Axsome Therapeutics(AXSM) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights This section provides an overview of Q2 2025 financial and operational achievements, including product performance and strategic pipeline advancements Second Quarter 2025 Overview Axsome Therapeutics achieved robust financial and operational growth in Q2 2025, driven by significant product revenue increases and key pipeline advancements | Metric | 2Q 2025 Amount (Million USD) | YoY Growth | QoQ Growth | | :----------------------- | :--------------------------- | :--------- | :--------- | | Total Net Product Revenue | 150.0 | 72% | 24% | | AUVELITY Net Product Sales | 119.6 | 84% | 24% | | SUNOSI Net Product Revenue | 30.0 | 35% | 19% | | SYMBRAVO Net Product Sales | 0.4 | - | - | - AUVELITY market access expanded to an additional 28 million covered lives in commercial channels[1] - SYMBRAVO secured its first Group Purchasing Organization (GPO) contract[1] - The supplemental New Drug Application (sNDA) for AXS-05 in Alzheimer's agitation is on track for submission in Q3 2025[1] - The New Drug Application (NDA) for AXS-12 for cataplexy in narcolepsy patients is anticipated for submission in Q4 2025[1] CEO Commentary CEO Dr. Herriot Tabuteau emphasized strong Q2 2025 performance driven by robust product demand, commercial execution, regulatory progress, and a promising neuroscience pipeline - The company demonstrated strong performance in Q2 2025, attributed to robust demand for life-changing medicines, precise commercial execution, solid regulatory progress, and continued advancement of a differentiated neuroscience pipeline[4] - SYMBRAVO has been approved and successfully launched, while AUVELITY and SUNOSI show accelerated performance[4] - The sNDA for AXS-05 in Alzheimer's agitation and the NDA for AXS-12 in narcolepsy are on schedule for submission in Q3 and Q4, respectively[4] - The company possesses a late-stage development pipeline, including ADHD, binge eating disorder, shift work disorder, depression with excessive sleepiness, fibromyalgia, and smoking cessation, with potential first-in-class or best-in-class medicines addressing serious conditions affecting over 150 million US patients[4] Financial Performance This section details Axsome Therapeutics' Q2 2025 financial performance, including key metrics, guidance, and consolidated financial statements Key Financial Highlights Axsome Therapeutics reported significant Q2 2025 revenue growth and a narrower net loss, driven by increased product sales and commercial activities, with sufficient cash reserves Q2 2025 Key Financial Data | Metric | 2Q 2025 (Million USD) | 2Q 2024 (Million USD) | YoY Growth | 1Q 2025 (Million USD) | QoQ Growth | | :----------------------------------- | :-------------------- | :-------------------- | :--------- | :-------------------- | :--------- | | Revenue | | | | | | | Total Net Product Revenue | 150.0 | 87.2 | 72% | 121.0 | 24% | | AUVELITY Net Product Sales | 119.6 | 65.0 | 84% | 96.4 | 24% | | SUNOSI Net Product Revenue | 30.0 | 22.1 | 35% | 25.2 | 19% | | SYMBRAVO Net Product Sales | 0.4 | - | - | - | - | | Expenses | | | | | | | Cost of Revenue | 13.4 | 8.1 | 65.4% | - | - | | Research and Development Expenses | 49.5 | 49.9 | -0.8% | - | - | | Selling, General and Administrative Expenses | 130.3 | 103.6 | 25.8% | - | - | | Net Loss | | | | | | | Net Loss | (48.0) | (79.3) | 39.5% | - | - | | Net Loss Per Share | (0.97) | (1.67) | 41.9% | - | - | | Assets | | | | | | | Cash and Cash Equivalents (as of June 30) | 303.0 | - | - | 315.4 (as of Dec 31) | -3.9% | | Common Shares Outstanding (as of June 30) | 49,815,301 | - | - | 48,667,587 (as of Dec 31) | 2.36% | Financial Guidance The company anticipates existing cash reserves will fund operations to positive cash flow, assuming no major changes to current plans - The company believes its existing cash is sufficient to fund operations until achieving positive cash flow, based on current operating plans[8] Consolidated Balance Sheets As of June 30, 2025, total assets and liabilities increased, driven by receivables, inventory, and short-term borrowings, with a slight rise in shareholder equity Consolidated Balance Sheets (as of June 30) | Item | June 30, 2025 (Thousand USD) | December 31, 2024 (Thousand USD) | | :----------------------------------- | :----------------------------- | :----------------------------- | | Assets | | | | Cash and Cash Equivalents | 303,016 | 315,353 | | Accounts Receivable, Net | 198,825 | 142,001 | | Inventory, Net | 18,441 | 15,732 | | Total Current Assets | 536,620 | 485,064 | | Total Assets | 639,785 | 568,498 | | Liabilities | | | | Accounts Payable | 91,628 | 71,997 | | Accrued Expenses and Other Current Liabilities | 170,902 | 147,987 | | Short-Term Borrowings | 70,000 | — | | Total Current Liabilities | 342,099 | 230,104 | | Long-Term Debt | 117,540 | 180,710 | | Total Liabilities | 566,710 | 511,483 | | Stockholders' Equity | | | | Common Stock | 5 | 5 | | Additional Paid-in Capital | 1,303,243 | 1,179,797 | | Accumulated Deficit | (1,230,173) | (1,122,787) | | Total Stockholders' Equity | 73,075 | 57,015 | Consolidated Statements of Operations Axsome Therapeutics reported substantial revenue growth in Q2 and H1 2025, narrowing net losses despite increased operating expenses, driven by product sales and royalty income Consolidated Statements of Operations (as of June 30) | Item | 2Q 2025 (Thousand USD) | 2Q 2024 (Thousand USD) | H1 2025 (Thousand USD) | H1 2024 (Thousand USD) | | :----------------------------------- | :--------------------- | :--------------------- | :--------------------- | :--------------------- | | Revenue | | | | | | Product Sales, Net | 148,959 | 86,520 | 269,317 | 160,616 | | Royalty Revenue | 1,083 | 646 | 2,188 | 1,549 | | Total Revenue | 150,042 | 87,166 | 271,505 | 162,165 | | Operating Expenses | | | | | | Cost of Revenue | 13,448 | 8,055 | 23,237 | 14,352 | | Research and Development Expenses | 49,541 | 49,853 | 94,326 | 86,683 | | Selling, General and Administrative Expenses | 130,280 | 103,554 | 251,067 | 202,524 | | Total Operating Expenses | 186,756 | 165,212 | 365,201 | 307,486 | | Loss from Operations | (36,714) | (78,046) | (93,696) | (145,321) | | Net Loss | (47,973) | (79,345) | (107,386) | (147,702) | | Net Loss Per Share, Basic and Diluted | (0.97) | (1.67) | (2.18) | (3.11) | Commercial Updates This section provides commercial updates on AUVELITY, SUNOSI, and the successful launch of SYMBRAVO, detailing prescription growth and market access AUVELITY AUVELITY, a unique rapid-acting oral treatment for MDD, demonstrated significant prescription growth and expanded market coverage in Q2 2025 - AUVELITY is the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the US for the treatment of major depressive disorder[9] AUVELITY Prescription Volume and Growth | Metric | 2Q 2025 | 2Q 2024 | YoY Growth | 1Q 2025 | QoQ Growth | | :------- | :------ | :------ | :--------- | :------ | :--------- | | Prescription Volume | ~192,000 | - | 56% | - | 15% | - As of July 1, AUVELITY's payer coverage in commercial channels expanded to an additional 28 million covered lives; overall payer coverage across all channels is approximately 83%, with commercial at approximately 73% and government channels (Medicare and Medicaid) at approximately 100%[11] SUNOSI SUNOSI, a unique treatment for excessive daytime sleepiness, sustained prescription growth and high payer coverage in Q2 2025 - SUNOSI is the first and only dopamine and norepinephrine reuptake inhibitor approved for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea[12] SUNOSI Prescription Volume and Growth | Metric | 2Q 2025 | 2Q 2024 | YoY Growth | 1Q 2025 | QoQ Growth | | :------- | :------ | :------ | :--------- | :------ | :--------- | | Prescription Volume | ~50,000 | - | 13% | - | 9% | - SUNOSI's payer coverage across all channels is approximately 83%, with commercial coverage at approximately 95% and government channels at approximately 60%[16] SYMBRAVO SYMBRAVO successfully launched on June 10, 2025, quickly advancing commercialization with GPO contracts, initial payer coverage, and patient support - SYMBRAVO became available in US pharmacies on June 10, 2025, and active engagement with healthcare providers has commenced[16] - As of July 1, Axsome has contracted with one of the top three GPOs for potential formulary coverage of SYMBRAVO[16] - SYMBRAVO's payer coverage across all channels is currently approximately 38%, with commercial at approximately 26% and government channels at approximately 56%[16] - The SYMBRAVO On My Side patient support program is fully operational, offering savings cards, educational resources, and HCP samples[16] Development Pipeline This section details the progress of Axsome's development pipeline, including AXS-05, Solriamfetol, AXS-12, and AXS-14, with upcoming regulatory and clinical milestones AXS-05 AXS-05 progressed in Alzheimer's agitation with sNDA submission on track, and a pivotal trial for smoking cessation is imminent - AXS-05 has received FDA Breakthrough Therapy designation for Alzheimer's agitation[15] - Alzheimer's Agitation: The company plans to submit a supplemental New Drug Application (sNDA) for AXS-05 to the FDA in Q3 2025[17] - Smoking Cessation: The company plans to initiate a pivotal Phase 2/3 trial for AXS-05 in Q4 2025[17] Solriamfetol Solriamfetol is progressing in its pipeline for ADHD, MDD with EDS, BED, and SWD, with multiple Phase 3 trials underway or planned - Attention-Deficit/Hyperactivity Disorder (ADHD): The company plans to initiate a Phase 3 trial of solriamfetol in pediatric and adolescent ADHD patients in Q4 2025, following positive top-line results from the FOCUS Phase 3 trial in adult ADHD[21] - Major Depressive Disorder (MDD) with Excessive Daytime Sleepiness (EDS): The company plans to initiate a Phase 3 trial of solriamfetol in MDD patients with EDS in Q4 2025, following numerically greater improvement in depressive symptoms in a severe EDS patient subgroup in the PARADIGM Phase 3 proof-of-concept trial[21] - Binge Eating Disorder (BED): The ENGAGE Phase 3 trial is ongoing, with top-line results expected in 2026[21] - Shift Work Disorder (SWD): The SUSTAIN Phase 3 trial is ongoing, with top-line results expected in 2026[21] AXS-12 AXS-12, with FDA Orphan Drug designation for narcolepsy, plans Q4 2025 NDA submission after positive clinical trial outcomes - AXS-12 has received FDA Orphan Drug designation for narcolepsy[19] - Narcolepsy: The company plans to submit an NDA for AXS-12 for the treatment of cataplexy in narcolepsy to the FDA in Q4 2025[19] - AXS-12 met its primary endpoints in three controlled Phase 2 and Phase 3 efficacy trials and a long-term safety trial, demonstrating rapid and significant reductions in cataplexy attacks, and improvements in excessive daytime sleepiness and cognitive function[19] AXS-14 Axsome plans to initiate a new Phase 3 fixed-dose trial for AXS-14 in Q4 2025, addressing prior FDA feedback on its fibromyalgia NDA - Fibromyalgia: To address prior FDA Refusal to File (RTF) feedback for the AXS-14 NDA for the management of fibromyalgia, the company plans to initiate a Phase 3 fixed-dose 12-week trial in Q4 2025[20] Corporate Information This section provides corporate updates, anticipated milestones, conference call details, company overview, forward-looking statements, and contact information Corporate Updates Axsome Therapeutics resolved SUNOSI patent litigation and hosted a successful "Brain Health R&D Day," highlighting its neuroscience leadership and innovative pipeline - In May 2025, Axsome resolved patent litigation with Hetero Labs Ltd. and its affiliates regarding generic versions of SUNOSI, allowing Hetero to begin selling its generic product after September 1, 2040 (if pediatric exclusivity is obtained) or March 1, 2040 (if pediatric exclusivity is not obtained)[26] - In July 2025, the company hosted a "Brain Health R&D Day" event, featuring six leading expert clinicians and key opinion leaders who discussed target indications for Axsome's late-stage pipeline and presented clinical data[26] Anticipated Milestones Axsome Therapeutics outlined key regulatory submissions, clinical trial results, and trial initiation plans for its product pipeline in upcoming quarters - Regulatory & Commercial: - AXS-05 sNDA submission for Alzheimer's agitation (Q3 2025) - AXS-12 NDA submission for narcolepsy (Q4 2025) - Clinical Trial Top-Line Results: - Solriamfetol Phase 3 ENGAGE trial for binge eating disorder (2026) - Solriamfetol Phase 3 SUSTAIN trial for shift work disorder (2026) - Clinical Trial Initiations & Progress: - AXS-05 pivotal Phase 2/3 trial initiation for smoking cessation (Q4 2025) - Solriamfetol Phase 3 trial initiation for pediatric and adolescent ADHD (Q4 2025) - Solriamfetol Phase 3 trial initiation for MDD with EDS (Q4 2025) - AXS-14 Phase 3 trial initiation for fibromyalgia (Q4 2025)[26] Conference Call Information Axsome Therapeutics provided details for its Q2 2025 financial results and business update conference call, including access information - The company is hosting a conference call and webcast today at 8:00 AM Eastern Time to discuss its Q2 2025 financial results and business update[24] - To participate in the live conference call, dial (877) 405-1239 (US Toll-Free) or +1 (201) 389-0851 (International)[24] - A live webcast can be accessed on the "Investors" section of the company's website at axsome.com, under the "Webcasts & Presentations" page, with a replay available for approximately 30 days after the live event[24] About Axsome Therapeutics Axsome Therapeutics is a leading biopharmaceutical company focused on CNS disorders, developing differentiated products to improve patient outcomes and address severe neurological and psychiatric conditions - Axsome Therapeutics is a biopharmaceutical company dedicated to ushering in a new era of central nervous system (CNS) disorder treatment[25] - The company achieves scientific breakthroughs by identifying critical gaps in care and developing differentiated products with novel mechanisms of action to significantly improve patient outcomes[25] - Its neuroscience portfolio includes FDA-approved treatments for major depressive disorder, narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnea, and migraine, along with multiple late-stage development programs targeting a broad spectrum of serious neurological and psychiatric conditions affecting over 150 million people in the US[25] Forward-Looking Statements This press release contains forward-looking statements subject to risks and uncertainties regarding commercial success, clinical trials, regulatory approvals, and financial factors, with no obligation to update - Certain matters in this press release are "forward-looking statements," pertaining to the commercial success of the company's products (SUNOSI, AUVELITY, SYMBRAVO) and efforts to obtain additional indications for solriamfetol and/or AXS-05[27] - Forward-looking statements involve risks and uncertainties, including but not limited to the company's ability to maintain and expand payer coverage, the success, timing, and cost of ongoing and anticipated clinical trials, the timing and ability of regulatory agencies to grant approvals, the protection of intellectual property, capital requirements, and macroeconomic and regulatory developments[27] - The company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances, and actual results and developments may differ materially from those expressed or implied in such statements[27] Investor & Media Contacts Contact information for Axsome Therapeutics' investor relations and media communications is provided - Investor Contact: Mark Jacobson, Chief Operating Officer, Phone: (212) 332-3243, Email: mjacobson@axsome.com[33] - Media Contact: Darren Opland, Director, Corporate Communications, Phone: (929) 837-1065, Email: dopland@axsome.com[33]