following:

•

•

•

•

•

•

•

•

•

•

•

•

restrictions on our or our partners’ products or manufacturing processes;

warning letters;

withdrawal of our or our partners’ products from the market;

voluntary or mandatory recall;

fines;

suspension or withdrawal of regulatory approvals;

suspension or termination of any of our partners’ ongoing clinical trials;

refusal to permit the import or export of our or our partners’ products;

refusal to approve pending applications or supplements to approved applications that we submit;

product seizure; 

injunctions; or

imposition of civil or criminal penalties. 

Failure of our auto-injector and specialty products business to perform could adversely impact future business and 
operations.

We acquired the Antares auto-injector and specialty products business with the expectation that the acquisition will result 
in  various  benefits  for  the  combined  company,  including  providing  an  opportunity  for  increased  revenues  through  growth  of 
device  revenue  and  commercial  products  and  development  of  a  new  high  volume  auto-injector.  Increased  competition, 
unresolvable technical issues and/or deterioration in business conditions may limit our ability to grow this business. As such, 
we may not be able to realize the benefits anticipated in connection with the acquisition.

Business  interruptions  resulting  from  pandemics  or  similar  public  health  crises  could  cause  a  disruption  of  the 
development  of  our  and  our  partnered  product  candidates  and  commercialization  of  our  approved  and  our  partnered 
products,  impede  our  ability  to  supply  bulk  rHuPH20  to  our  ENHANZE  partners  or  procure  and  sell  our  proprietary 
products and otherwise adversely impact our business and results of operations.

Public health crises such as pandemics or similar outbreaks could adversely impact our business and results of operations 
by, among other things, disrupting the development of our and our partnered product candidates and commercialization of our 
and  our  partnered  approved  products,  causing  disruptions  in  the  operations  of  our  third-party  contract  manufacturing 
organizations upon whom we rely for the production and supply of our proprietary products, including Hylenex and the bulk 
rHuPH20 we supply to our partners, and causing other disruptions to our operations.

For  example,  the  COVID-19  pandemic  led  to  the  implementation  of  various  responses,  including  government-imposed 
quarantines,  travel  restrictions  and  other  public  health  safety  measures.  The  extent  to  which  future  pandemics  impact  our 
operations  and/or  those  of  our  partners  will  depend  on  future  developments,  which  are  highly  uncertain  and  unpredictable, 
including  the  duration  or  recurrence  of  outbreaks,  potential  future  government  actions,  new  information  that  will  emerge 
concerning the severity and impact of that pandemic and the actions to contain the pandemic or address its impact in the short 
and long term, among others.

The business disruptions associated with a global pandemic could impact the business, product development priorities and 
operations  of  our  partners,  including  potential  delays  in  manufacturing  their  product  candidates  or  approved  products.  For 
example, clinical trial conduct may be impacted in geographies affected by a pandemic. The progress or completion of these 
clinical trials could be adversely impacted by the pandemic. Additionally, interruption or delays in the operations of the FDA, 
the EMA and other similar foreign regulatory agencies, or changes in regulatory priorities to focus on the pandemic, may affect 
required regulatory review, inspection, clearance and approval timelines. Disruptions such as these could result in delays in the 
development programs of our partnered products or impede the commercial efforts for approved products, resulting in potential 
reductions or delays in our revenues from partner royalty or milestone payments. 

29

We rely on many third parties to source active pharmaceutical ingredient and drug products, manufacture and assemble 
our devices, distribute finished products and provide various logistics activities in order to manufacture and sell our partnered 
and proprietary products. For example, we rely on third-party manufacturers to manufacture the bulk rHuPH20 that we supply 
to our partners for their commercial products and product candidates, as well as our commercial product Hylenex. If any such 
third  party  manufacturer  is  adversely  impacted  by  a  pandemic  and  related  consequences,  including  staffing  shortages, 
production  slowdowns  and  disruptions  in  delivery  systems,  availability  of  raw  materials,  reagents  or  components  or  if  they 
divert resources or manufacturing capacity to accommodate the development of treatments or vaccines, our supply chain may 
be  disrupted,  limiting  our  ability  to  sell  Hylenex  or  supply  bulk  rHuPH20  to  our  partners.  Any  such  disruptions  to  the 
operations of the third parties upon whom we rely to manufacture and sell our partnered and proprietary products could result in 
reductions or delays in our revenues.

We may need to raise additional capital in the future and there can be no assurance that we will be able to obtain such 
funds.

We may need to raise additional capital in the future to fund our operations for general corporate purposes if we do not 
achieve the level of revenues we expected. Our current cash reserves and expected revenues may not be sufficient for us to fund 
general  operations  and  conduct  our  business  at  the  level  desired.  In  addition,  if  we  engage  in  acquisitions  of  companies, 
products  or  technologies  in  order  to  execute  our  business  strategy,  we  may  need  to  raise  additional  capital.  We  may  raise 
additional  capital  in  the  future  through  one  or  more  financing  vehicles  that  may  be  available  to  us  including  (i)  new 
collaborative agreements; (ii) expansions or revisions to existing collaborative relationships; (iii) private financings; (iv) other 
equity or debt financings; (v) monetizing assets; and/or (vi) the public offering of securities.

If we are required to raise additional capital in the future, it may not be available on favorable financing terms within the 
time required, or at all. If additional capital is not available on favorable terms when needed, we will be required to raise capital 
on adverse terms or significantly reduce operating expenses through the restructuring of our operations or deferral of strategic 
business  initiatives.  If  we  raise  additional  capital  through  a  public  offering  of  securities  or  equity,  a  substantial  number  of 
additional shares of our common stock may be issued, which will dilute the ownership interest of our current investors and may 
negatively affect our stock price.

We currently have significant debt and may incur additional debt. Failure by us to fulfill our obligations under the 
applicable debt agreements may cause repayment obligations to accelerate.

The  aggregate  amount  of  our  consolidated  indebtedness,  net  of  debt  discount,  as  of  December  31,  2023  was  $1,499.2 
million,  which  includes  $805.0  million  in  aggregate  principal  amount  of  the  2027  Convertible  Notes  and  $720.0  million  in 
aggregate principal of the 2028 Convertible Notes, net of unamortized debt discount of $11.0 million and $14.8 million for the 
2027 Convertible Notes and 2028 Convertible Notes, respectively.

Our indebtedness may:

• make it difficult for us to satisfy our financial obligations, including making scheduled principal and interest payments 

on our indebtedness;

•

•

•

•

•

•

limit  our  ability  to  borrow  additional  funds  for  working  capital,  capital  expenditures,  acquisitions  or  other  general 
corporate purposes;

limit  our  ability  to  use  our  cash  flow  or  obtain  additional  financing  for  future  working  capital,  capital  expenditures, 
acquisitions, share repurchases or other general business purposes;

require us to use a portion of our cash flow from operations to make debt service payments;

limit our flexibility to plan for, or react to, changes in our business and industry;

place us at a competitive disadvantage compared to our less leveraged competitors; and

increase our vulnerability to the impact of adverse economic and industry conditions.

In  addition,  our  2022  Credit  Agreement  includes  certain  affirmative  and  negative  covenants,  that,  among  other  things, 
may restrict our ability to: create liens on assets; incur additional indebtedness; make investments; make acquisitions and other 
fundamental changes; and sell and dispose of property or assets. The 2022 Credit Agreement also includes financial covenants 
requiring us to maintain, measured as of the end of each fiscal quarter, a maximum consolidated net leverage ratio of 4.75 to 
1.00 initially, which declines to 4.00 to 1.00 over the term of the loan facility, and a minimum consolidated interest coverage 
ratio of 3.00 to 1.00. The 2022 Credit Agreement also contains customary representations and warranties and events of default. 
Complying  with  the  covenants  contained  in  the  2022  Credit  Agreement  could  make  it  more  difficult  for  us  to  execute  our 
business  strategy.  Further,  in  the  event  of  default  by  us  under  the  2022  Credit  Agreement,  the  lenders  would  be  entitled  to 
exercise  their  remedies  thereunder,  including  the  right  to  accelerate  the  debt,  upon  which  we  may  be  required  to  repay  all 
amounts then outstanding under the 2022 Credit Agreement which would harm our financial condition.

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Our  ability  to  make  payments  on  our  existing  or  any  future  debt  will  depend  on  our  future  operating  performance  and 
ability to generate cash and may also depend on our ability to obtain additional debt or equity financing. It will also depend on 
financial, business or other factors affecting our operations, many of which are beyond our control. We will need to use cash to 
pay principal and interest on our debt, thereby reducing the funds available to fund operations, strategic initiatives and working 
capital requirements. If we are unable to generate sufficient cash to service our debt obligations, an event of default may occur 
under any of our debt instruments which could result in an acceleration of such debt upon which we may be required to repay 
all the amounts outstanding under some or all of our debt instruments. Such an acceleration of our debt obligations could harm 
our financial condition. From time to time, we may seek to retire or repurchase our outstanding debt through cash purchases 
and/or  exchanges  for  equity  or  debt,  in  open-market  purchases,  privately  negotiated  transactions  or  otherwise.  Any  such 
repurchases  or  exchanges  would  be  on  such  terms  and  at  such  prices  as  we  determine,  and  will  depend  on  current  market 
conditions, our liquidity needs, any restrictions in our contracts and other factors. The amounts involved in such transactions 
could be material.

The conditional conversion feature of the Convertible Notes, if triggered, may adversely affect our financial condition and 
operating results.

In the event the conditional conversion feature of the Convertible Notes is triggered, holders of the Convertible Notes will 
be entitled to convert the notes at any time during specified periods at their option. If one or more holders elect to convert their 
notes,  we  would  be  required  to  settle  a  portion  or  all  of  our  conversion  obligation  in  cash,  which  could  adversely  affect  our 
liquidity.  Even  if  holders  of  the  Convertible  Notes  do  not  elect  to  convert  their  notes,  we  are  required  under  applicable 
accounting rules to reclassify all or a portion of the outstanding principal of the notes as a current rather than long-term liability 
when the conditional conversion feature is triggered, which results in a material reduction of our net working capital. 

Conversion of our Convertible Notes may dilute the ownership interest of existing stockholders or may otherwise depress 
the price of our common stock.

The  conversion  of  some  or  all  of  our  Convertible  Notes,  to  the  extent  we  deliver  shares  upon  conversion,  will  dilute  the 
ownership  interests  of  existing  stockholders.  Any  sales  in  the  public  market  of  the  Convertible  Notes  or  our  common  stock 
issuable  upon  conversion  of  the  Convertible  Notes  could  adversely  affect  prevailing  market  prices  of  our  common  stock.  In 
addition, the existence of the Convertible Notes may encourage short selling by market participants because the conversion of 
the Convertible Notes could be used to satisfy short positions, or anticipated conversion of the Convertible Notes into shares of 
our common stock could depress the price of our common stock.

If proprietary or partnered product candidates are approved for commercialization but do not gain market acceptance 
resulting in commercial performance below that which was expected or projected, our business may suffer.

Assuming that existing or future proprietary or partnered product candidates obtain the necessary regulatory approvals for 
commercial sale, a number of factors may affect the market acceptance of these newly-approved products, including, among 
others:

•

•

•

•

•

•

•

the degree to which the use of these products is restricted by the approved product label;

the price of these products relative to other therapies for the same or similar treatments;

the  extent  to  which  reimbursement  for  these  products  and  related  treatments  will  be  available  from  third-party 
payers including government insurance programs and private insurers;

the introduction of generic or biosimilar competitors to these products; 

the perception by patients, physicians and other members of the health care community of the effectiveness and 
safety  of  these  products  for  their  prescribed  treatments  relative  to  other  therapies  for  the  same  or  similar 
treatments;

the ability and willingness of our partners to fund sales and marketing efforts; and

the effectiveness of the sales and marketing efforts of our partners.

If these proprietary or partnered products do not gain or maintain market acceptance or experience reduced sales resulting 
in commercial performance below that which was expected or projected, the revenues we expect to receive from these products 
will be diminished which could harm our ability to fund future operations, including conduct acquisitions, execute our planned 
share repurchases, or affect our ability to use funds for other general corporate purposes and cause our business to suffer.

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In  addition,  our  proprietary  or  partnered  product  candidates  will  be  restricted  to  the  labels  approved  by  FDA  and 
applicable  regulatory  bodies,  and  these  restrictions  may  limit  the  marketing  and  promotion  of  the  ultimate  products.  If  the 
approved labels are restrictive, the sales and marketing efforts for these products may be negatively affected.

Our ability to license our ENHANZE and device technologies to our partners depends on the validity of our patents and 
other proprietary rights.

Patents and other proprietary rights are essential to our business. Our success will depend in part on our ability to obtain 
and maintain patent protection for our inventions, to preserve our trade secrets and to operate without infringing the proprietary 
rights  of  third  parties.  We  have  multiple  patents  and  patent  applications  throughout  the  world  pertaining  to  our  recombinant 
human hyaluronidase and methods of use and manufacture, including an issued U.S. patent which expires in 2027, an issued 
European patent which expires in 2024 and additional patents that are valid into 2029, which we believe cover the products and 
product candidates under our existing collaborations, and Hylenex. Although we believe our patent filings represent a barrier to 
entry  for  potential  competitors  looking  to  utilize  these  hyaluronidases,  upon  expiration  of  our  patents  other  pharmaceutical 
companies may (if they do not infringe our other patents) seek to compete with us by developing, manufacturing and selling 
biosimilars  to  the  active  drug  ingredient  in  our  ENHANZE  technology  used  by  our  partners  in  combination  with  their 
products. Any such loss of patent protection or proprietary rights could lead to a reduction or loss of revenues, incentivize one 
or  more  of  our  key  ENHANZE  partners  to  terminate  their  relationship  with  us  and  impact  our  ability  to  enter  into  new 
collaboration and license agreements.

Developing, manufacturing and marketing pharmaceutical products for human use involves significant product liability 
risks for which we may have insufficient insurance coverage.

The development, manufacture, testing, marketing and sale of pharmaceutical products and medical devices involves the 
risk  of  product  liability  claims  by  consumers  and  other  third  parties.  Product  liability  claims  may  be  brought  by  individuals 
seeking relief for themselves, or by groups seeking to represent a class of injured patients. Further, third-party payers, either 
individually  or  as  a  putative  class,  may  bring  actions  seeking  to  recover  monies  spent  on  one  of  our  products.  Although  we 
maintain  product  liability  insurance  coverage,  product  liability  claims  can  be  high  in  the  pharmaceutical  industry,  and  our 
insurance may not sufficiently cover our actual liabilities. If product liability claims were to be made against us, it is possible 
that  the  liabilities  may  exceed  the  limits  of  our  insurance  policy,  or  our  insurance  carriers  may  deny,  or  attempt  to  deny, 
coverage in certain instances. If a lawsuit against us is successful, then the insurance coverage may not be sufficient and could 
materially  and  adversely  affect  our  business  and  financial  condition.  Furthermore,  various  distributors  of  pharmaceutical 
products  require  minimum  product  liability  insurance  coverage  before  purchase  or  acceptance  of  products  for  distribution. 
Failure to satisfy these insurance requirements could impede our ability to achieve broad distribution of our proposed products, 
and  higher  insurance  requirements  could  impose  additional  costs  on  us.  In  addition,  since  many  of  our  partnered  product 
candidates  include  the  pharmaceutical  products  of  a  third-party,  we  run  the  risk  that  problems  with  the  third-party 
pharmaceutical  product  will  give  rise  to  liability  claims  against  us.  Product  liability  claims  can  also  result  in  additional 
regulatory  consequences  including,  but  not  limited  to,  investigations  and  regulatory  enforcement  actions,  as  well  as  recalls, 
revocation of approvals, or labeling, marketing or promotional restrictions or changes. Product liability claims could also harm 
our  reputation  and  the  reputation  of  our  products,  adversely  affecting  our  ability  to  market  our  products  successfully.  In 
addition, defending a product liability lawsuit is expensive and can divert the attention of our key employees from operating our 
business. Such claims can also impact our ability to initiate or complete clinical trials.

If our partners do not achieve projected development, clinical, or regulatory goals in the timeframes publicly announced 
or  otherwise  expected,  the  commercialization  of  our  partners  products  may  be  delayed  and,  as  a  result,  our  business, 
financial condition, and results of operations may be adversely affected.

From time to time, our partners may publicly articulate the estimated timing for the accomplishment of certain scientific, 
clinical,  regulatory  and  other  product  development  goals.  The  accomplishment  of  any  goal  is  typically  based  on  numerous 
assumptions, and the achievement of a particular goal may be delayed for any number of reasons both within and outside of our 
and  our  partners’  control.  If  scientific,  regulatory,  strategic  or  other  factors  cause  a  collaboration  partner  to  not  meet  a  goal, 
regardless of whether that goal has been publicly articulated or not, our stock price may decline rapidly. Stock price declines 
may also trigger direct or derivative shareholder lawsuits. As with any litigation proceeding, the eventual outcome of any legal 
action is difficult to predict. If any such lawsuits occur, we will incur expenses in connection with the defense of these lawsuits, 
and we may have to pay substantial damages or settlement costs in connection with any resolution thereof. Although we have 
insurance coverage against which we may claim recovery against some of these expenses and costs, the amount of coverage 
may  not  be  adequate  to  cover  the  full  amount  or  certain  expenses  and  costs  may  be  outside  the  scope  of  the  policies  we 
maintain.  In  the  event  of  an  adverse  outcome  or  outcomes,  our  business  could  be  materially  harmed  from  depletion  of  cash 
resources,  negative  impact  on  our  reputation,  or  restrictions  or  changes  to  our  governance  or  other  processes  that  may  result 
from  any  final  disposition  of  the  lawsuit.  Moreover,  responding  to  and  defending  pending  litigation  significantly  diverts 
management’s attention from our operations.

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In  addition,  the  consistent  failure  to  meet  publicly  announced  milestones  may  erode  the  credibility  of  our  management 

team with respect to future milestone estimates. 

Future acquisitions could disrupt our business and impact our financial condition.

In order to augment and extend our revenue, we acquired Antares in May 2022 and we may decide to acquire additional 
businesses, products and technologies. As we have limited experience in evaluating and completing acquisitions, our ability as 
an  organization  to  make  such  acquisitions  is  unproven.  Acquisitions  could  require  significant  capital  infusions  and  could 
involve many risks, including, but not limited to, the following:

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we  may  have  to  issue  additional  convertible  debt  or  equity  securities  to  complete  an  acquisition,  which  would 
dilute our stockholders and could adversely affect the market price of our common stock;

an acquisition may negatively impact our results of operations because it may require us to amortize or write down 
amounts related to goodwill and other intangible assets, or incur or assume substantial debt or liabilities, or it may 
cause adverse tax consequences, substantial depreciation or deferred compensation charges;

we  may  encounter  difficulties  in  assimilating  and  integrating  the  business,  products,  technologies,  personnel  or 
operations of companies that we acquire;

certain acquisitions may impact our relationship with existing or potential partners who are competitive with the 
acquired business, products or technologies;

acquisitions may require significant capital infusions and the acquired businesses, products or technologies may 
not generate sufficient value to justify acquisition costs;

we may take on liabilities from the acquired company such as debt, legal liabilities or business risk which could be 
significant;

an  acquisition  may  disrupt  our  ongoing  business,  divert  resources,  increase  our  expenses  and  distract  our 
management;

acquisitions  may  involve  the  entry  into  a  geographic  or  business  market  in  which  we  have  little  or  no  prior 
experience; and

key personnel of an acquired company may decide not to work for us.

If any of these risks occurred, it could adversely affect our business, financial condition and operating results. There is no 
assurance that we will be able to identify or consummate any future acquisitions on acceptable terms, or at all. If we do pursue 
any future acquisitions, it is possible that we may not realize the anticipated benefits from such acquisitions or that the market 
will not view such acquisitions positively.

Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.

Our  effective  tax  rate  is  derived  from  a  combination  of  applicable  tax  rates  in  the  various  places  that  we  operate.  In 
preparing  our  financial  statements,  we  estimate  the  amount  of  tax  that  will  become  payable  in  each  of  such  places. 
Nevertheless, our effective tax rate may be different than experienced in the past due to numerous factors, including changes in 
the  mix  of  our  profitability  between  different  tax  jurisdictions,  the  results  of  examinations  and  audits  of  our  tax  filings,  our 
inability to secure or sustain acceptable agreements with tax authorities, changes in accounting for income taxes and changes in 
tax laws. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or 
our current expectations and may result in tax obligations in excess of amounts accrued in our financial statements.

In addition, on September 30, 2021, we determined, based on our facts and circumstances, that it was more likely than not 
that  a  substantial  portion  of  our  deferred  tax  assets  would  be  realized  and,  as  a  result,  substantially  all  of  our  valuation 
allowance  against  our  deferred  tax  assets  was  released.  This  resulted  in  substantially  and  disproportionately  increasing  our 
reported net income and our earnings per share compared to our operating results for 2021. Historical and future comparisons to 
these amounts are not, and will not be, indicative of actual profitability trends for our business. Starting in 2022, we recorded 
income tax expense at an estimated tax rate that approximate statutory tax rates, resulting a reduction in our net income and net 
income per share.

Risks Related To Ownership of Our Common Stock

Our stock price is subject to significant volatility.

We participate in a highly dynamic industry which often results in significant volatility in the market price of common 
stock  irrespective  of  company  performance.  The  high  and  low  sales  prices  of  our  common  stock  during  the  twelve  months 
ended  December  31,  2023  were  $57.00  and  $29.85,  respectively.  In  addition  to  the  other  risks  and  uncertainties  described 
elsewhere in this Annual Report on Form 10-K and all other risks and uncertainties that are either not known to us at this time 
or which we deem to be immaterial, any of the following factors may lead to a significant drop in our stock price:

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the presence of competitive products to those being developed by our partners;

failure  (actual  or  perceived)  of  our  partners  to  devote  attention  or  resources  to  the  development  or 
commercialization of partnered products or product candidates licensed to such partner;

a dispute regarding our failure, or the failure of one of our partners, to comply with the terms of a collaboration 
agreement; 

the termination, for any reason, of any of our collaboration agreements;

the sale of common stock by any significant stockholder, including, but not limited to, direct or indirect sales by 
members of management or our Board of Directors;

the resignation, or other departure, of members of management or our Board of Directors;

general negative conditions in the healthcare industry;

pandemics or other global crises;

general negative conditions in the financial markets;

the cost associated with obtaining regulatory approval for any of our proprietary or partnered product candidates;

the failure, for any reason, to secure or defend our intellectual property position;

the failure or delay of applicable regulatory bodies to approve our proprietary or partnered product candidates;

identification of safety or tolerability issues associated with our proprietary or partnered products or product 
candidates;

failure of our or our partners’ clinical trials to meet efficacy endpoints;

suspensions or delays in the conduct of our or our partners’ clinical trials or securing of regulatory approvals;

adverse regulatory action with respect to our proprietary or partnered products and product candidates such as loss 
of  regulatory  approval  to  commercialize  such  products,  clinical  holds,  imposition  of  onerous  requirements  for 
approval or product recalls;

our  failure,  or  the  failure  of  our  partners,  to  successfully  commercialize  products  approved  by  applicable 
regulatory bodies such as the FDA;

our failure, or the failure of our partners, to generate product revenues anticipated by investors;

disruptions  in  our  clinical  or  commercial  supply  chains,  including  disruptions  caused  by  problems  with  a  bulk 
rHuPH20  contract  manufacturer  or  a  fill  and  finish  manufacturer  for  any  product  or  product  collaboration 
candidate; 

the sale of additional debt and/or equity securities by us;

our failure to obtain financing on acceptable terms or at all; 

a restructuring of our operations;

an inability to execute our share repurchase program in the time and manner we expect due to market, business, 
legal or other considerations; or 

a conversion of the Convertible Notes into shares of our common stock.

Future transactions where we raise capital may negatively affect our stock price.

We are currently a “Well-Known Seasoned Issuer” and may file automatic shelf registration statements at any time with 
the  SEC.  Sales  of  substantial  amounts  of  shares  of  our  common  stock  or  other  securities  under  any  future  shelf  registration 
statements could lower the market price of our common stock and impair our ability to raise capital through the sale of equity 
securities. 

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Anti-takeover provisions in our charter documents, the Indentures and Delaware law may make an acquisition of us more 
difficult.

Anti-takeover provisions in our charter documents, the Indentures and Delaware law may make an acquisition of us more 
difficult.  First,  our  Board  of  Directors  is  classified  into  three  classes  of  directors.  Under  Delaware  law,  directors  of  a 
corporation with a classified board may be removed only for cause unless the corporation’s certificate of incorporation provides 
otherwise. Our amended and restated certificate of incorporation does not provide otherwise. In addition, our bylaws limit who 
may call special meetings of stockholders, permitting only stockholders holding at least 50% of our outstanding shares to call a 
special  meeting  of  stockholders.  Our  amended  and  restated  certificate  of  incorporation  does  not  include  a  provision  for 
cumulative voting for directors. Under cumulative voting, a minority stockholder holding a sufficient percentage of a class of 
shares may be able to ensure the election of one or more directors. Finally, our bylaws establish procedures, including advance 
notice procedures, with regard to the nomination of candidates for election as directors and stockholder proposals.

These provisions in our charter documents may discourage potential takeover attempts, discourage bids for our common 
stock at a premium over market price or adversely affect the market price of, and the voting and other rights of the holders of, 
our common stock. These provisions could also discourage proxy contests and make it more difficult for stockholders to elect 
directors other than the candidates nominated by our Board of Directors.

Further, in connection with our Convertible Notes issuances, we have entered into indentures, dated as of March 1, 2021 
and  August  18,  2022  (the  “Indentures”),  with  The  Bank  of  New  York  Mellon  Trust  Company,  N.A.,  as  trustee.  Certain 
provisions in the Indentures could make it more difficult or more expensive for a third party to acquire us. For example, if a 
takeover would constitute a fundamental change, holders of the Convertible Notes will have the right to require us to repurchase 
their Convertible Notes in cash. In addition, if a takeover constitutes a make-whole fundamental change, we may be required to 
increase the conversion rate for holders who convert their Convertible Notes in connection with such takeover. In addition, a 
change of control constitutes an event of default under our 2022 Credit Agreement. Such event of default could result in the 
administrative agent or the lender parties thereto declaring the unpaid principal, all accrued and unpaid interest, and all other 
amounts owing or payable under the 2022 Credit Agreement to be immediately due and payable. In either case, and in other 
cases,  our  obligations  under  the  Convertible  Notes  and  the  Indentures  could  increase  the  cost  of  acquiring  us  or  otherwise 
discourage a third-party from acquiring us or removing incumbent management.

In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware 

General Corporation Law, which may prohibit large stockholders from consummating a merger with, or acquisition of, us.

These provisions may deter an acquisition of us that might otherwise be attractive to stockholders.

Risks Related to Our Industry

Our  and  our  partnered  products  must  receive  regulatory  approval  before  they  can  be  sold,  and  compliance  with  the 
extensive government regulations is expensive and time consuming and may result in the delay or cancellation of our or 
our partnered product sales, introductions or modifications.

Extensive industry regulation has had, and will continue to have, a significant impact on our business. All pharmaceutical 
and medical device companies, including ours, are subject to extensive, complex, costly and evolving regulation by the health 
regulatory  agencies  including  the  FDA  (and  with  respect  to  controlled  drug  substances,  the  U.S.  Drug  Enforcement 
Administration  (DEA))  and  equivalent  foreign  regulatory  agencies  and  state  and  local/regional  government  agencies.  The 
Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other domestic and foreign statutes and regulations 
govern  or  influence  the  testing,  manufacturing,  packaging,  labeling,  storing,  recordkeeping,  safety,  approval,  advertising, 
promotion,  sale  and  distribution  of  our  products  and  our  partners’  products  and  product  candidates.  We  are  dependent  on 
receiving  FDA  and  other  governmental  approvals,  including  regulatory  approvals  in  jurisdictions  outside  the  United  States, 
prior  to  manufacturing,  marketing  and  shipping  our  products.  Consequently,  there  is  always  a  risk  that  the  FDA  or  other 
applicable governmental authorities, including those outside the United States, will not approve our or our partners’ products or 
may  impose  onerous,  costly  and  time-consuming  requirements  such  as  additional  clinical  or  animal  testing.  Regulatory 
authorities  may  require  that  our  partners  change  our  studies  or  conduct  additional  studies,  which  may  significantly  delay  or 
make continued pursuit of approval commercially unattractive to our partners. For example, the approval of the HYQVIA BLA 
was delayed by the FDA until we and our partner provided additional preclinical data sufficient to address concerns regarding 
non-neutralizing  antibodies  to  rHuPH20  that  were  detected  in  the  registration  trial.  Although  these  antibodies  have  not  been 
associated with any known adverse clinical effects, and the HYQVIA BLA was ultimately approved by the FDA, the FDA or 
other foreign regulatory agency may, at any time, halt our and our partners’ development and commercialization activities due 
to safety concerns. In addition, even if our proprietary or partnered products are approved, regulatory agencies may also take 
post-approval action limiting or revoking our or our partners’ ability to sell these products. Any of these regulatory actions may 
adversely  affect  the  economic  benefit  we  may  derive  from  our  proprietary  or  our  partnered  products  and  therefore  harm  our 
financial condition.

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Under certain of these regulations, in addition to our partners, we and our contract suppliers and manufacturers are subject 
to periodic inspection of our or their respective facilities, procedures and operations and/or the testing of products by the FDA, 
the  DEA  and  other  authorities,  which  conduct  periodic  inspections  to  confirm  that  we  and  our  contract  suppliers  and 
manufacturers  are  in  compliance  with  all  applicable  regulations.  The  FDA  also  conducts  pre-approval  and  post-approval 
reviews and plant inspections to determine whether our systems, or our contract suppliers’ and manufacturers’ processes, are in 
compliance with cGMP and other FDA regulations. If our partners, we, or our contract suppliers and manufacturers, fail these 
inspections,  our  partners  may  not  be  able  to  commercialize  their  products  in  a  timely  manner  without  incurring  significant 
additional costs, or at all.

In  addition,  the  FDA  imposes  a  number  of  complex  regulatory  requirements  on  entities  that  advertise  and  promote 
pharmaceuticals including, but not limited to, standards and regulations for direct-to-consumer advertising, off-label promotion, 
industry-sponsored scientific and educational activities, and promotional activities involving the Internet.

Because  some  of  our  and  our  partners’  products  and  product  candidates  are  considered  to  be  drug/device  combination 
products, the approval and post-approval requirements that we and they are required to comply with can be more complex.

Many of our and our partners’ products and product candidates are considered to be drug/device combination products by 
the FDA, consisting of a drug product and a drug delivery device. If marketed individually, each component would be subject 
to  different  regulatory  pathways  and  reviewed  by  different  centers  within  the  FDA.  A  combination  product,  however,  is 
assigned to a center that will have primary jurisdiction over its pre-market review and regulation based on a determination of 
the product’s primary mode of action, which is the single mode of action that provides the most important therapeutic action. In 
the case of our and our partners’ products and product candidates, the primary mode of action is typically attributable to the 
drug component of the products, which means that the Center of Drug Evaluation and Research has primary jurisdiction over 
the products’ premarket development and review. These products and product candidates will be and have been subject to the 
FDA drug approval process and will not require a separate FDA clearance or approval for the device component. Even though 
these products and product candidates will not require a separate FDA clearance or approval, both the drug and device centers 
within the FDA will review the marketing application for safety, the efficacy of both the drug and device component, including 
the  design  and  reliability  of  the  injector,  and  a  number  of  other  different  areas,  such  as  to  ensure  that  the  drug  labeling 
adequately discloses all relevant information and risks, and to confirm that the instructions for use are accurate and easy to use. 
These  reviews  could  increase  the  time  needed  for  review  completion  of  a  successful  application  and  may  require  additional 
studies, such as usage studies, to establish the validity of the instructions for use. Such reviews and requirements may extend 
the time necessary for the approval of drug-device combinations. In the case of combination product candidates for which we or 
our partners are seeking approval via the ANDA pathway, it is also possible that the agency may decide that the unique nature 
of combination products leads it to question the claims of bioequivalence and/or same labeling, resulting in the need to refile the 
application under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. This may result in delays in product approval 
and  may  cause  us  or  our  partners  to  incur  additional  costs  associated  with  testing,  including  clinical  trials.  Approval  via  the 
505(b)(2)  pathway  may  also  result  in  additional  selling  expenses  and  a  decrease  in  market  acceptance  due  to  the  lack  of 
substitutability by pharmacies or formularies. In addition, approval under the 505(b)(2) or ANDA regulatory pathway is not a 
guarantee of an exclusive position for the approved product in the marketplace.

Further,  although  precedent  and  guidance  exist  for  the  approval  of  such  combination  products,  the  FDA  could  change 
what it requires or how it reviews submissions. Changes in review processes or the requirement for the study of combination 
products could delay anticipated launch dates or be cost prohibitive. Such delay or failure to launch these products or devices 
could  adversely  affect  our  revenues  and  future  profitability.  If  our  or  our  partners’  combination  product  candidates  are 
approved, we, our partners, and any of our respective contractors will be required to comply with FDA regulatory requirements 
related to both drugs and devices. For instance, drug/device combination products must comply with both the drug cGMPs and 
device QSRs. Depending on whether the drug and device components are at the same facility, however, the FDA regulations 
provide a streamlined method to comply with both sets of requirements. The FDA has specifically promulgated guidance on 
injectors, which discuss the FDA’s requirements with respect to marketing application and post-market injector design controls 
and reliability analyses. Additionally, drug/device combination products will be subject to additional FDA and constituent part 
reporting requirements. Compliance with these requirements will require additional effort and monetary expenditure.

We may be subject, directly or indirectly, to various broad federal and state healthcare laws. If we are unable to comply, or 
have  not  fully  complied,  with  such  laws,  we  could  face  civil,  criminal  and  administrative  penalties,  damages,  monetary 
fines, disgorgement, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, 
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.

Our business operations and activities may be directly, or indirectly, subject to various broad federal and state healthcare 
laws,  including  without  limitation,  anti-kickback  laws,  the  Foreign  Corrupt  Practices  Act  (FCPA),  false  claims  laws,  civil 
monetary penalty laws, data privacy and security laws, tracing and tracking laws, as well as transparency (or “sunshine”) laws 
regarding payments or other items of value provided to healthcare providers. These laws may restrict or prohibit a wide range 

36

of business activities, including, but not limited to, research, manufacturing, distribution, pricing, discounting, marketing and 
promotion and other business arrangements. These laws may impact, among other things, our current activities with principal 
investigators  and  research  subjects,  as  well  as  sales,  marketing  and  education  programs.  Many  states  have  similar  healthcare 
fraud and abuse laws, some of which may be broader in scope and may not be limited to items or services for which payment is 
made by a government health care program.

Efforts  to  ensure  that  our  business  arrangements  will  comply  with  applicable  healthcare  laws  may  involve  substantial 
costs.  While  we  have  adopted  a  healthcare  corporate  compliance  program,  it  is  possible  that  governmental  and  enforcement 
authorities  will  conclude  that  our  business  practices  may  not  comply  with  current  or  future  statutes,  regulations  or  case  law 
interpreting applicable fraud and abuse or other healthcare laws. If our operations or activities are found to be in violation of 
any  of  the  laws  described  above  or  any  other  governmental  regulations  that  apply  to  us,  we  may  be  subject  to,  without 
limitation,  civil,  criminal  and  administrative  penalties,  damages,  monetary  fines,  disgorgement,  possible  exclusion  from 
participation in Medicare, Medicaid and other federal healthcare programs, 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.

In addition, any sales of products outside the U.S. will also likely subject us to the FCPA and foreign equivalents of the 

healthcare laws mentioned above, among other foreign laws.

We may be required to initiate or defend against legal proceedings related to intellectual property rights, which may result 
in substantial expense, delay and/or cessation of certain development and commercialization of our products.

We  primarily  rely  on  patents  to  protect  our  intellectual  property  rights.  The  strength  of  this  protection,  however,  is 

uncertain. For example, it is not certain that:

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we will be able to obtain patent protection for our products and technologies;

the scope of any of our issued patents will be sufficient to provide commercially significant exclusivity for our 
products and technologies;

others will not independently develop similar or alternative technologies or duplicate our technologies and obtain 
patent protection before we do; and

any  of  our  issued  patents,  or  patent  pending  applications  that  result  in  issued  patents,  will  be  held  valid, 
enforceable and infringed in the event the patents are asserted against others.

We currently own or license patents in a portfolio and also have pending patent applications applicable to rHuPH20 and 
other proprietary materials. There can be no assurance that our existing patents, or any patents issued to us as a result of our 
pending  patent  applications,  will  provide  a  basis  for  commercially  viable  products,  will  provide  us  with  any  competitive 
advantages, or will not face third-party challenges or be the subject of further proceedings limiting their scope or enforceability. 
Any  weaknesses  or  limitations  in  our  patent  portfolio  could  have  a  material  adverse  effect  on  our  business  and  financial 
condition. In addition, if our pending patent applications do not result in issued patents, or result in issued patents with narrow 
or limited claims, this could result in us having no or limited protection against generic or biosimilar competition against our 
product candidates which would have a material adverse effect on our business and financial condition.

We or our partners may become involved in interference proceedings in the U.S. Patent and Trademark Office, or other 
proceedings  in  other  jurisdictions,  to  determine  the  priority,  validity  or  enforceability  of  our  patents  or  our  partners’  patents 
related to our collaborations. For example, as a result of one such proceeding, in March 2023 the Opposition Division of the 
European  Patent  Office  revoked  one  of  Janssen’s  co-formulation  patents  for  DARZALEX®  (daratumumab)  SC.  In  addition, 
costly litigation could be necessary to protect our patent position. Successful challenges to the priority, validity or enforceability 
of our or our partners’ patents could have a material adverse effect on our business and financial condition.

We also rely on trade secrets, unpatented proprietary know-how and continuing technological innovation that we seek to 
protect with confidentiality agreements with employees, consultants and others with whom we discuss our business. Disputes 
may arise concerning the ownership of intellectual property or the applicability or enforceability of agreements covering these 
rights, and we might not be able to resolve these disputes in our favor.

We  also  rely  on  trademarks  to  protect  the  names  of  our  products  (e.g.  Hylenex  recombinant).  We  may  not  be  able  to 
obtain trademark protection for any proposed product names we select. In addition, product names for pharmaceutical products 
must  be  approved  by  health  regulatory  authorities  such  as  the  FDA  in  addition  to  meeting  the  legal  standards  required  for 
trademark  protection  and  product  names  we  propose  may  not  be  timely  approved  by  regulatory  agencies  which  may  delay 
product launch. In addition, our trademarks may be challenged by others. If we enforce our trademarks against third parties, 
such enforcement proceedings may be expensive.

37

In  addition  to  protecting  our  own  intellectual  property  rights,  third  parties  may  assert  patent,  trademark  or  copyright 
infringement or other intellectual property claims against us. If we become involved in any intellectual property litigation, we 
may  be  required  to  pay  substantial  damages,  including  but  not  limited  to  treble  damages,  attorneys’  fees  and  costs,  for  past 
infringement  if  it  is  ultimately  determined  that  our  products  infringe  a  third-party’s  intellectual  property  rights.  Even  if 
infringement claims against us are without merit, defending a lawsuit takes significant time, may be expensive and may divert 
management’s  attention  from  other  business  concerns.  Further,  in  the  case  of  an  injunction,  we  could  be  stopped  from 
developing, manufacturing or selling our products until we obtain a license from the owner of the relevant technology or other 
intellectual property rights. If such a license is available at all, it may require us to pay royalties or other fees.

We may incur significant liability if it is determined that we are promoting or have in the past promoted the “off-label” 
use of drugs or medical devices, or otherwise promoted or marketed approved products in a manner inconsistent with the 
FDA’s requirements.

In the U.S. and certain other jurisdictions, companies may not promote drugs or medical devices for “off-label” uses, that 
is, uses that are not described in the product’s labeling and that differ from those that were approved or cleared by the FDA or 
other foreign regulatory agencies. However, physicians and other healthcare practitioners may prescribe drug products and use 
medical  devices  for  off-label  or  unapproved  uses,  and  such  uses  are  common  across  some  medical  specialties.  Although  the 
FDA does not regulate a physician’s choice of medications, treatments or product uses, the Federal Food, Drug and Cosmetic 
Act and FDA regulations significantly restrict permissible communications on the subject of off-label uses of drug products and 
medical  devices  by  pharmaceutical  and  medical  device  companies.  As  the  sponsors  of  FDA  approved  products,  we  and  our 
partners will not only be responsible for the actions of the companies but also can be held liable for the actions of employees 
and  contractors,  requiring  that  all  employees  and  contractors  engaging  in  regulated  functions,  such  as  product  promotion,  be 
adequately trained and monitored, which requires time and monetary expenditures.

If the FDA determines that a company has improperly promoted a product “off label” or otherwise not in accordance with 
the agency’s promotional requirements, the FDA may issue a warning letter or seek other enforcement action to limit or restrict 
certain promotional activities or materials or seek to have product withdrawn from the market or seize product, among other 
enforcement requirements. In addition, a company that is found to have improperly promoted off-label uses may be subject to 
significant  liability,  including  civil  fines,  criminal  fines  and  penalties,  civil  damages  and  exclusion  from  federal  funded 
healthcare  programs  such  as  Medicare  and  Medicaid  and/or  government  contracting,  consent  decrees  and  corporate  integrity 
agreements, as well as potential liability under the federal FCA and applicable state false claims acts. Conduct giving rise to 
such liability could also form the basis for private civil litigation by third-party payers or other persons allegedly harmed by 
such conduct.

Moreover,  in  addition  to  the  regulatory  restrictions  on  off-label  promotion,  there  are  other  FDA  restrictions  on  and 
requirements  concerning  product  promotion  and  advertising,  such  as  requirements  that  such  communications  be  truthful  and 
non-misleading  and  adequately  supported.  The  FDA  also  has  requirements  concerning  the  distribution  of  drug  samples.  The 
FDA and other authorities may take the position that we are not in compliance with promotional, advertising, and marketing 
requirements,  and,  if  such  non-compliance  is  proven,  we  may  be  subject  to  significant  liability,  including  but  not  limited  to 
administrative, civil and criminal penalties and fines, in addition to regulatory enforcement actions.

For certain of our products, we and our independent contractors, distributors, prescribers, and dispensers are required to 
comply  with  regulatory  requirements  related  to  controlled  substances,  which  will  require  the  expenditure  of  additional 
time  and  will  incur  additional  expenses  to  maintain  compliance  and  may  subject  us  to  additional  penalties  for 
noncompliance, which could inhibit successful commercialization.

Certain of our products are controlled substances and accordingly, we, and our contractors, distributors, prescribers, and 
dispensers  must  comply  with  Federal  controlled  substances  laws  and  regulations,  enforced  by  the  U.S.  Drug  Enforcement 
Administration  (“DEA”),  as  well  as  state-controlled  substances  laws  and  regulations  enforced  by  state  authorities.  These 
requirements include, but are not limited to, registration, security, recordkeeping, reporting, storage, distribution, importation, 
exportation, inventory, and other requirements. These requirements are enforced by the DEA through periodic inspections. Not 
only must continuous controlled substance registration be maintained, but compliance with the applicable controlled substance 
requirements  will  require  significant  efforts  and  expenditures,  which  could  also  inhibit  successful  commercialization.  These 
compliance requirements also add complexity to the distribution, prescribing and dispensing of certain of our products that may 
also impact commercialization, including the establishment of anti-diversion procedures. If we and our contractors, distributors, 
prescribers, and dispensers do not comply with the applicable controlled substance requirements, we or they may be subject to 
administrative, civil or criminal enforcement, including civil penalties, refusals to renew necessary registrations, revocation of 
registrations, criminal proceedings, or consent decrees.

38

Patent protection for biotechnology inventions and for inventions generally is subject to significant scrutiny; if patent laws 
or the interpretation of patent laws change, our business may be adversely impacted because we may lose the ability to 
obtain  patent  protection  or  enforce  our  intellectual  property  rights  against  competitors  who  develop  and  commercialize 
products based on our discoveries.

Patent  protection  in  general,  including  for  protein-based  products  is  based  on  evolving  complex  legal  principles  and 
factual questions, which introduce uncertainties as to patentability, patent scope, validity and enforcement. In recent years, there 
have  been  significant  changes  in  patent  law,  including  the  legal  standards  that  govern  the  patentability  and  scope  of 
biotechnology  patents.  Recent  court  decisions  have  made  it  more  difficult  to  obtain  patents,  by  making  it  more  difficult  to 
satisfy  the  patentable  subject  matter  requirements,  disclosure  and  enablement  requirements,  and  the  non-obviousness 
requirement;  decreasing  the  availability  of  injunctions  against  infringers;  and  increasing  the  likelihood  of  challenging  the 
validity  of  a  patent  through  a  declaratory  judgment  action.  Taken  together,  these  decisions  could  make  it  more  difficult  and 
costly for us to obtain, license and enforce our patents. In addition, patents may be challenged through post-grant opposition 
proceedings and be subject to a prior user defense to infringement. There also have been, and continue to be, policy discussions 
concerning  the  scope  of  patent  protection,  including  for  biotechnology  inventions.  Social  and  political  opposition  to 
biotechnology  patents  may  lead  to  narrower  patent  protection  within  the  biotechnology  industry.  Judicial  and  legislative 
changes  introduce  significant  uncertainty  in  the  patent  law  landscape  and  may  potentially  negatively  impact  our  ability  to 
procure, maintain and enforce patents to provide exclusivity for our products and may allow others to use our discoveries to 
develop and commercialize competitive products, which could impair our business.

If third-party reimbursement and customer contracts are not available, our proprietary and partnered products may not be 
accepted in the market resulting in commercial performance below that which was expected or projected.

Our and our partners’ ability to earn sufficient returns on proprietary and partnered products will depend in part on the 
extent  to  which  reimbursement  for  these  products  and  related  treatments  will  be  available  from  government  health 
administration authorities, private health insurers, managed care organizations and other healthcare providers.

Third-party  payers  are  increasingly  attempting  to  limit  both  the  coverage  and  the  level  of  reimbursement  of  new  drug 
products  to  contain  costs.  Consequently,  significant  uncertainty  exists  as  to  the  reimbursement  status  of  newly  approved 
healthcare products. Third-party payers may not establish adequate levels of reimbursement for the products that we and our 
partners commercialize, which could limit their market acceptance and result in a material adverse effect on our revenues and 
financial condition.

Customer contracts, such as with group purchasing organizations and hospital formularies, will often not offer contract or 
formulary  status  without  either  the  lowest  price  or  substantial  proven  clinical  differentiation.  If,  for  example,  Hylenex  is 
compared to animal-derived hyaluronidases by these entities, it is possible that neither of these conditions will be met, which 
could limit market acceptance and result in a material adverse effect on our revenues and financial condition.

The  rising  cost  of  healthcare  and  related  pharmaceutical  product  pricing  has  led  to  cost  containment  pressures  from 
third-party payers as well as changes in federal coverage and reimbursement policies and practices that could cause us 
and our partners to sell our products at lower prices, and impact access to our and our partners’ products, resulting in less 
revenue to us.

Any of our proprietary or partnered products that have been, or in the future are, approved by the FDA may be purchased 
or  reimbursed  by  state  and  federal  government  authorities,  private  health  insurers  and  other  organizations,  such  as  health 
maintenance  organizations  and  managed  care  organizations.  Such  third-party  payers  increasingly  challenge  pharmaceutical 
product  pricing.  The  trend  toward  managed  healthcare  in  the  U.S.,  the  growth  of  such  organizations,  and  various  legislative 
proposals and enactments to reform healthcare and government insurance programs, including the Medicare Prescription Drug 
Modernization  Act  of  2003  and  the  Affordable  Care  Act  of  2010  (ACA),  could  significantly  influence  the  manner  in  which 
pharmaceutical  products  are  prescribed  and  purchased,  resulting  in  lower  prices  and/or  a  reduction  in  demand.  Such  cost 
containment measures and healthcare reforms could adversely affect our ability to sell our product and our partners’ ability to 
sell their products.

In the U.S., our business may be impacted by changes in federal reimbursement policy resulting from executive actions, 

federal regulations, or federal demonstration projects.

The  federal  administration  and/or  agencies,  such  as  the  Centers  for  Medicare  &  Medicaid  Services,  or  CMS,  have 
announced a number of demonstration projects, recommendations and proposals to implement various elements described in the 
drug  pricing  blueprint.  CMS,  the  federal  agency  responsible  for  administering  Medicare  and  overseeing  state  Medicaid 
programs and Health Insurance Marketplaces, has substantial power to implement policy changes or demonstration projects that 
can quickly and significantly affect how drugs, including our products, are covered and reimbursed. For example, in November 
2020,  former  President  Trump  announced  the  interim  final  rule  to  implement  the  Most  Favored  Nations  drug  pricing  model 
seeking  to  tie  Medicare  payment  rates  to  an  international  index  price.  This  final  rule  was  subsequently  rescinded  by  CMS. 

39

Additionally,  a  number  of  Congressional  committees  have  also  held  hearings  and  evaluated  proposed  legislation  on  drug 
pricing and payment policy which may affect our business. For example, in July 2019, the Senate Finance Committee advanced 
a bill that in part would penalize pharmaceutical manufacturers for increasing drug list prices covered by Medicare Part B and 
Part  D,  faster  than  the  rate  of  inflation,  and  cap  out-of-pocket  expenses  for  Medicare  Part  D  beneficiaries.  Several  other 
proposals  have  been  introduced  that,  if  enacted  and  implemented,  could  affect  access  to  and  sales  of  our  and  our  partners’ 
products, allow the federal government to engage in price negotiations on certain drugs, and allow importation of prescription 
medication from Canada or other countries. For example, in August 2022, “The Inflation Reduction Act of 2022” was enacted 
which  will,  among  other  things,  allow  and  require  the  federal  government  to  negotiate  prices  for  some  drugs  covered  under 
Medicare Part B and Part D, require drug companies to pay rebates to Medicare if prices rise faster than inflation for drugs used 
by Medicare beneficiaries and cap out-of-pocket spending for individuals enrolled in Medicare Part D.

In  this  dynamic  environment,  we  are  unable  to  predict  which  or  how  many  federal  policy,  legislative  or  regulatory 
changes  may  ultimately  be  enacted.  To  the  extent  federal  government  initiatives  decrease  or  modify  the  coverage  or 
reimbursement  available  for  our  or  our  partners’  products,  limit  or  impact  our  decisions  regarding  the  pricing  of 
biopharmaceutical  products  or  otherwise  reduce  the  use  of  our  or  our  partners’  U.S.  products,  such  actions  could  have  a 
material adverse effect on our business and results of operations. 

Furthermore, individual states are considering proposed legislation and have become increasingly aggressive in passing 
legislation  and  implementing  regulations  designed  to  control  pharmaceutical  product  pricing,  including  price  or  patient 
reimbursement  constraints,  discounts,  restrictions  on  certain  product  access,  importation  from  other  countries  and  bulk 
purchasing. Legally mandated price controls on payment amounts by third-party payers or other restrictions could negatively 
and  materially  impact  our  revenues  and  financial  condition.  We  anticipate  that  we  may  encounter  similar  regulatory  and 
legislative issues in most other countries outside the U.S.

In  addition,  private  payers  in  the  U.S.,  including  insurers,  pharmacy  benefit  managers  (PBMs),  integrated  healthcare 
delivery systems, and group purchasing organizations, are continuously seeking ways to reduce drug costs. Many payers have 
developed and continue to develop ways to shift a greater portion of drug costs to patients through, for example, limited benefit 
plan  designs,  high  deductible  plans  and  higher  co-pay  or  coinsurance  obligations.  Consolidation  in  the  payer  space  has  also 
resulted in a few large PBMs and insurers which place greater pressure on pricing and utilization negotiations for our and our 
partners’ products in the U.S., increasing the need for higher discounts and rebates and limiting patient access and utilization. 
Ultimately, additional discounts, rebates and other price reductions, fees, coverage and plan changes, or exclusions imposed by 
these private payers on our and our partners’ products could have an adverse event on product sales, our business and results of 
operations.

To help patients afford certain of our products, we offer discount, rebate, and co-pay coupon programs. CMS recently has 
issued  a  regulation  imposing  additional  obligations  on  manufacturers  in  order  to  continue  excluding  such  programs  from 
government  pricing  calculations  to  avoid  payment  of  increased  Medicaid  rebates.  In  recent  years,  other  pharmaceutical 
manufacturers  have  been  named  in  class  action  lawsuits  challenging  the  legality  of  their  co-pay  programs  under  a  variety  of 
federal and state laws. Our co-pay coupon programs could become the target of similar lawsuits or insurer actions. It is possible 
that  the  outcome  of  litigation  against  other  manufacturers,  changes  in  insurer  policies  regarding  co-pay  coupons,  and/or  the 
introduction and enactment of new legislation or regulatory action could restrict or otherwise negatively affect these programs.

We also face risks relating to the reporting of pricing data that affects the reimbursement of and discounts provided for 
our products. Government price reporting regulations are complex and may require a manufacturer to update certain previously 
submitted  data.  If  our  submitted  pricing  data  is  incorrect,  we  may  become  subject  to  substantial  fines  and  penalties  or  other 
government  enforcement  actions,  which  could  have  a  material  adverse  effect  on  our  business  and  results  of  operations.  In 
addition, as a result of restating previously reported price data, we also may be required to pay additional rebates and provide 
additional discounts.

We face competition and rapid technological change that could result in the development of products by others that are 
competitive with our proprietary and partnered products, including those under development.

Our proprietary and partnered products have numerous competitors in the U.S. and abroad including, among others, major 
pharmaceutical and specialized biotechnology firms, universities and other research institutions that have developed competing 
products. Many of these competitors have substantially more resources and product development, manufacturing and marketing 
experience and capabilities than we do. The competitors for Hylenex recombinant include, but are not limited to, Amphastar 
Pharmaceuticals, Inc.’s product, Amphadase®, a bovine (bull) hyaluronidase. For our ENHANZE technology, such competitors 
may  include  major  pharmaceutical  and  specialized  biotechnology  firms.  These  competitors  may  develop  technologies  and 
products that are more effective, safer, or less costly than our current or future proprietary and partnered products and product 
candidates or that could render our and our partners’ products, technologies and product candidates obsolete or noncompetitive.

40

General Risks

If we are unable to attract, hire and retain key personnel our business could be negatively affected.

Our  success  depends  on  the  performance  of  key  employees  with  relevant  experience.  We  depend  substantially  on  our 
ability to hire, train, motivate and retain high quality personnel. If we are unable to identify, hire and retain qualified personnel, 
our ability to support current and future alliances with strategic partners could be adversely impacted. Our use of domestic and 
international  third-party  contractors,  consultants  and  staffing  agencies  also  subjects  us  to  potential  co-employment  liability 
claims.

Furthermore, if we were to lose key personnel, we may lose some portion of our institutional knowledge and technical 
know-how,  potentially  causing  a  disruption  or  delay  in  one  or  more  of  our  partnered  development  programs  until  adequate 
replacement personnel could be hired and trained. In addition, we do not have key person life insurance policies on the lives of 
any of our employees which would help cover the cost associated with the loss of key employees.

Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.

Our  operations,  including  laboratories,  offices  and  other  research  facilities,  are  headquartered  in  San  Diego,  California. 
We  have  additional  facilities  in  Ewing,  New  Jersey  and  Minnetonka,  Minnesota.  We  depend  on  our  facilities  and  on  our 
collaborators,  contractors  and  vendors  for  the  continued  operation  of  our  business.  Natural  disasters  or  other  catastrophic 
events,  pandemics,  interruptions  in  the  supply  of  natural  resources,  political  and  governmental  changes,  wildfires  and  other 
fires, tornadoes, floods, explosions, actions of animal rights activists, earthquakes and civil unrest could disrupt our operations 
or  those  of  our  partners,  contractors  and  vendors.  Even  though  we  believe  we  carry  commercially  reasonable  business 
interruption and liability insurance, and our contractors may carry liability insurance that protect us in certain events, we may 
suffer losses as a result of business interruptions that exceed the coverage available under our and our contractors’ insurance 
policies  or  for  which  we  or  our  contractors  do  not  have  coverage.  Any  natural  disaster  or  catastrophic  event  could  have  a 
significant negative impact on our operations and financial results. Moreover, any such event could delay our partners’ research 
and development programs.

Cyberattacks, security breaches or system breakdowns may disrupt our operations and harm our operating results and 
reputation.

We  and  our  partners  are  subject  to  increasingly  sophisticated  attempts  to  gain  unauthorized  access  to  our  information 
technology storage and access systems and are devoting resources to protect against such intrusion. Cyberattacks could render 
us  or  our  partners  unable  to  utilize  key  systems  or  access  important  data  needed  to  operate  our  business.  The  wrongful  use, 
theft, deliberate sabotage or any other type of security breach with respect to any of our or any of our vendors and partners’ 
information technology storage and access systems could result in the breakdown or other service interruption, or the disruption 
of  our  ability  to  use  such  systems  or  disclosure  or  dissemination  of  proprietary  and  confidential  information  that  is 
electronically stored, including intellectual property, trade secrets, financial information, regulatory information, strategic plans, 
sales trends and forecasts, litigation materials or personal information belonging to us, our staff, our patients, customers and/or 
other  business  partners  which  could  result  in  a  material  adverse  impact  on  our  business,  operating  results  and  financial 
condition.  We  continue  to  invest  in  monitoring,  and  other  security  and  data  recovery  measures  to  protect  our  critical  and 
sensitive  data  and  systems.  However,  these  may  not  be  adequate  to  prevent  or  fully  recover  systems  or  data  from  all 
breakdowns,  service  interruptions,  attacks  or  breaches  of  our  systems.  In  addition,  our  cybersecurity  insurance  may  not  be 
sufficient  to  cover  us  against  liability  related  to  any  such  breaches.  Furthermore,  any  physical  break-in  or  trespass  of  our 
facilities could result in the misappropriation, theft, sabotage or any other type of security breach with respect to our proprietary 
and  confidential  information,  including  research  or  clinical  data  or  damage  to  our  research  and  development  equipment  and 
assets.  Such  adverse  effects  could  be  material  and  irrevocable  to  our  business,  operating  results,  financial  condition  and 
reputation.

Item 1B. Unresolved Staff Comments

None.

41

Item 1C.  Cybersecurity

Our  information  technology  systems  (“IT  Systems”)  play  a  central  role  in  running  nearly  all  aspects  of  our  business 
operations.  Our  IT  Systems  are  used  for  a  variety  of  critical  business  functions  including,  but  not  limited  to,  internal  and 
external  communications,  managing  our  documents  and  records,  supporting  functional  and  enterprise  business  processes  and 
providing  shared  work  environments  across  various  business  functions.  Therefore,  responding  efficiently  and  effectively  to 
cybersecurity incidents and threats is an important component of our enterprise risk management strategy. In order to respond 
to such incidents and threats, we have implemented a carefully designed Incident Response Plan (“IRP”).

Cybersecurity Risk Management and Strategy

The  IRP  provides  our  management  and  information  technology  personnel  with  processes  and  procedures  for  assessing, 
identifying, managing and escalating material risks from cybersecurity threats which have been integrated into our overall risk 
management processes. For example, our enterprise risk management processes involve the identification of events that may 
arise in the course of operating our business and the potential impact of such events on our business. We have identified and 
prioritized cybersecurity events as requiring increased managerial focus and urgency in actions taken to mitigate cybersecurity 
risks due to the potential impact such events could have on our business. Although the risks from cybersecurity threats have not 
materially affected our business strategy, results of operations or financial condition, it is possible that a cybersecurity incident 
resulting in a serious compromise of our IT Systems or a demand for payment to restore our IT Systems, could have a material 
adverse effect on us by negatively impacting our ability to operate our business effectively and by diverting the attention of our 
management  and  other  resources,  including  financial  resources,  to  address  the  cybersecurity  incident.  Despite  our  efforts  to 
mitigate the risks associated with cybersecurity threats, we cannot eliminate all such risks or provide assurance that we have not 
experienced  undetected  cybersecurity  incidents.  For  additional  information  about  these  risks,  see  Part  I,  Item  1A,  “Risk 
Factors” in this Annual Report on Form 10-K.

In connection with our processes for assessing, identifying and managing risk from cybersecurity, we engage various third 

parties to assist in managing these processes including:

•

•

•

•

Outside cybersecurity legal counsel to assist in updating our IRP and for consultation and coordination with other third 
parties in the event of a cyber incident;

Cybersecurity  vendors  that  would  perform  various  investigation  services  in  the  event  of  a  cyber  incident  including 
assisting  in  determining  the  type  of  attack  and  impact  to  our  information  technology  network,  maintaining 
cybersecurity vigilance and assisting with the recovery and restoration of any impacted IT System services;

Cybersecurity experts who would, in the event of a cybersecurity incident, assist with validation of the incident; and

Vendors that would provide breach response services such as communications, notification to third parties and credit 
monitoring.

In  addition  to  our  IRP,  we  have  also  implemented  processes  to  oversee  and  identify  risks  from  cybersecurity  threats 
associated with our use of third-party service providers. For example, where appropriate, we seek to negotiate contractual terms 
with  certain  third-party  service  providers  that  impose  obligations  on  such  service  providers  with  the  goal  of  protecting  our 
confidential information.

Cybersecurity Governance

Our Incident Response Team has the primary responsibility of assessing and managing risks from cybersecurity threats 
and implementing the various stages of our IRP set forth above. The Incident Response Team is comprised of the following IT 
Systems management personnel and members of senior management:

•

Chief Information Officer (“CIO”) – Our CIO has over forty years of information technology experience across a wide 
range of industry sectors including insurance, financial and life sciences and forty years in life science research and 
development information security. For the past four years, our CIO has had oversight of our cybersecurity strategy and 
building  out  our  cybersecurity  capabilities  and  infrastructure  in  response  to  the  growing  threat  from  potential  cyber 
security incidents on our IT Systems. Our CIO has also led the initiative to integrate our cybersecurity management 

42

•

•

•

into  our  overall  enterprise  risk  management  strategy.  Our  CIO  has  an  NACD  CERT  certificate  in  cybersecurity 
oversight;

Associate  Director,  Information  Technology  (“IT  Security  Director”)  –  Our  IT  Security  Director  has  approximately 
twenty  years  of  relevant  information  technology  experience  including  at  least  fifteen  years  of  hands-on  experience 
working  in  various  cybersecurity  domains,  including  asset  and  network  security  and  architecture,  identity  access 
management, disaster recovery and business continuity. Our IT Security Director’s responsibilities include serving as 
the  lead  for  cybersecurity  under  the  direction  of  the  CIO  and  maturing  our  cybersecurity  program  across  all 
cybersecurity domains, including security and risk management. Our IT Security Director is a Certified Information 
Systems Security Professional and has an NACD CERT certificate in cybersecurity oversight;

Senior  Vice  President,  Chief  Legal  Officer  –  Our  Chief  Legal  Officer  oversees  our  enterprise  risk  management 
strategy and serves as the executive management representative on our Incident Response Team; and

Vice  President,  Business  Continuity  &  Sustainable  Operations  (“VP  Business  Continuity”)  –  Our  VP  Business 
Continuity  has  responsibility  for  overseeing  our  Business  Continuity  Plan  which  incorporates  our  IRP.  Our  VP 
Business Continuity has over 15 years leading the business continuity programs for various companies and has training 
on ISO 22301 (the Business Continuity ISO Standard).

Under its committee charter, the Audit Committee of the Board of Directors (the “Audit Committee”) is responsible for 
discussing with senior management our policies with respect to risk assessment and risk management and for discussing with 
management  our  financial  risk  exposures  and  the  steps  management  has  taken  to  monitor  and  control  such  exposures.  In 
particular,  the  Audit  Committee  oversees  our  cybersecurity  strategy  designed  to  identify,  assess  and  mitigate  cybersecurity 
risks,  and  reviews  our  cybersecurity  and  other  information  technology  risks,  controls  and  procedures,  and  receives  periodic 
updates  from  management  on  cybersecurity  regarding  the  adequacy  and  effectiveness  of  our  cybersecurity  measures.  In 
fulfilling this oversight responsibility, the Audit Committee receives a periodic update of our cybersecurity strategy. Included in 
this review is a thorough discussion of the risks from cybersecurity threats including the potential impact of such threats to our 
operations. Specifically, with respect to cybersecurity risks, Incident Response Team members report to the Audit Committee 
on the (i) potential impact of the risk to the business, (ii) our current capabilities in managing such risks, (iii) the urgency for 
action in managing such risks and (iv) the outlook for a potential impact on us as a result of the risk. The Audit Committee also 
receives reports from members of the Incident Response Team on our mitigation efforts to address cybersecurity risks.

We  have  also  instituted  a  separate  process  for  communicating  with  the  Audit  Committee  regarding  any  risks  from  an 
actual cybersecurity threat in the event we are the target of a specific cybersecurity incident. As part of our response to such an 
incident,  members  of  the  Incident  Response  Team  would  provide  an  initial  awareness  communication  of  the  incident  to  our 
Chief Executive Officer who would in turn inform the Chairman of our Board of Directors (“Board Chair”) and the Chair of the 
Audit  Committee  (“Audit  Committee  Chair”).  Following  an  initial  assessment  of  the  incident  by  senior  management  and  IT 
Systems  personnel,  we  would  provide  a  follow-up  communication  to  the  Board  Chair  and  Audit  Committee  Chair  and 
determine whether further escalation to the full Board of Directors is warranted.

43

Item 2.

Properties

Our  properties  consist  of  leased  office,  laboratory,  warehouse  and  assembly  facilities.  Our  administrative  offices  and 
research facilities are located in San Diego, California. We also lease a building in Minnetonka, Minnesota consisting of office, 
assembly operations, and warehousing space, and have a small administrative office in Ewing, New Jersey. As of December 31, 
2023,  we  leased  an  aggregate  of  approximately  162,000  square  feet  of  space.  We  believe  our  facilities  are  adequate  for  our 
current and near-term needs.

Item 3.

Legal Proceedings

From time to time, we may be involved in disputes, including litigation, relating to claims arising out of operations in the 
normal course of our business. Any of these claims could subject us to costly legal expenses and, while we generally believe 
that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage or our 
policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any 
such awards could have a material adverse effect on our consolidated results of operations and financial position. Additionally, 
any such claims, whether or not successful, could damage our reputation and business. We currently are not a party to any legal 
proceedings,  the  adverse  outcome  of  which,  in  our  opinion,  individually  or  in  the  aggregate,  would  have  a  material  adverse 
effect on our consolidated results of operations or financial position. 

Item 4. Mine Safety Disclosures

Not applicable.

44

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity 

PART II

Securities

Market Information

Our common stock is listed on the NASDAQ Global Select Market under the symbol “HALO.” As of February 14, 2024, 

we had approximately 72,264 stockholders of record and beneficial owners of our common stock.

Dividends

We  have  never  declared  or  paid  any  dividends  on  our  common  stock.  We  currently  intend  to  retain  available  cash  for 
funding  operations,  stock  repurchases  and  other  capital  initiatives;  therefore,  we  do  not  expect  to  pay  any  dividends  on  our 
common  stock  in  the  foreseeable  future.  Any  future  determination  to  pay  dividends  on  our  common  stock  will  be  at  the 
discretion of our Board of Directors and will depend upon, among other factors, our results of operations, financial condition, 
capital requirements, contract restrictions, business prospects and other factors our Board of Directors may deem relevant.

Purchase of Equity Securities by the Issuer

In December 2021, our Board of Directors authorized a capital return program to repurchase up to $750.0 million of our 
outstanding  common  stock  over  a  three-year  period.  During  2021,  we  repurchased  3.9  million  shares  of  common  stock  for 
$150.0  million  at  an  average  price  of  $38.51.  During  2022,  we  repurchased  4.5  million  shares  of  common  stock  for  $200.0 
million  at  an  average  price  of  $44.44.  During  2023,  excluding  the  shares  we  received  in  the  Accelerated  Share  Repurchase 
(“ASR”), we repurchased 4.2 million shares of common stock for $150.0 million at an average price of $36.01. We repurchased 
a total of 12.6 million shares for $500.0 million at an average price per share of $39.81 excluding the 5.5 million shares we 
received under the ASR in November 2023. 

We  accelerated  the  initiation  of  our  planned  2024  share  repurchases  and  in  November  2023,  we  entered  into  an  ASR 
agreement with Bank of America to accelerate the remaining $250.0 million of share repurchases under the approved capital 
return program. Pursuant to the agreement, at the inception of the ASR, we paid $250.0 million to Bank of America and took 
initial delivery of 5.5 million shares.

In February 2024, our Board of Directors authorized a new capital return program to repurchase up to $750.0 million of 

our outstanding common stock.

45

Stock Performance Graph and Cumulative Total Return

Notwithstanding  any  statement  to  the  contrary  in  any  of  our  previous  or  future  filings  with  the  SEC,  the  following 
information relating to the price performance of our common stock shall not be deemed to be “filed” with the SEC or to be 
“soliciting material” under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and it shall not be deemed 
to  be  incorporated  by  reference  into  any  of  our  filings  under  the  Securities  Act  of  1933,  as  amended,  or  the  Exchange  Act, 
except to the extent we specifically incorporate it by reference into such filing.

The graph below compares Halozyme Therapeutics, Inc.’s cumulative five-year total shareholder return on common stock 
with the cumulative total returns of the NASDAQ Composite Index and the NASDAQ Biotechnology Index. The graph tracks 
the performance of a $100 investment in our common stock and in each of the indexes (with the reinvestment of all dividends) 
from December 31, 2018 to December 31, 2023. The historical stock price performance included in this graph is not necessarily 
indicative of future stock price performance.

Halozyme Therapeutics, Inc.      . . . . . . . . . . . . .
NASDAQ Composite     . . . . . . . . . . . . . . . . . . .
NASDAQ Biotechnology     . . . . . . . . . . . . . . . .

12/31/2018
$100
$100
$100

12/31/2019
$121
$137
$125

12/31/2020
$292
$198
$158

12/31/2021
$275
$242
$158

12/31/2022
$389
$163
$142

12/31/2023
$253
$236
$149

46

Item 6.

[Reserved]

47

Item 7.

 Management’s Discussion and Analysis of Financial Condition and Results of Operations

In  addition  to  historical  information,  the  following  discussion  contains  forward-looking  statements  that  are  subject  to 
risks  and  uncertainties.  Actual  results  may  differ  substantially  from  those  referred  to  herein  due  to  a  number  of  factors, 
including but not limited to risks described in the Part I, Item 1A, Risks Factors, and elsewhere in this Annual Report on Form 
10-K. References to “Notes” are Notes included in our Notes to Consolidated Financial Statements.

Overview

Halozyme  Therapeutics,  Inc.  is  a  biopharmaceutical  company  advancing  disruptive  solutions  to  improve  patient 

experiences and outcomes for emerging and established therapies. 

As the innovators of ENHANZE ® drug delivery technology (“ENHANZE”) with our proprietary enzyme, rHuPH20, our 
commercially validated solution is used to facilitate the subcutaneous (“SC”) delivery of injected drugs and fluids with the goal 
of  reducing  the  treatment  burden  for  patients.  We  license  our  technology  to  biopharmaceutical  companies  to  collaboratively 
develop  products  that  combine  ENHANZE®  with  our  partners’  proprietary  compounds.  We  also  develop,  manufacture  and 
commercialize,  for  ourselves  or  with  our  partners,  drug-device  combination  products  using  our  advanced  auto-injector 
technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and 
tolerability, and enhanced patient comfort and adherence.

Our ENHANZE partners’ approved products and product candidates are based on rHuPH20, our patented recombinant 
human hyaluronidase enzyme. rHuPH20 works by breaking down hyaluronan (“HA”), a naturally occurring carbohydrate that 
is  a  major  component  of  the  extracellular  matrix  of  the  SC  space.  This  temporarily  reduces  the  barrier  to  bulk  fluid  flow 
allowing  for  improved  and  more  rapid  SC  delivery  of  high  dose,  high  volume  injectable  biologics,  such  as  monoclonal 
antibodies and other large therapeutic molecules, as well as small molecules and fluids. We refer to the application of rHuPH20 
to facilitate the delivery of other drugs or fluids as ENHANZE. We license the ENHANZE technology to form collaborations 
with  biopharmaceutical  companies  that  develop  or  market  drugs  requiring  or  benefiting  from  injection  via  the  SC  route  of 
administration.  In  the  development  of  proprietary  intravenous  (“IV”)  drugs  combined  with  our  ENHANZE  technology,  data 
have been generated supporting the potential for ENHANZE to reduce patient treatment burden, as a result of shorter duration 
of SC administration with ENHANZE compared to IV administration. ENHANZE may enable fixed-dose SC dosing compared 
to  weight-based  dosing  typically  required  for  IV  administration,  extend  the  dosing  interval  for  drugs  that  are  already 
administered subcutaneously and potentially allow for lower rates of infusion-related reactions. ENHANZE may enable more 
flexible  treatment  options  such  as  home  administration  by  a  healthcare  professional  or  potentially  the  patient  or  caregiver. 
Lastly, certain proprietary drugs co-formulated with ENHANZE have been granted additional exclusivity, extending the patent 
life of the product beyond the patent expiry of the proprietary IV drug.

We currently have ENHANZE collaborations and licensing agreements with F. Hoffmann-La Roche, Ltd. and Hoffmann-
La  Roche,  Inc.  (“Roche”),  Takeda  Pharmaceuticals  International  AG  and  Baxalta  US  Inc.  (“Takeda”),  Pfizer  Inc.  (“Pfizer”), 
Janssen Biotech, Inc. (“Janssen”), AbbVie, Inc. (“AbbVie”), Eli Lilly and Company (“Lilly”), Bristol Myers Squibb Company 
(“BMS”),  argenx  BVBA  (“argenx”),  ViiV  Healthcare  (the  global  specialist  HIV  Company  majority  owned  by 
GlaxoSmithKline)  (“ViiV”),  Chugai  Pharmaceutical  Co.,  Ltd  (“Chugai”)  and  Acumen  Pharmaceuticals,  Inc.  (“Acumen”).  In 
addition to receiving upfront licensing fees from our ENHANZE collaborations, we are entitled to receive event and sales-based 
milestone payments, revenues from the sale of bulk rHuPH20 and royalties from commercial sales of approved partner products 
co-formulated with ENHANZE. We currently earn royalties from four of these collaborations, including royalties from sales of 
one  product  from  the  Takeda  collaboration,  four  products  from  the  Roche  collaboration,  one  product  from  the  Janssen 
collaboration and one product from the argenx collaboration.

We  have  commercialized  auto-injector  products  with  several  pharmaceutical  companies  including  Teva  Pharmaceutical 
Industries, Ltd. (“Teva”) and Otter Pharmaceuticals, LLC (“Otter”). We have development programs including auto-injectors 
with Idorsia Pharmaceuticals Ltd. (“Idorsia”).

Our  commercial  portfolio  of  proprietary  products  includes  Hylenex®,  utilizing  rHuPH20,  and  our  specialty  product 

XYOSTED®, utilizing our auto-injector technology.

48

Our 2023 and recent key events are as follows:

Roche

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

In  January  2024,  Roche  received  EC  marketing  authorization  for  Tecentriq  SC  for  all  approved  indications  of 
Tecentriq IV for multiple cancer types.

In  September  2023,  Chugai,  a  member  of  the  Roche  Group,  announced  that  it  had  obtained  regulatory  approval  for 
Phesgo from the MHLW in Japan. We are entitled to receive royalties for Phesgo® sales in Japan under our agreement 
with Roche.

In September 2023, Roche informed us that there will be a delay in the projected launch timing for Tecentriq SC in the 
U.S.  as  a  result  of  Roche’s  need  to  update  CMC  processes  for  Tecentriq  SC.  Roche  expects  a  potential  launch  of 
Tecentriq SC in the U.S. in 2024. 

In  August  2023,  Roche  announced  the  approval  of  Tecentriq  SC  with  ENHANZE  by  the  MHRA  in  Great  Britain, 
resulting in an $8.0 million milestone payment to us and the right to receive royalties on net product sales.

In July 2023, Roche announced that the Phase III OCARINA II trial evaluating ocrelizumab SC with ENHANZE as a 
twice a year 10-minute SC injection met its primary and secondary endpoints in patients with relapsing forms of MS, 
RMS or PPMS. Subsequently, Roche filed with regulatory authorities in the EU, UK and U.S.

argenx

In February 2024, argenx announced that the FDA had accepted for priority review a sBLA for VYVGART Hytrulo 
for  the  treatment  of  CIDP.  The  application  has  been  granted  a  PDUFA  action  date  of  June  21,  2024.  In  July  2023, 
argenx reported positive data from the ADHERE study evaluating VYVGART Hytrulo with ENHANZE in adults with 
CIDP. The study met its primary endpoint resulting in a 61% reduction in risk of relapse compared to placebo.

In January 2024, argenx received regulatory approval in Japan for VYVDURA (efgartigimod alfa and hyaluronidase-
qvfc)  co-formulated  with  ENHANZE  for  the  treatment  of  adult  patients  with  gMG  including  options  for  self-
administration, resulting in a $5.0 million milestone payment.

In November 2023, argenx received EC approval of VYVGART SC (efgartigimod alfa and hyaluronidase-qvfc) co-
formulated  with  ENHANZE  for  the  treatment  of  gMG  in  adult  patients  who  are  AChR  antibody  positive,  and  in 
December 2023 VYVGART SC was made available to patients, resulting in $23.0 million in milestone payments. The 
European approval of VYVGART SC provides the option for patient self-administration. 

In September 2023, Zai Lab limited (argenx commercial partner for China) announced the CDE of the NMPA granted 
Breakthrough Therapy Designation for efgartigimod alfa injection (SC injection) (efgartigimod SC) for the treatment 
of patients with CIDP. The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both 
global and Chinese patients enrolled in the ADHERE study.

In June 2023, argenx received U.S. FDA approval for VYVGART Hytrulo injection with ENHANZE for SC use for 
the treatment of gMG in adult patients who are AChR antibody positive and in July 2023 VYVGART Hytrulo was 
made available to patients, resulting in $33.0 million in milestone payments and the right to receive royalties on net 
product sales.

Janssen

In  January  2024,  Janssen  announced  submission  of  a  sBLA  to  the  FDA  seeking  approval  of  a  new  indication  for 
DARZALEX  FASPRO  in  combination  with  D-VRd  for  induction  and  consolidation  treatment  and  with  D-R  for 
maintenance treatment of adult patients who are NDMM and are eligible for ASCT.

ViiV

In August 2023, ViiV initiated a Phase 2b study to evaluate the efficacy, safety, PK and tolerability of VH3810109 
(N6LS) administered subcutaneously with ENHANZE in combination with cabotegravir.

In August 2023, ViiV achieved a development milestone resulting in a $5.0 million milestone payment to us.

Takeda

In February 2024, Takeda submitted a New Drug Application in Japan seeking approval for TAK-771, subcutaneous 
10% human immunoglobulin with ENHANZE, for treatment of primary immunodeficiency.

In  January  2024,  Takeda  received  FDA  and  EC  approval  for  HYQVIA  for  the  treatment  of  CIDP  as  maintenance 
therapy to prevent the relapse of neuromuscular disability and impairment in adults.

49

•

•

•

•

•

•

•

•

•

•

In  October  2023,  Takeda  initiated  a  Phase  2/3  study  to  evaluate  PK,  safety,  and  tolerability  of  subcutaneous 
administration of TAK-881 in adult and pediatric participants with PIDD.

In April 2023, Takeda announced that the U.S. FDA approved a sBLA to expand the use of HYQVIA to treat primary 
immunodeficiency in children.

BMS

In  October  2023,  BMS  reported  positive  topline  results  from  the  Phase  3  CheckMate-67T  trial  evaluating  a  SC 
formulation  of  Opdivo  (nivolumab)  with  ENHANZE  in  patients  with  ccRCC  who  have  received  prior  systemic 
therapy. The study met its co-primary PK endpoints and a key secondary endpoint.

In  March  2023,  BMS  initiated  a  Phase  3  trial  to  demonstrate  the  drug  exposure  levels  of  nivolumab  and  relatlimab 
fixed-dose combination with ENHANZE is not inferior to IV administration in participants with previously untreated 
metastatic or unresectable melanoma (RELATIVITY-127).

Acumen

In  November  2023,  we  and  Acumen  entered  into  a  global  collaboration  and  non-exclusive  license  agreement  that 
provides Acumen access to ENHANZE for a single target. Acumen intends to explore the potential use of ENHANZE 
for ACU193, Acumen’s clinical stage monoclonal antibody candidate to target Amyloid-β Oligomers for treatment of 
early Alzheimer’s disease.

Teva

In  November  2023,  Teva  announced  FDA  approval  of  the  generic  version  of  Forteo,  featuring  our  multi-dose  auto-
injector pen platform for the treatment of osteoporosis among certain women and men.

Corporate

In February 2024, we announced our third capital return program to repurchase up to $750.0 million of our outstanding 
common stock.

During 2023, we repurchased 4.2 million shares of common stock in open market transactions for $150.0 million at an 
average  price  per  share  of  $36.01.  In  November  2023,  we  accelerated  the  initiation  of  our  planned  2024  share 
repurchases and entered into an ASR agreement with Bank of America to accelerate the remaining $250.0 million of 
share  repurchases  under  the  $750.0  million  approved  capital  return  program.  We  paid  $250.0  million  to  Bank  of 
America and took initial delivery of 5.5 million shares.

In August 2023, we announced positive results of a clinical study with our high-volume auto-injector demonstrating 
SC administration of 10 mL of a representative biologic product co-formulated with our ENHANZE® drug delivery 
technology in approximately 30 seconds. The results were presented at the 13th annual Partnership Opportunities in 
Drug Delivery (“PODD”) conference in October 2023.

In January 2023, we elected to redeem all of our remaining outstanding 1.25% convertible senior notes due 2024. In 
March  2023,  the  outstanding  amount  of  the  2024  Convertible  Notes  converted  in  full  and  we  paid  $13.5  million  in 
cash and issued 288,886 shares.

50

Results of Operations

Comparison of Years Ended December 31, 2023 and 2022 

Royalties – Royalties were as follows (in thousands): 

Year Ended December 31,

2023

2022

Change

Percentage 
Change

Royalties     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

447,865  $ 

360,475  $ 

87,390 

 24 %

The increase in royalties was primarily driven by continued sales uptake of DARZALEX SC by Janssen and Phesgo by 
Roche in all geographies and contributions from new device royalty revenue as a result of the Antares acquisition in May 2022, 
partially offset by slightly lower sales of Herceptin SC and MabThera SC by Roche. We expect royalty revenue to continue to 
grow as a result of our 2020 and 2023 ENHANZE partner product launches, offsetting the ongoing impact from IV biosimilars 
on pricing of mature partner products delivered SC with ENHANZE and the expected royalty rate reduction in March of 2024 
for certain sales of DARZALEX SC outside of the U.S.

Product Sales, Net – Product sales, net were as follows (in thousands):

Sales of proprietary products     . . . . . . . . . . . . . . . . . . . . . . .
Sales of bulk rHuPH20      . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sales of device partnered products      . . . . . . . . . . . . . . . . . . .
Total product sales, net        . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

$ 

Year Ended December 31,

2023
130,834  $ 
115,442 
54,578 
300,854  $ 

2022
72,849  $ 
82,084 
36,097 
191,030  $ 

Dollar Change
57,985 
33,358 
18,481 
109,824 

Percentage 
Change

 80 %
 41 %
 51 %
 57 %

 The increase in product sales was primarily due to contributions from our proprietary and device partnered products as 
the result of the Antares acquisition in May 2022 and higher sales of bulk rHuPH20 driven by partner demand. We expect sales 
of our proprietary products will grow in future years as we continue to gain market share in the TRT market. We expect product 
sales of bulk rHuPH20 and device partnered products to fluctuate in future periods based on the needs of our partners.

Revenues Under Collaborative Agreements – Revenues under collaborative agreements were as follows (in thousands): 

Upfront license fees, license fees for the election of 
additional targets, event-based payments, license 
maintenance fees and amortization of deferred upfront and 
other license fees:

Upfront license and target nomination fees       . . . . . . . . . .
Event-based development milestones and regulatory 
milestones and other fees        . . . . . . . . . . . . . . . . . . . . . . . .

Sales-based milestone . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device licensing and development revenue     . . . . . . . . . .

Total revenues under collaborative agreements    . . . .

$ 

Year Ended December 31,

2023

2022

Dollar Change

Percentage 
Change

$ 

2,000  $ 

30,000  $ 

(28,000) 

 (93) %

69,000 
— 

59,000 
10,000 

9,534 
80,534  $ 

9,611 
108,611  $ 

10,000 
(10,000) 

(77) 
(28,077) 

 17 %
 (100) %

 (1) %
 (26) %

The  decrease  in  revenue  from  license  fees  was  primarily  due  to  the  timing  of  milestones  driven  by  partner  activities. 
Revenue from upfront licenses fees, license fees for the election of additional targets, license maintenance fees and other license 
fees  and  event-based  payments  vary  from  period  to  period  based  on  our  ENHANZE  collaboration  activity.  We  expect  these 
revenues  to  continue  to  fluctuate  in  future  periods  based  on  our  partners’  ability  to  meet  various  clinical  and  regulatory 
milestones set forth in such agreements and our ability to obtain new collaborative agreements.

51

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Operating expenses – Operating expenses were as follows (in thousands):

Year Ended December 31,

2023

2022

Change

Percentage 
Change

Cost of sales     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

192,361  $ 

139,304  $ 

Amortization of intangibles      . . . . . . . . . . . . . . . . . . . . . . . .

Research and development   . . . . . . . . . . . . . . . . . . . . . . . . .

Selling, general and administrative       . . . . . . . . . . . . . . . . . .

73,773 

76,363 

43,148 

66,607 

149,182 

143,526 

53,057 

30,625 

9,756 

5,656 

 38 %

 71 %

 15 %

 4 %

Cost of Sales – Cost of sales consists primarily of raw material costs, third-party manufacturing costs, fill and finish costs, 
freight  costs,  internal  costs  and  manufacturing  overhead  associated  with  the  production  of  our  proprietary  products,  device 
partnered products and bulk rHuPH20. The increase in cost of sales was primarily due to an increase in sales of our proprietary 
and device partnered products as a result of the Antares acquisition in May 2022 and higher bulk rHuPH20 sales. 

Amortization of intangibles – The increase in amortization of intangibles expense was due to the recognition of a full year 
amortization  expense  during  the  current  year  for  our  acquired  intangible  assets  and  an  impairment  charge  of  $2.5  million  to 
fully  impair  the  TLANDO  product  rights  intangible  asset  as  a  result  of  the  license  agreement  termination  notice  provided  to 
Lipocine in September 2023.

Research  and  Development  –  Research  and  development  expenses  consist  of  external  costs,  salaries  and  benefits,  and 
allocation  of  facilities  and  other  overhead  expenses  related  to  research  manufacturing,  preclinical  and  regulatory  activities 
related to our collaborations, and our development platforms. The increase in research and development expenses was primarily 
due to an increase in compensation expense related to the ongoing combined larger workforce from the Antares acquisition to 
support the device platform in regulatory, quality and manufacturing, as well as planned investments in ENHANZE, partially 
offset by one-time transaction costs incurred in the prior year.

Selling,  General  and  Administrative  –  Selling,  general  and  administrative  (“SG&A”)  expenses  consist  primarily  of 
salaries and related costs for personnel in executive, selling and administrative functions as well as professional fees for legal 
and accounting, business development, commercial operations support for proprietary products and alliance management and 
marketing support for our collaborations. The increase in SG&A expenses was primarily due to an increase in compensation 
expense  related  to  the  ongoing  combined  larger  workforce,  including  the  addition  of  commercial  resources  in  sales  and 
marketing for TRT products, partially offset by one-time transaction costs incurred in the prior year.

Investment and other income (expense), net - Investment and other income (expense), net was as follows (in thousands):

Investment and other income, net   . . . . . . . . . . . . . . . . . . . .

$ 

Year Ended December 31,

2022

Change

Percentage 
Change

1,046  $ 

15,271 

 1,460 %

2023
16,317  $ 

Investment  and  other  income  (expense),  net  consists  primarily  of  interest  income  on  our  cash,  cash-equivalent  and 
marketable securities. The increase in investment and other income, net was primarily due to a significant increase in market 
interest rates as well as an increase in the average invested balance.

Interest Expense – Interest expense was as follows (in thousands):

Interest expense    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

Year Ended December 31,

2023
18,762  $ 

2022
16,947  $ 

Change

1,815 

Percentage 
Change

 11 %

The  modest  increase  in  interest  expense  was  primarily  due  to  an  increase  in  interest  expense  related  to  our  2028 
Convertible  Notes,  partially  offset  by  the  repayment  of  our  2022  Term  Facility  and  outstanding  Revolving  Credit  Facility 
during the third quarter of 2022 and a reduction in interest expense related to our 2024 Convertible Notes which were converted 
in the first quarter of 2023.

Income Taxes – Income taxes were as follows (in thousands):

Income tax expense     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

Year Ended December 31,

2023
66,735  $ 

2022
46,789  $ 

Change

19,946 

Percentage 
Change

 43 %

52

 
 
 
 
 
 
 
 
 
The increase in income tax expense was primarily due to higher income before taxes recognized during the current year, 

partially offset by federal research and development credits.

Comparison of Years Ended December 31, 2022 and 2021

For  discussion  related  to  changes  in  financial  condition  and  the  results  of  operations  for  the  year  ended  December  31, 
2022  compared  to  the  year  ended  December  31,  2021,  refer  to  Part  II  -  Item  7.  Management’s  Discussion  and  Analysis  of 
Financial  Condition  and  Results  of  Operations  included  in  the  Company’s  Annual  Report  on  Form  10-K  for  the  fiscal  year 
ended December 31, 2022, which was filed with the SEC on February 21, 2023.

Liquidity and Capital Resources

Overview

Our principal sources of liquidity are our existing cash, cash equivalents and available-for-sale marketable securities. As 
of December 31, 2023, we had cash, cash equivalents and marketable securities of $336.0 million. We believe that our current 
cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least the next 12 months. We 
expect to fund our operations going forward with existing cash resources, anticipated revenues from our existing collaboration 
agreements  and  cash  that  we  may  raise  through  future  financing  transactions.  We  may  raise  cash  through  any  one  of  the 
following  financing  vehicles:  (i)  new  collaborative  agreements;  (ii)  expansions  or  revisions  to  existing  collaborative 
relationships; (iii) private financings; (iv) other equity or debt financings; (v) monetizing assets; and/or (vi) the public offering 
of securities.

We may, in the future, draw on our existing line of credit or offer and sell additional equity, debt securities and warrants 
to  purchase  any  of  such  securities,  either  individually  or  in  units  to  raise  capital  for  additional  working  capital,  capital 
expenditures, share repurchases, acquisitions or for other general corporate purposes. Our material cash requirements include 
the following contractual and other obligations.

Long-term debt

Our  long-term  debt  consists  of  convertible  notes.  The  aggregate  principal  amount  of  our  convertible  notes  is  $1,525.0 
million. Future interest payments associated with our convertible notes total $39.7 million, with $9.2 million payable within 12 
months.

Leases

We have lease arrangements related to our office and research facilities and certain vehicles under non-cancelable 
operating leases. As of December 31, 2023, we have lease payment obligations of $40.7 million, with $6.6 million payable 
within 12 months.

Third-party manufacturing obligations

We have contracted with third-party manufacturers for the supply of bulk rHuPH20, fill/finish of Hylenex recombinant, 
other proprietary products and partnered products. Under these agreements, we are required to purchase certain quantities each 
year during the terms of the agreements. Contractual obligations for purchases of goods or services include agreements that are 
enforceable  and  legally  binding  to  us  and  that  specify  all  significant  terms,  including  fixed  or  minimum  quantities  to  be 
purchased;  fixed,  minimum  or  variable  price  provisions;  and  the  approximate  timing  of  the  transaction.  For  obligations  with 
cancellation  provisions,  the  amounts  disclosed  were  limited  to  the  non-cancelable  portion  of  the  agreement  terms  or  the 
minimum cancellation fee. As of December 31, 2023, we had third-party manufacturing obligations of $107.4 million, payable 
within 12 months.

Other purchase obligations and commitments

Purchase obligations represent an estimate of all open purchase orders and contractual obligations in the ordinary course 
of business for which we have not received the goods or services. As of December 31, 2023, we had other purchase obligations 
and other commitments of $20.3 million, with $19.1 million payable within 12 months.

The expected timing of payments of the obligations above is estimated based on information we have as of December 31, 
2023. Timing of payments and actual amounts paid may be different, depending on the time of receipt of goods or services, or 
changes to agreed-upon amounts for some obligations.

53

Our  future  capital  uses  and  requirements  and  anticipated  sources  of  funds  to  satisfy  these  requirements  depend  on 

numerous forward-looking factors. These factors may include, but are not limited to, the following:

•

•

•

•

•

•

•

•

the costs of investments in our ENHANZE platform and auto-injector technology including development of new versions 
of rHuPH20 and auto-injector devices;

the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

the costs to develop and validate additional manufacturing processes of rHuPH20, auto-injectors, and testosterone 
replacement therapies;

the costs to expand the number of collaboration partner products developed and launched by partners including costs to 
scale-up manufacturing;

the amount of royalties and milestones from our partners;

the effect of competing technological and market developments;

the terms and timing of any collaborative, licensing and other arrangements that we may establish; and

the extent to which we acquire or in-license new products, technologies or businesses and invest in development.

Cash Flows

Net cash provided by operating activities    . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Net cash used in investing activities     . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash (used in) provided by financing activities    . . . . . . . . . . . . . . . . . . . . .

Net (decrease) increase in cash, cash equivalents and restricted cash       $ 

Operating Activities

Year Ended December 31,

2023
388,571  $ 
(96,909) 
(407,987) 
(116,325)  $ 

2022
240,110  $ 
(487,005) 
362,371 
115,476  $ 

Change

148,461 
390,096 
(770,358) 
(231,801) 

The increase in net cash provided by operations was primarily due to an increase in revenue and a decrease in working 

capital spend.

Investing Activities

The  decrease  in  net  cash  used  in  investing  activities  was  primarily  due  to  the  acquisition  of  Antares  in  the  prior  year, 
partially offset by a decrease in cash from the sale and maturity of marketable securities, an increase in purchases of marketable 
securities as we continue to invest excess cash, a decrease in proceeds from the sale of assets, and an increase in capital spend 
for the purchase of manufacturing equipment and new facility improvements.

Financing Activities

The increase in net cash used in financing activities was primarily due to $702.0 million in cash received in the prior year 
from the issuance of our 2028 Convertible Notes, $202.5 million increase in the repurchase of common stock and a $6.2 million 
reduction in net proceeds from the issuance of common stock under equity incentive plans. The increase was partially offset by 
$69.1  million  cash  paid  for  our  Capped  Call  Transaction  in  the  prior  year,  $64.0  million  reduction  in  cash  paid  on  the 
conversion of our 2024 Convertible Notes, and $7.1 million cash paid for debt issuance costs in the prior year.

Share Repurchases

In December 2021, our Board of Directors authorized a share repurchase program to repurchase up to $750.0 million of 
our  outstanding  common  stock  over  a  three-year  period.  In  February  2024,  our  Board  of  Directors  authorized  a  new  capital 
return program to repurchase up to $750.0 million of our outstanding common stock. Refer to Note 10, Stockholders’ Equity, of 
our consolidated financial statements for additional information regarding our share repurchases.

54

 
 
 
 
 
 
 
 Long-Term Debt

1.00% Convertible Notes due 2028

In  August  2022,  we  completed  the  sale  of  $720.0  million  in  aggregate  principal  amount  of  1.00%  Convertible  Senior 
Notes  due  2028  (the  “2028  Convertible  Notes”  and  collectively  with  the  2024  Convertible  Notes  and  the  2027  Convertible 
Notes  the  “Convertible  Notes”).  The  net  proceeds  in  connection  with  the  issuance  of  the  2028  Convertible  Notes,  after 
deducting  the  initial  purchasers’  fee  of  $18.0  million,  was  approximately  $702.0  million.  We  also  incurred  additional  debt 
issuance costs totaling $1.0 million. Debt issuance costs and the initial purchasers’ fee are presented as a debt discount.

The 2028 Convertible Notes pay interest semi-annually in arrears on February 15th and August 15th of each year at an 
annual rate of 1.00%. The 2028 Convertible Notes are general unsecured obligations and rank senior in right of payment to all 
indebtedness that is expressly subordinated in right of payment to the 2028 Convertible Notes, rank equally in right of payment 
with  all  existing  and  future  liabilities  that  are  not  so  subordinated,  are  effectively  junior  to  any  secured  indebtedness  to  the 
extent  of  the  value  of  the  assets  securing  such  indebtedness  and  are  structurally  subordinated  to  all  indebtedness  and  other 
liabilities (including trade payables) of our current or future subsidiaries. The 2028 Convertible Notes have a maturity date of 
August 15, 2028.

Holders may convert their 2028 Convertible Notes at their option only in the following circumstances: (1) during any 
calendar quarter commencing after the calendar quarter ending on December 31, 2022, if the last reported sale price per share of 
common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days 
ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive 
business  days  immediately  after  any  five  consecutive  trading  day  period  (such  five  consecutive  trading  day  period,  the 
“measurement period”) in which the trading price per $1,000 principal amount of notes for each trading day of the measurement 
period was less than 98% of the product of the last reported sale price per share of our common stock on such trading day and 
the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on our common 
stock, as described in the offering memorandum for the 2028 Convertible Notes; (4) if we call such notes for redemption; and 
(5)  at  any  time  from,  and  including,  February  15,  2028  until  the  close  of  business  on  the  second  scheduled  trading  day 
immediately before the maturity date. As of December 31, 2023, the 2028 Convertible Notes were not convertible.

Upon  conversion,  we  will  pay  cash  for  the  settlement  of  principal,  and  for  the  premium,  if  applicable,  we  will  pay 
cash,  deliver  shares  of  common  stock  or  a  combination  of  cash  and  shares  of  common  stock,  at  our  election.  The  initial 
conversion  rate  for  the  2028  Convertible  Notes  is  17.8517  shares  of  common  stock  per  $1,000  in  principal  amount  of  2028 
Convertible Notes, equivalent to a conversion price of approximately $56.02 per share of our common stock. The conversion 
rate is subject to adjustment in some events but will not be adjusted for any accrued or unpaid interest.

0.25% Convertible Notes due 2027

In March 2021, we completed the sale of $805.0 million in aggregate principal amount of 0.25% Convertible Senior Notes 
due  2027  (the  “2027  Convertible  Notes”).  The  net  proceeds  in  connection  with  the  issuance  of  the  2027  Convertible  Notes, 
after deducting the initial purchasers’ fee of $20.1 million, was approximately $784.9 million. We also incurred additional debt 
issuance costs totaling $0.4 million. Debt issuance costs and the initial purchasers’ fee are presented as a debt discount.

The  2027  Convertible  Notes  pay  interest  semi-annually  in  arrears  on  March  1st  and  September  1st  of  each  year  at  an 
annual rate of 0.25%. The 2027 Convertible Notes are general unsecured obligations and rank senior in right of payment to all 
indebtedness that is expressly subordinated in right of payment to the 2027 Convertible Notes, rank equally in right of payment 
with  all  existing  and  future  liabilities  that  are  not  so  subordinated,  are  effectively  junior  to  any  secured  indebtedness  to  the 
extent  of  the  value  of  the  assets  securing  such  indebtedness  and  are  structurally  subordinated  to  all  indebtedness  and  other 
liabilities (including trade payables) of our current or future subsidiaries. The 2027 Convertible Notes have a maturity date of 
March 1, 2027.

Holders  may  convert  their  2027  Convertible  Notes  at  their  option  only  in  the  following  circumstances:  (1)  during  any 
calendar  quarter  commencing  after  the  calendar  quarter  ending  on  June  30,  2021,  if  the  last  reported  sale  price  per  share  of 
common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days 
ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive 
business  days  immediately  after  any  five  consecutive  trading  day  period  (such  five  consecutive  trading  day  period,  the 
“measurement period”) in which the trading price per $1,000 principal amount of notes for each trading day of the measurement 
period was less than 98% of the product of the last reported sale price per share of our common stock on such trading day and 
the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on our common 
stock, as described in the offering memorandum for the 2027 Convertible Notes; (4) if we call such notes for redemption; and 
(5) at any time from, and including, September 1, 2026 until the close of business on the scheduled trading day immediately 
before the maturity date. As of December 31, 2023, the 2027 Convertible Notes were not convertible.

55

Upon conversion, we will pay cash for the settlement of principal, and for the premium, if applicable, we will pay cash, 
deliver shares of common stock or a combination of cash and shares of common stock, at our election. The initial conversion 
rate for the 2027 Convertible Notes is 12.9576 shares of common stock per $1,000 in principal amount of 2027 Convertible 
Notes, equivalent to a conversion price of approximately $77.17 per share of our common stock. The conversion rate is subject 
to adjustment.

1.25% Convertible Notes due 2024

In November 2019, we completed the sale of $460.0 million in aggregate principal amount of 1.25% Convertible Senior 
Notes  due  2024  (the  “2024  Convertible  Notes”).  The  net  proceeds  in  connection  with  the  issuance  of  the  2024  Convertible 
Notes,  after  deducting  the  initial  purchasers’  fee  of  $12.7  million,  was  approximately  $447.3  million.  We  also  incurred  debt 
issuance cost totaling $0.3 million. Debt issuance costs and the initial purchasers’ fee were presented as a debt discount.

In January 2021, we notified the note holders of our irrevocable election to settle the principal of the 2024 Convertible 
Notes in cash and for the premium, to deliver shares of common stock. The conversion rate for the 2024 Convertible Notes was 
41.9208 shares of common stock per $1,000 in principal amount of 2024 Convertible Notes, equivalent to a conversion price of 
approximately $23.85 per share of our common stock. The conversion rate was subject to adjustment. 

In March 2021, we completed a privately negotiated, induced conversion of $369.1 million principal amount of the 2024 
Convertible  Notes  (“2021  Note  Repurchases”  or  the  “2021  Induced  Conversion”).  In  connection  with  the  2021  Induced 
Conversion,  we  paid  approximately  $370.2  million  in  cash,  which  included  principal  and  accrued  interest,  and  issued 
approximately  9.08  million  shares  of  our  common  stock  representing  the  intrinsic  value  based  on  the  contractual  conversion 
rate  and  incremental  shares  as  an  inducement  for  conversion.  As  a  result  of  the  2021  Induced  Conversion,  we  recorded 
$21.0 million in induced conversion expense which was included in other income (expense) of our consolidated statements of 
income  in  2021.  The  induced  conversion  expense  represented  the  fair  value  of  the  common  stock  issued  upon  conversion  in 
excess of the common stock issuable under the original terms of the 2024 Convertible Notes.

In August 2022, we completed a privately negotiated induced conversion of $77.4 million principal amount of the 2024 
Convertible  Notes  (“2022  Note  Repurchases”  or  the  “2022  Induced  Conversion”).  In  connection  with  the  2022  Induced 
Conversion,  we  paid  approximately  $77.6  million  in  cash,  which  included  principal  and  accrued  interest,  and  issued 
approximately  1.51  million  shares  of  our  common  stock  representing  the  intrinsic  value  based  on  the  contractual  conversion 
rate  and  incremental  shares  as  an  inducement  for  conversion.  As  a  result  of  the  2022  Induced  Conversion,  we  recorded 
$2.7 million in induced conversion expense which was included in other income (expense) of our consolidated statements of 
income  in  2022.  The  induced  conversion  expense  represented  the  fair  value  of  the  common  stock  issued  upon  conversion  in 
excess of the common stock issuable under the original terms of the 2024 Convertible Notes.

In  January  2023,  we  issued  a  notice  for  the  redemption  of  2024  Convertible  Notes.  Holders  of  the  notes  could  convert 
their notes at any time prior to the close of the business day prior to the redemption date. In March 2023, holders of the notes 
elected to convert the 2024 Convertible Notes in full. In connection with the conversion, we paid approximately $13.5 million 
in cash which included principal and accrued interest, and issued 288,886 shares of our common stock representing the intrinsic 
value based on the contractual conversion rate.

Revolving Credit and Term Loan Facilities (May 2022)

In May 2022, in connection with the closing of the Antares acquisition, we entered into a credit agreement, which was 
subsequently amended, with Bank of America, N.A., as Administrative Agent, Swing Line Lender and an L/C Issuer, and the 
other lenders and L/C Issuers party thereto (the “2022 Credit Agreement), evidencing a credit facility (the “2022 Facility”) that 
provides  for  (i)  a  $350  million  revolving  credit  facility  (the  “Revolving  Credit  Facility”)  and  (ii)  a  $250  million  term  loan 
facility (the “Term Facility”). Proceeds from a $120 million draw on the Revolving Credit Facility and the $250 million Term 
Facility  were  used  to  fund  a  portion  of  the  Antares  acquisition,  repay  Antares’  existing  debt  and  pay  fees  and  expenses  in 
connection with the Antares acquisition. The 2022 Credit Agreement contains an expansion feature, which allows us, subject to 
certain  conditions,  to  increase  the  aggregate  principal  amount  of  the  2022  Facility,  provided  we  remain  in  compliance  with 
underlying financial covenants on a pro forma basis including the consolidated interest coverage ratio and the consolidated net 
leverage ratio covenants set forth in the 2022 Credit Agreement. The 2022 Facility will mature on November 30, 2026 unless 
either  the  Revolving  Credit  Facility  or  the  Term  Facility  is  extended  prior  to  such  date  in  accordance  with  the  2022  Credit 
Agreement.

The Term Facility requires quarterly scheduled repayments of the term loans in each of the first, second, third and fourth 
years following the closing in annual amounts equal to 2.50%, 5.00%, 7.50% and 10.00% of the initial principal amount of the 
term  loans,  respectively.  The  term  loans  are  also  subject  to  mandatory  prepayments  from  the  proceeds  of  certain  asset  sales, 
subject to our right to reinvest the proceeds thereof.

Borrowings  under  the  2022  Facility  bear  interest,  at  our  option,  at  a  rate  equal  to  an  applicable  margin  plus:  (a)  the 
applicable Term Secured Overnight Financing Rate (“SOFR”) (which includes a SOFR adjustment of 0.10%), or (b) a base rate 

56

determined by reference to the highest of (1) the federal funds effective rate plus 0.50%, (2) the Bank of America prime rate, (3) 
the Term SOFR rate for an interest period of one month plus 1.10%, and (4) 1.00%. The margin for the 2022 Facility ranges, 
based on our consolidated total net leverage ratio, from 0.25% to 1.25% in the case of base rate loans and from 1.25% to 2.25% 
in the case of Term SOFR rate loans. In addition to paying interest on the outstanding principal under the 2022 Facility, we will 
pay  (i)  a  commitment  fee  in  respect  of  the  unutilized  commitments  thereunder  and  (ii)  customary  letter  of  credit  fees  and 
agency fees. The commitment fees range from 0.15% to 0.35% per annum based on our consolidated net leverage ratio.

In August 2022, we entered into Amendment No. 1 to the Credit Agreement (the “Amendment”) among the Company, the 
Guarantors (as defined in the Credit Agreement), each L/C Issuer from time to time party thereto, Bank of America, N.A., as 
Administrative Agent (in such capacity, the “Administrative Agent”) and swing line lender (in such capacity, the “Swing Line 
Lender”),  and  each  lender  party  thereto,  which  amends  the  Credit  Agreement  dated  as  of  May  24,  2022  (the  “Credit 
Agreement”) among the Company, the Guarantors, the Administrative Agent, the Swing Line Lender, each Lender and the L/C 
Issuers.  The  Amendment,  among  other  things,  increased  the  size  of  the  Revolving  Credit  Facility  from  $350  million  to 
$575  million.  The  terms  of  the  revolving  credit  facility  were  otherwise  unchanged.  Concurrently  with  the  entry  into  the 
Amendment,  we  repaid  the  entire  outstanding  term  loan  facility  and  repaid  all  outstanding  loans  under  the  revolving  credit 
facility under the 2022 Credit Agreement. 

 As of December 31, 2023, the revolving credit facility was undrawn. 

57

Critical Accounting Estimates

The discussion and analysis of our financial condition and results of operations are based on our consolidated financial 
statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The 
preparation  of  our  consolidated  financial  statements  requires  us  to  make  estimates  and  judgments  that  affect  the  reported 
amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. We review our 
estimates on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe 
to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of 
assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. Our significant 
accounting policies are outlined in Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements 
included in the Annual Report on Form 10-K. We believe the following accounting policies to be critical to the judgments and 
estimates used in the preparation of our consolidated financial statements.

Revenue Recognition

Methodology

Judgment and Uncertainties

Revenue is recognized when we 
determine it is probable a milestone 
will be achieved. This assessment is 
based on our past experience with 
our collaboration partners, market 
insight and partner communication. 

Effect if Actual Results Differ From 
Assumptions

A revenue reversal will be required in 
the event it is determined that 
achievement of a milestone, previously 
deemed probable, will not occur. This 
reversal may be material. 

For collaborative agreements, we are entitled 
to receive event-based payments subject to 
the collaboration partner's achievement of 
specified development and regulatory 
milestones. We recognize revenue when it is 
deemed probable that these milestones will 
be achieved, which could be in a period prior 
to its actual occurrence. At the end of each 
reporting period, we re-evaluate the 
probability of achievement of such 
milestones, and if necessary, adjust our 
estimate of the overall transaction price.

For collaborative agreements, royalty 
revenue is recognized in the period the 
underlying sales occur, but we do not receive 
final royalty reports from our collaboration 
partners until after we complete our financial 
statements for a prior quarter. Therefore, we 
recognize revenue based on estimates of the 
royalty earned, which are based on 
preliminary reports provided by our 
collaboration partners.

For collaborative arrangements, when 
necessary, we perform an allocation of the 
upfront amount based on relative stand-alone 
selling prices (“SSP”) of licenses for 
individual targets. We determine
license SSP using an income-based valuation 
approach utilizing risk-adjusted discounted 
cash flow projections.

The amount of royalty revenue 
recognized for the quarter is 
estimated using our knowledge of 
past royalty payments, market 
insight and an estimate made by our 
collaboration partners provided in a 
preliminary report.

A final royalty report and associated 
royalty payment is received 
approximately 60 days after quarter-
end. If necessary, a true-up is recorded 
at that time if there is a difference from 
the initial estimated royalty revenue 
recorded. To date, the true-up entries 
have not been material.

The inputs used in the valuation 
model to determine SSP are based 
on estimates utilizing market data 
and information provided by our 
collaboration partners. 

Differences in the allocation of the 
transaction price between delivered and 
undelivered performance obligations 
can impact the timing of revenue 
recognition but do not change the total 
revenue recognized under any 
agreement.

58

Share-Based Payments

Methodology

Judgment and Uncertainties

We maintain a Stock Incentive Plan, which 
provides for share-based payment awards, 
including stock options, restricted stock and 
performance awards. We determine the fair 
value of our stock option awards at the date 
of grant using a Black-Scholes model. We 
determine the fair value of our restricted 
stock unit awards at the date of grant using 
the closing market value of our common 
stock on the date of grant. We determine the 
grant date fair value for the PSU awards 
using a Monte Carlo simulation pricing 
model.

Option-pricing models and generally 
accepted valuation techniques 
require management to make 
assumptions and to apply judgment 
to determine the fair value of our 
awards. These assumptions and 
judgments include estimating the 
future volatility of our stock price, 
expected dividend yield and future 
employee stock option exercise 
behaviors. Changes in these 
assumptions can materially affect 
the fair value estimate. 

Our performance awards require 
management to make assumptions 
regarding the likelihood of 
achieving long-term Company 
goals.

Effect if Actual Results Differ From 
Assumptions

We do not currently believe there is a 
reasonable likelihood that there will be 
a material change in estimates or 
assumptions we used to determine 
stock-based compensation expense. 
However, if actual results are not 
consistent with our estimates or 
assumptions, we may be exposed to 
changes in share-based compensation 
expense that could be material. 

If actual results are not consistent with 
the assumptions used, the share-based 
compensation expense reported in our 
financial statements may not be 
representative of the actual economic 
cost of the share-based compensation. 
A 10% change in our share-based 
compensation expense for the year 
ended December 31, 2023 would have 
affected pre-tax earnings by 
approximately $3.7 million in 2023. 

Goodwill and Intangibles

Methodology

We estimate the fair value of acquired 
intangible assets that have finite useful lives 
whenever an event or change in 
circumstances indicates that the carrying 
value of the asset may not be recoverable. 
We test for potential impairment of goodwill 
and other intangible assets that have 
indefinite useful lives annually in the second 
fiscal quarter or whenever indicators of 
impairment arise.

Recent Accounting Pronouncements

Judgment and Uncertainties
In the year of acquisition, significant 
estimates and assumptions are used 
to estimate the fair value of the 
intangible assets. Subsequent to the 
initial recognition, we monitor these 
assets for impairment indicators.

Effect if Actual Results Differ From 
Assumptions

A change in any of the estimates or 
assumptions used may result an 
impairment charge in our consolidated 
statement of income.

Refer to Note 2, Summary of Significant Accounting Policies, of our consolidated financial statements for a discussion of 

recent accounting pronouncements and their effect, if any, on us.

59

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 

As  of  December  31,  2023,  our  cash  equivalents  and  marketable  securities  consisted  of  investments  in  money  market 
funds, asset-backed securities, U.S. Treasury securities, corporate debt securities, agency bonds and commercial paper. These 
investments  were  made  in  accordance  with  our  investment  policy  which  specifies  the  categories,  allocations,  and  ratings  of 
securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at 
the same time maximizing the income we receive without significantly increasing risk. Some of the financial instruments that 
we invest in could be subject to market risk. This means that a change in prevailing interest rates may cause the value of the 
instruments  to  fluctuate.  For  example,  if  we  purchase  a  security  that  was  issued  with  a  fixed  interest  rate  and  the  prevailing 
interest rate later rises, the value of that security may decline. Based on our current investment portfolio as of December 31, 
2023, we do not believe that our results of operations would be materially impacted by an immediate change of 10% in interest 
rates. 

We hedge a portion of foreign currency exchange risk associated with forecasted royalties revenue denominated in Swiss 
francs  to  reduce  the  risk  of  our  earnings  and  cash  flows  being  adversely  affected  by  fluctuations  in  exchange  rates.  These 
transactions are designated and qualify as cash flow hedges. The cash flow hedges are carried at fair value with mark-to-market 
gains  and  losses  recorded  within  AOCI  in  our  consolidated  balance  sheets  and  reclassified  to  royalty  revenue  in  our 
consolidated statements of income in the same period as the recognition of the underlying hedged transaction. We do not issue 
derivatives, derivative commodity instruments or other financial instruments for speculative trading purposes. 

Further,  we  do  not  believe  our  cash,  cash  equivalents  and  marketable  securities  have  significant  risk  of  default  or 
illiquidity. We made this determination based on discussions with our investment advisors and a review of our holdings. While 
we  believe  our  cash,  cash  equivalents  and  marketable  securities  do  not  contain  excessive  risk,  we  cannot  provide  absolute 
assurance that in the future our investments will not be subject to adverse changes in market value. All of our cash equivalents 
and marketable securities are recorded at fair market value.

Item 8.

Financial Statements and Supplementary Data

Our financial statements are annexed to this report beginning on page F-1.

Item 9.

Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

None.

60

Item 9A. Controls and Procedures

Evaluation of Disclosure 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 Securities and 
Exchange  Commission’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 decision 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.

Under  the  supervision  and  with  the  participation  of  our  management,  including  our  principal  executive  officer  and 
principal financial officer, we conducted an evaluation of our disclosure controls and procedures, as such term is defined under 
Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended. Based on this evaluation, our principal 
executive officer and our principal financial officer concluded that our disclosure controls and procedures were effective as of 
the end of the period covered by this Annual Report on Form 10-K.

Changes in Internal Control Over Financial Reporting 

There  have  been  no  significant  changes  in  our  internal  control  over  financial  reporting  that  occurred  during  the  period 
ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over 
financial reporting.

Management’s Report on Internal Control Over Financial Reporting

Our  management  is  responsible  for  establishing  and  maintaining  adequate  internal  control  over  financial  reporting. 
Internal control over financial reporting is defined in Rule 13a-15(f) and Rule 15d-15(f) promulgated under the Exchange Act 
of  1934,  as  amended,  as  a  process  designed  by,  or  under  the  supervision  of,  our  principal  executive  and  principal  financial 
officers 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:

•

•

•

Pertain  to  the  maintenance  of  records  that  in  reasonable  detail  accurately  and  fairly  reflect  the  transactions  and 
dispositions of our assets;

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  are  being  made  only  in 
accordance with authorizations of our management and directors; and

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of 
our assets that could have a material effect on our financial statements.

Because  of  its  inherent  limitations,  internal  control  over  financial  reporting  may  not  prevent  or  detect  misstatements. 
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.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In 
making  this  assessment,  our  management  used  the  criteria  set  forth  by  the  Committee  of  Sponsoring  Organizations  of  the 
Treadway Commission (“COSO”) in Internal Control-Integrated Framework (2013 framework) (the “COSO criteria”). Based 
on  our  assessment,  management  concluded  that,  as  of  December  31,  2023,  our  internal  control  over  financial  reporting  is 
effective based on the COSO criteria. The independent registered public accounting firm that audited the consolidated financial 
statements that are included in this Annual Report on Form 10-K has issued an audit report on the effectiveness of our internal 
control over financial reporting as of December 31, 2023. The report appears below.

61

Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors of 
Halozyme Therapeutics, Inc.

Opinion on Internal Control Over Financial Reporting

We have audited Halozyme Therapeutics, Inc.’s internal control over financial reporting as of December 31, 2023, 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,  Halozyme  Therapeutics,  Inc.  (the  Company) 
maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, 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, 2023 and 2022, the related consolidated 
statements  of  income,  comprehensive  income,  cash  flows  and  stockholders’  equity  for  each  of  the  three  years  in  the  period 
ended December 31, 2023, and the related notes the financial statement schedule listed in the Index at Item 15(a) and our report 
dated February 20, 2024 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 20, 2024 

62

Item 9B. Other Information

During the three months ended December 31, 2023, no director or officer adopted or terminated any Rule 10b5-1 trading 

arrangement or non-rule 10b5-1 trading arrangement (as such terms are defined pursuant to Item 408(a) of Regulation S-K).

Item 9C.   Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

None.

PART III

Item 10. Directors, Executive Officers and Corporate Governance

The information required by this item regarding directors is incorporated by reference to our definitive Proxy Statement 
(the “Proxy Statement”) to be filed with the Securities and Exchange Commission in connection with our 2024 Annual Meeting 
of Stockholders no later than 120 days after December 31, 2023 under the heading “Election of Directors.” The information 
required by this item regarding our code of ethics is incorporated by reference to the information under the caption “Code of 
Conduct and Ethics and Corporate Governance Guidelines” to be contained in the Proxy Statement. The information required 
by this item regarding our Audit Committee is incorporated by reference to the information under the caption “Board Meetings 
and Committees—Audit Committee” to be contained in the Proxy Statement. The information required by this item regarding 
material  changes,  if  any,  to  the  process  by  which  stockholders  may  recommend  nominees  to  our  Board  of  Directors  is 
incorporated by reference to the information under the caption “Board Meetings and Committees—Nominating and Governance 
Committee” to be contained in the Proxy Statement.

Executive Officers

Helen  I.  Torley,  M.B.  Ch.  B.,  M.R.C.P.  (61),  President,  Chief  Executive  Officer  and  Director.  Dr.  Torley  joined 
Halozyme  in  January  2014  as  President  and  Chief  Executive  Officer  and  as  a  member  of  Halozyme’s  Board  of  Directors. 
Throughout  her  career,  Dr.  Torley  has  led  several  successful  product  launches,  including  Kyprolis®,  Prolia®,  Sensipar®,  and 
Miacalcin®. Prior to joining Halozyme, Dr. Torley served as Executive Vice President and Chief Commercial Officer for Onyx 
Pharmaceuticals  (“Onyx”)  from  August  2011  to  December  2013  overseeing  the  collaboration  with  Bayer  on  Nexavar®  and 
Stivarga® and the U.S. launch of Kyprolis®. She was responsible for the development of Onyx's commercial capabilities in ex-
U.S. markets and in particular, in Europe. Prior to Onyx, Dr. Torley spent 10 years in management positions at Amgen Inc., 
most recently serving as Vice President and General Manager of the U.S. Nephrology Business Unit from 2003 to 2009 and the 
U.S.  Bone  Health  Business  Unit  from  2009  to  2011.  From  1997  to  2002,  she  held  various  senior  management  positions  at 
Bristol-Myers Squibb, including Regional Vice President of Cardiovascular and Metabolic Sales and Head of Cardiovascular 
Global Marketing. She began her career at Sandoz/Novartis, where she ultimately served as Vice President of Medical Affairs, 
developing and conducting post-marketing clinical studies across all therapeutic areas, including oncology. Within the past five 
years,  Dr.  Torley  served  on  the  Board  of  Directors  of  Quest  Diagnostics  Incorporated,  a  diagnostic  information  services 
company.  Before  joining  the  industry,  Dr.  Torley  was  in  medical  practice  as  a  senior  registrar  in  rheumatology  at  the  Royal 
Infirmary in Glasgow, Scotland. Dr. Torley received her Bachelor of Medicine and Bachelor of Surgery degrees (M.B. Ch.B.) 
from the University of Glasgow and is a Member of the Royal College of Physicians (M.R.C.P).

Nicole  LaBrosse  (41),  Senior  Vice  President,  Chief  Financial  Officer.  Ms.  LaBrosse  has  served  as  the  Senior  Vice 
President,  Chief  Financial  Officer  since  February  2022  and  has  over  20  years  of  public  accounting  and  corporate  finance 
experience. She previously served as the Company’s Vice President, Finance and Accounting from January 2020 to February 
2022 and as the Company’s Executive Director, Controller from July 2017 to December 2019. From June 2015 to June 2017, 
she was the Company’s Senior Director, Financial Reporting. Prior to joining the Company, Ms. LaBrosse was an auditor with 
PricewaterhouseCoopers,  LLP  from  2004  to  2015.  She  received  a  certified  public  accounting  license  after  receiving  a  B.S. 
degree in corporate finance and accounting and her M.S. degree in accounting from Bentley College.

Mark Snyder (57), Senior Vice President, General Counsel, Chief Compliance Officer and Secretary. Mr. Snyder joined 

Halozyme in January 2022 as Senior Vice President, General Counsel, Chief Compliance Officer and Secretary. Mr. Snyder has 

63

over 30 years of experience in legal and business management roles. Prior to joining Halozyme, from January 2008 to 
December 2021, Mr. Snyder served in various senior positions in the legal department at Qualcomm Incorporated, a wireless 
communications company, including his most recent positions as Senior Vice President & Deputy General Counsel, Litigation, 
from April 2016 to December 2021 and Vice President, Patent Counsel, from October 2010 to April 2016. Before Qualcomm, 
Mr. Snyder served as Lead Intellectual Property Counsel at Kyocera Wireless Corp., a wireless communications company, and 
has held legal and business management roles in two smaller companies. Mr. Snyder began his legal career as a patent attorney 
at the law firm of Sheridan Ross & McIntosh. Mr. Snyder received his B.S. degree in chemical engineering at the University of 
Rochester and his M.B.A. degree from Boston College Carroll School of Business. He received his J.D. from Boston College 
Law School.

Michael J. LaBarre (60), Senior Vice President, Chief Technical Officer. Dr. LaBarre joined Halozyme in June 2008 as 
Vice President, Product Development and has served in various officer positions most recently as Senior Vice President, Chief 
Technical Officer since January 2020. Prior to joining Halozyme, Dr. LaBarre served as Vice President, Product Development 
at  Paramount  BioSciences,  a  pharmaceutical  company,  from  April  2006  to  June  2008.  Prior  to  that  he  served  as  Director, 
Analytical and Protein Biochemistry, Discovery Research at Biogen Idec, a pharmaceutical company, from December 2003 to 
April 2006. He also served in various research and development roles at IDEC Pharmaceuticals Corporation, a pharmaceutical 
company, from November 1995 to December 2003 most recently as Director, Analytical and Formulation Sciences, R&D. Prior 
to joining IDEC, Dr. LaBarre held research and development positions at various pharmaceutical companies from July 1992 to 
November 1995. Dr. LaBarre received his Ph.D. in Chemistry from the University of Arizona and his B.S. in Chemistry from 
Southampton College of Long Island University.

Item 11. Executive Compensation

The  information  required  by  this  item  is  incorporated  by  reference  to  the  information  under  the  captions  “Executive 
Compensation and Related Information” and “Compensation Committee Interlocks and Insider Participation” to be contained 
in the Proxy Statement.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Other than as set forth below, the information required by this item is incorporated by reference to the information under 
the  caption  “Security  Ownership  of  Certain  Beneficial  Owners  and  Management  and  Related  Stockholder  Matters”  to  be 
contained in the Proxy Statement.

Equity Compensation Plan Information

The following table summarizes our compensation plans under which our equity securities are authorized for issuance as 

of December 31, 2023:

Plan Category
Equity compensation plans approved by stockholders (1)     . . . .
Equity compensation plans not approved by stockholders      . . .

Number of Shares 
to be Issued upon
Exercise of
Outstanding Options,
Restricted Stock
Units and 
Performance Stock 
Units
(a)

Weighted 
Average
Exercise Price
of Outstanding
Options
(b)

(2)

7,804,728 

$ 

— 

7,804,728 

$ 

30.50 

— 

30.50 

Number of Shares
Remaining Available 
for Future Issuance
under Equity
Compensation
Plans (Excluding
Shares Reflected 
in Column (a))
(c)

14,681,908 

— 

14,681,908 

(1) Represents stock options, restricted stock units, and performance stock units under the Amended and Restated 2021 

Stock Plan. This includes 2,604,222 shares available for future purchase under our ESPP plan.

(2) This amount does not include performance stock units as there is no exercise price for such units.

64

 
 
 
 
 
 
 
 
Item 13. Certain Relationships and Related Transactions, and Director Independence

The  information  required  by  this  item  is  incorporated  by  reference  to  the  information  under  the  captions  “Certain 
Relationships and Related Transactions” and “Corporate Governance - Director Independence” to be contained in the Proxy 
Statement.

Item 14. Principal Accounting Fees and Services

The  information  required  by  this  item  is  incorporated  by  reference  to  the  information  under  the  caption  “Principal 

Accounting Fees and Services” to be contained in the Proxy Statement.

65

PART IV

Item 15. Exhibits and Financial Statement Schedules

(a)

Documents filed as part of this report.

1.   Financial Statements 

Report of Independent Registered Public Accounting Firm ID 42      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Consolidated Balance Sheets as of December 31, 2023 and 2022      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Consolidated Statements of Income for Each of the Years Ended December 31, 2023, 2022 and 2021      . . . . . . . . .
Consolidated Statements of Comprehensive Income for Each of the Years Ended December 31, 2023, 2022 and 
2021       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Cash Flows for Each of the Years Ended December 31, 2023, 2022 and 2021     . . . . . .
Consolidated Statements of Stockholders’ Equity for Each of the Years Ended December 31, 2023, 2022 and 

2021       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes to the Consolidated Financial Statements     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  Page

  F-1

  F-3
  F-4

F-5
  F-6

  F-7

  F-8

2.   List of all Financial Statement schedules.

The following financial statement schedule of Halozyme Therapeutics, Inc. is filed as part of this Annual Report on 
Form 10-K and should be read in conjunction with the consolidated financial statements of Halozyme Therapeutics, 
Inc. 

Schedule II:  Valuation and Qualifying Accounts     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page

F-44

All other schedules are omitted because they are not applicable or the required information 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.

66

  
 
 
 
 
 
 
 
(b)

Exhibits.

Exhibit

Number

Exhibit Title

Herewith

Form

Date Filed

Incorporated by Reference

Filed

3.1

3.2

4.1

4.2

4.3

4.4

4.5

10.1

10.2

10.3

10.4

10.5

10.6

10.7

Amended and Restated Certification of Incorporation of Halozyme 
Therapeutics, Inc.

The Company's Bylaws, as amended

Indenture, dated March 1, 2021, between Halozyme Therapeutics, Inc. 
and The Bank of New York Mellon Trust Company, N.A., as trustee, and 
the Registrant

Form of Note, dated March 1, 2021, between Halozyme Therapeutics, 
Inc. and The Bank of New York Mellon Trust Company, N.A., as 
trustee, and the Registrant

Indenture, dated August 18, 2022, between Halozyme Therapeutics, Inc. 
and The Bank of New York Mellon Trust Company, N.A., as trustee and 
registrant.

Form of Note, dated August 18, 2022, between Halozyme Therapeutics, 
Inc. and The Bank of New York Mellon Trust Company, N.A., as 
trustee, and the Registrant (included within Exhibit 4.5)

Description of Securities

Form of Capped Call Confirmation

Credit Agreement, dated as of May 24, 2022, by and among Halozyme 
Therapeutics, Inc., the Guarantors, Bank of America N.A. and each of 
those additional Lenders that are a party to such agreement.

Security Agreement, dated as of May 24, 2022, by and among Halozyme 
Therapeutics, Inc., the Guarantors and Bank of America N.A 

Amendment No. 1 to the Credit Agreement 

Amendment No. 2 to the Credit Agreement

Agreement for Assignment and Assumption of Lease, Del Mar Corporate 
Centre I Office Lease and First Amendment to Office Lease

Lease Agreement, dated July 1, 2019, by and between Antares Pharma, 
Inc. and Whitewater Properties I, LLC.

8-K

5/3/2019

8-K

8-K

12/10/2021

3/1/2021

8-K

3/1/2021

8-K

8/18/2022

8-K

8/18/2022

10-K

2/22/2022

8-K

8-K

8/18/2022

5/24/2022

8-K

5/24/2022

8-K

8/19/2022

10-Q

10-Q

5/9/2023

5/10/2022

8-K

7/5/2019

10.8#

Halozyme Therapeutics, Inc. 2021 Employee Stock Purchase Plan

10-Q

11/8/2022

10.9#

Halozyme Therapeutics, Inc. 2021 Stock Plan

10.10#

Form of Stock Option Agreement (2021 Plan updated May 2023)

10.11#

10.12#

Form of Restricted Stock Units Agreement for Officers (2021 Plan 
updated May 2023)

Form of Restricted Stock Units Agreement (2021 Plan Sell-to-Cover 
updated May 2023)

8-K

10-Q

10-Q

5/5/2021

8/8/2023

8/8/2023

10-Q

8/8/2023

10.13#

Letter Agreement Amending Exercise Period for Employee Option

10-Q

8/8/2023

10.14#

Form of Performance Stock Units (2021 Stock Plan)

8-K

5/5/2021

67

Filed

Herewith

Exhibit

Number
10.15#

10.16#

10.17#

10.18#

10.19#

10.20#

10.21#

10.22#

10.23#

10.24#

Exhibit Title
Form of Directors Restricted Stock Units Agreement (2021 Stock Plan)

Form of Director Stock Option Agreement (2021 Plan)

Halozyme Therapeutics, Inc. 2011 Stock Plan (as amended through May 
2, 2018)

Form of Stock Option Agreement (2011 Stock Plan)

Form of Stock Option Agreement for Executive Officers (2011 Stock 
Plan)

Form of Restricted Stock Units Agreement for Officers (2011 Stock 
Plan)

Form of Restricted Stock Award Agreement for Officers (2011 Stock 
Plan)

Form of Stock Option Agreement (2011 Stock Plan -grants made on or 
after 11/4/2015)

Form of Restricted Stock Units Agreement (2011 Stock Plan - grants 
made on or after 11/4/2015)

Form of Restricted Stock Units Agreement (2011 Plan - grants made on 
or after 2/22/2017)

Incorporated by Reference

Form
8-K

Date Filed
5/5/2021

10-Q

8/8/2023

8-K

4/6/2018

8-K

8-K

5/6/2011

5/6/2011

10-Q

8/10/2015

10-Q

8/10/2015

10-Q

11/9/2015

10-Q

11/9/2015

10-K

2/28/2017

10.25#

Form of Indemnity Agreement for Directors and Executive Officers

8-K

12/20/2007

10.26#

Form of PSU Agreement (2011 Stock Plan)

10.27#

Form of PSU Agreement (2011 Stock Plan)

10.28#

Severance Policy

X

10.29#

10.30#

Form of Amended and Restated Change In Control Agreement with 
Officer

Halozyme Therapeutics, Inc. Non Qualified Deferred Compensation Plan 
Adoption Agreement

10-Q

10-K

8/10/2020

2/23/2021

10-Q

11/9/2015

10-K

2/22/2022

68

Exhibit Title

Herewith

Form

Date Filed

Halozyme Therapeutics, Inc Directors Deferred Equity Compensation 
Plan

10-K

2/22/2022

Incorporated by Reference

Filed

Exhibit

Number

10.31#

21.1

23.1

31.1

31.2

32

97

X

X

X

X

X

X

X

X

X

X

X

X

X

Subsidiaries of Registrant

Consent of Independent Registered Public Accounting Firm

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 
15d-14(a) of the Securities Exchange Act of 1934, as amended

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 
15d-14(a) of the Securities Exchange Act of 1934, as amended

Certification  of  Chief  Executive  Officer  and  Chief  Financial  Officer 
pursuant  to  18  U.S.C.  1350,  as  adopted  pursuant  to  Section  906  of  the 
Sarbanes-Oxley Act of 2002

Halozyme Therapeutics, Inc. Incentive Compensation Recoupment 
Policy

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Inline XBRL document.

101.SCH XBRL Taxonomy Extension Schema

101.CAL XBRL Taxonomy Extension Calculation Linkbase

101.DEF XBRL Taxonomy Extension Definition Linkbase

101.LAB XBRL Taxonomy Extension Label Linkbase

101.PRE XBRL Taxonomy Presentation Linkbase

104

Cover Page Interactive Data File (formatted as inline XBRL and 
contained in Exhibit 101)

_______________

#

Indicates management contract or compensatory plan or arrangement.

(c)

Financial Statement Schedules.

See Item 15(a) 2 above.

69

Item 16. Form 10-K Summary

None.

70

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.

SIGNATURES

Date:

February 20, 2024

Halozyme Therapeutics, Inc.,
a Delaware corporation

By:

  /s/  Helen I. Torley, M.B. Ch.B., M.R.C.P.
  Helen I. Torley, M.B. Ch.B., M.R.C.P.
  President and Chief Executive Officer

(Principal Executive Officer)

71

 
 
 
 
 
 
 
 
 
 
 
POWER OF ATTORNEY

Know  all  persons  by  these  presents,  that  each  person  whose  signature  appears  below  constitutes  and  appoints  Helen  I. 
Torley  and  Nicole  LaBrosse,  and  each  of  them,  as  his/her  true  and  lawful  attorneys-in-fact  and  agents,  with  full  power  of 
substitution and resubstitution, for him/her and in his/her name, place, and stead, in any and all capacities, to sign any and all 
amendments to this Annual Report, and to file the same, with all 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 
and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as 
fully to all intents and purposes as he/she might or could do in person, hereby ratifying and confirming that all said attorneys-in-
fact  and  agents,  or  any  of  them  or  their  or  his/her  substitute  or  substituted,  may  lawfully  do  or  cause  to  be  done  by  virtue 
thereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual Report has been signed below by the 

following persons on behalf of the registrant and in the capacities and on the dates indicated. 

Signature

  Title

  Date

/s/  Helen I. Torley, M.B. Ch.B., M.R.C.P.
Helen I. Torley, M.B. Ch.B., M.R.C.P.

  President and Chief Executive Officer, Director

  February 20, 2024

 (Principal Executive Officer)

/s/  Nicole LaBrosse

Nicole LaBrosse

/s/  Jeffrey W. Henderson

Jeffrey W. Henderson

/s/  Jean-Pierre Bizzari

Jean-Pierre Bizzari

/s/  Bernadette Connaughton

Bernadette Connaughton

/s/  Barbara Duncan
Barbara Duncan

/s/  Connie L. Matsui

Connie L. Matsui

/s/  Moni Miyashita

Moni Miyashita

/s/  Matthew L. Posard
Matthew L. Posard

  Senior Vice President and Chief Financial Officer

  February 20, 2024

(Principal Financial and Accounting Officer)

  Chair of the Board of Directors

  February 20, 2024

February 20, 2024

  February 20, 2024

February 20, 2024

February 20, 2024

February 20, 2024

February 20, 2024

Director

  Director

Director

Director

Director

Director

72

 
 
 
 
 
Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors of 
Halozyme Therapeutics, Inc.

Opinion on the Financial Statements

We  have  audited  the  accompanying  consolidated  balance  sheets  of  Halozyme  Therapeutics,  Inc.  (the  Company)  as  of 
December  31,  2023  and  2022,  the  related  consolidated  statements  of  income,  comprehensive  income,  cash  flows  and 
stockholders’  equity  for  each  of  the  three  years  in  the  period  ended  December  31,  2023,  and  the  related  notes  and  financial 
statement schedule listed in the Index at Item 15(a) (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 as of 
December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended 
December 31, 2023, 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,  2023,  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 20, 2024 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 matters 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 accounts or disclosures to which it relates.

F-1

Determination of Overall Transaction Price for Collaboration Agreements

Description of the Matter

How We Addressed the Matter in Our 
Audit

At December 31, 2023, the Company has eleven collaboration agreements. 
As  discussed  in  Notes  2  and  5  of  the  financial  statements,  amounts  are 
included  in  the  transaction  price  when  management  determines  that  it  is 
probable that the amount will not result in a significant reversal of revenue 
in  the  future.  During  2023,  the  Company  recognized  $69.0  million  of 
variable  consideration  in  the  transaction  price  under  their  collaboration 
arrangements.

Auditing management’s conclusions related to determining the probability 
of achievement of milestones is complex and highly judgmental given the 
progression  of  developing  and  commercializing  the  combined  targets  is 
completed by the collaboration partners.

We  obtained  an  understanding  and  evaluated  the  design  and  tested  the 
operating  effectiveness  of  controls  over  the  Company’s  process  to 
routinely  evaluate  the  probability  of  achievement  of  milestones  and  any 
related constraint for each collaboration, in addition to the controls over the 
completeness  and  accuracy  of  determining  the  population  of  agreements 
and potential milestone payments.

To test the milestone amounts included, or excluded, from the transaction 
price,  we  performed  audit  procedures  that  included,  among  others, 
inspecting evidence to support management’s assessment of the probability 
of  achievement.  For  each  milestone,  we  examined  evidence  including 
correspondence with the collaboration partner and evaluated management’s 
conclusions  on  the  probabilities  of  achievement.  We  reviewed  supporting 
documentation  to  corroborate  that  milestones  were  included  in  the 
transaction  price  when  determined  to  be  probable  of  achievement.  We 
reviewed the collaboration agreements and related amendments to validate 
the  completeness  of  the  list  of  targets  and  potential  milestone  payments 
that  management  considered  in  their  analysis.  We  performed  a  lookback 
analysis to validate the Company’s accuracy of determining the probability 
of achieving these milestones.

We have served as the Company’s auditor since 2006.

/s/    Ernst & Young LLP

San Diego, California
February 20, 2024 

F-2

 
 
 
 
 
 
 HALOZYME THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share amounts)

December 31,
2023

December 31,
2022

Current assets

ASSETS

Cash and cash equivalents     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Marketable securities, available-for-sale       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts receivable, net and other contract assets       . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventories, net    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other current assets       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current assets     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment, net     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other assets     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intangible assets, net       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred tax assets, net      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restricted cash    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total assets        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

118,370 
217,630 
234,210 
127,601 
48,613 
746,424 
74,944 
17,816 
416,821 
472,879 
4,386 
— 
1,733,270 

Current liabilities

LIABILITIES AND STOCKHOLDERS’ EQUITY

Accounts payable     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Accrued expenses     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current portion of long-term debt, net     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term debt, net   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long-term liabilities     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contingent liability

Total liabilities      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11,816 
100,678 
— 
112,494 
1,499,248 
37,720 
— 
1,649,462 

$ 

$ 

$ 

234,195 
128,599 
231,072 
100,123 
45,024 
739,013 
75,570 
26,301 
409,049 
546,652 
44,426 
500 
1,841,511 

17,693 
99,762 
13,334 
130,789 
1,492,766 
32,686 
15,472 
1,671,713 

Commitments and contingencies (Note 12)
Stockholders’ equity

Preferred stock - $0.001 par value; 20,000 shares authorized; no shares issued and 

outstanding      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Common stock - $0.001 par value; 300,000 shares authorized; 126,770 and 135,154 

shares issued and outstanding as of December 31, 2023 and 2022, respectively    . . . . .

Additional paid-in capital   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated other comprehensive loss   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Retained earnings      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total stockholders’ equity      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities and stockholders’ equity     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

— 

— 

127 
2,409 
(9,278) 
90,550 
83,808 
1,733,270 

$ 

135 
27,368 
(922) 
143,217 
169,798 
1,841,511 

See accompanying notes to consolidated financial statements.

F-3

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HALOZYME THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except per share amounts)

Revenues

Royalties      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Product sales, net         . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revenues under collaborative agreements    . . . . . . . . . . . . . . . . . . . . . . .

Total revenues     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operating expenses

Cost of sales     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amortization of intangibles      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Research and development      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Selling, general and administrative    . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total operating expenses     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating income     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other income (expense)

Investment and other income, net     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inducement expense related to convertible notes      . . . . . . . . . . . . . . . . . .

Contingent liability fair value measurement gain      . . . . . . . . . . . . . . . . . .

Interest expense   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Net income before income taxes       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Income tax expense (benefit)       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net income      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

Year Ended December 31,

2023

2022

2021

447,865 

$ 

360,475 

$ 

203,900 

300,854 

80,534 

829,253 

192,361 

73,773 

76,363 

149,182 

491,679 

337,574 

16,317 

— 

13,200 

(18,762) 

348,329 

66,735 

191,030 

108,611 

660,116 

139,304 

43,148 

66,607 

143,526 

392,585 

267,531 

1,046 

(2,712) 

— 

(16,947) 

248,918 

46,789 

104,224 

135,186 

443,310 

81,413 

— 

35,672 

50,323 

167,408 

275,902 

1,102 

(20,960) 

— 

(7,526) 

248,518 

(154,192) 

281,594 

$ 

202,129 

$ 

402,710 

Earnings per share       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Basic     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Diluted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

2.13 
2.10 

$ 
$ 

1.48 
1.44 

$ 
$ 

2.86 
2.74 

Weighted average common shares outstanding     . . . . . . . . . . . . . . . . . . . . . . .
Basic     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

131,927 
134,197 

136,844 
140,608 

140,646 
146,796 

See accompanying notes to consolidated financial statements.

F-4

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HALOZYME THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands)

Year Ended December 31,

2023

2022

2021

Net income      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

281,594 

$ 

202,129 

$ 

402,710 

Other comprehensive income

Unrealized gain (loss) on marketable securities     . . . . . . . . . . . . . . . . . .

Foreign currency translation adjustment       . . . . . . . . . . . . . . . . . . . . . . .

Unrealized gain on foreign currency      . . . . . . . . . . . . . . . . . . . . . . . . . .

Unrealized loss on derivative instruments, net    . . . . . . . . . . . . . . . . . . .

Realized gain on derivative instruments, net       . . . . . . . . . . . . . . . . . . . .

1,097 

24 

3 

(9,406) 

(74) 

(349) 

(683) 

8 

39 

— 

— 

15 

26 

— 

— 

Comprehensive income   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

273,238 

$ 

201,827 

$ 

402,068 

See accompanying notes to consolidated financial statements.

F-5

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HALOZYME THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)

Year Ended December 31,
2022

2021

2023

$ 

281,594 

$ 

202,129 

$ 

402,710 

Operating activities

Net income    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adjustments to reconcile net income to net cash provided by operating 
activities:

Share-based compensation      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Depreciation and amortization   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of intangible assets         . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of debt discount    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of (premium) discounts on marketable securities, net    . . . . . . .
Realized loss on marketable securities      . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss on disposal of equipment     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contingent liability fair value measurement adjustment    . . . . . . . . . . . . . . . .
Recognition of deferred revenue       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease payments deferred    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Induced conversion expense related to convertible notes      . . . . . . . . . . . . . . .
Deferred income taxes (including benefit from valuation allowance 
release)      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Changes in operating assets and liabilities

Accounts receivable, net and other contract assets       . . . . . . . . . . . . . . . .
Inventories, net     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other assets   . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable and accrued expenses     . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by operating activities      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Investing activities

Purchases of marketable securities     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sales and maturities of marketable securities     . . . . . . . . . . . . . . . .
Acquisitions of business, net of cash acquired    . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchases of property and equipment   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sale of assets     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash used in investing activities      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Financing activities

Proceeds from term loan      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repayment of term loan        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from revolving credit facilities  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repayment of revolving credit facilities     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from issuance of 2027 Convertible Notes, net      . . . . . . . . . . . . . . . . . . . .
Repayment of 2024 Convertible Notes    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from issuance of 2028 Convertible Notes, net      . . . . . . . . . . . . . . . . . . . .
Purchase of capped call     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payment of debt issuance cost      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repurchase of common stock     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from issuance of common stock under equity incentive plans, net of 
taxes paid related to net share settlement       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash (used in) provided by financing activities        . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net (decrease) increase in cash, cash equivalents and restricted cash     . . . . . . . . . . . . . .
Cash, cash equivalents and restricted cash at beginning of period    . . . . . . . . . . . . . . . .
Cash, cash equivalents and restricted cash at end of period    . . . . . . . . . . . . . . . . . . . $ 

Supplemental disclosure of cash flow information

Interest paid     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Income taxes paid (received), net     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

11,410 
31,756 

Supplemental disclosure of non-cash investing and financing activities

Amounts accrued for purchases of property and equipment       . . . . . . . . . . . . . . . . . $ 
Right-of-use assets obtained in exchange for lease obligation     . . . . . . . . . . . . . . . . $ 
Common stock issued for conversion of 2024 Convertible Notes      . . . . . . . . . . . . . $ 

25 
2,572 
125 

See accompanying notes to consolidated financial statements.

F-6

36,620 
11,083 
73,773 
7,304 
(6,319) 
— 
611 
(13,200) 
— 
1,270 
— 

34,506 
— 

(3,339) 
(26,884) 
4,098 
(12,546) 
388,571 

(292,911) 
211,296 
— 
(15,294) 
— 
(96,909) 

— 
— 
— 
— 
— 
(13,483) 
— 
— 
— 
(402,383) 

7,879 
(407,987) 
(116,325) 
234,695 
118,370 

24,397 
6,493 
43,148 
7,839 
1,106 
1,727 
129 
— 
(2,494) 
(903) 
2,712 

40,005 
(227) 

(83,941) 
(17,481) 
(9,064) 
24,535 
240,110 

(255,208) 
746,127 
(999,120) 
(4,810) 
26,006 
(487,005) 

250,000 
(250,000) 
120,000 
(120,000) 
— 
(77,453) 
702,000 
(69,120) 
(7,104) 
(200,002) 

14,050 
362,371 
115,476 
119,219 
234,695 

6,107 
16,224 

6,229 
34,435 
1,018 

$ 

$ 
$ 

$ 
$ 
$ 

20,820 
2,997 
— 
3,642 
2,257 
— 
— 
— 
(1,496) 
(751) 
20,960 

(155,434) 
(3) 

6,755 
7,371 
(11,555) 
1,167 
299,440 

(652,515) 
247,683 
— 
(1,457) 
— 
(406,289) 

— 
— 
— 
— 
784,875 
(369,064) 
— 
— 
(424) 
(350,058) 

12,536 
77,865 
(28,984) 
148,203 
119,219 

3,296 
(375) 

72 
318 
7,865 

$ 

$ 
$ 

$ 
$ 
$ 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HALOZYME THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)

Common Stock

Shares

Amount

Additional
Paid-In
Capital

Accumulated
Other
Comprehensive
Income (Loss)

 Retained 
Earnings 
(Accumulated
Deficit)

Total
Stockholders’
Equity

BALANCE AS OF DECEMBER 31, 2020    . . . . .

135,030 

$ 

135 

$  625,483  $ 

22  $ 

(474,593)  $ 

151,047 

Cumulative adjustment from adoption of ASU 
2020-06     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Share-based compensation expense       . . . . . . . . . . .

Issuance of common stock for the induced 
conversion of 2024 Convertible Notes       . . . . . . . . .
Issuance of common stock pursuant to exercise of 
stock options and vesting of restricted stock and 
performance stock units, net and shares issued 
under the ESPP plan      . . . . . . . . . . . . . . . . . . . . . . .

Repurchase of common stock      . . . . . . . . . . . . . . . .

Other comprehensive loss    . . . . . . . . . . . . . . . . . . .

Net income    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 

— 

9,083 

1,497 

(8,112) 

— 

— 

BALANCE AS OF DECEMBER 31, 2021    . . . . .

137,498 

Share-based compensation expense       . . . . . . . . . . .

— 

Issuance of common stock for the induced 
conversion of 2024 Convertible Notes       . . . . . . . . .

Issuance of common stock pursuant to exercise of 
stock options and vesting of restricted stock and 
performance stock units, net and shares issued 
under the ESPP plan      . . . . . . . . . . . . . . . . . . . . . . .

1,512 

1,077 

Capped call transaction    . . . . . . . . . . . . . . . . . . . . .

— 

Repurchase of common stock      . . . . . . . . . . . . . . . .

(4,933) 

Other comprehensive loss    . . . . . . . . . . . . . . . . . . .

Net income    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 

— 

BALANCE AS OF DECEMBER 31, 2022    . . . . .

135,154 

Share-based compensation expense       . . . . . . . . . . .
Issuance of common stock for the conversion of 
2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . .

Issuance of common stock pursuant to exercise of 
stock options and vesting of restricted stock and 
performance stock units, net and shares issued 
under the ESPP plan      . . . . . . . . . . . . . . . . . . . . . . .

— 

289 

— 

— 

9 

2 

(8) 

— 

— 

138 

— 

1 

1 

— 

(5) 

— 

— 

135 

— 

— 

(65,535) 

20,820 

13,095 

12,534 

(350,050) 

— 

— 

256,347 

24,397 

1,692 

14,049 

(69,120) 

(199,997) 

— 

— 

27,368 

36,620 

(126) 

— 

— 

— 

— 

(642) 

— 

(620) 

— 

— 

— 

— 

(302) 

— 

12,971 

— 

— 

— 

— 

402,710 

(58,912) 

— 

— 

— 

— 

— 

(52,564) 

20,820 

13,104 

12,536 

(350,058) 

(642) 

402,710 

196,953 

24,397 

1,693 

14,050 

(69,120) 

(200,002) 

(302) 

202,129 

202,129 

(922) 

143,217 

— 

— 

— 

— 

— 

— 

169,798 

36,620 

(126) 

7,879 

945 

2 

7,877 

Repurchase of common stock      . . . . . . . . . . . . . . . .

(9,618) 

(10) 

(69,330) 

(334,261) 

(403,601) 

Other comprehensive income       . . . . . . . . . . . . . . . .

Net income    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 

— 

— 

— 

— 

— 

(8,356) 

— 

(8,356) 

— 

281,594 

281,594 

BALANCE AS OF DECEMBER 31, 2023    . . . . .

126,770 

$ 

127 

$ 

2,409  $ 

(9,278)  $ 

90,550 

$ 

83,808 

See accompanying notes to consolidated financial statements.

F-7

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements

1. Organization and Business 

Halozyme  Therapeutics,  Inc.  is  a  biopharmaceutical  company  advancing  disruptive  solutions  to  improve  patient 

experiences and outcomes for emerging and established therapies.

As the innovators of ENHANZE ® drug delivery technology (“ENHANZE”) with our proprietary enzyme, rHuPH20, our 
commercially validated solution is used to facilitate the subcutaneous (“SC”) delivery of injected drugs and fluids with the goal 
of  reducing  the  treatment  burden  for  patients.  We  license  our  technology  to  biopharmaceutical  companies  to  collaboratively 
develop  products  that  combine  ENHANZE®  with  our  partners’  proprietary  compounds.  We  also  develop,  manufacture  and 
commercialize,  for  ourselves  or  with  our  partners,  drug-device  combination  products  using  our  advanced  auto-injector 
technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and 
tolerability, and enhanced patient comfort and adherence.

Our  ENHANZE  partners’  approved  products  and  product  candidates  are  based  on  rHuPH20,  our  patented  recombinant 
human hyaluronidase enzyme. rHuPH20 works by breaking down hyaluronan (“HA”), a naturally occurring carbohydrate that 
is  a  major  component  of  the  extracellular  matrix  of  the  SC  space.  This  temporarily  reduces  the  barrier  to  bulk  fluid  flow 
allowing  for  improved  and  more  rapid  SC  delivery  of  high  dose,  high  volume  injectable  biologics,  such  as  monoclonal 
antibodies and other large therapeutic molecules, as well as small molecules and fluids. We refer to the application of rHuPH20 
to facilitate the delivery of other drugs or fluids as ENHANZE. We license the ENHANZE technology to form collaborations 
with  biopharmaceutical  companies  that  develop  or  market  drugs  requiring  or  benefiting  from  injection  via  the  SC  route  of 
administration. In the development of proprietary intravenous (“IV”) drugs combined with our ENHANZE technology, data has 
been generated supporting the potential for ENHANZE to reduce patient treatment burden, as a result of shorter duration of SC 
administration  with  ENHANZE  compared  to  IV  administration.  ENHANZE  may  enable  fixed-dose  SC  dosing  compared  to 
weight-based dosing typically required for IV administration, extend the dosing interval for drugs that are already administered 
subcutaneously  and  potentially  allow  for  lower  rates  of  infusion-related  reactions.  ENHANZE  may  enable  more  flexible 
treatment  options  such  as  home  administration  by  a  healthcare  professional  or  potentially  the  patient  or  caregiver.  Lastly, 
certain proprietary drugs co-formulated with ENHANZE have been granted additional exclusivity, extending the patent life of 
the product beyond the patent expiry of the proprietary IV drug.

We currently have ENHANZE collaborations and licensing agreements with F. Hoffmann-La Roche, Ltd. and Hoffmann-
La  Roche,  Inc.  (“Roche”),  Takeda  Pharmaceuticals  International  AG  and  Baxalta  US  Inc.  (“Takeda”),  Pfizer  Inc.  (“Pfizer”), 
Janssen Biotech, Inc. (“Janssen”), AbbVie, Inc. (“AbbVie”), Eli Lilly and Company (“Lilly”), Bristol-Myers Squibb Company 
(“BMS”),  argenx  BVBA  (“argenx”),  ViiV  Healthcare  (the  global  specialist  HIV  Company  majority  owned  by 
GlaxoSmithKline)  (“ViiV”),  Chugai  Pharmaceutical  Co.,  Ltd  (“Chugai”)  and  Acumen  Pharmaceuticals,  Inc.  (“Acumen”).  In 
addition to receiving upfront licensing fees from our ENHANZE collaborations, we are entitled to receive event and sales-based 
milestone payments, revenues from the sale of bulk rHuPH20 and royalties from commercial sales of approved partner products 
co-formulated with ENHANZE. We currently earn royalties from four of these collaborations, including royalties from sales of 
one  product  from  the  Takeda  collaboration,  four  products  from  the  Roche  collaboration,  one  product  from  the  Janssen 
collaboration and one product from the argenx collaboration.

We  have  commercialized  auto-injector  products  with  several  pharmaceutical  companies  including  Teva  Pharmaceutical 
Industries, Ltd. (“Teva”) and Otter Pharmaceuticals, LLC (“Otter”). We have development programs including auto-injectors 
with Idorsia Pharmaceuticals Ltd. (“Idorsia”).

Our  commercial  portfolio  of  proprietary  products  includes  Hylenex®,  utilizing  rHuPH20,  and  our  specialty  product 

XYOSTED®, utilizing our auto-injector technology.

Except  where  specifically  noted  or  the  context  otherwise  requires,  references  to  “Halozyme,”  “the  Company,”  “we,” 
“our,” and “us” in these notes to consolidated financial statements refer to Halozyme Therapeutics, Inc. and each of its directly 
and indirectly wholly owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies.

F-8

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

2. Summary of Significant Accounting Policies

Basis of Presentation

The  consolidated  financial  statements  include  the  accounts  of  Halozyme  Therapeutics,  Inc.  and  our  wholly  owned 
subsidiaries, Halozyme, Inc. and Antares Pharma, Inc., and Antares Pharma, Inc.’s wholly owned Swiss subsidiaries, Antares 
Pharma IPL AG and Antares Pharma AG. All intercompany accounts and transactions have been eliminated. 

Use of Estimates

The  preparation  of  consolidated  financial  statements  in  conformity  with  U.S.  generally  accepted  accounting  principles 
(“U.S. GAAP”) requires us to make estimates and assumptions that affect the amounts reported in our consolidated financial 
statements  and  accompanying  notes.  On  an  ongoing  basis,  we  evaluate  our  estimates  and  judgments,  which  are  based  on 
historical  and  anticipated  results  and  trends  and  on  various  other  assumptions  that  we  believe  to  be  reasonable  under  the 
circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ 
from our estimates.

Cash Equivalents and Marketable Securities

Cash  equivalents  consist  of  highly  liquid  investments,  readily  convertible  to  cash,  which  mature  within  90  days  or  less 
from the date of purchase. As of December 31, 2023, our cash and cash equivalents consisted of money market funds, bank 
certificate of deposits, U.S. treasury securities and demand deposits at commercial banks.

Marketable  securities  are  investments  with  original  maturities  of  more  than  90  days  from  the  date  of  purchase  that  are 
specifically identified to fund current operations. Marketable securities are considered available-for-sale. These investments are 
classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date 
which  reflects  management’s  intention  to  use  the  proceeds  from  the  sale  of  these  investments  to  fund  our  operations,  as 
necessary.  Such  available-for-sale  investments  are  carried  at  fair  value  with  unrealized  gains  and  losses  recorded  in  other 
comprehensive income (loss) and included as a separate component of stockholders’ equity. The cost of marketable securities is 
adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in 
investment  and  other  income,  net  in  our  consolidated  statements  of  income.  We  use  the  specific  identification  method  for 
calculating realized gains and losses on marketable securities sold. None of the realized gains and losses and declines in value 
that were judged to be as a result of credit loss on marketable securities, if any, are included in investment and other income, net 
in our consolidated statements of income.

Restricted Cash

Under the lease terms of our facilities, we may be required to maintain letters of credit as security deposits during the 
terms of such leases. As of December 31, 2023, no restricted cash remained pledged as collateral for the letters of credit as the 
associated lease was terminated. As of December 31, 2022, restricted cash of $0.5 million was pledged as collateral for the 
letters of credit.

Fair Value of Financial Instruments

The authoritative guidance for fair value measurements establishes a three-tier fair value hierarchy, which prioritizes the 
inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active 
markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; 
and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its 
own assumptions. 

Our financial instruments include cash equivalents, available-for-sale marketable securities, accounts receivable, prepaid 
expenses and other assets, accounts payable, accrued expenses and long-term debt. Fair value estimates of these instruments are 
made at a specific point in time based on relevant market information. These estimates may be subjective in nature and involve 
uncertainties and matters of significant judgment and therefore, cannot be determined with precision. The carrying amount of 
cash equivalents, accounts receivable, prepaid expenses and other assets, accounts payable and accrued expenses are generally 
considered to be representative of their respective fair values because of the short-term nature of those instruments.

F-9

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Available-for-sale  marketable  securities  consist  of  asset-backed  securities,  corporate  debt  securities,  U.S.  Treasury 
securities,  agency  bonds  and  commercial  paper,  and  are  measured  at  fair  value  using  Level  1  and  Level  2  inputs.  Level  2 
financial  instruments  are  valued  using  market  prices  on  less  active  markets  and  proprietary  pricing  valuation  models  with 
observable  inputs,  including  interest  rates,  yield  curves,  maturity  dates,  issue  dates,  settlement  dates,  reported  trades,  broker-
dealer quotes, issue spreads, benchmark securities or other market related data. We obtain the fair value of Level 2 investments 
from our investment manager, who obtains these fair values from a third-party pricing source. We validate the fair values of 
Level  2  financial  instruments  provided  by  our  investment  manager  by  comparing  these  fair  values  to  a  third-party  pricing 
source.

Concentrations of Credit Risk, Sources of Supply and Significant Customers

We  are  subject  to  credit  risk  from  our  portfolio  of  cash  equivalents  and  marketable  securities.  These  investments  were 
made  in  accordance  with  our  investment  policy  which  specifies  the  categories,  allocations,  and  ratings  of  securities  we  may 
consider  for  investment.  The  primary  objective  of  our  investment  activities  is  to  preserve  principal  while  at  the  same  time 
maximizing  the  income  we  receive  without  significantly  increasing  risk.  We  maintain  our  cash  and  cash  equivalent  balances 
with  two  major  commercial  banks  and  marketable  securities  with  one  other  financial  institution.  Deposits  held  with  the 
financial institutions exceed the amount of insurance provided on such deposits. We are exposed to credit risk in the event of a 
default by the financial institutions holding our cash, cash equivalents and marketable securities to the extent recorded on the 
consolidated balance sheets. 

We are also subject to credit risk from our accounts receivable related to our product sales and revenues under our license 
and collaborative agreements. We have license and collaborative agreements with pharmaceutical companies under which we 
receive  payments  for  royalties,  license  fees,  milestone  payments  for  specific  achievements  designated  in  the  collaborative 
agreements, reimbursements of research and development services and supply of bulk formulation of rHuPH20. In addition, we 
sell  proprietary  products  in  the  United  States  (“U.S.”)  to  a  limited  number  of  established  wholesale  distributors  in  the 
pharmaceutical industry. Credit is extended based on an evaluation of the customer’s financial condition, and collateral is not 
required.  Management  monitors  our  exposure  to  accounts  receivable  by  periodically  evaluating  the  collectability  of  the 
accounts receivable based on a variety of factors including the length of time the receivables are past due, the financial health of 
the customer and historical experience. Based upon the review of these factors, we recorded no allowance for doubtful accounts 
as of December 31, 2023 and 2022. Approximately 69% of the accounts receivable balance as of December 31, 2023 represents 
amounts due from Janssen, Roche and Teva. Approximately 52% of the accounts receivable balance as of December 31, 2022 
represents amounts due from Janssen and Roche. 

The following table indicates the percentage of total revenues in excess of 10% with any single customer:

Partner A      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Partner B     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Partner C     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Partner D      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Year Ended December 31,

2023
44%
19%
10%
—%

2022
46%
20%
—%
—%

2021
48%
25%
—%
10%

We attribute revenues under collaborative agreements, including royalties, to the individual countries where the customer 
is  headquartered.  We  attribute  revenues  from  product  sales  to  the  individual  countries  to  which  the  product  is  shipped. 
Worldwide revenues from external customers are summarized by geographic location in the following table (in thousands):

Year Ended December 31,

2023

2022

2021

United States      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

587,196  $ 

437,989  $ 

Switzerland        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

149,024 

166,836 

Belgium      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Japan       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

All other foreign   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

58,354 

15,096 

19,583 

2,088 

47,939 

5,264 

293,089 

134,117 

199 

11,934 

3,971 

Total revenues     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

829,253  $ 

660,116  $ 

443,310 

F-10

 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Accounts Receivable, net

Accounts receivable is recorded at the invoiced amount and is non-interest bearing. Accounts receivable is recorded net of 
cash discounts for prompt payment, distribution fees and chargebacks. We recorded no allowance for doubtful accounts as of 
December 31, 2023 and 2022 as the collectability of accounts receivable was reasonably assured.

Inventories

Inventories are stated at lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable 
value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, 
and transportation. Inventories are reviewed periodically for potential excess, dated or obsolete status. We evaluate the carrying 
value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to 
quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the 
remaining shelf life of goods on hand.

Leases

We  have  entered  into  operating  leases  primarily  for  real  estate  and  automobiles.  These  leases  have  contractual  terms 
which  range  from  3  years  to  12  years.  We  determine  if  an  arrangement  contains  a  lease  at  inception.  Right  of  use  (“ROU”) 
assets and liabilities resulting from operating leases are included in property and equipment, accrued expenses and other long-
term  liabilities  on  our  consolidated  balance  sheets.  Operating  lease  ROU  assets  and  liabilities  are  recognized  based  on  the 
present value of the future minimum lease payments over the lease term at commencement date. As most of our leases do not 
provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date in 
determining the discount rate to calculate the present value of future payments. The operating lease ROU asset also includes 
any  lease  payments  made  and  excludes  lease  incentives  and  initial  direct  costs  incurred.  Our  leases  often  include  options  to 
extend or terminate the lease. These options are included in the lease term when it is reasonably certain that we will exercise 
that option. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense for 
minimum lease payments is recognized on a straight-line basis over the lease term. 

We have lease agreements with lease and non-lease components, which are generally accounted for separately. For certain 

leases, such as automobiles, we account for the lease and non-lease components as a single lease component. 

Property and Equipment, Net

Property  and  equipment,  including  ROU  assets  are  recorded  at  cost,  less  accumulated  depreciation  and  amortization. 
Equipment is depreciated using the straight-line method over its estimated useful life ranging from three years to ten years and 
leasehold  improvements  are  amortized  using  the  straight-line  method  over  the  estimated  useful  life  of  the  asset  or  the  lease 
term, whichever is shorter. 

Impairment of Long-Lived Assets

We  account  for  long-lived  assets  in  accordance  with  authoritative  guidance  for  impairment  or  disposal  of  long-lived 
assets. Long-lived assets are reviewed for events or changes in circumstances, which indicate that their carrying value may not 
be recoverable. 

Comprehensive Income

Comprehensive  income  is  defined  as  the  change  in  equity  during  the  period  from  transactions  and  other  events  and 

circumstances from non-owner sources.

Convertible Notes

The 2024 Convertible Notes, the 2027 Convertible Notes and the 2028 Convertible Notes (collectively, the “Convertible 
Notes”)  are  accounted  for  in  accordance  with  authoritative  guidance  for  debt  and  derivatives.  We  evaluate  all  the  embedded 
conversion options contained in the Convertible Notes to determine if there are embedded features that require bifurcation as a 
derivative as required by U.S. GAAP. Based on our analysis, we account for each of our Convertible Notes as single units of 
accounting,  a  liability,  because  we  concluded  that  the  conversion  features  do  not  require  bifurcation  as  a  derivative  under 
embedded derivative authoritative guidance.

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Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Cash Flow Hedges - Currency Risks

Beginning  in  the  second  quarter  of  2023,  we  entered  into  a  cash  flow  hedging  program  to  mitigate  foreign  currency 
exchange risk associated with forecasted royalty revenue denominated in Swiss francs. Under the program, we can hedge these 
forecasted royalties up to a maximum of four years into the future. We hedge these cash flow exposures to reduce the risk of 
our earnings and cash flows being adversely affected by fluctuations in exchange rates.

In accordance with the hedge accounting treatment, all hedging relationships are formally documented at the inception of 
the hedge and are highly effective in offsetting changes to future cash flows on hedged transactions. Both at inception of the 
hedge  and  on  an  ongoing  basis,  we  assess  whether  the  foreign  currency  forward  contracts  are  highly  effective  in  offsetting 
changes in cash flows of hedged items on a prospective and retrospective basis. If we determine a (i) foreign currency forward 
contract is not highly effective as a cash flow hedge, (ii) foreign currency forward contract has ceased to be a highly effective 
hedge  or  (iii)  forecasted  transaction  is  no  longer  probable  of  occurring,  we  would  discontinue  hedge  accounting  treatment 
prospectively. We measure effectiveness based on the change in fair value of the forward currency forward contract and the fair 
value of the hypothetical foreign currency forward contract with terms that match the critical terms of the risk being hedged. No 
portion  of  our  foreign  currency  forward  contracts  were  excluded  from  the  assessment  of  hedge  effectiveness.  As  of 
December 31, 2023, all hedges were determined to be highly effective. 

The  assets  or  liabilities  associated  with  our  hedging  contracts  are  recorded  at  fair  market  value  in  prepaid  expense  and 
other current assets, accrued expenses, or other long-term liabilities, respectively, in our consolidated balance sheets. Gains and 
losses related to changes in the fair market value of these hedging contracts are recorded as a component of accumulated other 
comprehensive  income  (loss)  (“AOCI”)  within  stockholder’s  equity  in  our  consolidated  balance  sheets  and  reclassified  to 
royalty  revenue  in  our  consolidated  statements  of  income  in  the  same  period  as  the  recognition  of  the  underlying  hedged 
transaction.  In  the  event  the  underlying  forecasted  transaction  does  not  occur,  or  it  becomes  probable  that  it  will  not  occur, 
within  the  defined  hedge  period,  we  reclassify  the  gains  or  losses  on  the  related  cash  flow  hedge  from  AOCI  to  royalties 
revenue in our consolidated statements of income. Settlements from the cash flow hedge are included in operating activities on 
the  Consolidated  Statements  of  Cash  Flows.  Since  the  fair  market  value  of  these  hedging  contracts  is  derived  from  current 
market rates, the hedging contracts are classified as derivative financial instruments. We do not use derivatives for speculative 
or  trading  purposes.  As  of  December  31,  2023,  amounts  expected  to  be  recognized  as  a  net  gain  out  of  AOCI  into  our 
consolidated statements of income during the next 12 months, are not material.

Business Combinations

Under the acquisition method of accounting, we allocate the fair value of the total consideration transferred to the tangible 
and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the date of acquisition. 
These  valuations  require  us  to  make  estimates  and  assumptions,  especially  with  respect  to  intangible  assets.  We  record  the 
excess consideration over the aggregate fair value of tangible and intangible assets, net of liabilities assumed, as goodwill. Costs 
incurred to complete a business combination, such as legal and other professional fees, are expensed as incurred.

If  the  initial  accounting  for  a  business  combination  is  incomplete  by  the  end  of  a  reporting  period  that  falls  within  the 
measurement period, we report provisional amounts in our financial statements. During the measurement period, we adjust the 
provisional amounts recognized at the acquisition date to reflect new information obtained about facts and circumstances that 
existed  as  of  the  acquisition  date  that,  if  known,  would  have  affected  the  measurement  of  the  amounts  recognized  as  of  that 
date.  We  record  these  adjustments  to  the  provisional  amounts  with  a  corresponding  offset  to  goodwill.  Any  adjustments 
identified after the measurement period are recorded in our consolidated statements of income.

Goodwill, Intangible Assets and Other Long-Lived Asset

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 during the second 
quarter, or 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 and operating 
segment  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  values  of  our  reporting  unit  is  less  than  the 

F-12

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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 our reporting unit is less than the carrying amounts, 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 exceeds 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  finite  useful  lives  are  typically  comprised  of  acquired  device  technologies  and 
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 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.

Revenue Recognition

We  generate  revenues  from  payments  received  (i)  as  royalties  from  licensing  our  ENHANZE  technology  and  other 
royalty  arrangements,  (ii)  under  collaborative  agreements  and  (iii)  from  sales  of  our  proprietary  and  partnered  products.  We 
recognize  revenue  when  we  transfer  promised  goods  or  services  to  customers  in  an  amount  that  reflects  the  consideration  to 
which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with 
customers,  we  perform  the  following  five  steps:  (i)  identify  the  promised  goods  or  services  in  the  contract;  (ii)  identify  the 
performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determine the 
transaction  price,  including  the  constraint  on  variable  consideration;  (iv)  allocate  the  transaction  price  to  the  performance 
obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations.

ENHANZE and Device Royalties

 Under the terms of our ENHANZE collaboration and license agreements, our partners will pay us royalties at an on average 
mid-single digit percent rate of their sales if products under the collaboration are commercialized. All amounts owed to us are 
noncancelable  after  the  underlying  triggering  event  occurs,  and  nonrefundable  once  paid.  Unless  terminated  earlier  in 
accordance  with  its  terms,  collaborations  generally  continue  in  effect  until  the  last  to  expire  royalty  payment  term,  as 
determined on a product by product and country by country basis, with each royalty term starting on the first commercial sale of 
that product and ending the later of: (i) a specified period or term set forth in the agreement or (ii) expiration of the last to expire 
of the valid claims of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid 
claim  covers  a  product  developed  under  the  collaboration.  In  general,  when  there  are  no  valid  claims  of  a  specified  patent 
developed  under  the  collaboration  covering  the  product  in  a  given  country,  the  royalty  rate  is  reduced  for  those  sales  in  that 
country upon the expiration of our patents covering rHuPH20. Janssen’s patents covering DARZALEX SC do not impact the 
timing for this royalty reduction. Partners may terminate the agreement prior to expiration for any reason in its entirety or on a 
target-by-target  basis  generally  upon  90  days  prior  written  notice  to  us.  Upon  any  such  termination,  the  license  granted  to 
partners (in total or with respect to the terminated target, as applicable) will terminate provided; however, that in the event of 
expiration of the agreement (as opposed to a termination), the on-going licenses granted will become perpetual, non-exclusive 
and fully paid. Sales-based milestones and royalties are recognized in the period the underlying sales or milestones occur. We 
do not receive final royalty reports from our ENHANZE partners until after we complete our financial statements for a prior 
quarter. Therefore, we recognize revenue based on estimates of the royalty earned, which are based on internal estimates and 
available preliminary reports provided by our partners. We will record adjustments in the following quarter, if necessary, when 
final royalty reports are received. To date, we have not recorded any material adjustments.

We  also  earn  royalties  in  connection  with  several  of  our  licenses  granted  under  license  and  development  arrangements 
with  our  device  partners.  These  royalties  are  based  upon  a  percentage  of  commercial  sales  of  partnered  products  with  rates 
ranging from mid-single digits to low double digits and are tiered based on levels of net sales. These sales-based royalties, for 
which the license was deemed the predominant element to which the royalties relate, are estimated and recognized in the period 
in which the partners’ commercial sales occur. The royalties are generally reported and payable to us within 45 to 60 days after 
the  end  of  the  period  in  which  the  commercial  sales  are  made.  We  base  our  estimates  of  royalties  earned  on  actual  sales 
information from our partners when available or estimated, prescription sales from external sources and estimated net selling 

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Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

price. We will record adjustments in the following quarter, if necessary, when final royalty reports are received. To date, we 
have not recorded any material adjustments.

Revenue under ENHANZE and Device Collaborative Agreements

ENHANZE Collaboration and License Agreements

Under these agreements, we grant the collaboration partner a worldwide license to develop and commercialize products 
using our ENHANZE technology to combine our patented rHuPH20 enzyme with their proprietary biologics directed at up to a 
specified number of targets. Targets are usually licensed on an exclusive, global basis. Targets selected subsequent to inception 
of  the  arrangement  generally  require  payment  of  an  additional  license  fee.  The  collaboration  partner  is  responsible  for  all 
development, manufacturing, clinical, regulatory, sales and marketing costs for any products developed under the agreement. 
We  are  responsible  for  supply  of  bulk  rHuPH20  based  on  the  collaboration  partner’s  purchase  orders,  and  may  also  be 
separately engaged to perform research and development services. While these collaboration agreements are similar in that they 
originate  from  the  same  framework,  each  one  is  the  result  of  an  arms-length  negotiation  and  thus  may  vary  from  one  to  the 
other.

We generally collect an upfront license payment from collaboration partners, and are also entitled to receive event-based 
payments  subject  to  collaboration  partners’  achievement  of  specified  development,  regulatory  and  sales-based  milestones.  In 
several  agreements,  collaboration  partners  pay  us  annual  fees  to  maintain  their  exclusive  license  rights  if  they  are  unable  to 
advance  product  development  to  specified  stages.  We  earn  separate  fees  for  bulk  rHuPH20  supplies  and  research  and 
development services.

Although these agreements are in form identified as collaborative agreements, we concluded for accounting purposes they 
represent contracts with customers and are not subject to accounting literature on collaborative arrangements. This is because 
we grant to partners licenses to our intellectual property and provide supply of bulk rHuPH20 and research and development 
services  which  are  all  outputs  of  our  ongoing  activities,  in  exchange  for  respective  consideration.  Under  these  collaborative 
agreements, our partners lead development of assets, and we do not share in significant financial risks of their development or 
commercialization activities. Accordingly, we concluded our collaborative agreements are appropriately accounted for pursuant 
to U.S. GAAP. 

Under all of our ENHANZE collaborative agreements, we have identified licenses to use functional intellectual property 
as the only performance obligation. The intellectual property underlying the license is our proprietary ENHANZE technology 
which represents application of rHuPH20 to facilitate delivery of drugs. Each of the licenses grants the partners rights to use our 
intellectual property as it exists and is identified on the effective date of the license, because there is no ongoing development of 
the  ENHANZE  technology  required.  Therefore,  we  recognize  revenue  from  licenses  at  the  point  when  the  license  becomes 
effective and the partner has received access to our intellectual property, usually at the inception of the agreement.

When  partners  can  select  additional  targets  to  add  to  the  licenses  granted,  we  consider  these  rights  to  be  options.  We 
evaluate whether such options contain material rights, i.e. have exercise prices that are discounted compared to what we would 
charge for a similar license to a new partner. The exercise price of these options includes a combination of the target selection 
fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds 
discounts  available  to  other  customers,  we  conclude  the  option  does  not  contain  a  material  right,  and  we  consider  grants  of 
additional licensing rights upon option exercises to be separate contracts (target selection contracts).

Generally, we provide indemnification and protection of licensed intellectual property for our customers. These provisions 
are part of assurance that the licenses meet the agreements’ representations and are not obligations to provide goods or services.

We also fulfill purchase orders for supply of bulk rHuPH20 and perform research and development services pursuant to 
projects authorization forms for our partners, which represent separate contracts. In addition to our licenses, we price our supply 
of bulk rHuPH20 and research and development services at our regular selling prices, called standalone selling prices (“SSP”). 
Therefore, our partners do not have material rights to order these items at prices not reflective of SSP. Refer to the discussion 
below regarding recognition of revenue for these separate contracts.

Transaction  price  for  a  contract  represents  the  amount  to  which  we  are  entitled  in  exchange  for  providing  goods  and 
services to the customer. Transaction price does not include amounts subject to uncertainties unless it is probable that there will 
be  no  significant  reversal  of  revenue  when  the  uncertainty  is  resolved.  Apart  from  the  upfront  license  payment  (or  target 
selection  fees  in  the  target  selection  contracts),  all  other  fees  we  may  earn  under  our  collaborative  agreements  are  subject  to 
significant  uncertainties  of  product  development.  Achievement  of  many  of  the  event-based  development  and  regulatory 
milestones  may  not  be  probable  until  such  milestones  are  actually  achieved.  This  generally  relates  to  milestones  such  as 
obtaining marketing authorization approvals. With respect to other development milestones, e.g., dosing of a first patient in a 
clinical  trial,  achievement  could  be  considered  probable  prior  to  its  actual  occurrence,  based  on  the  progress  towards 
commencement of the trial. In order to evaluate progress towards commencement of a trial, we assess the status of activities 

F-14

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

leading up to our partner’s initiation of a trial such as feedback received from the applicable regulatory authorities, completion 
of Investigational New Drug (“IND”) or equivalent filings, readiness and availability of drug, readiness of study sites and our 
partner’s commitment of resources to the program. We do not include any amounts subject to uncertainties in the transaction 
price  until  it  is  probable  that  the  amount  will  not  result  in  a  significant  reversal  of  revenue  in  the  future.  At  the  end  of  each 
reporting period, we re-evaluate the probability of achievement of such milestones and any related constraint, and if necessary, 
adjust our estimate of the overall transaction price.

When target exchange rights are held by partners, and the amounts attributed to these rights are not refundable, they are 
included  in  the  transaction  price.  However,  they  are  recorded  as  deferred  revenues  because  we  have  a  potential  performance 
obligation to provide a new target upon an exchange right being exercised. These amounts are recognized in revenue when the 
right of exchange expires or is exercised.

Because our agreements have one type of performance obligation (licenses) which are typically all transferred at the same 
time at agreement inception, allocation of transaction price often is not required. However, allocation is required when licenses 
for  some  of  the  individual  targets  are  subject  to  rights  of  exchange,  because  revenue  associated  with  these  targets  cannot  be 
recognized. When allocation is needed, we perform an allocation of the upfront amount based on relative SSP of licenses for 
individual targets. We determine license SSP using an income-based valuation approach utilizing risk-adjusted discounted cash 
flow projections of the estimated return a licensor would receive. When amounts subject to uncertainties, such as milestones 
and royalties, are included in the transaction price, we attribute them to the specific individual target licenses which generate 
such milestone or royalty amounts.

We also estimate SSP of bulk rHuPH20 and research and development services, to determine that our partners do not have 
material  rights  to  order  them  at  discounted  prices.  For  supplies  of  bulk  rHuPH20,  because  we  effectively  act  as  a  contract 
manufacturer to our partners, we estimate and charge SSP based on the typical contract manufacturer margins consistent with 
all of our partners. We determine SSP of research and development services based on a fully-burdened labor rate. Our rates are 
comparable to those we observe in other collaborative agreements. We also have a history of charging similar rates to all of our 
partners.

Upfront amounts allocated to licenses to individual targets are recognized as revenue when the license is transferred to the 
partner, as discussed above, if the license is not subject to exchange rights, or when the exchange right expires or is exercised. 
Development milestones and other fees are recognized in revenue when they are included in the transaction price, because by 
that time, we have already transferred the related license to the partner.

In contracts to provide research and development services, such services represent the only performance obligation. The 
fees are charged based on hours worked by our employees and the fixed contractual rate per hour, plus third-party pass-through 
costs,  on  a  monthly  basis.  We  recognize  revenues  as  the  related  services  are  performed  based  on  the  amounts  billed,  as  the 
partner consumes the benefit of research and development work simultaneously as we perform these services, and the amounts 
billed reflect the value of these services to the customer.

Device License, Development and Supply Arrangements

We  have  several  license,  development  and  supply  arrangements  with  pharmaceutical  partners,  under  which  we  grant  a 
license  to  our  device  technology  and  provide  research  and  development  services  that  often  involve  multiple  performance 
obligations and highly-customized deliverables. For such arrangements, we identify each of the promised goods and services 
within  the  contract  and  the  distinct  performance  obligations  at  inception  of  the  contract  and  allocate  consideration  to  each 
performance obligation based on relative SSP, which is generally determined based on the expected cost plus mark-up. 

If the contract includes an enforceable right to payment for performance completed to date and performance obligations 
are satisfied over time, we recognize revenue over the development period using either the input or output method depending on 
which  is  most  appropriate  given  the  nature  of  the  distinct  deliverable.  For  other  contracts  that  do  not  contain  an  enforceable 
right  to  payment  for  performance  completed  to  date,  revenue  is  recognized  when  control  of  the  product  is  transferred  to  the 
customer.  Factors  that  may  indicate  transfer  of  control  has  occurred  include  the  transfer  of  legal  title,  transfer  of  physical 
possession, the customer has obtained the significant risks and rewards of ownership of the assets, and we have a present right 
to payment. 

Our typical payment terms for development contracts may include an upfront payment equal to a percentage of the total 
contract value with the remaining portion to be billed upon completion and transfer of the individual deliverables or satisfaction 
of the individual performance obligations. We record a contract liability for cash received in advance of performance, which is 
presented  within  deferred  revenue  and  deferred  revenue,  long-term  in  our  consolidated  balance  sheets  and  recognized  as 
revenue in our consolidated statements of income when the associated performance obligations have been satisfied. 

License fees and milestones received in exchange for the grant of a license to our functional intellectual property, such as 
patented  technology  and  know-how  in  connection  with  a  partnered  development  arrangement,  are  generally  recognized  at 

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Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

inception  of  the  arrangement,  or  over  the  development  period  depending  on  the  facts  and  circumstances,  as  the  license  is 
generally not distinct from the non-licensed goods or services to be provided under the contract. Milestone payments that are 
contingent upon the occurrence of future events are evaluated and recorded at the most likely amount, and to the extent that it is 
probable that a significant reversal of revenue will not occur when the associated uncertainty is resolved.

Refer to Note 5, Revenue, for further discussion on our collaborative arrangements.

Product Sales, Net

Proprietary Product Sales

Our commercial portfolio of proprietary products includes XYOSTED and Hylenex recombinant which we sell primarily 
to wholesale pharmaceutical distributors and specialty pharmacies, who sell the products to hospitals, retail chain drug stores 
and  other  end-user  customers.  Sales  to  wholesalers  are  made  pursuant  to  purchase  orders  subject  to  the  terms  of  a  master 
agreement, and delivery of individual packages of products represents performance obligations under each purchase order. We 
use contract manufacturers to produce our proprietary products and third-party logistics (“3PL”) vendors to process and fulfill 
orders. We concluded we are the principal in the sales to wholesalers because we control access to services rendered by both 
vendors and direct their activities. We have no significant obligations to wholesalers to generate pull-through sales.

Revenue is recognized when control has transferred to the customer, which is typically upon delivery, at the net selling 
price, which reflects the variable consideration for which reserves and sales allowances are established for estimated returns, 
wholesale  distribution  fees,  prompt  payment  discounts,  government  rebates  and  chargebacks,  plan  rebate  arrangements  and 
patient  discount  and  support  programs.  We  recognize  revenue  from  product  sales  and  related  cost  of  sales  upon  product 
delivery to the wholesaler location. At that time, the wholesalers take control of the product as they take title, bear the risk of 
loss of ownership, and have an enforceable obligation to pay us. They also have the ability to direct sales of product to their 
customers on terms and at prices they negotiate. Although wholesalers have product return rights, we do not believe they have a 
significant incentive to return the product to us.

The determination of certain reserves and sales allowances requires us to make a number of judgements and estimates to 
reflect our best estimate of the transaction price and the amount of consideration to which we believe we would be ultimately 
entitled to receive. The expected value is determined based on unit sales data, contractual terms with customers and third-party 
payers, historical and estimated future percentage of rebates incurred on sales, historical and future insurance plan billings, any 
new or anticipated changes in programs or regulations that would impact the amount of the actual rebates, customer purchasing 
patterns,  product  expiration  dates  and  levels  of  inventory  in  the  distribution  channel.  The  estimated  amounts  of  credit  for 
product returns, chargebacks, distribution fees, prompt payment discounts, rebates and customer co-pay support programs are 
included in accrued expenses and accounts receivable, net in our consolidated balance sheets upon recognition of revenue from 
product  sales.  We  monitor  actual  product  returns,  chargebacks,  discounts  and  fees  subsequent  to  the  sale.  If  these  amounts 
differ  from  our  estimates,  we  make  adjustments  to  these  allowances,  which  are  applied  to  increase  or  reduce  product  sales 
revenue and earnings in the period of adjustment.

Selling  prices  initially  billed  to  wholesalers  are  subject  to  discounts  for  prompt  payment  and  subsequent  chargebacks 
when  wholesalers  sell  our  products  at  negotiated  discounted  prices  to  members  of  certain  group  purchasing  organizations 
(“GPOs”), Pharmacy Benefit Managers (“PBMs”) and government programs. We also pay quarterly distribution fees to certain 
wholesalers for inventory reporting and chargeback processing, and to PBMs and GPOs as administrative fees for services and 
for access to their members. We concluded the benefits received in exchange for these fees are not distinct from our sales of our 
products, and accordingly we apply these amounts to reduce revenues. Wholesalers also have rights to return unsold product 
nearing  or  past  the  expiration  date.  Because  of  the  shelf  life  of  our  products  and  our  lengthy  return  period,  there  may  be  a 
significant period of time between when the product is shipped and when we issue credits on returned product.

We estimate the transaction price when we receive each purchase order taking into account the expected reductions of the 
selling price initially billed to the wholesaler arising from all of the above factors. We have compiled historical experience and 
data to estimate future returns and chargebacks of our products and the impact of the other discounts and fees we pay. When 
estimating these adjustments to the transaction price, we reduce it sufficiently to be able to assert that it is probable that there 
will be no significant reversal of revenue when the ultimate adjustment amounts are known.

Each  purchase  order  contains  only  one  type  of  product,  and  is  usually  shipped  to  the  wholesaler  in  a  single  shipment. 

Therefore, allocation of the transaction price to individual packages is not required.

In  connection  with  the  orders  placed  by  wholesalers,  we  incur  costs  such  as  commissions  to  our  sales  representatives. 
However, as revenue from product sales is recognized upon delivery to the wholesaler, which occurs shortly after we receive a 
purchase order, we do not capitalize these commissions and other costs, based on application of the practical expedient allowed 
within the applicable guidance.

F-16

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Partnered Product Sales

Bulk rHuPH20 

We sell bulk rHuPH20 to partners for use in research and development and, subsequent to receiving marketing approval, 
we sell it for use in collaboration commercial products. Sales are made pursuant to purchase orders subject to the terms of the 
collaborative agreement or a supply agreement, and delivery of units of bulk rHuPH20 represent performance obligations under 
each  purchase  order.  We  provide  a  standard  warranty  that  the  product  conforms  to  specifications.  We  use  contract 
manufacturers to produce bulk rHuPH20 and have concluded we are the principal in the sales to partners. The transaction price 
for each purchase order of bulk rHuPH20 is fixed based on the cost of production plus a contractual markup, and is not subject 
to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each 
order contains only one type of product.

We recognize revenue from the sale of bulk rHuPH20 as product sales and related cost of sales upon transfer of title to our 
partners.  At  that  time,  the  partners  take  control  of  the  product,  bear  the  risk  of  loss  of  ownership,  and  have  an  enforceable 
obligation to pay us.

Devices

We are party to several license, development, supply and distribution arrangements with pharmaceutical partners, under 
which we produce and are the exclusive supplier of certain products, devices and/or components. Revenue is recognized when 
or as control of the goods transfers to the customer as discussed below.

We are the exclusive supplier of OTREXUP® to Otter. Because this product is custom manufactured with no alternative 
use and we have a contractual right to payment for performance completed to date, control is continuously transferred to the 
customer as the product is produced pursuant to firm purchase orders. Revenue is recognized over time using the output method 
based on the contractual selling price and number of units produced. The amount of revenue recognized in excess of the amount 
shipped/billed to the customer, if any, is recorded as contract assets in our consolidated balance sheets due to the short-term 
nature in which the amount is ultimately expected to be billed and collected from the customer.

All other device partnered product sales are recognized at the point in time in which control is transferred to the customer, 
which is typically upon shipment. Sales terms and pricing are governed by the respective supply and distribution agreements, 
and there is generally no right of return. Revenue is recognized at the transaction price, which includes the contractual per unit 
selling price and estimated variable consideration, such as volume-based pricing arrangements or profit-sharing arrangements, 
if any. We recognize revenue, including the estimated variable consideration we expect to receive for contract margin on future 
commercial sales, upon shipment of the goods to our partner. The estimated variable consideration is recognized at an amount 
we  believe  is  not  subject  to  significant  reversal  of  revenue  based  on  historical  experience  and  is  adjusted  at  each  reporting 
period if the most likely amount of expected consideration changes or becomes fixed.

Revenue Presentation

In  our  consolidated  statements  of  income,  we  report  the  upfront  payments,  event-based  development  and  regulatory 
milestones and sales milestones as revenues under collaborative agreements. We also include in this category revenues from 
separate research and development contracts pursuant to project authorization forms. We report royalties received from partners 
as a separate line in our consolidated statements of income.

Revenues  from  sales  of  our  proprietary  and  partnered  products  are  included  in  product  sales,  net  in  our  consolidated 

statements of income.

In  the  footnotes  to  our  consolidated  financial  statements,  we  provide  disaggregated  revenue  information  by  type  of 
arrangement (royalties; product sales, net; and collaborative agreements), and additionally, by type of payment stream received 
under collaborative agreements (upfront license and target nomination fees; event-based development and regulatory milestones 
and other fees; sales-based milestones; and device licensing and development revenue).

Cost of Sales

Cost  of  sales  consists  primarily  of  raw  materials,  third-party  manufacturing  costs,  fill  and  finish  costs,  freight  costs, 
internal costs and manufacturing overhead associated with the production of proprietary and partnered products. Cost of sales 
also  consists  of  the  write-down  of  excess,  dated  and  obsolete  inventories  and  the  write-off  of  inventories  that  do  not  meet 
certain product specifications, if any. 

F-17

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Research and Development Expenses

Research  and  development  expenses  include  salaries  and  benefits,  allocation  of  facilities  and  other  overhead  expenses, 
research related manufacturing services, contract services, and other outside expenses related to manufacturing, preclinical and 
regulatory  activities  and  our  partner  development  platforms.  Research  and  development  expenses  are  charged  to  operating 
expenses  as  incurred  when  these  expenditures  relate  to  our  research  and  development  efforts  and  have  no  alternative  future 
uses. 

We  are  obligated  to  make  upfront  payments  upon  execution  of  certain  research  and  development  agreements.  Advance 
payments,  including  nonrefundable  amounts,  for  goods  or  services  that  will  be  used  or  rendered  for  future  research  and 
development activities are deferred. Such amounts are recognized as expense as the related goods are delivered or the related 
services are performed or such time when we do not expect the goods to be delivered or services to be performed.

Share-Based Compensation

We record compensation expense associated with stock options, restricted stock units (“RSUs”), performance stock units 
(“PSUs”) and shares issued under our employee stock purchase plan (“ESPP”) in accordance with the authoritative guidance for 
share-based  compensation.  The  cost  of  employee  services  received  in  exchange  for  an  award  of  an  equity  instrument  is 
measured at the grant date, based on the estimated fair value of the award, and is recognized as expense on a straight-line basis 
over the requisite service period of the award. Share-based compensation expense for an award with a performance condition is 
recognized  when  the  achievement  of  such  performance  condition  is  determined  to  be  probable.  If  the  outcome  of  such 
performance  condition  is  not  determined  to  be  probable  or  is  not  met,  no  compensation  expense  is  recognized  and  any 
previously recognized compensation expense is reversed. Forfeitures are recognized as a reduction of share-based compensation 
expense as they occur.

Income Taxes 

We provide for income taxes using the liability method. Under this method, deferred income tax assets and liabilities are 
determined based on the differences between the financial statement carrying amounts of existing assets and liabilities and their 
respective tax bases at each reporting period. We measure deferred tax assets and liabilities using enacted tax rates for the year 
in which the differences are expected to reverse. Significant judgment is required by management to determine our provision 
for  income  taxes,  our  deferred  tax  assets  and  liabilities,  and  any  associated  valuation  allowances  recorded  against  our  net 
deferred  tax  assets,  which  are  based  on  complex  and  evolving  tax  regulations.  Deferred  tax  assets  (“DTA”)  and  other  tax 
benefits are recorded when they are more likely than not to be realized. On a quarterly basis, we assess the need for valuation 
allowance on our DTAs, weighing all positive and negative evidence, to assess if it is more-likely-than-not that some or all of 
our DTAs will be realized. 

 Segment Information

We operate our business in one operating segment, which includes all activities related to the research, development and 
commercialization  of  our  proprietary  enzymes  and  devices.  This  segment  also  includes  revenues  and  expenses  related  to 
(i) research and development and manufacturing activities conducted under our collaborative agreements with third parties, and 
(ii) product sales of proprietary and partnered products. The chief operating decision-maker (“CODM”), our Chief Executive 
Officer (“CEO”), reviews the operating results on an aggregate basis and manages the operations as a single operating segment.

F-18

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Adoption and Pending Adoption of Recent Accounting Pronouncements

The  following  table  provides  a  brief  description  of  recently  issued  accounting  standards,  those  adopted  in  the  current 

period and those not yet adopted:

Standard
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.

Description
The new standard is intended 
to improve annual and 
interim reportable segment 
disclosure requirements 
regardless of number of 
reporting units, primarily 
through enhanced disclosures 
of significant expenses. The 
amendment requires public 
entities to disclose significant 
segment expenses that are 
regularly provided to the 
CODM and included within 
each reported measure of 
segment profit and loss.

In December 2023, 
the FASB issued 
ASU 2023-09, 
Income Taxes (Topic 
740): Improvements 
to Income Tax 
Disclosures.

The new guidance includes 
amendments that further 
enhance income tax 
disclosures, primarily 
through standardization and 
disaggregation of rate 
reconciliation categories and 
income taxes paid by 
jurisdiction.

Effective Date
Annual periods 
beginning after 
December 15, 
2023 (our 2024 
Form 10-K), and 
interim periods 
within fiscal 
years beginning 
after December 
15, 2024 (our Q1 
2025 Form 10-
Q) - Early 
adoption is 
permitted, 
including 
adoption in an 
interim period

Annual periods 
beginning after 
December 15, 
2024 (our 2025 
Form 10-K) - 
Early adoption is 
permitted

Adoption 
Method

Effect on the Financial 
Statements or Other 
Significant Matters

Retrospective We are currently 

evaluating the impact of 
the standard on our 
consolidated financial 
statements and related 
disclosures.

Prospective 
or 
Retrospective

We are currently 
evaluating the impact of 
the standard on our 
consolidated financial 
statements and related 
disclosures.

F-19

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

3.  Business Combination

On May 24, 2022, we acquired all outstanding equity interests of Antares Pharma, Inc. (“Antares”) according to the terms 
and  conditions  of  the  Agreement  and  Plan  of  Merger,  dated  as  of  April  12,  2022  (the  “Merger  Agreement”).  Antares  is  a 
specialty  pharmaceutical  company  focused  primarily  on  the  development  and  commercialization  of  pharmaceutical  products 
and  technologies  that  address  patient  needs  in  targeted  therapeutic  areas.  We  acquired  Antares  as  a  part  of  our  strategy  to 
expand as a drug delivery company and include specialty products.

The  total  purchase  consideration  of  Antares  was  $1,045.7  million.  Each  share  of  Antares  common  stock  issued  and 
outstanding  was  converted  into  the  right  to  receive  $5.60  in  cash  without  interest,  less  any  applicable  withholding  taxes 
(“Merger Consideration”). Additionally, in connection with the transaction, each Antares equity award granted and outstanding 
as of May 24, 2022 under the Antares’ equity compensation plans was converted into the right to receive Merger Consideration. 
Other components of purchase consideration include cash paid at closing to settle Antares’ existing debt of $19.7 million and 
seller transaction costs paid by us on behalf of Antares of $22.9 million. 

The  acquisition  of  Antares  was  funded  by  cash  on  hand  and  borrowings  under  the  new  credit  agreement  with  Bank  of 
America, N.A. (“BofA”) and other lenders that provides for (i) a $350 million revolving credit facility (the “Revolving Credit 
Facility”)  and  (ii)  a  $250  million  term  loan  facility  (the  “Term  Facility”,  collectively  with  the  Revolving  Credit  Facility,  the 
“2022 Facility”) as described in Note 8, Long-term Debt, Net. We recognized transaction costs of $21.9 million in the twelve 
months ended December 31, 2022. These costs are reported in selling, general and administrative expenses in our consolidated 
statements  of  income.  Transaction  costs  include,  but  are  not  limited  to,  investment  banker,  advisory,  legal,  and  other 
professional fees.

Purchase Consideration

The total purchase consideration was comprised of the following (in thousands):

Cash consideration for Antares shares outstanding as of May 24, 2022     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $  956,886 
45,828 
Consideration for Antares equity compensation awards (a)     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
22,906 
Consideration for seller transaction costs paid by Halozyme      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19,683 
Consideration related to Antares closing indebtedness settled by Halozyme       . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash consideration related to cash bonus awards paid by Halozyme    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
365 
Total purchase consideration      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 1,045,668 

(a) Consideration for Antares equity compensation awards consists of $32.2 million paid for vested equity awards as well as $13.6 million paid for the pre-
combination portion of unvested equity awards that were accelerated as part of the Merger Agreement. The fair value of the unvested equity awards attributable 
to the post-combination period of $8.7 million is included in our consolidated statements of income during the year ended December 31, 2022.

Fair Value of Assets Acquired and Liabilities Assumed

The  acquisition  of  Antares  has  been  accounted  for  using  the  acquisition  method  of  accounting  in  accordance  with 
authoritative  guidance  for  business  combinations,  with  Halozyme  treated  as  the  accounting  acquirer,  which  requires,  among 
other things, that the assets acquired and liabilities assumed be recognized at their fair value on the acquisition date.

The table below presents the estimated fair values of assets acquired and liabilities assumed on the acquisition date based 
on valuations and management estimates (in thousands). Fair value estimates are based on a complex series of judgments about 
future events and uncertainties and rely heavily on estimates and assumptions. The judgments used to determine the estimated 
fair  value  assigned  to  each  class  of  assets  acquired  and  liabilities  assumed,  as  well  as  asset  lives,  can  materially  impact  our 
results of operations.

F-20

 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Amounts 
recognized as of 
12/31/2022

Total purchase consideration, net of $46,548 cash acquired    . . . . . . . $ 
Assets
Short-term investments    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts receivable, net      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventories, net      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other assets     . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment, net        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intangibles, net    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Liabilities
Accounts Payable     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued expenses    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue, current portion    . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue, net of current portion      . . . . . . . . . . . . . . . . . . . . . .
Deferred tax liabilities, net       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long-term liabilities   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net assets acquired, excluding goodwill         . . . . . . . . . . . . . . . . . . . . . .
Goodwill      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

999,120 

498 
82,160 
28,068 
5,241 
28,661 
589,800 

7,197 
41,654 
2,509 
1,207 
71,002 
20,788 
590,071 
409,049 

Measurement 
period adjustment
— 
$ 

Amounts 
recognized as of 
12/31/2023 (as 
adjusted )

$ 

999,120 

— 
(200) 
— 
— 
— 
— 

— 
2,038 
— 
— 
5,534 
— 
(7,772) 
7,772 

$ 

498 
81,960 
28,068 
5,241 
28,661 
589,800 

7,197 
43,692 
2,509 
1,207 
76,536 
20,788 
582,299 
416,821 

$ 

Goodwill is the excess of the consideration transferred over the net assets recognized and represents the expected revenue 
and cost synergies of the combined company and assembled workforce. Goodwill was allocated entirely to the single reportable 
unit. Goodwill recognized as a result of the acquisition is not deductible for tax purposes.

In  the  first  six  months  of  2023,  we  recorded  measurement  period  adjustments  to  increase  accrued  expenses  by 
$2.0 million, increase deferred tax liabilities by $5.5 million and reduce accounts receivable by $0.2 million. The measurement 
period adjustments were recorded to reflect facts and circumstances that existed as of the acquisition date. During the second 
quarter of 2023, we finalized the estimates impacting the allocation of the purchase price consideration.

Identifiable Intangible Assets

The  estimated  fair  values  of  identifiable  intangible  assets  were  prepared  using  the  excess  earnings  method  which 
calculates the present value of the incremental after-tax cash flows attributable solely to each intangible asset. The estimated 
useful  lives  are  based  on  forecasted  periods  of  benefit  for  each  intangible  asset  which  consider  commercialization  dates,  the 
estimated  revenue  cycle  based  on  the  products’  competitiveness  in  the  market,  and  the  loss  of  exclusivity  timing  with 
subsequent trending down of revenue. For the ATRS-1902 IPR&D, the useful life is considered indefinite as the asset has not 
been placed into service. As such, the ATRS-1902 IPR&D will be tested annually for impairment and will not be amortized. 
Useful lives and final values are presented in the table below.

Auto-Injector technology platform        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
XYOSTED proprietary product      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TLANDO product rights     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ATRS-1902 (IPR&D)    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fair value of intangible assets acquired    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

402,000 
136,200 
2,900 
48,700 
589,800 

Amount (in 
thousands)

Useful life 
(years)
7
10
10
Indefinite

F-21

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Unaudited Pro Forma Results

Our  prior  year  consolidated  financial  statements  include  Antares’  results  of  operations  from  the  date  of  acquisition  on 
May 24, 2022 through December 31, 2022. Total revenues and net loss after taxes attributable to Antares during this period and 
included  in  our  consolidated  financial  statements  for  the  twelve  months  ended  December  31,  2022  total  $112.7  million  and 
$67.6 million, respectively.

The  following  unaudited  pro  forma  financial  information  summarizes  combined  results  of  operations  of  Halozyme  and 

Antares as if the companies had been combined as of the beginning of our fiscal year 2021 (in thousands).

Twelve Months Ended 
December 31,

2022

2021

Total revenues       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 712,683  $ 627,292 

Net income     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  218,723 

  295,634 

The  unaudited  pro  forma  financial  information  for  all  periods  presented  includes  the  business  combination  accounting 
effects resulting from this acquisition. The unaudited pro forma results include adjustments to reflect the amortization of the 
inventory step-up and the incremental intangible asset amortization to be incurred based on preliminary valuations of assets as 
well  as  certain  material  non-recurring  transaction  adjustments  related  to  the  acquisition.  Adjustments  to  interest  expense, 
financing costs and investment income were made to reflect the capital structure of the combined entity. Adjustments to income 
tax  expense  also  were  made  to  reflect  the  anticipated  effective  tax  rate  of  the  combined  entity.  The  unaudited  pro  forma 
financial  information  as  presented  is  for  informational  purposes  only  and  is  not  necessarily  indicative  of  the  results  of 
operations  that  would  have  been  achieved  if  the  acquisition  had  taken  place  at  the  beginning  of  fiscal  year  2021,  nor  is  it 
necessarily an indication of trends in future results for a number of reasons, including, but not limited to, differences between 
the assumptions used to prepare the pro forma information, cost savings from operating efficiencies, potential synergies, and the 
impact of incremental costs incurred in integrating the businesses.

F-22

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

4.  Fair Value Measurement

Available-for-sale marketable securities consisted of the following (in thousands):

December 31, 2023

Amortized 
Cost

Gross 
Unrealized 
Gains

Gross 
Unrealized 
Losses

Estimated 
Fair Value

Asset-backed securities       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Corporate debt securities     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
U.S. treasury securities        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Agency bonds     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Commercial paper      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3,512  $ 
6,022 
175,996 
16,119 
15,826 

Total marketable securities, available-for-sale    . . . . . . . . . . . . $  217,475  $ 

—  $ 
1 
200 
— 
— 
201  $ 

3,504 
(8)  $ 
6,013 
(10)   
176,184 
(12)   
16,103 
(16)   
— 
15,826 
(46)  $  217,630 

December 31, 2022

Amortized 
Cost

Gross 
Unrealized 
Gains

Gross 
Unrealized 
Losses

Estimated 
Fair Value

Asset-backed securities       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

1,146  $ 

—  $ 

Corporate debt securities     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7,139 

U.S. treasury securities        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

111,469 

Agency bonds     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commercial paper      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2,783 

7,004 

— 

— 

2 

— 

—  $ 

(9)   

1,146 

7,130 

(934)   

110,535 

(1)   

— 

2,784 

7,004 

Total marketable securities, available-for-sale    . . . . . . . . . . . . $  129,541  $ 

2  $ 

(944)  $  128,599 

As of December 31, 2023, 20 available-for-sale marketable securities with a fair market value of $29.1 million were in a 
gross unrealized loss position of $46.3 thousand. Based on our review of these marketable securities, we believe none of the 
unrealized loss is as a result of a credit loss as of December 31, 2023 because we do not intend to sell these securities and it is 
not more-likely-than-not that we will be required to sell these securities before the recovery of their amortized cost basis.

The estimated fair value of our contractual maturities of available-for-sale debt securities were as follows (in thousands):

Due within one year       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

Due after one year but within five years     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total estimated fair value of contractual maturities, available-for-sale     . . . . $ 

197,633  $ 

19,997 
217,630  $ 

114,353 

14,246 
128,599 

December 31, 2023

December 31, 2022

F-23

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

The following table summarizes, by major security type, our cash equivalents and available-for-sale marketable securities 

measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands):

December 31, 2023

December 31, 2022

Level 1

Level 2

Total 
estimated 
fair value

Level 1

Level 2

Total 
estimated 
fair value

Assets

Cash equivalents

Money market funds      . . . . . . . . . . $  22,142  $ 
U.S. treasury securities      . . . . . . . .
Corporate debt securities       . . . . . . .

2,000 
— 

—  $  22,142 
2,000 
— 
— 
— 

$  191,704  $ 

— 
— 

—  $  191,704 
— 
— 
— 
— 

Available-for-sale marketable 
securities

Asset-backed securities    . . . . . . . .

— 

3,504 

3,504 

— 

1,146 

1,146 

Corporate debt securities       . . . . . . .
U.S. treasury securities      . . . . . . . .
Agency bonds        . . . . . . . . . . . . . . .
Commercial paper        . . . . . . . . . . . .

6,013 
  176,184 
16,103 
15,826 
Total assets     . . . . . . . . . . . . . . . . . . . $  216,429  $  25,343  $  241,772 

— 
  176,184 
16,103 
— 

6,013 
— 
— 
15,826 

7,130 
— 

— 
  110,535 
2,784 
— 

7,130 
  110,535 
2,784 
7,004 
$  305,023  $  15,280  $  320,303 

7,004 

Liabilities        . . . . . . . . . . . . . . . . . . . .
Derivative instruments     . . . . . . . . . .
Currency hedging contracts(1)        . . . $ 

—  $ 

9,480  $ 

— 

$ 

—  $ 

—  $ 

— 

(1)  Based  on  observable  market  transactions  of  spot  currency  rates,  forward  currency  rates  or  equivalently-termed 
instruments.  Carrying  amounts  of  the  financial  assets  and  liabilities  are  equal  to  the  fair  value.  As  of  December  31, 
2023, the derivative liabilities recorded within accrued expenses and other long-term liabilities were $2.9 million and 
$6.6 million, respectively.

We had no available for sale securities that were classified within Level 3 as of December 31, 2023 and 2022.

A contingent liability was assumed as part of the Antares acquisition related to TLANDO. The acquisition date fair value 
was  measured  using  the  income  approach,  specifically  the  probability  weighted  expected  return  method  for  the  development 
milestone payments and the option pricing methodology using the Monte Carlo simulation for commercial milestone payments 
and royalty payments. Estimates and assumptions used in the Monte Carlo simulation include forecasted revenues, cost of debt, 
risk  free  rate,  weighted  average  cost  of  capital,  revenue  market  price  risk  and  revenue  volatility.  Estimates  and  assumptions 
used in the income approach include the probability of achieving certain milestones and a discount rate. These unobservable 
inputs  represent  a  Level  3  measurement  because  they  are  supported  by  little  or  no  market  activity  and  reflect  our  own 
assumptions  in  measuring  fair  value.  Changes  in  the  fair  value  subsequent  to  the  acquisition  date  is  recognized  in  our 
consolidated statements of income. In September 2023, we provided Lipocine notice of termination of the TLANDO license 
agreement effective January 31, 2024. Based on the fair value remeasurement performed, we recognized a gain on change in 
fair  value  of  the  contingent  liability  of  $13.2  million  for  the  twelve  months  ended  December  31,  2023  in  our  consolidated 
statements of income. 

F-24

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

5.   Revenue

Our disaggregated revenues were as follows (in thousands):

Royalties

Product sales, net

Sales of bulk rHuPH20

Sale of proprietary products

Sale of device partnered products

Total product sales, net

Revenues under collaborative agreements:
Upfront license and target nomination fees
Event-based development and regulatory milestones and other fees
Sales-based milestones
Device licensing and development revenue
Total revenues under collaborative agreements

Total revenues

Year Ended December 31,

2023

2022

2021

$ 447,865  $ 360,475  $ 203,900 

  115,442 

  82,084 

  80,960 

  130,834 

  72,849 

  23,264 

  54,578 

  36,097 

— 

  300,854 

  191,030 

  104,224 

2,000 
  69,000 
— 
9,534 
  80,534 

  30,000 
  59,000 
  10,000 
9,611 
  108,611 

  42,000 
  42,000 
  50,000 
1,186 
  135,186 

$ 829,253  $ 660,116  $ 443,310 

During the year ended December 31, 2023 we recognized revenue related to licenses granted to partners in prior periods 
in the amount of $516.9 million. This amount represents royalties earned in the current period, in addition to $69.0 million of 
variable  consideration  in  the  contracts  where  uncertainties  were  resolved  and  the  development  milestones  are  expected  to  be 
achieved or were achieved. We also recognized revenue of $3.2 million during the year ended December 31, 2023 that had been 
included in deferred revenues in our consolidated balance sheets as of December 31, 2022.

Accounts  receivable,  other  contract  assets  and  deferred  revenues  (contract  liabilities)  from  contracts  with  customers, 

including partners, consisted of the following (in thousands):

Accounts receivable, net
Other contract assets
Deferred revenues

December 
31, 2023

December 
31, 2022

$ 233,254  $ 186,970 
44,102 
— 

956 
4,048 

As  of  December  31,  2023,  the  amounts  included  in  the  transaction  price  of  our  contracts  with  customers,  including 
partners, and allocated to goods and services not yet provided were $80.8 million of which $76.8 million relates to unfulfilled 
product purchase orders and $4.0 million has been collected and is reported as deferred revenues in our Consolidated Balance 
Sheets. The unfulfilled product purchase orders are estimated to be delivered by the end of 2024. Of the total deferred revenues 
of $4.0 million, $0.6 million is expected to be used by our customers within the next 12 months.

We recognized contract assets of $1.0 million as of December 31, 2023, which related to development milestones deemed 
probable of receipt for intellectual property licenses granted to partners in prior periods and for goods or services when control 
has  transferred  to  the  customer,  and  corresponding  revenue  is  recognized  on  an  over  time  basis  but  is  not  yet  billable  to  the 
customer in accordance with the terms of the contract.

F-25

 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

6.  Certain Balance Sheet Items

Accounts receivable, net and contract assets consisted of the following (in thousands):

December 31,
2023

December 31,
2022

Accounts receivable from product sales to partners     . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Accounts receivable from revenues under collaborative agreements    . . . . . . . . . . . . .
Accounts receivable from royalty payments        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts receivable from other product sales      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contract assets       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total accounts receivable and contract assets        . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Allowance for distribution fees and discounts    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total accounts receivable, net and contract assets    . . . . . . . . . . . . . . . . . . . . . . . . . $ 

58,588 
16,183 
118,170 
47,060 
956 
240,957 
(6,747) 
234,210 

$ 

$ 

62,979 
18,776 
100,900 
6,229 
44,102 
232,986 
(1,914) 
231,072 

Inventories consisted of the following (in thousands):

Raw materials     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Work-in-process      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finished goods     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total inventories, net     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

23,646 
34,025 
69,930 
127,601 

$ 

$ 

13,792 
40,361 
45,970 
100,123 

December 31,
2023

December 31,
2022

Prepaid expenses and other assets consisted of the following (in thousands):

Prepaid manufacturing expenses     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Other prepaid expenses     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other assets      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total prepaid expenses and other assets    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Less: Long-term portion      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total prepaid expenses and other assets, current     . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

36,850 
12,902 
16,677 
66,429 
(17,816) 
48,613 

$ 

$ 

51,694 
4,647 
14,984 
71,325 
(26,301) 
45,024 

December 31,
2023

December 31,
2022

Prepaid  manufacturing  expenses  include  raw  materials,  slot  reservation  fees  and  other  amounts  paid  to  contract 
manufacturing organizations. Such amounts are reclassified to work-in-process inventory as materials are used or the contract 
manufacturing organization services are complete.

F-26

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Property and equipment, net consisted of the following (in thousands):

December 31,
2023

December 31,
2022

Research equipment    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Manufacturing equipment    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Computer and office equipment      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Leasehold improvements       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Subtotal        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated depreciation and amortization    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Subtotal        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Right of use of assets     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Property and equipment, net  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

8,588 
32,472 
9,722 
6,987 
57,769 
(19,661) 
38,108 
36,836 
74,944 

$ 

$ 

7,380 
27,893 
7,855 
6,729 
49,857 
(14,756) 
35,101 
40,469 
75,570 

Depreciation  and  amortization  expense  was  approximately  $11.1  million,  $6.5  million,  and  $3.0  million,  inclusive  of 
ROU asset amortization of $5.5 million, $3.0 million and $1.6 million for the years ended December 31, 2023, 2022 and 2021, 
respectively. 

Accrued expenses consisted of the following (in thousands):

December 31,
2023

December 31,
2022

Accrued compensation and payroll taxes        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Accrued outsourced manufacturing expenses       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income taxes payable      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product returns and sales allowance    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued expenses       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease liability    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total accrued expenses   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less long-term portion     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total accrued expenses, current    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

17,361 
12,361 
963 
41,932 
33,584 
32,197 
138,398 
(37,720) 
100,678 

$ 

$ 

19,939 
12,190 
— 
30,261 
35,270 
34,788 
132,448 
(32,686) 
99,762 

Expense  associated  with  the  accretion  of  the  lease  liabilities  was  approximately  $2.5  million,  $0.5  million  and  $0.3 
million  for  the  twelve  months  ended  December  31,  2023,  2022  and  2021,  respectively.  Total  lease  expense  for  the  twelve 
months ended December 31, 2023, 2022 and 2021 was $8.0 million, $3.3 million and $1.9 million, respectively. 

Cash paid for amounts related to leases for the twelve months ended December 31, 2023, 2022 and 2021 was $6.7 million, 

$4.2 million and $2.7 million, respectively.

F-27

                            
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

7.  Goodwill and Intangible Assets

Goodwill

A summary of the activity impacting goodwill is presented below (in thousands):

Balance as of December 31, 2022       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Measurement period adjustments (1)     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance as of December 31, 2023       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

409,049 
7,772 
416,821 

(1)  Refer to Note 3, Business Combination, for further discussion on the measurement period adjustments.

Intangible Assets

Our acquired intangible assets are amortized using the straight-line method over their estimated useful lives of seven to 
ten  years.  The  following  table  shows  the  cost,  accumulated  amortization  and  weighted  average  useful  life  in  years  for  our 
acquired intangible assets as of December 31, 2023 (in thousands).

Auto-Injector technology platform        . . . . . . . . . . . . . . .
XYOSTED proprietary product      . . . . . . . . . . . . . . . . . .

Total finite-lived intangibles, net (1)

ATRS-1902 (IPR&D)

Total intangibles, net

Weighted average 
useful life (in 
years)
7
10

Indefinite

Gross 
Carrying 
Value

Accumulated 
Amortization

Net Carrying 
Value

$  402,000  $ 
136,200 

92,163  $  309,837 
114,342 
21,858 
$  538,200  $  114,021  $  424,179 
48,700 
$  472,879 

(1)  An impairment charge of $2.5 million was recognized during the year ended December 31, 2023 resulting in the full 
impairment  of  the  TLANDO  product  rights  intangible  asset.  The  impairment  charge  resulted  from  the  notice  of 
termination of the TLANDO license agreement provided to Lipocine in September 2023, effective January 31, 2024, 
and is included in amortization of intangibles in our consolidated statements of income.

Estimated  future  annual  amortization  of  finite-lived  intangible  assets  is  shown  in  the  following  table  (in  thousands). 
Actual  amortization  expense  to  be  reported  in  future  periods  could  differ  from  these  estimates  as  a  result  of  acquisitions, 
divestitures, and asset impairments, among other factors.

Year
2024     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

2025     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2026     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2027     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2028     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Thereafter     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amortization 
Expense

71,049 

71,049 

71,049 
71,049 

71,049 
68,934 

Total      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

424,179 

F-28

 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

8.  Long-Term Debt, Net

1.00% Convertible Notes due 2028

In  August  2022,  we  completed  the  sale  of  $720.0  million  in  aggregate  principal  amount  of  1.00%  Convertible  Senior 
Notes due 2028 (the “2028 Convertible Notes” and collectively with the 2024 Convertible Notes and 2027 Convertible Notes 
the “Convertible Notes”). The net proceeds in connection with the issuance of the 2028 Convertible Notes, after deducting the 
initial  purchasers’  fee  of  $18.0  million,  was  approximately  $702.0  million.  We  also  incurred  additional  debt  issuance  costs 
totaling $1.0 million. Debt issuance costs and the initial purchasers’ fee are presented as a debt discount.

The 2028 Convertible Notes pay interest semi-annually in arrears on February 15th and August 15th of each year at an 
annual rate of 1.00%. The 2028 Convertible Notes are general unsecured obligations and rank senior in right of payment to all 
indebtedness that is expressly subordinated in right of payment to the 2028 Convertible Notes, rank equally in right of payment 
with  all  existing  and  future  liabilities  that  are  not  so  subordinated,  are  effectively  junior  to  any  secured  indebtedness  to  the 
extent  of  the  value  of  the  assets  securing  such  indebtedness  and  are  structurally  subordinated  to  all  indebtedness  and  other 
liabilities (including trade payables) of our current or future subsidiaries. The 2028 Convertible Notes have a maturity date of 
August 15, 2028.

Holders may convert their 2028 Convertible Notes at their option only in the following circumstances: (1) during any 
calendar quarter commencing after the calendar quarter ending on December 31, 2022, if the last reported sale price per share of 
common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days 
ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive 
business  days  immediately  after  any  five  consecutive  trading  day  period  (such  five  consecutive  trading  day  period,  the 
“measurement period”) in which the trading price per $1,000 principal amount of notes for each trading day of the measurement 
period was less than 98% of the product of the last reported sale price per share of our common stock on such trading day and 
the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on our common 
stock, as described in the offering memorandum for the 2028 Convertible Notes; (4) if we call such notes for redemption; and 
(5)  at  any  time  from,  and  including,  February  15,  2028  until  the  close  of  business  on  the  second  scheduled  trading  day 
immediately before the maturity date. As of December 31, 2023, the 2028 Convertible Notes were not convertible.

Upon  conversion,  we  will  pay  cash  for  the  settlement  of  principal,  and  for  the  premium,  if  applicable,  we  will  pay 
cash,  deliver  shares  of  common  stock  or  a  combination  of  cash  and  shares  of  common  stock,  at  our  election.  The  initial 
conversion  rate  for  the  2028  Convertible  Notes  is  17.8517  shares  of  common  stock  per  $1,000  in  principal  amount  of  2028 
Convertible Notes, equivalent to a conversion price of approximately $56.02 per share of our common stock. The conversion 
rate is subject to adjustment in some events but will not be adjusted for any accrued or unpaid interest.

As of December 31, 2023, we were in compliance with all covenants and there was no material adverse change in our 

business, operations or financial condition. 

Capped Call Transactions

In connection with the offering of the 2028 Convertible Notes, we entered into capped call transactions with certain 
counterparties  (the  “Capped  Call  Transactions”).  The  Capped  Call  Transactions  are  expected  generally  to  reduce  potential 
dilution to holders of our common stock upon conversion of the 2028 Convertible Notes or at our election (subject to certain 
conditions)  offset  any  cash  payments  we  are  required  to  make  in  excess  of  the  principal  amount  of  such  converted  2028 
Convertible Notes. The cap price of the Capped Call Transactions is initially $75.4075 per share of common stock, representing 
a premium of 75% above the last reported sale price of $43.09 per share of common stock on August 15, 2022, and is subject to 
certain  adjustments  under  the  terms  of  the  Capped  Call  Transactions.  As  of  December  31,  2023,  no  capped  calls  had  been 
exercised.

Pursuant  to  their  terms,  the  capped  calls  qualify  for  classification  within  stockholders’  equity  in  our  consolidated 
balance sheets, and their fair value is not remeasured and adjusted as long as they continue to qualify for stockholders’ equity 
classification.  We  paid  approximately  $69.1  million  for  the  Capped  Calls,  including  applicable  transaction  costs,  which  was 
recorded  as  a  reduction  to  additional  paid-in  capital  in  the  consolidated  balance  sheets.  The  Capped  Call  Transactions  are 
separate transactions entered into by us with the capped call Counterparties, are not part of the terms of the Convertible Notes, 
and do not affect any holder’s rights under the Convertible Notes. Holders of the Convertible Notes do not have any rights with 
respect to the Capped Call Transactions.

0.25% Convertible Notes due 2027

In March 2021, we completed the sale of $805.0 million in aggregate principal amount of 0.25% Convertible Senior Notes 
due  2027  (the  “2027  Convertible  Notes”).  The  net  proceeds  in  connection  with  the  issuance  of  the  2027  Convertible  Notes, 

F-29

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

after deducting the initial purchasers’ fee of $20.1 million, was approximately $784.9 million. We also incurred additional debt 
issuance costs totaling $0.4 million. Debt issuance costs and the initial purchasers’ fee are presented as a debt discount.

The  2027  Convertible  Notes  pay  interest  semi-annually  in  arrears  on  March  1st  and  September  1st  of  each  year  at  an 
annual rate of 0.25%. The 2027 Convertible Notes are general unsecured obligations and rank senior in right of payment to all 
indebtedness that is expressly subordinated in right of payment to the 2027 Convertible Notes, rank equally in right of payment 
with  all  existing  and  future  liabilities  that  are  not  so  subordinated,  are  effectively  junior  to  any  secured  indebtedness  to  the 
extent  of  the  value  of  the  assets  securing  such  indebtedness  and  are  structurally  subordinated  to  all  indebtedness  and  other 
liabilities (including trade payables) of our current or future subsidiaries. The 2027 Convertible Notes have a maturity date of 
March 1, 2027.

Holders  may  convert  their  2027  Convertible  Notes  at  their  option  only  in  the  following  circumstances:  (1)  during  any 
calendar  quarter  commencing  after  the  calendar  quarter  ending  on  June  30,  2021,  if  the  last  reported  sale  price  per  share  of 
common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days 
ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive 
business  days  immediately  after  any  five  consecutive  trading  day  period  (such  five  consecutive  trading  day  period,  the 
“measurement period”) in which the trading price per $1,000 principal amount of notes for each trading day of the measurement 
period was less than 98% of the product of the last reported sale price per share of our common stock on such trading day and 
the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on our common 
stock, as described in the offering memorandum for the 2027 Convertible Notes; (4) if we call such notes for redemption; and 
(5) at any time from, and including, September 1, 2026 until the close of business on the scheduled trading day immediately 
before the maturity date. As of December 31, 2023, the 2027 Convertible Notes were not convertible.

Upon conversion, we will pay cash for the settlement of principal and for the premium, if applicable, we will pay cash, 
deliver shares of common stock or a combination of cash and shares of common stock, at our election. The initial conversion 
rate for the 2027 Convertible Notes is 12.9576 shares of common stock per $1,000 in principal amount of 2027 Convertible 
Notes, equivalent to a conversion price of approximately $77.17 per share of our common stock. The conversion rate is subject 
to adjustment.

As of December 31, 2023, we were in compliance with all covenants and there was no material adverse change in our 

business, operations or financial condition.

1.25% Convertible Notes due 2024

In November 2019, we completed the sale of $460.0 million in aggregate principal amount of 1.25% Convertible Senior 
Notes  due  2024  (the  “2024  Convertible  Notes”).  The  net  proceeds  in  connection  with  the  issuance  of  the  2024  Convertible 
Notes,  after  deducting  the  initial  purchasers’  fee  of  $12.7  million,  was  approximately  $447.3  million.  We  also  incurred  debt 
issuance cost totaling $0.3 million. Debt issuance costs and the initial purchasers’ fee were presented as a debt discount.

In January 2021, we notified the note holders of our irrevocable election to settle the principal of the 2024 Convertible 
Notes in cash and for the premium, to deliver shares of common stock. The conversion rate for the 2024 Convertible Notes was 
41.9208 shares of common stock per $1,000 in principal amount of 2024 Convertible Notes, equivalent to a conversion price of 
approximately $23.85 per share of our common stock. The conversion rate was subject to adjustment. 

In March 2021, we completed a privately negotiated, induced conversion of $369.1 million principal amount of the 2024 
Convertible  Notes  (“2021  Note  Repurchases”  or  the  “2021  Induced  Conversion”).  In  connection  with  the  2021  Induced 
Conversion,  we  paid  approximately  $370.2  million  in  cash,  which  included  principal  and  accrued  interest,  and  issued 
approximately  9.08  million  shares  of  our  common  stock  representing  the  intrinsic  value  based  on  the  contractual  conversion 
rate  and  incremental  shares  as  an  inducement  for  conversion.  As  a  result  of  the  2021  Induced  Conversion,  we  recorded 
$21.0 million in induced conversion expense which was included in other income (expense) of our consolidated statements of 
income  in  2021.  The  induced  conversion  expense  represented  the  fair  value  of  the  common  stock  issued  upon  conversion  in 
excess of the common stock issuable under the original terms of the 2024 Convertible Notes.

In August 2022, we completed a privately negotiated induced conversion of $77.4 million principal amount of the 2024 
Convertible  Notes  (“2022  Note  Repurchases”  or  the  “2022  Induced  Conversion”).  In  connection  with  the  2022  Induced 
Conversion,  we  paid  approximately  $77.6  million  in  cash,  which  included  principal  and  accrued  interest,  and  issued 
approximately  1.51  million  shares  of  our  common  stock  representing  the  intrinsic  value  based  on  the  contractual  conversion 
rate  and  incremental  shares  as  an  inducement  for  conversion.  As  a  result  of  the  2022  Induced  Conversion,  we  recorded 
$2.7 million in induced conversion expense which was included in other income (expense) of our consolidated statements of 
income  in  2022.  The  induced  conversion  expense  represented  the  fair  value  of  the  common  stock  issued  upon  conversion  in 
excess of the common stock issuable under the original terms of the 2024 Convertible Notes.

F-30

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

In  January  2023,  we  issued  a  notice  for  the  redemption  of  2024  Convertible  Notes.  Holders  of  the  notes  could  convert 
their notes at any time prior to the close of the business day prior to the redemption date. In March 2023, holders of the notes 
elected to convert the 2024 Convertible Notes in full. In connection with the conversion, we paid approximately $13.5 million 
in cash which included principal and accrued interest, and issued 288,886 shares of our common stock representing the intrinsic 
value based on the contractual conversion rate.

F-31

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Net Carrying Amounts of our Convertible Notes

The carrying amount and fair value of our Convertible Notes were as follows (in thousands).

Principal amount

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total principal amount       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

— 
805,000 
720,000 
1,525,000 

$ 

$ 

13,483 
805,000 
720,000 
1,538,483 

December 31,
2023

December 31,
2022

Unamortized debt discount

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total unamortized debt discount     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

$ 

— 
(10,950) 
(14,802) 
(25,752)  $ 

(149) 
(14,359) 
(17,875) 
(32,383) 

Carrying amount

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total carrying amount      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

Fair value based on trading levels (Level 2)

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total fair value of outstanding notes       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

— 
794,050 
705,198 
1,499,248 

— 
695,826 
670,522 
1,366,348 

$ 

$ 

$ 

$ 

13,334 
790,641 
702,125 
1,506,100 

32,176 
784,770 
849,823 
1,666,769 

Remaining amortization per period of debt discount (in years)

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 
3.2
4.6

1.9
4.2
5.6

F-32

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

The  following  table  summarizes  the  components  of  interest  expense  and  the  effective  interest  rates  for  each  of  our 

Convertible Notes (in thousands).

Twelve Months Ended December 31,

2023

2022

2021

Coupon interest

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total coupon interest      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

Amortization of debt discount

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total amortization of debt discount    . . . . . . . . . . . . . . . . . . . . . . . . $ 

36 
2,013 
7,200 
9,249 

24 
3,409 
3,073 
6,506 

Interest expense

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total interest expense      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

60 
5,422 
10,273 
15,755 

$ 

$ 

$ 

$ 

$ 

$ 

771 
2,013 
2,660 
5,444 

357 
3,386 
1,124 
4,867 

1,128 
5,399 
3,784 
10,311 

$ 

$ 

$ 

$ 

$ 

$ 

1,906 
1,677 
— 
3,583 

838 
2,804 
— 
3,642 

2,744 
4,481 
— 
7,225 

Effective interest rates

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 
 0.7 %
 1.5 %

 1.8 %
 0.7 %
 1.5 %

 1.8 %
 0.7 %
n/a

Revolving Credit and Term Loan Facilities (May 2022)

In May 2022, in connection with the closing of the Antares acquisition, we entered into a credit agreement, which was 
subsequently amended, with Bank of America, N.A., as Administrative Agent, Swing Line Lender and an L/C Issuer, and the 
other lenders and L/C Issuers party thereto (the “2022 Credit Agreement), evidencing a credit facility (the “2022 Facility”) that 
provides  for  (i)  a  $350  million  revolving  credit  facility  (the  “Revolving  Credit  Facility”)  and  (ii)  a  $250  million  term  loan 
facility (the “Term Facility”). Proceeds from a $120 million draw on the Revolving Credit Facility and the $250 million Term 
Facility  were  used  to  fund  a  portion  of  the  Antares  acquisition,  repay  Antares’  existing  debt  and  pay  fees  and  expenses  in 
connection with the Antares acquisition. The 2022 Credit Agreement contains an expansion feature, which allows us, subject to 
certain  conditions,  to  increase  the  aggregate  principal  amount  of  the  2022  Facility,  provided  we  remain  in  compliance  with 
underlying financial covenants on a pro forma basis including the consolidated interest coverage ratio and the consolidated net 
leverage ratio covenants set forth in the 2022 Credit Agreement. The 2022 Facility will mature on November 30, 2026 unless 
either  the  Revolving  Credit  Facility  or  the  Term  Facility  is  extended  prior  to  such  date  in  accordance  with  the  2022  Credit 
Agreement.

The Term Facility requires quarterly scheduled repayments of the term loans in each of the first, second, third and fourth 
years following the closing in annual amounts equal to 2.50%, 5.00%, 7.50% and 10.00% of the initial principal amount of the 
term  loans,  respectively.  The  term  loans  are  also  subject  to  mandatory  prepayments  from  the  proceeds  of  certain  asset  sales, 
subject to our right to reinvest the proceeds thereof.

F-33

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Borrowings  under  the  2022  Facility  bear  interest,  at  our  option,  at  a  rate  equal  to  an  applicable  margin  plus:  (a)  the 
applicable Term Secured Overnight Financing Rate (“SOFR”) (which includes a SOFR adjustment of 0.10%), or (b) a base rate 
determined by reference to the highest of (1) the federal funds effective rate plus 0.50%, (2) the Bank of America prime rate, (3) 
the Term SOFR rate for an interest period of one month plus 1.10%, and (4) 1.00%. The margin for the 2022 Facility ranges, 
based on our consolidated total net leverage ratio, from 0.25% to 1.25% in the case of base rate loans and from 1.25% to 2.25% 
in the case of Term SOFR rate loans. In addition to paying interest on the outstanding principal under the Facility, we will pay 
(i) a commitment fee in respect of the unutilized commitments thereunder and (ii) customary letter of credit fees and agency 
fees. The commitment fees range from 0.15% to 0.35% per annum based on our consolidated net leverage ratio. 

In August 2022, we entered into Amendment No. 1 to the Credit Agreement (the “Amendment”) among the Company, the 
Guarantors (as defined in the Credit Agreement), each L/C Issuer from time to time party thereto, Bank of America, N.A., as 
Administrative Agent (in such capacity, the “Administrative Agent”) and swing line lender (in such capacity, the “Swing Line 
Lender”),  and  each  lender  party  thereto,  which  amends  the  Credit  Agreement  dated  as  of  May  24,  2022  (the  “Credit 
Agreement”) among the Company, the Guarantors, the Administrative Agent, the Swing Line Lender, each Lender and the L/C 
Issuers.  The  Amendment,  among  other  things,  increased  the  size  of  the  revolving  credit  facility  from  $350  million  to 
$575  million.  The  terms  of  the  Revolving  Credit  Facility  were  otherwise  unchanged.  Concurrently  with  the  entry  into  the 
Amendment, we repaid the entire outstanding Term Loan Facility and repaid all outstanding loans under the Revolving Credit 
Facility under the 2022 Credit Agreement. 

As of December 31, 2023, the Revolving Credit Facility was undrawn. We incurred a total of $3.6 million in third-party 
costs related to the 2022 Credit Agreement which are recorded as debt issuance cost within prepaid expenses and other assets in 
our consolidated balance sheets. As of December 31, 2023, the unamortized debt issuance cost related to the revolving credit 
facility was $2.3 million.

Future maturities and interest payments of long-term debt as of December 31, 2023, are as follows (in thousands):

2024    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

2025    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2026    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2027    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2028    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Thereafter    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9,213 

9,213 

9,213 

812,535 

724,480 

— 

Total minimum payments        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  1,564,654 

Less amount representing coupon interest      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(39,654) 

Gross balance of long-term debt      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  1,525,000 

Less unamortized debt discount     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Carrying value of long-term debt       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(25,752) 
  1,499,248 

Less current portion of long-term debt     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term debt, less current portion and unamortized debt discount     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 
$  1,499,248 

F-34

 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

9.  Share-based Compensation

We currently grant stock options, RSUs and PSUs under the Amended and Restated 2021 Stock Plan (“2021 Stock Plan”), 
which was approved by the stockholders on May 5, 2021 and provides for the grant of up to 17.8 million shares of common 
stock  to  selected  employees,  consultants  and  non-employee  members  of  our  Board  of  Directors  as  stock  options,  stock 
appreciation  rights  (“SARs”),  RSAs,  RSUs  and  PSUs.  Awards  are  subject  to  terms  and  conditions  established  by  the 
Compensation  Committee  of  our  Board  of  Directors.  During  the  year  ended  December  31,  2023,  we  granted  share-based 
awards  under  the  2021  Stock  Plan.  As  of  December  31,  2023,  $7.8  million  shares  were  subject  to  outstanding  awards  and 
$12.1 million shares were available for future grants of share-based awards. 

Total share-based compensation expense related to share-based awards was comprised of the following (in thousands):

Research and development       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Selling, general and administrative    . . . . . . . . . . . . . . . . . . . . . . . . . . .

13,345  $ 

9,903  $ 

23,275 

14,494 

Total share-based compensation expense     . . . . . . . . . . . . . . . . . . . . $ 

36,620  $ 

24,397  $ 

6,992 

13,828 

20,820 

Share-based compensation expense by type of share-based award (in thousands):

Year Ended December 31,

2023

2022

2021

Year Ended December 31,

2023

2022

2021

Stock options    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
RSAs, RSUs, PSUs and ESPP     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16,351  $ 

10,973  $ 

20,269 

13,424 

Total share-based compensation expense     . . . . . . . . . . . . . . . . . . . . $ 

36,620  $ 

24,397  $ 

10,252 

10,568 

20,820 

Total unrecognized estimated compensation cost by type of award and the weighted-average remaining requisite service 

period over which such expense is expected to be recognized as of December 31, 2023 (in thousands, unless otherwise noted):

December 31, 2023

Stock options     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
RSUs      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PSUs        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ESPP    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39,841 
33,566 
6,110 
262 

Unrecognized
Expense

Remaining
Weighted-
Average
Recognition 
Period
( in years)

2.68
2.34
1.43
0.45

ESPP. In February 2021, our Board of Directors approved our 2021 ESPP and our stockholders approved the plan in May 
2021.  The  ESPP  enables  eligible  employees  to  purchase  shares  of  our  common  stock  at  the  end  of  each  offering  period  at  a 
price equal to 85% of the fair market value of the shares on the first business day or the last business day of the offering period, 
whichever  is  lower.  Share  purchases  are  funded  through  payroll  deduction  of  at  least  1%  and  up  to  15%  of  an  employee’s 
compensation for each payroll period, and no employee may purchase shares under the ESPP that exceeds $25,000 worth of our 
common stock for a calendar year. As of December 31, 2023, 2,604,222 shares were available for future purchase. The offering 
period  is  generally  for  a  six-month  period  and  the  first  offering  period  commenced  on  June  16,  2021.  Offering  periods  shall 
commence on or about the sixteenth day of June and December of each year and end on or about the fifteenth day of the next 
December and June respectively, occurring thereafter. During the twelve months ended December 31, 2023, 45,881 shares were 
issued pursuant to the ESPP.

F-35

 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Stock Options. Options granted under the 2021 Stock Plan must have an exercise price equal to at least 100% of the fair 
market value of our common stock on the date of grant. The options generally have a maximum contractual term of ten years 
and  vest  at  the  rate  of  one-fourth  of  the  shares  on  the  first  anniversary  of  the  date  of  grant  and  1/48  of  the  shares  monthly 
thereafter. Certain option awards provide for accelerated vesting if there is a change in control (as defined in the 2021 Stock 
Plan).

A summary of our stock option award activity as of and for the year ended December 31, 2023 is as follows: 

Shares
Underlying
Stock Options

Weighted
Average Exercise
Price per Share

Weighted
Average
Remaining
Contractual
Term ( in 
years)

Aggregate
Intrinsic
Value (in 
millions)

Outstanding as of December 31, 2022     . . . . . . . . . . . . . .

  5,368,225  $ 

Granted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  1,979,286 

Exercised   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Canceled/forfeited      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(565,343) 

(359,331) 

Outstanding as of December 31, 2023     . . . . . . . . . . . . . .

  6,422,837 

Vested and expected to vest as of December 31, 2023     . .

  6,422,837 

Exercisable as of December 31, 2023     . . . . . . . . . . . . . . .

  3,620,251  $ 

24.99 

43.93 

17.70 

42.33 

30.50 

30.50 

21.67 

6.64

6.64

4.96

$ 

$ 

64.0 

64.0 

60.0 

The weighted average grant date fair value of options granted during the years ended December 31, 2023, 2022 and 2021 
was $17.72 per share, $14.22 per share and $18.21 per share, respectively. The total intrinsic value of options exercised during 
the  years  ended  December  31,  2023,  2022  and  2021  was  approximately  $13.7  million,  $21.6  million  and  $33.5  million, 
respectively.  Cash  received  from  stock  option  exercises  for  the  years  ended  December  31,  2023,  2022  and  2021  was 
approximately $10.0 million, $15.3 million and $16.6 million, respectively.

The exercise price of stock options granted is equal to the closing price of the common stock on the date of grant. The fair 
value  of  each  option  award  is  estimated  on  the  date  of  grant  using  the  Black-Scholes-Merton  option  pricing  model  (“Black-
Scholes  Model”).  Expected  volatility  is  based  on  historical  volatility  of  our  common  stock.  The  expected  term  of  options 
granted is based on analyses of historical employee termination rates and option exercises. The risk-free interest rate is based on 
the  U.S.  Treasury  yield  for  a  period  consistent  with  the  expected  term  of  the  option  in  effect  at  the  time  of  the  grant.  The 
dividend  yield  assumption  is  based  on  the  expectation  of  no  future  dividend  payments.  The  assumptions  used  in  the  Black-
Scholes Model were as follows:

Year Ended December 31,

2023

2022

2021

39.68 - 40.82% 39.91 - 50.81% 41.01 - 46.45%
4.7

4.8

4.7

3.37 - 4.72%
 — 

1.37 - 4.27%
 — 

0.36 - 1.20%
 — 

Expected volatility      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Average expected term (in years)     . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk-free interest rate    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Expected dividend yield     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F-36

 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Restricted Stock Units. A RSU is a promise by us to issue a share of our common stock upon vesting of the unit. RSUs 

will generally vest at the rate of one-fourth of the shares on each anniversary of the date of grant. 

The following table summarizes our RSU activity during the year ended December 31, 2023:

Outstanding as of December 31, 2022     . . . . . . . . . . . . . . . . .
Granted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vested     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Forfeited      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Outstanding as of December 31, 2023     . . . . . . . . . . . . . . . . .

Number of
Shares
1,039,381 
646,793 
(400,309) 
(146,529) 
1,139,336 

Weighted
Average
Grant Date
Fair Value
35.76 
$ 
45.16 
32.11 
43.50 
41.38 

$ 

Weighted
Average
Remaining
Contractual
Term (in 
years)

Aggregate
Intrinsic
Value (in 
millions)

1.27

$ 

42.1 

The estimated fair value of the RSUs was based on the closing market value of our common stock on the date of grant. 
The total grant date fair value of RSUs vested during the years ended December 31, 2023, 2022 and 2021 was approximately 
$12.9 million, $8.6 million and $6.6 million, respectively. The fair value of RSUs vested during the years ended December 31, 
2023, 2022 and 2021 was approximately $18.3 million, $11.3 million and $19.0 million, respectively.

Performance Stock Units. A PSU is a promise by us to issue a share of our common stock upon achievement of a specific 

performance condition.

The following table summarizes our PSU activity during the year ended December 31, 2023:

Number of
Shares

Weighted
Average
Grant Date
Fair Value

Outstanding as of December 31, 2022   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

142,844 

$ 

Granted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

106,174 

Vested    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Forfeited   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3,803) 

(2,660) 

Outstanding as of December 31, 2023   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

242,555 

$ 

46.01 

59.34 

49.35 

52.79 

51.72 

The estimated fair value of the PSUs was based on the closing market value of our common stock on the date of grant. 
The fair value of PSUs vested during the years ended December 31, 2023, 2022 and 2021 was $0.2 million, $0.2 million and 
$0.1 million, respectively.

F-37

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.  Stockholders’ Equity

During the years ended December 31, 2023, 2022 and 2021, we issued an aggregate of 565,343, 789,870 and 1,179,032 
shares  of  common  stock,  respectively,  in  connection  with  the  exercises  of  stock  options,  for  net  proceeds  of  approximately 
$10.0 million, $15.3 million and $16.6 million, respectively. For the years ended December 31, 2023, 2022 and 2021, we issued 
333,379,  254,907  and  299,958  shares  of  common  stock,  respectively,  upon  vesting  of  certain  RSUs  and  PSUs  for  which  the 
RSU  holders  surrendered  70,733,  68,425  and  94,795  RSUs,  respectively,  to  pay  for  minimum  withholding  taxes  totaling 
approximately  $7.3  million,  $4.4  million  and  $8.2  million,  respectively.  Stock  options  and  unvested  restricted  units  totaling 
approximately 7.8 million, 6.6 million and 5.9 million shares of our common stock were outstanding as of December 31, 2023, 
2022 and 2021, respectively. 

Share Repurchases

In December 2021, the Board of Directors authorized a second capital return program to repurchase up to $750.0 million 
of  outstanding  stock  over  a  three-year  period.  During  2021,  we  repurchased  3.9  million  shares  of  common  stock  for 
$150.0  million  at  an  average  price  of  $38.51.  During  2022,  we  repurchased  4.5  million  shares  of  common  stock  for 
$200.0 million at an average price of $44.44. 

We  accelerated  the  initiation  of  our  planned  2024  share  repurchases  and  in  November  2023,  we  entered  into  an 
Accelerated Share Repurchase (“ASR”) agreement with Bank of America to accelerate the remaining $250.0 million of share 
repurchases  under  the  approved  capital  return  program.  Pursuant  to  the  agreement,  at  the  inception  of  the  ASR,  we  paid 
$250.0  million  to  Bank  of  America  and  took  initial  delivery  of  5.5  million  shares.  All  shares  repurchased  under  our  capital 
return programs have been retired and have resumed their status of authorized and unissued shares. As of December 31, 2023, 
excluding the shares we received under the ASR, we have repurchased a total of 12.6 million shares for $500.0 million at an 
average price per share of $39.81 under our $750 million 3-year share repurchase plan.

We had the following activity under the approved share repurchase programs (dollars in thousands, except share and per 

share data)

Total Number of Shares 
Purchased

2023

Weighted 
Average Price 
Paid Per Share

Total Cost (1)

First quarter    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4,165,258 

$ 

36.01  $ 

150,083 

Second quarter      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Third quarter     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fourth quarter     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 

— 

— 

— 

— 

— 

— 

— 

— 

4,165,258 

36.01  $ 

150,083 

Accelerated share repurchase (2)

     . . . . . . . . . . . . . . . . . . . . . . .

5,452,563 

$ 

—  $ 

250,000 

(1)

Included in the total cost of shares purchased is a commission fee of $0.02 per share.

(2) Purchased through an ASR agreement executed to repurchase $250.0 million of common stock. In November 2023, 
we took initial delivery of 5.5 million shares in accordance with the ASR. Final shares will be delivered on or before 
June 10, 2024.

F-38

 
 
 
 
 
 
 
 
 
 
 
 
 
11.  Earnings per share

Basic earnings per share is computed by dividing net income for the period by the weighted average number of common 
shares outstanding during the period, without consideration for common stock equivalents. Outstanding stock options, unvested 
RSUs,  unvested  PSUs,  common  shares  expected  to  be  issued  under  our  ESPP  and  the  Convertible  Notes  are  considered 
common stock equivalents and are only included in the calculation of diluted earnings per common share when net income is 
reported and their effect is dilutive. 

Potentially  dilutive  common  shares  issuable  upon  vesting  of  stock  options,  RSUs  and  PSUs  are  determined  using  the 
average  share  price  for  each  period  under  the  treasury  stock  method.  Potentially  dilutive  common  shares  issuable  upon 
conversion  of  the  Convertible  Notes  are  determined  using  the  if-converted  method.  Since  we  have  committed  to  settle  the 
principal amount of the Convertible Notes in cash upon conversion only, the number of shares for the conversion spread will be 
included as a dilutive common stock equivalent. 

 A reconciliation of the numerators and the denominators of the basic and diluted earnings per share computations is as 

follows (in thousands, except per share amounts):

Twelve Months Ended December 31,

2023

2022

2021

Numerator

Net income     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 281,594  $ 202,129  $ 402,710 

Denominator

Weighted average common shares outstanding for basic earnings 
per share    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dilutive potential common stock outstanding

Stock options      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

RSUs, PSUs and ESPP      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Convertible Notes     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Weighted average common shares outstanding for diluted 
earnings per share   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  131,927 

  136,844 

  140,646 

1,824 

388 

58 

2,265 

422 

1,077 

2,737 

555 

2,858 

  134,197 

  140,608 

  146,796 

Earnings per share

Basic      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Diluted      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

2.13  $ 
2.10  $ 

1.48  $ 
1.44  $ 

2.86 
2.74 

Shares which have been excluded from the calculation of diluted earnings per common share because their effect was anti-

dilutive, include the following (shares in millions):

Anti-dilutive securities (1)

Twelve Months Ended December 31,

2023

2022

2021

27.8 

20.7 

13.8 

(1)    The  anti-dilutive  securities  include  outstanding  stock  options,  unvested  RSUs,  unvested  PSUs,  common  shares 

expected to be issued under our ESPP and Convertible Notes.

F-39

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

12.  Commitments and Contingencies

Operating Leases

Our  properties  consist  of  leased  office,  laboratory,  warehouse  and  assembly  facilities.  Our  administrative  offices  and 
research facilities are located in San Diego, California. We also lease a building in Minnetonka, Minnesota consisting of office, 
assembly  operations,  and  warehousing  space,  and  have  a  small  administrative  office  in  Ewing,  New  Jersey.  We  lease  an 
aggregate of approximately 162,000 square feet of space. We pay a pro rata share of operating costs, insurance costs, utilities 
and  real  property  taxes.  Additionally,  we  lease  certain  office  equipment  under  operating  leases.  Total  rent  expense  was 
approximately $9.3 million, $3.3 million and $2.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.

Approximate annual future minimum operating lease payments as of December 31, 2023 are as follows (in thousands): 

Year
2024      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

2025      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2026      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2027      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2028      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Thereafter    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total minimum lease payments      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Less imputed interest     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operating
Leases

6,580 

6,025 

5,676 

5,296 

5,447 

11,686 

40,710 

(8,513) 

Total     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

32,197 

The weighted-average remaining lease term of our operating leases is approximately 6.66 years. 

Legal Contingencies

From time to time, we may be involved in disputes, including litigation, relating to claims arising out of operations in the 
normal course of our business. Any of these claims could subject us to costly legal expenses and, while we generally believe 
that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage or our 
policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any 
such awards could have a material adverse effect on our consolidated results of operations and financial position. Additionally, 
any such claims, whether or not successful, could damage our reputation and business. We currently are not a party to any legal 
proceedings,  the  adverse  outcome  of  which,  in  our  opinion,  individually  or  in  the  aggregate,  would  have  a  material  adverse 
effect on our consolidated results of operations or financial position.

F-40

 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

13.  Income Taxes

Total income (loss) before income taxes summarized by region was as follows (in thousands):

United States      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

348,828 

$ 

248,918 

$ 

248,071 

Foreign      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(499) 

— 

447 

Net income before income taxes   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

348,329 

$ 

248,918 

$ 

248,518 

Significant components of our net deferred tax assets (liabilities) were as follows (in thousands). 

Year Ended December 31,

2023

2022

2021

December 31,

2023

2022

Deferred tax assets

Net operating loss carryforwards       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

32,753 

$ 

32,887 

Deferred revenue   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Research and development and orphan drug credits       . . . . . . . . . . . . . . . . . . . . . . . . . .

Share-based compensation    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ASC 842 lease liability     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Capitalized research expense         . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transaction related expense     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inventory related reserves     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other, net         . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total deferred tax assets      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Valuation allowance for deferred tax assets    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Deferred tax assets, net of valuation allowance      . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Deferred tax liabilities

31 

38,192 

5,024 

7,258 

19,543 

— 

13,561 

6,715 

123,077 

(2,588) 

120,489 

837 

96,133 

6,353 

2,480 

10,168 

2,354 

18,395 

3,054 

172,661 

(707) 

171,954 

Non-deductible book amortization        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(103,492) 

(115,578) 

Depreciation      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ASC 842 right of use asset       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other, net         . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3,522) 

(8,259) 

(830) 

(2,559) 

(9,061) 

(330) 

Total deferred tax liabilities      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(116,103) 

(127,528) 

Net deferred tax asset       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

4,386 

$ 

44,426 

 A valuation allowance of $2.6 million and $0.7 million has been established to offset the net DTAs as of December 31, 

2023 and 2022, respectively, as realization of such assets is uncertain. 

On  a  periodic  basis,  we  reassess  the  valuation  allowance  of  our  DTAs,  weighing  all  positive  and  negative  evidence,  to 
assess if it is more-likely-than-not that some or all of our DTAs will be realized. In 2021, we demonstrated profitability and 
cumulative pretax income and are forecasting income growth in future tax years. After assessing both the positive and negative 
evidence, we determined that it was more likely than not that our DTAs would be realized and released the valuation allowance 
in 2021.

On  May  24,  2022,  we  acquired  the  outstanding  shares  of  Antares.  This  transaction  was  treated  as  a  non-taxable 
acquisition. We have increased our DTLs by approximately $119.7 million related to the acquired intellectual property and a 
step-up to the value of the inventory, the amortization of which will not be tax deductible.

F-41

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Income tax expense (benefit) was comprised of the following components (in thousands):

Year Ended December 31,

2023

2022

2021

Current - federal     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

24,963 

$ 

6,157 

$ 

Current - state     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Deferred - federal      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Deferred - state      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5,717 

34,037 

2,018 

2,525 

44,757 

(6,650) 

(9) 

1,251 

(117,925) 

(37,509) 

Total income tax expense (benefit)    . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

66,735 

$ 

46,789 

$ 

(154,192) 

The provision for income taxes on earnings subject to income taxes differs from the statutory federal income tax rate due 

to the following:

Federal income tax expense     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

State income tax expense, net of federal income tax impact    . . . . . . . . . .

Decrease in valuation allowance     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Foreign income subject to tax at other than federal statutory rate   . . . . . .

Share-based compensation       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Executive compensation limitation     . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Non-deductible expenses and other    . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Foreign-derived intangible income     . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transaction costs      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Research and development credits, net        . . . . . . . . . . . . . . . . . . . . . . . . . .

Effective income tax rate   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Year Ended December 31,

2023
 21.00 %

 2.76 %

 — %

 0.03 %

 (0.21) %

 0.90 %

 0.80 %

 (3.44) %

 — %

 (2.71) %

 19.13 %

2022
 21.00 %

 0.82 %

 (0.39) %

 — %

 (0.66) %

 2.61 %

 (0.40) %

 (5.06) %

 0.88 %

 — %

2021
 21.00 %

 2.67 %

 (84.92) %

 0.02 %

 (2.50) %

 2.32 %

 0.54 %

 (1.18) %

 — %

 — %

 18.80 %

 (62.05) %

 As of December 31, 2023, our unrecognized tax benefit and uncertain tax positions were $21.9 million, which will impact 
the effective tax rate when resolved. Of the unrecognized tax benefits, we do not expect any significant changes to occur in the 
next  12  months.  Interest  and/or  penalties  related  to  uncertain  income  tax  positions  are  recognized  by  us  as  a  component  of 
income tax expense. For the years ended December 31, 2023, 2022 and 2021, we recognized an immaterial amount of interest 
and penalties.

The following table summarizes the activity related to our unrecognized tax benefits (in thousands):

Gross unrecognized tax benefits, beginning of period      . . . . . . . . . . . . . .
Increases in tax positions for prior years      . . . . . . . . . . . . . . . . . . . . . . . . .
Decreases in tax positions for prior years and lapse in statute of 
limitations       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Increases in tax positions related to business acquisition      . . . . . . . . . . . .

Increases in tax positions for current year        . . . . . . . . . . . . . . . . . . . . . . .

Year Ended December 31,

2023

2022

2021

$ 

$ 

19,482 
1,645 

$ 

17,692 
— 

19,167 
21 

— 

— 

791 

(1,148) 

2,151 

787 

(1,496) 

— 

— 

Gross unrecognized tax benefits, end of period    . . . . . . . . . . . . . . . . . .

$ 

21,918 

$ 

19,482 

$ 

17,692 

F-42

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

As of December 31, 2023, we had federal, California and other state tax net operating loss carryforwards of approximately 
$46.8 million, $235.8 million and $66.8 million, respectively. The California and Minnesota net operating loss carryforwards 
begin to expire in 2037 and 2028, respectively.

As  of  December  31,  2023,  we  had  federal  and  California  research  and  development  tax  credit  carryforwards  of 
approximately $38.4 million, and $24.8 million, respectively. The federal research and development tax credits will begin to 
expire  in  2030  unless  previously  utilized.  The  California  research  and  development  tax  credits  will  carryforward  indefinitely 
until utilized. 

Pursuant to Internal Revenue Code Section 382, the annual use of the net operating loss carryforwards and research and 
development tax credits could be limited by any greater than 50% ownership change during any three-year testing period. As a 
result of any such ownership change, portions of our net operating loss carryforwards and research and development tax credits 
are subject to annual limitations. We completed an updated Section 382 analysis regarding the limitation of the net operating 
losses  and  research  and  development  credits  as  of  the  acquisition  of  Antares.  Based  upon  the  analysis,  we  determined  that 
ownership changes occurred in prior years; however, the annual limitations on net operating loss and research and development 
tax credit carryforwards will not have a material impact on the future utilization of such carryforwards.

We do not provide for U.S. income taxes on the undistributed earnings of our foreign subsidiary as it is our intention to 
utilize those earnings in the foreign operations for an indefinite period of time. As of December 31, 2023 and 2022, there were 
no undistributed earnings in foreign subsidiaries.

We are subject to taxation in the U.S. and in various state and foreign jurisdictions. Our tax years for 2008 and forward 
are  subject  to  examination  by  the  U.S.,  California,  and  Minnesota  tax  authorities  due  to  the  carryforward  of  unutilized  net 
operating losses and research and development credits.

F-43

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

14.  Employee Savings Plan

We have an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code. All employees are eligible to 
participate,  provided  they  meet  the  requirements  of  the  plan.  We  are  not  required  to  make  matching  contributions  under  the 
plan. However, we voluntarily contributed to the plan approximately $3.3 million, $2.6 million and $1.1 million for the years 
ended December 31, 2023, 2022 and 2021, respectively.

Halozyme Therapeutics, Inc.

Schedule II

Valuation and Qualifying Accounts
 (in thousands)

Balance at 
Beginning of 
Period

Acquired

Additions

Deductions

Balance at 
End of Period

For the year ended December 31, 2023
Accounts receivable allowances (1)
For the year ended December 31, 2022
Accounts receivable allowances (1)
For the year ended December 31, 2021
Accounts receivable allowances (1)

  . . . . . . . $ 

  . . . . . . . $ 

  . . . . . . . $ 

1,914  $ 

—  $ 

49,596  $ 

(44,763)  $ 

6,747 

1,140  $ 

924  $ 

5,946  $ 

(6,096)  $ 

1,914 

1,003  $ 

—  $ 

8,131  $ 

(7,994)  $ 

1,140 

(1) Allowances are for chargebacks, prompt payment discounts and distribution fees related to proprietary product sales. 

F-44

Halozyme Therapeutics, Inc.
12390 El Camino Real
San Diego, CA 92130
858-794-8889
info@halozyme.com
www.halozyme.com

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