Axsome Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
Axsome Therapeutics (NASDAQ:AXSM) reported strong Q2 2025 financial results, with total net product revenue of $150.0 million, up 72% year-over-year. The company's flagship product AUVELITY achieved sales of $119.6 million (+84% YoY), while SUNOSI revenue reached $30.0 million (+35% YoY). The newly launched SYMBRAVO contributed $0.4 million since its June 10th launch.
Key financial metrics include a net loss of $48.0 million ($0.97 per share) and cash reserves of $303.0 million. The company expanded AUVELITY's market access by 28 million new covered lives and signed its first GPO contract for SYMBRAVO. Axsome remains on track for upcoming regulatory submissions, including an sNDA for AXS-05 in Alzheimer's disease agitation (Q3 2025) and an NDA for AXS-12 in narcolepsy (Q4 2025).
[ "Total net product revenue grew 72% YoY to $150.0 million", "AUVELITY sales increased 84% YoY to $119.6 million", "SUNOSI revenue grew 35% YoY to $30.0 million", "AUVELITY market access expanded by 28 million new covered lives", "Strong cash position of $303.0 million sufficient to fund operations to cash flow positivity", "Net loss improved from $79.3 million in Q2 2024 to $48.0 million in Q2 2025" ]Axsome Therapeutics (NASDAQ:AXSM) ha riportato solidi risultati finanziari per il secondo trimestre 2025, con un fatturato netto totale da prodotti di 150,0 milioni di dollari, in crescita del 72% rispetto all'anno precedente. Il prodotto di punta dell'azienda, AUVELITY, ha raggiunto vendite per 119,6 milioni di dollari (+84% su base annua), mentre i ricavi di SUNOSI hanno toccato i 30,0 milioni di dollari (+35% YoY). Il nuovo SYMBRAVO, lanciato il 10 giugno, ha contribuito con 0,4 milioni di dollari.
I principali indicatori finanziari includono una perdita netta di 48,0 milioni di dollari (0,97 dollari per azione) e riserve di liquidità pari a 303,0 milioni di dollari. L'azienda ha ampliato l'accesso al mercato di AUVELITY aggiungendo 28 milioni di nuove persone coperte e ha firmato il primo contratto GPO per SYMBRAVO. Axsome mantiene il programma per le prossime submission regolatorie, tra cui una sNDA per AXS-05 nell'agitazione da Alzheimer (Q3 2025) e un NDA per AXS-12 nella narcolessia (Q4 2025).
- Il fatturato netto totale da prodotti è cresciuto del 72% su base annua raggiungendo 150,0 milioni di dollari
- Le vendite di AUVELITY sono aumentate dell'84% YoY a 119,6 milioni di dollari
- I ricavi di SUNOSI sono cresciuti del 35% YoY a 30,0 milioni di dollari
- L'accesso al mercato di AUVELITY è stato ampliato con 28 milioni di nuove persone coperte
- Forte posizione di cassa di 303,0 milioni di dollari, sufficiente a finanziare le operazioni fino al raggiungimento della positività del flusso di cassa
- La perdita netta si è ridotta da 79,3 milioni di dollari nel Q2 2024 a 48,0 milioni di dollari nel Q2 2025
Axsome Therapeutics (NASDAQ:AXSM) reportó sólidos resultados financieros en el segundo trimestre de 2025, con ingresos netos totales por productos de , un aumento del 72% interanual. El producto estrella de la compañía, AUVELITY, alcanzó ventas de 119,6 millones de dólares (+84% interanual), mientras que los ingresos de SUNOSI llegaron a 30,0 millones de dólares (+35% interanual). El recién lanzado SYMBRAVO contribuyó con 0,4 millones de dólares desde su lanzamiento el 10 de junio.
Los principales indicadores financieros incluyen una pérdida neta de 48,0 millones de dólares (0,97 dólares por acción) y reservas de efectivo de 303,0 millones de dólares. La empresa amplió el acceso al mercado de AUVELITY en 28 millones de nuevas vidas cubiertas y firmó su primer contrato GPO para SYMBRAVO. Axsome sigue en camino para las próximas presentaciones regulatorias, incluyendo una sNDA para AXS-05 en agitación por Alzheimer (Q3 2025) y una NDA para AXS-12 en narcolepsia (Q4 2025).
- Los ingresos netos totales por productos crecieron un 72% interanual hasta 150,0 millones de dólares
- Las ventas de AUVELITY aumentaron un 84% interanual a 119,6 millones de dólares
- Los ingresos de SUNOSI crecieron un 35% interanual a 30,0 millones de dólares
- El acceso al mercado de AUVELITY se amplió con 28 millones de nuevas vidas cubiertas
- Fuerte posición de efectivo de 303,0 millones de dólares, suficiente para financiar las operaciones hasta alcanzar flujo de caja positivo
- La pérdida neta mejoró de 79,3 millones de dólares en el Q2 2024 a 48,0 millones de dólares en el Q2 2025
Axsome Therapeutics (NASDAQ:AXSM)는 2025년 2분기 강력한 재무 실적을 보고했으며, 총 순제품 매출은 1억 5천만 달러로 전년 대비 72% 증가했습니다. 회사의 대표 제품인 AUVELITY는 1억 1,960만 달러의 매출을 기록하며(+84% YoY), SUNOSI 매출은 3,000만 달러(+35% YoY)에 달했습니다. 6월 10일 출시된 신제품 SYMBRAVO는 40만 달러의 매출을 기여했습니다.
주요 재무 지표로는 4,800만 달러(주당 0.97달러)의 순손실과 3억 300만 달러의 현금 보유고가 포함됩니다. 회사는 AUVELITY의 시장 접근성을 2,800만 명의 신규 보험 적용 인구로 확장했으며 SYMBRAVO에 대한 첫 번째 GPO 계약을 체결했습니다. Axsome은 알츠하이머병 불안정성에 대한 AXS-05의 sNDA(Q3 2025) 및 기면증에 대한 AXS-12의 NDA(Q4 2025) 등 향후 규제 제출 계획을 순조롭게 진행 중입니다.
- 총 순제품 매출이 전년 대비 72% 증가하여 1억 5천만 달러 달성
- AUVELITY 매출이 전년 대비 84% 증가하여 1억 1,960만 달러 기록
- SUNOSI 매출이 전년 대비 35% 증가하여 3,000만 달러 기록
- AUVELITY 시장 접근성이 2,800만 명의 신규 보험 적용 인구로 확대
- 운영 자금을 현금 흐름 흑자 전까지 충분히 지원할 수 있는 3억 300만 달러의 강력한 현금 보유
- 순손실이 2024년 2분기 7,930만 달러에서 2025년 2분기 4,800만 달러로 개선
Axsome Therapeutics (NASDAQ:AXSM) a annoncé de solides résultats financiers pour le deuxième trimestre 2025, avec un chiffre d'affaires net total des produits de 150,0 millions de dollars, en hausse de 72 % par rapport à l'année précédente. Le produit phare de la société, AUVELITY, a réalisé des ventes de 119,6 millions de dollars (+84 % en glissement annuel), tandis que les revenus de SUNOSI ont atteint 30,0 millions de dollars (+35 % en glissement annuel). Le nouveau SYMBRAVO, lancé le 10 juin, a contribué pour 0,4 million de dollars.
Les principaux indicateurs financiers comprennent une perte nette de 48,0 millions de dollars (0,97 dollar par action) et des réserves de trésorerie de 303,0 millions de dollars. La société a élargi l'accès au marché d'AUVELITY en ajoutant 28 millions de nouvelles personnes couvertes et a signé son premier contrat GPO pour SYMBRAVO. Axsome reste sur la bonne voie pour les prochaines soumissions réglementaires, y compris une sNDA pour AXS-05 dans l'agitation liée à la maladie d'Alzheimer (T3 2025) et une NDA pour AXS-12 dans la narcolepsie (T4 2025).
- Le chiffre d'affaires net total des produits a augmenté de 72 % en glissement annuel pour atteindre 150,0 millions de dollars
- Les ventes d'AUVELITY ont augmenté de 84 % en glissement annuel pour atteindre 119,6 millions de dollars
- Les revenus de SUNOSI ont augmenté de 35 % en glissement annuel pour atteindre 30,0 millions de dollars
- L'accès au marché d'AUVELITY a été étendu à 28 millions de nouvelles personnes couvertes
- Position de trésorerie solide de 303,0 millions de dollars, suffisante pour financer les opérations jusqu'à la rentabilité des flux de trésorerie
- La perte nette s'est améliorée, passant de 79,3 millions de dollars au T2 2024 à 48,0 millions de dollars au T2 2025
Axsome Therapeutics (NASDAQ:AXSM) meldete starke Finanzergebnisse für das zweite Quartal 2025 mit einem Gesamtumsatz aus Produkten von 150,0 Millionen US-Dollar, was einem Anstieg von 72 % im Jahresvergleich entspricht. Das Flaggschiff-Produkt AUVELITY erzielte einen Umsatz von 119,6 Millionen US-Dollar (+84 % YoY), während die Einnahmen von SUNOSI 30,0 Millionen US-Dollar (+35 % YoY) erreichten. Das neu eingeführte SYMBRAVO trug seit seiner Markteinführung am 10. Juni 0,4 Millionen US-Dollar bei.
Wichtige Finanzkennzahlen umfassen einen Nettogewinnverlust von 48,0 Millionen US-Dollar (0,97 US-Dollar pro Aktie) und Bargeldreserven von 303,0 Millionen US-Dollar. Das Unternehmen erweiterte den Marktzugang von AUVELITY um 28 Millionen neu versicherte Personen und unterzeichnete den ersten GPO-Vertrag für SYMBRAVO. Axsome bleibt auf Kurs für bevorstehende regulatorische Einreichungen, darunter eine sNDA für AXS-05 bei Alzheimer-Agitation (Q3 2025) und eine NDA für AXS-12 bei Narkolepsie (Q4 2025).
- Der Gesamtumsatz aus Produkten stieg im Jahresvergleich um 72 % auf 150,0 Millionen US-Dollar
- Die Umsätze von AUVELITY stiegen im Jahresvergleich um 84 % auf 119,6 Millionen US-Dollar
- Die Einnahmen von SUNOSI wuchsen im Jahresvergleich um 35 % auf 30,0 Millionen US-Dollar
- Der Marktzugang von AUVELITY wurde um 28 Millionen neu versicherte Personen erweitert
- Starke Barposition von 303,0 Millionen US-Dollar, ausreichend zur Finanzierung der Geschäftstätigkeit bis zur positiven Cashflow-Phase
- Der Nettoverlust verbesserte sich von 79,3 Millionen US-Dollar im Q2 2024 auf 48,0 Millionen US-Dollar im Q2 2025
- None.
- SG&A expenses increased to $130.3 million from $103.6 million YoY
- Continued net loss of $48.0 million despite revenue growth
- SYMBRAVO launch contributed only minimal revenue of $0.4 million
- Limited SYMBRAVO coverage at 38% of all lives covered
Insights
Axsome delivered impressive 72% YoY revenue growth with strong commercial execution across its CNS portfolio while advancing multiple late-stage pipeline candidates.
Axsome Therapeutics reported exceptional commercial performance in Q2 2025, with
The company's sleep disorder drug SUNOSI contributed
Despite the revenue growth, Axsome still reported a quarterly net loss of
Market access improvements are noteworthy, with AUVELITY gaining 28 million new covered commercial lives, reaching
The pipeline progression is equally impressive, with imminent regulatory submissions for AXS-05 in Alzheimer's disease agitation (Q3 2025) and AXS-12 for narcolepsy (Q4 2025). Four additional Phase 3 trial initiations are planned for Q4 2025, targeting large indications including smoking cessation, pediatric ADHD, depression with excessive daytime sleepiness, and fibromyalgia.
The robust commercial execution, expanding insurance coverage, near-term regulatory catalysts, and strong pipeline progress collectively indicate Axsome is successfully executing its CNS-focused specialty pharma strategy, with a clear path to profitability emerging as revenues continue to scale.
Total 2Q 2025 net product revenue of
AUVELITY® 2Q 2025 net product sales of
SUNOSI® 2Q 2025 net product revenue of
SYMBRAVO® launched June 10th, with 2Q 2025 net product sales of
AUVELITY® market access expanded by 28 million new covered lives in the commercial channel
First group purchasing organization (GPO) contract for SYMBRAVO® signed
Supplemental NDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025
NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 4Q 2025
Company to host conference call today at 8:00 AM Eastern
NEW YORK, Aug. 04, 2025 (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 second quarter of 2025 and provided a general business update.
“Axsome delivered robust second quarter performance, reflecting strong underlying demand for our life-changing medicines, exacting commercial execution, solid regulatory progress, and continued advancement of our differentiated neuroscience pipeline. We are excited by the recent approval and launch of SYMBRAVO for migraine, and are pleased with the accelerating performance of AUVELITY for depression and SUNOSI for excessive daytime sleepiness,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “We remain on track to submit new drug applications to the FDA for AXS-05 for Alzheimer’s disease agitation in the third quarter, and for AXS-12 in narcolepsy in the fourth quarter. The rest of our development pipeline is advancing apace, including late-stage programs in ADHD, binge eating disorder, shift work disorder, depression associated with excessive daytime sleepiness, fibromyalgia, and smoking cessation. In total, our portfolio of potentially first-in-class or best-in-class medicines have the potential to address serious conditions that affect more than 150 million patients in the U.S. alone.”
Financial Highlights
- Total net product revenue was
$150.0 million for the second quarter of 2025, representing72% year-over-year growth, and24% sequential growth compared to the first quarter of 2025. Total net product revenue for the second quarter of 2024 was$87.2 million . - AUVELITY net product sales were
$119.6 million for the second quarter of 2025, representing84% year-over-year growth, and24% sequential growth compared to the first quarter of 2025. AUVELITY net product sales for the second quarter of 2024 were$65.0 million . - SUNOSI net product revenue was
$30.0 million for the second quarter of 2025, representing35% year-over-year growth, and19% sequential growth compared to the first quarter of 2025. SUNOSI net product revenue for the second quarter of 2025 consisted of$28.9 million in net product sales and$1.1 million in royalty revenue associated with SUNOSI sales in out-licensed territories. SUNOSI net product revenue for the second quarter of 2024 was$22.1 million , which consisted of$21.5 million in net product sales and$0.6 million in royalty revenue. - SYMBRAVO was launched on June 10, 2025, and had net product sales of
$0.4 million for the second quarter of 2025. No SYMBRAVO sales were reported by Axsome for the comparable period in 2024 reflecting the timing of the product launch. - Total cost of revenue was
$13.4 million for the second quarter of 2025. Total cost of revenue for the comparable period in 2024 was$8.1 million . - Research and development (R&D) expenses were
$49.5 million for the second quarter of 2025, compared to$49.9 million for the comparable period in 2024. The decrease was primarily related to the completion of trials for solriamfetol in ADHD and MDD and for AXS-05 in Alzheimer’s disease agitation, which was partially offset by higher personnel costs. - Selling, general, and administrative (SG&A) expenses were
$130.3 million for the second quarter of 2025, compared to$103.6 million for the comparable period in 2024. The increase was primarily related to commercialization activities for AUVELITY, including the sales force expansion, and the commercial launch of SYMBRAVO. - Net loss for the second quarter of 2025 was
$48.0 million , or$(0.97) per share, compared to a net loss of$79.3 million , or$(1.67) per share, for the comparable period in 2024. The net loss in the second quarter of 2025 includes$24.6 million of stock-based compensation expense. - Cash and cash equivalents totaled
$303.0 million at June 30, 2025, compared to$315.4 million at December 31, 2024. - Shares of common stock outstanding were 49,815,301 at June 30, 2025.
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 the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the U.S. for the treatment of major depressive disorder.
- Approximately 192,000 prescriptions were written for AUVELITY in the second quarter of 2025, representing an increase of
56% compared to the same period in 2024, and an increase of15% compared to the first quarter of 2025. - Payer coverage for AUVELITY in the commercial channel expanded by 28 million new covered lives as of July 1. Overall payer coverage for AUVELITY across all channels is now at approximately
83% of all lives covered, with the proportion of covered lives in the commercial and government (Medicare and Medicaid) channels at approximately73% and100% , respectively.
SUNOSI
SUNOSI is the first and only dopamine and norepinephrine reuptake inhibitor approved for the treatment of excessive daytime sleepiness in narcolepsy or obstructive sleep apnea.
- Approximately 50,000 prescriptions were written for SUNOSI in the U.S. in the second quarter of 2025, representing an increase of
13% compared to the same period in 2024, and an increase of9% compared to the first quarter of 2025. - Payer coverage for SUNOSI across all channels is at approximately
83% of all lives covered. The proportion of lives covered for SUNOSI in the commercial and government channels are approximately95% and60% , respectively.
SYMBRAVO
SYMBRAVO is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist approved in the U.S. for the acute treatment of migraine with or without aura in adults.
- SYMBRAVO became commercially available in U.S. pharmacies on June 10, 2025. Our SYMBRAVO field force is actively engaging healthcare providers to provide comprehensive education on SYMBRAVO.
- Effective July 1, Axsome has contracted with one of the three largest group purchasing organizations (GPOs) for potential formulary coverage of SYMBRAVO. Pharmacy benefit managers and health plans under this GPO are now able to make coverage decisions for SYMBRAVO based on the contracted terms.
- Payer coverage for SYMBRAVO across all channels is currently at approximately
38% of all lives covered. The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are currently approximately26% and56% , respectively. - Axsome’s comprehensive patient support services, through the SYMBRAVO On My Side program, are operational and performing as planned. These include the SYMBRAVO On My Side Savings Card to reduce out-of-pocket expenses for commercially insured eligible patients who qualify, educational resources and tools for patients to facilitate discussions with their healthcare providers, and HCP samples.
Development Pipeline
Axsome is advancing an industry-leading neuroscience pipeline of innovative, late-stage, product candidates addressing serious psychiatric and neurological conditions. Recent and anticipated progress for key pipeline programs is summarized below.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation.
- Alzheimer’s Disease Agitation: Activities for the submission of the Company’s supplemental New Drug Application (sNDA) for AXS-05 in AD agitation are progressing. Axsome is on track to submit the sNDA to the FDA in the third quarter of 2025.
- Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in the fourth quarter of 2025.
Solriamfetol
Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
- Attention Deficit Hyperactivity Disorder: Axsome plans to initiate a Phase 3 trial of solriamfetol in children and adolescents with ADHD in the fourth quarter of 2025.
The Company previously announced positive topline results from the FOCUS Phase 3 trial evaluating the efficacy and safety of solriamfetol in ADHD in adults. In the trial, solriamfetol demonstrated rapid, substantial, and statistically significant improvements in ADHD symptoms and overall disease severity compared to placebo. Solriamfetol was safe and well tolerated in the trial, with a side effect profile consistent with the established safety profile of solriamfetol.
- Major Depressive Disorder: Axsome plans to initiate a Phase 3 trial of solriamfetol in MDD patients with excessive daytime sleepiness (EDS) in the fourth quarter of 2025.
The Company previously announced topline results from the PARADIGM Phase 3 proof-of-concept trial evaluating the efficacy and safety of solriamfetol in MDD with and without EDS. In the prespecified subgroup of patients with severe EDS, solriamfetol led to numerically greater improvements in depressive symptoms. Solriamfetol was safe and well tolerated in the trial, with a side effect profile consistent with the established safety profile of solriamfetol.
- Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in BED. The Company anticipates topline results from the ENGAGE Phase 3 trial in 2026.
- Shift Work Disorder: Axsome is conducting the SUSTAIN study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in SWD in adults. The Company anticipates topline results from the SUSTAIN Phase 3 trial in 2026.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy.
- Narcolepsy: Axsome plans to submit an NDA to the FDA for AXS-12 for the treatment of cataplexy in narcolepsy in the fourth quarter of 2025.
Axsome has completed three controlled Phase 2 and Phase 3 efficacy trials and a long-term safety trial. Across these trials, AXS-12 achieved the primary endpoints and rapidly and substantially reduced cataplexy attacks, improved excessive daytime sleepiness, and improved cognitive function compared to placebo.
AXS-14
AXS-14 (esreboxetine) is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine.
- Fibromyalgia: To address the FDA’s feedback in the previously disclosed Refusal to File (RTF) letter for the Company’s NDA for AXS-14 for the management of fibromyalgia, Axsome plans to initiate a Phase 3, fixed-dose, 12-week trial of AXS-14 in fibromyalgia in the fourth quarter of 2025.
Corporate Updates
- In May 2025, Axsome announced that it resolved patent litigation with Hetero Labs Ltd. and certain of its affiliates (Hetero) related to Hetero’s Abbreviated New Drug Application (ANDA) for a generic version of SUNOSI. The Company entered into a license and settlement agreement with Hetero, which permits Hetero to begin selling its generic version of SUNOSI on or after September 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type.
- In July 2025, the Company hosted its Frontiers in Brain Health R&D Day, featuring presentations from six leading expert clinicians and key opinion leaders who discussed current indications being targeted by Axsome’s late-stage pipeline and highlighted clinical data from the development programs.
Anticipated Milestones
- Regulatory and Commercial:
- AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025)
- AXS-12 for narcolepsy, NDA submission (4Q 2025)
- Clinical Trial Topline Results:
- Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026)
- Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026)
- Clinical Trial Initiations and Progress:
- Pivotal Phase 2/3 trial of AXS-05 in smoking cessation, initiation (4Q 2025)
- Phase 3 trial of solriamfetol in ADHD in pediatric patients, initiation (4Q 2025)
- Phase 3 trial of solriamfetol in MDD with EDS, initiation (4Q 2025)
- Phase 3 trial of AXS-14 in fibromyalgia, initiation (4Q 2025)
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its second quarter 2025 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the conference call will be available for approximately 30 days following the live event.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Axsome Therapeutics, Inc. Selected Consolidated Financial Data Axsome Therapeutics, Inc. Consolidated Balance Sheets (In thousands, except share and per share amounts) | ||||||||
June 30, 2025 | December 31, 2024 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 303,016 | $ | 315,353 | ||||
Accounts receivable, net | 198,825 | 142,001 | ||||||
Inventories, net | 18,441 | 15,732 | ||||||
Prepaid and other current assets | 16,338 | 11,978 | ||||||
Total current assets | 536,620 | 485,064 | ||||||
Equipment, net | 667 | 584 | ||||||
Right-of-use asset - operating lease | 22,472 | 5,383 | ||||||
Goodwill | 12,042 | 12,042 | ||||||
Intangible asset, net | 43,733 | 46,894 | ||||||
Non-current inventory and other assets | 24,251 | 18,531 | ||||||
Total assets | $ | 639,785 | $ | 568,498 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 91,628 | $ | 71,997 | ||||
Accrued expenses and other current liabilities | 170,902 | 147,987 | ||||||
Operating lease liability, current portion | 337 | 1,835 | ||||||
Contingent consideration, current | 9,232 | 8,285 | ||||||
Short-term borrowings | 70,000 | — | ||||||
Total current liabilities | 342,099 | 230,104 | ||||||
Contingent consideration, non-current | 79,655 | 91,680 | ||||||
Loan payable, long-term | 117,540 | 180,710 | ||||||
Operating lease liability, long-term | 23,624 | 6,046 | ||||||
Finance lease liability, long-term | 3,792 | 2,943 | ||||||
Total liabilities | 566,710 | 511,483 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, | — | — | ||||||
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 | ||||||
Total liabilities and stockholders’ equity | $ | 639,785 | $ | 568,498 |
Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) | ||||||||||||||||
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Revenues: | ||||||||||||||||
Product sales, net | $ | 148,959 | $ | 86,520 | $ | 269,317 | $ | 160,616 | ||||||||
Royalty revenue | 1,083 | 646 | 2,188 | 1,549 | ||||||||||||
Total revenues | 150,042 | 87,166 | 271,505 | 162,165 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of revenue (excluding amortization and depreciation) | 13,448 | 8,055 | 23,237 | 14,352 | ||||||||||||
Research and development | 49,541 | 49,853 | 94,326 | 86,683 | ||||||||||||
Selling, general and administrative | 130,280 | 103,554 | 251,067 | 202,524 | ||||||||||||
Loss (Gain) in fair value of contingent consideration | (8,102 | ) | 2,160 | (6,590 | ) | 748 | ||||||||||
Intangible asset amortization | 1,589 | 1,590 | 3,161 | 3,179 | ||||||||||||
Total operating expenses | 186,756 | 165,212 | 365,201 | 307,486 | ||||||||||||
Loss from operations | (36,714 | ) | (78,046 | ) | (93,696 | ) | (145,321 | ) | ||||||||
Interest expense, net | (1,834 | ) | (1,299 | ) | (4,265 | ) | (2,381 | ) | ||||||||
Loss on debt extinguishment | (10,385 | ) | — | (10,385 | ) | — | ||||||||||
Loss before income taxes | (48,933 | ) | (79,345 | ) | (108,346 | ) | (147,702 | ) | ||||||||
Income tax benefit | 960 | — | 960 | — | ||||||||||||
Net loss | $ | (47,973 | ) | $ | (79,345 | ) | $ | (107,386 | ) | $ | (147,702 | ) | ||||
Net loss per common share, basic and diluted | $ | (0.97 | ) | $ | (1.67 | ) | $ | (2.18 | ) | $ | (3.11 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 49,442,001 | 47,573,229 | 49,158,159 | 47,482,602 | ||||||||||||
Investors:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
mjacobson@axsome.com
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
