AXSM

EX-99.1

2 axsm-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Axsome Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update

Total 3Q 2026 net product revenue of $259.7 million, representing 52% year-over-year growth

AUVELITY® 3Q 2026 net product sales of $207.6 million, representing 53% year-over-year growth

SUNOSI® 3Q 2026 net product revenue of $48.2 million, representing 47% year-over-year growth

SYMBRAVO® 3Q 2026 net product sales of $3.9 million, representing 88% year-over-year growth

SUMMIT Phase 3 trial of AXS-05 for smoking cessation initiated

Company to host conference call today at 8:00 AM Eastern Time

NEW YORK, November 2, 2026 (Globe Newswire) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the third quarter of 2026 and provided a general business update.

“Axsome delivered 52% year-over-year total revenue growth in the third quarter, surpassing a one-billion-dollar annual run rate. We expect sustained momentum driven by strong underlying demand for Auvelity in major depressive disorder, and continued acceleration of new patient initiations in Alzheimer’s disease agitation,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “Our industry-leading neuroscience pipeline continued to advance, leading to multiple anticipated regulatory and clinical trial milestones in the coming quarters. Our commercial and research and development performance positions us to continue to deliver innovation targeting significant unmet needs in brain health, with the potential to improve the lives of millions of patients.”

Third Quarter 2026 Financial Highlights

• Total net product revenue was $259.7 million for the third quarter of 2026, representing 52% year-over-year growth. Total net product revenue for the comparable period in 2025 was $171.0 million.

• AUVELITY net product sales were $207.6 million for the third quarter of 2026, representing 53% year-over-year growth. AUVELITY net product sales for the comparable period in 2025 were $136.1 million.

• SUNOSI net product revenue was $48.2 million for the third quarter of 2026, representing 47% year-over-year growth, which consisted of $38.5 million in net product sales, $1.2 million in royalty revenue associated with SUNOSI sales in out-licensed territories, and $8.5 million in milestone revenue. SUNOSI net product revenue for the comparable period in 2025 was $32.8 million, which consisted of $31.6 million in net product sales and $1.2 million in royalty revenue.

• SYMBRAVO net product sales were $3.9 million for the third quarter of 2026, representing 88% year-over-year growth. SYMBRAVO net product sales for the comparable period in 2025 were $2.1 million.

• Total cost of revenue was $17.8 million for the third quarter of 2026. Total cost of revenue for the comparable period in 2025 was $11.9 million.

• Research and development (R&D) expenses were $50.6 million for the third quarter of 2026, compared to $40.2 million for the comparable period in 2025. The increase primarily reflects costs for the ongoing clinical programs for solriamfetol, AXS-14, and AXS-05.

1

• Selling, general, and administrative (SG&A) expenses were $203.1 million for the third quarter of 2026, compared to $150.2 million for the comparable period in 2025. The increase primarily reflects commercialization activities for AUVELITY and SYMBRAVO.

• Net loss for the third quarter of 2026 was $12.9 million, or $(0.25) per share, compared to a net loss of $47.2 million, or $(0.94) per share, for the comparable period in 2025. The net loss in the third quarter of 2026 includes $26.4 million in stock-based compensation expense.

• Cash and cash equivalents totaled $313.9 million at September 30, 2026, compared to $322.9 million at December 31, 2025.

• Shares of common stock outstanding were 52,576,839 at September 30, 2026.

Financial Guidance

• Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.

Commercial Highlights

AUVELITY

AUVELITY is a first‑in‑class oral N-methyl-D-aspartate (NMDA) receptor antagonist and sigma‑1 receptor agonist approved in the U.S. for the treatment of major depressive disorder in adults, and for the treatment of agitation associated with dementia due to Alzheimer’s disease.

• Approximately 302,000 total prescriptions were written for AUVELITY in the third quarter of 2026, representing year-over-year and quarter-over-quarter increases of 40% and 14%, respectively. New-to-brand prescriptions, representing new AUVELITY patient starts, increased by 44% year-over-year and 21% quarter-over-quarter.

• Third quarter AUVELITY new-to-brand and total prescriptions among patients aged 65 years and older increased by 211% and 101%, respectively, compared to the third quarter of 2025.

SEC.gov | Request Rate Threshold Exceeded

U.S. Securities and Exchange Commission

You’ve Exceeded the SEC’s Traffic Limit

Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.

Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.

The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.

For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.

For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.

Reference ID: 0.ed18d017.1786388402.cfeeccf6

More Information

Internet Security Policy

By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.

Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).

To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.

If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.

Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.

Note: We do not offer technical support for developing or debugging scripted downloading processes.

SEC.gov | Request Rate Threshold Exceeded

U.S. Securities and Exchange Commission

You’ve Exceeded the SEC’s Traffic Limit

Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.

Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.

The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.

For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.

For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.

Reference ID: 0.c706d217.1784665247.25d84962

More Information

Internet Security Policy

By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.

Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).

To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.

If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.

Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.

Note: We do not offer technical support for developing or debugging scripted downloading processes.