HRTX on Nasdaq

HERON THERAPEUTICS, INC. /DE/

In its 2026 annual report the company says: “We are a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard of care for acute care and oncology patients.”4 It is headquartered in San Diego, United States.2 Its shares trade on Nasdaq under the symbol HRTX.2

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Last updated Oct 21, 2026.

Overview

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  • TickerHRTX on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersSan Diego, United States2
  • Incorporated inDE3
  • Business address4242 Campus Point Court, Suite 200, San Diego, Ca 921213
  • Filer categoryAccelerated filer3
  • Legal formCorporation2
  • LEI549300DR2I1DOPD2IX532
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O UNITED STATES CORPORATION COMPANY, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 21168012

We are a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard of care for acute care and oncology patients.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

73.3%Gross margin5
-1.6%Operating margin5
-13.0%Net margin5
7.4%Revenue growth, 20255
-140.9%Return on equity5
-$27.9MFree cash flow5

What sells

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

Products and services

Cinvanti brought in 62% of the revenue HERON THERAPEUTICS, INC. /DE/ broke down this way in fiscal 2025.

  1. Cinvanti$96.8M562%down 3% from 2024
  2. Zynrelef$38.1M525%up 49% from 2024
  3. Aponvie$11.6M57%up 156% from 2024
  4. Sustol$8.5M55%down 40% from 2024
Products and services by year
Products and services202320242025
Cinvanti$94.9M$100.1M$96.8M
Zynrelef$17.7M$25.5M$38.1M
Aponvie$1.4M$4.5M$11.6M
Sustol$13.1M$14.1M$8.5M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue27¢$41.3M
  • Research and development8¢$12.4M
  • Other costs65¢$101.1M

Out of $154.9M in revenue.5 The company lost money this year.

Financial statements

Revenue6785$154.9M in 2025+6% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $146.0M$146.0M20192020: $88.6M$88.6M2020−39%2021: $86.3M$86.3M2021−3%2022: $107.7M$107.7M2022+25%2023: $127.0M$127.0M2023+18%2024: $144.3M$144.3M2024+14%2025: $154.9M$154.9M2025+7%
Gross profit85$113.6M in 2025+115% since 2022
0$50.0M$100.0M$150.0M2022: $52.8M$52.8M20222023: $61.9M$61.9M2023+17%2024: $105.6M$105.6M2024+71%2025: $113.6M$113.6M2025+7%
Operating income6785-$2.5M in 2025−99% since 2019
-$300.0M-$200.0M-$100.0M02019: -$210.7M-$210.7M20192020: -$228.2M-$228.2M2020+8%2021: -$217.8M-$217.8M2021−5%2022: -$174.7M-$174.7M2022−20%2023: -$110.6M-$110.6M2023−37%2024: -$11.5M-$11.5M2024−90%2025: -$2.5M-$2.5M2025−78%
Net income6785-$20.2M in 2025−90% since 2019
-$300.0M-$200.0M-$100.0M02019: -$204.7M-$204.7M20192020: -$227.3M-$227.3M2020+11%2021: -$220.7M-$220.7M2021−3%2022: -$182.0M-$182.0M2022−18%2023: -$110.6M-$110.6M2023−39%2024: -$13.6M-$13.6M2024−88%2025: -$20.2M-$20.2M2025+49%

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

Period ending2025-12-312024-12-312023-12-31
Net product sales$154.9M$144.3M$127.0M
Cost of product sales$41.3M$38.6M$65.1M
Gross profit$113.6M$105.6M$61.9M
Research and development$12.4M$16.7M$39.1M
General and administrative$54.6M$53.4M$65.8M
Sales and marketing$49.1M$47.1M$67.6M
Total operating expenses$116.1M$117.2M$172.6M
Loss from operations-$2.5M-$11.5M-$110.6M
Interest income$1.9M$3.5M$3.4M
Interest expense-$9.6M-$6.0M-$3.9M
Loss on debt extinguishment-$11.3M
Other income$1.3M$430.0K$560.0K
Total other (expense) income, net-$17.7M-$2.1M$56.0K
Net loss-$20.2M-$13.6M-$110.6M
Unrealized (losses) gains on short-term investments-$9.0K$32.0K
Comprehensive loss-$20.2M-$13.6M-$110.5M
Basic net loss per share-$0.12-$0.09-$0.80
Shares used in computing basic net loss per share166.7M shares152.4M shares138.1M shares
Diluted net loss per share-$0.12-$0.09-$0.80
Shares used in computing diluted net loss per share166.7M shares152.4M shares138.1M shares

Compare HERON THERAPEUTICS, INC. /DE/ with another company

Corporate structure

HERON THERAPEUTICS, INC. /DE/ 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 HERON THERAPEUTICS, INC. /DE/

  • Adage Capital Management, L.P. Filed SCHEDULE 13G/A on HERON THERAPEUTICS, INC. /DE/, latest May 13, 2026 (2 filings since Nov 12, 2024)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Mar 27, 2026 (6 filings since Feb 10, 2022)
  • Clearline Capital LP Filed SCHEDULE 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Feb 17, 2026 (2 filings since Nov 26, 2025)
  • Rubric Capital Management LP Filed SCHEDULE 13D/A on HERON THERAPEUTICS, INC. /DE/, latest Oct 17, 2025 (6 filings since Feb 6, 2023)
  • BlackRock Filed SC 13G on HERON THERAPEUTICS, INC. /DE/, latest Nov 8, 2024 (5 filings since Feb 1, 2022)
  • BAKER BROS. ADVISORS LP Filed SC 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Feb 14, 2024 (2 filings since Feb 14, 2022)
  • Deep Track Capital, LP Filed SC 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Feb 14, 2024 (2 filings since Aug 19, 2022)
  • GREAT POINT PARTNERS LLC Filed SC 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Feb 14, 2024 (2 filings since Apr 13, 2023)
  • Franklin Templeton Investments Filed SC 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Feb 6, 2024 (3 filings since Feb 3, 2022)
  • JPMorgan Chase Filed SC 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Dec 7, 2023 (3 filings since Jan 24, 2022)
  • ArrowMark Colorado Holdings LLC Filed SC 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Feb 15, 2023 (2 filings since Feb 14, 2022)
  • TANG CAPITAL PARTNERS LP Filed SC 13G/A on HERON THERAPEUTICS, INC. /DE/, latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • HERON THERAPEUTICS, INC. /DE/ San Diego, 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 HERON THERAPEUTICS, INC. /DE/ 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
Construction in progress$1.7M5 Dec 31, 2025$2.6M5 Dec 31, 2024−34.6%
Property and equipment, before depreciation$25.3M5 Dec 31, 2025$32.7M5 Dec 31, 2024−22.7%
Accumulated depreciation$12.9M5 Dec 31, 2025$17.8M5 Dec 31, 2024−27.8%
Property and equipment, net$12.4M5 Dec 31, 2025$14.9M5 Dec 31, 2024−16.6%
Operating-lease assets (leased space)$05 Dec 31, 2025$2.8M5 Dec 31, 2024−100.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$28.6M5 Dec 31, 2025$25.8M5 Dec 31, 2024+11.0%
Marketable securities, current$18.0M5 Dec 31, 2025$33.5M5 Dec 31, 2024−46.3%
Debt securities available for sale$18.0M5 Dec 31, 2025$33.5M5 Dec 31, 2024−46.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$92.7M5 Dec 31, 2025$53.2M5 Dec 31, 2024+74.5%
Raw materials$59.2M5 Dec 31, 2025$19.7M5 Dec 31, 2024+200.3%
Work in process$26.6M5 Dec 31, 2025$27.2M5 Dec 31, 2024−2.1%
Finished goods$6.9M5 Dec 31, 2025$6.2M5 Dec 31, 2024+10.4%

Properties, in its own words

We have an operating lease for 52,148 square feet of laboratory and office space in San Diego, California, which expired on December 31, 2025. In October 2021, we entered into a sublease agreement to sublet 23,873 square feet of laboratory and office space in San Diego, California. The space was delivered to the subtenant in March 2022. As a result of the sublease agreement, our one five-year option to renew this lease on expiration applied only with respect to our remaining 28,275 square feet of laboratory and office space.

We have a short-term operating lease for 9,882 square feet of office space in Cary, North Carolina, which was entered into in December 2025 and will expire on February 28, 2026.

The rest of Item 2

In August 2025, we entered into a lease agreement for 16,837 square feet of office space in Cary, North Carolina, with the lease term expected to commence no later than May 25, 2026 ("lease commencement date") and expire 111 months from the lease commencement date, with the option to extend for one additional period of 84 months upon written notice.

Item 2 of the 10-K filed Feb 26, 2026.4

Leadership

Who has led HERON THERAPEUTICS, INC. /DE/, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (30)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorChristian Waage named Aug 1, 202358

Former names

  • AP PHARMA INC /DE/Nov 13, 2001 to Jan 7, 20143
  • ADVANCED POLYMER SYSTEMS INC /DE/Feb 1, 1994 to Apr 6, 20013

Timeline

  1. Sep 29, 20268-K Entered a material agreement59
  2. Aug 14, 20268-K Entered a material agreement; Change to shareholders' rights60
  3. Aug 10, 20268-K Results of operations61
  4. Jun 25, 20268-K Listing notice or transfer62
  5. Jun 16, 20268-K Shareholder vote63
  6. Jun 2, 20268-K Other events64
  7. May 11, 20268-K Results of operations65
  8. Apr 6, 20268-K Executive or director change66
  9. Feb 26, 20268-K Results of operations67
  10. Jan 9, 20268-K Regulation FD disclosure68
  11. Nov 4, 20258-K Results of operations69
  12. Oct 29, 20258-K Executive or director change; Regulation FD disclosure70
  13. Apr 5, 2023New chief executive Craig A. Collard becomes CEO13
  14. May 3, 2013New chief executive Barry D. Quart becomes CEO14
  15. Jul 12, 2011New chief executive John Whelan becomes CEO15
  16. Jul 9, 2008New chief executive Ronald J. Prentki becomes CEO16
  17. Oct 10, 2006New chief executive Greg Turnbull becomes CEO18
  18. Jan 12, 2006New chief executive Michael Oconnell becomes CEO17
  19. Feb 5, 1987Founded HERON THERAPEUTICS, INC. /DE/ is founded2

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.05) a share, on Nov 4, 2025.71

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results61
  2. May 11, 2026Reported quarterly or annual results65
  3. Feb 26, 2026Reported quarterly or annual results67
  4. Nov 4, 2025Reported quarterly or annual results69
  5. Aug 8, 2025Reported quarterly or annual results72
  6. May 6, 2025Reported quarterly or annual results73
  7. Feb 27, 2025Reported quarterly or annual results74
  8. Nov 12, 2024Reported quarterly or annual results75

Drug trials and FDA: recently

  1. Oct 25, 2021Phase 3 trial completed Phase 3 trial of HTX-011, Ibuprofen and others in Analgesia: primary completion Oct 25, 2021, results posted Jun 4, 2026 (ClinicalTrials.gov NCT03907176).76

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

353 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 68 major events, 181 insider forms, 43 large holders, 1 private raises, 40 other. The latest 20:

  1. Sep 29, 20268-K EDGAR
  2. Aug 14, 20268-K EDGAR
  3. Aug 10, 20264 EDGAR
  4. Aug 10, 202610-Q EDGAR
  5. Aug 10, 20268-K EDGAR
  6. Aug 3, 20264 EDGAR
  7. Aug 3, 20264 EDGAR
  8. Aug 3, 20264 EDGAR
  9. Aug 3, 20264 EDGAR
  10. Jul 20, 20264 EDGAR
  11. Jul 20, 20264 EDGAR
  12. Jul 20, 20264 EDGAR
  13. Jun 25, 20268-K EDGAR
  14. Jun 17, 20264 EDGAR
  15. Jun 16, 20268-K EDGAR
  16. Jun 8, 20264 EDGAR
  17. Jun 2, 20268-K EDGAR
  18. May 13, 2026SCHEDULE 13G/A EDGAR
  19. May 11, 202610-Q EDGAR
  20. May 11, 20268-K EDGAR

The 353 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

10 open-market trades by officers, directors and large owners since October 2021: 7 buys and 3 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 8, 2025Morgan AdamDirectorBuy1,766,546$1.50$2.6MForm 4
Aug 8, 2025Rosen David Efraim10% ownerBuy2,387,225$1.50$3.6MForm 4
Nov 17, 2023Forbes William PEVP, Chief Development OfficerBuy25,000$1.09$27.2KForm 4
Nov 16, 2023Forbes William PEVP, Chief Development OfficerBuy50,000$0.94$47.0KForm 4
Nov 16, 2023Collard Craig AChief Executive OfficerBuy150,000$0.92$138.0KForm 4
Nov 16, 2023Duarte IraEVP, Chief Financial OfficerBuy85,000$0.89$75.7KForm 4
Jul 21, 2023Morgan AdamDirectorBuy2,486,744$1.37$3.4MForm 4
May 3, 2022MANHARD KIMBERLYEVP, Drug DevelopmentSale1,504$4.76$7.2KForm 4
Dec 21, 2021Christian WaageDirectorSale300$9.73$2.9KForm 4
Dec 21, 2021Johnson Craig ADirectorSale250$9.73$2.4KForm 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
2025Mark Hensley43$372.2K$4.3M92
2025Craig Collard,60$689.4K$3.5M92
2025William Forbes64$609.9K$1.7M92
2025Ira Duarte57$559.8K$1.6M92
2024Chief Executive Officer$669.5K$3.4M92
2024EVPChief Financial Officer$515.0K$1.4M92
2023Chief Executive Officer$493.0K$10.8M92
2023EVPChief Financial Officer$271.2K$1.5M92

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$30.0M 2023–2023
Money received by yearMoney received by year, 2023–2023: $30.0M in all. Private raises (Form D) $30.0M.$0$10M$20M$30M2023 · Private raises (Form D): $30.0M2023
Figures by year
YearPrivate raises (Form D)Total
2023$30.0M$30.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jul 25, 2023Raised $30 million in a private offering of equity58 Form D: 7 investors so far Form D

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
Rubric Capital Management LP30,046,828$12.8M0.1%No change
Clearline Capital LP11,383,961$4.9M0.3%−851,278
BlackRock, Inc.10,550,750$4.5M0.0%+444,328
Velan Capital Investment Management LP8,753,290$3.7M2.3%No change
Vanguard Capital Management LLC7,782,741$3.3M0.0%−27,588
Tejara Capital Ltd6,510,795$2.8M1.1%+174,040
Tang Capital Management LLC6,250,000$2.7M0.1%No change
Geode Capital Management, LLC4,270,980$1.8M0.0%+260,893
Millennium Management LLC4,070,101$1.7M0.0%−3,560,426
JW Asset Management, LLC3,751,073$1.6M0.5%No change
State Street Corp3,228,557$1.4M0.0%−615,115
UBS Group AG2,997,073$1.3M0.0%+711,190
Pale Fire Capital SE2,511,478$1.1M0.1%−204,850
Marshall Wace, Llp2,354,193$1.0M0.0%New
Congress Park Capital LLC2,016,447$860.6K0.2%−2,016,290
Richmond Brothers, Inc.1,792,319$765.0K0.4%+355,614
Vanguard Portfolio Management LLC1,580,510$674.9K0.0%+271,198
Aqr Capital Management LLC1,553,857$663.2K0.0%+912,270
Renaissance Technologies LLC1,506,900$643.1K0.0%−211,400
Vanguard Fiduciary Trust Co1,365,119$582.9K0.0%+212,405
Goldman Sachs Group Inc1,329,754$567.5K0.0%+272,810
Panagora Asset Management Inc1,281,796$547.1K0.0%+319,291
Northern Trust Corp1,223,480$522.2K0.0%+50,955
Charles Schwab Investment Management Inc1,217,463$519.6K0.0%−158,904
Qube Research & Technologies Ltd1,021,092$435.8K0.0%+990,737

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
Mar 31, 2021Ashley Hinson ArenholzRepublican, HouseSale$1,001 - $15,000+192.4%Report

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

SEC filer profile

How HERON THERAPEUTICS, INC. /DE/ is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARHERON THERAPEUTICS, INC. /DE/1
  • CIK0000818033
  • Employer ID (EIN)94-28755664
  • 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 address4242 Campus Point Court, Suite 200, San Diego, CA 921211
  • Phone85825144001
  • Shares outstanding189,852,307 as of Aug 5, 202610
  • Public float$235.1M as of Jun 30, 20254
  • AuditorWithumSmith+Brown, PC, Orlando, Florida PCAOB ID 100; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceFeb 1, 19941
  • Filings1,513 in all: 4 (510), 8-K (336), SC 13G/A (137), 10-Q (96), SC 13G (50), 3 (43), DEF 14A (34), 10-K (30)1
    All 53 form types

    S-8 (25), SC 13D/A (25), 424B5 (17), 424B3 (16), UPLOAD (16), EFFECT (15), S-3 (14), PRE 14A (12), 4/A (11), CORRESP (11), DEFA14A (11), 11-K (9), 5 (9), ARS (9), 10-K/A (6), 8-K/A (6), S-3/A (6), D (5), CT ORDER (4), SCHEDULE 13G/A (4), 3/A (3), 8-A12B/A (3), S-1 (3), S-1/A (3), S-3ASR (3), SC 13D (3), 10-C (2), 10-Q/A (2), 424B2 (2), 424B4 (2), 8-A12B (2), FWP (2), POS AM (2), SCHEDULE 13D/A (2), SCHEDULE 13G (2), 10-K405 (1), 25-NSE (1), 5/A (1), 8-A12G (1), CERTNAS (1), DEFR14A (1), NT 10-Q (1), PREC14A (1), PRER14A (1), RW (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01 per shareHRTXNasdaq

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks HERON THERAPEUTICS, INC. /DE/ names in Item 1A of its 10-K filed Feb 26, 2026: 54 risks under these headings, as written.4

  • Risks Related to Our Business
  • We are substantially dependent on the commercial success of our Products, and if these Products do not attain market acceptance by healthcare professionals and patients, our business and results of operations will suffer.
  • If we are unable to develop and maintain sales, marketing and distribution capabilities or enter into agreements with third parties to sell and market our Products, our sales may be adversely affected.
  • If we cannot maintain satisfactory pricing of our Products that is also acceptable to the U.S. government, insurance companies, managed care organizations and other payors, or arrange for favorable reimbursement policies, our product sales may be adversely affected and our future revenue may suffer.
  • If we fail to comply with our reporting and payment obligations under U.S. governmental pricing and contracting programs, we could be subject to additional reimbursement requirements, penalties and fines, which could have a negative impact on our business, financial condition, and results of operations.
  • If our suppliers or contract manufacturers are unable to manufacture in commercially viable quantities, we could face delays in our ability to commercialize our Products, our costs will increase and sales of our Products , may be severely hindered.
  • We depend on third-party suppliers and contract manufacturers to manufacture our Products, and we expect to do the same for any future products that we develop; if our contract manufacturers do not perform as expected, our business could suffer.
  • Certain of the components used in the manufacture of our Products are, or might be, sourced from a single vendor, and the loss or disruption of this vendor could significantly harm our business.
  • Some of our suppliers may experience disruption to their respective supply chains due to the adverse events or conditions, including the effects of a pandemic or disease outbreak, the imposition of tariffs and other trade protective measures, rising geopolitical tensions, armed conflict, regulatory and policy changes or other factors, which could delay, prevent or impair our development or commercialization efforts.
  • We have, or may have, significant inventory levels of drug products, and write-downs related to the impairment of those inventories may adversely impact or delay our profitability.
  • It is difficult to predict commercial demand for our Products, and, if our estimates of demand are too low, it may adversely impact our ability to generate revenue and profits in the short term and our ability to establish and maintain a competitive position in the relevant markets where our Products are sold, or may be sold, in the future.
  • We face intense competition from other companies developing products for the management of postoperative pain or the prevention of CINV and PONV, which may limit our ability to sell our Products.
The other 43 risks
  • Our Products may face competition from lower-cost generic products offered by our competitors, which may limit our ability to sell our Products or require us to reduce our pricing.
  • Our business and results of operations may suffer as a result of changes in our pricing or marketing strategies.
  • Guidelines and recommendations published by various organizations could reduce the demand for or use of our Products.
  • Because the results of preclinical studies and clinical trials are not necessarily predictive of future results, we can provide no assurances that our Products or product candidates will have favorable results in future studies or receive regulatory approval or expansion of approved indications.
  • Interim, topline or preliminary data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Although the FDA might grant Fast Track, Breakthrough Therapy and Priority Review or similar designations to our Products and product candidates, there can be no assurance that any of our Products or product candidates that receive similar designations in the U.S. or in any other regulatory jurisdictions will receive regulatory approval any sooner than other Products or product candidates that do not have such designations, or at all.
  • Our product platforms or product development efforts may not produce safe, efficacious or commercially viable products, and, if we are unable to develop new products, our business may suffer.
  • We rely on third parties to conduct our preclinical testing and conduct our clinical trials, and their failure to perform their obligations in a timely and competent manner may delay development and commercialization of our Products and product candidates and our business could be substantially harmed.
  • If we are unable to recruit and retain skilled employees, we may not be able to achieve our objectives.
  • Our business strategy may include acquisitions of other businesses, products or product licenses. We may not be able to successfully manage such activities.
  • Our business strategy may include entry into collaborative agreements. We may not be able to enter into collaborative agreements or may not be able to negotiate commercially acceptable terms for these agreements.
  • Natural or man-made disasters, including severe weather, epidemics, pandemics, cyber attacks, acts of war or terrorism, armed conflict, federal workforce uncertainty, or resource shortages, could disrupt our investigational drug candidate development and approved drug commercialization efforts or have other negative consequences on our business and adversely affect results.
  • Our potential international expansion of our business may expose us to new business, regulatory, political, operational, financial and economic risks associated with such expansion and could adversely affect our business, financial condition, results of operations and growth.
  • Risks Related to Our Financial Condition
  • We have a history of losses, we expect to generate losses in the near future, and we may never achieve or maintain profitability.
  • Additional capital may be needed in the future to enable us to implement our business plan, and we may be unable to raise capital, which would force us to limit or cease our operations.
  • Provisions contained in our debt instruments limit our ability to incur additional indebtedness.
  • We could be exposed to significant product liability claims that could be time-consuming and costly to defend, divert management attention and adversely impact our ability to obtain and maintain insurance coverage.
  • If any of our services providers are characterized as employees, we would be subject to employment and tax withholding liabilities and other additional costs.
  • Changes to existing tax laws, or challenges to our tax positions could adversely affect our business and financial condition.
  • The investment of our cash is subject to risks, which may cause losses or adversely affect the liquidity of these investments and our results of operations, liquidity and financial condition.
  • 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 current and projected business operations and its financial condition and results of operations.
  • Risks Related to Our Industry
  • Failure to obtain regulatory approval in international jurisdictions would prevent our Products from being marketed abroad.
  • If we fail to comply with continuing federal, state and foreign regulations with respect to our Products for which we obtain regulatory approval, we could lose our approvals to market drugs, and our business would be seriously harmed.
  • The commercial use of our Products may cause unintended side effects or adverse reactions, or incidents of misuse may occur, which could adversely affect our business.
  • The pharmaceutical industry is subject to significant regulation and oversight pursuant to anti-kickback laws, false claims statutes and anti-corruption laws, which may result in significant additional expense and limit our ability to commercialize our Products. In addition, any failure to comply with these regulations could result in substantial fines or penalties.
  • We may incur significant liability if it is determined that we are promoting the "off-label" use of drugs or promoting in a non-truthful and misleading way.
  • Healthcare reform could increase our expenses and adversely affect the commercial success of our Products.
  • Drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
  • Delays in, or suspensions and terminations of, clinical testing could increase our costs and delay our ability to obtain regulatory approval for, and commercialize, our product candidates.
  • Our use of hazardous materials could subject us to liabilities, fines and sanctions.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a negative impact on our business.
  • We are and may become subject to stringent and evolving laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse business consequences.
  • Security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer.
  • Changes in government policies, laws, and regulations and with respect to the government workforce may have a negative impact on our business and the markets in which we operate.
  • Risks Related to Our Intellectual Property
  • If we are unable to adequately protect or enforce our intellectual property rights, we may lose valuable assets or incur costly litigation to protect our rights.
  • We may be subject to claims that we have infringed on the intellectual property rights of others, and any litigation could force us to stop developing or selling potential products and could be costly, divert management attention and harm our business.
  • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • Risks Related to Our Common Stock
  • The price of our common stock has been and may continue to be volatile.
  • Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may prevent attempts by our stockholders to replace or remove our current management.
  • Future utilization of net operating loss carryforwards or research and development credit carryforwards may be impaired due to changes in ownership.
  • Actions of activist stockholders could impact the pursuit of our business strategies, cause us to incur substantial costs, divert our management’s attention and resources, and adversely affect our business, results of operations, liquidity, financial condition, and the trading price of our common stock.
  • If we identify a material weakness in our internal control over financial reporting, our ability to meet our reporting obligations and the trading price of our common stock could be negatively affected.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be the source of gain for our stockholders.

Legal proceedings

On June 14, 2022, the Company received a Paragraph IV notice of certification (the “Fresenius Kabi Notice”) from Fresenius Kabi advising that Fresenius Kabi had submitted an abbreviated new drug application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S. prior to the expiration of U.S. Patent Nos.: 9,561,229; 9,808,465; 9,974,742; 9,974,793; 9,974,794; 10,500,208; 10,624,850; 10,953,018; and 11,173,118 (the “CINVANTI Patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). The Fresenius Kabi Notice alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Fresenius Kabi’s ANDA.

On July 27, 2022, the Company filed a complaint for patent infringement of the CINVANTI Patents against Fresenius Kabi and a related entity in the U.S. District Court for the District of Delaware (the “Court”) in response to Fresenius Kabi’s ANDA filing. The complaint seeks, among other relief, equitable relief enjoining Fresenius Kabi from infringing the CINVANTI Patents. On May 15, 2024, the Court granted partial summary judgment of infringement for the Company and found no indefiniteness of U.S. Patent Nos. 9,561,229 and 9,974,794. On June 24, 2024, the parties commenced a four-day bench trial centered on Fresenius Kabi’s defense of obviousness of claims from U.S. Patent Nos. 9,561,229 and 9,974,794 that cover CINVANTI. Oral argument was held on August 29, 2024.

The opening of Item 3, Legal Proceedings.4

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