Financial Performance - Total net product revenue for Q2 2024 was $87.2 million, representing an 87% year-over-year growth from $46.7 million in Q2 2023 [3] - Auvelity net product sales reached $65.0 million in Q2 2024, marking a 135% increase from $27.6 million in Q2 2023 [3] - Sunosi net product revenue was $22.1 million in Q2 2024, which includes $21.5 million in net product sales and $0.6 million in royalty revenue, reflecting a 16% growth from $19.1 million in Q2 2023 [3] Expenses - Total cost of revenue for Q2 2024 was $8.1 million, up from $4.6 million in Q2 2023 [4] - Research and development (R&D) expenses were $49.9 million in Q2 2024, compared to $20.6 million in Q2 2023, primarily due to ongoing clinical trials and increased personnel costs [4] - Selling, general, and administrative (SG&A) expenses rose to $103.6 million in Q2 2024 from $78.9 million in Q2 2023, driven by commercialization efforts and field force expansion [5] Net Loss and Cash Position - The net loss for Q2 2024 was $79.3 million, or $(1.67) per share, compared to a net loss of $67.2 million, or $(1.54) per share, in Q2 2023 [6] - Cash and cash equivalents totaled $315.7 million as of June 30, 2024, down from $386.2 million at the end of 2023 [6] Commercial Highlights - Approximately 123,000 prescriptions for Auvelity were written in Q2 2024, representing a 29% sequential increase from Q1 2024 [7] - Payer coverage for Auvelity increased to 60% of lives covered as of August 1, 2024, up from 48% in the previous quarter [7] - Sunosi had approximately 45,000 prescriptions written in Q2 2024, an 8% increase from Q1 2024, with 95% payer coverage in the commercial channel [8] Development Pipeline - The NDA for AXS-07 in migraine has been resubmitted, with expectations for a Class 2 designation and a six-month review [2][11] - Topline results for several Phase 3 trials, including AXS-05 in Alzheimer's disease agitation and solriamfetol in ADHD, are anticipated in the second half of 2024 [2][19] - The NDA submission for AXS-14 in fibromyalgia is expected in Q3 2024 [2][18] Business Update - Axsome resolved patent litigation with Unichem Laboratories regarding a generic version of Sunosi, allowing Unichem to market its product starting June 30, 2042, or earlier under certain conditions [17]

Wall Street expects a year-over-year decline in earnings on higher revenues when Axsome Therapeutics (AXSM) reports results for the quarter ended June 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August ...

The second-quarter earnings season has kickstarted but only a handful of biotech companies have reported so far. The current outlook is encouraging, driven by new drug approvals and positive pipeline updates in the first half. Increasing R&D spending on lucrative areas of obesity and rare diseases, among others, is a positive as well.Companies in this volatile biotech industry continue to be in the spotlight as pharma/biotech goliaths are looking to bolster their product portfolios and pipelines through col ...

Core Insights - Axsome Therapeutics, Inc. will report its financial results for Q2 2024 on August 5, 2024, before U.S. market opening, followed by a conference call at 8:00 a.m. Eastern Time to discuss results and provide a business update [1] Company Overview - Axsome Therapeutics, Inc. is focused on developing novel therapies for central nervous system (CNS) disorders with limited treatment options, aiming to transform treatment approaches through innovative mechanisms of action [2] Investor Relations - Investors can participate in the conference call by dialing (877) 405-1239, and a live webcast will be available on the company's website [1]

Core Viewpoint - Axsome Therapeutics is facing scrutiny from a short-seller report alleging inflated revenue related to its depression therapy Auvelity, which may impact its stock performance in a challenging year [1][2]. Company Allegations - Culper Research accuses Axsome Therapeutics of inflating revenue from Auvelity, a combination therapy of two inexpensive off-patent drugs, which is priced significantly higher than its components [2]. - The report claims that Axsome uses mail-order pharmacies to bypass insurer requirements, with sales representatives directing patients to these pharmacies, raising concerns about the legitimacy of its sales practices [3]. Analyst Reactions - Despite the allegations, analysts from Morgan Stanley and Citigroup have maintained buy ratings on Axsome Therapeutics, arguing that the claims lack merit and that the company's sales practices align with industry standards [4]. Product Pipeline - Axsome Therapeutics is developing a robust late-stage pipeline, including treatments for migraine, fibromyalgia, narcolepsy, and Alzheimer's disease agitation, which could enhance its product lineup in the coming years [5]. - The company reported total revenue of $75 million in Q1, a decline from $94.6 million year-over-year, but net sales of $74.1 million showed a year-over-year increase of approximately 159% [6]. Market Valuation - As of the latest update, Axsome Therapeutics has a market capitalization of $3.72 billion, which may undervalue its potential based on its pipeline [6].

Core Viewpoint - A short-seller report by Culper Research has led to a significant sell-off of Axsome Therapeutics' stock, with shares declining by 6.8% following the allegations regarding the company's revenue practices related to its depression drug Auvelity [1] Group 1: Allegations and Impact - Culper Research claims that Axsome's commercialization of Auvelity involves undisclosed consignment deals with questionable mail-order pharmacies, which allegedly inflate script counts and reported revenues [1] - The report is based on interviews with former sales representatives, pharmacies, prescribing physicians, and patients, raising concerns about the legitimacy of Axsome's revenue [2] - A significant concern is that Axsome's recorded revenue may not be collectible if prescriptions are filled without prior authorizations, leading to potential financial repercussions for the company [2] Group 2: Financial Implications - Since the launch of Auvelity in October 2022, Axsome's receivables have increased from $20.4 million to $101.4 million, indicating a potential risk of uncollectible revenue [2] - If the allegations are substantiated, Axsome may need to restate its revenue and write down accounts receivable, which could lead to a substantial decline in stock value [3] Group 3: Investor Guidance - As of the report's publication, Axsome Therapeutics had not publicly addressed the allegations, leaving investors uncertain about the company's position [4] - Investors are advised to wait for the company's response before making any decisions regarding their holdings or potential purchases of Axsome shares [4]

NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM) (Axsome), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, result ...

Company Overview - Axsome Therapeutics, Inc. is a biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) disorders with limited treatment options [3] - The company aims to transform the treatment approach for CNS conditions by developing therapeutic options with novel mechanisms of action [3] Industry Context - More than 37 million Americans suffer from migraine, making it the leading cause of disability among neurological disorders in the United States [2] - Migraine is associated with significant economic impacts, accounting for an estimated $78 billion in direct and indirect costs annually in the U.S. [2] - Surveys indicate that over 70% of migraine sufferers are not fully satisfied with their current treatment, and nearly 80% are open to trying new therapies [2]

NEW YORK, June 04, 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, announced today it is joining the migraine advocacy community to raise awareness of unmet patient needs during Migraine & Headache Awareness Month this June. "Education plays a crucial role in addressing the stigma associated with migraine, a complex neurological disorder often misunderstood as ...

NEW YORK, May 29, 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, today announced five presentations, including two featured oral plenary presentations, on solriamfetol at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), being held June 1-5, 2024, in Houston, Texas. “Cognitive functioni ...