Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2024 Net Revenue
Axsome Therapeutics (NASDAQ: AXSM) has announced preliminary net product revenue for Q4 and full year 2024. The company reported strong revenue growth with total product revenue expected at $118.3 million for Q4 and $385.2 million for full year 2024.
Breaking down the revenue: Auvelity net product sales reached approximately $92.6 million in Q4 and $291.4 million for the full year, while Sunosi contributed approximately $25.7 million in Q4 and $93.8 million for the full year.
The company achieved positive Phase 3 results for AXS-05 in Alzheimer's disease agitation and AXS-12 in narcolepsy, with regulatory filings planned for 2025. Axsome is also preparing for the potential launch of AXS-07 for acute migraine treatment, pending approval.
Axsome Therapeutics (NASDAQ: AXSM) ha annunciato i ricavi netti preliminari da prodotto per il quarto trimestre e per l'intero anno 2024. L'azienda ha riportato una forte crescita dei ricavi, con un fatturato complessivo atteso di 118,3 milioni di dollari per il Q4 e 385,2 milioni di dollari per l'intero anno 2024.
Analizzando i ricavi: le vendite nette di prodotto di Auvelity hanno raggiunto circa 92,6 milioni di dollari nel Q4 e 291,4 milioni di dollari per l'intero anno, mentre Sunosi ha contribuito con circa 25,7 milioni di dollari nel Q4 e 93,8 milioni di dollari per l'intero anno.
L'azienda ha ottenuto risultati positivi negli studi di Fase 3 per AXS-05 nell'agitazione da malattia di Alzheimer e per AXS-12 nella narcolessia, con domande normative previste per il 2025. Axsome si sta anche preparando per il potenziale lancio di AXS-07 per il trattamento dell'emicrania acuta, in attesa di approvazione.
Axsome Therapeutics (NASDAQ: AXSM) ha anunciado los ingresos netos preliminares por producto para el cuarto trimestre y para todo el año 2024. La compañía reportó un fuerte crecimiento de ingresos, con un ingreso total esperado de 118,3 millones de dólares para el Q4 y 385,2 millones de dólares para todo el año 2024.
Desglosando los ingresos: las ventas netas de producto de Auvelity alcanzaron aproximadamente 92,6 millones de dólares en el Q4 y 291,4 millones de dólares para todo el año, mientras que Sunosi contribuyó con aproximadamente 25,7 millones de dólares en el Q4 y 93,8 millones de dólares para todo el año.
La compañía logró resultados positivos en la Fase 3 para AXS-05 en la agitación asociada con la enfermedad de Alzheimer y AXS-12 en la narcolepsia, con presentaciones regulatorias planeadas para 2025. Axsome también se está preparando para el posible lanzamiento de AXS-07 para el tratamiento de la migraña aguda, a la espera de aprobación.
Axsome Therapeutics (NASDAQ: AXSM)는 2024년 4분기 및 전체 연도의 초기 순제품 수익을 발표했습니다. 이 회사는 4분기에 1억 1830만 달러, 2024년 전체 연도에 3억 8520만 달러에 대한 강력한 수익 성장을 보고했습니다.
수익을 세분화하면, Auvelity의 순제품 판매가 4분기에 약 9260만 달러, 전체 연도에는 2억 9140만 달러에 달했으며, Sunosi는 4분기에 약 2570만 달러와 전체 연도에 9380만 달러를 기여했습니다.
회사는 알츠하이머병의 동요에 대한 AXS-05와 기면증에 대한 AXS-12의 3상 연구에서 긍정적인 결과를 달성했으며, 2025년으로 예정된 규제 제출을 계획하고 있습니다. Axsome은 또한 승인을 기다리고 있는 급성 편두통 치료를 위한 AXS-07의 잠재적 출시를 준비하고 있습니다.
Axsome Therapeutics (NASDAQ: AXSM) a annoncé des revenus produits nets préliminaires pour le quatrième trimestre et pour l'année entière 2024. La société a rapporté une forte croissance des revenus, avec un revenu total attendu de 118,3 millions de dollars pour le Q4 et 385,2 millions de dollars pour l'année entière 2024.
En décomposant les revenus : les ventes nettes de produits de Auvelity ont atteint environ 92,6 millions de dollars au Q4 et 291,4 millions de dollars pour l'année entière, tandis que Sunosi a contribué à hauteur d'environ 25,7 millions de dollars au Q4 et 93,8 millions de dollars pour l'année entière.
La société a obtenu des résultats positifs en Phase 3 pour AXS-05 dans l'agitation associée à la maladie d'Alzheimer et AXS-12 dans la narcolepsie, avec des dépôts réglementaires prévus pour 2025. Axsome se prépare également au potentiel lancement d'AXS-07 pour le traitement de la migraine aiguë, en attente d'approbation.
Axsome Therapeutics (NASDAQ: AXSM) hat die vorläufigen Nettoumsätze aus Produktverkäufen für das vierte Quartal und das gesamte Jahr 2024 bekannt gegeben. Das Unternehmen meldete ein starkes Umsatzwachstum, mit einem Gesamtumsatz von voraussichtlich 118,3 Millionen Dollar für das Q4 und 385,2 Millionen Dollar für das gesamte Jahr 2024.
Die Umsatzaufteilung: Die Nettoumsätze von Auvelity beliefen sich im Q4 auf etwa 92,6 Millionen Dollar und im gesamten Jahr auf 291,4 Millionen Dollar, während Sunosi im Q4 etwa 25,7 Millionen Dollar und im gesamten Jahr 93,8 Millionen Dollar beisteuerte.
Das Unternehmen erzielte positive Ergebnisse in der Phase 3 für AXS-05 bei der Erregung in Verbindung mit Alzheimer und AXS-12 bei der Narkolepsie, mit geplanten regulatorischen Einreichungen für 2025. Axsome bereitet sich auch auf die potenzielle Markteinführung von AXS-07 zur Behandlung von akuter Migräne vor, die noch genehmigt werden muss.
- Total product revenue reached $385.2 million for full year 2024
- Auvelity sales achieved $291.4 million for full year 2024
- Sunosi revenue reached $93.8 million for full year 2024
- Positive Phase 3 results for both AXS-05 and AXS-12
- None.
Insights
The preliminary Q4 2024 results showcase remarkable commercial execution. Auvelity achieved
The full-year revenue of
Most compelling is Auvelity's rapid adoption curve, suggesting potential peak sales could exceed initial
The Q4 performance indicates strong market positioning in the competitive CNS therapeutics space. Auvelity's growth trajectory outperforms comparable CNS drug launches, capturing approximately
Key competitive advantages driving adoption include Auvelity's rapid onset of action and favorable safety profile. The combined revenue streams from both products establish AXSM as a meaningful player in the CNS market, with potential for significant market share expansion through their pipeline developments.
The planned AXS-07 migraine launch could tap into a
Auvelity preliminary 4Q and full year 2024 net product sales of
Sunosi preliminary 4Q and full year 2024 net product revenue of
NEW YORK, Jan. 13, 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 preliminary net product revenue for the fourth quarter and full year ended December 31, 2024.
“We delivered strong revenue growth in 2024 and significantly advanced our industry leading neuroscience pipeline, including achievement of positive Phase 3 results for AXS-05 in Alzheimer’s disease agitation and for AXS-12 in narcolepsy, supporting planned regulatory filings for these indications and products in 2025,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We also look to carry our commercial momentum into 2025 with continued growth for Auvelity and Sunosi, and are making active launch preparations for AXS-07 for the acute treatment of migraine, if approved.”
Preliminary Fourth Quarter and Full Year 2024 Net Product Revenue (Unaudited)
Based on preliminary unaudited financial information, Axsome expects total product revenue to be approximately
- Auvelity® net product sales are expected to be approximately
$92.6 million and$291.4 million for the fourth quarter and full year of 2024, respectively. - Sunosi® net product revenue is expected to be approximately
$25.7 million and$93.8 million for the fourth quarter and full year of 2024, respectively.
The foregoing information reflects the Company's estimate with respect to net product revenue for Auvelity and Sunosi based on currently available unaudited information. This announcement is not a comprehensive statement of Axsome’s financial results and is subject to completion of Axsome’s financial closing procedures. Axsome’s final financial results will be issued upon completion of its closing procedures and may vary from these preliminary estimates.
About Axsome Therapeutics, Inc.
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 and excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea 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.
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 continued commercial success of the Company’s Sunosi® and Auvelity® 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, including statements regarding the ability of the ACCORD and ADVANCE clinical trials to support the filing of an NDA for Alzheimer’s disease agitation; 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; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to the Company’s special protocol assessment for the MOMENTUM clinical trial; 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 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 continued commercialization of Sunosi and Auvelity 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; differences between the Company’s 2024 preliminary financial information disclosed herein as compared to the Company’s final 2024 audited financial statements; the fact that estimated net product revenue is not a comprehensive statement of the Company’s financial results and is subject to completion of Company’s financial closing procedures; 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 circumstance.
Investors:
Mark Jacobson
Chief Operating Officer
Tel: 212-332-3243
Email: mjacobson@axsome.com
Media:
Darren Opland
Director, Corporate Communications
Tel: 929-837-1065
Email: dopland@axsome.com
FAQ
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