AXSM on Nasdaq

Axsome Therapeutics

Axsome Therapeutics is an American biopharmaceutical company based in New York City, founded in 2012.1 Its shares trade on Nasdaq under the symbol AXSM.1

Price unavailable

Last updated Oct 21, 2026.

Overview

2012Founded1

Compare with Amicus Therapeutics, Legend Biotech or TG Therapeutics, or pick any stock.

  • TickerAXSM on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersNew York City1
  • Websiteaxsome.com
  • Incorporated inDE4
  • Business addressOne World Trade Center, 29Th Floor, New York, Ny 100074
  • Filer categoryLarge accelerated filer4
  • Legal formCorporation3
  • LEI549300EXGR0XLRJEIB953
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 50911623
Axsome Therapeutics image from its website
Image: axsome.com6

Certain matters discussed in this report, including matters discussed under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, and the Securities Exchange Act of 1934, as amended, or the Exchange Act, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-looking statements. The words “anticipate,” “believe,” “estimate,” “may,” “expect” and similar expressions are generally intended to identify forward-looking statements. Our actual results may differ materially from the results anticipated in these forward-looking statements due…7 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

-26.1%Operating margin8
-28.7%Net margin8
65.5%Revenue growth, 20258
-207.5%Return on equity8
1.33×Debt to equity8
-$93.9MFree cash flow8

What sells

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

Products and services

Product brought in 99% of the revenue Axsome Therapeutics broke down this way in fiscal 2025.

  1. Product$633.8M899%up 66% from 2024
  2. Royalty and Milestone Revenue$4.7M81%up 17% from 2024
Products and services by year
Products and services202320242025
Product$202.5M$381.7M$633.8M
Royalty and Milestone Revenue$2.4M$4.0M$4.7M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development24¢$183.3M
  • Selling, general and admin74¢$570.6M
  • Interest2¢$15.9M
  • Income tax0¢$530.0K

Out of $638.5M in revenue.8 The company lost money this year.

Financial statements

Revenue98$638.5M in 2025+1176% since 2022
0$200.0M$400.0M$600.0M$800.0M2022: $50.0M$50.0M20222023: $270.6M$270.6M2023+441%2024: $385.7M$385.7M2024+43%2025: $638.5M$638.5M2025+66%
Operating income10111298-$166.8M in 2025+148% since 2019
-$300.0M-$200.0M-$100.0M02019: -$67.2M-$67.2M20192020: -$99.1M-$99.1M2020+47%2021: -$124.7M-$124.7M2021+26%2022: -$179.8M-$179.8M2022+44%2023: -$231.8M-$231.8M2023+29%2024: -$280.6M-$280.6M2024+21%2025: -$166.8M-$166.8M2025−41%
Net income10111298-$183.2M in 2025+168% since 2019
-$300.0M-$200.0M-$100.0M02019: -$68.3M-$68.3M20192020: -$102.9M-$102.9M2020+51%2021: -$130.4M-$130.4M2021+27%2022: -$187.1M-$187.1M2022+44%2023: -$239.2M-$239.2M2023+28%2024: -$287.2M-$287.2M2024+20%2025: -$183.2M-$183.2M2025−36%

Every line of the income statement as filed: the last 3 fiscal years, latest first.8

Period ending2025-12-312024-12-312023-12-31
Revenue$638.5M$385.7M$270.6M
Cost of revenue (excluding amortization and depreciation)$47.5M$33.3M$26.1M
Research and development$183.3M$187.1M$97.9M
Selling, general and administrative$570.6M$411.4M$323.1M
Loss (Gain) in fair value of contingent consideration-$2.5M$28.1M$48.9M
Intangible asset amortization$6.4M$6.4M$6.4M
Total operating expenses$805.3M$666.3M$502.4M
Loss from operations-$166.8M-$280.6M-$231.8M
Interest expense, net-$6.6M-$6.6M-$6.5M
Loss on debt extinguishment-$10.4M
Loss before income taxes-$183.7M-$287.1M-$238.3M
Income tax benefit (expense)$530.0K-$85.0K-$960.0K
Net loss-$183.2M-$287.2M-$239.2M
Net loss per common share, basic-$3.68-$5.99-$5.27
Net loss per common share, diluted-$3.68-$5.99-$5.27
Weighted average common shares outstanding, basic49.7M shares47.9M shares45.4M shares
Weighted average common shares outstanding, diluted49.7M shares47.9M shares45.4M shares

Compare Axsome Therapeutics with another company

Corporate structure

Axsome Therapeutics sits at the top of its group. 5 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Axsome Therapeutics

  • Axsome Therapeutics New York, New York, United States
    • Axsome Canada, Inc. Subsidiary · Canada
    • Axsome International Holdings LLC Subsidiary · Delaware, United States
    • Axsome Malta Holdings Ltd. Subsidiary · Malta
    • Axsome Malta Ltd. Subsidiary · Malta

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

What it owns

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

Property and equipment

ItemLatestA year beforeChange
Property and equipment, net$562.0K8 Dec 31, 2025$584.0K8 Dec 31, 2024−3.8%
Finance-lease assets$6.6M8 Dec 31, 2025$4.3M9 Dec 31, 2024+53.5%
Operating-lease assets (leased space)$20.9M8 Dec 31, 2025$5.4M8 Dec 31, 2024+287.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$322.9M8 Dec 31, 2025$315.4M8 Dec 31, 2024+2.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$12.0M8 Dec 31, 2025$12.0M8 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$40.5M8 Dec 31, 2025$46.9M8 Dec 31, 2024−13.6%
Finite-lived intangibles, gross$63.8M8 Dec 31, 2025$63.8M8 Dec 31, 20240%
Accumulated amortization$23.3M8 Dec 31, 2025$16.9M8 Dec 31, 2024+37.7%
Finite-lived intangibles, net$40.5M8 Dec 31, 2025$46.9M9 Dec 31, 2024−13.6%

Inventory

ItemLatestA year beforeChange
Inventory, total$27.9M8 Dec 31, 2025$15.7M8 Dec 31, 2024+77.6%
Raw materials$10.4M8 Dec 31, 2025$9.5M8 Dec 31, 2024+8.8%
Work in process$17.8M8 Dec 31, 2025$7.7M8 Dec 31, 2024+130.9%
Finished goods$11.3M8 Dec 31, 2025$9.0M8 Dec 31, 2024+25.5%

Properties, in its own words

On February 21, 2023, we entered into a Sublease with Advance Magazine Publishers d/b/a Conde Nast for the entirety of the twenty-second floor of One World Trade Center in New York, NY (“Sublease”). This space is utilized by the Company for its corporate and executive offices. The Sublease commenced on April 7, 2023 and was for ten (10) years. The Company had a one-time option to terminate the Sublease on its fifth anniversary upon the payment of a fee to the sublandlord.

On January 17, 2025, we entered into an Amendment to our Sublease (the “First Amendment”), pursuant to which we will relinquish our existing space in One World Trade Center and commence occupancy of different space within the building. The First Amendment extends the Sublease expiration date to January 31, 2036. We now have a one-time option to terminate the Sublease effective March 30, 2031 upon the payment of a fee to the sublandlord. The Company is responsible for base rent under the Sublease and certain additional customary variable costs, such as an allocable portion of building taxes and operating expenses. In connection with the Sublease and First Amendment, the Company received certain rent and work concessions from the sublandlord.

Item 2 of the 10-K filed Feb 23, 2026.7

Leadership

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

Chief operating officer

  1. Mark L. Jacobson2020–now
201520202025
Board members and other officers (10)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Axsome Canada, Inc. Canada5
  • Axsome International Holdings LLC Delaware5
  • Axsome Malta Holdings Ltd. Malta5
  • Axsome Malta Ltd. Malta5

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

Timeline

  1. Aug 10, 20268-K Results of operations; Other events29
  2. Jul 15, 20268-K Other events30
  3. Jun 9, 20268-K Shareholder vote31
  4. Jun 9, 20268-K Executive or director change32
  5. Jun 3, 20268-K Other events33
  6. May 4, 20268-K Results of operations; Other events34
  7. Apr 30, 20268-K Other events35
  8. Apr 1, 20268-K Other events36
  9. Feb 23, 20268-K Results of operations37
  10. Feb 17, 20268-K Other events38
  11. Jan 12, 20268-K Results of operations; Other events39
  12. Dec 31, 20258-K Other events40
  13. Nov 19, 2015New chief executive Herriot Tabuteau becomes CEO16
  14. 2012Founded Founded1

Calendar

Coming up

  1. Nov 2, 2026 · Before the openReports results for the quarter ending Sep/2026 A year earlier it reported ($0.94) a share, on Nov 3, 2025.41

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results29
  2. May 4, 2026Reported quarterly or annual results34
  3. Feb 23, 2026Reported quarterly or annual results37
  4. Jan 12, 2026Reported quarterly or annual results39
  5. Nov 3, 2025Reported quarterly or annual results42
  6. Aug 4, 2025Reported quarterly or annual results43
  7. May 5, 2025Reported quarterly or annual results44
  8. Feb 18, 2025Reported quarterly or annual results45

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

Filings

350 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 99 major events, 118 insider forms, 21 large holders, 92 other. The latest 20:

  1. Sep 3, 2026144 EDGAR
  2. Sep 3, 20264 EDGAR
  3. Aug 10, 202610-Q EDGAR
  4. Aug 10, 20268-K EDGAR
  5. Aug 7, 20264 EDGAR
  6. Aug 6, 2026144 EDGAR
  7. Aug 5, 2026144 EDGAR
  8. Jul 27, 2026SCHEDULE 13G/A EDGAR
  9. Jul 15, 20268-K EDGAR
  10. Jul 1, 2026144 EDGAR
  11. Jul 1, 20264 EDGAR
  12. Jun 11, 2026144 EDGAR
  13. Jun 11, 20264 EDGAR
  14. Jun 10, 2026144 EDGAR
  15. Jun 10, 2026144 EDGAR
  16. Jun 10, 2026144 EDGAR
  17. Jun 10, 20264 EDGAR
  18. Jun 10, 20264 EDGAR
  19. Jun 10, 20264 EDGAR
  20. Jun 10, 20264 EDGAR

The 350 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

74 open-market trades by officers, directors and large owners since October 2021: 5 buys and 69 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 3, 2026Jacobson Mark L.Chief Operating OfficerSale10,000$208.65$2.1MForm 4
Aug 6, 2026TABUTEAU HERRIOTChief Executive OfficerSale4,660$213.95$997.0KForm 4
Aug 5, 2026TABUTEAU HERRIOTChief Executive OfficerSale45,004$212.01$9.5MForm 4
Jul 1, 2026TABUTEAU HERRIOTChief Executive OfficerSale49,666$240.25$11.9MForm 4
Jun 11, 2026JEFFS ROGERDirectorSale286$249.12$71.2KForm 4
Jun 10, 2026JEFFS ROGERDirectorSale286$246.18$70.4KForm 4
Jun 10, 2026Mahony SusanDirectorSale300$246.18$73.9KForm 4
Jun 10, 2026Coleman MarkDirectorSale643$249.00$160.1KForm 4
Jun 9, 2026Mahony SusanDirectorSale300$237.21$71.2KForm 4
Jun 9, 2026TABUTEAU HERRIOTChief Executive OfficerSale49,670$241.01$12.0MForm 4
Jun 9, 2026Pizzie NickChief Financial OfficerSale33,000$240.09$7.9MForm 4
Jun 2, 2026Coleman MarkDirectorSale5,537$223.39$1.2MForm 4
Jun 1, 2026Coleman MarkDirectorSale6,000$230.30$1.4MForm 4
May 29, 2026Coleman MarkDirectorSale6,000$233.46$1.4MForm 4
May 5, 2026Jacobson Mark L.Chief Operating OfficerSale233$228.18$53.2KForm 4
May 4, 2026Jacobson Mark L.Chief Operating OfficerSale4,517$227.94$1.0MForm 4
Apr 22, 2026Maizel AriChief Commercial OfficerSale7,500$182.42$1.4MForm 4
Feb 26, 2026Coleman MarkDirectorSale25,000$161.11$4.0MForm 4
Feb 26, 2026Jacobson Mark L.Chief Operating OfficerSale35,378$161.88$5.7MForm 4
Feb 2, 2026TABUTEAU HERRIOTChief Executive OfficerSale32,410$185.60$6.0MForm 4

All 74 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
2025Herriot TabuteauM.D.57$835.0K$10.3M53
2025Mark JacobsonM.A.42$575.0K$4.2M53
2025Nick PizzieC.P.A., M.B.A.51$530.0K$3.7M53
2025Hunter MurdockEsq.46$530.0K$3.2M53
2025Ari MaizelM.B.A.47$530.0K$3.2M53
2024Chief Executive Officer,$780.0K$10.4M53
2024Chief Operating Officer$552.0K$4.2M53
2024Chief Financial Officer$505.0K$3.8M53
2024General Counsel$505.0K$3.2M53
2024Chief Commercial Officer$510.0K$3.2M53
2023President and Chairman of the Board$750.0K$9.9M53
2023Chief Operating Officer$530.0K$4.0M53
2023Chief Commercial Officer$445.0K$3.9M53
2023Chief Financial Officer$485.0K$3.6M53
2023General Counsel$485.0K$3.1M53

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.3,103,708$759.7M0.0%−809,136
Vanguard Portfolio Management LLC1,983,514$485.5M0.0%−74,656
Vanguard Capital Management LLC1,965,086$481.0M0.0%+27,334
Invesco Ltd.1,671,684$409.2M0.0%+374,006
Fmr LLC1,539,163$376.7M0.0%−27,832
Geode Capital Management, LLC967,172$236.8M0.0%−195,809
Assenagon Asset Management S.A.909,364$222.6M0.1%+43,406
Morgan Stanley804,082$196.8M0.0%+327,381
State Street Corp785,661$192.3M0.0%−201,148
Deep Track Capital, LP700,000$171.3M2.5%−400,000
Two Sigma Investments, LP669,478$163.9M0.1%+346,700
Franklin Resources Inc668,373$163.6M0.0%+229,883
Wellington Management Group Llp653,920$160.1M0.0%−491,386
Alethea Capital Management, LLC648,756$158.8M65.8%−358
D. E. Shaw & Co., Inc.604,753$148.0M0.1%+1,288
Millennium Management LLC556,088$136.1M0.1%+535,330
Nomura Asset Management International Inc.539,407$132.0M0.2%−273,402
Norges Bank514,266$125.9M0.0%New
First Trust Advisors LP482,061$118.0M0.1%−95,418
Bank Of America Corp /de/452,491$110.8M0.0%−145,600
Ameriprise Financial Inc428,079$104.8M0.0%+251,765
Pictet Asset Management Holding SA426,527$104.4M0.1%+10,544
Qube Research & Technologies Ltd426,336$104.4M0.1%+91,002
Point72 Asset Management, L.P.416,516$102.0M0.2%−8,234
Jane Street Group, LLC403,995$98.9M0.1%+399,917

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
Jun 16, 2022Christopher L. Jacobs, HouseBuy$15,001 - $50,000+512.3%Report

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

SEC filer profile

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

  • Name on EDGARAxsome Therapeutics, Inc.2
  • CIK0001579428
  • Employer ID (EIN)45-42419077
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business addressOne World Trade Center, 29Th Floor, New York, NY 100072
  • Phone(212) 332-32412
  • Shares outstanding52,380,818 as of Aug 3, 202614
  • Public float$4.4B as of Jun 30, 20257
  • AuditorDeloitte & Touche LLP, Morristown, New Jersey PCAOB ID 34; it also attests to the company’s internal control over financial reporting7
  • On EDGAR sinceJun 19, 20132
  • Filings670 in all: 8-K (230), 4 (194), 144 (69), 10-Q (32), SC 13G/A (22), 3 (15), 424B5 (12), SC 13G (12)2
    All 35 form types

    10-K (11), DEF 14A (11), S-8 (11), CORRESP (5), D (5), SCHEDULE 13G/A (5), ARS (4), DEFA14A (4), 8-K/A (3), S-3ASR (3), 10-Q/A (2), 4/A (2), EFFECT (2), SEC STAFF LETTER (2), UPLOAD (2), 10-K/A (1), 144/A (1), 424B4 (1), 8-A12B (1), CERTNAS (1), CT ORDER (1), D/A (1), DRS (1), S-1 (1), S-1/A (1), S-3 (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 23, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Aug 10, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, Par Value $0.0001 Per ShareAXSMNasdaq Global Market

From the cover page of the 10-K filed Feb 23, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks Axsome Therapeutics names in Item 1A of its 10-K filed Feb 23, 2026: 72 risks under these headings, as written.7

  • The Company is subject to a number of risks that if realized could materially adversely affect its business, results of operations, cash flow, financial condition or prospects. The following is a summary of the principal risk factors facing the Company. The list below is not exhaustive, and the Company faces additional challenges and risks. Investors should carefully consider all of the information set forth in this Annual Report on Form 10-K, including the following risk factors, before deciding to invest in any of the Company’s securities.
  • We have incurred significant losses since our inception, anticipate that we will continue to have losses, and may never achieve or maintain profitability.
  • We may need additional funding to conduct our future clinical trials and to complete development and commercialization of our product candidates. If we are unable to raise capital when needed, we would be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.
  • Our operating activities may be restricted as a result of covenants related to the outstanding indebtedness under our loan facility with Blackstone, and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.
  • We have a limited operating history of commercializing products, which may make it difficult to evaluate our business and prospects.
  • We are substantially dependent on the success of our products and cannot guarantee that any of our product candidates will successfully complete any planned or ongoing clinical trials, receive regulatory approval, or be successfully commercialized.
  • If safety and efficacy data for our product candidates, a reference drug, or published literature does not satisfactorily demonstrate safety and efficacy to the Food and Drug Administration (FDA), or if the FDA and other regulators do not permit us to rely on the data of a reference drug or published literature, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • Although Breakthrough Therapy, Fast Track, and other designations are designed to expedite the development and review of drugs, they may not ultimately lead to a faster approval process or faster development of regulatory review, and they will not increase the likelihood that our product candidates will receive marketing approval, for example, Breakthrough Therapy designation by the FDA for AXS-05 for the treatment of AD agitation.
  • We face significant competition from other pharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations. Our operating results will suffer if we fail to compete effectively.
  • If we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market, sell and distribute our products, we may be unable to generate substantial product revenues.
  • If any of our products do not achieve broad market acceptance, we may be unable to generate substantial product revenues.
  • If the manufacturers upon whom we rely fail to produce our products in the volumes that we require on a timely basis, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our products and may lose or fail to generate potential revenues.
The other 60 risks
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • We have licensed and may need to license certain intellectual property from third parties in the future. Such licenses may not be available or may not be available on commercially reasonable terms. Our business may be materially harmed if the licenses are not available or terminated for any reason.
  • If we fail to comply with federal, state, and foreign healthcare laws, including laws governing fraud and abuse, transparency, health and data protection, information privacy and security, we could face substantial penalties and liabilities, and our business, financial condition, results of operations, and prospects could be adversely affected.
  • If the government or third-party payors fail to provide adequate coverage and payment rates for any of our products, or if such payors and health care providers including health maintenance organizations (HMOs) and long-term care facilities choose to use therapies that are less expensive, our products may lose or fail to generate potential revenue and our prospects for profitability may be limited.
  • We have and may continue to significantly increase the size of our organization, and we may experience difficulties in managing growth. If we are unable to implement appropriate controls and procedures to manage our growth, we will not be able to implement our business plan successfully.
  • If we fail to maintain an effective system of internal controls over financial reporting, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
  • Our principal stockholders and management own a significant percentage of our stock and may be able to exert significant control over matters subject to stockholder approval.
  • The use of our net operating loss carryforwards and research tax credits may be limited.
  • RISKS RELATED TO OUR FINANCIAL CONDITION AND CAPITAL REQUIREMENTS
  • Political uncertainty may have an adverse impact on our operating performance and results of operations.
  • Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, results of operations, cash flows and prospects.
  • RISKS RELATED TO OUR BUSINESS AND THE DEVELOPMENT OF OUR PRODUCT CANDIDATES
  • Potential conflicts of interest exist with respect to the intellectual property rights that we license from an entity owned by our Chief Executive Officer and Chairman of the Board, and it is possible that our interests and their interests may diverge.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our future growth may depend on our ability to identify and develop product candidates, and if we do not successfully identify and develop product candidates or integrate them into our operations, we may have limited growth opportunities.
  • If safety and efficacy data for our product candidates, a reference drug, or published literature does not satisfactorily demonstrate safety and efficacy to the FDA, or if the FDA and other regulators do not permit us to rely on the data of a reference drug or published literature, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • The regulatory approval timelines and processes of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates as expected, and our ability to generate revenue will be materially impaired.
  • If we cannot demonstrate an acceptable safety and toxicity profile for our product candidates, we will not be able to continue our clinical trials of or obtain approval for those product candidates.
  • The FDA may determine that any of our current or future product candidates have undesirable side effects that could delay or prevent their regulatory approval or commercialization.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Development of combination product candidates may present more or different challenges than development of single agent product candidates.
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay.
  • Failure to obtain marketing approval in international jurisdictions would prevent our products from being marketed abroad.
  • Regulatory approval is limited by the FDA or comparable foreign regulatory authorities to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and we may be subject to fines, penalties, injunctions, or other enforcement actions if we are determined to be promoting the use of our products for unapproved or “off‑label” uses, resulting in damage to our reputation and business.
  • We are, and will continue to be subject to, ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, any of our products, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
  • A variety of risks associated with international operations could materially adversely affect our business.
  • We are exposed to market risk from fluctuations in currency exchange rates and interest rates.
  • We will need to obtain FDA approval (and that of comparable foreign regulatory authorities) of any proposed product names, and any failure or delay associated with such approval may adversely affect our business.
  • RISKS RELATED TO THE COMMERCIALIZATION OF OUR PRODUCTS
  • If the FDA or comparable foreign regulatory authorities approve generic or similar versions of any of our products that receive marketing approval, or such authorities do not grant our products appropriate periods of exclusivity before approving generic or similar versions of our products, the sales of our products could be adversely affected.
  • AXS-12 received Orphan Drug Designation from the FDA. However, there is no guarantee that we will receive this designation for any of our other product candidates or receive or maintain any corresponding benefits for any of our other product candidates that may receive Orphan Drug Designation in the future, including periods of exclusivity.
  • If we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market, sell and distribute our products, we may be unable to generate significant product awareness and that lack of awareness may limit the product revenues that we generate.
  • If any of our products do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and may have to limit our products’ commercialization.
  • SUNOSI is a controlled substance and may be subject to U.S. federal and state controlled substance laws and regulations, and our failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, could materially and adversely affect our business, results of operations, financial condition and growth prospects.
  • RISKS RELATED TO OUR DEPENDENCE ON THIRD PARTIES
  • If the manufacturers upon whom we rely fail to produce our products in the volumes that we require on a timely basis, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our products and may lose potential revenues.
  • As an NDA applicant and commercial “virtual manufacturer,” we may rely in many cases on third parties to perform many essential services for our products, including services related to warehousing and inventory control, distribution, government price reporting, customer service, and adverse event reporting. If these third parties fail to perform as expected or to comply with legal and regulatory requirements, our ability to commercialize any of our products will be significantly impacted and we may be subject to regulatory sanctions.
  • Any collaboration arrangements that we are a party to or may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
  • RISKS RELATED TO INTELLECTUAL PROPERTY
  • It is difficult and costly to protect our proprietary rights, and, as a result, we may not be able to ensure their protection. In addition, patents have a limited lifespan and will eventually expire.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • If we, or any future collaboration partner are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in any litigation would harm our business.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful.
  • We may be subject to claims that our employees, independent contractors, or consultants have wrongfully used or disclosed alleged trade secrets of their former employers or other third parties.
  • We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.
  • We, or our licensors, may not be able to protect our intellectual property rights throughout the world.
  • RISKS RELATED TO LEGAL AND COMPLIANCE MATTERS
  • If the government or third-party payors fail to provide adequate coverage and reimbursement for any of our products, or if such payors and health care providers including health maintenance organizations (HMOs) and long-term care facilities, choose to use therapies that are less expensive, our products may lose or fail to generate potential revenue and our prospects for profitability may be limited.
  • We are subject to new legislation, regulatory proposals, and healthcare payor initiatives that may increase our costs of compliance, and adversely affect our ability to market our products, obtain collaborators, and raise capital.
  • We are subject to a variety of U.S. and international laws and regulations.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • Our employees, independent contractors, consultants, commercial partners, principal investigators, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • Our third‑party manufacturers may use hazardous materials in the production of our products and, if so, they must comply with environmental laws and regulations, which can be expensive and restrict how we or they do business.
  • RISKS RELATED TO OUR BUSINESS OPERATIONS
  • Our continued growth could strain our personnel resources and infrastructure, and if we are unable to implement appropriate controls and procedures to manage our growth, we will not be able to implement our business plan successfully.
  • We may acquire businesses or products, or form strategic alliances in the future, and we may not realize the benefits of such acquisitions or alliances.
  • We may not be able to manage our business effectively if we are unable to attract and retain key personnel.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Our business and operations would suffer in the event of system failures.
  • Environmental, social and governance matters may impact our business and reputation.
  • RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK
  • An active trading market for our common stock may not be sustained.
  • The market price of our common stock may be highly volatile.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business, or our market, our stock price and trading volume could decline.
  • Our quarterly operating results may fluctuate significantly.
  • Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
  • Sales of a substantial number of shares of our common stock in the public market by our existing stockholders could cause our stock price to fall.

Legal proceedings

Except as described in Note 10. Commitments and Contingencies, we, and our subsidiaries, are currently not a party to, and our property is not currently the subject of, any material pending legal proceedings; however, we may also become involved in various claims and legal actions arising in the ordinary course of business.

The opening of Item 3, Legal Proceedings.7

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
    SEC EDGAROther events
  31. 31
  32. 32
  33. 33
    SEC EDGAROther events
  34. 34
  35. 35
    SEC EDGAROther events
  36. 36
    SEC EDGAROther events
  37. 37
  38. 38
    SEC EDGAROther events
  39. 39
  40. 40
    SEC EDGAROther events
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53