AXSM

MKT CAP $8.2BP/E —DIV YIELD —FCF YIELD -0.88%REV TTM $776.6M +56.9%NET INCOME −$191.6MNET CASH $131.9M52W 127.06 – 255.17SEC XBRL · TTM TO Invalid Date

How AXSM rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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New in FY2025

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”).
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 graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from 12/31/2020 to 12/31/2025.
Holders The number of record holders of our common stock as of February 16, 2026, was 5.
In addition, the Blackstone Loan Agreement contains restrictive covenants that prohibit us from declaring or paying any dividends or making any other distributions on our common stock, except as may be expressly permitted under the facility.
Overview We are a biopharmaceutical company dedicated to the development and commercialization of innovative medicines for people impacted by central nervous system (CNS) conditions.
We deliver scientific breakthroughs by identifying critical gaps in care and developing differentiated medicines with a focus on novel mechanisms of action that have the potential to transform patient outcomes.
Our broad commercial portfolio is comprised of AUVELITY, SUNOSI, and SYMBRAVO.
AUVELITY is the first and only oral NMDA receptor antagonist approved by the FDA for the treatment of MDD in adults, which we are further developing in additional psychiatric conditions, including Alzheimer’s disease agitation.
SUNOSI is the first and only DNRI approved by the FDA for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy, for which we also receive royalty revenue associated with sales in out-licensed territories.
SYMBRAVO is approved by the FDA for the acute treatment of migraine in adults with or without aura, which we recently launched in the U.S.
We are also advancing a pipeline of novel product candidates addressing a broad range of serious neurological and psychiatric conditions, including narcolepsy, fibromyalgia, and ADHD.
“Business” for a summary of our marketed products and clinical development programs.
We have recently begun commercial sales of AUVELITY and SUNOSI, and we launched SYMBRAVO, but we have limited experience with commercializing these, or any, products.
We incurred net losses of $183.2 million and $287.2 million for the years ended December 31, 2025 and 2024, respectively.
Our accumulated deficit as of December 31, 2025 was $1,306.0 million, and we expect to incur significant expenses and continuing operating losses.
Financial Overview Revenue We generated total revenues of $638.5 million and $385.7 million for the years ended December 31, 2025 and 2024, respectively.
We recognized royalty revenue of $4.7 million and $3.5 million for the years ended December 31, 2025 and 2024, respectively, related to Pharmanovia’s sales of SUNOSI.
Research and development expenses Research and development expenses primarily include preclinical studies, clinical trials, manufacturing costs, employee-related expenses including salaries, benefits, travel, and stock based compensation expense, contract services, including external research and development expenses incurred under arrangements with third parties, such as contract research organizations, or CROs, facilities costs, overhead costs, depreciation, and other related costs.
In addition, research and development costs also include costs related to asset acquisitions involving clinical development programs that have not yet received regulatory approval.
Selling, general and administrative expenses Selling, general and administrative expenses consist of salaries and related costs for personnel in executive, commercial, finance, and operational functions, including stock-based compensation and travel expenses.
Acquisitions To determine whether acquisitions should be accounted for as an acquisition of a business or as an acquisition of an asset, we make certain judgments, which include evaluating whether the acquired set of activities and assets would meet the definition of a business.
If, based upon our evaluation, we determine that the inputs, processes, and outputs associated with the acquired set of activities and assets in a transaction include an input and a substantive process that together significantly contribute to the ability to create outputs, the transaction is treated as an acquisition of a business.
If we determine that substantially all of the fair value of assets acquired in a transaction is concentrated in a single asset or a group of similar assets, the transaction is treated as an acquisition of assets.
An acquisition of a business is accounted for under the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recorded at their fair values as of the acquisition date.
Significant judgments and estimates are used in determining the fair value of assets acquired and liabilities assumed.
The fair values of identifiable intangible assets related to currently marketed products are determined by using an income approach, through which fair value is estimated based on each asset’s discounted projected net cash flows.
Inputs used in the projected cash flows include historical and projected pricing, the underlying asset patent life, our ability to manufacture and commercialize the asset, the ability to obtain regulatory approvals and the extent and timing of potential new product introductions by competitors in the marketplace.
An acquisition of a business also can include the potential for future payment of consideration that is contingent upon the achievement of certain milestones, including royalty payments on future product sales.
The fair value of contingent consideration liabilities is determined at the acquisition date using unobservable inputs.
Consideration in excess over the fair value of net assets acquired is recorded as goodwill.
If the acquired set of activities and assets does not meet the definition of a business, the acquisition is treated as an acquisition of an asset.
In an acquisition of an asset, in-process research and development (IPR&D) projects are recorded as research and development expense at the acquisition date unless there is an alternative future use, no goodwill is recorded, and contingent consideration relating to development, regulatory and commercial milestones are not recognized at the acquisition date and instead are recorded when it is probable they will occur and can be reasonably estimated.
As of December 31, 2025, we determined that we have one reporting unit.
We have not identified any events or changes in circumstances that indicate the existence of potential impairment of goodwill during the year ended December 31, 2025.
We have not identified any events or changes in circumstances that indicate the existence of potential impairment of the intangible asset during the year ended December 31, 2025.
As of December 31, 2025, if the discount rate increases or decreases by approximately 1%, the fair value of the contingent consideration would range from $79.5 million to $89.5 million.
As of December 31, 2025, if the revenue discount rate increases or decreases by approximately 1%, the fair value of the contingent consideration would range from $80.6 million to $88.3 million.
As of December 31, 2025, we recognized gross uncertain tax positions which have been recognized as a reduction to deferred tax assets.
As of December 31, 2025, we had U.S. federal net operating loss carryforwards of approximately $577.9 million and foreign NOL carryforwards of $281.3 million.

and 412 more.

Gone since FY2024

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 Word Trade Center in New York, NY, or the Sublease.
Except as described herein, 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.
District Court for the Southern District of New York, or the SDNY District Court, against the Company and certain of its current and former officers and one director, which we refer to as the Securities Class Action.
The complaint asserts claims under Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder, and alleges, among other things, that the defendants made false statements and omissions concerning the Company’s Chemistry Manufacturing and Controls practices, and its NDA with the FDA, with respect to one of its product candidates, AXS-07.
On October 13, 2023, plaintiffs’ counsel filed a letter seeking leave to file an amended complaint and to substitute new plaintiffs, which defendants opposed.
The SDNY District Court re-opened the lead plaintiff appointment process.
Thomas Giblin, Paul Berger, and Paul Sutherland moved jointly to be appointed replacement plaintiffs.
Shareholder Derivative Action On July 21, 2022, Daniel Engel filed a stockholder derivative complaint captioned Engel v.
Herriot Tabuteau, et al. in the SDNY District Court against the Company’s current directors, certain of the Company’s current and former officers, and the Company (as nominal defendant).
Tabuteau, et al. in the SDNY District Court against the Company’s current directors, certain of the Company’s current and former officers, and the Company (as nominal defendant).
The derivative complaints arise out of similar allegations as those made in the Securities Class Action.
The Engel and Guterba matters were consolidated on February 28, 2023 and are currently stayed pending further proceedings in the Securities Class Action.
Auvelity Paragraph IV Litigation On March 24, 2023, we commenced a patent infringement action against Teva Pharmaceuticals, Inc., or Teva, relating to Teva’s ANDA for Auvelity.
This action is captioned Axsome Therapeutics, Inc., and Antecip Bioventures II LLC v.
No. 2:23-CV-01695 in the United States District Court for the District of New Jersey, or the NJ District Court.
On December 15, 2023, we commenced a second patent infringement action against Teva relating to Teva’s ANDA.
No. 2:23-cv-23142 in the NJ District Court.
On February 26, 2024, the NJ District Court consolidated the first and second actions.
Fact discovery is currently scheduled to close on March 24, 2025 in the consolidated action.
On May 28, 2024, we commenced a third patent infringement action against Teva relating to Teva’s ANDA.
No. 2:24-cv-06489 in the NJ District Court.
On September 30, 2024, we commenced a fourth patent infringement action against Teva relating to Teva’s ANDA.
No. 2-24-cv-09535 in the NJ District Court.
On December 5, 2024, we commenced a fifth patent infringement action against Teva relating to Teva’s ANDA.
The fifth action is captioned Axsome Therapeutics, Inc., and Antecip Bioventures II LLC v.
No. 2-24-cv-10938 in the NJ District Court.
On January 7, 2025, the NJ District Court consolidated that third, fourth, and fifth actions.
On February 10, 2025, the Company announced that it had entered into a settlement agreement with Teva to resolve all outstanding litigation between the parties relating to Auvelity.
Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of Auvelity beginning on or after March 31, 2039, if pediatric exclusivity is granted for Auvelity, or on or after September 30, 2038, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type.
Sunosi Paragraph IV Litigation On September 13, 2023, we commenced a patent infringement action against Hikma and five other drug companies relating to each defendant’s ANDA for Sunosi.
No. 2:23-CV-20354 in the NJ District Court.
We commenced related patent infringement actions against the defendants relating to their ANDAs on December 20, 2023, January 11, 2024, January 18, 2024, February 14, 2024, March 19, 2024 (2 actions filed), April 5, 2024, July 2, 2024, August 8, 2024, August 21, 2024, September 16, 2024, November 20, 2024 (4 actions filed), January 21, 2025.
No 2:25-cv-00643, respectively, all of which are in the NJ District Court.
On June 4, 2024, Axsome and the Malta Subsidiary entered into a settlement agreement with Unichem under which agreement Unichem agreed not to launch its generic solriamfetol product until June 30, 2042, or earlier under certain circumstances.
On August 21, 2024, Axsome and the Malta Subsidiary reached an agreement to dismiss the actions pending against Sandoz.
All other actions are currently pending.
On September 25, 2024, Hikma Pharmaceuticals USA, Inc. filed a petition for Inter Partes Review of U.S.
That petition is captioned Hikma Pharmaceuticals USA Inc. f/k/a West-Ward Pharmaceuticals Corp. v.
The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from 12/31/2019 to 12/31/2024.
Holders The number of record holders of our common stock as of February 11, 2025, was two.

and 374 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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