HALO on Nasdaq

Halozyme Therapeutics

In its 2026 annual report the company says: “Halozyme Therapeutics, Inc. is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. We license our technology to biopharmaceutical companies to collaboratively develop products that combine ENHANZE with our partners’ proprietary compounds. We are also developing partner products with Hypercon™ drug delivery technology and developing the Surf Bio drug delivery technology to expand the breadth of our drug delivery technology portfolio.”6 It is headquartered in San Diego.1

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Last updated Oct 21, 2026.

Overview

1998Founded1

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  • TickerHALO on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersSan Diego1
  • Websitewww.Halozyme.com
  • Legal formDelaware corporation1
  • Incorporated inDE4
  • Business address12390 El Camino Real, San Diego, Ca 921304
  • Filer categoryLarge accelerated filer4
  • LEI529900242I3SV9AGM7533
  • StatusActive3
  • LEI statusIssued and current3
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 44065663

Halozyme Therapeutics, Inc. is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies.6 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

33.6%Operating margin7
22.7%Net margin7
37.6%Revenue growth, 20257
649.2%Return on equity7
43.89×Debt to equity7
$644.6MFree cash flow7

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Royalty brought in 62% of the revenue Halozyme Therapeutics broke down this way in fiscal 2025.

  1. Royalty$867.8M762%up 52% from 2024
  2. Proprietary Products Sales$194.6M714%up 17% from 2024
  3. Bulk rHuPH20$133.0M710%up 54% from 2024
  4. Sales-based milestone$70.0M75%up 133% from 2024
  5. Device Partnered Products$48.8M73%down 3% from 2024
  6. Event -based Development And Regulatory Milestone And Other Fees$47.0M73%down 35% from 2024
  7. Upfront Fees$18.5M71%down 32% from 2024
  8. Device Licensing and Development$16.9M71%up 49% from 2024
Products and services by year
Products and services202320242025
Royalty$447.9M$571.0M$867.8M
Proprietary Products Sales$130.8M$166.6M$194.6M
Bulk rHuPH20$115.4M$86.3M$133.0M
Sales-based milestone$0$30.0M$70.0M
Device Partnered Products$54.6M$50.5M$48.8M
Event -based Development And Regulatory Milestone And Other Fees$69.0M$72.5M$47.0M
Upfront Fees$2.0M$27.0M$18.5M
Device Licensing and Development$9.5M$11.3M$16.9M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue16¢$228.8M
  • Selling, general and admin15¢$207.1M
  • Other costs35¢$493.9M
  • Income tax11¢$150.0M
  • Profit23¢$316.9M

Out of $1.4B in revenue.7

Where each dollar of operating cash went, fiscal 2025

  • Capital spending1¢$7.0M
  • Share buybacks53¢$342.4M
  • Kept or used elsewhere46¢$302.2M

Out of $651.6M of cash from operations.7

Financial statements

Revenue8910117$1.4B in 2025+613% since 2019
0$500.0M$1.0B$1.5B2019: $196.0M$196.0M20192020: $267.6M$267.6M2020+37%2021: $443.3M$443.3M2021+66%2022: $660.1M$660.1M2022+49%2023: $829.3M$829.3M2023+26%2024: $1.0B$1.0B2024+22%2025: $1.4B$1.4B2025+38%
Operating income8910117$469.0M in 2025
-$200.0M0$200.0M$400.0M$600.0M2019: -$67.6M-$67.6M20192020: $144.3M$144.3M20202021: $275.9M$275.9M2021+91%2022: $267.5M$267.5M2022−3%2023: $337.6M$337.6M2023+26%2024: $551.5M$551.5M2024+63%2025: $469.0M$469.0M2025−15%
Net income8910117$316.9M in 2025
-$200.0M0$200.0M$400.0M$600.0M2019: -$72.2M-$72.2M20192020: $129.1M$129.1M20202021: $402.7M$402.7M2021+212%2022: $202.1M$202.1M2022−50%2023: $281.6M$281.6M2023+39%2024: $444.1M$444.1M2024+58%2025: $316.9M$316.9M2025−29%

Every line of the income statement as filed: the last 3 fiscal years, latest first.7

Period ending2025-12-312024-12-312023-12-31
Total revenues$1.4B$1.0B$829.3M
Cost of sales$228.8M$159.4M$192.4M
Amortization of intangibles$76.7M$71.0M$73.8M
Research and development$81.5M$79.0M$76.4M
Selling, general and administrative$207.1M$154.3M$149.2M
Impairment of intangible asset$48.7M$0$0
Acquired in-process research and development expense$284.9M$0$0
Total operating expenses$927.6M$463.8M$491.7M
Operating income$469.0M$551.5M$337.6M
Investment and other income, net$21.5M$23.8M$16.3M
Inducement expense related to convertible notes-$5.5M$0$0
Contingent liability fair value measurement gain$0$0$13.2M
Interest expense-$18.1M-$18.1M-$18.8M
Income before income tax expense$466.9M$557.1M$348.3M
Income tax expense$150.0M$113.0M$66.7M
Net income$316.9M$444.1M$281.6M
Basic (usd per share)$2.64$3.50$2.13
Diluted (usd per share)$2.56$3.43$2.10
Basic (in shares)119.8M shares126.8M shares131.9M shares
Diluted (in shares)123.9M shares129.4M shares134.2M shares

Compare Halozyme Therapeutics with another company

Corporate structure

Halozyme Therapeutics sits at the top of its group. 7 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Halozyme Therapeutics

  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Halozyme Therapeutics, latest Apr 30, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Halozyme Therapeutics, latest Mar 27, 2026 (6 filings since Feb 10, 2022)
  • BlackRock Filed SCHEDULE 13G/A on Halozyme Therapeutics, latest Jul 17, 2025 (7 filings since Jan 28, 2022)
  • State Street Corporation Filed SCHEDULE 13G on Halozyme Therapeutics, latest May 13, 2025 (2 filings since Oct 17, 2024)
  • Artisan Partners Limited Partnership Filed SC 13G/A on Halozyme Therapeutics, latest Nov 12, 2024 (4 filings since Feb 4, 2022)
  • Invesco Filed SC 13G/A on Halozyme Therapeutics, latest Feb 1, 2024 (2 filings since Feb 10, 2023)
  • Halozyme Therapeutics San Diego, California, United States
    • Antares Pharma GmbH Subsidiary · Switzerland
    • Antares Pharma IPL AG Subsidiary · Switzerland
    • Elektrofi Security Corp. Subsidiary · Massachusetts, United States
    • Halozyme Hypercon, Inc. Subsidiary · Delaware, United States
    • Halozyme Surf Bio, Inc. Subsidiary · Delaware, United States
    • Halozyme, Inc. Subsidiary · California, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Halozyme Therapeutics reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$77.6M7 Dec 31, 2025$66.3M7 Dec 31, 2024+17.1%
Accumulated depreciation$33.2M7 Dec 31, 2025$25.4M7 Dec 31, 2024+30.4%
Property and equipment, net$44.4M7 Dec 31, 2025$40.9M7 Dec 31, 2024+8.8%
Operating-lease assets (leased space)$37.7M7 Dec 31, 2025$34.2M7 Dec 31, 2024+10.3%

Real estate and locations

ItemLatestA year beforeChange
Area of real estate196,000 sq ft7 Dec 31, 2025162,000 sq ft11 Dec 31, 2024+21.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$133.8M7 Dec 31, 2025$115.8M7 Dec 31, 2024+15.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$580.4M7 Dec 31, 2025$416.8M7 Dec 31, 2024+39.2%
Intangible assets, net (excluding goodwill)$981.5M7 Dec 31, 2025$401.8M7 Dec 31, 2024+144.2%
Indefinite-lived intangibles (excluding goodwill)$48.7M7 Dec 31, 2024$48.7M10 Dec 31, 20230%
Finite-lived intangibles, gross$1.2B7 Dec 31, 2025$538.2M7 Dec 31, 2024+131.0%
Accumulated amortization$261.7M7 Dec 31, 2025$185.1M7 Dec 31, 2024+41.4%
Finite-lived intangibles, net$981.5M7 Dec 31, 2025$353.1M7 Dec 31, 2024+177.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$176.5M7 Dec 31, 2025$141.9M7 Dec 31, 2024+24.4%
Raw materials$21.9M7 Dec 31, 2025$24.0M7 Dec 31, 2024−8.9%
Work in process$30.9M7 Dec 31, 2025$30.2M7 Dec 31, 2024+2.5%
Finished goods$144.5M7 Dec 31, 2025$142.9M7 Dec 31, 2024+1.1%

Properties, in its own words

Our properties consist of leased office, laboratory, warehouse and assembly facilities. Our administrative offices and research facilities are located in San Diego, California. We also lease a building in Minnetonka, Minnesota consisting of office, assembly operations, and warehousing space, office and lab space in Boston, Massachusetts and have a small administrative office that primarily supports commercial operations in Ewing, New Jersey. As of December 31, 2025, we leased an aggregate of approximately 196,000 square feet of space. We believe our facilities are adequate for our current and near-term needs.

Item 2 of the 10-K filed Feb 17, 2026.6

Leadership

Who has led Halozyme Therapeutics, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (38)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Antares Pharma GmbH Switzerland5
  • Antares Pharma IPL AG Switzerland5
  • Antares Pharma, Inc. Delaware5
  • Elektrofi Security Corp. Massachusetts5
  • Halozyme Hypercon, Inc. Delaware5
  • Halozyme Surf Bio, Inc. Delaware5
  • Halozyme, Inc. California5

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • HALOZYME THERAPEUTICS INCMar 17, 2004 to Jul 3, 20194
  • GLOBAL YACHT SERVICES INCSep 21, 2001 to Mar 12, 20044

Timeline

  1. Sep 30, 20268-K Executive or director change62
  2. Sep 22, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares63
  3. Sep 18, 20268-K Other events64
  4. Sep 16, 20268-K Other events65
  5. Aug 18, 20268-K Executive or director change66
  6. Aug 6, 20268-K Results of operations67
  7. Jul 2, 20268-K Executive or director change68
  8. May 11, 20268-K Results of operations69
  9. May 7, 20268-K Shareholder vote70
  10. Apr 30, 20268-K Executive or director change71
  11. Apr 24, 20268-K Bylaws or fiscal year changed72
  12. Mar 12, 20268-K Executive or director change73
  13. Jan 8, 2014New chief executive Helen Torley becomes CEO16
  14. May 6, 2011New chief executive Gregory Ian Frost becomes CEO17
  15. Feb 7, 2007New chief executive Jonathan E. Lim becomes CEO18
  16. 1998Founded Founded1

Calendar

Coming up

  1. Nov 2, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $1.63 a share, on Nov 3, 2025.74

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results67
  2. May 11, 2026Reported quarterly or annual results69
  3. Feb 17, 2026Reported quarterly or annual results75
  4. Jan 28, 2026Reported quarterly or annual results76
  5. Nov 3, 2025Reported quarterly or annual results77
  6. Aug 5, 2025Reported quarterly or annual results78
  7. May 6, 2025Reported quarterly or annual results79
  8. Feb 18, 2025Reported quarterly or annual results80

Drug trials and FDA: recently

  1. Aug 4, 2025Phase 3 trial completed Phase 3 trial of Nivolumab + Relatlimab and rHuPH20 in Melanoma, run by Bristol-Myers Squibb: primary completion Aug 4, 2025, results posted Aug 26, 2026 (ClinicalTrials.gov NCT05625399).81

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

429 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 70 major events, 214 insider forms, 22 large holders, 103 other. The latest 20:

  1. Oct 8, 20264 EDGAR
  2. Oct 8, 20264/A EDGAR
  3. Oct 2, 20264 EDGAR
  4. Oct 2, 20263 EDGAR
  5. Oct 2, 20264 EDGAR
  6. Sep 30, 20268-K EDGAR
  7. Sep 22, 20268-K EDGAR
  8. Sep 18, 20268-K EDGAR
  9. Sep 17, 20264 EDGAR
  10. Sep 16, 2026144 EDGAR
  11. Sep 16, 20268-K EDGAR
  12. Sep 11, 20264 EDGAR
  13. Sep 2, 20264 EDGAR
  14. Aug 21, 20263 EDGAR
  15. Aug 19, 20264 EDGAR
  16. Aug 18, 20268-K EDGAR
  17. Aug 17, 2026144 EDGAR
  18. Aug 11, 2026144 EDGAR
  19. Aug 11, 20264 EDGAR
  20. Aug 10, 2026144 EDGAR

The 429 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

159 open-market trades by officers, directors and large owners since October 2021: 0 buys and 159 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 16, 2026Posard Matthew L.DirectorSale18,996$107.74$2.0MForm 4
Sep 11, 2026Torley HelenPRESIDENT AND CEOSale20,000$107.24$2.1MForm 4
Sep 10, 2026Torley HelenPRESIDENT AND CEOSale20,000$107.16$2.1MForm 4
Sep 9, 2026Torley HelenPRESIDENT AND CEOSale20,000$107.43$2.1MForm 4
Aug 19, 2026Torley HelenPRESIDENT AND CEOSale20,000$107.00$2.1MForm 4
Aug 18, 2026Torley HelenPRESIDENT AND CEOSale20,000$104.17$2.1MForm 4
Aug 17, 2026Torley HelenPRESIDENT AND CEOSale20,000$102.60$2.1MForm 4
Aug 10, 2026Connaughton BernadetteDirectorSale1,626$102.80$167.2KForm 4
Jul 8, 2026Torley HelenPRESIDENT AND CEOSale1,923$79.77$153.4KForm 4
Jul 1, 2026Connaughton BernadetteDirectorSale1,625$76.71$124.7KForm 4
Jun 29, 2026Krishnan MaheshDirectorSale7,304$75.00$547.8KForm 4
Jun 3, 2026Torley HelenPRESIDENT AND CEOSale10,000$69.07$690.7KForm 4
Jun 2, 2026Torley HelenPRESIDENT AND CEOSale20,000$66.38$1.3MForm 4
Jun 1, 2026Torley HelenPRESIDENT AND CEOSale20,000$67.58$1.4MForm 4
Jun 1, 2026Connaughton BernadetteDirectorSale1,625$66.21$107.6KForm 4
May 13, 2026Torley HelenPRESIDENT AND CEOSale10,000$69.19$691.9KForm 4
May 12, 2026Torley HelenPRESIDENT AND CEOSale20,000$71.75$1.4MForm 4
May 11, 2026Torley HelenPRESIDENT AND CEOSale20,000$65.35$1.3MForm 4
May 1, 2026Connaughton BernadetteDirectorSale1,625$63.48$103.2KForm 4
Apr 6, 2026Torley HelenPRESIDENT AND CEOSale10,000$63.50$635.0KForm 4

All 159 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Helen I. Torley$1.0M$23.2M88
2025Nicole LaBrosse$604.2K$4.6M88
2025Mark Snyder$619.0K$4.5M88
2025Cortney Caudill$561.0K$3.2M88
2025Michael J. LaBarre$120.3K$2.1M88
2024President andChief Executive Officer$960.0K$12.7M88
2024Senior Vice PresidentChief Financial Officer$568.2K$4.2M88
2024Former Senior Vice PresidentChief Technical Officer$556.2K$3.0M88
2023President andChief Executive Officer$920.0K$11.8M88
2023Senior Vice PresidentChief Financial Officer$546.2K$3.8M88
2023Former Senior Vice PresidentChief Technical Officer$538.2K$3.2M88

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.13,271,095$1.0B0.0%+6,042
Vanguard Capital Management LLC5,351,312$418.8M0.0%+80,094
Vanguard Portfolio Management LLC5,299,008$414.8M0.0%+49,802
State Street Corp5,179,434$405.4M0.0%+241,580
Invesco Ltd.3,177,997$248.7M0.0%−834,497
Morgan Stanley2,832,594$221.7M0.0%+270,285
Boston Partners2,773,568$216.8M0.2%+89,885
Bank Of America Corp /de/2,740,561$214.5M0.0%−172,548
Geode Capital Management, LLC2,519,951$197.3M0.0%+14,165
William Blair Investment Management, LLC2,511,050$196.5M0.6%−14,925
Snyder Capital Management L P2,396,101$187.5M3.2%+73,024
Dimensional Fund Advisors LP2,089,567$163.5M0.0%+9,740
D. E. Shaw & Co., Inc.2,006,479$157.0M0.1%+137,771
Assenagon Asset Management S.A.1,995,286$156.2M0.1%+1,973,964
Los Angeles Capital Management LLC1,938,035$151.7M0.6%+1,248,120
Royal London Asset Management Ltd1,810,815$141.7M0.3%+200,262
Arrowstreet Capital, Limited Partnership1,704,623$133.4M0.1%−213,526
Two Sigma Investments, LP1,653,285$129.4M0.1%+68,324
UBS Group AG1,492,224$116.8M0.0%+578,221
Fuller & Thaler Asset Management, Inc.1,491,004$116.7M0.3%+25,721
Norges Bank1,483,648$116.1M0.0%New
First Trust Advisors LP1,417,063$110.9M0.1%−65,277
Alliancebernstein L.P.1,696,538$109.6M0.0%−39,963
Stephens Investment Management Group LLC1,392,819$109.0M1.2%+174,151
Wells Fargo & Company/mn1,390,428$108.8M0.0%−145,309

13F reports cover disclosed long positions in U.S. stocks only.

Members of Congress who traded it

10 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Sep 29, 2026Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000−7.9%Report
Mar 9, 2026Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+64.5%Report
Mar 24, 2025Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000−55.4%Report
Sep 9, 2024Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000−63.9%Report
Jul 12, 2023Daniel S. GoldmanDemocratic, HouseSale$15,001 - $50,000−153.7%Report
Dec 6, 2022Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000−19.5%Report
Aug 5, 2022Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000−82.6%Report
Aug 20, 2021Josh GottheimerDemocratic, HouseBuy$1,001 - $15,000+133.2%Report
Oct 22, 2020Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+166.9%Report
Oct 19, 2020Josh GottheimerDemocratic, HouseBuy$1,001 - $15,000+186.8%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How Halozyme Therapeutics is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARHALOZYME THERAPEUTICS, INC.2
  • CIK0001159036
  • Employer ID (EIN)88-04886866
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address12390 El Camino Real, San Diego, CA 921302
  • Phone(858) 794-88892
  • Shares outstanding113,498,000 as of Jul 31, 202613
  • Public float$4.5B as of Jun 30, 20256
  • AuditorErnst & Young LLP, San Diego, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting6
  • On EDGAR sinceSep 21, 20012
  • Filings1,516 in all: 4 (687), 8-K (289), 144 (76), SC 13G/A (63), 10-Q (62), 3 (56), SC 13G (25), DEF 14A (23)2
    All 51 form types

    10-K (20), UPLOAD (17), DEFA14A (16), CORRESP (13), SC 13D/A (13), 10QSB (12), 4/A (12), 424B5 (12), 5 (11), S-8 (11), 3/A (7), 8-K/A (7), ARS (6), SB-2/A (6), 10KSB (5), 424B3 (5), EFFECT (5), PRE 14A (5), CT ORDER (4), POS AM (4), S-3 (4), S-8 POS (4), 10KSB/A (3), SC TO-C (3), SC TO-T/A (3), SCHEDULE 13G/A (3), 8-A12B (2), 8-A12G (2), NT 10-Q (2), S-3ASR (2), SB-2 (2), SC 13D (2), SCHEDULE 13G (2), 10-Q/A (1), 25 (1), 424A (1), 8-A12B/A (1), CERTAMX (1), CERTNAS (1), DEFM14C (1), PREM14C (1), REGDEX (1), SC TO-T (1)

  • Latest filingsAnnual report (10-K) Feb 17, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Mar 23, 2026
    Latest 8-K (8-K) Sep 30, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 Par ValueHALOThe NASDAQ Stock Market LLC

From the cover page of the 10-K filed Feb 17, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Halozyme Therapeutics names in Item 1A of its 10-K filed Feb 17, 2026: 40 risks under these headings, as written.6

  • Risks Related To Our Business
  • If our partnered or proprietary product candidates do not receive and maintain regulatory approvals, or if approvals are not obtained in a timely manner, such failure or delay would substantially impact our ability to generate revenues.
  • Use of our partnered or proprietary products and product candidates could be associated with adverse events or product recalls.
  • If our contract manufacturers or vendors are unable or unwilling for any reason to manufacture and supply to us bulk rHuPH20 or other raw materials, reagents, components or devices in the quantity and quality required by us or our partners for use in the production of our proprietary or partnered products and product candidates, our and our partners’ product development and commercialization efforts could be delayed or stopped and our business results associated with operations and our collaborations could be harmed.
  • We rely on third parties to perform necessary services for our products including services related to the distribution, invoicing, rebates and contract administration, co-pay program administration, sample distribution and administration, storage and transportation of our products. If anything should impede their ability to meet their commitments this could impact our business performance.
  • If we or any party to a key collaboration agreement fail to perform material obligations under such agreement, or if a key collaboration agreement is terminated for any reason, our business could suffer.
  • Hylenex and our partners’ ENHANZE products and product candidates rely on the rHuPH20 enzyme, and any adverse development regarding rHuPH20 could substantially impact multiple areas of our business, including current and potential ENHANZE collaborations, as well as any proprietary programs.
  • Our business strategy is focused on growth of our ENHANZE and auto-injector technologies, our commercial products and potential growth through acquisition. Currently, ENHANZE is the largest revenue driver and as a result there is a risk for potential negative impact from adverse developments. Future expansion of our strategic focus to additional applications of our ENHANZE technology or by acquiring new technologies may require the use of additional resources, result in increased expense and ultimately may not be successful.
  • 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 harm our collaborations. Our partners are also responsible for distributing and commercializing their products, and any failure to successfully commercialize their products could materially adversely affect our revenues.
  • If we or our partners fail to comply with regulatory requirements applicable to promotion, sale and manufacturing of approved products, regulatory agencies may take action against us or them, which could harm our business.
  • Failure of our auto-injector and specialty products business to perform could adversely impact future business and operations.
The other 29 risks
  • Workforce reduction at federal agencies and changes in U.S. trade policy, including tariffs and potential countermeasures by trading partners, could delay regulatory approval and increase our or our partners’ costs, disrupt global supply chains and have a material adverse impact on our business, financial condition, and results of operations.
  • Business interruptions resulting from pandemics or similar public health crises could cause a disruption of the development of our and our partnered product candidates and commercialization of our approved and our partnered products, impede our ability to supply bulk rHuPH20 to our ENHANZE partners or procure and sell our proprietary products and otherwise adversely impact our business and results of operations.
  • We may need to raise additional capital in the future and there can be no assurance that we will be able to obtain such funds.
  • We currently have significant debt and may incur additional debt. Failure by us to fulfill our obligations under the applicable debt agreements may cause repayment obligations to accelerate.
  • The conditional conversion feature of the Convertible Notes, if triggered, may adversely affect our financial condition and operating results.
  • Conversion of our Convertible Notes may dilute the ownership interest of existing stockholders or may otherwise depress the price of our common stock.
  • If proprietary or partnered product candidates are approved for commercialization but do not gain market acceptance resulting in commercial performance below that which was expected or projected, our business may suffer.
  • Our ability to license our ENHANZE and device technologies to our partners depends on the validity of our patents and other proprietary rights.
  • Developing, manufacturing and marketing pharmaceutical products for human use involves significant product liability risks for which we may have insufficient insurance coverage.
  • If our partners do not achieve projected development, clinical, or regulatory goals in the timeframes publicly announced or otherwise expected, the commercialization of our partners products may be delayed and, as a result, our business, financial condition, and results of operations may be adversely affected.
  • Future strategic corporate transactions could disrupt our business and impact our financial condition.
  • Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
  • Risks Related To Ownership of Our Common Stock
  • The market price of our common stock 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 convertible note indentures and Delaware law may make an acquisition of us more difficult.
  • Risks Related to Our Industry
  • Our and our partnered products must receive regulatory approval before they can be sold, and compliance with the extensive government regulations is expensive and time consuming and may result in the delay or cancellation of our or our partnered product sales, introductions or modifications.
  • Because some of our and our partners’ products and product candidates are considered to be drug/device combination products, the regulatory 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 certain development and commercialization of our products.
  • We may incur significant liability if it is determined that we are promoting or have in the past promoted the “off-label” use of drugs or medical devices, or otherwise promoted or marketed approved products in a manner inconsistent with the FDA’s requirements.
  • For certain of our products, we and our independent contractors, distributors, prescribers, and dispensers are required to comply with regulatory requirements related to controlled substances, which will require the expenditure of additional time and will incur additional expenses to maintain compliance and may subject us to additional penalties for noncompliance, which could inhibit successful commercialization.
  • Patent protection for biotechnology inventions and for inventions generally is subject to significant scrutiny; if patent laws or the interpretation of patent laws change, our business may be adversely impacted because we may lose the ability to obtain patent protection or enforce our intellectual property rights against competitors who develop and commercialize products based on our discoveries.
  • If third-party reimbursement and customer contracts are not available, our proprietary and 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 pricing has led to cost containment pressures from third-party payers as well as changes in federal coverage and reimbursement policies and practices that could cause us and our partners to sell our products at lower prices, and impact access to our and our partners’ products, resulting in less revenue to us.
  • We face competition and rapid technological change that could result in the development of products by others that are competitive with our proprietary and partnered products, including those under development.
  • General Risks
  • If we are unable to attract, hire and retain key personnel our business could be negatively affected.
  • Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.
  • Cyberattacks, security breaches or system breakdowns may disrupt our operations and harm our operating results and reputation.
  • Violence, physical attacks or threats of violence directed toward company facilities or key company personnel may disrupt company operations and undermine investor confidence.

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 statements of income and balance sheets. Additionally, any such claims, whether or not successful, could damage our reputation and business. We currently are not a party to any legal proceedings, the adverse outcome of which, in our opinion, individually or in the aggregate, would have a material adverse effect on our consolidated statements of income or balance sheets.

The opening of Item 3, Legal Proceedings.6

Sources

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