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Coherus BioSciences (United States)

American biological products company based in Redwood City, founded in 20101

In its 2026 annual report the company says: “We are a fully integrated commercial-stage innovative oncology company with an approved next-generation programmed death receptor-1 inhibitor, LOQTORZI® (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, head and neck, colorectal and other cancers.”5 Its shares trade on Nasdaq under the symbol CHRS.1

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Last updated Oct 21, 2026.

Overview

2010Founded1

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  • TickerCHRS on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersRedwood City1
  • Websitewww.coherus.com
  • Incorporated inDE3
  • Business addressC/O Dennis M. Lanfear, 333 Twin Dolphin Dr, Suite 600, Redwood City, Ca 940653
  • Filer categoryAccelerated filer, Smaller reporting company3

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We are a fully integrated commercial-stage innovative oncology company with an approved next-generation programmed death receptor-1 (“PD-1”) inhibitor, LOQTORZI® (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, head and neck, colorectal and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma (“NPC”) and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our partners, driving sales multiples and synergies from proprietary combinations. On May 29, 2025, we changed our corporate name from “Coherus BioSciences, Inc.” to “Coherus Oncology, Inc.” to better align with our exclusive focus on proprietary innovative immuno-oncology medicines following the completion of the recent divestitures of our biosimilar businesses.5 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

-429.5%Operating margin6
398.4%Net margin6
59.8%Revenue growth, 20256
275.4%Return on equity6

What sells

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

Products and services

Toripalimab brought in 97% of the revenue Coherus BioSciences (United States) broke down this way in fiscal 2025.

  1. Toripalimab$40.8M697%up 113% from 2024
  2. Product and Service, Other$1.3M63%down 82% from 2024
Products and services by year
Products and services20242025
Toripalimab$19.1M$40.8M
Product and Service, Other$7.3M$1.3M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue3¢$13.8M
  • Research and development27¢$108.9M
  • Selling, general and admin25¢$100.6M
  • Interest2¢$9.0M
  • Profit42¢$168.0M

Out of $42.2M in revenue.6

Financial statements

Revenue789106$42.2M in 2025−88% since 2019
0$200.0M$400.0M$600.0M2019: $356.1M$356.1M20192020: $475.8M$475.8M2020+34%2021: $326.6M$326.6M2021−31%2022: $211.0M$211.0M2022−35%2023: $257.2M$257.2M2023+22%2024: $26.4M$26.4M2024−90%2025: $42.2M$42.2M2025+60%
Operating income789106-$181.1M in 2025
-$400.0M-$200.0M0$200.0M2019: $107.8M$107.8M20192020: $156.3M$156.3M2020+45%2021: -$263.9M-$263.9M20212022: -$256.9M-$256.9M2022−3%2023: -$203.2M-$203.2M2023−21%2024: -$199.7M-$199.7M2024−2%2025: -$181.1M-$181.1M2025−9%
Net income789106$168.0M in 2025+87% since 2019
-$400.0M-$200.0M0$200.0M2019: $89.8M$89.8M20192020: $132.2M$132.2M2020+47%2021: -$287.1M-$287.1M20212022: -$291.8M-$291.8M2022+2%2023: -$237.9M-$237.9M2023−18%2024: $28.5M$28.5M20242025: $168.0M$168.0M2025+489%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Net revenue$42.2M$26.4M
Cost of goods sold$13.8M$8.7M
Research and development$108.9M$91.8M
Selling, general and administrative$100.6M$125.5M
Total costs and expenses$223.3M$226.0M
Loss from operations-$181.1M-$199.7M
Interest expense-$9.0M-$10.7M
Loss on debt extinguishment$0-$12.6M
Other income (expense), net$7.0M$7.6M
Loss from continuing operations before income taxes-$183.1M-$215.4M
Income tax provision$0$0
Net loss from continuing operations-$183.1M-$215.4M
Net income from discontinued operations, net of tax (Note 6)$351.1M$243.9M
Net income$168.0M$28.5M
Net loss from continuing operations - basic-$2-$2
Net loss from continuing operations - diluted-$2-$2
Net income from discontinued operations - basic$3$2
Net income from discontinued operations - diluted$3$2
Net income per share - Basic (In dollar per share)$1.43$0.25
Net income per share - Diluted (In dollar per share)$1.43$0.25
Basic (In shares)117.1M shares114.6M shares
Diluted (In shares)117.1M shares114.6M shares

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Corporate structure

Coherus BioSciences (United States) sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Coherus BioSciences (United States)

  • BlackRock Filed SCHEDULE 13G on Coherus BioSciences (United States), latest Jul 27, 2026 (10 filings since Jan 26, 2022)
  • Timothy G. Youngquist 2020 Irrevocable Trust Filed SCHEDULE 13G/A on Coherus BioSciences (United States), latest May 15, 2026 (3 filings since Feb 5, 2026)
  • Thomas A. Satterfield Jr. Filed SCHEDULE 13G/A on Coherus BioSciences (United States), latest Apr 29, 2026 (2 filings since Apr 16, 2025)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Coherus BioSciences (United States), latest Mar 26, 2026 (5 filings since Feb 9, 2022)
  • Bering Partners II, L.P. Filed SCHEDULE 13G on Coherus BioSciences (United States), latest Nov 4, 2025
  • Rubric Capital Management LP Filed SCHEDULE 13G/A on Coherus BioSciences (United States), latest Feb 13, 2025 (2 filings since Nov 13, 2024)
  • Temasek Holdings (Private) Ltd Filed SC 13G/A on Coherus BioSciences (United States), latest Jul 23, 2024 (2 filings since May 22, 2024)
  • AllianceBernstein Filed SC 13G/A on Coherus BioSciences (United States), latest Feb 14, 2024 (3 filings since Feb 14, 2022)
  • CITADEL ADVISORS LLC Filed SC 13G/A on Coherus BioSciences (United States), latest Feb 14, 2024 (2 filings since May 19, 2023)
  • State Street Corporation Filed SC 13G/A on Coherus BioSciences (United States), latest Jan 22, 2024 (3 filings since Feb 9, 2022)
  • JPMorgan Chase Filed SC 13G/A on Coherus BioSciences (United States), latest Dec 7, 2023 (3 filings since Jan 7, 2022)
  • PERCEPTIVE ADVISORS LLC Filed SC 13G/A on Coherus BioSciences (United States), latest Feb 14, 2023 (2 filings since Feb 15, 2022)
  • Coherus BioSciences (United States) Redwood City
    • Surface Oncology, LLC Subsidiary · Delaware, United States

Built from 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 Coherus BioSciences (United States) 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, net$1.3M6 Dec 31, 2025$2.6M6 Dec 31, 2024−47.8%
Operating-lease assets (leased space)$3.0M6 Dec 31, 2025$4.5M6 Dec 31, 2024−34.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$88.9M6 Dec 31, 2025$126.0M6 Dec 31, 2024−29.5%
Marketable securities, current$83.2M6 Dec 31, 2025$14.9M10 Dec 31, 2023+460.3%
Debt securities available for sale$163.2M6 Dec 31, 2025$104.3M10 Dec 31, 2023+56.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Indefinite-lived intangibles (excluding goodwill)$26.2M6 Dec 31, 2025$28.9M6 Dec 31, 2024−9.1%
Accumulated amortization$5.0M6 Dec 31, 2025$2.7M6 Dec 31, 2024+83.9%
Finite-lived intangibles, net$20.0M6 Dec 31, 2025$24.8M6 Dec 31, 2024−19.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$3.2M6 Dec 31, 2025$4.2M6 Dec 31, 2024−24.6%
Raw materials$18.0M10 Dec 31, 2024$13.0M10 Dec 31, 2023+38.8%
Work in process$83.2M10 Dec 31, 2024$82.6M10 Dec 31, 2023+0.7%
Finished goods$3.2M6 Dec 31, 2025$4.2M6 Dec 31, 2024−23.8%

Properties, in its own words

Our headquarters are located in Redwood City, California, where we occupy office space under a lease that will expire in September 2027. Our analytical and process development laboratory is located in Camarillo, California under a lease that expires in May 2027, and contains a one-time option to extend the lease term for five years.

We believe that our existing facilities are adequate for our current needs. In conjunction with the expiration of our leases or changes in our business, we may exercise our renewal option or look for additional or alternate space for our operations. We believe that suitable additional or alternative space will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 9, 2026.5

Leadership

Who has led Coherus BioSciences (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Dennis M. Lanfear2015–now

President

  1. Dennis M. Lanfear2015–now

Chief financial officer

  1. Jean-Frederic Viret2014–2021
  2. McDavid Stilwell2021–2024
  3. Bryan J. McMichael2024–now

Chief operating officer

  1. Vincent R. Anicetti2018–2021
201520202025
Board members and other officers (26)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

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

Former names

  • Coherus BioSciences, Inc.Jan 14, 2013 to May 28, 20253
  • BioGenerics, Inc.Feb 23, 2011 to Jan 3, 20123

Timeline

  1. Aug 28, 20268-K Other events44
  2. Aug 17, 20268-K Entered a material agreement; Ended a material agreement; New debt or obligation45
  3. Aug 17, 20268-K Regulation FD disclosure; Other events46
  4. Aug 5, 20268-K Results of operations47
  5. Jun 15, 20268-K Change of auditor48
  6. Jun 1, 20268-K Shareholder vote49
  7. May 11, 20268-K Results of operations50
  8. Mar 9, 20268-K Results of operations51
  9. Feb 17, 20268-K Other events52
  10. Feb 4, 20268-K Other events53
  11. Jan 23, 20268-K Other events54
  12. Jan 13, 20268-K Results of operations55
  13. Mar 12, 2015New chief executive Dennis M. Lanfear becomes CEO14
  14. 2010Founded Founded1

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.38) a share, on Nov 6, 2025.56

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results47
  2. May 11, 2026Reported quarterly or annual results50
  3. Mar 9, 2026Reported quarterly or annual results51
  4. Jan 13, 2026Reported quarterly or annual results55
  5. Nov 6, 2025Reported quarterly or annual results57
  6. Aug 7, 2025Reported quarterly or annual results58
  7. May 12, 2025Reported quarterly or annual results59
  8. Mar 10, 2025Reported quarterly or annual results60

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

335 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 87 major events, 115 insider forms, 38 large holders, 75 other. The latest 20:

  1. Aug 28, 20268-K EDGAR
  2. Aug 28, 2026424B5 EDGAR
  3. Aug 28, 2026424B3 EDGAR
  4. Aug 17, 20268-K EDGAR
  5. Aug 17, 20268-K EDGAR
  6. Aug 5, 2026S-8 EDGAR
  7. Aug 5, 202610-Q EDGAR
  8. Aug 5, 20268-K EDGAR
  9. Jul 27, 2026SCHEDULE 13G EDGAR
  10. Jun 15, 20268-K EDGAR
  11. Jun 9, 20264 EDGAR
  12. Jun 9, 20264 EDGAR
  13. Jun 9, 20264 EDGAR
  14. Jun 9, 20264 EDGAR
  15. Jun 9, 20264 EDGAR
  16. Jun 9, 20264 EDGAR
  17. Jun 9, 20264 EDGAR
  18. Jun 2, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Jun 2, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Jun 1, 20268-K EDGAR

The 335 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

3 open-market trades by officers, directors and large owners since October 2021: 0 buys and 3 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 23, 2025Wahlstrom MatsDirectorSale99,988$0.74$74.0KForm 4
Nov 22, 2023Lanfear Dennis MPresident & CEOSale223,100$2.02$450.7KForm 4
Oct 15, 2021Stilwell McDavidChief Financial OfficerSale3,507$16.80$58.9KForm 4

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
2025Dennis M. Lanfear70$2.7M73
2025Paul Reider$1.2M73
2025Bryan McMichael47$1.1M73
2024PresidentChief Executive Officer and Chairman of the Board of Directors$4.8M73
2024Former Chief Commercial Officer$1.7M73
2024Chief Financial Officer$1.0M73

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
Timothy G. Youngquist 2020 Irrevocable Trust13,050,623$18.3M3.7%+759,823
BlackRock, Inc.12,003,316$16.8M0.0%+1,638,242
Vanguard Capital Management LLC5,949,490$8.3M0.0%+496,728
Geode Capital Management, LLC3,685,567$5.2M0.0%+563,989
Samsara Biocapital, LLC3,428,571$4.8M0.4%No change
Kohlberg Kravis Roberts & Co. L.P.3,036,076$4.2M0.1%No change
State Street Corp2,382,305$3.3M0.0%+56,446
Two Sigma Investments, LP2,259,412$3.2M0.0%−42,589
CM Management, LLC2,100,000$2.9M1.9%No change
Alyeska Investment Group, L.P.1,733,234$2.4M0.0%−516,766
Hudson Bay Capital Management LP1,693,000$2.4M0.0%−11,980
Aqr Capital Management LLC1,330,201$1.9M0.0%+124,155
Charles Schwab Investment Management Inc1,228,069$1.7M0.0%+72,168
Panagora Asset Management Inc1,137,325$1.6M0.0%−321,985
Northern Trust Corp1,129,470$1.6M0.0%+215,670
Vanguard Fiduciary Trust Co1,015,991$1.4M0.0%+66,072
Nomura Asset Management International Inc.899,999$1.3M0.0%No change
Vanguard Portfolio Management LLC883,454$1.2M0.0%+278,929
UBS Group AG760,358$1.1M0.0%+213,149
Goldman Sachs Group Inc602,075$842.9K0.0%−94,083
Renaissance Technologies LLC563,056$788.3K0.0%+231,356
Strs Ohio395,600$553.8K0.0%+71,600
Bridgeway Capital Management, LLC391,000$547.4K0.0%−50,000
Invesco Ltd.353,922$495.5K0.0%+18,613
Bank of New York Mellon Corp319,687$447.6K0.0%+34,654

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

Members of Congress who traded it

1 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
Jan 23, 2023Shri ThanedarDemocratic, HouseSale$15,001 - $50,000+181.9%Report

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

SEC filer profile

How Coherus BioSciences (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARCoherus Oncology, Inc.2
  • CIK0001512762
  • Employer ID (EIN)27-36158215
  • Filer statusAccelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • 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 addressC/O Dennis M. Lanfear, 333 Twin Dolphin Dr, Suite 600, Redwood City, CA 940652
  • Phone(650) 649-35302
  • Shares outstanding154,500,966 as of Jul 31, 202612
  • Public float$81.9M as of Jun 30, 20255
  • AuditorErnst & Young LLP, San Francisco, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceFeb 23, 20112
  • Filings920 in all: 4 (344), 8-K (196), SC 13G/A (51), 10-Q (36), 3 (36), DEFA14A (23), S-8 (23), SC 13G (20)2
    All 48 form types

    CORRESP (17), 4/A (16), 424B5 (15), UPLOAD (15), 10-K (12), DEF 14A (12), CT ORDER (10), SCHEDULE 13G/A (9), 425 (8), D (8), EFFECT (8), S-1/A (6), 8-K/A (5), S-3 (5), SC 13D/A (5), ARS (4), SCHEDULE 13G (4), 3/A (3), DRS/A (3), 424B3 (2), 424B4 (2), FWP (2), S-1 (2), SC 13D (2), 10-Q/A (1), 144 (1), 8-A12B (1), CERTNAS (1), D/A (1), DEFM14A (1), DRS (1), DRSLTR (1), PRE 14A (1), PREM14A (1), S-1MEF (1), S-3/A (1), S-4 (1), S-4/A (1), SC TO-I (1), SC TO-I/A (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 20, 2026
    Latest 8-K (8-K) Aug 28, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareCHRSNasdaq

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Coherus BioSciences (United States) names in Item 1A of its 10-K filed Mar 9, 2026: 62 risks under these headings, as written.5

  • Risks Related to Our Financial Condition and Capital Requirements
  • We have a limited history of profitability, which we have not maintained and may not achieve again, and only one product that has been approved and marketed and with multiple product candidates that are not approved and still in development.
  • We continue to be dependent on the ability to raise funds. This additional funding may not be available on acceptable terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development and commercialization efforts or other operations.
  • Risks Related to Launch and Commercialization of our Product and our Product Candidates
  • We have a limited operating history in an emerging regulatory environment on which to assess our business.
  • The commercial success of our existing product or any future products will depend upon the degree of market acceptance and adoption by prescribing physicians, healthcare providers and the patients to whom our medicines are prescribed. Additionally, obtaining placement on national or local clinical guidelines/pathways, as well as coverage on third-party payor formularies, can impact our short and long-term financial performance.
  • The third-party coverage and reimbursement status of our product is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for any new products or our current product could limit our ability to market those products and decrease our ability to generate revenue.
  • Our product and our product candidates, even if approved, will remain subject to regulatory scrutiny.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, government shut-downs or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, and conduct inspections of manufacturing facilities, or otherwise prevent new or modified products from being developed, or approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Risks Related to Competitive Activity
  • Our product LOQTORZI and product candidates tagmokitug and casdozokitug, if approved, will face significant competition from other immuno-oncology biologics. If we fail to compete effectively, we may not achieve significant market penetration and expansion.
  • We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, less costly, easier to administer or more effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize our product candidates.
The other 53 risks
  • If other competitors to toripalimab (in indications besides those approved for LOQTORZI), casdozokitug and tagmokitug are approved and successfully commercialized before toripalimab (in indications besides those approved for LOQTORZI), casdozokitug and tagmokitug, our business would suffer.
  • Any product candidates for which we intend to seek approval as original biologic products may face competition sooner than anticipated.
  • Risks Related to Our Ability to Hire and Retain Highly Qualified Personnel
  • We are highly dependent on the services of our key executives and personnel, including our President and Chief Executive Officer, Dennis M. Lanfear, and if we are not able to retain these members of our management or recruit additional management, product development and scientific personnel, our business will suffer.
  • We may experience difficulties in managing changes in our number of employees, particularly due to employees departing due to divestitures, reductions in force and turnover, which could disrupt our operations.
  • Risks Related to Reliance on Third Parties
  • We rely on third parties, and in some cases a single third party, to manufacture nonclinical, clinical and commercial drug supplies of our product and product candidates and to store critical components of our product and product candidates for us. Our business could be harmed if those third parties fail to provide us with sufficient quantities of our product and product candidates or fail to do so at acceptable quality levels or prices.
  • We rely on third parties to conduct our nonclinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
  • We are dependent on Junshi Biosciences for the commercialization of our product and the failure to commercialize could have a material adverse effect on our business and operating results.
  • Risks Related to Our Future Operations Following the UDENYCA Sale
  • There is no guarantee that we will receive either of the Earnout Payments under the UDENYCA Purchase Agreement.
  • There are risks and uncertainties associated with the UDENYCA TSA, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows or stock price.
  • Risks Related to Manufacturing and Supply Chain
  • We are subject to a multitude of manufacturing risks and the risks of inaccurately forecasting sales of our product. Any adverse developments affecting the manufacturing operations of our product and product candidates,including the risks associated with transitioning our biomanufacturing processes from an offshoring business model to an onshoring business model, could substantially increase our costs and limit supply for our product and product candidates.
  • We currently engage single suppliers for manufacture, clinical trial services, formulation development and product testing of our product and product candidates. The loss of any of these suppliers or vendors could materially and adversely affect our business.
  • We and our collaboration partners and contract manufacturers are subject to significant regulation with respect to manufacturing our product candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements or may not be able to meet supply demands.
  • Risks Related to Adverse Events
  • Our product or our product candidates may cause undesirable side effects or have other properties that could, as applicable, delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if granted.
  • Adverse events involving another anti-PD-1 or PD-L1 antibody product may negatively affect our business.
  • Risks Related to Intellectual Property
  • If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed. Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • We may be involved in lawsuits or IPR proceedings to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • We may not be successful in obtaining or maintaining necessary rights to our product and product candidates through acquisitions and in-licenses.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • We are heavily dependent on the development, clinical success, regulatory approval and commercial success of our product candidates. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized.
  • The regulatory approval processes of the FDA, EMA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If we and our collaboration partners are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Clinical drug development involves a lengthy and expensive process and we may encounter substantial delays in our clinical studies or may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Failure to obtain regulatory approval in any targeted regulatory jurisdiction would prevent us from marketing our product to a larger patient population and reduce our commercial opportunities.
  • We may not be successful in our efforts to identify, develop or commercialize additional product candidates.
  • We may fail to obtain orphan drug designations from the FDA for our product candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • Risks Related to Our Compliance with Applicable Laws
  • Healthcare reform measures, including the IRA and the OBBBA, may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product, affect the prices we may set, and have a material adverse effect on our business and results of operations.
  • We may be subject, directly or indirectly, to federal and state healthcare laws, including fraud and abuse, false claims and physician payment transparency laws. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the United States, we could be subject to additional reimbursement requirements, penalties, sanctions and fines which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Risks Related to Ownership of Our Common Stock
  • The market price of our common stock may be highly volatile, and purchasers of our common stock could incur substantial losses.
  • Our indebtedness could adversely affect our financial condition, our ability to raise additional capital to fund our operations, our ability to operate our business, our ability to react to changes in the economy or our industry and our ability to pay our debts and could divert our cash flow from operations for debt payments.
  • Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans and convertible notes, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our business operations, financial condition, results of operations and prospects.
  • We do not intend to pay cash dividends on our common stock so any returns would be limited to the value of our stock.
  • Provisions in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.
  • General Risk Factors
  • We depend on a limited number of wholesalers for a significant amount of our total revenue, and if we lose any of our significant wholesalers, our business could be harmed.
  • The international aspects of our business expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • So called “submarine” patents may be granted to our competitors that may significantly alter our launch timing expectations, reduce our projected market size, cause us to modify our product or process or block us from the market altogether.
  • We may not identify relevant patents or may incorrectly interpret the relevance, scope or expiration of a patent, which might adversely affect our ability to develop and market our product.
  • Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our product and product candidates.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submissions, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If we are unable to maintain effective (non-patent) proprietary rights for our product and product candidates, we may not be able to compete effectively in our markets.
  • We may be subject to claims challenging the inventorship of our patent filings and other intellectual property.
  • We or the third parties upon whom we depend on may be adversely affected by earthquakes, wildfires or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • The continuation of the war in Ukraine and conflicts in the Middle East may exacerbate certain risks we face.
  • We incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives. We may fail to comply with the rules that apply to public companies, including Section 404 of the Sarbanes-Oxley Act of 2002, which could result in sanctions or other penalties that would harm our business.
  • Our information technology systems, or those used by our third-party CROs or other contractors or consultants, may fail or suffer security breaches and geopolitical tensions or conflicts, such as the ongoing war in Ukraine or conflicts in the Middle East, may create a heightened risk of cyberattacks.
  • We are subject to governmental regulation and other legal obligations related to privacy, data protection and information security. Compliance with these requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data, and the failure to comply with such requirements could have a material adverse effect on our business, financial condition or results of operations.
  • We may be negatively impacted by continued inflation.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

Legal proceedings

The information called for by this Item is incorporated herein by reference to Item 8. “Financial Statements and Supplementary Data,” Note 9, “Commitments and Contingencies.”

The opening of Item 3, Legal Proceedings.5

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