Axsome Therapeutics, Inc. (AXSM) incurred an adjusted loss of $1.34 per share in the third quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of $1.38. The company had incurred a loss of $1.32 per share in the year-ago quarter.Axsome’s total revenues surged 81% year over year to $104.8 million in the third quarter, beating the Zacks Consensus Estimate of $99 million. The increase in revenues can be attributed to strong sales of Auvelity (AXS-05).Shares of Axsome were up 9.4% on Nov. 12 ow ...

Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q3 2024 Earnings Conference Call November 12, 2024 8:00 AM ET Company Participants Darren Opland - Director, Corporate Communications Herriot Tabuteau - CEO Nick Pizzie - CFO Ari Maizel - EVP and Head, Commercial Mark Jacobson - Chief Operating Officer Conference Call Participants Jason Gerberry - Bank of America Leonid Timashev - RBC Capital Markets Charles Duncan - Cantor Fitzgerald Cerena Chen - Wells Fargo David Amsellem - Piper Sandler Marc Goodman - Leerink Part ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 001-37635 AXSOME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 45- ...

Axsome Therapeutics (AXSM) came out with a quarterly loss of $1.34 per share versus the Zacks Consensus Estimate of a loss of $1.38. This compares to loss of $1.32 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 2.90%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.30 per share when it actually produced a loss of $1.24, delivering a surprise of 4.62%.Over the last four quarters, the ...

业绩总结 - 2024年第三季度总净产品收入为1.048亿美元，同比增长81%[17] - 2024年第三季度净产品销售额为8040万美元，同比增长113%[81] - 2024年第三季度Sunosi的净产品收入为2440万美元，同比增长21%[82] - Auvelity的销售额在2024年第三季度达到8040万美元，创下历史新高[88] - Sunosi在2024年第三季度的销售额为2440万美元，显示出稳定的市场需求[90] 用户数据 - Auvelity的销售额中，约有140,000名新患者和超过28,000名独特开处方医生自上市以来[81] - Sunosi的销售中，超过76,000名新患者和超过13,000名独特开处方医生自初次上市以来[82] - Auvelity的处方中，50%的处方来自于一线或二线用药[81] - Sunosi的患者满意度高，主要原因包括副作用少或没有副作用[82] - Auvelity的覆盖人群中，78%为商业和政府渠道的受保人群[81] - Sunosi的覆盖人群中，83%为商业和政府渠道的受保人群[82] 未来展望 - 预计到2025/2026年将获得至少3项FDA批准，并在2027年前推出7个新产品/适应症[14] - AXS-07的PDUFA目标日期为2025年1月31日[16] - 预计AXS-14在纤维肌痛症的NDA提交预计在2024年11月[21] - 预计AXS-12在嗜睡症的ENCORE三期试验结果将在2024年第四季度公布[40] - 预计AXS-05在阿尔茨海默病激动症的ADVANCE-2三期试验结果将在2024年第四季度公布[30] - 预计AXS-05在重度抑郁症的FOCUS三期试验结果将在2025年第一季度公布[39] - 预计AXS-07在偏头痛的NDA重新提交将于2025年1月进行[79] - 预计Solriamfetol在注意力缺陷多动障碍的PARADIGM三期试验结果将在2025年第一季度公布[53] 新产品和新技术研发 - AXS-07在MOMENTUM Phase 3临床试验中，1594名患者显示出显著的疼痛缓解效果[27] - AXS-12在SYMPHONY Phase 3试验中，显示出对比安慰剂有统计学显著的猫癫痫发作减少（p<0.001）[123] - 预计2025年第一季度发布AXS-12在嗜睡症中的顶线数据[126] - 预计2025年第一季度发布solriamfetol在注意力缺陷多动障碍（ADHD）中的顶线数据[138] 市场扩张和并购 - Axsome Therapeutics的现金余额为3.273亿美元，债务面值为1.8亿美元，市值为44亿美元[165] - Axsome Therapeutics拥有超过98项已授予的美国专利和超过129项已授予的国际专利，专利保护延续至2043年[163] 负面信息 - 超过70%的偏头痛患者对当前治疗不满意，渴望更快、更持久的疗法[26] - 超过70%的重度抑郁症患者在一线标准治疗中仅部分改善症状[148] - 在美国，约有700万人患有暴食症（BED），该病在女性中比男性更常见，比例为1.75倍[154] - 在美国，约有1500万工人可能患有轮班工作障碍（SWD），该病与多种健康问题相关[159]

产品收入情况 - 2024年第三季度总净产品收入为1.048亿美元同比增长81%[2] - 2024年第三季度Auvelity净产品销售额为8040万美元同比增长113%[3] - 2024年第三季度Sunosi净产品收入为2440万美元同比增长21%[3] - 2024年三季度产品销售净额为103736千美元2023年同期为57127千美元[34] - 2024年前三季度产品销售净额为264352千美元2023年同期为131713千美元[34] 产品相关计划与试验结果公布 - 计划2025年第一季度第二次扩充Auvelity精神病学销售团队[1] - 2025年1月31日为AXS - 07治疗偏头痛的PDUFA目标日期[1] - 预计2024年第四季度公布AXS - 05在阿尔茨海默病躁动中的ADVANCE - 2和ACCORD - 2 3期试验的主要结果[1] - 预计2024年第四季度公布AXS - 12在发作性睡病中的ENCORE 3期试验的主要结果[1] - 预计2025年1月公布solriamfetol在ADHD中的FOCUS 3期试验的主要结果[1] - 预计2025年1月公布solriamfetol在MDD中的PARADIGM 3期试验的主要结果[1] - 预计2024年11月提交AXS - 14用于纤维肌痛管理的NDA[1] 公司财务状况 - 2024年三季度净亏损64602千美元2023年同期为62199千美元[34] - 2024年前三季度净亏损212304千美元2023年同期为140587千美元[34] - 2024年三季度末现金及现金等价物为327341千美元2023年末为386193千美元[33] - 2024年三季度末总资产为561458千美元2023年末为588236千美元[33] - 2024年三季度末总负债为468560千美元2023年末为397259千美元[33] 公司风险与不确定因素 - 公司存在多种前瞻性陈述包含产品商业成功、临床试验、监管批准等多方面风险[31] - 公司面临如维持和扩大付款人覆盖范围等多种能力相关风险[31] - 公司面临如成功捍卫知识产权等多种不确定因素[31]

The third-quarter 2024 reporting cycle of the Medical sector is about to end as most firms have already reported their earnings results. The sector mainly comprises pharma/biotech and medical device companies. The earnings season for the drug and biotech sector kicked off around mid-October when bellwether Johnson & Johnson reported strong third-quarter results, beating estimates for earnings and sales. J&J consequently raised its total revenue expectation for the year while lowering its adjusted earnings e ...

Yes, bargains can still be found in the stock market.How richly valued are stocks right now? Legendary investor Warren Buffett has built Berkshire Hathaway's cash stockpile up to roughly $277 billion. When Buffett is sitting on that much cash because he can't find appealing investments to buy, you know stocks are expensive. There are exceptions, though. In a market that's broadly speaking priced for perfection, three Motley Fool contributors have identified what they think are bargain stocks to buy: Axsome ...

NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, will report its financial results for the third quarter of 2024 on Tuesday, November 12, 2024, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate i ...

Axsome Therapeutics’ (AXSM) Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio.Auvelity generated sales worth $118.4 million in the first half of 2024, up 172.8% year over year, owing to strong underlying demand.AXSM is also conducting several label expansion studies on Auvelity targeting other central nervous system (CNS) disorders like Alzheimer’s disease (AD) associated agitation an ...