RIGL on Nasdaq

RIGEL PHARMACEUTICALS INC

In its 2026 annual report the company says: “We are a biotechnology company dedicated to developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. We focus on products that address signaling pathways that are critical to disease mechanisms.”4 It is headquartered in San Francisco, United States.2 Its shares trade on Nasdaq under the symbol RIGL.2

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Last updated Oct 21, 2026.

Overview

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  • TickerRIGL on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersSan Francisco, United States2
  • Incorporated inDE3
  • Business address611 Gateway Boulevard, Suite 900, South San Francisco, Ca 940803
  • Filer categoryAccelerated filer3
  • Legal formCorporation2
  • LEI529900KPTNUS5J8K9K662
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o NORTHWEST REGISTERED AGENT SERVICE, INC., 19901 Dover, United States2
  • Registered withDivision of Corporations, Department of State, 26263462

We are a biotechnology company dedicated to developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. We focus on products that address signaling pathways that are critical to disease mechanisms.4 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

42.6%Operating margin5
124.7%Net margin5
64.1%Revenue growth, 20255
93.8%Return on equity5
0.13×Debt to equity5

What sells

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

Products and services

Gross Product brought in 83% of the revenue RIGEL PHARMACEUTICALS INC broke down this way in fiscal 2025.

  1. Gross Product$310.0M583%up 48% from 2024
  2. Release Of Share Cost Liability$40.0M511%
  3. Royalty Delivery Of Drug Supplies And Others$19.1M55%down 6% from 2024
  4. Development Milestones$3.0M51%
  5. Government Contract$265.0K50%
Products and services by year
Products and services202320242025
Gross Product$147.1M$209.9M$310.0M
Release Of Share Cost Liability$0$0$40.0M
Royalty Delivery Of Drug Supplies And Others$11.4M$20.4M$19.1M
Development Milestones$75.0K$0$3.0M
Government Contract$1.1M$0$265.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue3¢$19.6M
  • Research and development4¢$33.3M
  • Selling, general and admin15¢$115.9M
  • Income tax31¢$245.2M
  • Profit47¢$367.0M

Out of $294.3M in revenue.5

Where each dollar of operating cash went, fiscal 2025

  • Kept or used elsewhere100¢$75.7M

Out of $75.7M of cash from operations.5

Financial statements

Revenue67895$294.3M in 2025+396% since 2019
0$100.0M$200.0M$300.0M2019: $59.3M$59.3M20192020: $108.6M$108.6M2020+83%2021: $149.2M$149.2M2021+37%2022: $120.2M$120.2M2022−19%2023: $116.9M$116.9M2023−3%2024: $179.3M$179.3M2024+53%2025: $294.3M$294.3M2025+64%
Operating income67895$125.5M in 2025
-$100.0M-$50.0M0$50.0M$100.0M$150.0M2019: -$69.1M-$69.1M20192020: -$29.0M-$29.0M2020−58%2021: -$12.5M-$12.5M2021−57%2022: -$55.5M-$55.5M2022+345%2023: -$20.5M-$20.5M2023−63%2024: $24.2M$24.2M20242025: $125.5M$125.5M2025+419%
Net income67895$367.0M in 2025
-$200.0M0$200.0M$400.0M2019: -$66.9M-$66.9M20192020: -$29.7M-$29.7M2020−56%2021: -$17.9M-$17.9M2021−40%2022: -$58.6M-$58.6M2022+227%2023: -$25.1M-$25.1M2023−57%2024: $17.5M$17.5M20242025: $367.0M$367.0M2025+1999%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Total revenues$294.3M$179.3M$116.9M
Cost of product sales$19.6M$18.6M$7.1M
Research and development$33.3M$23.4M$24.5M
Selling, general and administrative$115.9M$113.1M$105.7M
Total costs and expenses$168.8M$155.1M$137.4M
Income (loss) from operations$125.5M$24.2M-$20.5M
Interest income$3.7M$2.1M$2.3M
Interest expense-$7.3M-$7.9M-$6.9M
Income (loss) before income taxes$121.8M$18.4M-$25.1M
(Benefit from) provision for income taxes-$245.2M$881.0K$0
Net income (loss)$367.0M$17.5M-$25.1M
Basic (in dollars per share)$20.40$0.99-$1.44
Diluted (in dollars per share)$19.48$0.99-$1.44
Basic (in shares)18.0M shares17.6M shares17.4M shares
Diluted (in shares)18.8M shares17.7M shares17.4M shares

Compare RIGEL PHARMACEUTICALS INC with another company

Corporate structure

RIGEL PHARMACEUTICALS INC sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of RIGEL PHARMACEUTICALS INC

  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on RIGEL PHARMACEUTICALS INC, latest Aug 14, 2026 (9 filings since Feb 14, 2023)
  • Soleus Capital Master Fund, L.P. Filed SCHEDULE 13G/A on RIGEL PHARMACEUTICALS INC, latest Aug 13, 2026 (7 filings since Feb 22, 2023)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on RIGEL PHARMACEUTICALS INC, latest Mar 27, 2026 (4 filings since Feb 10, 2022)
  • State Street Corporation Filed SCHEDULE 13G on RIGEL PHARMACEUTICALS INC, latest Feb 9, 2026 (5 filings since Feb 14, 2022)
  • Morgan Stanley Filed SCHEDULE 13G/A on RIGEL PHARMACEUTICALS INC, latest Oct 7, 2025 (2 filings since Feb 9, 2024)
  • BlackRock Filed SCHEDULE 13G/A on RIGEL PHARMACEUTICALS INC, latest Apr 17, 2025 (5 filings since Feb 1, 2022)
  • Invesco Filed SCHEDULE 13G/A on RIGEL PHARMACEUTICALS INC, latest Feb 7, 2025 (2 filings since Nov 8, 2024)
  • Goldman Sachs Filed SC 13G/A on RIGEL PHARMACEUTICALS INC, latest Feb 5, 2024 (2 filings since Feb 14, 2023)
  • FMR LLC Filed SC 13G/A on RIGEL PHARMACEUTICALS INC, latest Jun 12, 2023 (4 filings since Feb 9, 2022)
  • MILLENNIUM MANAGEMENT LLC Filed SC 13G on RIGEL PHARMACEUTICALS INC, latest Sep 22, 2022
  • RIGEL PHARMACEUTICALS INC San Francisco, California, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What RIGEL PHARMACEUTICALS INC 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$347.0K5 Dec 31, 2025$353.0K5 Dec 31, 2024−1.7%
Accumulated depreciation$317.0K5 Dec 31, 2025$261.0K5 Dec 31, 2024+21.5%
Property and equipment, net$30.0K5 Dec 31, 2025$92.0K5 Dec 31, 2024−67.4%
Operating-lease assets (leased space)$920.0K5 Dec 31, 2025$246.0K5 Dec 31, 2024+274.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$40.6M5 Dec 31, 2025$56.7M5 Dec 31, 2024−28.5%
Marketable securities, current$114.4M5 Dec 31, 2025$20.6M5 Dec 31, 2024+455.9%
Debt securities available for sale$120.4M5 Dec 31, 2025$40.8M5 Dec 31, 2024+195.2%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, gross$30.4M5 Dec 31, 2025$30.4M5 Dec 31, 20240%
Accumulated amortization$5.6M5 Dec 31, 2025$3.3M5 Dec 31, 2024+72.1%
Finite-lived intangibles, net$24.7M5 Dec 31, 2025$27.1M5 Dec 31, 2024−8.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$11.5M5 Dec 31, 2025$6.0M5 Dec 31, 2024+91.7%
Raw materials$4.5M5 Dec 31, 2025$1.1M5 Dec 31, 2024+319.1%
Work in process$3.9M5 Dec 31, 2025$1.2M5 Dec 31, 2024+218.9%
Finished goods$4.7M5 Dec 31, 2025$5.0M5 Dec 31, 2024−6.0%

Properties, in its own words

We lease a 13,670 rentable square feet office space located at 611 Gateway Boulevard, Suite 900, South San Francisco, California, which lease expires in July 2027. The lease was originally entered into with 611 Gateway Center LLP (611 Gateway). In January 2026, Healthpeak OP, LLC (Healthpeak) assumed ownership of the property following its acquisition from 611 Gateway. This facility currently serves as our corporate headquarters. We believe the facility is in good operating condition and is adequate to meet our current and near-term operational needs.

Item 2 of the 10-K filed Mar 3, 2026.4

Leadership

Who has led RIGEL PHARMACEUTICALS INC, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (31)

Timeline

  1. Aug 4, 20268-K Results of operations50
  2. Jul 1, 20268-K Executive or director change51
  3. Jun 17, 20268-K Completed an acquisition or sale52
  4. May 20, 20268-K Executive or director change; Shareholder vote53
  5. May 12, 20268-K Entered a material agreement54
  6. May 5, 20268-K Results of operations55
  7. Apr 21, 20268-K Ended a material agreement56
  8. Mar 3, 20268-K Results of operations57
  9. Feb 3, 20268-K Executive or director change58
  10. Jan 12, 20268-K Results of operations; Other events59
  11. Dec 10, 20258-K Other events60
  12. Nov 4, 20258-K Results of operations61
  13. Jan 28, 2015New chief executive Raul R. Rodriguez becomes CEO14
  14. Jan 27, 2006New chief executive James M. Gower becomes CEO15

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $1.46 a share, on Nov 4, 2025.62

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results50
  2. May 5, 2026Reported quarterly or annual results55
  3. Mar 3, 2026Reported quarterly or annual results57
  4. Jan 12, 2026Reported quarterly or annual results59
  5. Nov 4, 2025Reported quarterly or annual results61
  6. Aug 5, 2025Reported quarterly or annual results63
  7. May 6, 2025Reported quarterly or annual results64
  8. Mar 4, 2025Reported quarterly or annual results65

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

Filings

296 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 58 major events, 136 insider forms, 41 large holders, 41 other. The latest 20:

  1. Sep 3, 20264 EDGAR
  2. Sep 3, 20264 EDGAR
  3. Sep 3, 20264 EDGAR
  4. Sep 3, 20264 EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 13, 2026SCHEDULE 13G/A EDGAR
  7. Aug 4, 2026S-8 EDGAR
  8. Aug 4, 20268-K EDGAR
  9. Aug 4, 202610-Q EDGAR
  10. Jul 10, 20264 EDGAR
  11. Jul 1, 20268-K EDGAR
  12. Jun 24, 20264 EDGAR
  13. Jun 22, 2026144 EDGAR
  14. Jun 22, 20264 EDGAR
  15. Jun 22, 20264 EDGAR
  16. Jun 22, 20264 EDGAR
  17. Jun 22, 20264 EDGAR
  18. Jun 22, 20264 EDGAR
  19. Jun 17, 20268-K EDGAR
  20. Jun 3, 20264 EDGAR

The 296 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

22 open-market trades by officers, directors and large owners since October 2021: 1 buys and 21 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 22, 2026Ali-Jackson KamilDirectorSale2,500$35.00$87.5KForm 4
May 26, 2026Ali-Jackson KamilDirectorSale2,500$29.17$72.9KForm 4
Feb 20, 2026MOOS WALTER HDirectorSale4,000$36.36$145.4KForm 4
Feb 5, 2025Schorno Dean LEVP & Chief Financial OfficerSale1,734$21.93$38.0KForm 4
Feb 5, 2025Santos David AEVP, Chief Commercial OfficerSale1,796$21.93$39.4KForm 4
Feb 5, 2025RODRIGUEZ RAUL RCEO, PresidentSale4,400$21.93$96.5KForm 4
Feb 5, 2025Furey Raymond J.EVP, GC, CCO & Corp SecSale1,339$21.93$29.4KForm 4
Feb 4, 2025Schorno Dean LEVP & Chief Financial OfficerSale2,036$20.92$42.6KForm 4
Feb 4, 2025Santos David AEVP, Chief Commercial OfficerSale2,125$20.92$44.5KForm 4
Feb 4, 2025RODRIGUEZ RAUL RCEO, PresidentSale4,952$20.92$103.6KForm 4
Feb 4, 2025Furey Raymond J.EVP, GC, CCO & Corp SecSale1,448$20.92$30.3KForm 4
Feb 5, 2024Santos David AEVP, Chief Commercial OfficerSale8,918$1.14$10.2KForm 4
Feb 5, 2024Schorno Dean LEVP & Chief Financial OfficerSale7,027$1.14$8.0KForm 4
Feb 5, 2024RODRIGUEZ RAUL RCEO, PresidentSale30,545$1.14$34.8KForm 4
Feb 2, 2024Santos David AEVP, Chief Commercial OfficerSale5,601$1.13$6.3KForm 4
Feb 2, 2024Schorno Dean LEVP & Chief Financial OfficerSale5,601$1.13$6.3KForm 4
Feb 2, 2024RODRIGUEZ RAUL RCEO, PresidentSale22,349$1.13$25.3KForm 4
Feb 6, 2023RODRIGUEZ RAUL RCEO, PresidentSale20,340$1.75$35.6KForm 4
Feb 2, 2023Santos David AEVP, Chief Commercial OfficerSale5,388$1.66$8.9KForm 4
Feb 2, 2023Schorno Dean LEVP & Chief Financial OfficerSale5,389$1.66$8.9KForm 4

All 22 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
2025Raul R. Rodriguez65$787.4K$4.7M76
2025David A. Santos63$515.9K$1.8M76
2025Lisa RojkjaerM.D.60$517.3K$1.8M76
2025Dean L. Schorno63$515.0K$1.8M76
2025Raymond J. Furey58$480.5K$1.8M76
2024President and Chief Executive Officer$757.0K$3.0M76
2024Executive VicePresident and Chief Financial Officer$495.1K$1.4M76
2024Executive Vice PresidentGeneral Counsel, Chief Compliance Officer and Corporate Secretary$462.0K$1.3M76
2023President and Chief Executive Officer$728.0K$3.4M76
2023Executive VicePresident and Chief Financial Officer$476.1K$1.2M76
2023Executive Vice PresidentGeneral Counsel, Chief Compliance Officer and Corporate Secretary$440.0K$683.0K76

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.1,939,818$75.9M0.0%+170,911
Soleus Capital Management, L.P.1,843,504$72.1M2.5%+1,833,504
Armistice Capital, LLC1,672,000$65.4M1.8%+392,000
State Street Corp1,039,994$40.7M0.0%−80,244
Vanguard Capital Management LLC785,107$30.7M0.0%+20,914
American Century Companies Inc741,718$29.0M0.0%+197,287
D. E. Shaw & Co., Inc.542,539$21.2M0.0%+96,861
Geode Capital Management, LLC483,175$18.9M0.0%+42,549
Marshall Wace, Llp367,393$14.4M0.0%−230,985
CM Management, LLC250,000$9.8M6.2%+15,000
Vanguard Portfolio Management LLC233,728$9.1M0.0%+86,193
Dimensional Fund Advisors LP227,951$8.9M0.0%−151,590
Goldman Sachs Group Inc226,780$8.9M0.0%−212,321
Two Sigma Investments, LP207,578$8.1M0.0%−198,229
Nomura Asset Management International Inc.195,000$7.6M0.0%New
Morgan Stanley186,049$7.3M0.0%+87,181
Charles Schwab Investment Management Inc154,627$6.0M0.0%−22,223
Northern Trust Corp146,381$5.7M0.0%+11,811
Renaissance Technologies LLC145,846$5.7M0.0%−192,595
O'shaughnessy Asset Management, LLC131,177$5.1M0.0%+5,515
Aqr Capital Management LLC124,801$4.9M0.0%+33,793
Bridgeway Capital Management, LLC124,184$4.9M0.1%New
Nuveen, LLC123,961$4.8M0.0%−213,466
Bank Of America Corp /de/123,506$4.8M0.0%−20,625
Franklin Resources Inc123,364$4.8M0.0%+9,486

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

SEC filer profile

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

  • Name on EDGARRIGEL PHARMACEUTICALS INC1
  • CIK0001034842
  • Employer ID (EIN)94-32485244
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address611 Gateway Boulevard, Suite 900, South San Francisco, CA 940801
  • Phone650-624-11001
  • Shares outstanding18,679,864 as of Jul 30, 202611
  • Public float$331.6M as of Jun 30, 20254
  • AuditorErnst & Young LLP, San Francisco, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceFeb 4, 20001
  • Filings1,462 in all: 4 (619), 8-K (253), SC 13G/A (131), 10-Q (77), SC 13G (41), 3 (32), S-8 (31), DEF 14A (26)1
    All 49 form types

    10-K (24), 424B5 (21), CT ORDER (20), DEFA14A (20), UPLOAD (14), 144 (12), S-3 (12), SCHEDULE 13G/A (12), 424B3 (11), CORRESP (11), 4/A (10), ARS (10), S-1/A (9), EFFECT (7), PRE 14A (4), REGDEX (4), S-3MEF (4), SCHEDULE 13G (4), 10-K/A (3), SC 13D (3), 10-K405 (2), 10-Q/A (2), 3/A (2), 424A (2), 424B2 (2), 8-A12G (2), 8-K/A (2), DEFR14A (2), POS AM (2), POSASR (2), S-1 (2), S-3/A (2), S-3ASR (2), SC 13D/A (2), SC TO-I/A (2), SEC STAFF LETTER (2), 424B4 (1), 5 (1), FWP (1), RW (1), SC TO-I (1)

  • Latest filingsAnnual report (10-K) Mar 3, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 3, 2026
    Latest 8-K (8-K) Aug 4, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $.001 per shareRIGLNasdaq

From the cover page of the 10-K filed Mar 3, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks RIGEL PHARMACEUTICALS INC names in Item 1A of its 10-K filed Mar 3, 2026: 58 risks under these headings, as written.4

  • Risks Related to Our Business and Our Industry
  • If the market opportunities for our products and product candidates are smaller than we believe they are, our revenues may be adversely affected, and our business may suffer.
  • We may need to continue to increase the size of our organization and we may encounter difficulties with managing our growth, which could adversely affect our business and results of operations.
  • Our strategy to expand our hematology and oncology pipeline on our own, or through acquisitions or in-licensing of early or late-stage products or companies, or through partnerships with pharmaceutical and biotechnology companies, as well as academic institutions and government organizations, may not be successful.
  • There is a high risk that drug discovery and development efforts might not generate successful product candidates.
  • We are subject to federal and state healthcare fraud and abuse laws, false claims laws and other federal and state healthcare laws, and the failure to comply with such laws could result in substantial penalties. Our employees, independent contractors, consultants, principal investigators, CROs, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We are subject to stringent and evolving privacy and information security laws, regulations, rules, policies, and contractual obligations, and changes in such laws, regulations, rules, policies, contractual obligations and our actual or perceived failure to comply with such requirements could subject us to significant investigations, fines, penalties and claims, any of which may have a material adverse effect on our business, financial condition, results of operations or prospects.
  • Significant changes or developments in US laws or policies, including changes in US healthcare regulation, may have a material adverse effect on our business.
  • The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
  • Enhanced governmental and public scrutiny over, or investigations or litigation involving, pharmaceutical manufacturer donations to patient assistance programs may require us to modify our programs and could negatively impact our business practices, harm our reputation, divert the attention of management and increase our expenses.
  • If manufacturers obtain approval for generic versions of our products, or of products with which we compete, our business may be harmed.
  • Unforeseen safety issues could emerge with our products that could require us to change the prescribing information to add warnings, limit use of the product, and/or result in litigation. Any of these events could have a negative impact on our business.
The other 47 risks
  • Our business could be materially and adversely affected by pandemics as a result of their potential impacts on our sales force and commercialization efforts, supply chain, regulatory, clinical development and corporate development activities and other business operations, in addition to the impact of a global economic slowdown.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the US, we could be subject to additional rebate or discount requirements, fines, sanctions and exposure under other laws which could have an adverse effect on our business, results of operations and financial condition.
  • Even for those product candidates that have or may receive regulatory approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.
  • We may need to seek additional capital in the future to sufficiently fund our operations, research and corporate development opportunities.
  • We have indebtedness in the form of a term loan pursuant to the Credit Agreement with MidCap, which could adversely affect our financial condition and our ability to respond to changes in our business. Further, if we are unable to satisfy certain conditions of the Credit Agreement, we will be unable to draw down the remainder of the facility.
  • We rely and may continue to rely on two distribution facilities for the sale of our products and potential sale of any of our product candidates.
  • Forecasting potential sales for any of our product candidates will be difficult, and if our projections are inaccurate, our business may be harmed, and our stock price may be adversely affected.
  • We do not and will not have access to all information regarding our products and product candidates we licensed to our collaboration partners.
  • Our future funding requirements will depend on many uncertain factors.
  • Our recent operating income may not be sustainable, and we may continue to incur significant losses.
  • If our corporate collaborations or license agreements are unsuccessful, or if we fail to form new corporate collaborations or license agreements, our research and development efforts could be delayed.
  • If conflicts arise between our collaborators or advisors and us, any of them may act in their self-interest, which may be adverse to our stockholders’ interests.
  • Our success is dependent on intellectual property rights held by us and third parties, and our interest in such rights is complex and uncertain.
  • If a dispute arises regarding the infringement or misappropriation of the proprietary rights of others, such dispute could be costly and result in delays in our research and development activities, partnering and commercialization activities.
  • Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
  • Our ability to use net operating losses (NOLs) and certain other tax attributes is uncertain and may be limited.
  • Changes in valuation allowance of deferred tax assets may affect our future operating results
  • Because we expect to be dependent upon collaborative and license agreements, we might not meet our strategic objectives.
  • Securities class action lawsuits or other litigation could result in substantial damages and may divert management’s time and attention from our business.
  • If our competitors develop technologies that are more effective than ours, our commercial opportunity will be reduced or eliminated.
  • Our stock price may be volatile, and our stockholders’ investment in our common stock could decline in value.
  • The withdrawal of the UK from the EU may adversely impact our ability to obtain regulatory approvals of our product candidates in the UK, result in restrictions or imposition of taxes and duties for importing our product candidates into the UK, and may require us to incur additional expenses in order to develop, manufacture and commercialize our product candidates in the UK.
  • If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
  • We depend on various scientific consultants and advisors for the success and continuation of our research and development efforts.
  • If we use biological and hazardous materials in a manner that causes injury or violates laws, we may be liable for damages, penalties or fines.
  • Our information technology systems, or those used by our CROs or other contractors or consultants, may fail or suffer other breakdowns, cyber-attacks, or information security breaches.
  • Future equity issuances or a sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.
  • Risks Related to Clinical Development and Regulatory Approval
  • Enacted or future legislation, and/or potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain regulatory approval of our product candidates and/or commercialize our products or our product candidates, once approved, and affect the prices we may set or obtain.
  • Regulatory approval for any approved product is limited by the FDA, the EC and other regulators to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and we may incur significant liability if it is determined that we are promoting the “off-label” use of our products or any of our future product candidates if approved.
  • Delays in clinical testing could result in increased costs to us.
  • A Fast Track designation by the FDA may not lead to a faster development or regulatory review and does not increase the likelihood that our product candidates will receive approval.
  • Public perception of the risk-benefit balance for our product candidates may be affected by adverse events in clinical trials involving our product candidate or other treatments.
  • We lack the capability to manufacture compounds for clinical development, and we rely on and intend to continue relying on third parties for commercial supply, manufacturing and distribution if any of our product candidates which receive regulatory approval and we may be unable to obtain required material or product in a timely manner, at an acceptable cost or at a quality level required to receive regulatory approval.
  • If any of our third-party contractors fail to perform their responsibilities to comply with FDA rules and regulations, the marketing and sales of our products could be delayed and we may be subject to enforcement action, which could decrease our revenues.
  • If we are unable to obtain regulatory approval to market products in the US and foreign jurisdictions, we will not be permitted to commercialize products we or our collaborative partners may develop.
  • We have orphan drug designations from the FDA but we may not be able to obtain additional orphan drug designations in the future, or maintain the orphan drug designations or exclusivity for the approved drugs for the treatment of respective indications, or we may be unable to maintain the benefits associated with orphan drug designations, including the potential for market exclusivity.
  • Risks Related to Commercialization
  • Our prospects are highly dependent on our commercial products. To the extent that the commercial success of our products in the US is diminished or is not commercially successful, our business, financial condition and results of operations may be adversely affected, and the price of our common stock may decline.
  • Even if we, or any of our collaborative partners, are able to continue to commercialize our products or any product candidate that we, or they, develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or labeling restrictions, all of which may vary from country to country and any of which could harm our business.
  • If we are unable to successfully market and distribute our products and retain experienced commercial personnel, our business will be substantially harmed.
  • We may not be able to successfully develop or commercialize our product candidates if problems arise in the clinical testing and approval process.
  • General Risk Factors
  • Global economic conditions could adversely impact our business.
  • Shareholder activism and private securities-related litigation could cause material disruption to our business.
  • Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult.
  • Our Bylaws designate a state or federal court located within the State of Delaware as the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our current or former directors, officers, stockholders, or other employees.
  • Increasing use of social media could give rise to liability and may harm our business.
  • Our future success depends on our ability to attract and retain key employees and relationships.
  • Our facilities are located near known earthquake fault zones, and the occurrence of an earthquake or other catastrophic disaster could cause damage to our facilities and equipment, which could require us to cease or curtail operations.

Legal proceedings

From time to time, we may be a party or subject to legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. Some of these proceedings that we may be involved in the future are claims that are subject to substantial uncertainties and unascertainable damages or other remedies.

Our threshold for disclosing material environmental legal proceedings involving a government authority where potential monetary sanctions are involved is $1.0 million.

In June 2022, we received a notice letter regarding an ANDA submitted to the FDA by Annora, requesting approval to market a generic version of TAVALISSE. The notice letter included a Paragraph IV certification with respect to our US Patent Nos. 7,449,458; 8,263,122; 8,652,492; 8,771,648 and 8,951,504, which are listed in the FDA’s Orange Book. The notice letter asserts that these patents will not be infringed by Annora’s proposed product, are invalid and/or are unenforceable. Annora’s notice letter does not provide a Paragraph IV certification against our other patents listed in the Orange Book. On July 25, 2022, we filed a lawsuit in the US District Court for the District of New Jersey against Annora and its affiliates, Hetero Labs Ltd., and Hetero USA, Inc., for infringement of our US patents identified in Annora’s Paragraph IV certification. On September 21, 2022, Annora and its affiliates answered and counterclaimed for declaratory judgment of non-infringement and invalidity of the ’458, ’122, ’492, ’648, and ’504 patents. We served an answer to Annora’s counterclaims in October 2022. Annora served invalidity and non-infringement contentions in December 2022. We served an answer to Annora’s invalidity and non-infringement contentions in March 2023.

The opening of Item 3, Legal Proceedings.4

Sources

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