UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
ý☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended SeptemberJune 30, 20172022
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)
___________________________
Delaware88-0488686
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
11388 Sorrento Valley Road San Diego, CA92121
San Diego(Zip Code)
California
(Address of principal executive offices)(Zip Code)
(858) 794-8889
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par valueHALOThe Nasdaq Stock Market LLC
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 x    No  ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).    Yes  x    No  ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” andfiler,” “smaller reporting company”company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer☒Accelerated filer☐
Non-accelerated filer  ☐Smaller reporting company☐
Emerging growth company☐
Large accelerated filer
x
Accelerated filer
¨
Non-accelerated filer
¨
Smaller reporting company
¨
Emerging growth company
¨
(Do not check if a smaller reporting 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨☐    No  x
The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 142,357,000137,779,370 as of November 1, 2017August 2, 2022.






HALOZYME THERAPEUTICS, INC.
INDEX
Page
3
PART I — FINANCIAL INFORMATION
Item 1.
December 31, 20162021
36
Ended SeptemberJune 30, 20172022 and 20162021
46
- Three and NineSix Months Ended SeptemberJune 30, 20172022 and 20162021
57
     September June 30, 20172022 and 20162021
68
9
710
Item 2.
3139
Item 3.
6678
Item 4.
6678
PART II — OTHER INFORMATION
Item 1.
6779
Item 1A.
6779
Item 2.
6779
Item 3.
6779
Item 4.
6779
Item 5.
6779
Item 6.
6880
6981

2


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
•Business interruptions resulting from the COVID-19 outbreak 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.
•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 side effects or adverse events or product recalls.
•If our contract manufacturers or vendors are unable or elect not 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 many 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 significantly 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 and our strategic focus is currently limited to only a few fields or applications of our technology which may increase the risk for potential negative impact from adverse developments. Future expansion of our strategic focus to additional applications of our technology 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.
•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 damage 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 significantly harm our business.
•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.
•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.
3

•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 the 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 marketing 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 partnered products may be delayed and, as a result, our stock price may decline, and we may face lawsuits relating to such declines.
•Future acquisitions could disrupt our business and harm 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.
•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 the 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 protein-based therapeutic products and other biotechnology inventions is subject to a great deal of uncertainty, and if patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize products based on our discoveries.
4

•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 intense competition and rapid technological change that could result in the development of products by others that are competitive with or superior to our proprietary and partnered products, including those under development.

General Risks
•Our inability to attract, hire and retain key management and scientific personnel could negatively affect our business.
•Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.
•Cyberattacks, security breaches or system breakdowns may disrupt our operations and harm our operating results and reputation.
5

PART I — FINANCIAL INFORMATION
Item 1.Financial Statements
Item 1.     Financial Statements
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except per share amounts)
 September 30,
2017		 December 31,
2016		June 30,
2022		December 31,
2021
ASSETS    ASSETS
Current assets:    Current assets:
Cash and cash equivalents $164,397
 $66,764
Cash and cash equivalents$90,932 $118,719 
Marketable securities, available-for-sale 152,525
 138,217
Marketable securities, available-for-sale118,428 622,203 
Accounts receivable, net 14,695
 15,680
Inventories 9,331
 14,623
Prepaid expenses and other assets 12,397
 21,248
Accounts receivable, net and contract assetsAccounts receivable, net and contract assets189,368 90,975 
Inventories, netInventories, net97,615 53,908 
Prepaid expenses and other current assetsPrepaid expenses and other current assets45,595 40,482 
Total current assets 353,345
 256,532
Total current assets541,938 926,287 
Property and equipment, net 3,232
 4,264
Property and equipment, net37,091 8,794 
Prepaid expenses and other assets 72
 219
Prepaid expenses and other assets26,283 13,414 
GoodwillGoodwill199,481 — 
Intangible assets, netIntangible assets, net976,097 — 
Deferred tax assets, netDeferred tax assets, net— 155,434 
Restricted cash 500
 500
Restricted cash500 500 
Total assets $357,149
 $261,515
Total assets$1,781,390 $1,104,429 
    
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)    
LIABILITIES AND STOCKHOLDERS’ EQUITYLIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:    Current liabilities:
Accounts payable $4,152
 $3,578
Accounts payable$12,232 $1,541 
Accrued expenses 32,370
 28,821
Accrued expenses84,101 24,441 
Deferred revenue, current portion 4,093
 4,793
Deferred revenue, current portion4,131 1,746 
Current portion of long-term debt, net 61,433
 17,393
Current portion of long-term debt, net99,048 89,419 
Total current liabilities 102,048
 54,585
Total current liabilities199,512 117,147 
Deferred revenue, net of current portion 36,755
 39,825
Deferred revenue, net of current portion2,739 2,530 
Long-term debt, net 145,417
 199,228
Long-term debt, net1,147,129 787,255 
Other long-term liabilities 540
 358
Other long-term liabilities5,551 544 
Commitments and contingencies (Note 9) 
 
Stockholders’ equity (deficit):    
Deferred tax liabilities, netDeferred tax liabilities, net3,288 — 
Contingent liabilityContingent liability130,000 — 
Commitments and contingencies (Note 12)Commitments and contingencies (Note 12)00
Stockholders’ equity:Stockholders’ equity:
Preferred stock - $0.001 par value; 20,000 shares authorized; no shares
issued and outstanding
 —
 —
Preferred stock - $0.001 par value; 20,000 shares authorized; no shares
issued and outstanding
— — 
Common stock - $0.001 par value; 200,000 shares authorized; 142,301 and
129,502 shares issued and outstanding at September 30, 2017 and
December 31, 2016, respectively
 142
 130
Common stock - $0.001 par value; 300,000 shares authorized; 137,681 and 137,498 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectivelyCommon stock - $0.001 par value; 300,000 shares authorized; 137,681 and 137,498 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively138 138 
Additional paid-in capital 718,553
 552,737
Additional paid-in capital271,169 256,347 
Accumulated other comprehensive loss (53) (6)Accumulated other comprehensive loss(2,017)(620)
Accumulated deficit (646,253) (585,342)
Total stockholders’ equity (deficit) 72,389
 (32,481)
Total liabilities and stockholders’ equity (deficit) $357,149
 $261,515
Retained earnings (accumulated deficit)Retained earnings (accumulated deficit)23,881 (58,912)
Total stockholders’ equityTotal stockholders’ equity293,171 196,953 
Total liabilities and stockholders’ equityTotal liabilities and stockholders’ equity$1,781,390 $1,104,429 
See accompanying notes to condensed consolidated financial statements.

6


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


 Three Months Ended
September 30,		 Nine Months Ended
September 30,		Three Months Ended
 June 30,		Six Months Ended
June 30,
 2017 2016 2017 2016 2022202120222021
Revenues:        Revenues:
RoyaltiesRoyalties$85,340 $45,778 $154,945 $82,701 
Product sales, net $13,589
 $13,331
 $37,803
 $39,970
Product sales, net46,300 30,360 68,440 52,126 
Royalties 17,119
 13,036
 45,839
 36,695
Revenues under collaborative agreements 33,023
 5,486
 43,407
 31,023
Revenues under collaborative agreements20,725 60,317 46,259 90,650 
Total revenues 63,731
 31,853
 127,049
 107,688
Total revenues152,365 136,455 269,644 225,477 
Operating expenses:        Operating expenses:
Cost of product sales 8,332
 9,134
 23,664
 25,204
Cost of salesCost of sales33,943 23,018 49,865 41,237 
Amortization of intangiblesAmortization of intangibles11,403 — 11,403 — 
Research and development 33,993
 33,863
 109,267
 109,493
Research and development15,483 8,069 27,336 17,078 
Selling, general and administrative 13,329
 11,599
 39,045
 33,626
Selling, general and administrative57,476 12,321 71,310 23,380 
Total operating expenses 55,654
 54,596
 171,976
 168,323
Total operating expenses118,305 43,408 159,914 81,695 
Operating income (loss) 8,077
 (22,743) (44,927) (60,635)
Operating incomeOperating income34,060 93,047 109,730 143,782 
Other income (expense):        Other income (expense):
Investment and other income, net 790
 334
 1,512
 960
Investment and other (expense) income, netInvestment and other (expense) income, net(945)221 (447)497 
Inducement expense related to convertible notesInducement expense related to convertible notes— — — (20,960)
Interest expense (5,538) (5,253) (16,526) (14,378)Interest expense(3,104)(1,752)(4,863)(3,717)
Income (loss) before income taxes 3,329
 (27,662) (59,941) (74,053)
Net income before income taxesNet income before income taxes30,011 91,516 104,420 119,602 
Income tax expense 580
 1,284
 970
 1,584
Income tax expense7,326 58 21,627 249 
Net income (loss) $2,749
 $(28,946) $(60,911) $(75,637)
Net incomeNet income$22,685 $91,458 $82,793 $119,353 
        
Net income (loss) per share:        
Net income per share:Net income per share:
Basic $0.02
 $(0.23) $(0.45) $(0.59)Basic$0.16 $0.64 $0.60 $0.85 
Diluted $0.02
 $(0.23) $(0.45) $(0.59)Diluted$0.16 $0.62 $0.58 $0.81 
        
Shares used in computing net income (loss) per share:        
Shares used in computing net income per share:Shares used in computing net income per share:
Basic 141,190
 128,154
 134,633
 127,886
Basic137,937 142,487 137,798 140,201 
Diluted 143,236
 128,154
 134,633
 127,886
Diluted142,216 147,624 141,795 148,096 
See accompanying notes to condensed consolidated financial statements.

6


HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
(In thousands)
  Three Months Ended
September 30,		 Nine Months Ended
September 30,
  2017 2016 2017 2016
Net income (loss) $2,749
 $(28,946) $(60,911) $(75,637)
Other comprehensive income (loss):        
Unrealized gain (loss) on marketable securities 24
 (133) (40) 182
Foreign currency translation adjustment 1
 —
 (6) —
Unrealized loss on foreign currency (17) —
 (1) —
Total comprehensive income (loss) $2,757
 $(29,079) $(60,958) $(75,455)
Three Months Ended
 June 30,		Six Months Ended
June 30,
2022202120222021
Net income$22,685 $91,458 $82,793 $119,353 
Other comprehensive income:
Unrealized gain (loss) on marketable securities732 (1)(1,439)(84)
Foreign currency translation adjustment2 (20)2 15 
Unrealized gain on foreign currency40 6 40 23 
Total comprehensive income$23,459 $91,443 $81,396 $119,307 
See accompanying notes to condensed consolidated financial statements.

7


HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
 Nine Months Ended
September 30,		Six Months Ended
June 30,
 
 2017 2016 20222021
Operating activities:    Operating activities:
Net loss $(60,911) $(75,637)
Adjustments to reconcile net loss to net cash used in operating activities:    
Net incomeNet income$82,793 $119,353 
Adjustments to reconcile net income to net cash provided by in operating activities:Adjustments to reconcile net income to net cash provided by in operating activities:
Share-based compensation 23,268
 18,843
Share-based compensation10,377 10,295 
Depreciation and amortization 1,668
 1,766
Depreciation and amortization1,921 1,473 
Non-cash interest expense 1,242
 2,444
Payment-in-kind interest expense on long-term debt —
 9,152
(Accretion of discounts) amortization of premiums on marketable securities, net (94) 505
Amortization of intangible assetsAmortization of intangible assets11,403 — 
Amortization of debt discountAmortization of debt discount2,082 1,706 
Accretion of discounts on marketable securities, netAccretion of discounts on marketable securities, net800 945 
Realized loss on marketable securitiesRealized loss on marketable securities1,727 — 
Loss on disposal of equipment 44
 —
Loss on disposal of equipment80 — 
Deferral of unearned revenue 422
 5,623
Recognition of deferred revenue (4,192) (8,105)Recognition of deferred revenue(1,122)(499)
Recognition of deferred rent (125) (260)
Other (6) —
Lease payments deferredLease payments deferred(394)(385)
Induced conversion expense related to convertible notesInduced conversion expense related to convertible notes— 20,960 
Deferred income taxesDeferred income taxes(372)— 
Changes in operating assets and liabilities:    Changes in operating assets and liabilities:
Accounts receivable, net 985
 14,732
Accounts receivable, net and other contract assetsAccounts receivable, net and other contract assets(32,252)(55,466)
Inventories 5,292
 (3,363)Inventories(9,025)2,427 
Prepaid expenses and other assets 8,998
 1,085
Prepaid expenses and other assets(9,319)(5,831)
Accounts payable and accrued expenses 4,213
 (1,401)Accounts payable and accrued expenses29,323 207 
Net cash used in operating activities (19,196) (34,616)
Net cash provided by operating activitiesNet cash provided by operating activities88,022 95,185 
Investing activities:    Investing activities:
Purchases of marketable securities (198,748) (152,404)Purchases of marketable securities(225,689)(241,926)
Proceeds from maturities of marketable securities 184,494
 57,283
Proceeds from sales and maturities of marketable securitiesProceeds from sales and maturities of marketable securities725,995 152,863 
Acquisitions of business, net of cash acquiredAcquisitions of business, net of cash acquired(999,120)— 
Purchases of property and equipment (490) (2,690)Purchases of property and equipment(1,458)(803)
Proceeds from the sale of assetsProceeds from the sale of assets16,021 — 
Net cash used in investing activities (14,744) (97,811)Net cash used in investing activities(484,251)(89,866)
Financing activities:    Financing activities:
Proceeds from issuance of common stock, net

 134,875
 —
Proceeds from issuance of long-term debt, net —
 203,005
Repayment of long-term debt (10,988) (54,285)
Proceeds from term loanProceeds from term loan250,000 — 
Proceeds from revolving credit facilitiesProceeds from revolving credit facilities120,000 — 
Proceeds from issuance of 2027 Convertible NotesProceeds from issuance of 2027 Convertible Notes— 784,875 
Repayment of 2024 Convertible NotesRepayment of 2024 Convertible Notes— (369,064)
Payment of debt issuance costPayment of debt issuance cost(6,003)(424)
Repurchase of common stockRepurchase of common stock— (125,021)
Proceeds from issuance of common stock under equity incentive plans, net of taxes paid related to net share settlement 7,686
 1,622
Proceeds from issuance of common stock under equity incentive plans, net of taxes paid related to net share settlement4,445 3,578 
Net cash provided by financing activities 131,573
 150,342
Net cash provided by financing activities368,442 293,944 
Net increase in cash, cash equivalents and restricted cash 97,633
 17,915
Net (decrease) increase in cash, cash equivalents and restricted cashNet (decrease) increase in cash, cash equivalents and restricted cash(27,787)299,263 
Cash, cash equivalents and restricted cash at beginning of period 67,264
 43,792
Cash, cash equivalents and restricted cash at beginning of period119,219 148,203 
Cash, cash equivalents and restricted cash at end of period $164,897
 $61,707
Cash, cash equivalents and restricted cash at end of period$91,432 $447,466 
Supplemental disclosure of non-cash investing and financing activities:Supplemental disclosure of non-cash investing and financing activities:
Amounts accrued for purchases of property and equipmentAmounts accrued for purchases of property and equipment$336 $242 
Right-of-use assets obtained in exchange for lease obligationRight-of-use assets obtained in exchange for lease obligation$217 $318 
Common stock issued for induced conversion related to convertible notesCommon stock issued for induced conversion related to convertible notes$— $7,865 
See accompanying notes to condensed consolidated financial statements.

8


HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited) (in thousands)
Three Months Ended June 30, 2022
 Common StockAdditional
Paid-In
Capital		Accumulated
Other
Comprehensive Income/(Loss)		Retained Earnings (Accumulated
Deficit)		Total
Stockholders’
Equity
 SharesAmount
BALANCE AS OF MARCH 31, 2022137,888 $138 $261,713 $(2,791)$1,196 $260,256 
Share-based compensation expense— — 5,635 — — 5,635 
Issuance of common stock pursuant to exercise of stock options and vesting of restricted stock units, net and shares issued under the ESPP plan226 — 3,821 — — 3,821 
Repurchase of common stock(433)— — — 
Other comprehensive income— — — 774 — 774 
Net income— — — — 22,685 22,685 
BALANCE AS OF JUNE 30, 2022137,681 $138 $271,169 $(2,017)$23,881 $293,171 
Six Months Ended June 30, 2022
 Common StockAdditional
Paid-In
Capital		Accumulated
Other
Comprehensive Income/(Loss)		Retained Earnings (Accumulated
Deficit)		Total
Stockholders’
Equity
 SharesAmount
BALANCE AS OF DECEMBER 31, 2021137,498 $138 $256,347 $(620)$(58,912)$196,953 
Share-based compensation expense— — 10,377 — 10,377 
Issuance of common stock pursuant to exercise of stock options and vesting of restricted stock units, net and shares issued under the ESPP plan616 — 4,445 — 4,445 
Repurchase of common stock(433)— — — 
Other comprehensive loss— — — (1,397)(1,397)
Net income— — — — 82,793 82,793 
BALANCE AS OF JUNE 30, 2022137,681 $138 $271,169 $(2,017)$23,881 $293,171 
Three Months Ended June 30, 2021
 Common StockAdditional
Paid-In
Capital		Accumulated
Other
Comprehensive Income/(Loss)		Retained Earnings (Accumulated
Deficit)		Total
Stockholders’
Equity
 SharesAmount
BALANCE AS OF MARCH 31, 2021143,380 $143 $501,186 $(9)$(433,725)$67,595 
Share-based compensation expense— — 5,372 — — 5,372 
Issuance of common stock pursuant to exercise of stock options and vesting of restricted stock units, net318 1 4,179 — — 4,180 
Repurchase of common stock(1,517)(2)(48,840)(48,842)
Other comprehensive loss— — — (15)— (15)
Net income— — — — 91,458 91,458 
BALANCE AS OF JUNE 30, 2021142,181 $142 $461,897 $(24)$(342,267)$119,748 
Six Months Ended June 30, 2021
 Common StockAdditional
Paid-In
Capital		Accumulated
Other
Comprehensive Income (Loss)		Retained Earnings (Accumulated
Deficit)		Total
Stockholders’
Equity
 SharesAmount
BALANCE AS OF DECEMBER 31, 2020135,030 $135 $625,483 $22 $(474,593)$151,047 
Adjustment to beginning accumulated deficit— — (65,535)— 12,973 (52,562)
Share-based compensation expense— — 10,295 — — 10,295 
Issuance of common stock for the induced conversion related to convertible notes9,083 9 13,095 13,104 
Issuance of common stock pursuant to exercise of stock options and vesting of restricted stock units, net881 1 3,577 — — 3,578 
Repurchase of common stock(2,813)(3)(125,018)(125,021)
Other comprehensive loss— — — (46)— (46)
Net income— — — — 119,353 119,353 
BALANCE AS OF JUNE 30, 2021142,181 $142 $461,897 $(24)$(342,267)$119,748 
See accompanying notes to condensed consolidated financial statements.
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HALOZYME THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Organization and Business
Halozyme Therapeutics, Inc. is a biotechnologybiopharma technology platform company focused on developing and commercializing novel oncology therapies. We are seeking to translate our unique knowledge of the tumor microenvironment to create therapies that have the potential to improve cancer patient survival. Our research primarily focuses on human enzymes that alter the extracellular matrix and tumor microenvironment. The extracellular matrix is a complex matrix of proteins and carbohydrates surrounding the cell that provides structural support in tissuesinnovative and orchestrates many important biological activities, including cell migration, signalingdisruptive solutions with the goal of improving patient experience and survival. Over many years, we have developed unique technology and scientific expertise enabling us to pursue this target-rich environment for the development of therapies.
outcomes. Our proprietary enzymes areenzyme, rHuPH20, is used to facilitate the delivery of injected drugs and fluids, potentially enhancing the efficacy and the convenience of other drugs or can be used to alter tissue structures for potential clinical benefit.fluids. We exploit our technology and expertise using a two pillar strategy that we believe enables us to manage risk and cost by: (1) developing our own proprietary products in therapeutic areas with significant unmet medical needs, with a focus on oncology, and (2) licensinglicense our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug deliverytechnology with the collaborators’partners’ proprietary compounds.
The majority of ourOur first commercially approved product, Hylenex® recombinant, (“Hylenex”), and our partners’ approved products and product candidates are based on rHuPH20, our patented recombinant human hyaluronidase enzyme. rHuPH20 is the active ingredient in our first commercially approved product, Hylenex® recombinant, and it works by temporarily breaking down hyaluronan (or “HA”), a naturally occurring complex carbohydrate that is a major component of the extracellular matrix in tissues throughoutof the body such as skinsubcutaneous (SC) space. This temporarily increases dispersion and cartilage. We believe this temporary degradation creates an opportunistic windowabsorption allowing for the improved subcutaneousSC delivery of 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 our ENHANZE™ Technology.® drug delivery technology (“ENHANZE”). We license the ENHANZE Technologytechnology to form collaborations with biopharmaceutical companies that develop or market drugs requiring or benefiting from injection via the subcutaneousSC 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. ENHANZE may enable fixed-dose SC dosing compared to weight-based dosing required for IV administration, 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. 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 with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc. (“Roche”), Baxalta US Inc. and Baxalta GmbH (Baxalta Incorporated was acquired by Shire plc in June 2016)(members of the Takeda group of companies) (“Baxalta”), Pfizer Inc. (“Pfizer”), Janssen Biotech, Inc. (“Janssen”), AbbVie, Inc. (“AbbVie”), Eli Lilly and Company (“Lilly”) and, 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 attainment 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 two3 of these collaborations, including royalties from sales of one1 product from the Baxalta collaboration, and two3 products from the Roche collaboration and 1 product from the Janssen collaboration. Future potential revenues from ENHANZE collaborations and from the sales and/or royalties of our approved products product candidates, and ENHANZE collaborations will depend on the ability of Halozyme and our collaboratorspartners to develop, manufacture, secure and maintain regulatory approvals for approved products and product candidates and commercialize product candidates.
Our proprietary development pipeline consists primarilyThrough our recent acquisition of pre-clinicalAntares Pharma, Inc. (“Antares”), we also develop, manufacture and clinical stage product candidates in oncology. Our lead oncology program is PEGPH20 (PEGylated recombinant human hyaluronidase), a molecular entity wecommercialize, for ourselves or with our partners, drug-device combination products using our advanced auto-injector technologies that are developing in combination with currently approved cancer therapiesdesigned to provide commercial or functional advantages such as convenience, improved tolerability, and enhanced patient comfort and adherence. Also, as a candidate for the systemic treatment of tumors that accumulate HA. We have demonstrated that when HA accumulates in a tumor, it can cause higher pressure in the tumor, reducing blood flow into the tumor and with that, reduced access of cancer therapies to the tumor. PEGPH20 has been demonstrated in animal models to work by temporarily degrading HA surrounding cancer cells resulting in reduced pressure and increased blood flow to the tumor thereby enabling increased amounts of anticancer treatments administered concomitantly gaining access to the tumor. Through our efforts and effortsresult of our partnersacquisition of Antares, our commercial portfolio of proprietary products includes XYOSTED®, TLANDO™ and collaborators, we are currently in Phase 3 clinical testing for PEGPH20NOCDURNA® and partnered commercial products and ongoing product development programs with ABRAXANE® (nab-paclitaxel)industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (“Teva”), Covis Group S.a.r.l. (“Covis”), Pfizer and gemcitabine in stage IV pancreatic ductal adenocarcinomaIdorsia Pharmaceuticals Ltd. (“PDA”Idorsia”) (Halo 109-301), in Phase 1b clinical testing forPEGPH20 with KEYTRUDA® (pembrolizumab) in non-small cell lung cancer and gastric cancer (Halo 107-101), in


Phase 1b/2 clinical testing for PEGPH20 with HALAVEN® (eribulin) in patients treated with up to two lines of prior therapy for HER2-negative metastatic breast cancer, in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq® (atezolizumab) in patients with previously treated metastatic PDA, in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq in patients with gastric cancer and in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq in patients with cholangiocarcinoma and gall bladder cancer (Halo 110-101/MATRIX).
Except where specifically noted or the context otherwise requires, references to “Halozyme,” “the Company,” “we,” “our,” and “us” in these notes to the condensed consolidated financial statements refer to Halozyme Therapeutics, Inc. and its wholly owned subsidiary,subsidiaries, Halozyme, Inc. and Antares Pharma, Inc., and Halozyme, Inc.’s wholly owned subsidiaries, Halozyme Holdings Ltd., Halozyme Royalty LLC andsubsidiary, Halozyme Switzerland GmbH.Holdings GmbH and Antares Pharma, Inc.’s wholly owned subsidiaries Antares Pharma IPL AG and Antares Pharma AG.
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2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for a complete set of financial statements. These interim unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2016,2021, filed with the SEC on February 28, 2017.22, 2022. The unaudited financial information for the interim periods presented herein reflects all adjustments which, in the opinion of management, are necessary for a fair presentation of the financial condition and results of operations for the periods presented, with such adjustments consisting only of normal recurring adjustments. Operating results for interim periods are not necessarily indicative of the operating results for an entire fiscal year.
The accompanying interim unaudited condensed consolidated financial statements include the accounts of Halozyme Therapeutics, Inc. and our wholly owned subsidiary,subsidiaries, Halozyme, Inc. and Antares Pharma, Inc., and Halozyme, Inc.’s wholly owned subsidiaries, Halozyme Holdings Ltd., Halozyme Royalty LLC andsubsidiary Halozyme Switzerland GmbH.Holdings GmbH 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 interim unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in our interim unaudited condensed 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 management believes 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 management’s estimates.
Cash Equivalents and Marketable Securities
Cash equivalents consist of highly liquid investments, readily convertible to cash, that mature within ninety days or less from the date of purchase. As of SeptemberJune 30, 2017,2022, our cash and cash equivalents consisted of money market funds, bank certificate of deposits and demands deposits at commercial paper and U.S. Treasury securities.banks.
Marketable securities are investments with original maturities of more than ninety 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 gainincome (loss) and included as a separate component of stockholders’ equity (deficit).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 interim unaudited condensed consolidated statements of operations.income. We use the specific identification method for


calculating realized gains and losses on marketable securities sold. RealizedNone of the realized gains and losses and declines in value that were judged to be other-than-temporaryas a result of credit loss on marketable securities, if any, are included in investment and other income, net in the interim unaudited condensed 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 SeptemberAs of June 30, 20172022 and December 31, 2016,2021, 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 tierthree-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.
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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 long-term debt.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. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, we believe the fair value of long-term debt approximates its carrying value.
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.
Inventories
Inventories are stated at lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Inventories are reviewed periodically for potential excess, dated or obsolete status. We evaluate the carrying value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the remaining shelf life of goods on hand.
PriorLeases
The Company has entered into operating leases primarily for real estate and automobiles. These leases have contractual terms which range from 3 years to receiving marketing approval12 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 condensed consolidated balance sheets. Operating lease ROU assets and liabilities are recognized based on the U.S. Food and Drug Administration (“FDA”) or comparable regulatory agencies in foreign countries, costs related to purchases of bulk rHuPH20 and raw materials and the manufacturingpresent value of the product candidatesfuture 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.
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 will assume Seismic’s office lease, as amended with Kilroy Realty L.P. for approximately 72,534 square feet of space in office and research facilities which is expected to commence on January 1, 2023. The premises are intended to serve as our new headquarters.
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 they are 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 asin the consolidated statements of income.

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Goodwill, Intangible Assets and Other Long-Lived Asset
Assets acquired, including intangible assets and in-process research and development expense. All direct manufacturing costs incurred after receiving marketing approval(IPR&D), and liabilities assumed are capitalizedmeasured at fair value as inventory. Inventoriesof 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 clinical trialsthe period of abandonment.
Goodwill and IPR&D are expensednot 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 timereporting unit level, which aligns with our reporting structure and availability of discrete financial information. During the inventoriesgoodwill impairment review, we assess qualitative factors to determine whether it is more likely than not that the fair values of our reporting units are packaged forless than the clinical trials.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 a finite life 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.

AsWe 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 September 30, 2017impairment 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 December 31, 2016, inventories consistedrecord an impairment loss if the carrying value of $2.4 millionthe assets exceeds the fair value. Factors that may indicate potential impairment include a significant decline in our stock price and $2.3 million, respectively, of Hylenex recombinant inventory,market capitalization compared to the net and $6.9 million and $12.3 million, respectively, of bulk rHuPH20 for usebook value, significant changes in the manufactureability of Baxalta’sa particular asset to generate positive cash flows for our strategic business objectives, and Roche’s collaboration products.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.
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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. 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 the terms of our ENHANZE collaboration agreements, we grant the partner a worldwide license to develop and commercialize products using our ENHANZE technology to combine our patented rHuPH20 enzyme with their proprietary biologics directed at up to a specified number of targets. Targets are usually licensed on an exclusive, global basis. Targets selected subsequent to inception of the arrangement generally require payment of an additional license fee. The 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 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, in general, collect an upfront license payment from partners and are also entitled to receive event-based payments subject to partners’ achievement of specified development, regulatory and sales-based milestones. In several agreements, 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 consideration. Under these collaborative agreements, we do not develop assets jointly with partners, and do not share in significant 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 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 or fluids. Each of the licenses grants the partners rights to use
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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 under collaborative agreements. Collaborative agreement payments may include nonrefundable feesaccess to our intellectual property, usually at the inception of the agreements,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 event-based paymentsroyalties. 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).
We provide customary indemnification and protection of licensed intellectual property for specific achievements designatedour 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. Additionally, 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 reimbursementsare subject to significant uncertainties of product development. Achievement of many of the event-based development and regulatory milestones may not be probable until such milestones are actually achieved. This generally relates to milestones such as obtaining marketing authorization approvals. With respect to other development milestones, e.g. dosing of a first patient in a clinical trial, achievement could be considered probable prior to its actual occurrence, based on the progress towards commencement of the trial. In order to evaluate progress towards commencement of a trial, we assess the status of activities 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 into 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 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.
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Development milestones and supply of bulk rHuPH20, and/or royaltiesother 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 sales of products resulting from collaborative arrangements.
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 in accordanceas 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 know-how 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 and allocate consideration to each performance obligation based on relative standalone selling price, 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 authoritative guidance for revenue recognition. We recognize revenue when allremaining portion to be billed upon completion and transfer of the following criteriaindividual deliverables or satisfaction of the individual performance obligations. We record a contract liability for cash received in advance of performance, which is presented within deferred revenue and deferred revenue, long-term in the Condensed Consolidated Balance Sheets and recognized as revenue in the 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 met: (1) persuasive evidencegenerally recognized at inception of anthe arrangement, exists; (2) delivery has occurredor over the development period depending on the facts and circumstances, as the license is generally not distinct from the non-licensed goods or services have been rendered; (3)to be provided under the seller’s pricecontract. Milestone payments that are contingent upon the occurrence of future events are evaluated and recorded at the most likely amount, and to the buyerextent that it is fixed or determinable; and (4) collectibilityprobable that a significant reversal will not occur when the associated uncertainty is reasonably assured.resolved.
Refer to Note 5 Revenue, for further discussion on our collaborative arrangements.
Product Sales,Net
Hylenex RecombinantProprietary Product Sales
HylenexRecombinant
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 provideare 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 sellingprompt payment and subsequent chargebacks when wholesalers sell Hylenex recombinant at negotiated discounted prices that are fixed on the dateto members of sale, although we offer discounts to certain group purchasing organizations (“GPOs”), hospitals and government programs. TheWe also pay quarterly distribution fees to certain wholesalers take titlefor inventory reporting and chargeback processing, and to GPOs as administrative fees for services and for access to GPO members. We concluded the product, bear the risk of loss of ownership and have economic substance to the inventory. Further, we have no significant obligationsbenefits received in exchange for future performance to generate pull-through sales.
We have developed sufficient historical experience and data to reasonably estimate future returns and chargebacks of Hylenex recombinant. As a result, we recognize Hylenex recombinant product sales and related cost of product sales at the time title transfers to the wholesalers.
Upon recognition of revenuethese fees are not distinct from productour sales of Hylenexrecombinant, and accordingly we record certain sales reserves and allowances as a reductionapply these amounts to gross revenue. These reserves and allowances include amounts forreduce revenues. Wholesalers also have rights to return unsold product returns (based primarily on an analysis of historical return patterns), distribution fees, prompt payment discounts, and GPO fees and other discounts and fees.
We recognize product sales reserves and allowances as a reduction of product sales innearing or past the same period the related revenue is recognized.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. If
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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. We monitor actual product return resultsreturns, chargebacks, discounts and fees subsequent to the sale. If these amounts differ from our estimates, we will be required to make adjustments to these allowances, in the future, which could have an effect onare applied to increase or reduce product sales revenue and earnings in the period of adjustments.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
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.
Partnered Product Sales
Bulk rHuPH20
SubsequentWe sell bulk rHuPH20 to partners for use in research and development and, subsequent to receiving marketing approval, from the FDA or comparable regulatory agencies in foreign countries, sales of bulk rHuPH20we sell it for use in collaboration commercial productsproducts. Sales are recognized as product sales when the materials have met all the specifications required for the customer’s acceptance and title and risk of loss have transferredmade pursuant to the customer. Following the receipt of European marketing approvals of Roche’s Herceptin SC product in August 2013 and MabThera® SC product in March 2014 and Baxalta’s HYQVIA product in May 2013, revenue from the sales of bulk rHuPH20 for these collaboration products has been recognized as product sales.


Revenues under Collaborative Agreements
We have entered into license and collaboration agreements under which our collaborators obtained worldwide rights for the use of our proprietary rHuPH20 enzyme in the development and commercialization of their biologic compounds identified as targets. These agreements may also contain other elements. Pursuantpurchase orders subject to the terms of these agreements, collaborators could be required to make various payments to us for each target, including nonrefundable upfront license fees, exclusivity fees, payments based on achievement of specified milestones designated in the collaborative agreements, annual maintenance fees, reimbursementsagreement or a supply agreement, and delivery of research and development services, payments for supplyunits of bulk rHuPH20 used byrepresent performance obligations under each purchase order. We provide a standard warranty that the collaborator and/or royalties onproduct conforms to specifications. We use contract manufacturers to produce bulk rHuPH20 and have concluded we are the principal in the sales of products resulting from collaborative agreements.
In order to account for the multiple-element arrangements, we identify the deliverables included within the collaborative agreement and evaluate which deliverables represent units of accounting. We then determine the appropriate method of revenue recognitionpartners. The transaction price for each unitpurchase order of bulk rHuPH20 is fixed based on the naturecost of production plus a contractual markup, and timingis not subject to adjustments. Allocation of the delivery process. Analyzingtransaction price to individual quantities of the arrangement to identify deliverables requiresproduct is usually not required because each order contains only one type of product.
We recognize revenue from the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. The deliverables under our collaborative agreements include (i) the license to our rHuPH20 technology, (ii) at the collaborator’s request, research and development services which are reimbursed at contractually determined rates, and (iii) at the collaborator’s request, supplysale 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.
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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 reimbursed at our cost plus a margin. A delivered item is considered a separate unitrecognized when or as control of accounting when the delivered item has valuegoods transfers to the collaborator oncustomer 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 standalone basiscontractual 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 consideration of the relevant facts and circumstances for each arrangement. We base this determination on the collaborators’ ability to use the delivered items on their own without us supplying undelivered items, which we determine taking into consideration factors such as the research capabilities of the collaborator, the availability of research expertise in this field in the general marketplace, and the ability to procure the supply of bulk rHuPH20 from the marketplace.
Arrangement consideration is allocated at the inception of the agreement to all identified units of accounting based on their relative selling price. The relativecontractual selling price for each deliverable is determined using vendor specific objective evidence (“VSOE”)and number of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, we use our best estimate of the selling price for the deliverable.units produced. The amount of allocable arrangement consideration is limited to amounts that are not contingent upon the delivery of additional items or meeting other specified performance conditions. The consideration received is allocated among the separate units of accounting and the applicable revenue recognition criteria are applied to each of the separate units. Changes in the allocation of the sales price between delivered and undelivered elements can impact revenue recognition but do not change the total revenue recognized under any agreement.
Nonrefundable upfront license fees are recognized upon delivery of the license if facts and circumstances dictate that the license has standalone value from the undelivered items, which generally include research and development services and the manufacture of bulk rHuPH20, the relative selling price allocation of the license is equal to or exceeds the upfront license fee, persuasive evidence of an arrangement exists, our price to the collaborator is fixed or determinable and collectibility is reasonably assured. Upfront license fees are deferred if facts and circumstances dictate that the license does not have standalone value. The determination of the length of the period over which to defer revenue is subject to judgment and estimation and can have an impact on the amount of revenue recognized in a given period.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.
When collaborators have rights to elect additional targets, the rightsAll other device partnered product sales are assessed as to whether they represent deliverablesrecognized at the inceptionpoint 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 arrangement. In assessing these contingent deliverables,goods to our partner. The estimated variable consideration is recognized at an amount we consider whether the rightbelieve is a substantive option. We consider a rightnot subject to be a substantive optionsignificant reversal based on historical experience and is adjusted at each reporting period if the electionmost likely amount of the additional targets is not essential to the functionalityexpected consideration changes or becomes fixed.
Revenue Presentation
In our statements of the other elements in the arrangement and ifincome, we are truly at risk of the right being exercised. If the right is determined to be a substantive option, we further consider whether the right is priced at a significant and incremental discount that should be accounted forreport as an element of the arrangement. If a right is determined to be a substantive option and is not priced at a significant and incremental discount, it is not treated as a deliverable in the arrangement and receives no allocation at the inception of the arrangement of the original arrangement consideration. The right is then accounted for when and if it is exercised.


Certain of ourrevenues under collaborative agreements provide for milestonethe upfront payments, upon achievement ofevent-based development and regulatory events and/or specifiedmilestones and sales volumes of commercialized products by the collaborator.milestones. We account for milestone paymentsalso include in accordance with the provisions of ASU No. 2010-17, Revenue Recognition - Milestone Method (“Milestone Method of Accounting”). We recognize consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria:
1.The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone;
2.The consideration relates solely to past performance; and
3.The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.
A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resultingthis category revenues from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved, and (iii) that would result in additional payments being due to the vendor.
Reimbursements ofseparate research and development services are recognizedcontracts pursuant to project authorization forms. We report royalties received from partners as revenue during the perioda separate line in which the services are performed as long as there is persuasive evidenceour statements of an arrangement, the fee is fixed or determinable and collection of the related receivable is reasonably assured. Revenue from the manufacture of bulk rHuPH20 is recognized when the materials have met all specifications required for the collaborator’s acceptance and title and risk of loss have transferred to the collaborator. We do not directly control when any collaborator will request research and development services or supply of bulk rHuPH20; therefore, we cannot predict when we will recognize revenues in connection with research and development services and supply of bulk rHuPH20.income.
Since we receive royalty reports 60 days after quarter end, royalty revenueRevenues from sales of collaborationour proprietary and partnered products are included in product sales, net.
In the footnotes to our condensed consolidated financial statements, we provide disaggregated revenue information by our collaborators is recognized in the quarter following the quarter in which the correspondingtype of arrangement (product sales, occurred.
Thenet, collaborative agreements typically provide the collaborators the right to terminate such agreement in whole or on a product-by-product or target-by-target basis at any time upon 30 to 90 days prior written notice to us. There are no performance, cancellation, termination or refund provisions in anyand research and device licensing and development revenues), and additionally, by type of ourpayment stream received under collaborative agreements that contain material financial consequences to us.
Refer to Note 4, Collaborative Agreements, for further discussion on our collaborative arrangements.(upfront license and target nomination fees, event-based development and regulatory milestones and other fees, sales milestones and royalties).
Cost of Product Sales
Cost of product 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 Hylenex recombinantproprietary and bulk rHuPH20 for use in approved collaborationpartnered products. Cost of product 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, external clinical trial 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.After receiving approval from the FDA or comparable regulatory agencies in foreign countries for a product, costs related to purchases and manufacturing of bulk rHuPH20 for such product are capitalized as inventory. The manufacturing costs of bulk rHuPH20 for the collaboration products, Herceptin SC, MabThera SC (RITUXAN HYCELA™ in the U.S.) and HYQVIA, incurred after the receipt of marketing approvals are capitalized as inventory.
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.
Milestone payments that we make in connection with in-licensed technology for a particular research and development project that have no alternative future uses (in other research and development projects or otherwise) and therefore no separate economic value are expensed as research and development costs at the time the costs are incurred. We currently have no in-licensed technologies that have alternative future uses in research and development projects or otherwise.
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Clinical Trial Expenses

We make payments in connection with our clinical trials under contracts with contract research organizations that support conducting and managing clinical trials. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of our obligation to make payments under these contracts depends on factors such as the successful enrollment or treatment of patients or the completion of other clinical trial milestones.
Expenses related to clinical trials are accrued based on our estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts we are obligated to pay under our clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), we adjust our accruals accordingly on a prospective basis. Revisions to our contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.
Share-Based Compensation
We record compensation expense associated with stock options, restricted stock awards (“RSAs”), restricted stock units (“RSUs”), performance stock units (“PSUs”) and RSUs with performance conditionsshares issued under our employee stock purchase plan (“PRSUs”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 at each year end and their respective tax bases at each reporting period. We measure deferred tax assets and are measuredliabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income.reverse. Significant judgment is required by management to determine our provision for income taxes, our deferred tax assets and liabilities, and theany associated valuation allowance to recordallowances recorded against our net deferred tax assets, which are based on complex and evolving tax regulations throughout the world.regulations. Deferred tax assets (“DTA”) and other tax benefits are recorded when it isthey 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 the positionsome or all of our DTAs will be sustained upon audit. Whilerealized. We recorded a provision for income taxes of $7.3 million and $21.6 million using an effective tax rate of 8.1% and 20.7% the three and six months ended June 30, 2022 respectively. The difference between our effective tax rate and the U.S. federal statutory rate of 21% is primarily due to tax benefits on Foreign Derived Intangible Income Deduction (FDII), and tax detriments on 162(m), other share-based compensation and non-deductible transaction costs related to Antares acquisition.
Segment Information
As a result of the acquisition of Antares, we have begun to utilize certainassessed the organization of our net operating losses,business and concluded that we have not yet established a track record of profitability. Accordingly, valuation allowances have been recordedcontinue to reduce our net deferred tax assets to zero until such time we can demonstrate an ability to realize them.
Net Income (Loss) Per Share
Basic net income (loss) per common share is computed by dividing net income (loss) 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 and unvested PRSUs 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. Outstanding common stock equivalents totaling approximately 7.8 million and 13.8 million, respectively, were excluded from the calculation of diluted net income (loss) per common share for the three months ended September 30, 2017 and 2016, respectively, because their effect was anti-dilutive. For the nine months ended September 30, 2017 and 2016, approximately 14.3 million and 13.8 million shares, respectively, of outstanding stock options, unvested RSAs, unvested RSUs and unvested PRSUs were excluded from the calculation of diluted net loss per common share because a net loss was reported in each of these periods and therefore their effect was anti-dilutive. A reconciliation of the numerators and the denominators of the basic and diluted net income (loss) per common share computations is as follows (in thousands, except per share amounts):
  Three Months Ended
September 30,		 Nine Months Ended
September 30,
  2017 2016 2017 2016
Numerator:        
Net income (loss) $2,749
 $(28,946) $(60,911) $(75,637)
Denominator:        
Weighted average common shares outstanding for basic
net income (loss) per share		 141,190
 128,154
 134,633
 127,886
Net effect of dilutive common stock equivalents 2,046
 —
 —
 —
Weighted average common shares outstanding for diluted
net income (loss) per share		 143,236
 128,154
 134,633
 127,886
Net income (loss) per share:        
Basic $0.02
 $(0.23) $(0.45) $(0.59)
Diluted $0.02
 $(0.23) $(0.45) $(0.59)



Segment Information
We operate our business in one1 segment, which includes all activities related to the research, development and commercialization of our proprietary enzymes.enzymes and devices. This segment also includes revenues and expenses related to (i) research and development and bulk rHuPH20 manufacturing activities conducted under our collaborative agreements with third parties and (ii) product sales of Hylenex recombinant.proprietary and partnered products. The chief operating decision-maker reviews the operating results on an aggregate basis and manages the operations as a single operating segment. Our long-lived assets located in foreign countries had minimal book value as of September 30, 2017 and December 31, 2016.

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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:
StandardDescriptionEffective DateEffect on the Financial
Statements or Other Significant Matters
StandardDescriptionEffective Date
Effect on the Financial
Statements or Other Significant Matters
In July 2015,October 2021, the FASB issued ASU 2015-11, Inventory: Simplifying the Measurement of Inventory.2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from contracts with customersThe new guidance requires that for entities thatan acquirer to recognize and measure inventory usingcontract assets and contract liabilities acquired in a business combination in accordance with topic 606 as if it had originated the first-in, first-out method, inventory should be measured at the lower of cost or net realizable value. Topic 330, Inventory, currently requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximate normal profit margin. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.contracts
January 1, 2017.2023
(Early adoption is permitted, including adoption in an interim period)
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.
In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments.

In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash.		Current U.S. GAAP either is unclear or does not include specific guidance on the eight cash flow classification issues included in ASU 2016-15. The new guidance is an improvement to U.S. GAAP and is intended to reduce the current and potential future diversity in practice. ASU 2016-18 provides additional classification guidance for restricted cash, which requires that restricted cash be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows.January 1, 2018. We have elected to early adopt as of January 1, 2017.Cash and cash equivalents at the beginning-of-period and end-of-period total amounts in the Condensed Consolidated Statements of Cash Flows have been adjusted to include $0.5 million of restricted cash for each of the periods presented.



0
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3. Business Combination
On May 24, 2022, we acquired all outstanding equity interests of Antares Pharma, Inc. ("Antares") according to the terms and conditions of the Agreement and Plan of Merger, dated as of April 12, 2022 (the “Merger Agreement”). Antares is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in targeted therapeutic areas. We acquired Antares as a part of our strategy to expand as a drug delivery company and include specialty products.
The total purchase consideration of Antares was $1,045.7 million. Each share of Antares common stock issued and outstanding was converted into the right to receive $5.60 in cash without interest, less any applicable withholding taxes (“Merger Consideration”). Additionally, in connection with the transaction, each Antares equity award granted and outstanding as of May 24, 2022 under the Antares’ equity compensation plans was converted into the right to receive Merger Consideration. Other components of purchase consideration include cash paid at closing to settle Antares existing debt of $19.7 million and seller transaction costs paid by us on behalf of Antares of $22.9 million.
The acquisition of Antares was funded by cash on hand and borrowings under the new credit agreement with Bank of America, N.A. (“BofA”) and other lenders that provides for (i) a $350 million revolving credit facility (the “Revolving Credit Facility”) and (ii) a $250 million term loan facility (the “Term Facility”, collectively with the Revolving Credit Facility, the “2022 Facility”) as described in Note 8. We recognized transaction costs of $18.6 million and $20.1 million in the three and six months ended June 30, 2022, respectively. These costs are reported in the selling, general and administrative expenses line of our consolidated statements of income. Transaction costs include, but are not limited to, investment banker, advisory, legal, and other professional fees.

Purchase Consideration
The total purchase consideration was comprised of the following (in thousands):

StandardCash consideration for Antares shares outstanding as of May 24, 2022Description$956,886 Effective Date
Effect on the Financial
Statements or Other Significant Matters
In January 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall; Recognition and Measurement of Financial Assets and Financial Liabilities.
Consideration for Antares equity compensation awards (a)
The new guidance supersedes the guidance to classify equity securities with readily determinable fair values into different categories (that is, trading or available-for-sale) and requires equity securities to be measured at fair value with changes in the fair value recognized through net income. The new guidance requires public business entities that are required to disclose fair value of financial instruments measured at amortized cost on the balance sheet to measure that fair value using the exit price notion consistent with Topic 820, Fair Value Measurement.45,828 January 1, 2018.We currently do not hold equity securities, and we are evaluating the effect the updated standard will have on our consolidated financial statements and related disclosures.
Consideration for seller transaction costs paid by Halozyme22,906 
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). In March, April, May and December 2016, the FASB issued additional guidanceConsideration related to Topic 606.Antares closing indebtedness settled by Halozyme
The new standard will supersede nearly all existing revenue recognition guidance. Under Topic 606, an entity is required to recognize revenue upon transfer of promised goods or services to customers in an amount that reflects the expected19,683 
Cash consideration to be received in exchange for those goods or services. Topic 606 defines a five-step process in order to achieve this core principle, which may require the use of judgment and estimates, and also requires expanded qualitative and quantitative disclosures relating to the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers, including significant judgments and estimates used. The new standard also defines accounting for certain costs related to origination and fulfillment of contracts with customers, including whether such costs should be capitalized. The new standard permits adoption eithercash bonus awards paid by using (i) a full retrospective approach for all periods presented in the period of adoption or (ii) a modified retrospective approach where the new standard is applied in the financial statements starting with the year of adoption. Under both approaches, cumulative impact of the adoption is reflected as an adjustment to retained earnings (accumulated equity (deficit)) as of the earliest date presented in accordance with the new standard.


Halozyme		January 1, 2018. Early adoption is permitted.365 
We plan to implement the new guidance on January 1, 2018 using the modified retrospective approach. We are currently finalizing our evaluation of the effect that the updated standard will have on our consolidated financial statements and related disclosures. We anticipate an impact to the timing of recognition of payments related to certain of our license and collaboration agreements (1) and the timing of recognition of our sales-based royalties.(2) We anticipate that this standard will have a material impact on our consolidated financial statements. We cannot reasonably estimate additional quantitative information related to the impact of the new standard on our consolidated financial statements at this time.

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 Statement of Income in Q2 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 preliminary valuations and management estimates that are subject to change when formal valuations and other studies are finalized. 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. These preliminary estimates may be revised during the measurement period as third-party valuations are finalized, additional information becomes available, and as additional analyses are performed, and 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.
21

StandardDescriptionEffective Date
Effect on the Financial
Statements or Other Significant Matters
Amount (in thousands)
In February 2016, the FASB issued ASU 2016-02, Leases.Total purchase consideration, net of $46,548 cash acquiredThe new guidance requires lessees to recognize assets and liabilities for most leases and provides enhanced disclosures.$January 1, 2019. Early adoption is permitted.We are currently evaluating the effect the updated standard will have on our consolidated financial statements and related disclosures. We anticipate recognition of additional assets and corresponding liabilities related to our leases on our consolidated balance sheet.
_______________
999,120 
(1)Assets:
Short-term investmentsUnder the new standard, we are required to assess whether licenses granted under our collaboration and license agreements are distinct in the context of the agreement from other performance obligations and functional when granted. We expect that license-related amounts, including upfront payments, exclusive designation fees, annual license maintenance fees, additional target fees, development, regulatory and sales-based milestones will be recognized, generally, at a point in time when earned. Currently, these amounts related to certain of our license and collaboration agreements are being amortized over the term of the collaboration agreement. For example, during the year ended December 31, 2016, we recognized revenue from amortization of license payments of $4.1 million, and total deferred revenue related to license payments under collaboration agreements as of December 31, 2016 was $43.9 million. We anticipate an elimination of our associated deferred revenue balances upon adoption of Topic 606.
498 
(2)Under the new standard, we expect sales-based royalties will be recognized in the quarter they are earned based on estimates, with true-up to actual results following in the subsequent quarter. Sales-based royalty revenue earned under our collaboration and license agreements is presently recognized when the royalty reports are made available. Upon adoption of Topic 606, we will evaluate and reduce our accumulated equity (deficit) and increase our accountsAccounts receivable, net by the amount earned but not yet reported in our consolidated balance sheet at the time82,160 
Inventories, net34,379 
Prepaid expenses and other assets5,241 
Property and equipment, net28,661 
Intangibles, net987,500 
Liabilities:
Accounts Payable7,197 
Accrued expenses33,705 
Deferred revenue, current portion2,509 
Deferred revenue, net of adoption. We have established a process to estimate sales-based royalty revenues in the quarter in which the sales occur.current portion1,207 
Deferred tax liabilities, net159,094 
Other long-term liabilities135,088 
Net assets acquired, excluding goodwill$799,639 
Goodwill199,481 
3.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 segment. Goodwill recognized as a result of the acquisition is not deductible for tax purposes.

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.
Amount (in thousands)Useful life (years)
Auto Injector technology platform$372,900 7
XYOSTED proprietary product277,400 10
TLANDO product rights277,600 10
ATRS-1902 (IPR&D)59,600 Indefinite
Estimated fair value of intangible assets acquired987,500 

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.

Unaudited Pro Forma Results
Our consolidated financial statements include Antares' results of operations from the date of acquisition on May 24, 2022 through June 30, 2022. Total revenues and net loss before taxes attributable to Antares during this period and included in our consolidated financial statements for both the three and six months ended June 30, 2022 total $18.7 million and $39.8 million, respectively.
22

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.
Three Months Ended
 June 30,		Six Months Ended
June 30,
2022202120222021
Total Revenues$163,376 $168,839 $322,212 $312,538 
Net income (loss)$60,461 $70,259 $96,752 $18,615 
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 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.


23

4. Fair Value Measurement
Available-for-sale marketable securities consisted of the following (in thousands):
June 30, 2022
Amortized CostGross Unrealized GainsGross Unrealized LossesEstimated Fair Value
Asset-backed securities$— $— $— $— 
Corporate debt securities— — — — 
U.S. Treasury securities120,460 — (2,032)118,428 
Non-US Government securities— — — — 
Commercial paper— — — — 
$120,460 $— $(2,032)$118,428 
December 31, 2021
 September 30, 2017Amortized CostGross Unrealized GainsGross Unrealized LossesEstimated Fair Value
 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value
Asset-backed securitiesAsset-backed securities$32,745 $— $(53)$32,692 
Corporate debt securities $79,786
 $3
 $(43) $79,746
Corporate debt securities58,885 — (86)58,799 
U.S. Treasury securities 11,973
 2
 (8) 11,967
U.S. Treasury securities231,230 — (469)230,761 
Non- U.S Government securitiesNon- U.S Government securities17,232 — (12)17,220 
Commercial paper 60,812
 —
 —
 60,812
Commercial paper282,731 — — 282,731 
 $152,571
 $5
 $(51) $152,525
$622,823 $— $(620)$622,203 


  December 31, 2016
  Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value
Corporate debt securities $40,221
 $1
 $(15) $40,207
U.S. Treasury securities 94,002
 24
 (16) 94,010
Commercial paper 4,000
 —
 —
 4,000
  $138,223
 $25
 $(31) $138,217
As of SeptemberJune 30, 2017, $146.5 million of our2022, 6 available-for-sale marketable securities were scheduled to mature within the next 12 months. Aswith a fair market value of September 30, 2017, fourteen available-for-sale marketable securities$118.4 million were in a gross unrealized loss position all of which had been in such position for less than 12 months.$2.0 million. Based on our review of these marketable securities, we believe we had no other-than-temporary impairments on these securitiesnone of the unrealized loss is as a result of a credit loss as of SeptemberJune 30, 2017,2022, 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):
June 30, 2022December 31, 2021
Due within one year$118,428 $500,965 
After one but within five years— 121,238 
$118,428 $622,203 
24

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):
June 30, 2022December 31, 2021
Level 1Level 2Total estimated fair valueLevel 1Level 2Total estimated fair value
Cash equivalents:
Money market funds$70,843 $— $70,843 $118,707 $— $118,707 
Commercial paper— — — — — — 
Available-for-sale marketable
   securities:
Asset-backed securities— — — — 32,692 32,692 
Corporate debt securities— — — — 58,799 58,799 
U.S. Treasury securities118,428 — 118,428 230,761 — 230,761 
Non-US Government securities— — — — 17,220 17,220 
Commercial paper— — — — 282,731 282,731 
$189,271 $— $189,271 $349,468 $391,442 $740,910 
  September 30, 2017 December 31, 2016
  Level 1 Level 2 Total estimated fair value Level 1 Level 2 Total estimated fair value
Cash equivalents:            
Money market funds $138,194
 $—
 $138,194
 $60,916
 $—
 $60,916
U.S. Treasury securities 8,000
 —
 8,000
 —
 —
 —
Commercial paper —
 4,000
 4,000
 —
 —
 —
             
Available-for-sale marketable
   securities:
            
Corporate debt securities —
 79,746
 79,746
 —
 40,207
 40,207
U.S. Treasury securities 11,967
 —
 11,967
 94,010
 —
 94,010
Commercial paper —
 60,812
 60,812
 —
 4,000
 4,000
  $158,161
 $144,558
 $302,719
 $154,926
 $44,207
 $199,133
There were no transfers between Level 1 and Level 2 of the fair value hierarchy during the nine months ended September 30, 2017. We had no instrumentsavailable for sale securities that were classified within Level 3 as of SeptemberJune 30, 20172022 and December 31, 2016.

2021.

4. Collaborative Agreements
Roche Collaboration
In December 2006, weA contingent liability with a preliminary value of $130.0 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 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 thirteen Roche target compounds (the “Roche Collaboration”). Roche initially had the exclusive right to apply rHuPH20 to three pre-defined Roche biologic targets with the option to developpricing methodology using the Monte Carlo simulation for commercial milestone payments and commercialize rHuPH20 with ten additional targets. Roche hadroyalty payments. We will remeasure the right to exercise this option to identify additional targets for ten years. Asfair value of the ten year anniversary in December 2016, Roche had electedcontingent liability on a total of eight targets, two of which are exclusive.
In August 2013, Roche received European marketing approval for its collaboration product, Herceptin SC, for the treatment of patients with HER2-positive breast cancerquarterly basis. Estimates and launched Herceptin SCassumptions used in the European Union (“EU”) in September 2013. In March 2014, Roche received European marketing approval for its collaboration product, MabThera SC, for the treatmentMonte Carlo simulation include forecasted revenues, cost of patients with common formsdebt, risk free rate, weighted average cost of non-Hodgkin lymphoma (“NHL”). In June 2014, Roche launched MabThera SCcapital, revenue market price risk and revenue volatility. Estimates and assumptions used in the EU. In May 2016, Roche announced thatincome approach include the EMA approved Mabthera SC to treat patients with chronic lymphocytic leukemia (“CLL”). In June 2017, the FDA approved Genentech’s (a memberprobability of the Roche Group) RITUXAN HYCELA™,achieving certain milestones and a combination of rituximabdiscount rate. These unobservable inputs represent a Level 3 measurement because they are supported by little or no market activity and rHuPH20 (approved and marketed under the MabThera SC brandreflect our own assumptions in countries outside the U.S.), for CLL and two types of NHL, follicular lymphoma and diffuse large B-cell lymphoma. Following FDA approval, Genentech launched RITUXAN HYCELAmeasuring fair value. Changes in the U.S..
Roche assumes all development, manufacturing, clinical, regulatory, sales and marketing costs under the Roche Collaboration, while we are responsible for the supply of bulk rHuPH20. We are entitled to receive reimbursements for providing research and development services and supplying bulk rHuPH20 to Roche at its request.
Under the terms of the Roche Collaboration, Roche pays us a royalty on each product commercialized under the agreement consisting of a mid-single digit percent of the net sales of such product. Unless terminated earlier in accordance with its terms, the Roche Collaboration continues in effect until the expiration of Roche’s obligation to pay royalties. Roche has the obligation to pay royalties to us with respect to each product commercialized in each country, during the period equalfair value subsequent to the longer of: (a) the durationacquisition date will be recognized in our consolidated statements of any valid claim of our patents covering rHuPH20 or other specified patents developed under the Roche Collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. In the event such valid claims expire, the royalty rate is reduced for the remaining royalty term.income.
Payments received from Roche, excluding royalties and reimbursements for providing research and development services and supplying bulk rHuPH20, since inception of the Roche Collaboration are
25

5. Revenue
Our disaggregated revenues were as follows (in thousands):
Three Months Ended
 June 30,		Six Months Ended
June 30,
2022202120222021
Royalties$85,340 $45,778 $154,945 $82,701 
Product sales, net
  Sales of bulk rHuPH20$25,057 $24,087 $41,505 $40,857 
Sales of proprietary products14,687 6,273 20,379 11,269 
Sales of device partnered products6,556 — 6,556 — 
Total product sales, net$46,300 $30,360 $68,440 $52,126 
Revenues under collaborative agreements:
  Upfront license and target nomination fees$5,000 $40,000 $30,000 $40,000 
  Event-based development and regulatory milestones and other fees15,000 — 15,000 30,000 
  Sales-based milestones— 20,000 — 20,000 
  Device Licensing and development revenue725 317 1,259 650 
Total revenues under collaborative agreements$20,725 $60,317 $46,259 $90,650 
Total revenue$152,365 $136,455 $269,644 $225,477 
 As of September 30, 2017
Upfront license fee payment for the application of rHuPH20 to the initial exclusive targets$20,000
Election of additional exclusive targets and annual license maintenance fees for the
   right to designate the remaining targets as exclusive targets
23,000
Clinical development milestone payments13,000
Regulatory milestone payments8,000
Sales-based milestone payments15,000
Total payments received$79,000
Due to our continuing involvement obligations (for example, support activities associated with rHuPH20) under the Roche Collaboration, revenues from the upfront payment, exclusive designation fees, annual license maintenance fees and sales-based milestone payments were deferred and are being amortized over the remaining term of the Roche Collaboration.


For each ofDuring the three months ended SeptemberJune 30, 2017 and 2016,2022 we recognized $0.8revenue related to licenses granted to partners in prior periods in the amount of $100.3 million. This amount represents royalties earned in the current period in addition to $15.0 million of Rochevariable consideration in the contracts where uncertainties have been resolved and the development milestones were expected to be achieved or were achieved. We also recognized revenue of $0.5 million during the three months ended June 30, 2022 that had been included in deferred revenues excluding reimbursements for providing researchat December 31, 2021.
During the six months ended June 30, 2022 we recognized revenue related to licenses granted to partners in prior periods in the amount of $169.9 million. This amount represents royalties earned in the current period in addition to $15.0 million of variable consideration.in the contracts where uncertainties have been resolved and the development servicesmilestones were expected to be achieved or were achieved. We also recognized revenue of $1.0 million during the six months ended June 30, 2022 that had been included in deferred revenues at December 31, 2021. We did not recognize any adjustments to reduce sales reserves and supplying bulk rHuPH20, asallowances liability related to Hylenex recombinant sales in prior periods
Accounts receivable, net, and deferred revenues under collaborative agreements. For each(contract liabilities) from contracts with customers, including partners, consisted of the nine months ended Septemberfollowing (in thousands):
June 30, 2022December 31, 2021
Accounts receivable, net$169,526 $90,975 
Contract assets19,842 — 
Deferred revenues6,870 4,276 
As of June 30, 20172022, the amounts included in the transaction price of our contracts with customers and 2016, we recognized $2.5allocated to goods and services not yet provided were $68.1 million, of Rochewhich $61.2 million relates to unfulfilled purchase commitments and $6.9 million has been collected and is reported as deferred revenues. The unfulfilled purchase commitments are estimated to be delivered by the end of 2023. Of the total deferred revenues excluding reimbursements for providing research and development services and supplying bulk rHuPH20, as revenues under collaborative agreements. Total Roche deferred revenues, excluding deferred revenuesof $6.9 million, $4.1 million is expected to be used by our customers within the next 12 months.
We recognized contract assets of $19.8 million at June 30, 2022, which related to reimbursementsdevelopment milestones deemed probable of receipt for providing researchintellectual property licenses granted to partners in prior periods and developmentfor goods or services when control has transferred to the customer, and supplying bulk rHuPH20, were $33.2 million and $35.7 million as of September 30, 2017 and December 31, 2016, respectively.
In September 2017, we and Roche entered intocorresponding revenue is recognized on an agreement providing Rocheover time basis but is not yet billable to the right to develop and commercialize products with one additional exclusive target using our ENHANZE Technology for an upfront payment of $30.0 million (the “2017 Roche Collaboration”). 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 consisting of a mid-single digit percent of the net sales of such product. Unless terminated earliercustomer in accordance with its terms, the 2017 Roche Collaboration continues in effect until the expiration of Roche’s obligation to pay royalties. Roche has the obligation to pay royalties to us with respect to each product commercialized in each country, during the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the 2017 Roche Collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. In the event such valid claims expire, the royalty rate is reduced for the remaining royalty term. Roche may terminate the agreement prior to expiration for any reason in its entirety upon 90 days prior written notice to us. Upon any such termination, the license granted to Roche (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement, the licenses granted will become perpetual, non-exclusive and fully paid.
At the inception of the 2017 Roche Collaboration, we identified the deliverables in the arrangement to include the license, research and development services and supply of bulk rHuPH20 and determined that each individually represent separate units of accounting, because each deliverable has standalone value. The estimated selling prices for the units of accounting we identified were determined based on market conditions, the terms of comparable collaborative arrangements for similar technology in the pharmaceutical and biotech industry and entity-specific factors such as the terms of our previous collaborative agreements, our pricing practices and pricing objectives. The arrangement consideration was allocated to the deliverables based on the relative selling price method and the nature of the research and development services to be performed for the collaborator. The amount allocable to the delivered unit or units of accounting is limited to the amount that is not contingent upon the delivery of additional items or meeting other specified performance conditions (non-contingent amount). As such, we excluded from the allocable arrangement consideration the event-based payments, milestone payments and royalties regardless of the probability of receipt. Based on the results of our analysis, we allocated the $30.0 million to the license fee deliverable. We determined that the upfront payment was earned upon the granting of the worldwide, exclusive right to our technology to Roche. As a result, we recognized the $30.0 million license fee under the 2017 Roche Collaboration as revenues under collaborative agreements for the three and nine months ended September 30, 2017.


Baxalta Collaboration
In September 2007, we and Baxalta entered into a collaboration and license agreement, under which Baxalta obtained a worldwide, exclusive license to develop and commercialize HYQVIA, a combination of Baxalta’s current product GAMMAGARD LIQUID™ and our patented rHuPH20 enzyme (the “Baxalta Collaboration”). In 2013, the European Commission granted Baxalta marketing authorization in all EU Member States for the use of HYQVIA (solution for subcutaneous use), a combination of GAMMAGARD LIQUID and rHuPH20 in dual vial units, as replacement therapy for adult patients with primary and secondary immunodeficiencies, and Baxalta launched HYQVIA in the EU. In 2014, Baxalta launched HYQVIA in the U.S following the FDA’s approval of HYQVIA for treatment of adult patients with primary immunodeficiency. In May 2016, Baxalta announced that HYQVIA received a marketing authorization from the European Commission for a pediatric indication, which is being launched in Europe to treat primary and certain secondary immunodeficiencies.
The Baxalta Collaboration is applicable to both kit and formulation combinations. Baxalta assumes all development, manufacturing, clinical, regulatory, sales and marketing costs under the Baxalta Collaboration, while we are responsible for the supply of bulk rHuPH20. We perform research and development activities and supply bulk rHuPH20 at the request of Baxalta, and are reimbursed by Baxalta under the terms of the Baxalta Collaboration. In addition, Baxalta has certain product development and commercialization obligations in major markets identified in the Baxalta Collaboration.
Under the terms of the Baxalta Collaboration, Baxalta pays us a royalty consisting of a mid-single digit percent of the net sales of HYQVIA. Unless terminated earlier in accordance with its terms, the Baxalta Collaboration continues in effect until the expiration of Baxalta’s obligation to pay royalties to us. Baxalta has the obligation to pay royalties to us, with respect to each product commercialized in each country, during the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the Baxalta Collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. In the event such valid claims expire, the royalty rate is reduced for the remaining royalty term.
Payments received from Baxalta, excluding royalties and reimbursements for providing research and development services and supplying bulk rHuPH20, since inception of the collaboration agreement are as follows (in thousands):contract.
26
 As of September 30, 2017
Upfront license fee payment for the application of rHuPH20 to the initial exclusive target$10,000
Regulatory milestone payments3,000
Sales-based milestone payments4,000
Total payments received$17,000
Due to our continuing involvement obligations (for example, support activities associated with rHuPH20 enzyme), the upfront license fee and sales-based milestone payments were deferred and are being recognized over the term of the Baxalta Collaboration.
For each of the three months ended September 30, 2017 and 2016, we recognized $0.2 million of Baxalta deferred revenues, excluding reimbursements for providing research and development services and supplying bulk rHuPH20, as revenues under collaborative agreements. For each of the nine months ended September 30, 2017 and 2016, we recognized $0.6 million of Baxalta deferred revenues, excluding reimbursements for providing research and development services and supplying bulk rHuPH20, as revenues under collaborative agreements. Total Baxalta deferred revenues, excluding reimbursements for providing research and development services and supplying bulk rHuPH20, were $7.6 million and $8.2 million as of September 30, 2017 and December 31, 2016, respectively.


Other Collaborations
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 patented rHuPH20 enzyme with Lilly proprietary biologics directed at up to five targets (the “Lilly Collaboration”). Targets, once selected, will be on an exclusive, global basis, with the exception of one semi-exclusive target. As of September 30, 2017, Lilly has elected two specified exclusive targets and one specified semi-exclusive target. Lilly has the right to elect up to two additional targets for additional fees. The upfront license payment may be followed by event-based payments subject to Lilly’s achievement of specified development, regulatory and sales-based milestones. In addition, Lilly will pay royalties to us if products under the collaboration are commercialized. Unless terminated earlier in accordance with its terms, the Lilly Collaboration continues in effect until the later of: (i) 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, and (ii) expiration of the last to expire royalty term for a product developed under the collaboration. The royalty term of a product developed under the Lilly Collaboration, with respect to each country, consists of the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. In the event such valid claims expire, the royalty rate is reduced for the remaining royalty term. Lilly may terminate the agreement prior to expiration for any reason in its entirety upon 60 days prior written notice to us. Upon any such termination, the license granted to Lilly (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement, the licenses granted will become perpetual, non-exclusive and fully paid.
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 patented rHuPH20 enzyme with AbbVie proprietary biologics directed at up to nine targets (the “AbbVie Collaboration”). Targets, once selected, will be on an exclusive, global basis. As of September 30, 2017, AbbVie has elected one specified exclusive target, and subsequently returned the target. AbbVie has the right to elect up to eight additional targets for additional fees. The upfront license payment may be followed by event-based payments subject to AbbVie’s achievement of specified development, regulatory and sales-based milestones. In addition, AbbVie will pay tiered royalties to us if products under the collaboration are commercialized. Unless terminated earlier in accordance with its terms, the AbbVie Collaboration continues in effect until the later of: (i) 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, and (ii) expiration of the last to expire royalty term for a product developed under the collaboration. The royalty term of a product developed under the AbbVie Collaboration, with respect to each country, consists of the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. In the event such valid claims expire, the royalty rate is reduced for the remaining royalty term. AbbVie may terminate the agreement prior to expiration for any reason in its entirety or on a target-by-target basis upon 90 days prior written notice to us. Upon any such termination, the license granted to AbbVie (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement, the licenses granted will become perpetual, non-exclusive and fully paid.


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 patented rHuPH20 enzyme with Janssen proprietary biologics directed at up to five targets (the “Janssen Collaboration”). Targets, once selected, will be on an exclusive, global basis. As of September 30, 2017, Janssen has elected one specified exclusive target. Janssen has the right to elect four additional targets in the future upon payment of additional fees. In addition, Janssen will pay royalties to us if products under the collaboration are commercialized. Unless terminated earlier in accordance with its terms, the Janssen Collaboration continues in effect until the later of (i) 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, and (ii) expiration of the last to expire royalty term for a product developed under the collaboration. The royalty term of a product developed under the Janssen Collaboration, with respect to each country, consists of the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. In the event such valid claims expire, the royalty rate is reduced for the remaining royalty term. Janssen may terminate the agreement prior to expiration for any reason in its entirety or on a product-by-product basis upon 90 days prior written notice to us. Upon any such termination, the license granted to Janssen (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement, the licenses granted will become perpetual, non-exclusive and fully paid.
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 patented rHuPH20 enzyme with Pfizer proprietary biologics directed at up to six targets (the “Pfizer Collaboration”). Targets may be selected on an exclusive or non-exclusive basis. As of September 30, 2017, Pfizer has elected five specified exclusive targets and has returned two of its elected targets. Pfizer has the right to elect three additional targets in the future, two of which are contingent on payment of additional fees. In addition, Pfizer will pay royalties to us if products under the collaboration are commercialized. Unless terminated earlier in accordance with its terms, the Pfizer Collaboration continues in effect until the later of (i) 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, and (ii) expiration of the last to expire royalty term for a product developed under the collaboration. The royalty term of a product developed under the Pfizer Collaboration, with respect to each country, consists of the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. Royalties are subject to adjustment as set forth in the agreement. Pfizer may terminate the agreement prior to expiration for any reason in its entirety or on a target-by-target basis upon 30 days prior written notice to us. Upon any such termination, the license granted to Pfizer (in total or with respect to the terminated target, as applicable) will terminate, provided, however, that in the event of expiration of the agreement, the licenses granted will become perpetual, non-exclusive and fully paid.
Payments received under collaboration agreements for upfront license fees, license fees for the election of additional targets, maintenance fees and event-based payments since inception of the collaboration agreements are as follows (in thousands):

 As of September 30, 2017
Lilly Collaboration$33,000
AbbVie Collaboration29,000
Janssen Collaboration15,250
Pfizer Collaboration16,500
Total payments received$93,750


At the inception of the Pfizer, Janssen, AbbVie, and Lilly arrangements, we identified the deliverables in each arrangement to include the license, research and development services and supply of bulk rHuPH20. We have determined that the license, research and development services and supply of bulk rHuPH20 individually represent separate units of accounting, because each deliverable has standalone value. We determined that the rights to elect additional targets in the future upon the payment of additional license fees are substantive options that are not priced at a significant and incremental discount. Therefore, we determined for each collaboration that the rights to elect additional targets are not deliverables at the inception of the arrangement. The estimated selling prices for the units of accounting we identified were determined based on market conditions, the terms of comparable collaborative arrangements for similar technology in the pharmaceutical and biotech industry and entity-specific factors such as the terms of our previous collaborative agreements, our pricing practices and pricing objectives. The arrangement consideration was allocated to the deliverables based on the relative selling price method and the nature of the research and development services to be performed for the collaborator.
The amount allocable to the delivered unit or units of accounting is limited to the amount that is not contingent upon the delivery of additional items or meeting other specified performance conditions (non-contingent amount). As such, we excluded from the allocable arrangement consideration the event-based payments, milestone payments, annual exclusivity fees and royalties regardless of the probability of receipt. Based on the results of our analysis, we allocated the $12.5 million license fees from Pfizer, the $15.3 million license fee from Janssen, the $23.0 million upfront license fee from AbbVie and the $33.0 million license fees from Lilly to the license fee deliverable under each of the arrangements. We determined that the upfront payments were earned upon the granting of the worldwide, exclusive right to our technology to the collaborators in these arrangements. As a result, we recognized the $12.5 million license fees under the Pfizer Collaboration, the $15.3 million license fee under the Janssen Collaboration, the $23.0 million upfront license fee under the AbbVie Collaboration and the $33.0 million license fees under the Lilly Collaboration as revenues under collaborative agreements in the period when such license fees were earned. We recognized no revenue for the three and nine months ended September 30, 2017 related to event-based payments or milestone payments under these collaborations. We recognized no revenue for the three months ended September 30, 2016 related to event-based payments or milestone payments under these collaborations and $6.0 million in the nine months ended September 30, 2016.
The collaborators are each solely responsible for the development, manufacturing and marketing of any products resulting from their respective collaborations. We are entitled to receive payments for research and development services and supply of bulk rHuPH20 if requested by any collaborator. We recognize amounts allocated to research and development services as revenues under collaborative agreements as the related services are performed. We recognize amounts allocated to the sales of bulk rHuPH20 as revenues under collaborative agreements or product sales, as appropriate, when such bulk rHuPH20 has met all required specifications by the collaborators and the related title and risk of loss and damages have passed to the collaborators. We cannot predict the timing of delivery of research and development services and bulk rHuPH20 as they are at the collaborators’ requests.
Pursuant to the terms of the Roche Collaboration and the Pfizer Collaboration, certain future payments meet the definition of a milestone in accordance with the Milestone Method of Accounting. We are entitled to receive additional milestone payments under our collaboration agreements with Roche and Pfizer for the successful development of the elected targets in the aggregate of up to $62.5 million upon achievement of specified clinical development milestone events and up to $12.0 million upon achievement of specified regulatory milestone events in connection with specified regulatory filings and receipt of marketing approvals.


5.6. Certain Balance Sheet Items
Accounts receivable, net consisted of the following (in thousands):
June 30,
2022		December 31,
2021
 September 30,
2017		 December 31,
2016
Accounts receivable from product sales to collaborators $11,072
 $7,854
Accounts receivable from product sales to partnersAccounts receivable from product sales to partners$56,570 $18,504 
Accounts receivable from revenues under collaborative agreements 1,973
 6,151
Accounts receivable from revenues under collaborative agreements11,478 5,422 
Accounts receivable from royalty paymentsAccounts receivable from royalty payments87,634 63,555 
Accounts receivable from other product sales 2,150
 2,234
Accounts receivable from other product sales6,259 4,634 
Other receivableOther receivable9,985 — 
Contract assetsContract assets19,842 — 
Subtotal 15,195
 16,239
 Subtotal191,768 92,115 
Allowance for distribution fees and discounts (500) (559)Allowance for distribution fees and discounts(2,400)(1,140)
Total accounts receivable, net $14,695
 $15,680
 Total accounts receivable, net$189,368 $90,975 
Inventories consisted of the following (in thousands):
 September 30,
2017		 December 31,
2016		June 30,
2022		December 31,
2021
Raw materials $709
 $761
Raw materials$10,194 $10,672 
Work-in-process 7,556
 12,850
Work-in-process44,165 17,451 
Finished goods 1,066
 1,012
Finished goods43,256 25,785 
Total inventories $9,331
 $14,623
 Total inventories$97,615 $53,908 
Prepaid expenses and other assets consisted of the following (in thousands):
 September 30,
2017		 December 31,
2016		June 30,
2022		December 31,
2021
Prepaid manufacturing expenses $1,672
 $9,663
Prepaid manufacturing expenses$50,848 $47,991 
Prepaid research and development expenses 7,954
 8,613
Other prepaid expenses 2,072
 1,661
Other prepaid expenses14,180 3,809 
Other assets 771
 1,530
Other assets6,850 2,096 
Total prepaid expenses and other assets 12,469
 21,467
 Total prepaid expenses and other assets71,878 53,896 
Less long-term portion 72
 219
Less long-term portion(26,283)(13,414)
Total prepaid expenses and other assets, current $12,397
 $21,248
 Total prepaid expenses and other assets, current$45,595 $40,482 
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 onceas materials are used or the contract manufacturing process has commenced.


organization services are complete.
Property and equipment, net consisted of the following (in thousands):
 September 30,
2017		 December 31,
2016		June 30,
2022		December 31,
2021
Research equipment $10,804
 $10,479
Research equipment$7,046 $7,174 
Manufacturing equipmentManufacturing equipment22,758 5,719 
Computer and office equipment 3,573
 3,373
Computer and office equipment6,497 5,370 
Leasehold improvements 2,402
 2,331
Leasehold improvements8,816 1,628 
Subtotal 16,779
 16,183
 Subtotal45,117 19,891 
Accumulated depreciation and amortization (13,547) (11,919)Accumulated depreciation and amortization(13,749)(13,100)
Subtotal Subtotal31,368 6,791 
Right of use of assetsRight of use of assets5,723 2,003 
Property and equipment, net $3,232
 $4,264
 Property and equipment, net$37,091 $8,794 
Depreciation and amortization expense totaled $0.5was approximately $1.1 million and $0.7$0.8 million, inclusive of ROU asset amortization of $0.6 million and $0.4 million for the three months ended SeptemberJune 30, 20172022 and 2016,2021 respectively.
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Depreciation and $1.7amortization expense was approximately $1.9 million and $1.8$1.5 million, inclusive of ROU asset amortization of $1.0 million and $0.8 million for the ninesix months ended SeptemberJune 30, 20172022 and 2016,2021 respectively.
Accrued expenses consisted of the following (in thousands):
June 30,
2022		December 31,
2021
Accrued compensation and payroll taxes$15,858 $9,858 
Accrued outsourced manufacturing expenses6,242 6,514 
Income taxes payable23,036 1,439 
Product returns and sales allowance21,222 706 
Other accrued expenses15,506 3,648 
Lease liability7,788 2,820 
     Total accrued expenses89,652 24,985 
Less long-term portion(5,551)(544)
     Total accrued expenses, current$84,101 $24,441 
  September 30,
2017		 December 31,
2016
Accrued outsourced research and development expenses $16,026
 $9,522
Accrued compensation and payroll taxes 9,010
 11,539
Accrued outsourced manufacturing expenses 2,256
 3,225
Other accrued expenses 5,150
 4,552
     Total accrued expenses 32,442
 28,838
Less long-term portion 72
 17
     Total accrued expenses, current $32,370
 $28,821
Deferred revenue consistedExpense associated with the accretion of the followinglease liabilities was approximately $0.1 million and $0.1 million for the three months ended June 30, 2022 and 2021 respectively and $0.2 million and $0.2 million for the six months ended June 30, 2022 and 2021 respectively. Total lease expense for the three months ended June 30, 2022 and 2021 was $0.6 million and $0.5 million respectively and $1.1 million and $1.0 million for the six months ended June 30, 2022 and 2021, respectively. .
Cash paid for amounts related to leases for the three months ended June 30, 2022 and 2021 was $0.9 million and $0.7 million, and $1.6 million and $1.4 million for the six months ended June 30, 2022 and 2021 respectively.


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7. Goodwill and Intangible Assets
Goodwill
On May 24, 2022, we acquired all outstanding equity interests of Antares Pharma, Inc. A Goodwill balance of $199.5 million is recognized for the the excess of the consideration transferred over the net assets acquired and represents the expected revenue and cost synergies of the combined company and assembled workforce.
A summary of the activity impacting goodwill is presented below (in thousands):
Balance at December 31, 2021$— 
Goodwill acquired199,481 
Balance at June 30, 2022$199,481 
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 life in years for our acquired intangible assets at June 30, 2022 (in thousands).
Weighted average remaining life (in years)Gross Carrying ValueAccumulated AmortizationNet Carrying Value
Auto Injector technology platform7$372,900 $5,585 $367,315 
XYOSTED proprietary product10277,400 2,908 274,492 
TLANDO product rights10277,600 2,910 274,690 
Total definite-lived intangibles, net$927,900 $11,403 $916,497 
ATRS-1902 (IPR&D)59,600 
Total Intangibles, net$976,097 

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.

Year:Amortization (in thousands)
Remainder of 2022$54,387 
2023108,771 
2024108,771 
2025108,771 
2026108,771 
Thereafter427,026 
Total$916,497 
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  September 30,
2017		 December 31,
2016
Collaborative agreements    
License fees and event-based payments:    
Roche $33,213
 $35,709
Other 7,635
 8,209
  40,848
 43,918
Reimbursement for research and development services —
 700
Total deferred revenue 40,848
 44,618
Less current portion 4,093
 4,793
Deferred revenue, net of current portion $36,755
 $39,825




6.8. Long-Term Debt, Net
Royalty-backed Loan0.25% Convertible Notes due 2027
In January 2016, through our wholly-owned subsidiary Halozyme Royalty LLC (“Halozyme Royalty”),March 2021, we received a $150completed the sale of $805.0 million loanin aggregate principal amount of 0.25% Convertible Senior Notes due 2027 (the “Royalty-backed Loan”) pursuant to a credit agreement (the “Credit Agreement”)“2027 Convertible Notes” and collectively with BioPharma Credit Investments IV Sub, LP and Athyrium Opportunities II Acquisition LP (the “Royalty-backed Lenders”). Under the terms of2024 Convertible Notes the Credit Agreement, Halozyme Therapeutics, Inc. transferred to Halozyme Royalty the right to receive royalty payments from the commercial sales of ENHANZE products owed under the Roche Collaboration and Baxalta Collaboration (“Collaboration Agreements”“Convertible Notes”). The royalty payments fromnet proceeds in connection with the Collaboration Agreementsissuance of the 2027 Convertible Notes, after deducting the initial purchasers’ fee of $20.1 million, was approximately $784.9 million. We also incurred additional debt issuance costs totaling $0.4 million. Debt issuance costs and the initial purchasers’ fee are presented as a debt discount.
The 2027 Convertible Notes pay interest semi-annually in arrears on March 1st and September 1st of each year at an annual rate of 0.25%. The 2027 Convertible Notes are general unsecured obligations and 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 usedeffectively junior to repayany 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 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 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 June 30, 2022, the 2027 Convertible Notes are not convertible.
Upon conversion, we will pay cash for the settlement of principal and interest onfor the loan (the “Royalty Payments”).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 Royalty-backed Loan bears interest atinitial 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 annum rateshare of 8.75% plus the three-month LIBOR rate.our common stock. The three-month LIBORconversion rate is subject to a floor of 0.7% and a cap of 1.5%. The interest rate as of September 30, 2017 was 10.1%.
The Credit Agreement provides that none of the Royalty Payments were required to be applied to the Royalty-backed Loan prior to January 1, 2017, 50% of the Royalty Payments are required to be applied to the Royalty-backed Loan between January 1, 2017 and January 1, 2018 and thereafter all Royalty Payments must be applied to the Royalty-backed Loan. However, the amounts available to repay the Royalty-backed Loan are subject to caps of $13.75 million per quarter in 2017, $18.75 million per quarter in 2018, $21.25 million per quarter in 2019 and $22.5 million per quarter in 2020 and thereafter. Amounts available to repay the Royalty-backed Loan will be applied first to pay interest and second to repay principal on the Royalty-backed Loan. Any accrued interest that is not paid on any applicable quarterly payment date, as defined, will be capitalized and added to the principal balance of the Royalty-backed Loan on such date. Halozyme Royalty will be entitled to receive and distribute to Halozyme any Royalty Payments that are not required to be applied to the Royalty-backed Loan or which are in excess of the foregoing caps.
Because the repayment of the term loan is contingent upon the level of Royalty Payments received, the repayment term may be shortened or extended depending on the actual level of Royalty Payments. The final maturity date of the Royalty-backed Loan will be the earlier of (i) the date when principal and interest is paid in full, (ii) the termination of Halozyme Royalty’s right to receive royalties under the Collaboration Agreements, and (iii) December 31, 2050.  Currently, we estimate that the loan will be repaid in the first quarter of 2020. This estimate could be adversely affected and the repayment period could be extended if future royalty amounts are less than currently expected. Under the terms of the Credit Agreement, at any time after January 1, 2019, Halozyme Royalty may, subject to certain limitations, prepay the outstanding principal of the Royalty-backed Loan in whole or in part, at a price equal to 105% of the outstanding principal on the Royalty-backed Loan, plus accrued but unpaid interest. The Royalty-backed Loan constitutes an obligation of Halozyme Royalty, and is non-recourse to Halozyme. Halozyme Royalty retains its right to the Royalty Payments following repayment of the loan.adjustment.
As of SeptemberJune 30, 2017,2022, we were in compliance with all covenants under the Royalty-backed Loan and there was no material adverse change in our business, operations or financial condition.
During1.25% Convertible Notes due 2024
In November 2019, we completed the nine months ended September 30, 2016, accrued interestsale of $460.0 million in theaggregate principal amount of $9.2 million was capitalized and added to the principal balance of the Royalty-backed Loan. We began making principal and interest payments against the Royalty-backed Loan1.25% Convertible Senior Notes due 2024 (“2024 Convertible Notes”). The net proceeds in the first quarter of 2017 and therefore had no capitalized interest in the nine months ended September 30, 2017. In addition, we recorded accrued interest, which is included in accrued expenses, of $0.7 million as of September 30, 2017 and December 31, 2016.
In connection with the Royalty-backed Loan, we paid2024 Convertible Notes, after deducting the Royalty-backed Lenders ainitial purchasers’ fee of $1.5$12.7 million, andwas approximately $447.3 million. We also incurred additional debt issuance costscost totaling $0.4 million, which includes expenses that we paid on behalf of the Royalty-backed Lenders and expenses incurred directly by us.$0.3 million. Debt issuance costs and the lenderinitial 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 been netted againsta maturity date of December 1, 2024.
Holders may convert their 2024 Convertible Notes at their option only in the debtfollowing 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 5 consecutive business days immediately after any 5 consecutive trading day period (such 5 consecutive trading day period, the
30

“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 Septemberbusiness on the scheduled trading day immediately before the maturity date. As of June 30, 2017,2022, the 2024 Convertible Notes are convertible and are being amortized overclassified as a current liability.
In January 2021 we notified the estimated termnote holders of our irrevocable election to settle the principal of the debt using the effective interest method. For the three months ended September 30, 20172024 Convertible Notes in cash and 2016, the Company recognized interest expense, including amortization of the debt discount, related to the Royalty-backed Loan of $4.2 million and $3.8 million, respectively, and $12.4 million and $10.2 million for the nine months ended September 30, 2017 and 2016, respectively.premium, if applicable, to deliver shares of common stock. The assumptions used in determiningconversion rate for the expected repayment term of the debt and amortization period of the issuance costs requires that we make estimates that could impact the short- and long-term


classification of these costs, as well as the period over which these costs2024 Convertible Notes will be amortized.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 outstanding balance of the Royalty-backed Loan as of September 30, 2017 was $151.3 million, inclusive of payment-in-kind interest expense of $2.2 million and net of unamortized debt discount of $0.9 million.
Oxford and SVB Loan and Security Agreementconversion rate is subject to adjustment.
In December 2013,March 2021, we entered into an Amended and Restated Loan and Security Agreement (the “Original Loan Agreement”) with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB”) (collectively, the “Lenders”), amending and restating in its entirety our previous loan agreement with the Lenders, dated December 2012. The Original Loan Agreement provided for an additional $20completed a privately negotiated induced conversion of $369.1 million principal amount of new term loan, bringing the total term loan balance to $50 million. The amended term loan facility was scheduled to mature on January 1, 2018.
In January 2015, we entered into2024 Convertible Notes (“Note Repurchases” or the second amendment to the Original Loan Agreement with the Lenders, amending and restating the term loan repayment schedules of the Original Loan Agreement. The amended and restated term loan repayment schedule provided for interest only payments through January 2016, followed by consecutive equal monthly payments of principal and interest in arrears starting in February 2016 and continuing through the previously established maturity date of January 1, 2018. Consistent with the original loan, the amended Original Loan Agreement provided for a 7.55% interest rate on the term loan and a final payment equal to 8.5% of the original principal amount, or $4.25 million, which was due when the term loan became due or upon the prepayment of the facility.
In June 2016, we entered into a Loan and Security Agreement (the “Loan Agreement”“Induced Conversion”) with the Lenders, providing a senior secured loan facility of up to an aggregate principal amount of $70.0 million, comprising a $55.0 million draw in June 2016 and an additional $15.0 million tranche, which we had the option to draw during the second quarter of 2017 and did not exercise. The initial proceeds carry an interest rate of 8.25% and were partially used to pay the outstanding principal and final payment of $4.25 million owed on the previous loan agreement with the Lenders. The remaining proceeds are being used for working capital and general business requirements. The repayment schedule provides for interest only payments for the first 18 months, followed by consecutive equal monthly payments of principal and interest in arrears through the maturity date of January 1, 2021. The Loan Agreement provides for a final payment equal to 5.50% of the initial $55.0 million principal amount. The final payment is due when the Loan Agreement becomes due or upon the prepayment of the facility. We have the option to prepay the outstanding balance of the Loan Agreement in full, subject to a prepayment fee of 2% in the first year and 1% in the second year of the Loan Agreement.
. In connection with the Loan Agreement,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 debt offering costs have been recordedintrinsic value based on the contractual conversion rate and incremental shares as an inducement for conversion. As a debt discount in our condensed consolidated balance sheets which, together with the final payment and fixed interest rate payments, are being amortized and recorded as interest expense throughout the liferesult of the loan using the effective interest rate method.
The Loan AgreementInduced Conversion, we recorded $21.0 million in induced conversion expense which is secured by substantially allincluded in Other income (expense) of the assetsCondensed Consolidated Statements of Income in 2021. The induced conversion expense represents the fair value of the Company and our subsidiary, Halozyme, Inc., except that the collateral does not include any equity interestscommon stock issued upon conversion in Halozyme, Inc., any of our intellectual property (including all licensing, collaboration and similar agreements relating thereto), and certain other excluded assets. The Loan Agreement contains customary representations, warranties and covenants by us, which covenants limit our ability to convey, sell, lease, transfer, assign or otherwise dispose of certain of our assets; engage in any business other than the businesses currently engaged in by us or reasonably related thereto; liquidate or dissolve; make certain management changes; undergo certain change of control events; create, incur, assume, or be liable with respect to certain indebtedness; grant certain liens; pay dividends and make certain other restricted payments; make certain investments; make payments on any subordinated debt; enter into transactions with any of our affiliates outsideexcess of the ordinary course of business or permit our subsidiaries to docommon stock issuable under the same; and make any voluntary prepayment of or modify certainoriginal terms of the Royalty-backed Loan. In addition, subject to certain exceptions, we are required to maintain with SVB our primary deposit accounts, securities accounts and commodities, and to do the same for our subsidiary, Halozyme, Inc.2024 Convertible Notes.


The Loan Agreement also contains customary indemnification obligations and customary events of default, including, among other things, our failure to fulfill certain of our obligations under the Loan Agreement and the occurrence of a material adverse change which is defined as a material adverse change in our business, operations, or condition (financial or otherwise), a material impairment of the prospect of repayment of any portion of the loan, a material impairment in the perfection or priority of the Lender’s lien in the collateral or in the value of such collateral or the occurrence of an event of default under the Royalty-backed Loan. In the event of default by us under the Loan 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 Loan Agreement, which could harm our financial condition.
As of SeptemberJune 30, 2017,2022, we were in compliance with all covenants under the Loan Agreement and there was no material adverse change in our business, operations or financial condition.
Interest expense, including amortizationNet Carrying Amounts of the Convertible Notes
The carrying amount and fair value of our Convertible Notes were as follows as of the dates indicated (in thousands).
June 30,
2022		December 31,
2021
Principal amount:
2024 Convertible Notes$90,936 $90,936 
2027 Convertible Notes805,000 805,000 
Total Principal Amount$895,936 $895,936 
Unamortized debt discount:
2024 Convertible Notes$(1,263)$(1,517)
2027 Convertible Notes(16,055)(17,745)
Total unamortized debt discount$(17,318)$(19,262)
Carrying amount:
2024 Convertible Notes$89,673 $89,419 
2027 Convertible Notes788,945 787,255 
Total carrying amount$878,618 $876,674 
Fair value based on trading levels (Level 2):
2024 Convertible Notes$172,743 $159,678 
2027 Convertible Notes711,660 718,889 
Total fair value of outstanding notes$884,403 $878,567 
Remaining amortization per period of debt discount (in years):
2024 Convertible Notes2.42.9
2027 Convertible Notes4.75.2


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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).
Three Months Ended
 June 30,		Six Months Ended
June 30,
2022202120222021
Coupon Interest:
2024 Convertible Notes$284 $284 $568 $1,337 
2027 Convertible Notes503 503 1,006 671 
Total Coupon Interest$787 $787 $1,574 $2,008 
Amortization of debt discount:
2024 Convertible Notes$127 $125 $254 $586 
2027 Convertible Notes846 840 1,690 1,120 
Total amortization of debt discount$973 $965 $1,944 $1,706 
Interest expense:
2024 Convertible Notes$411 $409 $822 $1,923 
2027 Convertible Notes1,349 1,343 2,696 1,791 
Total interest expense$1,760 $1,752 $3,518 $3,714 
Effective interest rates:
2024 Convertible Notes1.8 %1.8 %1.8 %1.8 %
2027 Convertible Notes0.7 %0.7 %0.7 %0.7 %
Revolving Credit Facility (December 2021)
In May 2022, we terminated that certain credit agreement entered into on December 23, 2021 with Bank of America and the other lenders party thereto (the “2021 Credit Agreement”) evidencing a revolving credit facility (the “2021 Facility”) that provided for secured revolving loans and letters of credit in an aggregate amount of up to $75.0 million. No proceeds from the 2021 Facility were drawn down as of the date the 2021 Credit Agreement was terminated.
Revolving Credit and Term Loan Facilities (May 2022)
In May 2022, in connection with the closing of 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, pay off Antares’ existing debt discount,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%
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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. As of June 30, 2022, we had $120.0 million and $250 million in principal amount of outstanding borrowings under the 2022 Revolving Credit Facility and the 2022 Term Facility, respectively. We incurred a total of $6.0 million in third party costs related to the Loan Agreement totaled $1.42022 credit agreement and recorded $3.5 million as the revolving credit facility debt issuance cost and $2.5 million as the term loan debt issuance cost. As of June 30, 2022, the unamortized debt issuance cost related to the revolving credit facility and the term loan is $3.4 million and $1.5$2.4 million, for the three months ended September 30, 2017 and 2016, respectively, and $4.1 million and $4.2 million for the nine months ended September 30, 2017 and 2016, respectively. Accrued interest, which is included in accrued expenses, was $0.4 million and $1.1 million as of September 30, 2017 and December 31, 2016, respectively. The outstanding term loan balance was $55.6 million as of September 30, 2017, inclusive of $1.0 million of accretion of the final payment and net of unamortized debt discount related to offering costs of $0.4 million.

7.
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9. Share-based Compensation
Total share-based compensation expense related to share-based awards excluding the acceleration of Antares unvested equity awardswas comprised of the following (in thousands):
 Three Months Ended
September 30,		 Nine Months Ended
September 30,		Three Months Ended
 June 30,		Six Months Ended
June 30,
 2017 2016 2017 2016 2022202120222021
Research and development $3,060
 $3,045
 $9,891
 $8,459
Research and development$2,456 $1,764 $4,473 $3,412 
Selling, general and administrative 4,702
 3,610
 13,377
 10,384
Selling, general and administrative3,179 3,608 5,904 6,883 
Share-based compensation expense $7,762
 $6,655
 $23,268
 $18,843
Share-based compensation expense$5,635 $5,372 $10,377 $10,295 
Share-based compensation expense by type of share-based award (in thousands):
 Three Months Ended
September 30,		 Nine Months Ended
September 30,		Three Months Ended
 June 30,		Six Months Ended
June 30,
 2017 2016 2017 2016 2022202120222021
Stock options $4,973
 $4,327
 $14,971
 $12,103
Stock options$2,503 $2,637 $5,123 $5,119 
RSAs, RSUs and PRSUs 2,789
 2,328
 8,297
 6,740
RSAs, RSUs, PSUs and ESPPRSAs, RSUs, PSUs and ESPP3,132 2,735 5,254 5,176 
 $7,762
 $6,655
 $23,268
 $18,843
$5,635 $5,372 $10,377 $10,295 
We granted stock options to purchase approximately 0.10.2 million and 0.8 million36.3 thousand shares of common stock during the three months ended SeptemberJune 30, 20172022 and 2016,2021, respectively and 2.51.5 million and 4.30.7 million shares of the Company’s common stock during the ninesix months ended SeptemberJune 30, 20172022 and 2016,2021, 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:
Three Months Ended
 June 30,		Six Months Ended
June 30,
 2022202120222021
Expected volatility41.05-41.29%44.91-44.91%41.05-41.29%44.91%-46.45%
Average expected term (in years)4.84.74.74.7
Risk-free interest rate2.56-3.01%0.81-0.81%1.37-3.01%0.36%-0.81%
Expected dividend yield— — — — 
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 June 30, 2022, 2,665,369 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 three months ended June 30, 2022, 16,858 shares were issued pursuant to the ESPP.
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  Three Months Ended
September 30,		 Nine Months Ended
September 30,
  2017 2016 2017 2016
Expected volatility 70.5-70.8% 70.5-70.7% 70.5-71.7% 67.5-70.7%
Average expected term (in years) 5.6 5.4 5.6 5.4
Risk-free interest rate 1.73-1.93% 1.00-1.18% 1.73-1.94% 1.00-1.73%
Expected dividend yield — — — —

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):
June 30, 2022
 Unrecognized
Expense		Remaining
Weighted-Average
Recognition Period
(years)
Stock options$28,109 2.81
RSUs$33,922 2.82
PSUs$5,073 2.41
ESPP$172 0.46

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  September 30, 2017
  
Unrecognized
Expense
 
Remaining
Weighted-Average
Recognition Period
(years)
Stock options $38,522
 2.5
RSAs $5,755
 1.8
RSUs $17,287
 2.9

8.10. Stockholders’ Equity (Deficit)
In May 2017, we completed an underwritten public offering pursuant to which we sold 11.5 million shares of common stock, including 1.5 million shares sold pursuant to the full exercise of an over-allotment option granted to the underwriters. All of the shares were offered at a public offering price of $12.50 per share, generating $134.9 million in net proceeds, after deducting underwriting discounts and commissions and other offering expenses. We intend to use the net proceeds from this offering to fund continued development of our PEGPH20 oncology program and for other general corporate purposes.
During the ninesix months ended SeptemberJune 30, 20172022 and 2016,2021, we issued an aggregate of 1,020,028350,216 and 383,719591,891 shares of common stock, respectively, in connection with the exercises of stock options at a weighted average exercise price of $8.71$17.94 and $6.74$13.64 per share, respectively, for net proceeds of approximately $8.9$6.3 million and $2.6$8.1 million, respectively. For the ninesix months ended SeptemberJune 30, 20172022 and 2016,2021, we issued 375,906248,343 and 215,779290,149 shares of common stock, respectively, upon vesting of certain RSUs and PSUs for which 68,425 and 91,383 RSUs were withheld from the RSU holders, surrendered 96,069 and 82,396 RSUs, respectively, to pay for minimum withholding taxes totaling approximately $1.9$4.3 million and $0.8$8.0 million, respectively. In addition, we issued 98,945 and 968,652 shares of common stock in connection with the grants of RSAs during the nine months ended September 30, 2017 and 2016, respectively. Stock options and unvested restricted units totaling approximately 14.36.8 million shares and 12.55.9 million shares of our common stock were outstanding as of SeptemberJune 30, 20172022 and December 31, 2016,2021, respectively.


Share Repurchases
9.In November 2019, we announced that the Board of Directors has authorized the initiation of 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 to Bank of America and took initial delivery of 3.5 million shares. In June 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.




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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):
Three Months Ended
 June 30,		Six Months Ended
June 30,
 2022202120222021
Numerator:
Net income$22,685 $91,458 $82,793 $119,353 
Denominator:
Weighted average common shares outstanding for basic net income per share137,937 142,487 137,798 140,201 
Dilutive potential common stock outstanding:
Stock Options2,274 2,932 2,182 3,076 
RSAs, RSUs, PSUs and ESPP296 447 331 609 
Convertible Notes1,709 1,758 1,484 4,210 
Weighted average common shares outstanding for diluted net income per share142,216 147,624 141,795 148,096 
Net income per share:
Basic$0.16 $0.64 $0.60 $0.85 
Diluted$0.16 $0.62 $0.58 $0.81 
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):
Three Months Ended
 June 30,		Six Months Ended
June 30,
 2022202120222021
Anti-dilutive securities (1)
15.0 13.5 15.3 13.5 
(1). The anti-dilutive securities include outstanding stock options, unvested RSAs, unvested RSUs, unvested PSUs, common shares expected to be issued under our ESPP and Convertible Notes.
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12. Commitments and 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.

10. Subsequent Event
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Our collaboration and license agreement with BMS (the “BMS Collaboration”), which we entered into in September 2017, became effective in November 2017 upon expiration of the waiting period provided by the Hart-Scott-Rodino Act. Under the BMS Collaboration, BMS has the worldwide license to develop and commercialize products combining our rHuPH20 enzyme with BMS immuno-oncology targets directed at up to eleven targets for an upfront payment of $105.0 million, payable on the effective date of the agreement, of which $101.4 million will be recognized as revenue under collaborative agreements in the fourth quarter of 2017. Targets, once selected, will be on an exclusive, global basis, with the exception of one co-exclusive target. BMS has elected several specified exclusive targets, including programmed death 1 (PD-1), and has the right to elect additional targets, some of which are subject to additional fees. The upfront license payment may be followed by event-based payments subject to BMS’s achievement of specified development, regulatory and sales-based milestones. In addition, BMS will pay royalties to us if products developed under the collaboration are commercialized. Unless terminated earlier in accordance with its terms, the BMS Collaboration continues in effect until the later of: (i) 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, and (ii) expiration of the last to expire royalty term for a product developed under the collaboration. The royalty term of a product developed under the BMS Collaboration, with respect to each country, consists of the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. In the event such valid claims expire, the royalty rate is reduced for the remaining royalty term. BMS may terminate the agreement prior to expiration for any reason in its entirety upon prior written notice to us. Upon any such termination, the license granted to BMS (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement, the licenses granted will become perpetual, non-exclusive and fully paid.

Item 2.
Item 2.     Management’s Discussion and Analysis of Financial Condition and Results of Operations
As used in this report, unless the context suggests otherwise, references to “Halozyme,” “the Company,” “we,” “our,” “ours,” and “us” refer to Halozyme Therapeutics, Inc., its wholly owned subsidiary,subsidiaries, Halozyme, Inc. andAntares Pharma Inc., Halozyme Inc.’s wholly owned subsidiaries, Halozyme Holdings Ltd., Halozyme Royalty LLC andwholly-owned subsidiary Halozyme Switzerland Holdings GmbH. and Antares Pharma Inc.s’ wholly-owned subsidiaries, Antares Pharma IPL AG and Antares Pharma AG. References to “Notes” refer to the Notes to Condensed Consolidated Financial Statements included herein (refer to Item 1 of Part I).
The following information should be read in conjunction with the interim unaudited condensed consolidated financial statements and Notes thereto included in Item 1 of this Quarterly Report on Form 10-Q, as well as the audited financial statements and notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fiscal year ended December 31, 2016,2021, included in our Annual Report on Form 10-K for the year ended December 31, 2016.2021. Past financial or operating performance is not necessarily a reliable indicator of future performance, and our historical performance should not be used to anticipate results or future period trends.


This report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this report other than statements of historical fact 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 report. Additionally, statements concerning future matters such as the anticipated timing and scope of planned clinical trials, 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 or by our collaborators,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 manufacturers to provide adequate supply for our partners, revenue, expense, and cash burn levels and our ability to make timely repayments of debt, anticipated amounts and timing of share repurchases, anticipated profitability and expected repaymenttrends, the potential impact of the Royalty-backed LoanCOVID-19 global pandemic on our business and trends and other statements regarding matters that are not historical are forward-looking statements. Such statements reflect management’s current forecast of certain aspects of our future, are based on currently available operating, financial and competitive information and are subject to various risks, uncertainties and assumptions that could cause actual results to differ materially from those anticipated or implied in our forward-looking statements due to a number of factors including, but not limited to, those set forth below under the section entitled “Risks Factors” and elsewhere in this Quarterly Report on Form 10-Q and our most recent Annual Report on Form 10-K. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly 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 Quarterly Report.
Overview
Halozyme Therapeutics, Inc. is a biotechnologybiopharma technology platform company focused on developingthat provides innovative and commercializing novel oncology therapies.disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzymes areenzyme, rHuPH20, is used to facilitate the delivery of injected drugs and fluids, potentially enhancing the efficacy and the convenience of other drugs or can be used to alter tissue structures for potential clinical benefit.fluids. We exploit our technology and expertise using a two pillar strategy that we believe enables us to manage risk and cost by: (1) developing our own proprietary products in therapeutic areas with significant unmet medical needs, with a focus on oncology, and (2) licensinglicense our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology (ENHANZE) with the collaborators’partners’ proprietary compounds.
The majority of ourOur first commercially approved product, Hylenex® recombinant, (“Hylenex”), and our partners’ approved products and product candidates are based on rHuPH20, our patented recombinant human hyaluronidase enzyme. Our proprietary development pipeline consists primarily of pre-clinicalrHuPH20 is the active ingredient in Hylenex®, and clinical stage product candidates in oncology. Our lead oncology program is PEGPH20 (PEGylated recombinant human hyaluronidase)it works by breaking down hyaluronan (or HA), a molecular entity we are developing in combination with currently approved cancer therapiesnaturally occurring carbohydrate that is a major component of the extracellular matrix of the subcutaneous (SC) space. This temporarily increases dispersion and absorption allowing for improved SC delivery of injectable biologics, such as a candidate for the systemic treatment of tumors that accumulate HA. We have demonstrated that when HA accumulates in a tumor, it can cause higher pressure in the tumor, reducing blood flow into the tumormonoclonal antibodies and with that, reduced access of cancer therapies to the tumor. Through our effortsother large therapeutic molecules, as well as small molecules and efforts of our partners and collaborators, we are currently in Phase 3 clinical testing for PEGPH20 with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreatic ductal adenocarcinoma (PDA) (Halo 109-301), in Phase 1b clinical testing for PEGPH20 with KEYTRUDA® (pembrolizumab) in non-small cell lung cancer and gastric cancer (Halo 107-101), in Phase 1b/2 clinical testing for PEGPH20 with HALAVEN® (eribulin) in patients treated with up to two lines of prior therapy for HER2-negative metastatic breast cancer, in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq® (atezolizumab) in patients with previously treated metastatic PDA, in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq in patients with gastric cancer and in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq in patients with cholangiocarcinoma and gall bladder cancer (Halo 110-101/MATRIX).


fluids. We refer to the application of rHuPH20 to facilitate the delivery of other drugs or fluids as our ENHANZE™ Technology.ENHANZE. We license the ENHANZE Technologytechnology to form collaborations with biopharmaceutical companies that develop or market drugs requiring or benefiting from injection via the subcutaneous 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. ENHANZE may enable fixed-dose SC dosing compared to weight-based dosing required for IV administration, 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. 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 of the proprietary IV drug.
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We currently have ENHANZE collaborations with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc. (Roche), Baxalta US Inc. and Baxalta GmbH (Baxalta Incorporated was acquired by Shire plc in June 2016)(members of the Takeda group of companies) (Baxalta), Pfizer Inc. (Pfizer), Janssen Biotech, Inc. (Janssen), AbbVie, Inc. (AbbVie), Eli Lilly and Company (Lilly) and Bristol-Myers, 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 attainment 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 twothree of these collaborations, including royalties from sales of one product from the Baxalta collaboration, and twothree products from the Roche collaboration and one product from the Janssen collaboration. Future potential revenues from from ENHANZE collaborations and from the sales and/or royalties of our approved products product candidates, and ENHANZE collaborations will depend on the ability of Halozyme and our collaboratorspartners 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 that are designed to seek to provide commercial or functional advantages such as convenience, improved tolerability, and enhanced patient comfort and adherence. Also as a result of our acquisition of Antares, our commercial portfolio of proprietary products includes XYOSTED®, TLANDO™ and NOCDURNA® and partnered commercial products and ongoing product development programs with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (“Teva”), Covis Group S.a.r.l. (“Covis”), Pfizer and Idorsia Pharmaceuticals Ltd. (“Indorsia”).
Our thirdsecond quarter of 20172022 and recent highlights include:key events are as follows:
Partners
•In October 2017, JanssenAugust 2022, Roche announced that the Phase III IMscin001 study evaluating a subcutaneous (SC) 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 intravenous (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 July 2022, Baxalta US Inc., a Takeda company, 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)
•In June 2022, we recognized $15 million in milestone revenues related to variable consideration in the contracts where uncertainties have been resolved and the development milestones were expected to be achieved.
•In June 2022, BMS nominated an undisclosed target resulting in a $5 million payment.
•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 June 2022, argenx initiated a Phase 3phase 2 study of daratumumab combinedevaluating efgartigimod with the ENHANZE Technology in amyloidosis patients,subjects with additional Phase 3 studies in multiple myeloma and smoldering myeloma patients planned to initiate in the near term. We will receive a $15.0 million milestone payment from Janssen upon dosing of the third patient in the recently initiated study.bullous pemphigoid.
•In October 2017, Genentech (a member of the Roche Group) initiated a Phase 1b/2 clinical trial evaluating PEGPH20 in combination with Tecentriq in patients with gastric cancer.
In October 2017, we initiated the second study in our clinical agreement with Genentech, a Phase 1b/2 open-label randomized study to assess Tecentriq in combination with PEGPH20 and chemotherapy in patients with cholangiocarcinoma and gall bladder cancer.
In September 2017, we entered into a collaboration and license agreement with BMS, under which BMS has the worldwide license to develop and commercialize products combining our ENHANZE Technology with BMS immuno-oncology targets directed at up to eleven targets for an upfront payment of $105.0 million payable on the effective date of the agreement. BMS has designated multiple immuno-oncology targets including programmed death 1 (PD-1) and has an option to select additional targets within five years from the effective date. The agreement became effective in November 2017 upon expiration of the waiting period provided by the Hart-Scott-Rodino Act.
In September 2017, we entered into an agreement with Roche for the right to develop and commercialize one additional exclusive target using our ENHANZE Technology for an upfront payment of $30.0 million.
In August 2017, LillyMay 2022, Chugai initiated a Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and safety of targeted antibody administered subcutaneously with ENHANZE.
•In April 2022, Roche initiated a phase 3 study evaluating OCREVUS (ocrelizumab) with ENHANZE in subjects with multiple sclerosis.
Corporate
•In June 2022, we announced the commercial launch of TLANDO™ (testosterone undecanoate), an investigational neworal treatment indicated for testosterone replacement therapy in combinationadult males for conditions associated with rHuPH20.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.
•In July 2017, GenentechJune 2022, we completed the $150 million ASR that was initiated in December of 2021, resulting in the total repurchase of 3.9 million shares at a Phase 1b/2 clinical trial evaluating PEGPH20price of $38.51 per share.
•In May 2022, we completed the acquisition of Antares resulting in combinationan expansion of our commercial portfolio of proprietary and partnered products and the potential for future growth through new agreements
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•In May 2022, in connection with Tecentriqthe closing of 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 patientsconnection with previously treated metastatic PDA.the acquisition.



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Product and Product Candidates
We have one marketed proprietary product, three partnered products, one proprietary product candidate targeting several indications in various stages of development, and two preclinical product candidates. The following table summarizes our marketed proprietary productproducts and product candidate as well ascandidates under development and our marketed partnered products and product candidates under development with our collaborators:partners:
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Proprietary PipelineProducts and Product Candidates
Hylenex Recombinant (hyaluronidase human injection)
We market and sell Hylenex recombinant which is a formulation of rHuPH20 that has received U.S. Food and Drug Administration (FDA) approval to facilitatefacilitates subcutaneous fluid administration for achieving hydration, to increaseincreases the dispersion and absorption of other injected drugs and, in subcutaneous urography, to improve resorption of radiopaque agents. Hylenex recombinant is currently the number one prescribed branded hyaluronidase.
PEGPH20XYOSTED® (testosterone enanthate) Injection
We are developing PEGPH20 in combination with currently approved cancer therapies as a candidate for the systemic treatment of tumors that accumulate HA. ‘PEG’ refers to the attachment of polyethylene glycol to rHuPH20, thereby creating PEGPH20. One of the novel properties of PEGPH20 is that it lasts for an extended durationmarket and sell in the bloodstreamU.S. our proprietary product XYOSTED® injection for subcutaneous administration of testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadism). Safety and therefore, can be administered systemicallyefficacy of XYOSTED® in males less than 18 years old have not been established. XYOSTED® is the only FDA approved subcutaneous 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. XYOSTED® provides an easy and virtually pain-free administration and the ability to achieve and maintain its therapeutic effect to treat disease.
Cancer malignancies, including pancreatic, lung, breast, gastric, colon and prostate cancers can accumulate highsteady target levels of HAtestosterone.
NOCDURNA® (desmopressin acetate) Sublingual Tablets
We market and therefore we believe that PEGPH20 has the potential to help patients with these types of cancer when used with certain currently approved cancer therapies. Among solid tumors, PDA has been reported to be associated with the highest frequency of HA accumulation. There are approximately 65,000 annual diagnoses of PDAsell NOCDURNA® in the United States and the European Union, and we estimate that 35-40% have high levels of HA.
The pathologic accumulation of HA, along with other matrix components, creates a unique microenvironment for the growth of tumor cells compared to normal cells. We believe that degrading the HA component of the tumor microenvironment with PEGPH20 remodels the tumor microenvironment, resulting in tumor growth inhibition in animal models. Removal of HA from the tumor microenvironment results in expansion of previously constricted blood vessels allowing increased blood flow, potentially increasing the access of activated immune cells and factors in the blood into the tumor microenvironment. If PEGPH20U.S., which is administered in conjunction with other anti-cancer therapies, the increase in blood flow may allow anti-cancer therapies to have


greater access to the tumor, which may enhance the treatment effect of therapeutic modalities like chemotherapies, monoclonal antibodies and other agents.
We are developing PEGPH20 as a targeted therapy, for patients who have tumors with high levels of HA. We have a collaboration with Ventana Medical Systems Inc. (Ventana), a member of the Roche Group, to develop, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with PEGPH20. The companion diagnostic assay is being used to identify high levels of HA in tumor biopsies, and may be the first diagnostic to target tumor-associated HA and possibly the first companion diagnostic assay in pancreatic cancer.
Pancreatic cancer indications:
Halo 109-201:
In January 2015, we presented the final results from Halo 109-201, a multi-center, international open label dose escalation Phase 1b clinical study of PEGPH20 in combination with gemcitabineonly sublingual tablet indicated for the treatment of patients with stage IV PDAnocturia due to nocturnal polyuria (“NP”) in adults who awaken at the 2015 Gastrointestinal Cancers Symposium (also known as ASCO-GI meeting). This study enrolled 28 patients with previously untreated stage IV PDA. Patients were treated with one of three doses of PEGPH20 (1.0, 1.6 and 3.0 µg/kg twice weekly for four weeks, then weekly thereafter) in combination with gemcitabine 1000 mg/m2 administered intravenously. In this study, the confirmed overall response rate (complete response + partial response confirmed on a second scan as assessed by an independent radiology review) was 29 percent (7 of 24 patients) for those treated at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg). Median progression-free survival (PFS) was 154 days (95% CI, 50-166) in the efficacy-evaluable population (n = 24). Among efficacy-evaluable patients with baseline tumor HA staining (n = 17), the median PFS in patients with high baseline tumor HA staining (6/17 patients) was substantially longer, 219 days, than in the patients with low baseline tumor HA staining (11/17 patients), 108 days. Median overall survival (OS) was 200 days (95% CI, 123-370) in the efficacy-evaluable population (n = 24). Among efficacy-evaluable patients with baseline tumor HA staining (n = 17), the median OS in patients with high baseline tumor HA staining (6/17 patients) was substantially longer, 395 days, than in the patients with low baseline tumor HA staining (11/17 patients), 174 days. The most common treatment-emergent adverse events (occurring in ≥ 15% of patients) were peripheral edema, muscle spasms, thrombocytopenia, fatigue, myalgia, anemia, and nausea. Thromboembolic (TE) events were reported in 8 patients (28.6%) and musculoskeletal events were reported in 21 patients (75%) which were generally grade 1/2 in severity.
Halo 109-202:
least two times per night to urinate. In the second quarterNOCDURNA® clinical trials, NP was defined as night-time urine production exceeding one-third of 2013,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.
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). Safety and efficacy of TLANDO® in males less than 18 years old have not been established. TLANDO® was granted FDA approval on March 28, 2022. In June 2022, we initiated Halo 109-202,announced the commercial launch of TLANDO®.
ATRS - 1902
We have an ongoing program to develop a proprietary drug device combination product for the endocrinology market, a pen 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. We have conducted initial formulation work and developed a working prototype of a new device to support this program.
In June 2021, we submitted an IND application with the FDA for the initiation of a Phase 2 multicenter randomized1 clinical trial evaluating PEGPH20 asstudy 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 first-line therapy for patients with stage IV PDA.liquid stable formulation of hydrocortisone, was initiated in September 2021. The study was designeda cross-over design to enroll patients who would receive gemcitabine and nab-paclitaxel (ABRAXANE®) either with or without PEGPH20. The primary endpoint is to measureestablish the improvement in PFS in patients receiving PEGPH20 plus gemcitabine and ABRAXANE (PAG arm)PK profile of ATRS-1902 (100 mg) compared to those who are receiving gemcitabine and ABRAXANE alone (AG arm). In April 2014, after 146 patients had been enrolled,Solu-Cortef® (100 mg), the trial was put on clinical hold by Halozyme and the FDA to assess a question raised by the Data Monitoring Committee regarding a possible differencereference-listed drug, in the TE events rate between the group of patients treated in the PAG arm versus the group of patients treated in the AG arm. This portion of the study and patients in this portion are now referred to as Stage 1. At the time of the clinical hold all patients remaining in the study continued on gemcitabine and ABRAXANE. In July 2014, Halo 109-202 was reinitiated (Stage 2) under a revised protocol, which excludes patients that are expected to be at a greater risk for TE events. The revised protocol provides for thromboembolism prophylaxis of all patients in both arms of the study with low molecular weight heparin, and adds evaluation of the TE events rate in Stage 2 PEGPH20-treated patients as a co-primary end point. Stage 2 of Halo 109-202 enrolled an additional 133 patients, to add to the 146 patients already in the clinical trial, with a 2:1 randomization for the PAG arm compared to the AG arm.
In March 2016, our partner Ventana received approval for an investigational device exemption (IDE) application from the FDA for our companion diagnostic test to enable patient selection in our Phase 3 Study 301 of PEGPH20 in HA-High patients. Based on the cutpoint for the Ventana diagnostic, we expect approximately 35 to 40 percent of stage IV PDA patients to have HA-High tumors, similar to the previously reported interim results from Stage 1 of Study 202 using the Halozyme prototype assay.


32 healthy adults.
In January 2017,2022, we announced toplinethe positive results from the combined analysis of StagePhase 1 and Stage 2, and Stage 2 alone, based on a December 2016 data cutoff. The combined analysis included 135 treated patients in Stage 1, of whom a total of 45 patients (25 in the PAG arm and 21 in the AG arm) were determined to have high HA, and 125 treated patients in Stage 2, of whom a total of 35 patients (24 in the PAG arm and 11 in the AG arm) were determined to have high HA. This analysis of secondary and exploratory endpoints was conducted using the Ventana companion diagnostic to prospectively identify high levels of HA. The key results showed in the combined Stage 1 and Stage 2 dataset:
The primary endpoint of PFS in the efficacy evaluable population (total of 231 patients) was met with statistical significance with a median PFS of 6.0 months in the PAG arm compared to 5.3 months in the AG arm, hazard ratio (HR) with a 95% confidence interval (CI): 0.73 (0.53, 1.00); p=0.048;
The secondary endpoint of PFS in the HA-High intent to treat population (total of 84 HA-High patients) was met with statistical significance with a median PFS of 9.2 months in the PAG arm compared to 5.2 months in the AG arm, HR 0.51 (95% CI: 0.26, 1.00); p=0.048;
The exploratory analysis of median OS was 11.5 months vs. 8.5 months in the PAG vs. AG arms, respectively. Factors potentially having an impact on these results include less aggressive disease among patients in the AG arm within the Stage 1 patient population, and 9 of the 24 patients in the PAG arm (approximately 40 percent) discontinued PEGPH20 treatment at the time of the clinical hold, resulting in many patients receiving AG alone in both arms.
In the Stage 2 cohort population, in a total of 35 HA-High patients, the key results showed:
Median PFS was 8.6 months in the PAG arm compared to 4.5 months in the AG arm, hazard ratio of 0.63 (95% CI: 0.21, 1.93);
Median overall survival (OS) was 11.7 months in the PAG arm compared to 7.8 months in the AG arm, hazard ratio of 0.52 (95% CI: 0.22, 1.23);
The primary safety endpoint of decreasing the rate of TE events in Stage 2 was also met with the rate of TE events reducing from 43 percent to 10 percent in the PAG arm and from 25 percent to 6 percent in the AG arm, following a protocol amendment that excluded patients at high risk of TE events and with the introduction of prophylaxis with low molecular weight heparin (enoxaparin) in Stage 2 of the study with the current 1mg/kg/day dose of enoxaparin prophylaxis given in both treatment arms of the study.
In June 2017, results from Study 202 were presented at the ESMO World Congress of Gastrointestinal Cancer and the Annual Meeting of the American Society of Clinical Oncology (ASCO). Study 202 is an ongoing study with an open database and therefore we continue to collect and receive data on both Stage 1 and Stage 2 patients. When the database is considered complete and locked, an updated analysis and Final Study Report will be generated.
Halo 109-301:
In March 2015, we met with the FDA to discuss both the interim efficacy and safety data from Halo 109-202, which included the potential risk profile including TE event rate. Based on the feedback from that meeting, we proceeded with a Phase 3 clinical study (Halo 109-301) of PEGPH20 in patients with stage IV PDA, using a design allowing for potential marketing application based on PFS (accelerated approval pathway) or OS. The study will enroll patients whose tumors accumulate high levels of HA measured using the Ventana companion diagnostic test. The FDA provided feedback on the current companion diagnostic approach and confirmed that an approved IDE is required for the Phase 3 study.
The use of PFS as the basis for marketing approval will be subject to the overall benefit and risk associated with PEGPH20 combined with gemcitabine and ABRAXANE therapy, including the:
Magnitude of the PFS treatment effect observed;
Toxicity profile; and
Interim OS data.


In June 2015, we received scientific advice/protocol assistance from the European Medicines Agency (EMA) regarding our Phase 3 study. The EMA agreed to the patient population, and the use of both PFS and OS as co-primary endpoints stating that OS is the preferred endpoint and that ultimate approval would require an overall positive benefit:risk balance.
In March 2016, we dosed the first patient in Halo 109-301, a Phase 3 multicenter randomized clinical trial evaluating PEGPH20 as a first-line therapy for patients with stage IV PDA. The study will evaluate the effects on PFS and OS of PEGPH20 with gemcitabine and ABRAXANE compared with gemcitabine and ABRAXANE alone in stage IV PDA patients. In September 2017, our independent Data Safety Monitoring Committee met to review ongoing safety data from the trial and informed us the study should proceed as planned. Approximately 220 sites in 22 countries located in North America, Europe, South America and Asia have been initiated to participate in the HALO 301 study. An interim analysis will be conducted for our first primary endpoint when we achieve the target number of PFS events. We project that the target number of PFS events will be achieved in the fourth quarter of 2018. At that time we project we will have enrolled approximately 500 patients.
SWOG Study S1313:
In October 2013, SWOG, a cancer research cooperative group of more than 4,000 researchers in over 500 institutions around the world, initiated a 144 patient Phase 1b/2 randomized clinical trial in some of their study centers, examining PEGPH20 in combination with modified FOLFIRINOX chemotherapy compared to modified FOLFIRINOX treatment alone in patients with stage IV PDA (funded by the National Cancer Institute). As announced in March 2017, SWOG stopped enrollment in the Phase 1b/2 trial. While PEGPH20 is a targeted investigational therapy for patients with high levels of HA, the SWOG study was enrolling patients irrespective of HA levels, referred to as an all-comer population. During a planned early futility analysis, SWOG’s independent Data Monitoring Committee found, based on preliminary data, that the addition of PEGPH20 given every two weeks to modified FOLFIRINOX in this all-comer population would be unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival. SWOG further reported that a higher rate of death was observed in the PEGPH20 arm versus modified FOLFIRINOX alone. SWOG has stopped the study and continues its ongoing effort to collect and clean outstanding data. Upon completion, we will work with SWOG to analyze and evaluate the dataset. Our PEGPH20 studies and clinical collaborations in combination with agents other than modified FOLFIRINOX continue unchanged.
Clinical collaboration:
In October 2016, we announced that PEGPH20 will be included in a pancreatic cancer clinical trial initiative called Precision Promise, an initiative that aims to change the current treatment approach to pancreatic cancer by offering options to patients based on the molecular profile of their tumor. This is being accomplished through the Pancreatic Cancer Action Network leading a collaboration that brings together clinicians, researchers, and drug developers. Pancreatic Cancer Action Network continues to work to finalize the trial design and protocol which is expected to start in 2018.
Other indications outside of pancreatic cancer:
Halo 107-101:
In November 2015, we initiated a Phase 1b study exploring the combination of PEGPH20 and KEYTRUDA®, an immuno-oncology agent in relapsed non-small cell lung cancer (NSCLC) and gastric cancer. In December 2016, we identified a dose of PEGPH20, namely 2.2 ug/kg, to move into the dose expansion phase of the study with KEYTRUDA in combination with PEGPH20. We are enrolling both NSCLC and gastric cancer patients prospectively based on a patient being determined to be HA-High using the Ventana companion diagnostic test. In September 2017, our standing Independent Data Monitoring Safety Committee met to review ongoing safety data from the trial and informed us that the study should proceed with study protocol modifications to exclude patients at risk and increase liver safety monitoring, after observing clinical and laboratory signs of hepato-biliary dysfunction.


Clinical collaborations:
In July 2015, we entered into a clinical collaboration agreement with Eisai Co., Ltd. (Eisai) to evaluate Eisai's HALAVEN® (eribulin) with PEGPH20 in HER2-negative metastatic breast cancer. In July 2016, the first patient was dosed in a Phase 1b/2 study for patients treated with up to two lines of prior therapy for HER2-negative HA-High metastatic breast cancer. Halozyme and Eisai are jointly sharing the costs to conduct this global study which continues in Phase 1b.
In November 2016, we entered into an agreement with Genentech, a member of the Roche Group, to collaborate on clinical studies to evaluate their cancer immunotherapy Tecentriq, an anti-PD-L1 monoclonal antibody, in combination with PEGPH20, in up to eight different tumor types. Genentech initiated a Phase 1b/2 clinical trial in patients with previously treated metastatic PDA in July 2017 and a Phase 1b/2 clinical trial in patients with gastric cancer in October 2017, as part of its Morpheus master protocol. We will supply PEGPH20 for the Genentech-funded studies. In October 2017, we initiated a Phase 1b/2 clinical trial to assess Tecentriq with PEGPH20 in patients with cholangiocarcinoma and gall bladder cancer (Halo 110-101/MATRIX). Genentech will supply Tecentriq for the Halozyme sponsored study.
Regulatory
The FDA haswere granted Fast Track designation forby the FDA. The positive results support the advancement of our ATRS-1902 development program investigating PEGPH20 in combination with gemcitabine and nab-paclitaxelto a pivotal study for the treatment of patientsacute adrenal insufficiency, known as adrenal crisis, using our Vai™ novel proprietary rescue pen platform to deliver a liquid stable formulation of hydrocortisone. The pivotal study in adults is on target to start in the third quarter of 2022 and we expect to submit a 505(b)(2) NDA with stage IV PDA to demonstrate an improvement in OS. The Fast Track designation process was developedthe FDA by the FDA to facilitateend of 2022 pending the development and expedite the review of drugs to treat serious or life-threatening diseases and address unmet medical needs.
The FDA has granted Orphan Drug designation for PEGPH20 for the treatment of pancreatic cancer. The FDA Office of Orphan Products Development’s mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Similarly, the European Committee for Orphan Medicinal Productssuccess of the EMA designated PEGPH20 an orphan medicinalstudy, the completion of a summative human factors study and confirmation of the product for the treatment of pancreatic cancer.stability from our ongoing stability program.
Other Pipeline Assets
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HTI-1511: HTI-1511 is a novel antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) to treat solid tumors, including those with drug-resistant mutations. We are exploring potential collaboration or partnership interest in this program prior to making additional investments in the development of HTI-1511.
PEG-ADA2: PEGylated adenosine deaminase 2, or PEG-ADA2, is an immune checkpoint inhibitor that targets adenosine, which may accumulate to high levels in the tumor microenvironment and has been linked to immunosuppression. We are currently in preclinical development with PEG-ADA2 and are exploring potential collaboration or partnership interest in this program prior to making additional investments in the development of PEG-ADA2.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 thirteentwelve Roche target compounds (the Roche Collaboration). Roche initially had the exclusive right to apply rHuPH20 to three pre-defined Roche biologic targets with the option to develop and commercialize rHuPH20 with ten additional targets. Roche had the right to exerciseUnder this option to identify additional targets for ten years. As of the ten year anniversary of theagreement, Roche Collaboration in December 2016, Roche had elected a total of eight targets, two of which are exclusive.


In September 2013, Roche launched a subcutaneous (SC) formulation of Herceptin (trastuzumab) (Herceptin® SC) in Europe for the treatment of patients with HER2-positive breast cancer.cancer followed by launches in additional countries. This formulation utilizes our patented ENHANZE Technologytechnology and is administered in two to five minutes, compared to 30 to 90 minutes with the standard intravenous form. In September 2018, we announced that Roche received European marketing approval from Health Canada for Herceptin SC in August 2013. Breast cancer isfor the most common cancer among women worldwide.treatment of patients with HER2-positive cancer is reported to be a particularly aggressive form of breast cancer. Directed atIn February 2019, we announced that Roche received approval from the same target,U.S. Food and Drug Administration (“FDA”) for Herceptin SC under the brand name Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk). In April 2019, Roche initiated a Phase 1 studymade Herceptin Hylecta available in the U.S. In June 2020, the FDA approved the fixed-dose combination of rHuPH20Perjeta® (pertuzumab) and Herceptin for subcutaneous injection (Phesgo™) utilizing ENHANZE technology for the treatment of patients with PERJETA® (pertuzumab) inHER2-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 March 2016.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 patented ENHANZE Technologytechnology and is administered in approximately five minutes compared to the approximately 1.5 to 4 hour infusion time for intravenous MabThera. The European Commission approved MabThera SC in March 2014.infusion. In May 2016, Roche announced that the EMAEuropean Medicines Agency (EMA) approved Mabthera SC to treat patients with chronic lymphocytic leukemia (CLL). In June 2017, the FDA approved Genentech’s (a member of the Roche Group) RITUXAN HYCELA™HYCELA®, a combination of rituximab and rHuPH20using 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 September 2017, we and Roche entered into an agreement providing Roche the right to develop and commercialize one additional exclusive target using our ENHANZE Technology (the 2017 Roche Collaboration).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 September 2020, Roche presented a poster with data from Part 1 of its Phase 1b study (IMscin001) evaluating TECENTRIQ for subcutaneous administration utilizing ENHANZE technology in patients with locally advanced or metastatic non-small cell lung cancer at the ESMO Virtual Congress 2020. The poster concluded that atezolizumab utilizing ENHANZE technology provided similar exposure as atezolizumab IV and that results support further development of subcutaneous atezolizumab in IMscin001 Part 2, a confirmatory Phase 3 study. In December 2020, Roche initiated a Phase 3 study in patients with non-small cell lung cancer for TECENTRIQ using ENHANZE technology. In August 2022, Roche announced that the Phase III IMscin001 study evaluating a subcutaneous (SC) formulation of Tecentriq (atezolizumab) met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The safety profile of the SC formulation was consistent with that of IV Tecentriq.
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.
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Baxalta Collaboration
In September 2007, we and Baxalta entered into a collaboration and license agreement under which Baxalta obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 with GAMMAGARD LIQUID (HYQVIA)(HYQVIA®) (the Baxalta Collaboration). HYQVIA is indicated for the treatment of primary immunodeficiency disorders associated with defects in the immune system.
In May 2013, the European CommissionEC granted Baxalta marketing authorization in all EU Member States for the use of HYQVIA (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. Baxalta 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 subcutaneous 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. Prior to the approval of HYQVIA, the majority of primary immunodeficiency patients received intravenous infusions in a doctor’s office or infusion center, and other subcutaneous IG treatments require weekly or bi-weekly treatment with multiple infusion sites per treatment. The FDA’s approval of HYQVIA was a significant milestone for us as it represented the first U.S. approved BLA which utilizes our rHuPH20 platform.
In May 2016, Baxalta announced that HYQVIA received a marketing authorization from the European CommissionEC for a pediatric indication, which is beingwas 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 subcutaneous immunoglobulin replacement therapy in adults, adolescents and children with an expanded range of secondary immunodeficiencies (SID).
In October 2021, Baxalta initiated a Phase 1 single-dose, single-center, open-label, three-arm study to assess the tolerability and safety of immune globulin subcutaneous (human), 20% solution with ENHANZE (TAK-881) at various infusion rates in healthy adult subjects.
In July 2022, Baxalta announced positive topline results from pivotal Phase 3 trial evaluating HYQVIA, for maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
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 directed to up to six targets in primary care and specialty care indications. Targets may be selected on an exclusive or non-exclusive basis. Pfizer has elected five targets on an exclusive basis and has returned 2two 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. In November 2015, Janssen has initiated dosing in aseveral Phase 1b clinical trial evaluating subcutaneous delivery3 studies, Phase 2 studies and Phase 1 studies of daratumumab,DARZALEX® (daratumumab), directed at CD38, using ENHANZE Technology,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 subcutaneous DARZALEX in comparison to intravenous 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 ENHANZEin the European Union. 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 (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 December 2016,2021, Janssen received FDA approval for DARZALEX FASPRO in combination with
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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 resultsapproval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for subcutaneous formulation of DARZALEX (known as DARZQURO in Japan) for the trial,treatment of multiple myeloma, and in May 2021 Janssen commenced commercial sale in Japan. In August 2021, Janssen received approval of DARZQURO (Daratumumab SC) 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 supported continued development of daratumumab with rHuPH20.is being studied in solid tumors. In October 2017,November 2020, Janssen initiated a Phase 31 study of daratumumab combined withamivantamab and ENHANZE.
In July 2021, Janssen elected the ENHANZE Technology in amyloidosis patients, with additionaltarget HIV reverse transcriptase limited to non-nucleoside reverse transcriptase inhibitors. In December 2021, Janssen initiated a Phase 3 studies in multiple myeloma1 clinical trial combining rilpivirine and smoldering myeloma patients planned to initiate inENHANZE. Janssen and ViiV are exploring the near term.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 directed to up to five 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. In August 2017, Lilly initiated a Phase 1 study of an investigational new therapy in combination with rHuPH20.
BMS Collaboration
In September 2017, we and BMS entered into a collaboration and license agreement, which became effective in November 2017, under which BMS will havehad the worldwide license to develop and commercialize products combining our rHuPH20 enzyme with BMS immuno-oncology targetsproducts directed at up to eleven targets upon effectiveness of the agreement. The agreement became effective in November 2017 upon expiration of the waiting period provided by the Hart-Scott-Rodino Act.targets. Targets may be selected on an exclusive 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 within fiveby 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 June 2021, BMS initiated a Phase 3 study of nivolumab using ENHANZE technology for patients with advanced or metastatic clear cell renal cell carcinoma, 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.
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 targets and has access to three 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 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 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
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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, ADDRESS, evaluating Efgartigimod with ENHANZE in bullous pemphigoid.
In October 2020, we and argenx entered into 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.
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 subcutaneous 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 subcutaneous 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 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 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), enabling the VRC’s use of ENHANZE technology to develop subcutaneous formulations of VRC07-523LS and N6LS broadly neutralizing antibodies (bnAbs) against HIV for HIV treatment. In March 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.
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 CAPR256V2LS 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.
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Device 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. This agreement has been amended to provide for payment of capital equipment and other ongoing development work that was outside the scope of the original agreement. 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 may receive royalties on future product sales. This agreement has been amended numerous times and provides for payment of capital equipment and other development work that was outside the scope of the original agreement. This agreement will continue until the expiration date of the last to expire patent covering the device or product that is filed no later than 12 months after FDA approval and will be automatically renewed for successive periods of two years each. Currently, the expiration date of the last to expire patent is 2035. 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 is 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, our partner Teva launched Teriparatide Injection, the generic version of Eli Lilly’s branded product Forsteo® featuring the Antares 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. Under the agreement, we received an upfront payment and a milestone payment upon commercial launch. Teva is responsible for the manufacture and supply of the drug, and we are 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 split 50/50 between us 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 effective date.terms of the agreement. We, through our partner Teva, sell Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine headaches and cluster headache in adults. Sumatriptan Injection USP is a generic equivalent to Imitrex® STATdose Pen®, and available in the 4 mg/0.5 mL and 6 mg/0.5 mL single-dose pre-filled syringe auto-injectors. We have a license, supply and distribution agreement with Teva, under which Teva is responsible for the manufacture and supply of the drug, and we manufacture the device and complete assembly and packaging of the finished product. Teva is responsible for commercialization and distribution.
Covis Agreements
In September 2014, we entered into a development and license agreement with Lumara Health, Inc., which was subsequently acquired by AMAG, which was subsequently acquired by Covis, to develop and supply an auto-injector system for use with Makena®, a progestin drug (hydroxyprogesterone caproate) indicated to reduce the risk of preterm birth. Under the agreement, we granted an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, including know-how, patents and trademarks, and received an upfront payment for our license and development activities. We are also entitled to milestone payments upon the achievement of pre-determined amounts of net sales of the product.
Covis was responsible for the clinical development and preparation, 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
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and sell the product. We are the exclusive supplier of the auto injection system devices for the product and are responsible for the manufacture and supply of the devices and final assembly and packaging of the finished product. Under the arrangement, we receive payment for each device, and royalties based on net sales of products commencing on product launch in a particular country until the product is no longer developed, marketed, sold or offered for sale in such country. The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of products and decrease after the expiration of licensed patents or where there are generic equivalents to the auto-injector product being sold in a particular country.
In March 2018, we entered into a manufacturing agreement with Covis for the exclusive supply of the devices and fully assembled and packaged final finished product of the Makena® subcutaneous auto-injector. The term of the agreement is concurrent with the term of the development and license agreement and will continue until such time as commercialization of the product is halted. We receive a contracted price per unit on each product manufactured. We are the exclusive supplier of the device, a variation of our VIBEX® QuickShot® subcutaneous auto injector developed by us, for the progestin hormone drug Makena® (hydroxyprogesterone caproate injection). The Makena® subcutaneous auto injector drug-device combination product is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. The product was approved by the FDA under the accelerated approval pathway. We are the exclusive supplier of the devices and the final assembled and packaged commercial product.
In October 2019, Covis announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) confirmatory clinical trial for Makena® (hydroxyprogesterone caproate) injection. Nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena® and seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial. In October 2020, Covis received notice that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection). Covis then formally requested a public hearing in response to the FDA’s proposal to withdraw its approval and has stated that it remains committed to working with the FDA to maintain patient access to Makena® as a treatment option to reduce pre-term birth. In August 2021, Covis announced the FDA had granted the request for a public hearing. In June 2022, Covis announced that the FDA anticipates holding the public meeting in October 2022.
Pfizer Agreement
In August 2018, we entered into a development agreement with Pfizer to jointly develop a combination drug device rescue pen. This rescue pen will use the Antares QuickShot® auto-injector and an undisclosed Pfizer drug. In 2022, we continued to work on this development program, and we expect to continue development of this product candidate.
Idorsia Agreement
In November 2019, we entered into a new 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 we 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.
Lipocine Agreement

In October 2021, we entered into an exclusive license agreement with Lipocine for the product TLANDO® (testosterone undecanoate) in the U.S. TLANDO® was granted tentative approval from the FDA in December 2020. On February 3, 2022, we announced the FDA’s acceptance of our NDA resubmission for TLANDO® with a target action date set for March 28, 2022. 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®. The license agreement also granted us the option to license and develop LPCN 1111 (TLANDO XR) in the U.S., a potential once daily oral testosterone product containing testosterone tridecanoate in development
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for the treatment of hypogonadism in adult males. Following a review of our product portfolio, we decided not to exercise the option which expired on June 30, 2022.
Otter Agreement

In December 2021, we entered into an Asset Purchase Agreement with Otter to sell certain worldwide assets used in the operation of the OTREXUP® product line for $44.0 million, subject to finalization of changes in closing inventory to be transferred, and a license agreement for rights to commercialize OTREXUP®. Simultaneously, 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 subcutaneous 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 material terms of our collaboration agreements, refer to Note 4, Collaborative Agreements and Note 10, Subsequent Event5, Revenue.
Impact of COVID-19 to our condensed consolidated financial statements.Business
In March 2020, the World Health Organization declared a disease caused by a strain of novel coronavirus (“COVID-19”) to be a pandemic. In an effort to contain COVID-19 or slow its spread, governments around the world have enacted various measures, including orders to close all businesses not deemed “essential,” isolate residents to their homes or places of residence, and practice social distancing when engaging in essential activities. In an effort to protect the health and safety of our employees and in compliance with state regulations, we instituted working from home, limited the number of people that work on site at any one time, and suspended employee travel. As an organization we have returned to the office and continue to effectively operate with a combination of remote and office work utilizing a hybrid model. Importantly, our suppliers continue to operate without interruption related to COVID-19. We recognize that the duration of the pandemic and its continued impact on the global economy as a whole remains unknown at this time. We are not clear the extent to which long term operational and economic impacts of COVID-19, if any, will have on our business, including the effects on our suppliers, partners, proprietary product sales. customers, employees, and prospects. We will continue to monitor the COVID-19 situation closely.
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Results of Operations
Three Months Ended SeptemberJune 30, 20172022 Compared to Three Months Ended SeptemberJune 30, 20162021
Royalties– Royalty revenue was $85.3 million for the three months ended June 30, 2022 compared to $45.8 million for the three months ended June 30, 2021. The increase was mainly driven by continued sales uptake of DARZALEX FASPRO by Janssen and Phesgo by Roche in all geographies, 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):
Three Months Ended
June 30,
20222021Change
Sales of bulk rHuPH20$25,057 $24,087 $970 
Sales of proprietary products14,687 6,273 8,414 
Sales of device partnered product6,556 — 6,556 
Total product sales, net$46,300 $30,360 $15,940 
  Three Months Ended  
  September 30,  
  2017 2016 Change
Sales of bulk rHuPH20:      
Roche $5,947
 $6,758
 $(811)
Baxalta 3,302
 2,618
 684
Other 499
 245
 254
Sales of Hylenex
 3,841
 3,710
 131
Total product sales, net $13,589
 $13,331
 $258


Product sales, net increased by $15.9 million in the three months ended SeptemberJune 30, 20172022 compared to the same period in 2016, mainly2021, primarily due to a increasecontribution 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 sales of bulk rHuPH20 to Baxalta and others and an increase in the sales of Hylenex, offset by a decrease in sales of bulk rHuPH20 to Roche.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 collaborators. In 2016, we performed services for Roche to bring on-line a second contract manufacturing facility for bulk rHuPH20. This new facility will become the primary source for Roche of bulk rHuPH20 once it receives regulatory approval. As a result, we anticipate Roche will deplete their existing inventory of rHuPH20 ahead of the transition to the new facility, which will result in lower bulk product sales during 2017 and 2018. We expect that future product sales of Hylenex to be flat or experience modest growth, although there may be periods with declining revenue as we experience competition for market share.partners.
Royalties– Royalty revenue was $17.1 million for the three months ended September 30, 2017 compared to $13.0 million for the three months ended September 30, 2016. The increase was driven by higher sales of Herceptin SC and MabThera SC (RITUXAN HYCELA™ in the U.S.) by Roche and of HYQVIA by Baxalta. We recognize royalties on sales of the collaboration products by the collaborators in the quarter following the quarter in which the corresponding sales occurred. In general, we expect royalty revenue to increase in future periods reflecting expected increases in sales of collaboration products, although there may be periods with flat or declining royalty revenue as sales of products under collaborations vary.
Revenues Under Collaborative Agreements – Revenues under collaborative agreements were as follows (in thousands):
  Three Months Ended  
  September 30,  
  2017 2016 Change
Upfront license fees, license fees for the election of additional targets,
     license maintenance fees and amortization of deferred upfront and
     other license fees and event-based payments:
     
Roche $30,831
 $831
 $30,000
Baxalta 192
 192
 —
  31,023
 1,023
 30,000
Reimbursements for research and development services 2,000
 4,463
 (2,463)
Total revenues under collaborative agreements $33,023
 $5,486
 $27,537
Three Months Ended
June 30,
20222021Change
ENHANZE licensing and development revenue:
Janssen$15,000 $20,000 $(5,000)
BMS5,000 — 5,000 
ViiV— 40,000 (40,000)
       Subtotal20,000 60,000 (40,000)
Device licensing and development revenue725 317 408 
Total revenues under collaborative agreements$20,725 $60,317 $(39,592)
Revenue from license fees increased indecreased $39.6 million for the three months ended SeptemberJune 30, 2017,2022, compared to the same period in 20162021, primarily due to a $30.0 millionthe upfront license fee forpayment associated with entering into the 2017 Roche Collaboration recognizedViiV collaborations in the three months ended September 30, 2017 and no such revenue recognized in the three months ended September 30, 2016.prior year period. Revenue from upfront licenses fees, license fees for the election of additional targets, license maintenance fees and amortization of deferred upfront 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 collaborators’ abilitiespartners’ ability to meet various clinical and regulatory milestones set forth in such agreements and our abilitiesability to obtain new collaborative agreements.
The BMS Collaboration went effectiveacquisition of Antares is expected to be accretive to revenue in November 2017, triggering revenue recognition related2022, supported by Antares' proprietary product revenues and royalty revenues. The addition of Antares is also expected to the upfront license paymentaccelerate top- and bottom-line growth and enhance cash flow generation through 2027 and beyond.
Cost of $101.4 million in the fourth quarterSales– Cost of 2017.
Revenue from reimbursements for researchsales consists primarily of raw materials, third-party manufacturing costs, fill and development services decreased in the three months ended September 30, 2017, compared to the same period in 2016 mainly due to a decrease in services provided to Roche related to workfinish costs, freight costs, internal costs and manufacturing overhead associated with bringing on-line a second contract manufacturing facility. The validation of the new facility was completed in the second quarter of 2017 and, therefore, we expect to continue to see a decrease in research and development service revenue from Roche going forward. Research and development services rendered by us on behalfproduction of our collaborators are at the request of the collaborators; therefore, the amountproprietary and timing of future revenues related to reimbursable researchdevice partnered products and development services is uncertain.
bulk rHuPH20. Cost of Product Sales– Cost of product sales were $8.3$33.9 million for the three months ended SeptemberJune 30, 20172022 compared to $9.1$23.0 million for the three months ended SeptemberJune 30, 2016.2021. The decreaseincrease of $0.8$10.9 million in cost of product sales was mainly due to a decreasean increase in sales in our proprietary and partnered products as a result of bulk rHuPH20Antares acquisition.
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Amortization of intangibles– Amortization of intangibles expense were $11.4 million for the three months ended June 30, 2022. The increase in amortization of intangibles expense is due to Roche.the acquisition of Antares in May 2022, in which we acquired intangible assets that are amortized over their useful lives.


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, clinical trials, preclinical and regulatory activities.activities related to our collaborations, our development platforms. Research and development expenses incurred were as follows (in thousands):
  Three Months Ended  
  September 30,  
Programs 2017 2016 Change
PEGPH20 $29,279
 $24,248
 $5,031
ENHANZE collaborations and rHuPH20 platform 4,081
 6,139
 (2,058)
Other 633
 3,476
 (2,843)
Total research and development expenses $33,993
 $33,863
 $130
Research and development expenses relating to our PEGPH20 programs$15.5 million for the three months ended SeptemberJune 30, 2017 increased by 21%,2022 compared to the same period in 2016, primarily due to increased clinical trial activities. We expect PEGPH20 program expenses to increase in future periods reflecting expected increases in our PEGPH20 development activities.
Research and development expenses relating to our ENHANZE collaborations and our rHuPH20 platform$8.1 million for the three months ended SeptemberJune 30, 2017 decreased by 34%, compared to the same period in 2016,2021. The increase of $7.4 million is primarily due to a decreaseplanned investments in manufacturing expensesENHANZE and one-time compensation cost related to Roche, due to work associated with bringing on-line a second contract manufacturing facility. As we completed the validation of the new manufacturing facility in the second quarter of 2017, we expect these expenses to continue to decrease going forward. The rHuPH20 platform includes research, development and manufacturing expenses related to our proprietary rHuPH20 enzyme. These expenses were not designated to a specific program at the time the expenses were incurred.Antares acquisition.
Research and development expenses relating to other programs for the three months ended September 30, 2017 decreased by 82%, compared to the same period in 2016, due to a decrease in preclinical development of HTI-1511 and PEG-ADA2.
Selling, General and Administrative– Selling, general and administrative (SG&A) expenses were $13.3 millionconsist primarily of salaries and related costs for the three months ended September 30, 2017 compared to $11.6 millionpersonnel in executive, selling and administrative functions as well as professional fees for the three months ended September 30, 2016. The increase of $1.7 million, or 15%, was primarily due to an increase in compensation expense including stock compensation. We expectlegal and accounting, business development, commercial operations support for proprietary products and alliance management and marketing support for our collaborations. SG&A expenses to increase moderately in future periods as our operations expand.
Interest Expense– Interest expense was $5.5were $57.5 million for the three months ended SeptemberJune 30, 20172022 compared to $5.3$12.3 million for the three months ended SeptemberJune 30, 2016.2021. The increase of $0.2$45.2 million, was primarily due to one-time transaction and compensation costs related to the Antares Pharma acquisition and an increase in compensation expense related to the ongoing combined workforce.
Interest Expense– Interest expense was $3.1 million for the three months ended June 30, 2022 compared to $1.8 million for the three months ended June 30, 2021. The increase of $1.3 million was primarily due to an increase in interest expense related to the Royalty-backed Loan balance.2022 term loans and revolving credit facility.
Income Tax ExpenseTaxes– Income tax expense was $0.6$7.3 million for the three months ended SeptemberJune 30, 20172022, compared to $1.3income tax expense of $0.1 million for the three months ended SeptemberJune 30, 2016 and2021. The increase in income tax expense is due to the recording of a full quarter income tax expense in the current year whereas in the prior year period there was comprised of U.S. federal alternative minimum tax. Forminimal income tax expense due to a full valuation allowance in place.

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Six Months Ended June 30, 2022 Compared to Six Months Ended June 30, 2021
Royalties– Royalty revenue was $154.9 million for the threesix months ended SeptemberJune 30, 2017, we generated taxable income2022 compared to $82.7 million for the six months ended June 30, 2021. The increase was mainly driven by continued sales uptake of DARZALEX FASPRO by Janssen and Phesgo by Roche in the U.S., which wasall geographies and contribution from Antares royalty revenue, partially offset by utilizing net operating losses carried forward from earlier years.slightly lower sales of Herceptin SC and MabThera SC by Roche.


Nine Months Ended September 30, 2017 Compared to Nine Months Ended September 30, 2016
Product Sales, Net– Product sales, net were as follows (in thousands):
Six Months Ended
June 30,
20222021Change
Sales of bulk rHuPH20$41,505 $40,857 $648 
Sales of proprietary products20,379 11,269 9,110 
Sales of device partnered products6,556 — 6,556 
Total product sales, net$68,440 $52,126 $16,314 
  Nine Months Ended  
  September 30,  
  2017 2016 Change
Sales of bulk rHuPH20      
Roche $16,543
 $19,563
 $(3,020)
Baxalta 9,328
 7,538
 1,790
Other 954
 1,122
 (168)
Sales of Hylenex
 10,978
 11,747
 (769)
Total product sales, net $37,803
 $39,970
 $(2,167)
Product sales, net decreasedincreased by $16.3 million in the ninesix months ended SeptemberJune 30, 20172022 compared to the same period in 2016,2021, primarily due to a decrease in the sale of bulk rHuPH20 to Rochecontribution from our proprietary and a decrease in the sales of Hylenex, offset by an increase in the sale of bulk rHuPH20 to Baxalta. We expect that product sales of bulk rHuPH20 will fluctuate in future periods based on the needs of our collaborators. In 2016, we performed services for Roche to bring on-line a second contract manufacturing facility for bulk rHuPH20. This new facility will become the primary source for Roche of bulk rHuPH20 once it receives regulatory approval. As a result, we anticipate Roche will deplete their existing inventory of rHuPH20 ahead of the transition to the new facility, which will result in lower bulk product sales during 2017 and 2018. We expect that future product sales of Hylenex to be flat or experience modest growth, although there may be periods with declining revenue as we experience competition for market share.
Royalties– Royalty revenue was $45.8 million for the nine months ended September 30, 2017 compared to $36.7 million for the nine months ended September 30, 2016. The increase wasdevice partnered products driven by higher salesthe acquisition of Herceptin SC and MabThera SC (RITUXAN HYCELA in the U.S.) by Roche and of HYQVIA by Baxalta. We recognize royalties on sales of the collaboration products by the collaborators in the quarter following the quarter in which the corresponding sales occurred. In general, we expect royalty revenue to increase in future periods reflecting expected increases in sales of collaboration products, although there may be periods with flat or declining royalty revenue as sales of products under collaborations vary.Antares.


Revenues Under Collaborative Agreements – Revenues under collaborative agreements were as follows (in thousands):
  Nine Months Ended  
  September 30,  
  2017 2016 Change
Upfront license fees, license fees for the election of additional targets, license maintenance fees and amortization of deferred upfront and other license fees and event-based payments:     
Roche $32,496
 $2,496
 $30,000
Baxalta 574
 574
 —
Lilly —
 8,000
 (8,000)
AbbVie —
 6,000
 (6,000)
Pfizer —
 2,500
 (2,500)
Other —
 250
 (250)
  33,070
 19,820
 13,250
Reimbursements for research and development services:     
Roche 6,928
 9,897
 (2,969)
Janssen 2,038
 859
 1,179
Baxalta 1,168
 159
 1,009
Lilly, Pfizer, and other
 203
 288
 (85)
  10,337
 11,203
 (866)
Total revenues under collaborative agreements $43,407
 $31,023
 $12,384
Six Months Ended
June 30,
20222021Change
ENHANZE licensing and development revenue:
Chugai$25,000 $— $25,000 
Janssen15,000 25,000 (10,000)
BMS5,000 25,000 (20,000)
ViiV— 40,000 (40,000)
Subtotal45,000 90,000 (45,000)
Device licensing and development revenue1,259 650 609 
Total revenues under collaborative agreements$46,259 $90,650 $(44,391)
Revenue from license fees increaseddecreased $45.0 million in the ninesix months ended SeptemberJune 30, 2017,2022, compared to the same period in 20162021 primarily due to a $30.0 millionthe upfront license fee forpayment associated with entering into the 2017 Roche Collaboration recognizedViiV collaborations in the nine months ended September 30, 2017 compared to $15.5 million in license and milestone revenue in connection withprior year period, as well as the Lilly, AbbVie and Pfizer collaborations recognized in the nine months ended September 30, 2016. Revenue from upfront licenses fees, license fees for the electiontiming of additional targets, license maintenance fees and amortization of deferred upfront 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 collaborators’ abilities to meet various clinical and regulatory milestones set forth in such agreements and our abilities to obtain new collaborative agreements.driven by partner activities.
Revenue from reimbursements for research and development services decreased in the nine months ended September 30, 2017, compared to the same period in 2016 mainly due to a decrease in services provided to Roche related to the validation of a new manufacturing facility, partially offset by an increase in services provided to Janssen and Baxalta. The validation of the new Roche facility was completed in the second quarter of 2017 and, therefore, we expect to continue to see a decrease in research and development service revenue from Roche going forward. Research and development services rendered by us on behalf of our collaborators are at the request of the collaborators; therefore, the amount of future revenues related to reimbursable research and development services is uncertain. We expect the non-reimbursement revenues under our collaborative agreements to continue to fluctuate in future periods based on our collaborators’ abilities to meet various clinical and regulatory milestones set forth in such agreements and our abilities to obtain new collaborative agreements.
Cost of Product Sales– Cost of product sales were $23.7$49.9 million for the ninesix months ended SeptemberJune 30, 20172022 compared to $25.2$41.2 million for the ninesix months ended SeptemberJune 30, 2016.2021. The decreaseincrease of $1.5$8.7 million in cost of product sales was mainly due to a decreasean increase in sales in our proprietary and partnered products as a result of bulk rHuPH20the Antares acquisition.
Amortization of intangibles– Amortization of intangibles expense were $11.4 million for the six months ended June 30, 2022. The increase in amortization of intangibles expense is due to Roche.the acquisition of Antares in May 2022.


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, clinical trials, preclinical and regulatory activities. Research and development expenses incurred were as follows (in thousands):
  Nine Months Ended  
  September 30,  
Programs 2017 2016 Change
PEGPH20 $89,023
 $81,119
 $7,904
ENHANZE collaborations and rHuPH20 platform 13,305
 19,661
 (6,356)
Other 6,939
 8,713
 (1,774)
Total research and development expenses $109,267
 $109,493
 $(226)
Research and development expenses relating to our PEGPH20 program$27.3 million for the ninesix months ended SeptemberJune 30, 2017 increased by 10%,2022 compared to $17.1 million for the same period in 2016,six months ended June 30, 2021. The increase of $10.2 million is primarily due to increased clinical trial activities. We expect theseplanned investments in ENHANZE and one-time compensation cost related to the Antares acquisition.
Selling, General and Administrative– SG&A expenses to increase in future periods reflecting expected increases in our PEGPH20 development activities.
Research and development expenses relating to our ENHANZE collaborations and our rHuPH20 platformwere $71.3 million for the ninesix months ended SeptemberJune 30, 2017 decreased by 32%,2022 compared to $23.4 million for the same period in 2016,six months ended June 30, 2021. The increase of $47.9 million was primarily due to a decrease in manufacturing expensesone-time transaction and compensation costs related to Roche, due to work associated with bringing on-line a second contract manufacturing facility. As we completed the validation of the new manufacturing facilityAntares Pharma acquisition and an increase in the second quarter of 2017, we expect these expenses to continue to decrease going forward. The rHuPH20 platform includes research, development and manufacturing expensescompensation expense related to our proprietary rHuPH20 enzyme. These expenses were not designated to a specific program at the time the expenses were incurred.ongoing combined workforce.
Research and development expenses relating to other programs for the nine months ended September 30, 2017 decreased by 20%, compared to the same period in 2016, due to a decrease in preclinical development of HTI-1511 and PEG-ADA2.
Selling, General and AdministrativeInterest Expense– SG&A expenses were $39.0 Interest expense was $4.9 million for the ninesix months ended SeptemberJune 30, 20172022 compared to $33.6$3.7 million for the ninesix months ended SeptemberJune 30, 2016.2021. The increase of $5.4$1.2 million or 16%, was primarily due to an increase in compensationinterest expense including stock compensation. We expect SG&A expensesrelated to increase moderately in future periods as our operations expand.the 2022 term loans and revolving credit facility.
Interest ExpenseIncome Taxes– Interest expense Income tax benefit was $16.5$21.6 million for the ninesix months ended SeptemberJune 30, 20172022, compared to $14.4income tax expense of $0.2 million for the ninesix months ended SeptemberJune 30, 2016.2021. The increase of $2.1 million was primarilyin income tax expense is due to interest expense incurred on the Royalty-backed Loan we received in January 2016.recording of a
Income Tax Expense– Income
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full six months of income tax expense was $1.0 million for the nine months ended September 30, 2017 compared to $1.6 million for the nine months ended September 30, 2016 and was comprised of U.S. federal alternative minimum tax. For the nine months ended September 30, 2017, we generated taxable income in the U.S., whichcurrent year whereas in the prior year period there was partially offset by utilizing net operating losses carried forward from earlier years.minimal income tax expense due to a full valuation allowance in place.







55

Liquidity and Capital Resources
Overview
Our principal sources of liquidity are our existing cash, cash equivalents and available-for-sale marketable securities. As of SeptemberJune 30, 2017,2022, we had cash, cash equivalents and marketable securities of $316.9 million. We will continue to have significant cash requirements to support product development activities. The amount and timing of cash requirements will depend on the progress and success of our clinical development programs, regulatory and market acceptance, and the resources we devote to research and commercialization activities. The amount of cash on hand will depend on the progress of various preclinical and clinical programs, the timing of our manufacturing scale-up and the achievement of various milestones and royalties under our existing collaborative agreements.


$209.4 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) the public offering of securities; (ii) new collaborative agreements; (iii)(ii) expansions or revisions to existing collaborative relationships; (iv)(iii) private financings; (v)(iv) other equity or debt financings; (v) monetizing assets; and/or (vi) monetizing assets.
In February 2017, we filed an automatic shelf registration statement on Form S-3 (Registration No. 333-216315) with the SEC, which allow us, from time to time, to offer and sell equity, debt securities and warrants to purchase any of such securities, either individually or in units. In May 2017, we completed an underwritten public offering pursuant to which we sold 11.5 million shares of common stock, generating $134.9 million in net proceeds, after deducting underwriting discounts and comissions and other offering expenses. 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 fund the continued development of our product candidates, the commercialization of our productsraise funds for additional working capital, capital expenditures, share repurchases, acquisitions or for other general corporate purposes.
Our existing cash, cash equivalents and marketable securities may not be adequate to fund our operations until we become profitable, if ever. We cannot be certain that additional financing will be available when needed or, if available, financing will be obtained on favorable terms. If we are unable to raise sufficient funds, we may need to delay, scale back or eliminate some or all of our research and development programs, delay the launch of our product candidates, if approved, and/or restructure our operations. If we raise additional funds by issuing equity securities, substantial dilution to existing stockholders could result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations, the issuance of warrants that may ultimately dilute existing stockholders when exercised and covenants that may restrict our ability to operate our business.
Cash Flows
Operating Activities
Net cash used inprovided by operations was $19.2$88.0 million for the ninesix months ended SeptemberJune 30, 20172022 compared to $34.6$95.2 million forcash provided in the ninesix months ended SeptemberJune 30, 2016.2021. The $15.4$7.2 million decrease in utilization of cash inprovided by operations was mainly due to an increase in transaction expenses associated with Antares acquisition, partially offset by a decrease in operating lossworking capital spend and an increase in working capital forroyalties revenue during the ninesix months ended SeptemberJune 30, 20172022 compared to the corresponding period in the prior year.
Investing Activities
Net cash used in investing activities was $14.7$484.3 million for the ninesix months ended SeptemberJune 30, 20172022 compared to net$89.9 million cash used in investing activities of $97.8 million for the ninesix months ended SeptemberJune 30, 2016.2021. The decreaseincrease in net cash used in investing activities was primarily due to the acquisition of Antares, partially offset by an increase in proceedscash from salesthe sale of marketable securities and the sale of assets for the ninesix months ended SeptemberJune 30, 2017.2022.
Financing Activities
Net cash provided by financing activities was $131.6$368.4 million for the ninesix months ended SeptemberJune 30, 2017,2022, compared to $293.9 million cash provided by financing activities for the six months ended June 30, 2021, mainly due primarily to $134.9$370.0 million cash received from the term loan and the revolving credit facility during the current year, prior year $125.0 million in repurchase of common stock, $369.1 million related to the Induced Conversion of the 2024 Convertible Notes and a $0.9 million increase in net proceeds during the current year 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.
Share Repurchases
In November 2019, our Board of Directors approved a share repurchase program, pursuant to which we may 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.
Long-Term Debt
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
56

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 5 consecutive trading day period (such 5 consecutive trading day period, the “measurement period”) in May 2017 compared to $150.3 millionwhich 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 nine months ended2027 Convertible Notes; (4) if we call such notes for redemption; and (5) at any time from, and including, September 30, 2016, when we drew net proceeds1, 2026 until the close of $148.0 millionbusiness on the Royalty-backed Loan.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 June 30, 2022, the 2027 Convertible Notes are not convertible.


Long-Term Debt
Royalty-backed Loan
In January 2016, throughUpon 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 wholly-owned subsidiary Halozyme Royalty LLC (Halozyme Royalty), we received a $150 million loan (the Royalty-backed Loan) pursuantelection. 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 credit agreement (the Credit Agreement) with BioPharma Credit Investments IV Sub, LP and Athyrium Opportunities II Acquisition LP (the Royalty-backed Lenders). Under the termsconversion price of the Credit Agreement, Halozyme Therapeutics, Inc. transferred to Halozyme Royalty the right to receive royalty payments from the commercial salesapproximately $77.17 per share of ENHANZE products owed under the Roche Collaboration and Baxalta Collaboration (Collaboration Agreements).our common stock. The royalty payments from the Collaboration Agreements will be used to repay the principal and interest on the loan (the Royalty Payments).  The Royalty-backed Loan bears interest at a per annum rate of 8.75% plus the three-month LIBOR rate. The three-month LIBORconversion rate is subject to a flooradjustment.
1.25% Convertible Notes due 2024
In November 2019, we completed the sale of 0.7% and a cap$460.0 million in aggregate principal amount of 1.5%1.25% Convertible Senior Notes due 2024 (“2024 Convertible Notes”). The net proceeds in connection with the issuance of the 2024 Convertible Notes, after deducting the initial purchasers’ fee of $12.7 million, was approximately $447.3 million. We also incurred debt issuance cost totaling $0.3 million. Debt issuance costs and the initial purchasers’ fee 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 as of September 30, 2017 was 10.1%1.25%. The outstanding balance2024 Convertible Notes are general unsecured obligations and will rank senior in right of the Royalty-backed Loan aspayment to all indebtedness that is expressly subordinated in right of September 30, 2017 was $151.3 million, inclusive of payment-in-kind interest expense of $2.2 million and net of unamortized debt discount of $0.9 million.
The Credit Agreement provides that none of the Royalty Payments were required to be appliedpayment to the Royalty-backed Loan prior to January 1, 2017, 50%2024 Convertible Notes, will rank equally in right of the Royalty Payments are required to be applied to the Royalty-backed Loan between January 1, 2017payment with all existing and January 1, 2018 and thereafter all Royalty Payments must be applied to the Royalty-backed Loan. However, the amounts available to repay the Royalty-backed Loan are subject to caps of $13.75 million per quarter in 2017, $18.75 million per quarter in 2018, $21.25 million per quarter in 2019 and $22.5 million per quarter in 2020 and thereafter. Amounts available to repay the Royalty-backed Loan will be applied first, to pay interest and second, to repay principal on the Royalty-backed Loan. Any accrued interest that is not paid on any applicable quarterly payment date, as defined, will be capitalized and added to the principal balance of the Royalty-backed Loan on such date. Halozyme Royalty will be entitled to receive and distribute to Halozyme any Royalty Paymentsfuture liabilities that are not requiredso subordinated, will be effectively junior to be appliedany secured indebtedness to the Royalty-backed Loanextent 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 June 30, 2022, the 2024 Convertible Notes are convertible.
In January 2021 we notified the note holders our irrevocable election to settle the principal of the 2024 Convertible Notes in cash and for the premium, if applicable, deliver shares of common stock. The conversion rate for the 2024 Convertible Notes is 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 and induced conversion of $369.1 million principal amount of the 2024 Convertibles (“Note Repurchases” or the “Induced Conversion”). In connection with the 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 Induced Conversion, we recorded $21.0 million in induced conversion expense which is included in Other income (expense) of the Condensed Consolidated Statements of Income in 2021. The induced
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conversion expense represents the fair value of the common stock issued upon conversion in excess of the foregoing caps.
The final maturity date of the Royalty-backed Loan will be the earlier of (i) the date when principal and interest is paid in full, (ii) the termination of Halozyme Royalty’s right to receive royaltiescommon stock issuable under the Collaboration Agreements, and (iii) December 31, 2050. Currently, we estimate that the loan will be repaid in the first quarter of 2020. This estimate could be adversely affected and the repayment period could be extended if future royalty amounts are less than currently expected. Under theoriginal terms of the 2024 Convertible Notes.
Revolving Credit Facility (December 2021)
In May 2022, we terminated that certain credit agreement entered into on December 23, 2021 with Bank of America and the other lenders party thereto (the “2021 Credit Agreement”) evidencing a revolving credit facility (the “2021 Facility”) that provided for secured revolving loans and letters of credit in an aggregate amount of up to $75.0 million. No proceeds from the 2021 Facility were drawn down as of the date the 2021 Credit Agreement at any time after January 1, 2019, Halozyme Royalty may, subject to certain limitations, prepay the outstanding principal of the Royalty-backedwas terminated.
Revolving Credit and Term Loan in whole or in part, at a price equal to 105% of the outstanding principal on the Royalty-backed Loan, plus accrued but unpaid interest. The Royalty-backed Loan constitutes an obligation of Halozyme Royalty, and is non-recourse to Halozyme. Halozyme Royalty retains its right to the Royalty Payments following repayment of the loan.
Oxford and SVB Loan and Security AgreementFacilities (May 2022)
In June 2016,May 2022, in connection with the closing of Antares acquisition, we entered into a Loancredit agreement with Bank of America, N.A., as Administrative Agent, Swing Line Lender and Security Agreementan L/C Issuer, and the other lenders and L/C Issuers party thereto (the Loan“2022 Credit Agreement) with Oxford Finance LLC (Oxford), evidencing a credit facility (the “2022 Facility”) that provides for (i) a $350 million revolving credit facility (the “Revolving Credit Facility”) and Silicon Valley Bank (SVB) (collectively, the Lenders), providing(ii) a senior secured$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 upthe 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 ancertain conditions, to increase the aggregate principal amount of $70 million, comprisingthe 2022 Facility, provided we remain in compliance with underlying financial covenants on a $55.0 million drawpro forma basis including the consolidated interest coverage ratio and the consolidated net leverage ratio covenants set forth in June 2016the 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 additional $15.0 million tranche, which we hadapplicable margin plus: (a) the optionapplicable Term Secured Overnight Financing Rate (SOFR) (which includes a SOFR adjustment of 0.10%), or (b) a base rate determined by reference to draw during the second quarterhighest of 2017(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 did not exercise.(4) 1.00%. The proceeds were partially usedmargin for the 2022 Facility ranges, based on our consolidated total net leverage ratio, from 0.25% to pay1.25% 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 and final payment owed onunder the Facility, we will pay (i) a previous loan agreement with the Lenders. The remaining proceeds are being used for working capital and general business requirements. The Loan Agreement repayment schedule provides for interest only payments for the first 18 months, followed by consecutive equal monthly payments of principal and interestcommitment fee in arrears through the maturity date of January 1, 2021. The Loan Agreement provides for a final payment equal to 5.50%respect of the initial $55unutilized 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. As of June 30, 2022, we had $120.0 million and $250 million in principal amount. The final payment is due whenamount of outstanding borrowings under the Loan Agreement becomes due or upon2022 Revolving Credit Facility and the prepayment2022 Term Facility, respectively.
Additional Capital Requirements.
Our expected working and other capital requirements are described in our 2021 Annual Report on Form 10-K in “Part II, Item 7. Management’s Discussion and Analysis of the facility. We have the option to prepay the outstanding balanceFinancial Condition and Results of the Loan Agreement in full, subject to a prepayment fee of 2% in the first year and 1% in the second year of the term loan. The outstanding term loan balance was $55.6 million as of SeptemberOperations.” At June 30, 2017, inclusive of $1.0 million of accretion of the final payment and net of unamortized debt discount related to offering costs of $0.4 million.


The Loan Agreement is secured by substantially all of the assets of the Company and its subsidiary, Halozyme, Inc., except that the collateral does not include any equity interests in Halozyme, Inc. and any intellectual property (including all licensing, collaboration and similar agreements relating thereto), and certain other excluded assets. The Loan Agreement contains customary representations, warranties and covenants by us, which covenants limit our ability to convey, sell, lease, transfer, assign or otherwise dispose of certain of our assets; engage in any business2022, other than the businesses currently engaged in by us or reasonably related thereto; liquidate or dissolve; make certain management changes; undergo certain change of control events; create, incur, assume, or be liable with respectadditional financing obtained to certain indebtedness; grant certain liens; pay dividends and make certain other restricted payments; make certain investments; make paymentscomplete the Antares acquisition, which was completed on any subordinated debt; enter into transactions with any of our affiliates outside of the ordinary course of business or permit our subsidiaries to do the same; and make any voluntary prepayment of or modify certain terms of the Royalty-backed Loan. In addition, subject to certain exceptions, we are required to maintain with SVB our primary deposit accounts, securities accounts and commodities, and to do the same for our domestic subsidiary.
The Loan Agreement also contains customary indemnification obligations and customary events of default, including, among other things, our failure to fulfill certain of our obligations under the Loan AgreementMay 24, 2022 and the occurrence of achanges disclosed in the “Notes to Condensed Consolidated Financial Statements” and “Liquidity and Capital Resources” in this Quarterly Report, there have been no other material adverse change which is defined as a material adverse changechanges to our expected working and other capital requirements described in our business, operations or condition (financial or otherwise), a material impairment of the prospect of repayment of any portion of the loan, a material impairment in the perfection or priority of the Lender’s lien in the collateral or in the value of such collateral or the occurrence of an event of default under the Royalty-backed Loan. In the event of default by us under the Loan 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 Loan Agreement, which could harm our financial condition.2021 Annual Report on Form 10-K.
Off-Balance Sheet Arrangements
As of September 30, 2017, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we did not engage in trading activities involving non-exchange traded contracts. As such, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The preparation of our condensed 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
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Our significant accounting policies are described in Note 2 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. Please see our audited consolidated financial statements and notes thereto included in Part II,our Annual Report on Form 10-K for the fiscal year ended December 31, 2021. The accounting policies and estimates that are most critical to a full understanding and evaluation of our reported financial results are described in Management’s Discussion and Analysis of Financial Condition and Results of Operations in Item 87 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (2016 Form 10-K), which contain our critical accounting policies and other disclosures required by U.S. GAAP.2021. There were no material changes from thoseto our critical accounting policies and disclosures included in our 2016 Form 10-K.or estimates during the six months ended June 30, 2022.
Recent Accounting Pronouncements
Refer to Note 2, Summary of Significant Accounting Policies, of our condensed consolidated financial statements for a discussion of recent accounting pronouncements and their effect, if any.


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Risk Factors
Risks Related To Our Business
WeBusiness interruptions resulting from the COVID-19 outbreak or similar public health crises could cause a disruption of the development of our and 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 approved partnered products, disrupting our ability to enter into new ENHANZE and other collaborations with potential partners in a timely manner, 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. 
The COVID-19 pandemic has led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures. The extent to which COVID-19 and its variants impacts 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 the outbreak, additional or modified government actions, new information that will emerge concerning the severity and impact of COVID-19 and the actions to contain COVID-19 or address its impact in the short and long term, among others.
As a result of COVID-19 restrictions and closures, our sales force has been subject to varying limitations on its ability to visit physicians and patient’s access to physicians has been negatively impacted. As a result, we have generated only limitedexperienced, and may continue to experience, a decrease in new prescriptions for our proprietary products. Our partners may also experience a decrease in demand for our partnered products.
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, some of our partners are conducting or are planning to conduct clinical trials in geographies affected by the COVID-19 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 COVID-19 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. We do not know the extent to which our partners’ development programs or product salescommercialization efforts will be impacted or delayed.
We rely on many third parties to date;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 the COVID-19 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.
The effects of COVID-19 could worsen in countries that are already afflicted with the coronavirus which could further adversely impact our ability to conduct our business and could have a history of net losses and negative cash flows, and we may never achieve or maintain profitability.
Relative to expenses incurred inmaterial adverse impact on our operations, wefinancial condition and results.
In addition, the trading prices for our common shares and other biopharmaceutical companies have generated only limited revenuesbeen highly volatile as a result of market and investor reactions to the COVID-19 pandemic and its potential consequences. As a result, access to sources of financing, should those be needed, may be more difficult and/or expensive. In addition, a recession, depression or other sustained adverse market event resulting from product sales, royalties, licensing fees, milestone payments, bulk rHuPH20 supply paymentsthe spread of the coronavirus could materially and research reimbursements to dateadversely affect our business and we may never generate sufficient revenues from future product sales, licensing fees and milestone payments to offset expenses. Even if we ultimately do achieve significant revenues from product sales, royalties, licensing fees, research reimbursements, bulk rHuPH20 supply payments and/or milestone payments, we expect to incur significant operating losses over the next few years. We have never been profitable, and we may never become profitable. Through September 30, 2017, we have incurred aggregate net lossesvalue of $646.3 million.our common shares.


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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 collaboratorspartners attempt to 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 collaboratorspartners 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 us or our collaborators to conduct additional clinical or animal safety studies which may cause lengthy delays and increased costs to ours or our partners’ development programs. For example, the approval of Baxalta’s HYQVIA BLA in the U.S. was delayed until we and Baxalta 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 beenAny such issues associated with any known adverse clinical effects, and the HYQVIA BLA was approved by the FDA in September 2014, we cannot assure you that they will not arise andrHuPH20 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 collaborations, or be raised by the FDA or other health authorities in connection with testing or approval of products including rHuPH20.new ENHANZE collaborations.
We and our collaboratorspartners 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 and collaboration product candidates or companion diagnostic assays 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 collaboratorspartners must maintain our regulatory approvals. If we or any of our collaboratorspartners are unsuccessful in maintaining ourthe required regulatory approvals, our ability to generate revenues would be adversely affected.


We will likely need to raise additional capital in the future and there can be no assurance that we will be able to obtain such funds.
We will likely need to raise additional capital in the future to continue the development of our product candidates or for other current corporate purposes. Our current cash reserves and expected revenues during the next few years will not be sufficient for us to continue the development of our proprietary product candidates, 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) the public offering of securities; (ii) new collaborative agreements; (iii) expansions or revisions to existing collaborative relationships; (iv) private financings; (v) other equity or debt financings; and/or (vi) monetizing assets.
In view of our stage of development, business prospects, the nature of our capital structure and general market conditions, if we are required to raise additional capital in the future, the additional financing may not be available on favorable terms, 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 one or more product development programs. If we raise additional capital, a substantial number of additional shares may be issued, which may negatively affect our stock price and these additional shares will dilute the ownership interest of our current investors.
Use of our partnered or proprietary products and product candidates or those of our collaborators could be associated with side effects or adverse events.events or product recalls.*
As with most pharmaceutical products, use of our partnered or proprietary products and product candidates or those of our collaborators could be associated with side effects or adverse events which can vary in severity (from minor reactions to death) and frequency (infrequent or prevalent). and product recalls. Side effects or adverse events associated with the use of our partnered or proprietary products or product candidates or those of our collaboratorspartners may be observed at any time, including in clinical trials or when a product is commercialized, and any such side effects or adverse events may negatively affect our or our collaborators’partners’ ability to obtain or maintain regulatory approval or market oursuch products and product candidates. Side effects such as toxicity or other safety issues associated with the use of our partnered or proprietary products and product candidates or those of our collaborators could require us or our collaboratorspartners 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 collaboratorspartners 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. Furthermore, thereThere can be no assurance that we or our collaboratorspartners will resolve any issues related to any product relatedor product candidate side effects or 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. For example, in April 2014,
To the extent that a clinical hold was placed on patient enrollmentproduct 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 dosing of PEGPH20 in Study 202 asby adversely affecting our reputation. Recalls are costly and take time and effort to administer. Even if a resultrecall only initially relates to a single product, product batch, or a portion of a possible differencebatch, 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 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
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could result in an investigation of the TE event rate that had been observed at that time in the trial between the groupsafety or efficacy of patients treated with PEGPH20 versus the group of patients treated without PEGPH20. The clinical hold was liftedour products, our manufacturing processes and facilities, or our marketing programs conducted by the FDA in June 2014,or the authorities of the EU member states and we have completed enrollment and continueother jurisdictions. Such investigations could also potentially lead to monitor ongoing patients who remain eithera recall of our products or more serious enforcement actions, limitations on treatmentthe indications for which they may be used, or in follow-up on Study 202 under a revised clinical protocol.suspension, variation, or withdrawal of approval. Any such regulatory action by the FDA, the EMA or the competent authorities of the EU member states could lead to product liability lawsuits as well.
If our contract manufacturers or vendors are unable or elect not 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 collaboratorspartners for use in the production of Hylenex or our other proprietary or partnered products and product candidates, our and our partners’ product development andor commercialization efforts could be delayed or stopped and our business results of operations and our collaborations could be damaged.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, many 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 Cook PharmicaCatalent Indiana LLC (Cook)(Catalent) to produce bulk rHuPH20. These manufacturers each produce bulk rHuPH20 under cGMP for clinical uses. Cook currently produces bulk rHuPH20use in Hylenex recombinant, and for use in Hylenex recombinant, product candidatespartnered products and collaboration product candidates. Avid currently producesWe rely on their ability to successfully manufacture bulk rHuPH20 for use in collaboration products.according to product specifications. In addition to supply obligations, Avid and Cookour contract manufacturers will also provide support for the chemistry, manufacturing and controls sections for FDA and other regulatory filings. We also rely on their abilityvendors to successfully manufacture these batches accordingsupply us with raw materials to product specifications.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 either Avidany of our contract manufacturers or Cook:vendors: (i) is unable to retain its status as an FDA approved manufacturing facility; (ii) is unable to otherwise successfully scale up bulk rHuPH20 production to meet corporate or regulatory authority quality standards; (iii) is unable to procure the labor, raw materials, reagents or (iii)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 collaboratorspartners for use in our proprietaryHylenex and collaborationpartnered 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 Avid and/or Cook.any of our contract manufacturers. Any delays, interruptions or other problems regarding the ability or willingness of Avid and/or Cookour 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 proprietary or collaborationour partners’ product candidates; (ii) delay or prevent the effective commercialization of our proprietary or collaboration products;partnered products and product candidates; and/or (iii) cause us to breach contractual obligations to deliver bulk rHuPH20 to our collaborators.partners. Such delays would likely damage our relationship with our collaborators,partners, and they would 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 the same risks as 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 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.
We rely on third parties to perform many necessary services for our products including services related to the distribution, invoicing, rebates and contract administration, co-pay program administration, sample distribution and administration,
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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 are responsible 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 significantly 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 collaboratorspartners 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 collaboratorspartners 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 could 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 delay or suspendnegatively impact our product development activities for some of our product candidates, as well as our commercialization efforts for some or all of our products. Specifically,operations. In addition, the termination of a key collaboration agreement by one or more of our collaboratorspartners could materiallyhave a material adverse impact on our ability to enter into additional collaboration agreements with new collaboratorspartners 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 reevaluate the applications and value of our technology.
Most ofHylenex and our current proprietary and collaborationpartners’ 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 ENHANZE TechnologyHylenex and our ENHANZE technology and most advanced proprietary and collaborationof our ENHANZE partnered products and product candidates, including the current and future products and product candidates under our Roche, Pfizer, Janssen, Baxalta, AbbVie and Lilly collaborations,ENHANZE collaborations. We drive substantial portion of our PEGPH20 program, and Hylenex recombinant. Ifrevenues 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 Baxalta’s HYQVIA product as well as in a former collaborator’spartner’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 collaborator’spartner’s program will have a significant impact on our other proprietary product and other collaborationour partners’ product and product candidates, there can be no assurance that there will not be other such occurrences in the foregoing programs or our other 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.

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We routinely evaluate, and may modify, ourOur business strategy and our strategic focus is currently limited to only a few fields or applications of our technology which may increase the risk for potential negative impact from adverse developments. Future expansion of our strategic focus to additional applications of our technology 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 thirdfourth quarter of 2014,2019, we decided to focus our resources on advancing PEGPH20 and expanding utilization of our ENHANZE Technology. While we believe these are applications with the greatest potential value, we have reduced the diversification oftechnology and our programs and increased our dependence on the success of the areas we are pursuing.commercial product, Hylenex. By focusing on one or a fewthese areas, we increase the potential impact on us if one of those partner programs or product candidates does not successfully complete clinical trials, achieve commercial acceptance or meet expectations regarding sales and revenue. Our decision to focus on one or a few programsWe may also reduce the value of programs that are no longer withinexpand our principal strategic focus by seeking new therapeutics applications of our technology or by acquiring new technologies which could impairmay 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 expand our ability to pursue collaborationsstrategic focus into new therapeutic applications with a goal of diversifying the sources of our revenues. There can be no assurance that our investment in Antares or other strategic alternatives for those programs we are not pursuing.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 and collaboration product candidates or companion diagnostic assays may not receive regulatory approvals or their development may be delayed for a variety of reasons, including delayed or unsuccessful clinical trials, regulatory requirements or safety concerns. If we or our partners fail to obtain, or have delays in obtaining, regulatory approvals for any product candidates, our business, financial condition and results of operations may be materially adversely affected.*
Clinical testing of pharmaceutical products is a long, expensive and uncertain process, and the failure or delay of a clinical trial can occur at any stage, including the patient enrollment stage. Even if initial results of preclinical and nonclinical studies or clinical trial results are promising, we or our collaboratorspartners may obtain different results in subsequent trials or studies that fail to show the desired levels of dose safety and efficacy, or we may not, or our collaboratorspartners may not obtain applicable regulatory approval for our products for a variety of other reasons. Preclinical, nonclinical, and clinical trials for any of our proprietary or collaborationand partnered product candidates or development of any collaboration companion diagnostic assays could be unsuccessful, which would delay or preclude regulatory approval and commercialization of the product candidates or companion diagnostic assays.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 may differ from initial reported data, 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, side effects, adverse events or unexpected safety issues associated with the use of our partners’ product candidates; for example, in April 2014, a clinical hold was placed on patient enrollment and dosing of PEGPH20 in Study 202 as a result of a possible difference in the TE event rate that had been observed at that time in the trial between the group of patients treated with PEGPH20 versus the group of patients treated without PEGPH20. The clinical hold was lifted by the FDA in June 2014, and we have completed enrollment and continue to monitor ongoing patients who remain either on treatment or in follow-up on Study 202 under a revised clinical protocol;
completion of clinical trials may be delayed for a variety of reasons including the amount of time it may take to identify and enroll patients with high levels of HA in our target population, and the ability to procure drug supply required in clinical trial protocols;
third parties, such as contract research organizations, upon whom we rely to help conduct and manage our clinical trials may not perform satisfactorily, fulfill their contractual obligations to us, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols;
regulatory review may not find a product candidate safe or effective enough to merit either continued testing or final approval;
•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 ourtheir 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 ourtheir interpretations of either clinical trial data or applicable regulations;


•a regulatory agency may approve only a narrow use of our product or may require additional safety monitoring and reporting through Risk Evaluation and Mitigation Strategies or conditions to assure safe use programs;
the cost of clinical trials required for product approval may be greater than what •we originally anticipate, and weor a partner may decide to not pursue regulatory approval for such a product;
•a regulatory agency may not approve our manufacturing processes or facilities, or the processes or facilities of our collaborators,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 collaborators,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.
If a proprietary or collaborationpartnered product candidate or companion diagnostic assay is not approved in a timely fashion or obtained on commercially viable terms, or if development of any product candidate or a companion diagnostic assay 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
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would become more dependent on the development of other proprietary or collaborationpartnered product candidates and/or our ability to successfully acquire other products and technologies. There can be no assurances that we or our any proprietary or collaborationpartnered product candidate or companion diagnostic assay will receive regulatory approval in a timely manner, or at all. There can be no assurance that wepartners 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 thisan opportunity will be limited or may not be possible.
We anticipate that certain proprietary and collaborationor 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 collaboratorspartners are responsible for providing certain proprietary materials that are essential components of our collaborationpartnered products and product candidates, and any failure to supply these materials could delay the development and commercialization efforts for these collaborationpartnered products and product candidates and/or damage 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 collaboratorspartners are responsible for providing certain proprietary materials that are essential components of our collaborationpartnered products and product candidates. For example, Roche is responsible for producing the Herceptin and MabThera required for its subcutaneous products and Baxalta is responsible for producing the GAMMAGARD LIQUID for its product HYQVIA. If a collaborator,partner, or any applicable third party service provider of a collaborator,partner, encounters difficulties in the manufacture, storage, delivery, fill, finish or packaging of the collaborationpartnered 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 collaborationpartnered product candidates; and/or (ii) delay or prevent the effective commercialization of collaborationpartnered products. Such delays could have a material adverse effect on our business and financial condition.


We also rely on third partiesour partners to manufacture, prepare, fill, finishcommercialize and package ourdistribute their products and product candidates, and if such third parties should fail to perform, our commercialization and development efforts for ourthey are unsuccessful in commercializing their products, and product candidates could be delayed or stopped.
We rely on third parties to manufacture, prepare, fill, finish, package, store and ship our products and product candidates on our behalf. Ifthe resulting royalty revenue we are unable to locate third parties to perform these functions on terms that are acceptable to us, or if the third parties we identify fail to perform their obligations, the progress of clinical trials could be delayed or even suspended and the commercialization of approved product candidates could be delayed or prevented. In addition, we are scaling up our manufacturing of PEGPH20 with third party suppliers to support additional clinical trials, including the Phase 3 trial, and ultimately, if approved, potential commercial supply. If our contract manufacturers are unable to successfully manufacture and supply PEGPH20, the progress of our clinical trials could be delayed or halted for a period of time.
If we are unable to sufficiently develop our sales, marketing and distribution capabilities or enter into successful agreements with third parties to perform these functions, we will not be able to fully commercialize our products.
Wewould receive may not be successful in marketing and promoting our approved product, Hylenex recombinant, or any other products we develop or acquire in the future. Our sales, marketing and distribution capabilities are very limited. In order to commercialize any products successfully, we must internally develop substantial sales, marketing and distribution capabilities or establish collaborations or other arrangements with third parties to perform these services. We do not have extensive experience in these areas, and we may not be able to establish adequate in-house sales, marketing and distribution capabilities or engage and effectively manage relationships with third parties to perform any or all of such services. To the extent that we enter into co-promotion or other licensing arrangements, our product revenues are likely to be lower than if we directly marketed and sold our products, and any revenues we receive will depend upon the efforts of third parties, whose efforts may not meet our expectations or be successful. These third parties would be largely responsible for the speed and scope of sales and marketing efforts, and may not dedicate the resources necessary to maximize product opportunities. Our ability to cause these third parties to increase the speed and scope of their efforts may also be limited. In addition, sales and marketing efforts could be negatively impacted by the delay or failure to obtain additional supportive clinical trial data for our products. In some cases, third party collaborators are responsible for conducting these additional clinical trials, and our ability to increase the efforts and resources allocated to these trials may be limited.expected.
If we or our collaboratorspartners 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 significantly harm our business.*
Any approved products, along with the manufacturing processes, post-approval clinical data, 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 collaboratorspartners 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 collaboratorspartners 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, entirelysubstantially 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 collaboratorspartners 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:
•restrictions on our or our partners’ products or manufacturing processes;
•warning letters;
•withdrawal of theour 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 management and other key employees; aligning and prioritizing product development initiatives, 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, expansion into additional market segments and the ability to leverage existing U.S. commercial infrastructure to promote the companies' proprietary products. Increased competition and/or deterioration in business conditions may limit our ability to expand this business. As such, we may not be able to realize the benefits anticipated in connection with the acquisition.
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 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 failureexpect to incur additional debt. Failure by us to fulfill our obligations under the applicable loandebt agreements may cause the repayment obligations to accelerate.*
The aggregate amount of our consolidated indebtedness, net of debt discount, as of June 30, 2022 was $1,246.2 million, which includes $250.0 million under our 2022 term facility, $120.0 million under our 2022 Revolving facility, $90.9 million in aggregate principal amount of the 2024 Convertible Notes and $805.0 million in aggregate principal amount of the 2027 Convertible Notes, net of unamortized debt discount of $1.3 million, $16.1 million and $2.4 million for 2024 Convertible Notes, 2027 Convertible Notes and 2022 term facility, 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;
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•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 December 2015,addition, our subsidiaries, Halozyme, Inc. (Halozyme) and Halozyme Royalty LLC (Halozyme Royalty) entered into a credit agreement (the Credit Agreement) with BioPharma Credit Investments IV Sub, LP and Athyrium Opportunities II Acquisition LP (the Royalty-backed Lenders) pursuant to which we borrowed $150 million through Halozyme Royalty (the Royalty-backed Loan). The Royalty-backed Loan will be repaid primarily from a specified percentage of the royalty payments we receive under our collaboration agreements with Roche and Baxalta (the Royalty Payments).
The obligations of Halozyme Royalty under the2022 Credit Agreement to repay the Royalty-backed Loan may be accelerated upon the occurrence ofincludes certain events of default under the Credit Agreement, including but not limited to:
if any payment of principal is not made within three days of when such payment is due and payable or otherwise made in accordance with the terms of the Credit Agreement;
if any representations or warranties made in the Credit Agreement or any other transaction document proves to be incorrect or misleading in any material respect when made;
if there occurs a default in the performance of affirmative and negative covenants, set forth in thethat, 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 or any other transaction document;
the failure by either Baxalta or Rochealso includes financial covenants requiring us to pay material amounts owed under our collaboration agreements because of an actual breach or default by us under the collaboration agreements;
the voluntary or involuntary commencement of bankruptcy proceedings by either Halozyme or Halozyme Royalty and other insolvency related defaults;
any materially adverse effect on the binding nature of anymaintain, measured as of the transaction documents orend 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 collaboration agreements with Baxalta and Roche; or
Halozyme ceases to own, of record and beneficially, 100%term of the equity interests in Halozyme Royalty.
loan facility, and a minimum consolidated interest coverage ratio of 3.00 to 1.00. The 2022 Credit Agreement also contains covenants applicable to Halozymecustomary representations and Halozyme Royalty, including certain visitation, informationwarranties and audits rights granted to the collateral agent and the lenders and restrictions on the conductevents of business, including continued compliancedefault. Complying with the Baxalta and Roche collaboration agreements and specified affirmative actions regardingcovenants contained in the escrow account established to facilitate payment of Royalty Payments to the Royalty-backed Lenders or other specified parties. The2022 Credit Agreement also contains covenants solely applicable to Halozyme Royalty, including restrictions on incurring indebtedness, creating or granting liens, making acquisitions and making specified restricted payments. These covenants could make it more difficult for us to execute our business strategy.


In connection with the Royalty-backed Loan, Halozyme Royalty granted a first priority lien and security interest (subject only to permitted liens) Further, in all of its assets and all real, intangible and personal property, including all of its right, title and interest in and to the Royalty Payments.
In June 2016, we entered into a Loan and Security Agreement (the Loan Agreement) with Oxford Finance LLC (Oxford) and Silicon Valley Bank (SVB) (collectively, the Lenders), providing a senior secured loan facility of up to an aggregate principal amount of $70 million, comprising a $55.0 million draw in June 2016 and an additional $15.0 million tranche, which we had the option to draw during the second quarter of 2017 and did not exercise. The initial proceeds were partially used to pay the outstanding principal and final payment owed on our previous loan agreement with the Lenders. The remaining proceeds are to be used for working capital and general business requirements. The Loan Agreement is secured by substantially all of the assets of the Company and its subsidiary, Halozyme, Inc., except that the collateral does not include any equity interests in Halozyme, Inc., any intellectual property (including all licensing, collaboration and similar agreements relating thereto), and certain other excluded assets. The Loan Agreement contains customary representations, warranties and covenants by us, which covenants limit our ability to convey, sell, lease, transfer, assign or otherwise dispose of certain of our assets; engage in any business other than the businesses currently engaged in by us or reasonably related thereto; liquidate or dissolve; make certain management changes; undergo certain change of control events; create, incur, assume, or be liable with respect to certain indebtedness; grant certain liens; pay dividends and make certain other restricted payments; make certain investments; make payments on any subordinated debt; and enter into transactions with any of our affiliates outside of the ordinary course of business or permit our subsidiaries to do the same. In addition, subject to certain exceptions, we are required to maintain with SVB our primary deposit accounts, securities accounts and commodities, and to do the same for our domestic subsidiary. Complying with these covenants may make it more difficult for us to successfully execute our business strategy.
The Loan Agreement also contains customary indemnification obligations and customary events of default, including, among other things, our failure to fulfill certain of our obligations under the Loan Agreement and the occurrence of a material adverse change which is defined as a material adverse change in our business, operations or condition (financial or otherwise), a material impairment of the prospect of repayment of any portion of the loan, or a material impairment in the perfection or priority of the Lender’s lien in the collateral or in the value of such collateral.
Our ability to make payments on our 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. We will need to use cash to pay principal and interest on our debt, thereby reducing the funds available to fund our research and development programs, strategic initiatives and working capital requirements. If we are unable to generate sufficient cash to service our debt obligation, an event of default may occur. In the event of default by us under the 2022 Credit Agreement or the Loan 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.
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 Loan Agreementfunds 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 June 30, 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 collaborationpartnered product candidates are approved for marketing but do not gain market acceptance resulting in commercial performance below that which was expected or projected, our business may suffer and we may not be able to fund future operations.suffer.*
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Assuming that ourexisting or future proprietary or collaborationpartnered product candidates obtain the necessary regulatory approvals for commercial sale, a number of factors may affect the market acceptance of these existing product candidates or any othernewly-approved products, which are developed or acquired in the future, 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 payors 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;
our ability to fund our sales and marketing efforts and •the ability and willingness of our collaboratorspartners to fund sales and marketing efforts; and
the degree to which the use of these products is restricted by the approved product label;
the effectiveness of our sales and marketing efforts and •the effectiveness of the sales and marketing efforts of our collaborators;
the introduction of generic competitors; and


the extent to which reimbursement for our products and related treatments will be available from third party payors including government insurance programs (Medicare and Medicaid) and private insurers.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 may notexpect to receive from these products will be ablediminished which could harm our ability to fund future operations, including the developmentconduct acquisitions, execute our planned share repurchases, or acquisition of new product candidates and/oraffect our salesability to use funds for other general corporate purposes and marketing efforts for our approved products, which would cause our business to suffer.
In addition, our proprietary and collaborationor 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 currentlymay have limitedinsufficient 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 lack or insufficiency of 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 collaborationpartnered 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.
Our inability Product liability claims can also result in additional regulatory consequences including, but not limited to, attract, hireinvestigations and retain key managementregulatory 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 scientific personnel could negatively affectthe reputation of our business.
Our success depends on the performance of key management and scientific employees with relevant experience. For example, in order to pursue our current business strategy, we will need to recruit and retain personnel experienced in oncology drug development which is a highly competitive market for talent. We depend substantially onproducts, adversely affecting our ability to hire, train, motivate and retain high quality personnel, especially our scientists and management team. Particularly in view of the small number of employees on our staff to cover our numerous programs and key functions, if we are unable to retain existing personnel or identify or hire additional personnel, we may not be able to research, develop, commercialize or market our products successfully. In addition, defending a product liability lawsuit is expensive and product candidates as expected or on a timely basis and we may not be able to adequately support current and future alliances with strategic collaborators. 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 management personnel, we would likely lose some portioncan divert the attention of our institutional knowledge and technical know-how, potentially causing a substantial delay in one or more of our development programs until adequate replacement personnel could be hired and trained. We currently have a severance policy applicable to allkey employees and a change in control policy applicable to senior executives.
We do not have key man life insurance policies on the lives of any of our 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 located in four buildings in San Diego, California. In addition, we have a satellite office in South San Francisco, California. We depend on our facilities and on our collaborators, contractors and vendors for the continued operation offrom operating our business. Natural disastersSuch claims can also impact our ability to initiate or other catastrophic events, interruptions in the supply of natural resources, political and governmental changes, wildfires and other fires, floods, explosions, actions of animal rights activists, earthquakes and civil unrest could disrupt our operations or those of our collaborators, 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 research and development programs.complete clinical trials.
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If we or our collaboratorspartners do not achieve projected development, clinical, regulatory or salesregulatory goals in the timeframes we publicly announceannounced or otherwise expect,expected, the commercialization of our partnered products and the development of our product candidates may be delayed and, as a result, our stock price may decline, and we may face lawsuits relating to such declines.
From time to time, we or our collaboratorspartners may publicly articulate the estimated timing for the accomplishment of certain scientific, clinical, regulatory and other product development goals. The accomplishment of any goal is typically based on numerous assumptions, and the achievement of a particular goal may be delayed for any number of reasons both within and outside of our and our partners’ control. If scientific, regulatory, strategic or other factors cause usa partner to not meet a goal, regardless of whether that goal has been publicly articulated or not, our stock price may decline rapidly. For example, the announcement in April 2014 of the temporary halting of our Phase 2 clinical trial for PEGPH20 caused a rapid decline in our stock price. 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.
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 harm our financial condition.
In order to augment our product pipeline or otherwise strengthen our business, 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 collaboratorspartners 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.
Security breachesOur effective tax rate may disruptfluctuate, 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 operationsfinancial 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 harmaudits 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.
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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.
The wrongful use, theft, deliberate sabotage or any other typeresults for 2021. Historical and future comparisons to these amounts are not, and will not be, indicative of security breach with respectactual profitability trends for our business. Beginning in 2022, we expect to any of our information technology storage and access systems couldcommence recording income tax expense at an estimated tax rate that will likely approximate statutory tax rates, which would result in the disruption ofa significant reduction in our ability to use such systems or disclosure or dissemination of our proprietarynet income and confidential information that is electronically stored, including research or clinical data, resulting in a material adverse impact on our business, operating results and financial condition. Our security and data recovery measures may not be adequate to protect against computer viruses, break-ins, and similar disruptions from unauthorized tampering with our electronic storage systems. 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 and financial condition.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 SeptemberJune 30, 20172022 were $17.62$48.58 and $8.18,$31.36, respectively. We expect our stock price to continue to be subject to significant volatility and, inIn addition to the other risks and uncertainties described elsewhere in this Quarterly Report on Form 10-Q 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 us;our partners;
•failure (actual or perceived) of our collaboratorspartners to devote attention or resources to the development or commercialization of partnered products or product candidates licensed to such collaborator;partner;
•a dispute regarding our failure, or the failure of one of our third party collaborators,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 collaborationpartnered product candidates;
•the failure, for any reason, to secure or defend our intellectual property position;


for those products that are not yet approved for commercial sale, •the failure or delay of applicable regulatory bodies to approve such products;our proprietary partnered product candidates;
•identification of safety or tolerability issues;
•failure of our 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 and our collaborators’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 third party collaborators,partners, to successfully commercialize products approved by applicable regulatory bodies such as the FDA;
•our failure, or the failure of our third party collaborators,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; or
•a restructuring of our operations.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. In February 2017, we filed an automatic shelf registration statement on Form S-3 (Registration No. 333-216315) with the SEC. Sales of substantial amounts of shares of our common stock or other securities under our current orany 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 boardBoard of directorsDirectors 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 as amended, 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 as amended, 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 entered into an indenture dated as of November 18, 2019 and an indenture dated as of March 1, 2021 (the “Indentures”), with The Bank of New York Mellon Trust Company, N.A., as trustee. Certain provisions in the Indenture 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, the Indentures and the 2022 Credit Agreement 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.product 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 partners’ products or may impose onerous, costly and time-consuming requirements such as additional clinical or animal testing. Regulatory authorities may require that weour partners’ change our studies or conduct additional studies, which may significantly delay or make continued pursuit of approval commercially unattractive.unattractive to our partners. For example, the approval of Baxalta’s HYQVIA BLA was delayed by the FDA until we and Baxalta 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, in September 2014, the FDA or other foreign regulatory agency may, at any time, halt our and our collaborators’partners’ development and commercialization activities due to safety concerns. In addition, even if our proprietary or or partnered products are approved, regulatory agencies may also take post-approval action limiting or revoking our or our partners’ ability to sell ourthese 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 supplier,suppliers, fail these inspections, weour partners may not be able to commercialize our producttheir 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.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. 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). 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, 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 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
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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 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 the 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. Hylenexrecombinant). 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 the successful commercialization. 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 protein-based therapeutic products and other biotechnology inventions is subject to a great deal of uncertainty, and if patent laws or the interpretation of patent laws change, our competitors may be able to 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.market resulting in commercial performance below that which was expected or projected.
Our and our partners’ ability to earn sufficient returns on ourproprietary and partnered products will depend in part on the extent to which reimbursement for ourthese products and related treatments will be available from government health administration authorities, private health insurers, managed care organizations and other healthcare providers.
Third-party payors 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 payors 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, our products arefor 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 theour proprietary or collaborationpartnered 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 payors 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 March 2010, the U.S. adopted, our business may be impacted by changes in federal reimbursement policy resulting from executive actions, federal regulations, or federal demonstration projects.
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The federal administration and/or agencies, such as the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (the PPACA). This law substantially changes the way healthcare is financed by both governmental and private insurers, and significantly impacts the pharmaceutical industry. The PPACA containsCenters for Medicare & Medicaid Services, or CMS, have announced a number of provisionsdemonstration projects, recommendations and proposals to implement various elements described in the drug pricing blueprint. CMS, the federal agency responsible for administering Medicare and overseeing state Medicaid programs and Health Insurance Marketplaces, has substantial power to implement policy changes or demonstration projects that can quickly and significantly affect how drugs, including our products, are expectedcovered and reimbursed. For example, in November 2020, former President Trump announced the interim final rule to impact our businessimplement 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 operations, in some cases in ways we cannot currently predict. Changes thatevaluated proposed legislation on drug pricing and payment policy which may affect our business include those governing enrollment in federal healthcare programs, reimbursement changes, fraud and abuse and enforcement. These changes will impact existing government healthcare programs and will result in the development of new programs, including Medicare payment for performance initiatives and improvements to the physician quality reporting system and feedback program.
Additional provisions of the PPACA may negatively affect our revenues in the future.business. For example, in July 2019, the PPACA imposesSenate Finance Committee advanced a non-deductible excise tax onbill that in part would penalize pharmaceutical manufacturers or importers that sell branded prescription drugs to U.S. government programs that we believe will impact our revenues from our products. In addition, as partfor increasing drug list prices covered by Medicare Part B and Part D, faster than the rate of the PPACA’s provisions closing a funding gap that currently exists in theinflation, 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 drug program,medication from Canada or other countries.
In this dynamic environment, we will alsoare unable to predict which or how many federal policy, legislative or regulatory changes may ultimately be required to provide a 50% discount on branded prescription drugs dispensed to beneficiaries under this prescription drug program. Recently, Congress andenacted. To the new administration have proposed and taken various steps to revise, repealextent federal government initiatives decrease or delay implementationmodify the coverage or reimbursement available for our or our partners’ products, limit or impact our decisions regarding the pricing of various aspectsbiopharmaceutical products or otherwise reduce the use of the Healthcare Reform Act. We expect that the PPACA, as it may be amended, and other healthcare reform measures that may be adopted in the futureour or our partners’ U.S. products, such actions could have a material adverse effect on our industry generallybusiness and on our ability to maintain or increase our product sales or successfully commercialize our product candidates and could limit or eliminate our future spending on development projects.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 payors 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. Co-pay coupon programs have received some negative publicity related to their use to promote branded pharmaceutical products over other less costly alternatives. 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 intense competition and rapid technological change that could result in the development of products by others that are competitive with or superior to our proprietary and collaborationpartnered products, including those under development.
Our proprietary and collaborationpartnered 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 Hylenexrecombinant include, but are not limited to, Valeant Pharmaceuticals International,Bausch Health
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Companies, Inc.’s FDA-approved product, Vitrase®, an ovine (ram) hyaluronidase, and Amphastar Pharmaceuticals, Inc.’s product, Amphadase®, a bovine (bull) hyaluronidase. For our PEGPH20 product candidate,ENHANZE technology, such competitors may include major pharmaceutical and specialized biotechnology firms. These competitors may develop technologies and products that are more effective, safer, or less costly than our current or future proprietary and collaborationpartnered products and product candidates or that could render our and our partners’ products, technologies and product candidates obsolete or noncompetitive. Many
General Risks
Our inability to attract, hire and retain key management and scientific personnel could negatively affect our business.
Our success depends on the performance of these competitors havekey management and scientific employees with relevant experience. We depend substantially on our ability to hire, train, motivate and retain high quality personnel, especially our scientists and management team. 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 management personnel, we may lose some portion of our institutional knowledge and technical know-how, potentially causing a disruption or delay in one or more resourcesof our partnered development programs until adequate replacement personnel could be hired and product development, manufacturing and marketing experience and capabilities than we do.trained. In addition, manywe do not have key person life insurance policies on the lives of any of our competitors have significantly greater experience than we do in undertaking preclinical testing and clinical trialsemployees which would help cover the cost of pharmaceutical product candidates and obtaining FDAassociated 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 located in multiple buildings in San Diego, California. We depend on our facilities and on our partners, 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, 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 approvalsinformation, 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 productsour 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 therapies for use in healthcare.

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.



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Item 3.Quantitative and Qualitative Disclosures About Market Risk
Item 3.Quantitative and Qualitative Disclosures About Market Risk
There have been no material changes in our market risks during the quarter ended SeptemberJune 30, 2017.2022.
As of SeptemberJune 30, 2017,2022, our cash equivalents and marketable securities consisted of investments in money market funds, U.S. Treasury securities, asset-backed securities, corporate debt obligations 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 SeptemberJune 30, 2017,2022, 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 4.Controls and Procedures
Item 4.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 Quarterly Report on Form 10-Q.
Changes in Internal Control Over Financial Reporting
ThereOn 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 Antares from our evaluation for the period ended June 30, 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 quarter ended SeptemberJune 30, 20172022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


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PART II – OTHER INFORMATION
Item 1.Legal Proceedings
Item 1.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 1A.Risk Factors
WeItem 1A.Risk Factors
Reflecting our recent acquisition of Antares Pharma, Inc., we have provided some new and updated Risk Factors in the section labeled “Risk Factors” in Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. We believe these new and updated Risk Factors provide important disclosures regarding additional risks we face. The “Risk Factors” section providesheading of each new and significantly updated information in certain areas, particularlyRisk Factor is marked with respect toan “*”. Other than the risks and uncertainties regardingadditions reflecting the regulatory approvalacquisition of proprietary and collaboration product candidates.We do not believe theAntares, there have been no updates that have materially changed the type or magnitude of risks we face in comparison to the disclosure provided in our most recent Annual Report on Formform 10-K.
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds
The table below sets forth information regarding repurchases of our common stock during the three months ended June 30, 2022:
Item 2.PeriodUnregistered SalesTotal Number of Equity Securities and UseShares PurchasedWeighted-Average Price paid per shareTotal Number of ProceedsShares Purchased as Part of Publicly Announced ProgramsApproximate Dollar Value of Shares That May Yet Be Purchased under the Programs (thousands)
April 1, 2022 through April 30, 2022— $— — $600,000 
May 1, 2022 through May 31, 2022— $— — $600,000 
June 1, 2022 through June 30, 2022— $— — $600,000 
Total— — 
None.

In November, 2019, we announced that our Board of Directors authorized a capital return program to repurchase up to $550.0 million of outstanding common stock during a three-year period. The $550.0 million share repurchase program was completed in October 2021. 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 to Bank of America and took initial delivery of 3.5 million shares. In June 2022, we finalized the transaction and received an additional 0.4 million shares.
Item 3.Defaults Upon Senior Securities
Item 3.Defaults Upon Senior Securities
Not applicable.
Item 4.Mine Safety Disclosures
Item 4.Mine Safety Disclosures
Not applicable.
Item 5.Other Information
Item 5.Other Information
None.

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Item 6.Exhibits
Item 6.2.1Exhibits
Agreement and Plan Merger among Halozyme Therapeutics, Inc., Atlas Merger Sub, Inc. and Antares Pharma, Inc. dated as of April 12, 2022 (1)
3.1
Composite
Amended and Restated Certificate of Incorporation (1)(2)
3.2
Bylaws, as amended (2)(3)
4.1
10.1
First Amendment to Amended and Restated Lease (11388 Sorrento Valley Road), dated June 30, 2017 (3)
4.2
10.2
First Amendment to Lease (11404 and 11408 Sorrento Valley Road), dated June 30, 2017 (3)
4.3
10.3
Second Modification to Lease (11436 Sorrento Valley Road), dated June 30, 2017 (3)
4.4
10.4
Transition Services
4.5
4.6
Security Agreement, effectivedated as of September 30, 2017 (4)May 24, 2022, by and among Halozyme Therapeutics, Inc., the Guarantors and Bank of America N.A (6).
10.1
31.1Lease Agreement, dated July 1, 2019, by and between Antares Pharma, Inc. and Whitewater Properties I, LLC. (7)
31.1
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended
31.2
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended
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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.INSInstance Document
101.SCHTaxonomy Extension Schema Document
101.CALTaxonomy Extension Calculation Linkbase Document
101.DEFTaxonomy Extension Definition Linkbase Document
101.LABTaxonomy Extension Label Linkbase Document
101.PRETaxonomy Extension Presentation Linkbase Document
- the instance document does not appear in the interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCHInline Taxonomy Extension Schema Document.
(1)101.CALIncorporated by reference to the Registrant’s Quarterly Report on Form 10-Q, filed August 7, 2013 (File No. 001-32335).Inline Taxonomy Extension Calculation Linkbase Document.
(2)101.DEFIncorporated by reference to the Registrant’s Current Report on Form 8-K, filed December 19, 2016 (File No. 001-32335).Inline Taxonomy Extension Definition Linkbase Document.
(3)101.LABIncorporated by reference to the Registrant’s Current Report on Form 8-K, filed July 5, 2017 (File No. 001-32335).Inline Taxonomy Extension Label Linkbase Document.
(4)101.PREIncorporated by reference to the Registrant’s Current Report on Form 8-K, filed September 29, 2017 (File No. 001-32335).Inline Taxonomy Extension Presentation Linkbase Document.
104Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)


# Indicates management contract or compensatory plan or arrangement
(1)Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed April 13, 2022.
(2)Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed May 3, 2019.
(3)Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed December 10, 2021.
(4)Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed November 18, 2019.
(5)Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed March 1, 2021.
(6)Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed May 24, 2022.
(7)Incorporated by reference to Antares Pharma, Inc.’s Current Report on Form 8-K, filed July 5, 2019.



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SIGNATURES
Pursuant to the requirements 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.
Halozyme Therapeutics, Inc.,
a Delaware corporation
Dated:August 9, 2022
Halozyme Therapeutics, Inc.,
a Delaware corporation
Dated:November 7, 2017/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)
Dated:November 7, 2017August 9, 2022/s/ Laurie D. StelzerNicole LaBrosse
Laurie D. Stelzer
Nicole LaBrosse
Senior Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)


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