Quarterlytics / Healthcare / Biotechnology / Halozyme Therapeutics

Halozyme Therapeutics

halo · NASDAQ Healthcare
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Ticker halo
Exchange NASDAQ
Sector Healthcare
Industry Biotechnology
Employees 201-500
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FY2022 Annual Report · Halozyme Therapeutics
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2022
Annual Report

Dear Fellow Shareholders:

2022 was a transformative year for 
Halozyme. We delivered record revenue 
from our ENHANZE® business and 
extended our drug delivery leadership 
and expanded our commercial portfolio 
with the acquisition of Antares Pharma. 
We had many successes and learnings 
this year and together, as One Team, we 
demonstrated operational excellence 
throughout the organization for the 
benefit of patients around the world. 
Halozyme’s successes were marked by 
strong growth in revenue and profits as 
we strengthened our partnerships and 
enhanced our capabilities to support 
current and new partners with ENHANZE® 
and an innovative auto-injector 
technology platform. All of this and more, 
delivers on our commitment to our 
stakeholders, including our shareholders. 

RECORD GROWTH 
FOR HALOZYME 
Our strong performance across the 
business, including the successful 
integration of Antares Pharma, drove 
another year of record revenue, with 
$660.1 million, representing 49% year-
over-year growth. Revenue from 
royalties in 2022 also achieved record 
levels, increasing 77% to $360.5 million, 
primarily driven by strong adoption of our 
ENHANZE® partner products DARZALEX® 
Faspro and Phesgo® and the addition of 
the auto-injector royalty revenue.

Our leadership in drug delivery with a 
commercial portfolio has augmented 
our growth potential, diversified our 
revenue streams and extended our 
revenue durability. We look forward 
to further strengthening our position 
as the drug delivery partner of choice 
for pharmaceutical and biotechnology 
companies with ENHANZE® and our 
auto-injector technology platforms. 

As a profitable biopharma company, we 
have a strong balance sheet and continue 
to generate cash that has supported 
our commitment to our strategic capital 
allocation strategy, including returning 
capital to our shareholders. In 2022, we 
completed $350 million of our 3-year $750 
million dollar share repurchase plan that 
was approved by the Board of Directors 
in December 2021. As part of this plan, we 
expect to complete another $150 million 
of share repurchases in 2023, pending 
market conditions and other factors. 

Halozyme is well-positioned to embark on 
our next chapter of accelerating financial 
growth to drive shareholder value.

PARTNER SUCCESS 
WITH ENHANZE®

With an established leadership in drug 
delivery, we have five globally-approved 
partner products utilizing ENHANZE® 
available in more than 100 countries. More 
than 600,000 patients have received 
commercial products utilizing ENHANZE®. 
We currently have twelve pharma and 
biotech partners with access to our 
ENHANZE® drug delivery technology and 
work closely with our partners to support 
the development of their innovative 
products in combination with ENHANZE®. 

Our ENHANZE® development pipeline is 
robust and diverse. There were significant 
achievements and successes with our 
partners related to our ENHANZE® 
technology in 2022, including:
 • argenx’s submission of a Marketing 
Authorization Application to the 
European Medicines Agency and the 
FDA acceptance of its Biologics License 
Application for SC efgartigimod for the 
treatment of adults with generalized 
myasthenia gravis with a PDUFA date 
of June 20, 2023.

 • Roche’s submission of a Marketing 
Authorization Application to the 
European Medicines Agency and 
the FDA acceptance of its Biologics 
License Application for SC atezolizumab 
with ENHANZE® across all approved 
indications of IV Tecentriq® with a 
PDUFA date of September 15, 2023.
 • Roche’s initiation of a Phase 3 study 

evaluating ocrelizumab with ENHANZE® 
in subjects with multiple sclerosis.
 • Janssen’s initiation of a Phase 3 study 
of lazertinib and amivantamab with 
ENHANZE® in patients with epidermal 
growth factor receptor mutated 
advanced or metastatic non-small cell 
lung cancer (PALOMA-3).

 • Bristol Myers Squibb’s initiation of a 
Phase 3 study to compare the drug 
levels of nivolumab with ENHANZE® 
administered subcutaneously 
versus intravenous administration in 
participants with melanoma following 
complete resection (CheckMate-6GE).
 • Takeda’s positive topline results from a 
pivotal Phase 3 trial evaluating HYQVIA® 
(Immunoglobulin infusion 10% (Human) 
with ENHANZE®), for maintenance 
treatment of chronic inflammatory 
demyelinating polyradiculoneuropathy.

 • Eight partner products are in or have 
completed Phase 1 development.

2 partner products with 
ENHANZE® pending 
completion of regulatory 
review and potential for 
approval in 2023

4 Phase 3 study data 
readouts by collaboration 
partners in 2023 from two 
products utilizing ENHANZE® 

Helen Torley, President and Chief Executive Officer

Halozyme is continuing to enhance our 
capabilities to support current and new 
partners utilizing our ENHANZE® and 
auto-injector technologies, with the goal 
of reducing the burden of treatment for 
patients and providing new options for 
patients with the goal of driving long-
term, durable growth. 

CONTINUED 
OPERATIONAL 
EXCELLENCE
Just as our vision remains to deliver 
disruptive solutions that significantly 
improve patient experiences and bring 
the potential to positively influence 
outcomes for emerging and established 
therapies, we have remained dedicated 
to delivering on our commitment to 
corporate citizenship. Sustainability and 
environmental consciousness have been 
critical to our decision-making as the 
organization has grown and expanded our 
footprint. This core responsibility, together 
with our drive for continuous learning 
and development, drove our efforts 
to transform our internal and external 
environment. In 2022, we successfully 
executed multiple actions to progress 
our ESG ambition:

 • Continued to build a diverse team of 
employees who are passionate about 
and committed to positively impacting 
the lives of patients and their families. 
This dedication has resulted in a diverse 
and inclusive employee base consisting 
of 43.8% female and 30.5% non-white/
Caucasian employees as of December 
2022. We value and celebrate the unique 
talents, backgrounds, and perspectives 
each employee contributes to achieving 
our mission and corporate objectives. 
Our diverse and inclusive culture is 
key to attracting, developing, and 
retaining top talent within the globally 
competitive biotechnology industry.

 • As Halozyme welcomed two new office 
sites, we expanded our approach to 
employee engagement. These efforts 
include a focus on supporting the 
Halozyme team culture and connectivity 
through events and activities to support 
the local community. These initiatives 
achieved strong participation in both 
engagement and community events.
 • We are committed to protecting our 

data assets and systems’ confidentiality, 
integrity and availability. In 2022, 
an industry leading management 
consulting firm assessed the security 
controls for our integrated business 
between Halozyme and Antares 
following the acquisition. That 
assessment helped us create a robust 
and comprehensive cybersecurity plan 
of action for 2023 and beyond.

 • Implemented a global Environment 

Health and Safety program to support 
integration initiatives. The program 
also includes a Global Policy rollout 
with site-specific procedures. We also 
initiated a Laboratory Waste-to-Energy 
program to reduce waste from our labs 
and prevent it from entering the landfill 
while leveraging it as a raw material to 
produce renewed energy.

Our goal is to achieve 
NetZero energy usage at 
our company headquarters 
by 2030

Approximately 85 percent 
of our waste, by volume, 
is recycled

All our initiatives, progress and 
accomplishments are possible because of 
Halozyme’s One Team commitment. One 
Team is all about exceptional collaboration 
and accountability as we execute on our 
mission for all of our stakeholders. 

The dedication and commitment I have 
seen this past year have been astounding, 
and the motivation to enhance the patient 
experience is reflected across every facet 
of our business.

I am grateful to all of our stakeholders, 
including our employees, partners, board 
of directors and shareholders for your 
support and commitment in 2022.

Best regards,

HELEN TORLEY, M.B. Ch. B., M.R.C.P. 
PRESIDENT & CEO

include 

to  shareholders 

FORWARD LOOKING STATEMENTS
Statements  set  forth  in  this  annual  report  and 
letter 
forward-looking 
statements including, without limitation, statements 
concerning the Company’s expected future financial 
performance,  plans  to  repurchase  shares  under 
its  share  repurchase  program  and  expectations 
concerning its partners’ development programs and 
potential  approvals  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,”  “continue,”  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  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.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒ ANNUAL  REPORT  PURSUANT  TO  SECTION  13  OR  15(d)  OF  THE  SECURITIES  EXCHANGE  ACT  OF 

1934

For the fiscal year ended December 31, 2022 
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
CA
(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  Exchange 

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, 
2022 was approximately $5.1 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  135,366,862  as  of 

February 14, 2023.

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 2023 Annual Meeting of Stockholders are incorporated by 
reference into Part III of this Annual Report.

 
 
 
HALOZYME THERAPEUTICS, INC.

INDEX

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

PART I

Business        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk Factors       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unresolved Staff Comments      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 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
25
42
43
43
43

44
46
47
60
60
60
61
63
63

63

64

64

65

65

65

68

69

3

  
 
 
Summary of Risk Factors

Our  business  is  subject  to  a  number  of  risks  and  uncertainties,  including  those  described  in  the  section  labeled  “Risk 
Factors” in “Part I, Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this 
Quarterly Report. These risks include the following:

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 impair our ability to generate revenues.

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

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 Hylenex or other proprietary or partnered products and product candidates, our 
and our partners’ product development or commercialization efforts could be delayed or suspended and our business 
results of operations and our collaborations could be harmed.

• 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.

•

•

•

•

•

•

•

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.

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.

Our  business  strategy  is  focused  on  growth  of  our  ENHANZE  technology,  our  auto-injector  technology,  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.

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 or delayed.

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.

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.

Failure  to  successfully  integrate  the  Antares  business,  or  failure  of  the  Antares  business  to  perform  could  adversely 
impact our future business and operations.

4

•

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.

• 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 currently have significant debt and expect to incur additional debt. Failure by us to fulfill our obligations under the 

applicable debt agreements may cause repayment obligations to accelerate.

•

•

•

•

•

•

•

•

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

Conversion  of  our  Convertible  Notes  may  dilute  the  ownership  interest  of  existing  stockholders  or  may  otherwise 
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.

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

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

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 or delayed.

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

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

•

•

Our  or  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.

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.

• 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.

5

• 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 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.

•

•

•

•

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.

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 enforce our intellectual property rights against competitors who develop and commercialize products based 
on our discoveries.

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

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.

• 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.

6

This  Annual  Report  on  Form  10-K  contains  “forward-looking  statements”  within  the  meaning  of  the  “safe  harbor” 
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.  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  to  successfully  integrate  Antares  Pharma, 
Inc. into our business, 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  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 below, as well as those discussed elsewhere in this Annual Report. Readers are urged not to place undue reliance on these 
forward-looking  statements,  which  speak  only  as  of  the  date  of  this  Annual  Report.  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. Readers are urged to carefully review and consider the various disclosures made in this Annual Report, 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,” “us,” and “our” refer to Halozyme Therapeutics, Inc. and its wholly 
owned  subsidiary,  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  Consolidated  Financial  Statements 
included herein (refer to Part II, Item 8).

PART I

7

Item 1.

Business

Overview

Halozyme  Therapeutics,  Inc.  is  a  biopharma  technology  platform  company  that  provides  innovative  and  disruptive 

solutions with the goal of improving the patient experience and potentially outcomes. 

Our proprietary enzyme, rHuPH20, is used to facilitate the subcutaneous (“SC”) delivery of injected drugs and fluids. We 
license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug 
delivery technology (“ENHANZE”) with the partners’ proprietary compounds.

  Our  first  commercially  approved  product,  Hylenex®  recombinant  (“Hylenex”),  and  our  ENHANZE  partners’  approved 
products and product candidates are based on rHuPH20, our patented recombinant human hyaluronidase enzyme. rHuPH20 is 
the active ingredient in Hylenex, that 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”), Alexion Pharma International Operations Unlimited Company (an indirect wholly owned subsidiary of AstraZeneca 
PLC)(“Alexion”), argenx BVBA (“argenx”), Horizon Therapeutics plc. (“Horizon”), ViiV Healthcare (the global specialist HIV 
Company  majority  owned  by  GlaxoSmithKline)  (“ViiV”)  and  Chugai  Pharmaceutical  Co,  Ltd  (“Chugai”).  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 receive royalties from three of these collaborations, including royalties from sales of 
one  product  from  the  Takeda  collaboration,  three  products  from  the  Roche  collaboration  and  one  product  from  the  Janssen 
collaboration.  Future  potential  revenues  from  ENHANZE  collaborations  and  from  the  sales  and/or  royalties  of  our  approved 
products will depend on the ability of our partners, in some areas supported by Halozyme, to develop, manufacture, secure and 
maintain regulatory approvals for approved products and product candidates and commercialize product candidates.

Through our recent acquisition of Antares Pharma, Inc. (“Antares”), we also develop, manufacture and commercialize, for 
ourselves  or  with  our  partners,  drug-device  combination  products  using  our  advanced  auto-injector  technologies.  Also  as  a 
result  of  our  acquisition  of  Antares,  our  commercial  portfolio  of  proprietary  products  includes  XYOSTED®,  TLANDO®  and 
NOCDURNA®.  We  have  commercialized  auto-injector  products  with  several  pharmaceutical  companies  including  Teva 
Pharmaceutical Industries, Ltd. (“Teva”), Covis Group S.a.r.l. (“Covis”) and Otter Pharmaceuticals, LLC (“Otter”). We have 
development programs including auto-injectors with Idorsia Pharmaceuticals Ltd. (“Idorsia”) and Pfizer.

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 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. 

Through our recent acquisition of Antares, our technology also includes pressure-assisted auto-injector technology. 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,  migraine  headaches,  testosterone  deficiency  and  maternal  health.  Our 
current  platforms  include  the  VIBEX®  and  the  VIBEX®  QuickShot®  disposable  pressure-assisted  auto-injection  systems,  the 
Vai™ auto-injector and disposable pen injection systems. Our auto-injectors offer a does capacity ranging from 0.5 mL to 2.25 
mL.  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, 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 subcutaneously delivered products. 
We  currently  have  twelve  collaborations  with  five  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,  initiating 
development of a high volume auto-injector, and further extend the number of partners by gaining more partners for the current 
auto-injectors.

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  in  the  U.S.  our  proprietary  product  XYOSTED  injection  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  FDA-approved  SC  testosterone  enanthate  product  for  once-weekly,  at-
home  self-administration  and  is  approved  and  marketed  in  three  dosage  strengths,  50  mg,  75  mg  and  100  mg.  Safety  and 
efficacy of XYOSTED in males less than 18 years old have not been established.

NOCDURNA (desmopressin acetate) Sublingual Tablets

We market and sell NOCDURNA in the U.S., which is the first and only sublingual tablet indicated for the treatment of 
nocturia due to nocturnal polyuria (“NP”) in adults who awaken at least two times per night to urinate. In the NOCDURNA 
clinical  trials,  NP  was  defined  as  night-time  urine  production  exceeding  one-third  of  the  24-hour  urine  production. 
NOCDURNA is a sublingual tablet, marketed in two dosage strengths, that dissolves quickly under the tongue without water 
and has been shown in clinical studies to reduce nighttime urination by nearly one-half (in patients who average three nighttime 
bathroom visits.) We license NOCDURNA from Ferring. In October 2022, we sent a notice to Ferring that we are terminating 
the NOCDURNA license agreement with an effective termination date in October 2023.

TLANDO (testosterone undecanoate) Oral Formulation

TLANDO is a twice daily oral formulation of testosterone indicated for testosterone replacement therapy in adult males 
for  conditions  associated  with  a  deficiency  or  absence  of  endogenous  testosterone  (primary  or  hypogonadotropic 
hypogonadism). TLANDO was granted FDA approval in March 2022. In June 2022, we announced the commercial launch of 
TLANDO. Safety and efficacy of TLANDO in males less than 18 years old have not been established.

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 IND application with the FDA for the initiation of a Phase 1 clinical study of ATRS-1902 
for adrenal crisis rescue. The IND application includes the protocol for an initial clinical study to compare the pharmacokinetic 
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  pharmacokinetics  (“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. 

12

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. In September 2018, we announced that Roche received approval from Health Canada for Herceptin SC for the treatment 
of  patients  with  HER2-positive  breast  cancer.  In  February  2019,  we  announced  that  Roche  received  approval  from  the  U.S. 
Food  and  Drug  Administration  (“FDA”)  for  Herceptin  SC  under  the  brand  name  Herceptin  Hylecta™  (trastuzumab  and 
hyaluronidase-oysk).  In  April  2019,  Roche  made  Herceptin  Hylecta  available  in  the  U.S.  In  October  2022,  Roche 
Pharmaceuticals  China  announced  the  approval  of  Herceptin  in  China  for  the  treatment  of  patients  with  early-stage  and 
metastatic HER2-positive breast cancer.

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. In December 2020, 
the European Commission (“EC”) also approved Phesgo for the treatment of patients with early and metastatic HER2-positive 
breast  cancer.  In  July  2022,  Roche  submitted  the  Initial  Marketing  Application  (“IMA”)  for  the  fixed-dose  combination  of 
Perjeta (pertuzumab) and Herceptin for SC injection (Phesgo) to Center for Drug Evaluation (“CDE”) in China.  In September 
2022, Chugai Pharmaceutical Co., Ltd. (a Member of the Roche Group) announced the submission of a new NDA in Japan for 
fixed-dose  SC  combination  of  pertuzumab  and  trastuzumab  (same  monoclonal  antibodies  as  in  Perjeta  and  Herceptin)  with 
ENHANZE. This application is based on data from two clinical studies including the results from the global Phase 3 FeDeriCa 
study in patients with HER2-positive breast cancer. 

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  approximately  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 a combination of rituximab and rHuPH20 (approved and marketed under the brand name RITUXAN® SC) for 
patients with CLL. In November 2022, Roche submitted the IMA for Mabthera SC to CDE in China.

In  September  2017,  we  entered  into  an  agreement  with  Roche  to  develop  and  commercialize  one  additional  exclusive 
target 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  October  2018,  we  entered  into  an  agreement  with  Roche  for  the  right  to  develop  and  commercialize  one  additional 
exclusive  target  and  an  option  to  select  two  additional  targets  within  four  years  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. Roche subsequently returned the rights for the first exclusive target. 

In  December  2018,  Roche  initiated  a  Phase  1b/2  study  in  patients  with  non-small  cell  lung  cancer  for  TECENTRIQ® 
(atezolizumab)  using  ENHANZE  technology.  In  December  2020,  Roche  initiated  a  Phase  3  study  in  patients  with  non-small 
cell lung cancer (NSCLC) for TECENTRIQ using ENHANZE technology. In August 2022, Roche announced that the Phase 3 
study met its co-primary endpoints, showing non-inferior levels of Tecentriq  in the blood (pharmacokinetics), 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 
November  2022,  Roche  submitted  a  Biologics  License  Application  (“BLA”)  to  the  FDA  and  a  Marketing  Authorization 
Application  (“MAA”)  to  the  EMA  for  SC  formulation  of  Tecentriq  (atezolizumab)  with  ENHANZE  across  all  approved 
indications  of  IV  Tecentriq.  In  January  2023,  FDA  accepted  the  BLA  for  the  SC  formulation  of  Tecentriq  with  the  official 
PDUFA goal date of September 15, 2023. 

 In August 2019, Roche initiated a Phase 1 study evaluating OCREVUS® (ocrelizumab) with ENHANZE technology in 
subjects  with  multiple  sclerosis.  In  April  2022,  Roche  initiated  a  Phase  3  study  evaluating  OCREVUS  with  ENHANZE 
technology in subjects with multiple sclerosis.

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.

13

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 European Union (“EU”) Member States for the use of 
HYQVIA  (solution  for  SC  use)  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 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 May 2016, Takeda announced that HYQVIA received a marketing authorization from the EC for a pediatric indication, 
which  was  launched  in  Europe  to  treat  primary  and  certain  secondary  immunodeficiencies.  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 July 2022, Takeda announced positive topline results from pivotal Phase 3 trial evaluating HYQVIA, for maintenance 
treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), and Takeda confirmed its intention to submit 
regulatory  applications  in  the  United  States  and  European  Union  in  its  fiscal  year  2022.  In  July  2022,  Takeda  filed  a 
supplemental  Biologics  License  Application  (sBLA)  for  the  potential  expanded  use  of  HYQVIA  for  pediatric  indication  for 
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 has elected CD38 as the first target on an 
exclusive  basis.  Janssen  has  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 February 2019, Janssen’s development partner, Genmab, announced positive Phase 3 trial results from the COLUMBA 
study evaluating SC DARZALEX in comparison to IV DARZALEX in patients with relapsed or refractory multiple myeloma. 
DARZALEX  SC®  (utilizing  ENHANZE  technology)  was  found  to  be  non-inferior  to  DARZALEX  IV  with  regard  the  co-
primary endpoints of Overall Response Rate and Maximum Trough concentration. In May 2020, we announced that Janssen 
received  US  FDA  approval  and  launched  the  commercial  sale  of  DARZALEX  FASPRO®  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 US, EU, Japan and China.  Beginning with the US, in January 2021, Janssen received FDA approval 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 January 2021, Janssen received accelerated approval 
from the FDA for DARZALEX FASPRO in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for 
the treatment of adult patients with newly diagnosed AL amyloidosis (not recommended for the treatment of patients with AL 
amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials). In 
July 2021, Janssen received FDA approval for DARZALEX FASPRO in combination with pomalidomide and dexamethasone 

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(D-Pd) for patients with multiple myeloma after first or subsequent relapse. In July 2021, Janssen received FDA approval for 
DARZALEX  FASPRO  in  combination  with  D-Pd  for  patients  with  multiple  myeloma  after  first  or  subsequent  relapse.  In 
November 2021, Janssen received FDA approval for DARZALEX FASPRO 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, in June 2021, we announced that Janssen received marketing authorization from the EC for DARZALEX SC in two 
new indications, 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 in March 2021, Janssen announced approval from 
Japan’s Ministry of Health, Labour and Welfare (MHLW) for the SC formulation of DARZALEX (known as DARZQURO) in 
Japan for the treatment of multiple myeloma, and in May 2021 Janssen commenced commercial sale in Japan. In August 2021, 
Janssen  received  approval  of  DARZQURO  for  systemic  AL  amyloidosis  in  Japan.  In  China  in  October  2021,  Janssen’s 
DARZALEX  FASPRO  was  approved  by  the  China  National  Medical  Products  Administration  (NMPA)  for  the  treatment  of 
primary light chain amyloidosis, in combination with D-VCd in newly diagnosed patients.

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 November 2020, Janssen initiated a Phase 1 study of amivantamab and ENHANZE. 
In September 2022, 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 epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (PALOMA-2).  

  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. Janssen and ViiV 
are exploring the possibility of an ultra-long acting version of CABENUVA using ENHANZE.

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. AbbVie elected one target on an exclusive basis, TNF alpha, 
for which it has discontinued development and returned the target.

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 
3 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  June  2022,  BMS  nominated  a  new 
undisclosed target. In August 2022, BMS initiated a Phase 3 trial to compare the drug levels of nivolumab with ENHANZE 
administered  subcutaneously  vs  IV  administration 
in  participants  with  melanoma  following  complete  resection 
(CheckMate-6GE). BMS plans to initiate a Phase 3 trial in early 2023 to demonstrate the drug exposure levels of nivolumab 
and  relatlimab  fixed-dose  combination  with  ENHANZE  is  not  inferior  than  intravenous  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,  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 and has access to utilize ENHANZE with up to three exclusive targets.

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 

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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. Under the newly announced expansion, argenx gained the 
ability  to  exclusively  access  our  ENHANZE  technology  for  three  additional  targets  for  a  total  of  up  to  six  targets  under  the 
existing and newly expanded collaboration. 

In  July  2019,  argenx  dosed  the  first  subject  in  a  phase  1  clinical  trial  evaluating  the  safety,  pharmacokinetics  and 
pharmacodynamics of efgartigimod (ARGX-113), using ENHANZE technology. In December 2019, argenx reported that based 
on  data  from  the  phase  1  study  and  internal  company  analysis,  a  one  minute  injection  administered  every  2  weeks  may  be 
possible.  In  December  2020,  argenx  initiated  a  Phase  3  study  of  ARGX-113  using  ENHANZE  technology  for  patients  with 
immune  thrombocytopenia  (ITP),  an  immune  disorder  in  which  the  blood  does  not  clot  normally.  In  January  2021,  argenx 
initiated  a  Phase  3  study  of  ARGX-113  using  ENHANZE  technology  in  pemphigus  vulgaris  and  foliaceus  (PV),  a  rare 
autoimmune disease that causes painful blisters on the skin and mucous membranes.  In February 2021, argenx initiated a Phase 
3  study  of  ARGX-113  using  ENHANZE  technology  for  patients  with  chronic  inflammatory  demyelinating  polyneuropathy 
(CIDP) and initiated a Phase 3 study of ARGX-113 using ENHANZE technology in myasthenia gravis (MG), an autoimmune 
disorder of the musculoskeletal system caused by IgG autoantibodies. In December 2021, argenx announced the FDA approval 
of efgartigimod (VYVGARTTM) for the treatment of generalized myasthenia gravis for the IV dosing regimen.  In March 2022, 
argenx announced that data from argenx’s phase 3 ADAPT-SC study evaluating SC efgartigimod (1000mg efgartigimod-PH20) 
for the treatment of generalized myasthenia gravis (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 2022, argenx initiated a study, BALLAD, evaluating Efgartigimod with ENHANZE in bullous pemphigoid. In September 
2022, argenx announced the submission of a BLA to the US FDA for SC efgartigimod for the treatment of adults with gMG. In 
November 2022, argenx announced the acceptance of the BLA application for SC efgartigimod in gMG with a priority review 
and a Prescription Drug User Free Act (“PDUFA”) date of March 20, 2023. In January 2023, argenx announced the review time 
was extended by the FDA to June 20, 2023 to allow the FDA sufficient time to review. Argenx has also submitted a marketing 
authorization application to the European Medicines Agency for SC efgartigimod for the treatment of adults with gMG with an 
anticipated regulatory approval decision in the fourth quarter of 2023.

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 
pharmacokinetic  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.

ViiV Healthcare Collaboration

In June 2021, we entered into a global collaboration and license agreement with ViiV. The license 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  pharmacokinetics  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 pharmacokinetics, safety and tolerability of long-acting cabotegravir administered subcutaneously 
with ENHANZE technology. 

Chugai Collaboration 

In March 2022, we entered into a global collaboration and license agreement with Chugai Pharmaceutical Co., Ltd.  The 
license  gives  Chugai  exclusive  access  to  ENHANZE  drug  delivery  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 pharmacokinetics, pharmacodynamics, and safety of targeted antibody administered subcutaneously with ENHANZE.

NIH CRADA

In  June  2019,  we  announced  a  Cooperative  Research  and  Development  Agreement  (“CRADA”)  with  the  National 
Institute  of  Allergy  and  Infectious  Diseases’  Vaccine  Research  Center  (VRC),  part  of  National  Institute  of  Health  (NIH), 

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enabling  the  VRC’s  use  of  ENHANZE  technology  to  develop  SC  formulations  of    VRC07-523LS  and  N6LS  broadly 
neutralizing antibodies (bnAbs) against HIV for HIV treatment. In April 2021, we were notified that the first patient was dosed 
with N6LS and rHuPH20 in VRC 609 Phase 1 dose-escalation  study to evaluate safety, tolerability, and pharmacokinetics of 
N6LS using ENHANZE technology. In October 2022, the VRC 609 Phase 1 study was completed.

CAPRISA

In September 2020, we entered into a collaboration with the Centre for the AIDS Programme of Research in South Africa 
(CAPRISA),  a  non-profit  company,  to  evaluate  safety,  tolerability  and  pharmacokinetics  of  a  human  monoclonal  antibody 
(CAP256V2LS)  in  HIV-negative  and  HIV-positive  women  in  South  Africa.  In  October  2020,  we  were  notified  that  the  first 
patient  was  dosed  with  CAP256V2LS  and  rHuPH20  in  CAPRISA  012B  Phase  1  dose-escalation  study  to  evaluate  safety, 
tolerability,  and  pharmacokinetics  of  CAP256V2LS  alone  and  in  combination  with  VRC07-523LS  using  ENHANZE 
technology.  In  January  2021,  we  were  notified  the  first  patient  was  dosed  with  CAP256V2LS  and  rHuPH20  in  combination 
with  VRC07-523LS  and  rHuPH20  in  CAPRISA  012B  Phase  1  study.  VRC07-523LS  broadly  neutralizing  antibody  was 
supplied  by  the  NIH/VRC  under  a  research  collaboration  with  CAPRISA.  In  June  2022,  we  received  final  study  reports  for 
CAPRISA 012B Phase 1 study and concluded our collaboration with CAPRISA.

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.  Pursuant  to  the  agreement,  Teva  is  obligated  to  purchase  all  of  its 
delivery  device  requirements  from  us.  We  received  an  upfront  cash  payment  and  a  milestone  payment  upon  FDA  product 
approval. We also receive a negotiated purchase price for each device sold, as well as royalties on Teva’s commercial sales of 
the product. The agreement will continue until the expiration of the last to expire patent that is filed no later than 12 months 
after  FDA  approval.  We  have  multiple  patents  that  have  been  granted  by  the  United  States  Patent  and  Trademark  Office 
(“USPTO”)  that  cover  this  product,  the  latest  of  which  will  expire  in  2033.  We  have  and  plan  to  continue  to  file  patent 
applications  covering  this  product.  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. 
We supply the device and Teva is responsible for the drug, assembly and packaging, distribution and commercialization of the 
finished product, for which we also receive royalties on Teva’s net sales.

In December 2007, we entered into a license, development and supply agreement with Teva under which we developed 
and  will  supply  a  disposable  pen  injector  for  two  therapeutic  products:  exenatide  and  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. On February 25, 2022, Teva notified us that it was terminating the exenatide program and 
related agreement due to a lack of commercial viability. The termination was effective August 23, 2022.

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.  Under  an  exclusive  development, 
license and supply agreement with Teva, we are responsible for the manufacturing and supply of the multi-dose pen used in 
Teva’s generic teriparatide product and Teva is responsible for the sale and distribution of the product. We are compensated for 
devices sold to Teva and we are entitled to receive royalties on net product sales by Teva in the territories.

In November 2012, we entered into a license, supply and distribution agreement with Teva for an auto-injector product 
containing sumatriptan for the treatment of migraines.  Teva is responsible for the manufacture, supply, commercialization and 
distribution of the drug, and Halozyme is responsible for the manufacture and supply of the device and assembly and packaging 
of the finished product. We are compensated at cost for product shipment to Teva and Teva distributes the product in the U.S. 
Teva  also  received  an  option  for  distribution  rights  in  other  territories.  In  addition,  net  profits  are  shared  equally  between 
Halozyme and Teva. The term of the agreement continues seven years from commercial launch, which was in June 2016, with 
automatic one-year renewals unless terminated sooner by either party in accordance with the terms of the agreement. 

Covis Agreements

In September 2014, we entered into a development and license agreement with Covis, to develop and supply a SC auto-
injector system for use with Makena, a progestin drug (hydroxyprogesterone caproate) indicated to reduce the risk of preterm 
birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. Under the agreement, 
we were granted an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property 
rights,  including  know-how,  patents  and  trademarks.  Covis  is  responsible  for  the  clinical  development  and  preparation, 

17

submission and maintenance of all regulatory applications, and is responsible for the manufacture and supply of the drug to be 
used in the product, and to market, distribute and sell the product. 

In March 2018, we entered into a manufacturing agreement with Covis for the exclusive supply of the device, a variation 
of  our  VIBEX  QuickShot  SC  auto-injector  developed  by  us,  and  fully  assembled  and  packaged  final  finished  product  of  the 
Makena SC auto-injector. We receive a contracted price per unit on each product manufactured and royalties based on net sales 
of products commencing on product launch in a particular country.

 In October 2020, Covis received notice that the FDA proposed to withdraw approval of Makena (hydroxyprogesterone 
caproate injection). Covis requested a public hearing in an effort to maintain patient access to Makena as a treatment option to 
reduce  pre-term  birth.  In  October  2022  the  hearing  resulted  in  the  FDA  Advisory  Committee  recommending  that  Makena 
should not remain on the market.

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. 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.  Idorsia  will  pay  for  the  development  of  the  combination  product  and  will  be 
responsible for applying for and obtaining global regulatory approvals for the product. The parties intend to enter into a separate 
commercial  license  and  supply  agreement  pursuant  to  which  Antares  will  provide  fully  assembled  and  labelled  product  to 
Idorsia  at  cost  plus  mark-up.  Idorsia  will  then  be  responsible  for  global  commercialization  of  the  product,  pending  FDA  or 
foreign approval. Halozyme will be entitled to receive royalties on net sales of the commercial product.

Ferring Agreement

In October 2020, we entered into an exclusive license and commercial supply agreement with Ferring for the marketed 
product NOCDURNA (desmopressin acetate) in the U.S. Under the terms of the license agreement, we paid Ferring an upfront 
payment of $5.0 million upon execution and paid an additional $2.5 million on October 1, 2021. Ferring is eligible for tiered 
royalties  and  additional  commercial  milestone  payments  potentially  totaling  up  to  $17.5  million  based  on  our  net  sales  of 
NOCDURNA  in  the  U.S.  In  October  2022,  we  sent  a  notice  to  Ferring  that  we  are  terminating  the  NOCDURNA  license 
agreement with an effective termination date in October 2023.

Lipocine Agreement

In October 2021, we entered into an exclusive license agreement with Lipocine for the product TLANDO (testosterone 
undecanoate)  in  the  U.S.  In  June  2022,  we  announced  the  commercial  launch  of  TLANDO.  Under  the  terms  of  the  license 
agreement, we paid Lipocine an upfront payment of $11.0 million. Lipocine is eligible for additional milestone payments up to 
$10.0 million and tiered royalty and commercial milestones based on net sales of TLANDO in the U.S. We will be responsible 
for the manufacturing and commercialization of TLANDO. 

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 

18

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  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.  Our  issued  patents  will  expire  between  2023  and  2039.  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 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 and an issued European patent which expires in 
2024, 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,  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 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.

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 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. Prior to our 
November  2019  restructuring,  our  research  and  development  activities  were  primarily  focused  on  the  development  of 
PEGPH20.

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.

19

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 product candidates. Avid currently produces bulk rHuPH20 for use in collaboration products. 
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  will  also  provide 
support  for  data  and  information  used  in  the  chemistry,  manufacturing  and  controls  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 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, 
our QuickShot auto-injector device for the Makena product with Covis, 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  sumatriptan  auto-
injector product and for the teriparatide pen product with Teva.

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, 
Sumatriptan Injection USP and the Makena auto-injector products, and the OTREXUP auto-injector product for 
Otter.

Pfizer supplies the active pharmaceutical ingredient (“API”) for TLANDO.

NextPharma,  an  international  pharmaceutical  manufacturing  company,  supplies  the  bulk  capsule  product  for 
TLANDO.

PCI Pharma Services (“PCI”), an international contract packaging company, bottles and packages TLANDO.

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 products XYOSTED and TLANDO. 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.

20

We sell XYOSTED, TLANDO and Hylenex recombinant in the U.S. to wholesale pharmaceutical distributors, who sell 
Hylenex  to  hospitals  and  XYOSTED  and  TLANDO  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 United States. We also 
contract  with  numerous  wholesale  distributors, 
(“McKesson”)  and 
AmerisourceBergen  Corporation  to  distribute  our  other  proprietary  products  (including  XYOSTED  and  TLANDO)  to  retail 
pharmacies as well as the Veterans Administration and other governmental agencies

including  Cardinal,  McKesson  Corporation 

 In addition to shipping and distribution services, these distributors and third-party logistics provider, Cardinal Health 105, 
Inc.,  also  known  as  Specialty  Pharmaceutical  Services  (“Cardinal”)  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  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,  but  are  not  limited  to,  Bausch  Health  Companies,  Inc.’s  product,  Vitrase®,  an 
ovine (ram) hyaluronidase, and Amphastar Pharmaceuticals, Inc.’s product, Amphadase®, a bovine (bull) hyaluronidase.

XYOSTED and TLANDO

In the U.S., there are several different formulations for TRT including intramuscular injection, transdermal patches and gels, 
oral formulations and nasal gels. 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 Allergan plc’s (“Allergan”) Androderm®. 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 
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.

21

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.

Human Capital Management

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

As  of  February  14,  2023,  we  had  393  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.

22

Diversity and Inclusion:

We seek to build and maintain a diverse team of employees that is 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 attract, develop and retain 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 45% female and 31% non-
white/Caucasian employees as of February 14, 2023.

As an equal opportunity employer, we strive to attract and connect with diverse talent who best match our core values and 
who  will  be  successful  and  thrive  at  Halozyme.  Our  recruiting  team  partners  with  hiring  managers  and  we  select  diverse 
interview panels to help provide insight at every stage of the process to identify the best possible candidate – whether internal 
or external – to fill open roles in the company. 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  two  internal  training  programs:  our  senior  leader  development  program  is  focused  on 
advancing  business  acumen  and  leadership  skills  and  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.

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 Halozyme. 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 training on cross-functional teamwork and a learning series to equip employees 
to give and receive constructive feedback.

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. Beginning in 2020 and continuing 
into  2023  we  have  increased  the  frequency  of  our  all-employee  meetings  from  monthly  to  semi-monthly  while  transitioning 
from work-from-home to a hybrid workplace to keep employees well-informed, connected and to 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, 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.

23

Employee Health and Safety:

We  are  dedicated  to  promoting  the  health  and  safety  of  our  employees  because  we  believe  it  fosters  employee 
productivity and job performance. We have developed and implemented annual workplace safety training which is intended to 
remind our employees of workplace safety procedures that may be useful in the event of emergency situations and to assist our 
employees in helping to prevent workplace accidents. We have a Safety Operations Team which meets on a quarterly basis to 
review workplace safety and adherence to safety policies. This team reports safety metrics and results of ongoing initiatives to 
the  CEO  semi-annually  and  the  Board  annually.  Further,  our  Code  of  Conduct  emphasizes  our  commitment  to  preventing 
unlawful employment discrimination and workplace harassment including mandatory, on-going sexual harassment training and 
provides a mechanism for reporting any violations of this policy.  

Our response to COVID-19:

Because  we  take  the  health  and  safety  of  our  employees,  their  families  and  our  local  communities  very  seriously,  we 
continued  case  monitoring,  contact  tracing  and  notifications  as  required,  diagnostic  testing  and  enhanced  safety  protocols  to 
ensure business continuity and risk of transmission is minimized. 

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).

24

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 impair 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 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 and the products and product candidates could be associated with adverse events or 
product recalls.

As with most pharmaceutical 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 
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 

25

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 to 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 Hylenex or our other 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 of 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,  several  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.  We  also  have  a  commercial  manufacturing  and  supply  agreement  with  Patheon  under  which 
Patheon  provides  the  final  fill  and  finishing  steps  in  the  production  process  of  Hylenex  recombinant.  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  is  intended  to  eventually  provide  additional  manufacturing  and  warehousing  capabilities  in  the  future.    If  we 
begin manufacturing and producing commercial products in the future, we will be 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.

26

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 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. 

27

Our business strategy is focused on growth of our ENHANZE technology, our auto-injector technology, 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 or delayed.

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.

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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  we  or  our  any  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 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  their  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, 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.

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

of the following:

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•

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•

•

•

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  to  successfully  integrate  the  Antares  business,  or  failure  of  the  Antares  business  to  perform  could  adversely 
impact our stock price and future business and operations.

In May 2022, we completed the acquisition of Antares. Our integration of the Antares business into our operations will be 
a complex and time-consuming process that may not be successful. The primary areas of focus for successfully combining the 
business  of  Antares  with  our  operations  may  include,  among  others:  retaining  and  integrating  key  employees,  integrating 
information, communications and other systems, and managing the growth of the combined company.

Even if we successfully integrate the business of Antares into our operations, we may not realize the anticipated benefits. 
We  acquired  Antares  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. 

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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 coronavirus 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 expect to 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,  2022  was  $1,506.1 
million,  which  includes  $13.5  million  in  aggregate  principal  amount  of  the  2024  Convertible  Notes  and  $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 $0.1 million,  $14.4 million and $17.9 million for the 2024 Convertible Notes, 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.  For 
example,  as  of  December  31,  2022,  the  conditional  conversion  feature  was  triggered  and  our  2024  Convertible  Notes  are 
classified as a current liability. 

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 and an issued 
European  patent  which  expires  in  2024,  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 sufficient 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 or 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 or delayed.

From  time  to  time,  our  collaborators  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 collaborators’ 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:

•

•

•

•

•

•

•

•

•

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,  2022  were  $59.46  and  $31.36,  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:

•

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

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•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

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 November 18, 
2019, 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  or  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 

37

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:

•

•

•

•

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 several patents 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  any  of  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 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.  In  addition,  costly  litigation  could  be 
necessary to protect our patent position.

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.

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 these agreements, and we 
might not be able to resolve these disputes in our favor.

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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, we may 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 substantial 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.

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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 
enforce our intellectual property rights against competitors develop and commercialize products based on our discoveries.

Patent  protection  for  protein-based  therapeutic  products  is  highly  uncertain  and  involves  complex  legal  and  factual 
questions. In recent years, there have been significant changes in patent law, including the legal standards that govern the scope 
of  protein  and  biotechnology  patents.  Standards  for  patentability  of  full-length  and  partial  genes,  and  their  corresponding 
proteins,  are  changing.  Recent  court  decisions  have  made  it  more  difficult  to  obtain  patents,  by  making  it  more  difficult  to 
satisfy  the  patentable  subject  matter  requirement  and  the  requirement  of  non-obviousness,  have  decreased  the  availability  of 
injunctions  against  infringers,  and  have  increased  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,  the  Leahy-Smith  America  Invents  Act  (HR  1249)  was  signed  into  law  in  September  2011,  which 
among other changes to the U.S. patent laws, changes patent priority from “first to invent” to “first to file,” implements a post-
grant opposition system for patents and provides for a prior user defense to infringement. These judicial and legislative changes 
have introduced 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.

There  also  have  been,  and  continue  to  be,  policy  discussions  concerning  the  scope  of  patent  protection  awarded  to 
biotechnology  inventions.  Social  and  political  opposition  to  biotechnology  patents  may  lead  to  narrower  patent  protection 
within the biotechnology industry. Social and political opposition to patents on genes and proteins and recent court decisions 
concerning patentability of isolated genes may lead to narrower patent protection, or narrower claim interpretation, for isolated 
genes, their corresponding proteins and inventions related to their use, formulation and manufacture. Patent protection relating 
to  biotechnology  products  is  also  subject  to  a  great  deal  of  uncertainty  outside  the  U.S.,  and  patent  laws  are  evolving  and 
undergoing  revision  in  many  countries.  Changes  in,  or  different  interpretations  of,  patent  laws  worldwide  may  result  in  our 
inability to obtain or enforce patents, and may allow others to use our discoveries to develop and commercialize competitive 
products, which would 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 

40

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. 
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  will  encounter  similar  regulatory  and 
legislative issues in most other countries outside the U.S.

In  addition,  private  payers  in  the  US,  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 are 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, Bausch Health 
Companies,  Inc.’s  FDA-approved  product,  Vitrase®,  an  ovine  (ram)  hyaluronidase,  and  Amphastar  Pharmaceuticals,  Inc.’s 
product,  Amphadase®,  a  bovine  (bull)  hyaluronidase.  For  our  ENHANZE  technology,  such  competitors  may  include  major 

41

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.

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 of 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.

42

Item 2. Properties

Our properties consist of leased office, laboratory, warehouse and manufacturing facilities. Our administrative offices and 
research facilities are currently located in San Diego, California. In addition, we have an office in Ewing, New Jersey. We also 
lease  a  building  in  Minnetonka,  Minnesota  consisting  of  office,  laboratory,  manufacturing  and  warehousing  space.  As  of 
December  31,  2022,  we  leased  an  aggregate  of  approximately  194,000  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 management’s 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.

43

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, 2023, 

we had approximately 69,016 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  November  2019,  we  announced  that  the  Board  of  Directors  authorized  the  initiation  of  a  capital  return  program  to 
repurchase  up  to  $550.0  million  of  outstanding  common  stock  over  a  three-year  period.  The  shares  were  purchased  through 
open  market  transactions  and  through  an  Accelerated  Share  Repurchase  (ASR)  agreement.  During  2021,  we  repurchased  4.6 
million shares of common stock for $200.0 million at an average price of $43.02 under the program. We completed the program 
in October 2021 having repurchased a total of 22.3 million shares for $550.0 million at an average price per share of $24.72. 
We retired the repurchased shares and they resumed the status of authorized and unissued shares.

In December 2021, the Board of Directors authorized our second share repurchase program, to repurchase up to $750.0 
million of our outstanding common stock over a three-year period. In August 2022, we entered into an ASR agreement with 
Bank  of  America  to  repurchase  $109.8  million  of  our  common  stock.  At  inception,  pursuant  to  the  agreement,  we  paid 
$109.8  million  to  Bank  of  America  and  took  an  initial  delivery  of  2.0  million  shares.  In  December  2022,  we  finalized  the 
transaction  and  received  an  additional  0.4  million  shares.  We  retired  the  repurchased  shares  and  they  resumed  the  status  of 
authorized  and  unissued  shares.  Under  this  program,  through  December  31,  2022,  we  repurchased  8.4  million  shares  of 
common stock for $350.0 million at an average price of $41.69.

44

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, 2017 to December 31, 2022. 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     . . . . . . . . . . . . . . . .

12/31/2017
$100
$100
$100

12/31/2018
$72
$97
$91

12/31/2019
$88
$133
$114

12/31/2020
$211
$192
$144

12/31/2021
$198
$235
$144

12/31/2022
$281
$159
$130

45

Item 6.

(Reserved)

46

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. 
References to “Notes” are Notes included in our Notes to Consolidated Financial Statements.

Overview

Halozyme  Therapeutics,  Inc.  is  a  biopharma  technology  platform  company  that  provides  innovative  and  disruptive 

solutions with the goal of improving the patient experience and potentially outcomes. 

Our proprietary enzyme, rHuPH20, is used to facilitate the subcutaneous (“SC”) delivery of injected drugs and fluids. We 
license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug 
delivery technology (“ENHANZE”) with the partners’ proprietary compounds. 

Our  first  commercially  approved  product  Hylenex®  recombinant  (“Hylenex”),  and  our  ENHANZE  partners’  approved 
products and product candidates are based on rHuPH20, our patented recombinant human hyaluronidase enzyme. rHuPH20 is 
the active ingredient Hylenex®, that 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”), Alexion Pharma International Operations Unlimited Company (an indirect wholly owned subsidiary of AstraZeneca 
PLC)(“Alexion”), argenx BVBA (“argenx”), Horizon Therapeutics plc. (“Horizon”), ViiV Healthcare (the global specialist HIV 
Company  majority  owned  by  GlaxoSmithKline)  (“ViiV”)  and  Chugai  Pharmaceutical  Co.,  Ltd  (“Chugai”).  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 receive royalties from three of these collaborations, including royalties from sales of 
one  product  from  the  Takeda  collaboration,  three  products  from  the  Roche  collaboration  and  one  product  from  the  Janssen 
collaboration.  Future  potential  revenues  from  ENHANZE  collaborations  and  from  the  sales  and/or  royalties  of  our  approved 
products will depend on the ability of our partners, in some areas supported by Halozyme, to develop, manufacture, secure and 
maintain regulatory approvals for approved products and product candidates and commercialize product candidates.

Through our recent acquisition of Antares Pharma, Inc. (“Antares”), we also develop, manufacture and commercialize, for 
ourselves  or  with  our  partners,  drug-device  combination  products  using  our  advanced  auto-injector  technologies.  Also  as  a 
result  of  our  acquisition  of  Antares,  our  commercial  portfolio  of  proprietary  products  includes  XYOSTED®,  TLANDO®  and 
NOCDURNA®.  We  have  commercialized  auto-injector  products  with  several  pharmaceutical  companies  including  Teva 
Pharmaceutical Industries, Ltd. (“Teva”), Covis Group S.a.r.l. (“Covis”) and Otter Pharmaceuticals, LLC (“Otter”). We have 
development programs including auto-injectors with Idorsia Pharmaceuticals Ltd. (“Idorsia”) and Pfizer.

47

Our 2022 and recent key events are as follows:

Roche

•

•

•

•

•

In  August  2022,  Roche  announced  that  the  Phase  3  IMscin001  study  evaluating  a  subcutaneous  formulation  of 
Tecentriq®  (atezolizumab)  with  ENHANZE  met  its  co-primary  endpoints.  The  study  showed  non-inferior  levels  of 
Tecentriq  in  the  blood  (pharmacokinetics),  when  injected  subcutaneously,  compared  with  IV  infusion,  in  cancer 
immunotherapy-naïve  patients  with  advanced  or  metastatic  non-small  cell  lung  cancer  for  whom  prior  platinum 
therapy  has  failed.  The  safety  profile  of  the  SC  formulation  was  consistent  with  that  of  IV  Tecentriq.  In  November 
2022, Roche submitted a BLA to the FDA and a MAA to the EMA for SC atezolizumab with ENHANZE across all 
approved  indications  of  IV  Tecentriq.  In  January  2023,  the  FDA  accepted  the  BLA  with  a  PDUFA  goal  date  of 
September 15, 2023.

In  November  2022,  Roche  submitted  an  Initial  Market  Application  (IMA)  for  Mabthera  SC  to  the  Center  for  Drug 
Evaluation (CDE) in China.

In  October  2022,  Roche  Pharmaceuticals  China  announced  the  approval  of  Herceptin  SC  (trastuzumab  injection 
subcutaneous with ENHANZE) in China for the treatment of patients with early-stage and metastatic HER2-positive 
breast cancer.

In  July  2022,  Roche  submitted  an  IMA  for  the  fixed-dose  combination  of  Perjeta®  (pertuzumab)  and  Herceptin  for 
subcutaneous injection (Phesgo™) to the CDE in China.

In April 2022, Roche initiated a phase 3 study evaluating OCREVUS (ocrelizumab) with ENHANZE in subjects with 
multiple sclerosis.

argenx

•

In November 2022, argenx announced the acceptance of the BLA for SC efgartigimod for the treatment of adults with 
generalized  myasthenia  gravis  (gMG).  In  January  2023,  argenx  announced  that  FDA  extended  the  PDUFA  date  to 
June 20, 2023.

•

•

•

•

•

•

•

•

In November 2022, argenx announced the submission of a Marketing Authorization Application to the EMA for SC 
efgartigimod for the treatment of adults with gMG.

In  June  2022,  argenx  initiated  a  phase  2  study  evaluating  efgartigimod  with  ENHANZE  in  subjects  with  bullous 
pemphigoid.

In  March  2022,  argenx  announced  that  data  from  argenx’s  phase  3  ADAPT-SC  study  evaluating  SC  efgartigimod 
(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)  intravenous  IV 
formulation in gMG patients. 

Chugai

In September 2022, Chugai Pharmaceutical Co., Ltd. (a Member of the Roche Group) announced the submission of a 
NDA in Japan for the fixed-dose SC combination of pertuzumab and trastuzumab (same monoclonal antibodies as in 
Perjeta and Herceptin) with ENHANZE®.

In May 2022, Chugai initiated a Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and safety of a 
targeted antibody administered subcutaneously with ENHANZE.

In  March  2022,  we  entered  into  a  global  collaboration  and  license  agreement  with  Chugai  Pharmaceutical  Co.,  Ltd.  
The license gives Chugai exclusive access to ENHANZE drug delivery technology for an undisclosed target. Under 
the  terms  of  the  agreement,  we  received  an  upfront  payment  of  $25  million  and  Chugai  is  obligated  to  make  future 
payments  of  up  to  $160  million,  in  the  aggregate,  subject  to  achievement  of  specified  development,  regulatory  and 
sales-based milestones. We will also be entitled to receive royalties on sales of commercialized medicines using our 
ENHANZE technology.

Janssen

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 epidermal growth factor receptor (EGFR)-mutated non-small cell 
lung cancer (PALOMA-2).

In September 2022, Janssen initiated a Phase 3 study of lazertinib and amivantamab with ENHANZE in patients with 
EGFR-mutated advanced or metastatic non-small cell lung cancer (PALOMA-3).

48

ViiV

In  June  2022,  ViiV  initiated  enrollment  of  a  Phase  1  single  dose  escalation  study  in  subjects  with  HIV  to  evaluate 
pharmacokinetics, safety and tolerability of long-acting cabotegravir administered subcutaneously with ENHANZE.

In March 2022, ViiV initiated enrollment of a Phase 1 study to evaluate the safety and pharmacokinetics of N6LS, a 
broadly neutralizing antibody, administered subcutaneously with ENHANZE.

Takeda

In December 2022, Takeda achieved a sales milestone for HYQVIA, triggering a payment of $10 million.

In  July  2022,  Takeda  filed  a  sBLA  for  the  potential  expanded  use  of  HYQVIA  for  pediatric  indication  for  primary 
immunodeficiency.

In  July  2022,  Takeda  announced  positive  topline  results  from  pivotal  Phase  3  trial  evaluating  HYQVIA® 
(Immunoglobulin  infusion  10%  (Human)  with  rHuPH20),  for  maintenance  treatment  of  chronic  inflammatory 
demyelinating polyradiculoneuropathy (CIDP), and Takeda confirmed its intention to submit regulatory applications in 
the United States and European Union in its fiscal year 2022.

BMS

BMS plans to initiate a Phase 3 trial in early 2023 to demonstrate the drug exposure level 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).

In August 2022, BMS initiated a Phase 3 trial to compare the drug levels of nivolumab with ENHANZE administered 
subcutaneously  versus 
resection 
(CheckMate-6GE).

in  participants  with  melanoma 

following  complete 

IV  administration 

In June 2022, BMS nominated an undisclosed target resulting in a $5 million payment.

•

•

•

•

•

•

•

•

Corporate

•

•

•

•

•

•

In January 2023, we elected to redeem on March 17, 2023 all of our remaining outstanding 1.25% convertible senior 
notes due 2024. 

In August 2022, we completed the sale of $720.0 million aggregate principal amount of the 2028 Convertible Senior 
Note. We used a portion of the net proceeds to facilitate an induced conversion of a portion of the 2024 Convertible 
Senior Notes. In connection with the induced conversion, we paid the holders $77.6 million in cash and issued 1.51 
million shares.  We also used a portion of the net proceeds to repay the $250.0 million term loan facility due 2026 and 
the $120.0 million revolving credit facility.

In August 2022, we entered into an amendment to our credit agreement that increased the size of our revolving credit 
facility from $350 million to $575 million.

In the third quarter of 2022, we accelerated $100 million share repurchase from 2023 into 2022. We repurchased 2.1 
million shares of common stock in open market purchases for $90.2 million at an average price per share of $43.09 
and entered into an ASR agreement to repurchase $109.8 million of our common stock for which we took an initial 
delivery 2.0 million shares. In December 2022, we finalized the ASR transaction and received an additional 0.4 million 
shares for a total of 2.4 million shares at an average price per share of $45.62. During 2022, we repurchased a total of 
4.5  million  shares  for  $200.0  million  at  an  average  price  per  share  of  $44.44.  As  of  December  31,  2022,  we 
repurchased  a  total  of  8.4  million  shares  for  $350.0  million  at  an  average  price  per  share  of  $41.69  under  our  $750 
million 3-year share repurchase plan.

In  June  2022,  we  completed  an  $150  million  ASR  that  was  initiated  in  December  of  2021,  resulting  in  the  total 
repurchase of 3.9 million shares at a price of $38.51 per share.

In  June  2022,  we  announced  the  commercial  launch  of  TLANDO®  (testosterone  undecanoate),  an  oral  treatment 
indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of 
endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO® was approved by the U.S. Food 
and Drug Administration (FDA) on March 28, 2022.

49

•

•

•

In  May  2022,  we  completed  the  acquisition  of  Antares  resulting  in  an  expansion  of  our  commercial  portfolio  of 
proprietary and partnered products and the potential for future growth through new agreements. 

In May 2022, in connection with the closing of Antares acquisition, we entered into a credit agreement that provided 
for a $350 million revolving credit facility and a $250 million term loan facility. The 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, refinance Antares’ existing debt and pay fees and expenses in connection with the acquisition.  

In March 2022, we entered into an agreement for assignment and assumption of a lease with Seismic Software, Inc. 
pursuant to which effective January 1, 2023 we assumed Seismic’s office lease, as amended with Kilroy Realty L.P. 
for approximately 73,238 square feet of space in office and research facilities. The premises are intended to serve as 
our new headquarters which we occupied on January 1, 2023.

50

Results of Operations

Comparison of Years Ended December 31, 2022 and 2021 

Royalties – Royalty revenue was $360.5 million in 2022 compared to $203.9 million in 2021. The increase was mainly 
driven  by  continued  sales  uptake  of  DARZALEX  FASPRO  by  Janssen  and  Phesgo  by  Roche  in  all  geographies  and 
contribution from new device royalty revenue as a result of the Antares acquisition, 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 ENHANZE 
partner product launches, offsetting the ongoing impact from biosimilars related to our mature ENHANZE partner products.

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

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

$ 

$ 

Year Ended December 31,

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

2021
80,961 
23,263 
— 
104,224 

Dollar Change
1,123 
$ 
49,586 
36,097 
86,806 

$ 

Percentage 
Change

 1 %
 213 %
 100 %
 83 %

  Total  product  sales,  net  increased  by  $86.8  million  in  2022  compared  to  2021,  primarily  due  to  contribution  from  our 
proprietary and device partnered products as the result of the Antares acquisition. We expect that sales of proprietary products 
will grow in future years as we work to expand market share in the TRT market. We expect that product sales of bulk rHuPH20 
and device partnered products will fluctuate in future periods based on the needs of our partners. 

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

Year Ended December 31,

2022

2021

Dollar Change

Percentage 
Change

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:

BMS     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chugai      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Roche    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Janssen    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

Takeda       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViiV      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Subtotal      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device licensing and development revenue     . . . . . . . . . . . . .
Total revenues under collaborative agreements     . . . . .

$ 

$ 

30,000  $ 
25,000 
19,000 

15,000 
10,000 
— 
99,000  $ 
9,611 
108,611  $ 

25,000 
— 
5,000 

59,000 
— 
45,000 
134,000 
1,186 
135,186 

$ 

$ 

$ 

5,000 
25,000 
14,000 

(44,000) 
10,000 
(45,000) 
(35,000) 
8,425 
(26,575) 

 20 %
 100 %
 280 %

 (75) %
 100 %
 (100) %
 (26) %
 710 %
 (20) %

Revenue  from  license  fees  decreased  by  $35.0  million  in  2022,  compared  to  2021  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. 

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 our proprietary and device partnered 
products  and  bulk  rHuPH20.  Cost  of  product  sales  were  $139.3  million  in  2022  compared  to  $81.4  million  in  2021.  The 
increase of $57.9 million in cost of product sales was mainly due to an increase in sales in our proprietary, partnered products as 
a result of the Antares acquisition and amortization of inventory step-up associated with purchase accounting for the Antares 
acquisition.

Amortization  of  intangibles  –  Amortization  of  intangibles  expense  was  $43.1  million  for  2022.  The  amortization  of 
intangibles expense is due to the acquisition of Antares in May 2022, in which we acquired intangible assets that are amortized 
over their useful lives.

51

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  ENHANZE  collaborations  and  our  development  platform.  Research  and  development  expenses  were  $66.6 
million in 2022 compared to $35.7 million in 2021. The increase of $30.9 million is primarily due to planned investments in 
ENHANZE  and  an  increase  in  compensation  expense  related  to  the  ongoing  combined  larger  workforce  as  a  result  of  the 
Antares acquisition.

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. SG&A expenses were $143.5 million in 2022 compared to $50.3 million in 2021. The 
increase  of  $93.2  million,  was  primarily  due  to  one-time  Antares  Pharma  acquisition  costs  and  an  increase  in  compensation 
expense related to the ongoing combined larger workforce.

Interest  Expense  –  Interest  expense  was  $16.9  million  in  2022  compared  to  $7.5  million  in  2021.  The  increase  of  $9.4 
million was primarily due an increase in interest expense related to the 2022 term loans, the revolving credit facility and the 
2028 Convertible Notes.

Income Taxes – Income tax expense was $46.8 million in 2022 compared to income tax benefit of $154.2 million in 2021. 
The increase in income tax expense is due to the recording of our first year of income tax expense in the current year whereas in 
the prior year period there was an income tax benefit due to the release of the valuation allowance.

Comparison of Years Ended December 31, 2021 and 2020

For  discussion  related  to  changes  in  financial  condition  and  the  results  of  operations  for  fiscal  year  2021  compared  to 
fiscal  year  2020,  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, 2021, which was 
filed with the SEC on February 22, 2022.

Liquidity and Capital Resources

Our principal sources of liquidity are our existing cash, cash equivalents and available-for-sale marketable securities. As 
of December 31, 2022, we had cash, cash equivalents and marketable securities of $362.8 million. We believe that our current 
cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least the next twelve months. We 
expect to fund our operations going forward with existing cash resources, anticipated revenues from our existing collaborations 
and cash that we may raise through future 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, offer and sell additional equity, debt securities and warrants to 
purchase  any  of  such  securities,  either  individually  or  in  units  to  raise  capital  to  raise  funds  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  $1,538.5 
million, with $13.5 million classified as short term. Future interest payments associated with our convertible notes total $48.9 
million, with $9.3 million payable within 12 months.

Leases

We have lease arrangements related to our office and research facilities and certain autos under non-cancelable operating 

leases. As of December 31, 2022, we have lease payment obligations of $47.0 million, with $7.8 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 here were limited to the non-cancelable portion of the agreement terms or the 
minimum cancellation fee. As of December 31, 2022, we had third-party manufacturing obligations of $97.8 million, payable 
within 12 months.

52

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.  We  also  have  commitments  which  represents  minimum 
royalty payments to be paid in accordance with the TLANDO exclusive license agreement with Lipocine. As of December 31, 
2022,  we  had  other  purchase  obligations  and  other  commitments  of  $48.7  million,  with  $44.2  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, 
2022. 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.

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

Operating Activities

Net  cash  provided  by  operations  was  $240.1  million  in  2022  compared  to  $299.4  million  in  2021.  The  $59.3  million 
decrease  in  cash  provided  by  operations  was  mainly  due  to  an  increase  in  transaction  expenses  associated  with  the  Antares 
acquisition and an increase in working capital spend, partially offset by an increase in royalties revenue for 2022 compared to 
the prior year.

Investing Activities

Net  cash  used  in  investing  activities  was  $487.0  million  in  2022  compared  to  net  cash  used  in  investing  activities  of 
$406.3  million  in  2021.  The  increase  in  cash  used  in  investing  activities  was  primarily  due  to  the  acquisition  of  Antares, 
partially offset by an increase in cash from the sale of marketable securities and the sale of assets in 2022.

Financing Activities

Net  cash  provided  by  financing  activities  was  $362.4  million  in  2022,  compared  to  net  cash  provided  by  financing 
activities of $77.9 million in 2021, mainly due to $702.0 million cash received from the 2028 Convertible Notes offering and 
$291.6 million decrease related to the 2024 Convertible Notes induced conversion, a $150.1 million decrease in repurchase of 
common stock and a $1.5 million increase in net proceeds from the issuance of common stock under equity incentive plans, 
partially offset by, $784.9 million cash received from the 2027 Convertible Notes offering in the prior year and a $69.1 million 
payment for the Capped Call Transactions during the current year.

Share Repurchases

In  November  2019,  our  Board  of  Directors  approved  a  $550  million  share  repurchase  program,  pursuant  to  which  we 
could repurchase our issued and outstanding shares of common stock from time to time. We completed the share repurchase 
program in October 2021 and retired the repurchased shares. In December 2021, we announced our second share repurchase 
program,  to  repurchase  up  to  $750.0  million  of  our  outstanding  common  stock  over  a  three-year  period.  See  Note  10. 
Stockholders’ Equity, within the notes to the consolidated financial statements for additional information regarding our share 
repurchases.

53

 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 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  5  consecutive 
business days immediately after any 5 consecutive trading day period (such 5 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, 2022, the 2028 Convertible Notes are 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” and collectively with the 2024 Convertible Notes the “Convertible Notes”). The net 
proceeds  in  connection  with  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 will rank senior in right of payment to 
all indebtedness that is expressly subordinated in right of payment to the 2027 Convertible Notes, will rank equally in right of 
payment  with  all  existing  and  future  liabilities  that  are  not  so  subordinated,  will  be  effectively  junior  to  any  secured 
indebtedness  to  the  extent  of  the  value  of  the  assets  securing  such  indebtedness  and  will  be  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.  The  Notes  will  be  convertible,  regardless  of  the  foregoing  circumstances,  at  any  time  from,  and 

54

including, September 1, 2026 until the close of business on the scheduled trading day immediately preceding the maturity date. 
As of December 31, 2022, the 2027 Convertible Notes are 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.

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 (“2024 Convertible Notes”). The net proceeds in connection with 2024 Convertible Notes, after deducting the 
initial  purchases’  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 are presented as a debt discount.

The 2024 Convertible Notes pay interest semi-annually in arrears on June 1st and December 1st of each year, beginning 
on June 1, 2020, at an annual rate of 1.25%. The 2024 Convertible Notes are general unsecured obligations and will rank senior 
in right of payment to all indebtedness that is expressly subordinated in right of payment to the 2024 Convertible Notes, will 
rank equally in right of payment with all existing and future liabilities that are not so subordinated, will be effectively junior to 
any  secured  indebtedness  to  the  extent  of  the  value  of  the  assets  securing  such  indebtedness  and  will  be  structurally 
subordinated  to  all  indebtedness  and  other  liabilities  (including  trade  payables)  of  the  our  current  or  future  subsidiaries.  The 
2024 Convertible Notes have a maturity date of December 1, 2024.

Holders  may  convert  their  2024  Convertible  Notes  at  their  option  only  in  the  following  circumstances:  (1)  during  any 
calendar quarter commencing after the calendar quarter ending on March 31, 2020, 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 2024 Convertible Notes; (4) if we call such notes for redemption; and 
(5) at any time from, and including, June 1, 2024 until the close of business on the scheduled trading day immediately before 
the maturity date. As of December 31, 2022, the 2024 Convertible Notes are convertible and are classified as a current liability

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,  if  applicable,  to  deliver  shares  of  common  stock.  The  conversion  rate  for  the  2024 
Convertible  Notes  will  be  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  is  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  includes  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 is included in Other income (expense) of the Condensed Consolidated Statements 
of Operations for the twelve months ended December 31, 2022. The induced conversion expense represents 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  includes  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  is  included  in  other  income  (expense)  of  the  consolidated  statements  of 
income. The induced conversion expense represents 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, and we expect to make cash payment 

of $13.5 million to effect the redemption in March 2023.

55

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 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”). The 
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,  refinance  Antares’  existing  debt  and  pay  fees  and  expenses  in  connection  with  the 
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 
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,  increases  the  size  of  the  revolving  credit  facility  from  $350  million  to 
$575  million.  The  terms  of  the  revolving  credit  facility  are  otherwise  unchanged.  Concurrently  with  the  entry  into  the 
Amendment, the Company repaid the entire outstanding term loan facility and repaid all outstanding loans under the revolving 
credit facility under the Credit Agreement. 

 As of December 31, 2022, the revolving credit facility was undrawn.   

56

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, or 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 to the Consolidated Financial Statements included in the 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.

57

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 use 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, 2022 would have 
affected pre-tax earnings by 
approximately $2.4 million in 2022. 

If  the  subsequent  actual  results  and 
updated  projections  of  the  underlying 
business activity change compared with 
the assumptions and projections used to 
develop  these  values,  we  could  record 
impairment  charges.  In  addition,  we 
have  estimated  the  economic  lives  of 
certain  acquired  assets  and  these  lives 
to  calculate  amortization 
are  used 
expense. 
the 
If  our  estimates  of 
economic  lives  change,  amortization 
expenses  could  be  accelerated  or 
slowed.

If  there  is  a  change  in  the  inputs  and 
assumptions  used  to  fair  value  the 
contingent  liability,  that  could  have  a 
material  impact  on  our  consolidated 
statements  of 
balance 
income.

sheet  and 

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 awards at the date of grant using the 
closing market value of our common stock 
on the date of grant. 

Business Combinations
In  connection  with  the  Antares  acquisition, 
as  disclosed  in  Note  3,  the  acquisition  of 
Antares  has  been  accounted  for  using  the 
in 
acquisition  method  of 
accounting 
accordance  with  ASC  805,  under 
the 
acquisition  method  of  accounting  we 
recognized  the  identifiable  assets  acquired 
and the liabilities assumed at their fair values 
as  of  the  date  of  acquisition.  We  measured 
the  goodwill  as  the  excess  of  consideration 
transferred,  which  we  also  measure  at  fair 
value, over the net of the acquisition date fair 
values of the identifiable assets acquired and 
liabilities assumed.

Contingent Liability
liability  with  a  value  of 
A  contingent 
$15.7  million  was  assumed  related 
to 
TLANDO.  The  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. 
the 
fair  value  of 
the 
We 
contingent liability on a quarterly basis.

remeasure 

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.

estimates 

and 
Significant 
assumptions  used  in  estimating  the 
fair  value  of  acquired  technology 
and  other 
intangible 
identifiable 
assets include future cash flows that 
we  expect  to  generate  from  the 
acquired assets.

risk 

free 

The  inputs  used  in  the  Monte  Carlo 
simulation 
significant 
include 
estimates  and  assumptions  which 
include  forecasted  revenues,  cost  of 
rate,  weighted 
debt, 
average  cost  of  capital,  revenue 
revenue 
market  price 
volatility. 
and 
assumptions  used  in  the  income 
approach  include  the  probability  of 
achieving  certain  milestones  and  a 
discount rate. 

risk  and 
Estimates 

58

or 

an 

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

change 

Significant 
and 
assumptions  used  in  estimating  the 
fair value of the intangible assets.

estimates 

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

Recent Accounting Pronouncements

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,  2022,  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  will  probably  decline.  Based  on  our  current  investment  portfolio  as  of 
December 31, 2022, we do not believe that our results of operations would be materially impacted by an immediate change of 
10% in interest rates. 

We  do  not  hold  or  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

On  May  24,  2022,  we  completed  the  acquisition  of  Antares.  Under  guidelines  established  by  the  SEC,  companies  are 
permitted to exclude acquisitions from their assessment of internal control over financial reporting during the first year of an 
acquisition  while  integrating  the  acquired  company.  In  conducting  our  evaluation  of  the  effectiveness  of  our  internal  control 
over  financial  reporting,  we  excluded  the  internal  control  activities  of  Antares  from  our  evaluation  for  the  period  ended 
December 31, 2022. We are in the process of integrating Antares into our system of internal control over financial reporting. 

Except  as  noted  above,  there  have  been  no  significant  changes  in  our  internal  control  over  financial  reporting  that 
occurred during the period ended December 31, 2022 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 
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.

We have included the financial results of Antares in the consolidated financial statements from the date of acquisition. 
Antares represented approximately 9% of total assets as of December 31, 2022 and 17% of total revenues, for the year ended 
December 31, 2022. 

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2022.  In 
conducting  its  assessment  of  the  effectiveness  of  our  internal  control  over  financial  reporting,  our  management  excluded  the 
internal control activities of Antares from its evaluation for the period ended December 31, 2022. 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, 2022, 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, 2022. The report appears below.

61

Report of Independent Registered Public Accounting Firm

The Board of Directors and Stockholders
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, 2022, 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, 2022, based on the 
COSO criteria.

As  indicated  in  the  accompanying  Management’s  Report  On  Internal  Control  Over  Financial  Reporting,  management’s 
assessment  of  and  conclusion  on  the  effectiveness  of  internal  control  over  financial  reporting  did  not  include  the  internal 
controls  of  Antares  Pharma,  Inc.,  which  is  included  in  the  2022  consolidated  financial  statements  of  the  Company  and 
constituted 9% of total assets as of December 31, 2022 and 17% of total revenues, for the year then ended. Our audit of internal 
control  over  financial  reporting  of  the  Company  also  did  not  include  an  evaluation  of  the  internal  control  over  financial 
reporting of Antares Pharma, Inc.

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, 2022 and 2021,  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, 2022, and the related notes and the financial statement schedule listed in the Index at Item 15(a) and our 
report dated February 21, 2023 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 21, 2023 

62

Item 9B. Other Information

None.

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 2023 Annual Meeting 
of Stockholders 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.  (60),  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-
US 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 US 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  (40),  Senior  Vice  President,  Chief  Financial  Officer.  Ms.  LaBrosse  has  served  as  the  Senior  Vice 
President,  Chief  Financial  Officer  since  February  2022  and  has  over  19  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 (56), 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 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, 

63

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 (59), 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, 2022:

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)

6,550,450 

— 
6,550,450 

$24.99

—
$24.99

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

17,413,834 

— 
17,413,834 

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

Stock Plan. This includes 2,650,103 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  caption  “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.

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 at December 31, 2022 and 2021    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Consolidated Statements of Income for Each of the Years Ended December 31, 2022, 2021 and 2020      . . . . . . . . .
Consolidated Statements of Comprehensive Income for Each of the Years Ended December 31, 2022,
     2021 and 2020     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Cash Flows for Each of the Years Ended December 31, 2022, 2021 and 2020     . . . . . .
Consolidated Statements of Stockholders’ Equity for Each of the Years Ended December  31, 2022,
     2021 and 2020     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes to the Consolidated Financial Statements     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page

F-1

F-4
F-5

F-6
F-7

F-9

  F-10

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-45

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.

65

  
 
 
 
 
 
 
 
 
 
 
 
 
 
(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

4.6

4.7

10.1

10.2

10.3

10.4

10.5

10.6

Amended and Restated Certification of Incorporation

Bylaws, as amended

Indenture, dated November 18, 2019, between The Bank of New 
York Mellon Trust Company, N.A., as trustee, and the Registrant

Form of Note, dated November 18, 2019, between the Bank of New 
York Mellon Trust Company, N.A., as trustee, and the Registrant

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 

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

8-K

8-K

8-K

5/3/2019

12/10/2021

11/18/2019

8-K

11/18/2019

8-K

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

5/10/2022

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

8-K

7/5/2019

10.7#

Halozyme Therapeutics, Inc. 2021 Employee Stock Purchase Plan

10-Q

11/8/2022

10.8#

10.9#

Halozyme Therapeutics, Inc. 2021 Stock Plan

Form of Stock Option Agreement (2021 Stock Plan)

8-K

8-K

5/5/2021

5/5/2021

66

Exhibit

Number

10.10#

Exhibit Title

Herewith

Form

Date Filed

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

8-K

5/5/2021

Incorporated by Reference

Filed

10.11#

Form of Restricted Stock Units Agreement (2021 Stock Plan)

10.12#

Form of Restricted Stock Award Agreement (2021 Stock Plan)

10.13#

Form of Performance Stock Units (2021 Stock Plan)

10.14#

10.15#

10.16#

10.17#

10.18#

10.19#

10.20#

10.21#

10.22#

Form of Directors Restricted Stock Units Agreement (2021 Stock 
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)

8-K

8-K

8-K

8-K

8-K

8-K

8-K

5/5/2021

5/5/2021

5/5/2021

5/5/2021

4/6/2018

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

10.23#

Form of Indemnity Agreement for Directors and Executive Officers

8-K

12/20/2007

10.24#

Form of PSU Agreement (2011 Stock Plan)

10.25#

Form of PSU Agreement (2011 Stock Plan)

10.26#

Severance Policy

10.27#

Form of Amended and Restated Change In Control Agreement with 
Officer

10-Q

8/10/2020

10-K

10-Q

10-Q

2/23/2021

11/8/2022

11/9/2015

67

Incorporated by Reference

Filed

Herewith

Form

Date Filed
DEF-14A 3/23/2016

10-K

10-K

2/22/2022

2/22/2022

X
X

X

X

X

X

X
X
X
X

X

X

Exhibit

Number
10.28#

10.29#

10.30#

21.1
23.1

31.1

31.2

32

Halozyme Therapeutics, Inc. Executive Incentive Plan

Exhibit Title

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

Halozyme Therapeutics, Inc Directors Deferred Equity 
Compensation Plan
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

101.INS XBRL Instance Document - the instance document does not appear 

in the interactive Data File because its XBRL tags are embedded 
within the Inline XBRL document.

101.SCH 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.

Item 16. Form 10-K Summary

None.

68

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 21, 2023

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

69

 
 
 
 
 
 
 
 
 
 
 
 
 
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
 (Principal Executive Officer), Director

  February 21, 2023

/s/   Nicole LaBrosse

       Nicole LaBrosse

/s/    Jeffrey W. Henderson

       Jeffrey W. Henderson

/s/    Connie L. Matsui

       Connie L. Matsui

/s/   Jean-Pierre Bizzari

     Jean-Pierre Bizzari

/s/    Bernadette Connaughton

       Bernadette Connaughton

/s/    James M. Daly

       James M. Daly

/s/    Barbara Duncan
        Barbara Duncan

/s/    Matthew L. Posard
 Matthew L. Posard

/s/   Moni Miyashita

      Moni Miyashita

  Senior Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)

  February 21, 2023

Chair of the Board of Directors

  February 21, 2023

Director

Director

Director

Director

Director

Director

Director

  February 21, 2023

February 21, 2023

  February 21, 2023

  February 21, 2023

February 21, 2023

February 21, 2023

February 21, 2023

70

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Report of Independent Registered Public Accounting Firm

The Board of Directors and Stockholders
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,  2022  and  2021,  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, 2022, and the related notes and the 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 at 
December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended 
December 31, 2022, 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,  2022,  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 21, 2023 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 Matters

The critical audit matters communicated below are matters arising from the current period audit of the financial statements 
that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures 
that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The 
communication of these critical audit matters do not alter in any way our opinion on the consolidated financial statements, taken 
as  a  whole,  and  we  are  not,  by  communicating  these  critical  audit  matters  below,  providing  separate  opinions  on  the  critical 
audit matters or on the accounts or disclosures to which they relate.

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, 2022 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  2022,  the  Company  recognized  $59.0  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 as a result 
of 
the  progression  of  developing  and 
commercializing  the  combined  targets  is  completed  by  the  collaboration 
partners.

the  uncertainties  given 

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, 
observing  the  meetings  of  the  Company’s  accounting  and  alliance 
managers  discussing  the  status  of  each  collaboration  agreement.  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.

Valuation of intangible assets acquired in connection with the Antares Pharma, Inc. acquisition

Description of the Matter

As  disclosed  in  Note  3  of  the  consolidated  financial  statements,  the 
Company  completed  the  acquisition  of  Antares  Pharma,  Inc.  (“Antares”) 
on May 24, 2022 for total consideration of approximately $1,045.7 million. 
The  transaction  was  accounted  for  as  a  business  combination.  The 
Company recorded intangible assets of $589.8 million, which includes in-
process research and development (“IPR&D”) of $48.7 million.

Auditing  the  Company’s  accounting  for  its  acquisition  of  Antares  was 
complex  due  to  the  significant  estimation  uncertainty  in  determining  the 
fair value of the intangible assets. A significant emphasis is placed on the 
appropriateness  of  the  estimate  considerations  used  by  management  to 
determine the fair value of the acquired intangible assets due to sensitivity 
of the respective fair values to the underlying assumptions. The Company 
used an income approach to measure the intangible assets. The significant 
assumptions  used  to  estimate  the  value  of  the  intangible  assets  included 
discount  rates  and  revenue  growth  rates.  These  significant  assumptions 
related  to  the  intangible  assets  are  forward  looking  and  could  be  affected 
by future economic and market conditions.

F-2

How We Addressed the Matter in Our 
Audit

We  obtained  an  understanding,  evaluated  the  design  and  tested  the 
operating effectiveness of internal controls over the Company's process for 
determining the fair value of intangible assets acquired in connection with 
the  Antares  acquisition.  This  included  controls  over  management’s 
development  of  the  above-described  assumptions  used  in  the  valuation 
models applied.

To test the estimated fair value of the intangible assets, we performed audit 
procedures that included, among others, evaluating the Company’s use of 
the  income  approach  and  testing  the  significant  assumptions  used  in  the 
valuation  model,  as  described  above.  We  evaluated  the  completeness  and 
accuracy  of  underlying  data  used  in  supporting  the  assumptions  and 
estimates.  We  evaluated  the  reasonableness  of  projected  revenue  growth 
used  within  the  valuations  against  analyst  expectations,  industry  trends, 
and  other  market  information.  In  addition,  we  involved  valuation 
specialists 
the  significant  assumptions  and 
in  assessing 
methodologies used by the Company.

to  assist 

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

/s/    Ernst & Young LLP

San Diego, California
February 21, 2023 

F-3

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

December 31,
2022

December 31,
2021

Current assets:

ASSETS

Cash and cash equivalents     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Marketable securities, available-for-sale       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts receivable, net and other contract assets       . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventories    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

Current liabilities:

LIABILITIES AND STOCKHOLDERS’ EQUITY

Accounts payable     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Accrued expenses     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue, current portion       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current portion of long-term debt, net     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue, net of current portion      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term debt, net   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long-term liabilities     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contingent liability
Commitments and contingencies (Note 12)
Stockholders’ equity:

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 
96,516 
3,246 
13,334 
130,789 
2,253 
1,492,766 
30,433 
15,472 

$ 

$ 

$ 

118,719 
622,203 
90,975 
53,908 
40,482 
926,287 
8,794 
13,414 
— 
— 
155,434 
500 
1,104,429 

1,541 
24,441 
1,746 
89,419 
117,147 
2,530 
787,255 
544 
— 

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; 135,154 and 
    137,498 shares issued and outstanding at December 31, 2022 and 2021, 
    respectively       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional paid-in capital   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated other comprehensive loss   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Retained earnings (Accumulated deficit)    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total stockholders’ equity      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities and stockholders’ equity     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

— 

— 

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

$ 

138 
256,347 
(620) 
(58,912) 
196,953 
1,104,429 

See accompanying notes to consolidated financial statements.

F-4

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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      . . . . . . . . . . . . . . . . . .

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

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

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

Year Ended December 31,

2022

2021

2020

360,475 

$ 

203,900 

$ 

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) 

88,596 

55,987 

123,011 

267,594 

43,367 

— 

34,236 

45,736 

123,339 

144,255 

5,425 

— 

(20,378) 

129,302 

217 

202,129 

$ 

402,710 

$ 

129,085 

Net income per share:   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

1.48 
1.44 

$ 
$ 

2.86 
2.74 

$ 
$ 

0.95 
0.91 

Shares used in computing net income per share:      . . . . . . . . . . . . . . . . . . . . . .
Basic     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

136,844 
140,608 

140,646 
146,796 

136,206 
141,463 

See accompanying notes to consolidated financial statements.

F-5

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

Year Ended December 31,

2022

2021

2020

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

202,129 

$ 

402,710 

$ 

129,085 

Other comprehensive income:

Unrealized loss on marketable securities      . . . . . . . . . . . . . . . . . . . . . . .

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

Unrealized gain (loss) on foreign currency       . . . . . . . . . . . . . . . . . . . . .

(349) 

8 

39 

(683) 

15 

26 

(164) 

(32) 

(22) 

Total comprehensive income     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

201,827 

$ 

402,068 

$ 

128,867 

See accompanying notes to consolidated financial statements.

F-6

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

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 (accretion of discounts) premiums on marketable 
securities        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Realized loss on marketable securities       . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss (gain) on disposal of equipment    . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferral of unearned revenue  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Recognition of deferred revenue      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease payments deferred      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss on impairment of right-of-use asset      . . . . . . . . . . . . . . . . . . . . . . . . .
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     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventories    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other assets      . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable and accrued expenses      . . . . . . . . . . . . . . . . . . . . . .
Net cash  provided by operating activities       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Investing activities:

Purchases of marketable securities      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from 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) provided by  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 long-term debt        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from issuance of 2028 Convertible Notes   . . . . . . . . . . . . . . . . . . . . .
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 provided by (used in) financing activities      . . . . . . . . . . . . . . . . . . . . . . . . .
Net increase (decrease) 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    . . . . . . . . . . . . . . . . . . . $ 

Year Ended December 31,
2021

2020

2022

202,129 

$ 

402,710 

$ 

129,085 

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 

$ 

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 

$ 

17,204 
3,284 
— 
14,136 

839 
— 
(772) 
4,632 
(4,119) 
(1,033) 
577 
— 

— 
(13) 

(38,288) 
(31,388) 
2,518 
(41,208) 
55,454 

(226,185) 
305,967 
— 
(2,504) 
1,076 
78,354 

— 
— 
— 
— 
— 
(19,560) 
— 
— 
— 
(150,117) 

63,393 
(106,284) 
27,524 
120,679 
148,203 

F-7

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Year Ended December 31,
2021

2020

2022

Supplemental disclosure of cash flow information:

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

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 induced conversion related to convertible notes        . . . . .

6,107 
16,224 

6,229 
34,435 
1,018 

$ 
$ 

$ 
$ 
$ 

$ 
3,296 
(375)  $ 

72 
318 
7,865 

$ 
$ 
$ 

6,534 
180 

117 
1,746 
— 

See accompanying notes to consolidated financial statements.

F-8

 
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 AT DECEMBER 31, 2019      . . . . . . . .

136,713 

$ 

137 

$  695,066  $ 

240 

$ 

(603,678)  $ 

91,765 

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

— 

— 

17,204 

Issuance of common stock pursuant to exercise of 
stock options and vesting of restricted stock 
units, net      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5,278 

5 

63,388 

Issuance of restricted stock awards, net       . . . . . . . .

61 

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

(7,022) 

Equity component of convertible notes     . . . . . . . .

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

Net lncome    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 

— 

— 

(7) 

— 

— 

— 

(150,110) 

(65) 

— 

— 

BALANCE AT DECEMBER 31, 2020      . . . . . . . .

135,030 

$ 

135 

$  625,483  $ 

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

Share-based compensation expense       . . . . . . . . . . .
Issuance of common stock for the induced 
conversion related to convertible notes         . . . . . . . .

— 

9,083 

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

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

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

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

1,497 

(8,112) 

— 

— 

(65,535) 

20,820 

13,095 

12,534 

(350,050) 

— 

— 

— 

9 

2 

(8) 

— 

— 

— 

— 

— 

(218) 

— 

22 

— 

— 

(642) 

— 

— 

— 

— 

— 

17,204 

63,393 

— 

(150,117) 

(65) 

(218) 

129,085 

129,085 

$ 

(474,593)  $ 

151,047 

12,971 

— 

(52,564) 

20,820 

13,104 

— 

— 

12,536 

(350,058) 

(642) 

402,710 

402,710 

BALANCE AT DECEMBER 31, 2021      . . . . . . . .

137,498 

$ 

138 

$  256,347  $ 

(620)  $ 

(58,912)  $ 

196,953 

Share-based compensation expense       . . . . . . . . . . .
Issuance of common stock for the induced 
conversion related to convertible notes         . . . . . . . .

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

— 

1,512 

— 

1 

24,397 

1,692 

— 

— 

24,397 

1,693 

1,077 

1 

14,049 

— 

— 

14,050 

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

(69,120) 

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

(4,933) 

(5) 

(199,997) 

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

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

— 

— 

— 

— 

— 

— 

(302) 

— 

(69,120) 

(200,002) 

(302) 

202,129 

202,129 

BALANCE AT DECEMBER 31, 2022      . . . . . . . .

135,154 

$ 

135 

$ 

27,368  $ 

(922)  $ 

143,217 

$ 

169,798 

See accompanying notes to consolidated financial statements.

F-9

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements

1. Organization and Business 

Halozyme  Therapeutics,  Inc.  is  a  biopharma  technology  platform  company  that  provides  innovative  and  disruptive 

solutions with the goal of improving the patient experience and potentially outcomes. 

Our proprietary enzyme, rHuPH20, is used to facilitate the subcutaneous (“SC”) delivery of injected drugs and fluids. We 
license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug 
delivery technology (“ENHANZE”) with the partners’ proprietary compounds. 

Our  first  commercially  approved  product  Hylenex®  recombinant  (“Hylenex”),  and  our  ENHANZE  partners’  approved 
products and product candidates are based on rHuPH20, our patented recombinant human hyaluronidase enzyme. rHuPH20 is 
the active ingredient in Hylenex, that 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”), Alexion Pharma (International Operations Unlimited Company (an indirect wholly owned subsidiary of AstraZeneca 
PLC)(“Alexion”), argenx BVBA (“argenx”), Horizon Therapeutics plc. (“Horizon”), ViiV Healthcare (the global specialist HIV 
Company  majority  owned  by  GlaxoSmithKline)  (“ViiV”)  and  Chugai  Pharmaceutical  Co.,  Ltd  (“Chugai”).  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 receive royalties from three of these collaborations, including royalties from sales of 
one  product  from  the  Takeda  collaboration,  three  products  from  the  Roche  collaboration  and  one  product  from  the  Janssen 
collaboration.  Future  potential  revenues  from  ENHANZE  collaborations  and  from  the  sales  and/or  royalties  of  our  approved 
products will depend on the ability of our partners, in some areas supported by Halozyme to develop, manufacture, secure and 
maintain regulatory approvals for approved products and product candidates and commercialize product candidates.

Through our recent acquisition of Antares Pharma, Inc. (“Antares”), we also develop, manufacture and commercialize, for 
ourselves  or  with  our  partners,  drug-device  combination  products  using  our  advanced  auto-injector  technologies.  Also  as  a 
result  of  our  acquisition  of  Antares,  our  commercial  portfolio  of  proprietary  products  includes  XYOSTED®,  TLANDO®  and 
NOCDURNA®
.  We  have  commercialized  auto-injector  products  with  several  pharmaceutical  companies  including  Teva 
Pharmaceutical Industries, Ltd. (“Teva”), Covis Group S.a.r.l. (“Covis”) and Otter Pharmaceuticals, LLC (“Otter”). We have 
development programs including auto-injectors with Idorsia Pharmaceuticals Ltd. (“Idorsia”) and Pfizer.

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 disclosed in Note 2.

F-10

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, that mature within 90 days or less from 
the  date  of  purchase.  As  of  December  31,  2022,  our  cash  and  cash  equivalents  consisted  of  money  market  funds,  bank 
certificate of deposits 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  the  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 the consolidated statements of operations.

Restricted Cash

Under the terms of the leases of our facilities, we are required to maintain letters of credit as security deposits during the 
terms of such leases. At December 31, 2022 and 2021, 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, long-term debt and contingent liability. 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.

Available-for-sale  marketable  securities  consist  of  asset-backed  securities,  corporate  debt  securities,  U.S.  Treasury 
securities 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.

F-11

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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 one major commercial bank and marketable securities with another 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 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 at 
December  31,  2022  and  2021.  Approximately  52%  of  the  accounts  receivable  balance  at  December  31,  2022  represents 
amounts due from Janssen and Roche. Approximately 90% of the accounts receivable balance at December 31, 2021 represents 
amounts due from Janssen, Roche and Takeda. 

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,

2022
20%
46%
—%
—%

2021
25%
48%
—%
10%

2020
35%
26%
11%
—%

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,

2022

2021

2020

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

437,989  $ 
166,836 

293,089  $ 
134,117 

Ireland     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

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

3 

2,088 

47,939 

5,261 

14 

199 

11,934 

3,957 

106,918 
95,949 

30,552 

20,086 

10,644 

3,445 

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

660,116  $ 

443,310  $ 

267,594 

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 at 
December 31, 2022 and 2021 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, 

F-12

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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 

equipment 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.

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 
that we incur to complete the 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 the 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.

F-13

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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 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  units  are  less  than  the  carrying  amounts,  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 values of our reporting units are less than the carrying amounts, then no additional assessment is 
deemed necessary. Otherwise, we proceed to compare the estimated fair values of the reporting units with the carrying values, 
including goodwill. If the carrying amounts of the reporting units exceed the fair values, 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  that  intangible  assets  with  finite 
useful  lives  and  other  long-lived  assets  are  potentially  impaired.  If  indicators  of  impairment  exist,  an  impairment  test  is 
performed to assess the recoverability of the affected assets by determining whether the carrying amount of such assets exceeds 
the undiscounted expected future cash flows. If the affected assets are not recoverable, we estimate the fair value of the assets 
and  record  an  impairment  loss  if  the  carrying  value  of  the  assets  exceeds  the  fair  value.  Factors  that  may  indicate  potential 
impairment include a significant decline in our stock price and market capitalization compared to the net book value, significant 
changes in the ability of a particular asset to generate positive cash flows for our strategic business objectives, and the pattern of 
utilization of a particular asset.

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 on a 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. When there are no valid claims during the applicable 
royalty  term  in  a  given  country,  the  royalty  rate  is  reduced  for  those  sales.  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.

In addition to the royalties received from licensing our ENHANZE technology, we also earn royalties in connection with 
licenses granted under license and development arrangements with our device partners as a result of our acquisition of Antares. 

F-14

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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 of 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  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 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 ASC Topic 606, Revenue from Contracts with Customers. 

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  price  or 
(“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 

F-15

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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 
leading up to our partner’s initiation of a trial such as feedback received from the applicable regulatory authorities, completion 
of  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 consistently 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 as a result of our acquisition 
of Antares, 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  that  the  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 

F-16

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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  the  condensed  consolidated  balance  sheets  and 
recognized as revenue in the condensed 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 
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 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

Hylenex Recombinant

We sell Hylenex recombinant in the U.S. to wholesale pharmaceutical distributors, who sell the product to hospitals 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 Hylenex recombinant represent performance obligations under each purchase order. We 
use  a  contract  manufacturer  to  produce  Hylenex  recombinant  and  a  third-party  logistics  (3PL)  vendor  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.

Selling  prices  initially  billed  to  wholesalers  are  subject  to  discounts  for  prompt  payment  and  subsequent  chargebacks 
when  wholesalers  sell  Hylenex  recombinant  at  negotiated  discounted  prices  to  members  of  certain  group  purchasing 
organizations (“GPOs”) and government programs. We also pay quarterly distribution fees to certain wholesalers for inventory 
reporting  and  chargeback  processing,  and  to  GPOs  as  administrative  fees  for  services  and  for  access  to  GPO  members.  We 
concluded  the  benefits  received  in  exchange  for  these  fees  are  not  distinct  from  our  sales  of  Hylenex  recombinant,  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 Hylenex recombinant 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 Hylenex recombinant 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.

We  recognize  revenue  from  Hylenex  recombinant  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.

Upon  recognition  of  revenue  from  product  sales  of  Hylenex  recombinant,  the  estimated  amounts  of  credit  for  product 
returns, chargebacks, distribution fees, prompt payment discounts, and GPO fees are included in accrued liabilities and net of 
accounts  receivable  in  the  consolidated  balance  sheet.  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.

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.

Other Proprietary Product Sales

F-17

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

As  a  result  of  our  acquisition  of  Antares,  our  commercial  portfolio  of  proprietary  products  includes  XYOSTED,  
TLANDO  and  NOCDURNA,  which  we  sell  primarily  to  wholesale  and  specialty  distributors.  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.

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 liabilities and net of accounts receivable in the condensed consolidated balance sheets.

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

As  a  result  of  our  acquisition  of  Antares,  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 the Makena® subcutaneous auto-injector product to Covis and the exclusive supplier of 
OTREXUP® to Otter Pharmaceuticals, LLC (“Otter”). Because these products are custom manufactured for each customer 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 the condensed 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 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  as  revenues  under  collaborative  agreements  the  upfront  payments, 
event-based  development  and  regulatory  milestones  and  sales  milestones.  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.

F-18

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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 (product sales, net, collaborative agreements and research and device licensing, and development revenues), 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 milestones and royalties).

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. 

Research and Development Expenses

Research and development expenses include salaries and benefits, facilities and other overhead expenses, research related 
manufacturing  services,  contract  services  and  other  outside  expenses.  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 
stock-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

As a result of the acquisition of Antares, we assessed the organization of our business and concluded that we continue to 
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 products. The chief operating decision-maker reviews the operating results on an aggregate 
basis and manages the operations as a single operating segment.

F-19

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

Description

Effective Date

In October 2021, the 
FASB issued ASU 
2021-08, Business 
Combinations (Topic 
805): Accounting for 
Contract Assets and 
Contract Liabilities 
from contracts with 
customers

The new guidance requires an 
acquirer to recognize and 
measure contract assets and 
contract liabilities acquired in 
a business combination in 
accordance with Topic 606 as 
if it had originated the 
contracts.

January 1, 2023
(Early adoption 
is permitted, 
including 
adoption in an 
interim period)

Effect on the Financial 
Statements or Other Significant Matters

We early adopted ASU 2021-08 on April 1, 
2022. The adoption did not have a material 
impact on our condensed consolidated financial 
position or results of operations.

F-20

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.  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.  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  condensed  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 in twelve months 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 ASC 
805, 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.  Acquisition  accounting  is 
dependent upon certain valuations and other studies that have yet to commence or progress to a stage where there is sufficient 
information for a definitive measurement. The process for estimating the fair values of identifiable intangible assets and certain 
tangible assets and assumed liabilities requires the use of judgment in determining the appropriate assumptions and estimates.

The table below presents the preliminary estimated fair values of assets acquired and liabilities assumed on the acquisition 
date  based  on  valuations  and  management  estimates.  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. We are still finalizing the allocation of the purchase price, therefore, the fair value estimates assigned to 
intangible assets, goodwill and the related tax impacts of the acquisition, among other items, are subject to change as additional 
information is received to complete our analysis and certain tax returns are finalized. As a result, the preliminary estimates may 
be  revised  during  the  measurement  period.  These  differences  could  change  the  value  of  the  intangible  assets  acquired,  the 
contingent liability assumed, and the tax impacts related to the acquisition and could have a material impact on our results of 
operations and financial position.

F-21

 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Amounts 
recognized as of 
Acquisition date 
(as initially 
reported)

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 
34,379 
5,241 
28,661 
987,500 

7,197 
33,705 
2,509 
1,207 
159,094 
135,088 
799,639 
199,481 

Amounts (in thousands)

Measurement 
period adjustment
— 
$ 

Amounts 
recognized as of 
Acquisition date 
(as adjusted )

$ 

999,120 

— 
— 
(6,311) 
— 
— 
(397,700) 

— 
7,949 
— 
— 
(88,092) 
(114,300) 
(209,568)  $ 
$ 
209,568 

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 

$ 
$ 

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  will  be  allocated  entirely  to  the  single 
reportable unit. Goodwill recognized as a result of the acquisition is not deductible for tax purposes.

A  contingent  liability  with  a  preliminary  value  of  $130.0  million  was  assumed  related  to  TLANDO.  We  assumed  an 
obligation  to  pay  development  milestone  payments  as  well  as  commercial  milestone  payments  and  minimum  tiered  royalty 
payments based on TLANDO net sales which are contingent upon future events. 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. 

We recorded measurement period adjustments in fourth quarter of 2022 to decrease intangible assets as a result of revised 
future cash flow estimates from the initial purchase price allocation and adjustments to accrued expenses. These measurement 
period  adjustments  were  made  to  reflect  facts  and  circumstances  that  existed  as  of  the  acquisition  date.  We  also  recorded  a 
measurement period adjustment in the fourth quarter of 2022 to reduce the acquisition-date fair value of contingent liability by 
$114.3  million  as  a  result  of  revised  future  cash  flow  estimates.  The  measurement  period  adjustment  has  been  recorded  to 
reflect facts and circumstances that existed as of the acquisition date.

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 preliminary values are presented in the table below.

F-22

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Auto-Injector technology platform        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
XYOSTED proprietary product      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TLANDO product rights     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ATRS-1902 (IPR&D)    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Estimated 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

Unaudited Pro Forma Results

Our 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.

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-23

 
 
 
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, 2022

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      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1,146  $ 
7,139 
111,469 
2,783 
7,004 
$  129,541  $ 

—  $ 
— 
— 
2 
— 
2  $ 

—  $ 
(9)   
(934)   
(1)   
— 

1,146 
7,130 
110,535 
2,784 
7,004 
(944)  $  128,599 

December 31, 2021

Amortized 
Cost

Gross 
Unrealized 
Gains

Gross 
Unrealized 
Losses

Estimated 
Fair Value

Asset-backed securities       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

32,745  $ 

—  $ 

(53)  $ 

32,692 

Corporate debt securities     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

U.S. Treasury securities    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Non-U.S. Government Securities         . . . . . . . . . . . . . . . . . . . . . . . .

Commercial paper      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

58,885 

231,230 

17,232 

282,731 

— 

— 

— 

— 

(86)   

58,799 

(469)   

230,761 

(12)   

17,220 

— 

282,731 

$  622,823  $ 

—  $ 

(620)  $  622,203 

As of December 31, 2022, 20 available-for-sale marketable securities with a fair market value of $117.2 million were in a 
gross  unrealized  loss  position  of  $0.9  million.  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, 2022, 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 are as follows (in thousands):

Due within one year       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

After one but within five years     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

114,353  $ 

14,246 
128,599  $ 

500,965 

121,238 
622,203 

December 31, 2022

December 31, 2021

F-24

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 

that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands):

December 31, 2022

December 31, 2021

Level 1

Level 2

Total 
estimated 
fair value

Level 1

Level 2

Total 
estimated 
fair value

Cash equivalents:

Money market funds      . . . . . . . . . . $  191,704  $ 

—  $  191,704 

$  118,707  $ 

—  $  118,707 

Available-for-sale marketable 
   securities:

Asset-backed securities    . . . . . . . .

— 

1,146 

1,146 

— 

Corporate debt securities       . . . . . . .
U.S. Treasury securities      . . . . . . . .
Non-US Government securities       . .
Agency bonds        . . . . . . . . . . . . . . .
Commercial paper        . . . . . . . . . . . .

— 
  110,535 
— 
2,784 
— 

7,130 
  110,535 
— 
2,784 
7,004 
$  305,023  $  15,280  $  320,303 

7,130 
— 
— 
— 
7,004 

— 
  230,761 
— 

32,692 

58,799 
— 
17,220 

32,692 

58,799 
  230,761 
17,220 

— 

  282,731 
  282,731 
$  349,468  $  391,442  $  740,910 

We had no available for sale securities that were classified within Level 3 as of December 31, 2022 and 2021.

A contingent liability with a value of $15.7 million was assumed 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.  We  will  remeasure  the  fair  value  of  the  contingent  liability  on  a  quarterly  basis.  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.

F-25

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 milestones and regulatory milestone and other fees
  Sales-based milestones
  Device Licensing and development revenue
Total revenues under collaborative agreements

Year Ended December 31,

2022

2021

2020

$ 360,475  $ 203,900  $  88,596 

  82,084 

  80,960 

  38,956 

  72,849 

  23,264 

  17,031 

  36,097 

— 

— 

$ 191,030  $ 104,224  $  55,987 

  30,000 
  59,000 
  10,000 
9,611 

  37,264 
  69,500 
  15,000 
1,247 
$ 108,611  $ 135,186  $ 123,011 

  42,000 
  42,000 
  50,000 
1,186 

Total revenue

$ 660,116  $ 443,310  $ 267,594 

During the year ended December 31, 2022 we recognized revenue related to licenses granted to collaboration partners in 
prior periods in the amount of $429.5 million. This amount represents royalties and sales milestone earned in the current period, 
as well as $59.0 million of variable consideration in the contracts where uncertainties have been resolved and the development 
milestones are probable of being achieved or were achieved. We also recognized revenue of $2.0 million during the year ended 
December 31, 2022 that had been included in deferred revenues at December 31, 2021. We did not recognize any adjustments 
to reduce sales reserves and allowances liability related to Hylenex recombinant sales in prior periods.

Accounts  receivable,  other  contract  assets  and  deferred  revenues  (contract  liabilities)  from  contracts  with  customers, 

including collaboration partners, consisted of the following (in thousands):

Accounts receivable, net
Other contract assets
Deferred revenues

December 
31, 2022

December 
31, 2021

$ 186,970  $  90,975 
— 
$  44,102  $ 
4,276 
5,499  $ 
$ 

As  of  December  31,  2022,  the  amounts  included  in  the  transaction  price  of  our  contracts  with  customers,  including 
collaboration partners, and allocated to goods and services not yet provided were $80.7 million of which $75.2 million relates to 
unfulfilled  product  purchase  orders  and  $5.5  million  has  been  collected  and  reported  as  deferred  revenues.  The  unfulfilled 
product purchase orders are estimated to be delivered in 2023. Of the total deferred revenues of $5.5 million, $3.2 million is 
expected to be used by our customers within the next 12 months.

We  recognized  contract  assets  of  $44.1  million  as  of  December  31,  2022,  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-26

 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

6. Certain Balance Sheet Items

Accounts receivable consisted of the following (in thousands):

December 31,
2022

December 31,
2021

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       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
     Subtotal      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Allowance for distribution fees and discounts    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
     Total accounts receivable         . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

62,979 
18,776 
100,900 
6,229 
44,102 
232,986 
(1,914) 
231,072 

$ 

$ 

$ 

18,504 
5,422 
63,555 
4,634 
— 
92,115 
(1,140) 
90,975 

Inventories consisted of the following (in thousands):

Raw materials     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Work-in-process      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finished goods     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
     Total inventories      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

13,792 
40,361 
45,970 
100,123 

$ 

$ 

10,672 
17,451 
25,785 
53,908 

December 31,
2022

December 31,
2021

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    . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

51,694 
4,647 
14,984 
71,325 
(26,301) 
45,024 

$ 

$ 

$ 

47,991 
3,809 
2,096 
53,896 
(13,414) 
40,482 

December 31,
2022

December 31,
2021

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-27

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Property and equipment, net consisted of the following (in thousands):

December 31,
2022

December 31,
2021

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       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

7,380 
27,893 
7,855 
6,729 
49,857 
(14,756) 
35,101 
40,469 
75,570 

$ 

$ 

$ 

$ 

7,174 
5,719 
5,370 
1,628 
19,891 
(13,100) 
6,791 
2,003 
8,794 

Depreciation and amortization expense was approximately $6.5 million, $3.0 million, and $3.3 million, inclusive of ROU 
asset  amortization  of  $3.0  million,  $1.6  million  and  $1.7  million  for  the  years  ended  December  31,  2022,  2021  and  2020, 
respectively. 

Accrued expenses consisted of the following (in thousands):

December 31,
2022

December 31,
2021

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     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

19,939 
12,190 
— 
30,261 
29,771 
34,788 
126,949 
(30,433) 
96,516 

$ 

$ 

$ 

9,858 
6,514 
1,439 
706 
3,648 
2,820 
24,985 
(544) 
24,441 

Expense  associated  with  the  accretion  of  the  lease  liabilities  was  approximately  $0.5  million,  $0.3  million  and  $0.5 
million  for  the  twelve  months  ended  December  31,  2022,  2021  and  2020,  respectively.  Total  lease  expense  for  the  twelve 
months ended December 31, 2022, 2021 and 2020 was $3.3 million, $1.9 million and $2.2 million, respectively. 

Cash paid for amounts related to leases for the twelve months ended December 31, 2022, 2021 and 2020 was $4.2 million, 

$2.7 million and $3.2 million, respectively.

F-28

                            
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

7. Goodwill and Intangible Assets

Goodwill

On  May  24,  2022,  we  acquired  all  outstanding  equity  interests  of  Antares.  A  Goodwill  balance  of  $409.0  million  was 
recognized for the excess of the consideration transferred over the net assets acquired and represents the expected revenue and 
cost synergies of the combined company and assembled workforce.

A summary of the activity impacting goodwill is presented below (in thousands):

Balance as of December 31, 2021       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Goodwill acquired     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance as of December 31, 2022       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

— 
409,049 
409,049 

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 remaining life in years for our 
acquired intangible assets as of December 31, 2022 (in thousands).

Auto-Injector technology platform        . . . . . . . . . . . . . . .
XYOSTED proprietary product      . . . . . . . . . . . . . . . . . .
TLANDO product rights     . . . . . . . . . . . . . . . . . . . . . . .

Total definite-lived intangibles, net

ATRS-1902 (IPR&D)

Total Intangibles, net

Weighted average 
remaining life (in 
years)
7
10
10

Indefinite

Gross 
Carrying 
Value

Accumulated 
Amortization

Net Carrying 
Value

$  402,000  $ 
136,200 
2,900 
$  541,100  $ 

34,735  $  367,265 
127,962 
8,238 
2,725 
175 
43,148  $  497,952 
48,700 
$  546,652 

The estimated future annual amortization of finite-lived intangible assets is shown in the following table. 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.

Amortization (in 
thousands)

$ 

71,339 

71,339 

71,339 
71,339 

71,339 
141,257 

497,952 

Year:
2023     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2024     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2025     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2026     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2027     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Thereafter     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

F-29

 
 
 
 
 
 
 
 
 
 
 
 
 
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 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, 2022, the 2028 Convertible Notes are 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, 2022, 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,  2022,  no  capped  calls  have  been 
exercised.

Pursuant  to  their  terms,  the  capped  calls  qualify  for  classification  within  stockholders’  equity  in  the  condensed 
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  Condensed  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” and collectively with the 2024 Convertible Notes the “Convertible Notes”). The net 
proceeds  in  connection  with  the  issuance  of  the  2027  Convertible  Notes,  after  deducting  the  initial  purchasers’  fee  of 

F-30

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

$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 will rank senior in right of payment to 
all indebtedness that is expressly subordinated in right of payment to the 2027 Convertible Notes, will rank equally in right of 
payment  with  all  existing  and  future  liabilities  that  are  not  so  subordinated,  will  be  effectively  junior  to  any  secured 
indebtedness  to  the  extent  of  the  value  of  the  assets  securing  such  indebtedness  and  will  be  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.  The  Notes  will  be  convertible,  regardless  of  the  foregoing  circumstances,  at  any  time  from,  and 
including, September 1, 2026 until the close of business on the scheduled trading day immediately preceding the maturity date. 
As of December 31, 2022, the 2027 Convertible Notes are 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  will  be  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, 2022, 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 (“2024 Convertible Notes”). The net proceeds in connection with 2024 Convertible Notes, after deducting the 
initial  purchases’  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 are presented as a debt discount.

The 2024 Convertible Notes pay interest semi-annually in arrears on June 1st and December 1st of each year, beginning 
on June 1, 2020, at an annual rate of 1.25%. The 2024 Convertible Notes are general unsecured obligations and will rank senior 
in right of payment to all indebtedness that is expressly subordinated in right of payment to the 2024 Convertible Notes, will 
rank equally in right of payment with all existing and future liabilities that are not so subordinated, will be effectively junior to 
any  secured  indebtedness  to  the  extent  of  the  value  of  the  assets  securing  such  indebtedness  and  will  be  structurally 
subordinated  to  all  indebtedness  and  other  liabilities  (including  trade  payables)  of  the  our  current  or  future  subsidiaries.  The 
2024 Convertible Notes have a maturity date of December 1, 2024.

Holders  may  convert  their  2024  Convertible  Notes  at  their  option  only  in  the  following  circumstances:  (1)  during  any 
calendar quarter commencing after the calendar quarter ending on March 31, 2020, 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 2024 Convertible Notes; (4) if we call such notes for redemption; and 
(5) at any time from, and including, June 1, 2024 until the close of business on the scheduled trading day immediately before 
the maturity date. As of December 31, 2022, the 2024 Convertible Notes are convertible and are classified as a current liability

F-31

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

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,  if  applicable,  to  deliver  shares  of  common  stock.  The  conversion  rate  for  the  2024 
Convertible  Notes  will  be  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  is  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  includes  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 is included in Other income (expense) of the Condensed Consolidated Statements 
of Operations for the twelve months ended December 31, 2022. The induced conversion expense represents 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  includes  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  is  included  in  other  income  (expense)  of  the  consolidated  statements  of 
income. The induced conversion expense represents 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, and we expect to make cash payment 

of $13.5 million to effect the redemption in March 2023.

As of December 31, 2022, we were in compliance with all covenants and there was no material adverse change in our 

business, operations or financial condition.

F-32

Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Net Carrying Amounts of the Convertible Notes

The  carrying  amount  and  fair  value  of  our  Convertible  Notes  were  as  follows  as  of  the  dates  indicated  (amount  in 

thousands).

Principal amount:

December 31,
2022

December 31,
2021

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total Principal Amount   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

13,483 
805,000 
720,000 
1,538,483 

$ 

$ 

90,936 
805,000 
— 
895,936 

Unamortized debt discount:

2024 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total unamortized debt discount     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

(149)  $ 

(14,359) 
(17,875) 
(32,383)  $ 

(1,517) 
(17,745) 
— 
(19,262) 

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       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

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      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.9
4.2
5.6

89,419 
787,255 
— 
876,674 

159,678 
718,889 
— 
878,567 

2.9
5.2
n/a

F-33

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 for the periods shown (in thousands).

Twelve Months Ended
December 31,

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     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

771 
2,013 
2,660 
5,444 

357 
3,386 
1,124 
4,867 

Interest expense:

2024 Convertible Notes       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
2027 Convertible Notes       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2028 Convertible Notes       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total interest expense       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

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       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

 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 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-34

 
 
 
 
 
 
 
 
 
 
 
 
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  are  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, 2022, 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 is recorded as debt issuance cost within prepaid expenses and other assets in 
the  condensed  consolidated  balance  sheets.  As  of  December  31,  2022,  the  unamortized  debt  issuance  cost  related  to  the 
revolving credit facility was $3.1 million.

Future maturities and interest payments of long-term debt as of December 31, 2022, are as follows (in thousands):

2023    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

22,745 

2024    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2025    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2026    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2027    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Thereafter    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9,213 

9,213 

9,213 

812,535 

724,480 

Total minimum payments        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$  1,587,399 

Less amount representing coupon interest      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(48,916) 

Gross balance of long-term debt      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$  1,538,483 

Less unamortized debt discount     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Carrying value of long-term debt       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(32,383) 
$  1,506,100 

Less current portion of long-term debt     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term debt, less current portion and unamortized debt discount     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(13,334) 
$  1,492,766 

F-35

 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

9. Share-based Compensation

We  currently  grant  stock  options,  restricted  stock  awards,  performance  stock  units  and  restricted  stock  units  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,  restricted  stock  awards,  restricted  stock  unit 
awards and performance awards. Awards are subject to terms and conditions established by the Compensation Committee of 
our Board of Directors. During the year ended December 31, 2022, we granted share-based awards under the 2021 Stock Plan. 
At December 31, 2022, 6,550,075 shares were subject to outstanding awards and 14,764,481 shares were available for future 
grants of share-based awards. 

Total share-based compensation expense related to share-based awards excluding the acceleration of Antares equity 

awards was comprised of the following (in thousands):

Year Ended December 31,

2022

2021

2020

Research and development       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
Selling, general and administrative    . . . . . . . . . . . . . . . . . . . . . . . . . . .

9,903  $ 

6,992  $ 

14,494 

13,828 

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

24,397  $ 

20,820  $ 

5,484 

11,720 

17,204 

Share-based compensation expense by type of share-based award (in thousands):

Stock options    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
RSAs, RSUs, PSUs and ESPP     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Year Ended December 31,

2022

2021

2020

10,973  $ 

10,252  $ 

13,424 

10,568 

8,955 

8,249 

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 (in thousands, unless otherwise noted):

$ 

24,397  $ 

20,820  $ 

17,204 

December 31, 2022

Stock options     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
RSUs      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
PSUs        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 
ESPP    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 

26,730 
26,488 
3,986 
247 

Unrecognized
Expense

Remaining
Weighted-
Average
Recognition 
Period
(years)

2.66
2.32
1.91
0.45

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, 2022, 2,650,103 shares were available for future purchase. The offering 
period is generally for a six-months 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, 2022, 32,124 shares were 
issued pursuant to the ESPP.

F-36

 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

Stock Options. Options granted under the Plans 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 Plans).

A summary of our stock option award activity as of and for the year ended December 31, 2022 is as follows: 

Shares
Underlying
Stock Options

Weighted
Average Exercise
Price per Share

Weighted
Average
Remaining
Contractual
Term (years)

Aggregate
Intrinsic
Value (in 
Millions)

Outstanding at December 31, 2021      . . . . . . . . . . . . . . . . .

  4,965,374 

Granted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  1,773,912 

Exercised   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Canceled/forfeited      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(789,870) 

(581,191) 

Outstanding at December 31, 2022      . . . . . . . . . . . . . . . . .

  5,368,225 

Vested and expected to vest at December 31, 2022      . . . .

  5,368,225 

Exercisable at December 31, 2022      . . . . . . . . . . . . . . . . .

  3,176,691 

$20.76

$37.25

$19.40

$33.87

$24.99

$24.99

$17.22

6.48

6.48

4.92

$171.3

$171.3

$126.0

The weighted average grant date fair values of options granted during the years ended December 31, 2022, 2021 and 2020 
were $14.22 per share, $18.21 per share and $20.74 per share, respectively. The total intrinsic value of options exercised during 
the  years  ended  December  31,  2022,  2021  and  2020  was  approximately  $21.6  million,  $33.5  million  and  $49.7  million, 
respectively.  Cash  received  from  stock  option  exercises  for  the  years  ended  December  31,  2022,  2021  and  2020  was 
approximately $15.3 million, $16.6 million and $66.2 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:

Expected volatility      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Average expected term (in years)     . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk-free interest rate    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Expected dividend yield     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39.91-50.81%
4.7

41.01-46.45%
4.7

47.57-51.82%
5.1

1.37-4.27%
 — 

0.36-1.20%
 — 

0.22-1.67%
 — 

Year Ended December 31,

2022

2021

2020

F-37

 
 
 
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.  The 

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, 2022:

Outstanding at December 31, 2021      . . . . . . . . . . . . . . . . . . . .
Granted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vested     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Forfeited      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Outstanding at December 31, 2022      . . . . . . . . . . . . . . . . . . . .

Number of
Shares
858,742 
706,096 
(320,767) 
(204,690) 
1,039,381 

Weighted
Average
Grant Date
Fair Value
$29.54
$39.18
$26.68
$35.69
$35.76

Weighted
Average
Remaining
Contractual
Term (yrs)

Aggregate
Intrinsic
Value (in 
Millions)

1.25

$59.1

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, 2022, 2021 and 2020 was approximately 
$8.6 million, $6.6 million and $10.1 million, respectively. The fair value of RSUs vested during the years ended December 31, 
2022, 2021 and 2020 was approximately $11.3 million, $19.0 million and $14.0 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, 2022:

Outstanding at December 31, 2021       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Granted     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vested    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Forfeited   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Outstanding at December 31, 2022       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Number of
Shares

69,382 

129,773 

(2,565) 

(53,746) 

142,844 

Weighted
Average
Grant Date
Fair Value

$40.66

$41.42

$63.41

$27.20

$46.01

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,  2022  and  2021  was  $0.2  million  and  $0.1  million, 
respectively.

F-38

 
 
 
 
 
 
 
 
 
 
10. Stockholders’ Equity

During the years ended December 31, 2022, 2021 and 2020, we issued an aggregate of 789,870, 1,179,032 and 4,705,843 
shares  of  common  stock,  respectively,  in  connection  with  the  exercises  of  stock  options,  for  net  proceeds  of  approximately 
$15.3 million, $16.6 million and $66.2 million, respectively. For the years ended December 31, 2022, 2021 and 2020, we issued 
254,907,  299,958  and  571,963  shares  of  common  stock,  respectively,  upon  vesting  of  certain  RSUs  and  PSUs  for  which  the 
RSU  holders  surrendered  68,425,  94,795  and  142,905  RSUs,  respectively,  to  pay  for  minimum  withholding  taxes  totaling 
approximately  $4.4  million,  $8.2  million  and  $5.5  million,  respectively.  Stock  options  and  unvested  restricted  units  totaling 
approximately 6.6 million, 5.9 million and 6.7 million shares of our common stock were outstanding as of December 31, 2022, 
2021 and 2020, respectively. 

Share Repurchases

In  November  2019,  the  Board  of  Directors  authorized  a  capital  return  program  to  repurchase  up  to  $550.0  million  of 
outstanding  common  stock  over  a  three-year  period.  During  2020,  we  repurchased  6.5  million  shares  of  common  stock  for 
$150.0  million  at  an  average  price  of  $23.05.  During  2021,  we  repurchased  4.6  million  shares  of  common  stock  for 
$200.0 million at an average price of $43.02 under the program. The shares were purchased through open market transactions 
and  through  an  ASR  agreement.  The  $550.0  million  share  repurchase  program  was  completed  in  October  2021  having 
repurchased a total of 22.3 million shares at an average price of $24.72.

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. Also in December 2021, as part of the second capital return program, we entered 
into  an  ASR  agreement  to  repurchase  $150.0  million  of  common  stock.  At  inception  pursuant  to  the  agreement,  we  paid 
$150.0  million    and  took  initial  delivery  of  3.5  million  shares.  In  June  2022,  we  finalized  the  transaction  and  received  an 
additional 0.4 million shares. 

In August 2022, concurrent with the sale of  2028 Convertible Notes and the 2022 Induced Conversion, we repurchased 
2.1 million shares of common stock in open market purchases for $90.2 million. Also, in August 2022, we entered into an ASR 
agreement to repurchase $109.8 million of our common stock. At inception, pursuant to the agreement, we paid $109.8 million 
and took an initial delivery of 2.0 million shares.  In December 2022, we finalized the transaction and received an additional 
0.4 million shares. We retired the repurchased shares and they resumed their status of authorized and unissued shares. 

We had the following activity under the approved share repurchase programs (dollars in thousands, except share and per 

share data)

First quarter    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Second quarter      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Third quarter(2)     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fourth quarter     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total Number of Shares 
Purchased

2022

Weighted 
Average Price 
paid Per Share

— 

— 
4,500,216 

— 
4,500,216 

$0.00

$0.00
$44.44

$0.00
$44.44

Total Cost(1)

$0

$0
$200,000

$0
$200,000

(1)  Included in the total cost of shares purchased is a commission fee of $0.02 per share.
(2)  Included is 0.4 million shares delivered in December 2022 upon completion of the ASR.

F-39

 
 
 
 
 
11. Net Income per share

Basic net income per common 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  RSAs,  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, RSAs, 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  our  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  net  income  per  common  share 

computations is as follows (in thousands, except per share amounts):

Twelve Months Ended
December 31,

2022

2021

2020

Numerator:

Net income     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 202,129  $ 402,710  $ 129,085 

Denominator:

Weighted average common shares outstanding for basic net 
income per share     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dilutive potential common stock outstanding:

Stock Options    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

RSAs, RSUs, PSUs and ESPP    . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Convertible Notes     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Weighted average common shares outstanding for diluted net 
income per share     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  136,844 

  140,646 

  136,206 

2,265 

422 

1,077 

2,737 

555 

2,858 

2,317 

627 

2,313 

  140,608 

  146,796 

  141,463 

Net income per share:

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

1.48  $ 
1.44  $ 

2.86  $ 
2.74  $ 

0.95 
0.91 

Shares which have been excluded from the calculation of diluted net income per common share because their effect was 

anti-dilutive, include the following (shares in millions):

Anti-dilutive securities (1)

Twelve Months Ended
December 31,

2022

2021

2020

20.7 

13.8 

18.6 

(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-40

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

12. Commitments and Contingencies

Operating Leases

Our properties consist of leased office, laboratory, warehouse and manufacturing facilities. Our administrative offices and 
research facilities are located in San Diego, California. In addition, we have an office in Ewing, New Jersey. We also lease a 
building  in  Minnetonka,  Minnesota  consisting  of  office,  laboratory,  manufacturing  and  warehousing  space.  We  lease  an 
aggregate of approximately 194,000 square feet of space. 

In  March  2022,  we  entered  into  an  agreement  for  assignment  and  assumption  of  lease  with  Seismic  Software,  Inc. 
pursuant  to  which  effective  January  1,  2023,  we  assumed  Seismic’s  office  lease,  as  amended  with  Kilroy  Realty  L.P.  for 
approximately 73,238 square feet of space in office and research facilities which commenced on December 1, 2022.

We also 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  $3.3 

million, $2.0 million and $2.3 million for the years ended December 31, 2022, 2021 and 2020, respectively.

Approximate annual future minimum operating lease payments as of December 31, 2022 are as follows (in thousands): 

Year:
2023      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

2024      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2025      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2026      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2027      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Thereafter    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total minimum lease payments      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

Less imputed interest     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operating
Leases

7,800 

6,173 

5,464 

5,149 

5,296 

17,133 

47,015 

(12,227) 

Total     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

34,788 

The weighted-average remaining lease term of our operating leases is approximately 7.64 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 management’s opinion, individually or in the aggregate, would have a material 
adverse effect on our consolidated results of operations or financial position.

F-41

 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

13. Income Taxes

Total income (loss) before income taxes summarized by region were as follows (in thousands):

Year Ended December 31,

2022

2021

2020

United States      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

248,918 

$ 

248,071 

$ 

130,427 

Foreign      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

— 

447 

(1,125) 

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

$ 

248,918 

$ 

248,518 

$ 

129,302 

Significant components of our net deferred tax assets/(liabilities) were as follows (in thousands). 

December 31,

2022

2021

Deferred tax assets:

Net operating loss carryforwards       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

32,887 

$ 

42,182 

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     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interest expense limitation        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other, net         . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Valuation allowance for deferred tax assets    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Deferred tax assets, net of valuation allowance      . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Deferred tax liabilities:

837 

96,133 

6,353 

2,480 

10,168 

2,354 

18,395 

— 

3,054 

909 

109,041 

1,814 

600 

— 

— 

— 

— 

3,449 

$ 

$ 

172,661 

$ 

157,995 

(707) 

(500) 

171,954 

$ 

157,495 

Non-deductible book amortization        . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Depreciation      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Convertible note   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ASC 842 right of use asset       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other, net         . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total deferred tax liabilities      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Net deferred tax asset      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(115,578) 

(2,559) 

— 

(9,061) 

(330) 
(127,528)  $ 
$ 
44,426 

$ 
$ 

(1,185) 

(17) 

(426) 

(433) 
(2,061) 
155,434 

 A valuation allowance of $0.7 million and $0.5 million has been established to offset the net deferred tax assets as of 

December 31, 2022 and 2021, 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 have demonstrated profitability 
and cumulative pretax income and are forecasting income growth. 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.

F-42

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

On  May  24,  2022,  we  acquired  the  outstanding  shares  of  Antares  Pharma  Inc.  This  transaction  was  treated  as  a  non-
taxable  acquisition,  we  have  increased  our  deferred  tax  liabilities  by  approximately  $119.7  million  related  to  acquired 
intellectual property and a step-up to the value of inventory the amortization of which will not be tax deductible.

Income tax (benefit) expense was comprised of the following components (in thousands):

Year Ended December 31,

2022

2021

2020

Current - federal     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

6,157 

$ 

(9)  $ 

Current - state     . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Deferred - federal      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Deferred - state      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2,525 

44,757 

(6,650) 

1,251 

(117,925) 

(37,509) 

$ 

46,789 

$ 

(154,192)  $ 

(11) 

228 

— 

— 

217 

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 (benefit) at 21%    . . . . . . . . . . . . . . . . . . . . .

State income tax expense (benefit), net of federal income tax impact   . .

(Decrease) increase in valuation allowance    . . . . . . . . . . . . . . . . . . . . . . .

Worthless stock deduction of international subsidiary       . . . . . . . . . . . . . .

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      . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Year Ended December 31,

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) %

2020
 21.00 %

 (1.59) %

 34.59 %

 (52.07) %

 0.16 %

 (1.89) %

 1.61 %

 (1.64) %

 — %

 — %

 0.17 %

 At December 31, 2022, our unrecognized tax benefit and uncertain tax positions were $19.5 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, 2022, 2021 and 2020, we recognized an immaterial amount of interest 
and penalties.

F-43

 
 
 
 
 
 
 
 
 
Halozyme Therapeutics, Inc.

Notes to Consolidated Financial Statements — (Continued)

The following table summarizes the activity related to our unrecognized tax benefits (in thousands):

Year Ended December 31,

2022

2021

2020

Gross unrecognized tax benefits at beginning of period      . . . . . . . . . . . . .

$ 

17,692 

$ 

19,167 

$ 

21,483 

Increases in tax positions for prior years      . . . . . . . . . . . . . . . . . . . . . . . . .
Decreases in tax positions for prior years and lapse in statue of 
limitations       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Increases in tax positions related to business acquisition      . . . . . . . . . . . .

Increases in tax positions for current year        . . . . . . . . . . . . . . . . . . . . . . .

— 

21 

41 

(1,148) 

2,151 

787 

(1,496) 

(2,357) 

— 

— 

— 

— 

Gross unrecognized tax benefits at end of period        . . . . . . . . . . . . . . . . . .

$ 

19,482 

$ 

17,692 

$ 

19,167 

At December 31, 2022, we had federal, California and other state tax net operating loss carryforwards of approximately 
$31.2 million, $237.4 million and $63.4 million, respectively. The California and Minnesota net operating loss carryforwards 
begin to expire in 2028 and 2022, respectively.

As  a  result  of  the  acquisition  of  Antares,  we  acquired  federal  and  Minnesota  research  and  development  credits  of 
approximately  $7.4  million  and  $0.72  million,  respectively.  We  expect  to  be  able  to  fully  utilize  these  attributes  without 
limitation.

At December 31, 2022, we had federal, California and Minnesota research and development tax credit carryforwards of 
approximately  $30.8  million,  $17.0  million  and  $0.7  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.  The  Minnesota  research  and  development  credit  will  begin  to  expire  in  2023  unless  previously 
utilized. Additionally, we had Orphan Drug Credit carryforwards of $70.0 million which will begin to expire in 2034. 

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 December 31, 2020. 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. At December 31, 2022 and 2021, 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. and California tax authorities due to the carryforward of unutilized net operating losses 
and research and development credits.

F-44

 
 
 
 
 
 
 
 
 
 
 
 
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 $2.6 million, $1.1 million and $1.1 million for the years 
ended December 31, 2022, 2021 and 2020, 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, 2022
Accounts receivable allowances (1)
For the year ended December 31, 2021
Accounts receivable allowances (1)
For the year ended December 31, 2020
Accounts receivable allowances (1)

  . . . . . . . $ 

  . . . . . . . $ 

  . . . . . . . $ 

1,140  $ 

924  $ 

5,946  $ 

(6,096)  $ 

1,914 

1,003  $ 

—  $ 

8,131  $ 

(7,994)  $ 

1,140 

797  $ 

—  $ 

13,276  $ 

(13,070)  $ 

1,003 

_______________

(1) Allowances are for chargebacks, prompt payment discounts and distribution fees related to proprietary product sales. 

F-45

Halozyme Therapeutics, Inc.
12390 El Camino Real 
San Diego, CA 92130
858-794-8889
info@halozyme.com
www.halozyme.com

Copyright © 2023. Halozyme, Inc.
All rights reserved. All trademarks
belong to their respective owners.