Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Axsome Therapeutics (AXSM) reported strong financial results for Q4 and full year 2024, with total net product revenue reaching $118.8M in Q4 (66% YoY growth) and $385.7M for the full year (88% YoY growth). Auvelity sales showed impressive growth of 89% YoY to $92.6M in Q4, while Sunosi revenue grew 16% to $26.2M.
The company achieved significant milestones including FDA approval of Symbravo for acute migraine treatment, completion of Phase 3 clinical program for AXS-05 in Alzheimer's disease agitation, and positive results from ENCORE Phase 3 trial of AXS-12 in narcolepsy. Both products are anticipated for NDA submission in 2H 2025.
Net loss for Q4 2024 was $74.9M ($1.54 per share), compared to $98.7M ($2.08 per share) in Q4 2023. Cash position stood at $315.4M as of December 31, 2024, which the company believes is sufficient to fund operations until cash flow positivity.
Axsome Therapeutics (AXSM) ha riportato risultati finanziari solidi per il quarto trimestre e l'intero anno 2024, con un fatturato netto totale di $118,8 milioni nel quarto trimestre (crescita del 66% anno su anno) e $385,7 milioni per l'intero anno (crescita dell'88% anno su anno). Le vendite di Auvelity hanno mostrato una crescita impressionante del 89% anno su anno, raggiungendo $92,6 milioni nel quarto trimestre, mentre il fatturato di Sunosi è cresciuto del 16%, arrivando a $26,2 milioni.
L'azienda ha raggiunto traguardi significativi, tra cui l'approvazione della FDA per Symbravo nel trattamento dell'emicrania acuta, il completamento del programma clinico di Fase 3 per AXS-05 nell'agitazione della malattia di Alzheimer e risultati positivi dalla sperimentazione ENCORE di Fase 3 di AXS-12 nella narcolessia. Entrambi i prodotti sono previsti per la presentazione della NDA nella seconda metà del 2025.
La perdita netta per il quarto trimestre 2024 è stata di $74,9 milioni ($1,54 per azione), rispetto a $98,7 milioni ($2,08 per azione) nel quarto trimestre 2023. La posizione di cassa si attestava a $315,4 milioni al 31 dicembre 2024, cifra che l'azienda ritiene sufficiente per finanziare le operazioni fino al raggiungimento della positività del flusso di cassa.
Axsome Therapeutics (AXSM) reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024, con ingresos netos totales por productos alcanzando los $118.8 millones en el cuarto trimestre (crecimiento del 66% interanual) y $385.7 millones para el año completo (crecimiento del 88% interanual). Las ventas de Auvelity mostraron un impresionante crecimiento del 89% interanual, alcanzando los $92.6 millones en el cuarto trimestre, mientras que los ingresos de Sunosi crecieron un 16% hasta los $26.2 millones.
La compañía logró hitos significativos, incluyendo la aprobación de la FDA para Symbravo en el tratamiento de la migraña aguda, la finalización del programa clínico de Fase 3 para AXS-05 en la agitación de la enfermedad de Alzheimer, y resultados positivos del ensayo ENCORE de Fase 3 de AXS-12 en narcolepsia. Se anticipa que ambos productos serán presentados para NDA en la segunda mitad de 2025.
La pérdida neta para el cuarto trimestre de 2024 fue de $74.9 millones ($1.54 por acción), en comparación con $98.7 millones ($2.08 por acción) en el cuarto trimestre de 2023. La posición de efectivo se situó en $315.4 millones al 31 de diciembre de 2024, cifra que la empresa considera suficiente para financiar las operaciones hasta alcanzar la positividad del flujo de caja.
Axsome Therapeutics (AXSM)는 2024년 4분기 및 전체 연도의 강력한 재무 결과를 보고했으며, 4분기 총 순제품 수익이 1억 1,880만 달러에 달하며(전년 대비 66% 성장), 전체 연도 수익은 3억 8,570만 달러로(전년 대비 88% 성장) 기록했습니다. Auvelity 판매는 4분기 동안 전년 대비 89% 성장하여 9,260만 달러에 도달했으며, Sunosi 수익은 16% 증가하여 2,620만 달러에 달했습니다.
회사는 급성 편두통 치료를 위한 Symbravo의 FDA 승인, 알츠하이머병의 불안 증세에 대한 AXS-05의 3상 임상 프로그램 완료, 그리고 기면증에서 AXS-12의 ENCORE 3상 시험의 긍정적인 결과를 포함한 중대한 이정표를 달성했습니다. 두 제품 모두 2025년 하반기 NDA 제출이 예상됩니다.
2024년 4분기 순손실은 7,490만 달러($1.54 per share)로, 2023년 4분기의 9,870만 달러($2.08 per share)와 비교되었습니다. 현금 잔고는 2024년 12월 31일 기준으로 3억 1,540만 달러였으며, 회사는 현금 흐름이 긍정적으로 전환될 때까지 운영 자금을 지원하기에 충분하다고 믿고 있습니다.
Axsome Therapeutics (AXSM) a annoncé de solides résultats financiers pour le quatrième trimestre et l'année complète 2024, avec un chiffre d'affaires net total de produits atteignant 118,8 millions de dollars au quatrième trimestre (croissance de 66 % en glissement annuel) et 385,7 millions de dollars pour l'année complète (croissance de 88 % en glissement annuel). Les ventes de Auvelity ont montré une croissance impressionnante de 89 % en glissement annuel, atteignant 92,6 millions de dollars au quatrième trimestre, tandis que les revenus de Sunosi ont augmenté de 16 % pour atteindre 26,2 millions de dollars.
La société a atteint des jalons significatifs, y compris l'approbation de la FDA pour Symbravo pour le traitement des migraines aiguës, l'achèvement du programme clinique de Phase 3 pour AXS-05 dans l'agitation liée à la maladie d'Alzheimer, et des résultats positifs de l'essai ENCORE de Phase 3 de AXS-12 dans la narcolepsie. Les deux produits devraient être soumis pour NDA au second semestre de 2025.
La perte nette pour le quatrième trimestre 2024 s'élevait à 74,9 millions de dollars (1,54 dollar par action), contre 98,7 millions de dollars (2,08 dollars par action) au quatrième trimestre 2023. La position de trésorerie s'élevait à 315,4 millions de dollars au 31 décembre 2024, ce que l'entreprise considère suffisant pour financer ses opérations jusqu'à ce que le flux de trésorerie devienne positif.
Axsome Therapeutics (AXSM) hat starke finanzielle Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 gemeldet, mit einem Gesamtumsatz aus Produkten von 118,8 Millionen Dollar im vierten Quartal (66% Wachstum im Jahresvergleich) und 385,7 Millionen Dollar für das gesamte Jahr (88% Wachstum im Jahresvergleich). Die Verkäufe von Auvelity zeigten ein beeindruckendes Wachstum von 89% im Jahresvergleich und erreichten 92,6 Millionen Dollar im vierten Quartal, während die Einnahmen von Sunosi um 16% auf 26,2 Millionen Dollar stiegen.
Das Unternehmen erreichte bedeutende Meilensteine, einschließlich der FDA-Zulassung von Symbravo zur Behandlung von akuten Migräneanfällen, dem Abschluss des klinischen Programms der Phase 3 für AXS-05 bei Unruhe in der Alzheimer-Krankheit und positiven Ergebnissen der ENCORE-Phase-3-Studie zu AXS-12 bei Narkolepsie. Beide Produkte werden voraussichtlich in der zweiten Hälfte von 2025 zur NDA eingereicht.
Der Nettoverlust für das vierte Quartal 2024 betrug 74,9 Millionen Dollar (1,54 Dollar pro Aktie), verglichen mit 98,7 Millionen Dollar (2,08 Dollar pro Aktie) im vierten Quartal 2023. Die Liquiditätsposition belief sich zum 31. Dezember 2024 auf 315,4 Millionen Dollar, was das Unternehmen für ausreichend hält, um die Betriebe bis zur positiven Cashflow-Phase zu finanzieren.
- Strong revenue growth: Q4 net product revenue up 66% YoY to $118.8M
- Auvelity sales grew 89% YoY to $92.6M in Q4
- FDA approval of Symbravo for migraine treatment
- Successful completion of Phase 3 program for AXS-05 in Alzheimer's disease agitation
- Cash position of $315.4M sufficient until cash flow positivity
- Net loss increased to $287.2M for full year 2024 vs $239.2M in 2023
- R&D expenses increased 91% YoY to $187.1M in 2024
- SG&A expenses rose 27% to $411.4M in 2024
Insights
The Q4 and FY2024 results demonstrate exceptional commercial execution, with Auvelity emerging as the primary growth driver, contributing
The company's operational landscape shows both strengths and challenges. While revenue growth is robust, the increased R&D spending of
The recent patent settlement with Teva securing Auvelity's exclusivity until at least 2038 represents a significant strategic victory, providing clear visibility on the product's commercial runway. The expanded payer coverage for both Auvelity (
Looking ahead, the company's assertion of sufficient cash to reach cash flow positivity appears credible given the
Total 4Q and full year 2024 net product revenue of
Auvelity® 4Q and full year 2024 net product sales of
Sunosi® 4Q and full year 2024 net product revenue of
Symbravo® approved in the U.S. for the acute treatment of migraine with or without aura in adults
Successful completion of Phase 3 clinical program of AXS-05 in Alzheimer’s disease agitation announced; NDA submission anticipated in 2H 2025
Positive topline results of ENCORE Phase 3 trial of AXS-12 in narcolepsy announced; NDA submission anticipated in 2H 2025
Topline results of EMERGE Phase 3 trial of Symbravo in migraine in patients with prior inadequate response to oral CGRP inhibitors on track for 1Q 2025
Topline results of FOCUS and PARADIGM Phase 3 trials of solriamfetol in ADHD and MDD, respectively, on track for 1Q 2025
Company to host conference call today at 8:00 AM Eastern
NEW YORK, Feb. 18, 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 fourth quarter and full year of 2024 and provided a general business update.
“2024 was another defining year for Axsome, driven by strong commercial growth and a rapidly advancing late-stage pipeline, which culminated in the successful completion of our Phase 3 clinical program for AXS-05 in Alzheimer’s disease agitation, and most recently, the U.S. approval of Symbravo last month for the acute treatment of migraine with or without aura in adults,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “With potentially five marketed products across six CNS indications of great unmet need over the next 12-18 months, we are well positioned to continue delivering innovative new medicines to patients, and significant near- and long-term value to shareholders.”
Fourth Quarter and Full Year 2024 Financial Highlights
- Total net product revenues were
$118.8 million and$385.7 million for the fourth quarter and full year of 2024, representing66% and88% year-over-year growth, respectively. Total net product revenues for the comparable periods in 2023 were$71.5 million and$204.9 million , respectively. - Auvelity net product sales were
$92.6 million and$291.4 million for the fourth quarter and full year of 2024, representing89% and124% year-over-year growth, respectively. Auvelity net product sales for the comparable periods in 2023 were$49.0 million and$130.1 million , respectively. - Sunosi net product revenues were
$26.2 million and$94.3 million for the fourth quarter and full year of 2024, representing16% and26% year-over-year growth, respectively, which consisted of$24.7 million and$90.3 million in net products sales and$1.4 million and$4.0 million in royalty and milestone revenue associated with Sunosi sales in out-licensed territories, respectively. Sunosi net product revenues for the comparable periods in 2023 were$22.5 million and$74.8 million , which consisted of$21.7 million and$72.4 million in net product sales, respectively. - Total costs of revenue were
$10.5 million and$33.3 million for the fourth quarter and full year of 2024, respectively. Total cost of revenue for the fourth quarter of 2024 included a one-time$2.5 million sales-based milestone expense related to world-wide Sunosi sales. Total costs of revenue for the comparable periods in 2023 were$7.4 million and$26.1 million , respectively. - Research and development (R&D) expenses were
$55.0 million and$187.1 million for the fourth quarter and full year of 2024, respectively, compared to$30.8 million and$97.9 million for the comparable periods in 2023. The increase in R&D expenses for the year was primarily related to the Company’s ongoing Phase 3 trials of solriamfetol in ADHD, MDD, BED, and SWD, the advancement of Phase 3 trials of AXS-05 and AXS-12, manufacturing costs for AXS-07 and AXS-14, and higher personnel costs, including non-cash stock-based compensation, associated with organizational growth. - Selling, general, and administrative (SG&A) expenses were
$113.3 million and$411.4 million for the fourth quarter and full year of 2024, respectively, compared to$86.8 million and$323.1 million for the comparable periods in 2023. The increase in SG&A expenses for the year was primarily related to commercialization activities for Auvelity and Sunosi, and higher personnel costs, including non-cash stock-based compensation, associated with organizational growth. - Net loss for the fourth quarter of 2024 was
$74.9 million , or$(1.54) per share, compared to a net loss of$98.7 million , or$(2.08) per share for the comparable period in 2023. The net loss in the fourth quarter of 2024 includes$35.9 million in non-cash charges, primarily consisting of$22.0 million in stock-based compensation expense,$11.0 million in acquisition-related contingent consideration expense, and$1.6 million in intangible asset amortization. Net loss for the full year of 2024 was$287.2 million , or$(5.99) per share, compared to a net loss of$239.2 million , or$(5.27) per share for the full year of 2023. The net loss for the full year of 2024 includes$124.9 million in non-cash charges, including$85.2 million in stock-based compensation expense,$28.1 million in acquisition-related contingent consideration expense, and$6.4 million in intangible amortization, compared to$62.6 million ,$48.9 million , and$6.4 million for the full year of 2023, respectively. - Cash and cash equivalents totaled
$315.4 million at December 31, 2024, compared to$386.2 million at December 31, 2023. - Shares of common stock outstanding were 48,667,587 at December 31, 2024.
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
- Approximately 158,000 prescriptions were written for Auvelity in the fourth quarter of 2024, representing an increase of
87% compared to the same period in 2023, and an increase of10% compared to the third quarter of 2024. - Payer coverage for Auvelity across all channels is at approximately
78% of all covered lives. The proportion of lives covered for Auvelity in the commercial and government (Medicare and Medicaid) channels are approximately63% and100% , respectively. - The previously announced expansion of the Auvelity psychiatry sales force from 260 to 300 sales representatives is now complete. The sales force expansion is expected to support continued growth within the primary care market and further improvements in payer coverage.
Sunosi
- Approximately 49,000 prescriptions were written for Sunosi in the U.S. in the fourth quarter of 2024, representing an increase of
16% compared to the same period in 2023, and an increase of4% compared to the third quarter of 2024. - Payer coverage for Sunosi across all channels is at approximately
83% of all covered lives. The proportion of lives covered for Sunosi in the commercial and government channels are approximately95% and60% , respectively.
Symbravo
- On January 30, 2025, the U.S. Food and Drug Administration (FDA) approved Symbravo for the acute treatment of migraine with or without aura in adults. Symbravo represents a novel, multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack, and is engineered with Axsome’s patented MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) rapid absorption technology. Pre-launch activities, including sales force hiring and payer discussions, are underway. The Company anticipates Symbravo to be commercially available in the U.S. in approximately four months.
Development Pipeline
Axsome is advancing an industry-leading neuroscience pipeline of multiple, innovative, late-stage, patent-protected product candidates addressing a broad range of 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: Axsome has completed the Phase 3 clinical program of AXS-05 in Alzheimer’s disease agitation consisting of four controlled Phase 3 efficacy trials and a long-term safety trial. AXS-05 demonstrated statistically significant improvements in Alzheimer’s disease agitation compared to placebo in three efficacy trials (ADVANCE-1, ACCORD-1, and ACCORD-2), with supportive efficacy and controlled safety results in a fourth trial (ADVANCE-2). Based on the results from these studies, Axsome plans to submit a New Drug Application (NDA) for AXS-05 for the treatment of Alzheimer’s disease agitation to the FDA in the second half of 2025.
- Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in 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), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
- Attention Deficit Hyperactivity Disorder: Axsome is conducting the FOCUS study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in ADHD in adults. The Company is on track to report topline results from the FOCUS Phase 3 trial in the first quarter of 2025.
- Major Depressive Disorder: Axsome is conducting the PARADIGM study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in MDD. The study will examine the effect of solriamfetol in MDD patients with and without excessive daytime sleepiness (EDS). The Company is on track to report topline results from the PARADIGM Phase 3 trial in the first quarter of 2025.
- 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. Based on current enrollment trends, the Company now 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.
Symbravo
Symbravo (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist indicated for the acute treatment of migraine with or without aura in adults.
- Migraine: Axsome is conducting the EMERGE study, a Phase 3, single-group, multicenter trial evaluating the efficacy and safety of Symbravo for the acute treatment of migraine in adults with a prior inadequate response to an oral CGRP inhibitor. The Company anticipates topline results from the EMERGE Phase 3 trial in the first quarter of 2025.
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 has completed three controlled Phase 2 and Phase 3 efficacy trials and a long-term safety trial of AXS-12 in patients with narcolepsy with cataplexy. AXS-12 demonstrated statistically significant efficacy compared to placebo in all three efficacy trials (CONCERT, SYMPHONY, and ENCORE). Based on the results from these studies, Axsome plans to submit an NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy to the FDA in the second half of 2025.
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: Axsome plans to submit an NDA to the FDA for AXS-14 for the management of fibromyalgia in the first quarter of 2025.
Corporate Update
- In February 2025, Axsome announced that it has entered into a settlement agreement resolving all outstanding patent litigation related to Auvelity (dextromethorphan HBr – bupropion HCl). The litigation resulted from submission by Teva of an ANDA to the FDA seeking approval to market a generic version of Auvelity in the United States prior to the expiration of applicable Axsome patents. 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, 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.
Anticipated Milestones
- Regulatory and Commercial:
- AXS-14 for fibromyalgia, NDA submission (1Q 2025)
- AXS-05 for Alzheimer’s disease agitation, NDA submission (2H 2025)
- AXS-12 for narcolepsy, NDA submission (2H 2025)
- Clinical Trial Topline Results:
- Phase 3 EMERGE trial of AXS-07 in migraine in patients with inadequate response to oral CGRP inhibitors (1Q 2025)
- Phase 3 FOCUS trial of solriamfetol in ADHD in adults (1Q 2025)
- Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (1Q 2025)
- 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 (2025)
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its fourth quarter and full year 2024 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 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 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 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 circumstance.
Axsome Therapeutics, Inc.
Selected Consolidated Financial Data
| Axsome Therapeutics, Inc. Consolidated Balance Sheets (Unaudited, in thousands, except share and per share amounts) | ||||||||
| December 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 315,353 | $ | 386,193 | ||||
| Accounts receivable, net | 142,001 | 94,820 | ||||||
| Inventories, net | 15,732 | 15,135 | ||||||
| Prepaid and other current assets | 11,978 | 8,115 | ||||||
| Total current assets | 485,064 | 504,263 | ||||||
| Equipment, net | 584 | 846 | ||||||
| Right-of-use asset - operating lease | 5,383 | 6,772 | ||||||
| Goodwill | 12,042 | 12,042 | ||||||
| Intangible asset, net | 46,894 | 53,286 | ||||||
| Non-current inventory and other assets | 18,531 | 11,027 | ||||||
| Total assets | $ | 568,498 | $ | 588,236 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 71,997 | $ | 40,679 | ||||
| Accrued expenses and other current liabilities | 147,987 | 90,501 | ||||||
| Operating lease liability, current portion | 1,835 | 1,267 | ||||||
| Contingent consideration, current | 8,285 | 6,407 | ||||||
| Total current liabilities | 230,104 | 138,854 | ||||||
| Contingent consideration, non-current | 91,680 | 73,300 | ||||||
| Loan payable, long-term | 180,710 | 178,070 | ||||||
| Operating lease liability, long-term | 6,046 | 7,035 | ||||||
| Finance lease liability, long-term | 2,943 | — | ||||||
| Total liabilities | 511,483 | 397,259 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 5 | 5 | ||||||
| Additional paid-in capital | 1,179,797 | 1,026,543 | ||||||
| Accumulated deficit | (1,122,787 | ) | (835,571 | ) | ||||
| Total stockholders’ equity | 57,015 | 190,977 | ||||||
| Total liabilities and stockholders’ equity | $ | 568,498 | $ | 588,236 | ||||
| Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
| Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 117,325 | $ | 70,747 | $ | 381,677 | $ | 202,460 | ||||||||
| License revenue | — | — | — | 65,735 | ||||||||||||
| Royalty and milestone revenue | 1,441 | 784 | 4,016 | 2,405 | ||||||||||||
| Total revenues | 118,766 | 71,531 | 385,693 | 270,600 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue (excluding amortization and depreciation) | 10,514 | 7,377 | 33,303 | 26,065 | ||||||||||||
| Research and development | 55,006 | 30,803 | 187,077 | 97,944 | ||||||||||||
| Selling, general and administrative | 113,271 | 86,810 | 411,359 | 323,123 | ||||||||||||
| Loss in fair value of contingent consideration | 10,985 | 43,207 | 28,124 | 48,918 | ||||||||||||
| Intangible asset amortization | 1,607 | 1,607 | 6,392 | 6,375 | ||||||||||||
| Total operating expenses | 191,383 | 169,804 | 666,255 | 502,425 | ||||||||||||
| Loss from operations | (72,617 | ) | (98,273 | ) | (280,562 | ) | (231,825 | ) | ||||||||
| Interest expense, net | (2,210 | ) | (703 | ) | (6,569 | ) | (6,453 | ) | ||||||||
| Loss before income taxes | (74,827 | ) | (98,976 | ) | (287,131 | ) | (238,278 | ) | ||||||||
| Income tax benefit (expense) | (85 | ) | 325 | (85 | ) | (960 | ) | |||||||||
| Net loss | $ | (74,912 | ) | $ | (98,651 | ) | $ | (287,216 | ) | $ | (239,238 | ) | ||||
| Net loss per common share, basic and diluted | $ | (1.54 | ) | $ | (2.08 | ) | $ | (5.99 | ) | $ | (5.27 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 48,541,905 | 47,329,782 | 47,914,253 | 45,425,212 | ||||||||||||
Investors:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
mjacobson@axsome.com
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
FAQ
What was Axsome's (AXSM) revenue growth in Q4 2024?
When will Axsome (AXSM) submit the NDA for AXS-05 in Alzheimer's disease agitation?
What is Axsome's (AXSM) cash position as of December 31, 2024?
When will Symbravo be commercially available following AXSM's FDA approval?
What is the patent settlement agreement between Axsome (AXSM) and Teva regarding Auvelity?
