Core Viewpoint - Axsome Therapeutics reported a wider adjusted loss per share in Q4 2024 compared to the previous year, despite a significant increase in total revenues driven by strong sales of its products, particularly Auvelity. Financial Performance - Axsome incurred an adjusted loss of $0.96 per share in Q4 2024, compared to a loss of $0.73 per share in the same quarter last year [1] - Total revenues surged 66% year over year to $118.8 million, slightly exceeding the Zacks Consensus Estimate of $118 million [2] - Net product revenues reached $117.3 million in Q4, up from $70.7 million in the year-ago period, beating the model estimate of $112.2 million [3] Product Sales - Auvelity sales were $92.6 million, reflecting an 89% year-over-year increase and surpassing the model estimate of $87.7 million [4] - Approximately 158,000 prescriptions for Auvelity were recorded in the quarter, marking a 10% sequential increase and an 87% year-over-year increase [4] - Sunosi's net product sales were $26.2 million, up 16% from the previous year, with total prescriptions growing 4% sequentially to 49,000 [5] Expenses - Research and development expenses increased to $55 million, up 78.6% from the previous year, driven by higher costs related to clinical studies [7] - Selling, general and administrative expenses totaled $113.3 million, a 30.5% increase year over year, attributed to higher commercial activities for Sunosi and Auvelity [8] Full-Year Results - For the full year 2024, Axsome generated revenues of $385.7 million, reflecting approximately 42.5% growth year over year [9] - The company reported an adjusted loss of $5.99 per share for the full year, wider than a loss of $5.27 in the previous year [9] Guidance and Future Prospects - Management indicated that the cash balance of $315.4 million as of December 31, 2024, is sufficient to fund future operations until reaching cash flow positivity [10] - The FDA approved Symbravo for migraine treatment, expected to launch in about four months, which will diversify Axsome's commercial drug portfolio [11] - Axsome plans to submit a new drug application for AXS-05 in Alzheimer's disease agitation in the second half of 2025 [13] - The company is also evaluating AXS-12 and AXS-14 for various central nervous system indications, with NDA submissions planned for 2025 [15][16]

Financial Data and Key Metrics Changes - Total net product revenue for 2024 was $386 million, reflecting high double-digit year-over-year growth for Auvelity and Sunosi [9][17] - Total product revenues for Q4 2024 were $118.8 million, representing year-over-year growth of 66% [17] - Net loss for Q4 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 Q4 2023 [22] - Cash and cash equivalents at the end of 2024 were $315.4 million, down from $386.2 million at the end of 2023 [23] Business Line Data and Key Metrics Changes - Auvelity net product sales were $92.6 million for Q4 2024, representing 89% year-over-year growth [18] - Sunosi net product revenues were $26.2 million for Q4 2024, representing 16% year-over-year growth [18] - Auvelity experienced approximately 158,000 prescriptions in Q4 2024, with 10% quarter-over-quarter growth [27] Market Data and Key Metrics Changes - Auvelity access is 78% of all lives across channels and 63% of lives in commercial [28] - Sunosi payer coverage in Q4 was stable, with 83% of lives covered across channels [31] Company Strategy and Development Direction - The company aims to commercialize seven products or indications through 2027, with a focus on CNS conditions [9] - The recent approval of Symbravo for migraine treatment is expected to enhance the product portfolio [10] - The company plans to submit NDAs for AXS-05 and AXS-12 in the second half of 2025 [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in 2025, supported by salesforce expansion and improved market access dynamics [10] - The company anticipates NDA submissions for three product candidates and topline readouts from three Phase 3 trials in the near term [15] - Management highlighted the importance of their digital-centric commercialization platform in driving growth [27] Other Important Information - The company expects to achieve cash flow positivity based on the current operating plan [24] - Total costs of revenue for Q4 2024 included a one-time $2.5 million expense related to Sunosi sales [20] Q&A Session Summary Question: DTC promotional activities for Auvelity and Symbravo - Management plans to launch a broad-based media outreach plan for Auvelity and will share more details on Symbravo's commercial go-to-market plans soon [38] Question: Salesforce expansion for Auvelity - Approximately 40 additional representatives were added to the Auvelity sales team, creating potential synergies with Symbravo [43][44] Question: NDA filing for AXS-05 - The NDA submission for AXS-05 is a top priority, with updates expected in the second half of the year [48] Question: Seasonal cadence of scripts and revenues for Auvelity - Q1 is expected to be a growth quarter, albeit slower than the previous year, with salesforce expansion anticipated to drive growth [66] Question: M&A and business development strategy - The company is open to opportunities that complement its pipeline, including earlier-stage assets [74] Question: Impact of Medicare Part D restructure on Auvelity revenues - No significant impact is expected from the Medicare Part D restructure on Auvelity revenues [128] Question: Timeline for AXS-05 in smoking cessation - The Phase 3 trial for smoking cessation is expected to start in 2025, focusing initially on patients who smoke cigarettes [133]

axsome 4Q and Full Year 2024 Corporate Presentation February 18, 2025 Forward Looking Statements & Safe Harbor Certain matters discussed in this press release are "forward-looking statements". The Company may, in some cases, use terms such as "predicts," "believes," "potential," "c t"estimates," "anticipates;" "expects, "intends," "may, " "could," "hight," "will," "should" or other words that convey uncertainty of future events or outcomes to identif forward-looking statements. In particular, the Company's ...

Core Insights - Axsome Therapeutics reported substantial revenue growth in Q4 2024, achieving $118.8 million, exceeding analyst expectations of $118 million, despite a wider-than-expected adjusted EPS loss of $1.54 compared to the anticipated loss of $1 per share [2][4]. Financial Performance - Revenue for Q4 2024 was $118.8 million, a 66% increase from $71.5 million in Q4 2023 [4][7]. - The adjusted EPS loss was $1.54, an improvement from a loss of $2.08 in Q4 2023 [4][7]. - The net loss for the quarter was $74.9 million, down 24% from $98.7 million in the previous year [4]. - R&D expenses rose to $55 million, reflecting a 79% increase year-over-year [4][8]. Product Performance - The revenue growth was primarily driven by the commercial products Auvelity and Sunosi, with Auvelity generating $92.6 million and Sunosi contributing $26.2 million [7]. - The company is focused on expanding its product pipeline, with recent advancements including a completed Phase 3 trial for AXS-05 in Alzheimer's agitation and positive results for AXS-12 in narcolepsy [9]. Strategic Focus - Axsome is actively investing in its R&D pipeline, aiming to launch AXS-05, AXS-12, and other late-stage candidates [6]. - The management plans to enhance its sales force and prepare for upcoming product launches to capture more market share in the CNS sector [10]. - The company is optimistic about ongoing revenue growth driven by potential new product approvals and market expansions [10][11].

Financial Performance - Axsome Therapeutics reported preliminary net revenue for Q4 2024 at $50 million, representing a 25% increase year-over-year[6]. - For the full year 2024, the company achieved net revenue of $180 million, up 30% compared to 2023[6]. - The company anticipates continued growth in 2025, projecting net revenue to reach between $220 million and $250 million, indicating a growth rate of 22% to 39%[6]. Product Development and Innovation - Axsome Therapeutics is focusing on expanding its product pipeline, with two new drug candidates expected to enter clinical trials in 2025[6]. - The company emphasized its commitment to innovation and research, allocating 20% of its revenue towards R&D initiatives[6]. - Axsome Therapeutics is investing in new technology for drug development, aiming to improve efficiency and reduce time to market[6]. Market Strategy - The company plans to enhance its market presence through strategic partnerships and collaborations in the upcoming year[6]. - Axsome Therapeutics aims to expand its international market presence, targeting key regions in Europe and Asia for growth[6]. - Axsome Therapeutics is exploring potential acquisition opportunities to bolster its product offerings and market reach[6]. Clinical Studies - The company reported an increase in user data, with a 15% rise in patient enrollment for ongoing clinical studies[6].

Core Insights - Axsome Therapeutics reported strong financial results for Q4 and full year 2024, with total net product revenue of $118.8 million and $385.7 million, reflecting year-over-year growth of 66% and 88% respectively [5] - The company achieved significant sales growth for its products, particularly Auvelity, which saw Q4 sales of $92.6 million, a 89% increase year-over-year, and full year sales of $291.4 million, a 124% increase [5] - The approval of Symbravo for migraine treatment and advancements in the clinical pipeline, including AXS-05 for Alzheimer's disease agitation and AXS-12 for narcolepsy, position the company for continued growth [4][11] Financial Performance - Total net product revenues for Q4 2024 were $118.8 million, up from $71.5 million in Q4 2023, while full year revenues reached $385.7 million compared to $204.9 million in 2023 [5] - Auvelity's net product sales for Q4 2024 were $92.6 million, compared to $49.0 million in Q4 2023, and for the full year, sales were $291.4 million versus $130.1 million in 2023 [5] - Sunosi generated net product revenues of $26.2 million in Q4 2024 and $94.3 million for the full year, representing year-over-year growth of 16% and 26% respectively [5] Research and Development - Axsome completed the Phase 3 clinical program for AXS-05 in Alzheimer's disease agitation and plans to submit a New Drug Application (NDA) in the second half of 2025 [4][15] - Positive topline results from the ENCORE Phase 3 trial of AXS-12 in narcolepsy were announced, with an NDA submission anticipated in the second half of 2025 [4][18] - The company is on track to report topline results from the FOCUS and PARADIGM Phase 3 trials of solriamfetol in ADHD and major depressive disorder, respectively, in Q1 2025 [4][16] Commercial Highlights - Approximately 158,000 prescriptions for Auvelity were written in Q4 2024, marking an 87% increase from Q4 2023 [10] - Payer coverage for Auvelity is approximately 78% across all channels, with 63% in commercial and 100% in government channels [10] - Sunosi prescriptions reached approximately 49,000 in Q4 2024, a 16% increase from the same period in 2023, with payer coverage at 83% [10] Corporate Developments - Axsome entered into a settlement agreement resolving patent litigation related to Auvelity, allowing Teva to market a generic version starting in 2038 or 2039, depending on pediatric exclusivity [20] - The company has a strong cash position of $315.4 million as of December 31, 2024, down from $386.2 million a year earlier, which is expected to fund operations into cash flow positivity [6][29]

Industry Overview - The fourth-quarter 2024 earnings season for the Medical sector is currently underway, primarily involving pharma/biotech and medical device companies [1] - As of February 12, 72.1% of companies in the Medical sector, representing 91.4% of the sector's market capitalization, reported quarterly earnings, with 81.8% surpassing earnings estimates and 79.5% beating revenue estimates [2] - Year-over-year, earnings in the Medical sector increased by 16.9%, while revenues rose by 10.1% [2] - Overall, fourth-quarter earnings are expected to increase by 13.4%, with sales projected to rise by 9.6% compared to the previous year [2] Company Performances Axsome Therapeutics (AXSM) - Axsome has a strong earnings track record, beating estimates in each of the last four quarters with an average earnings surprise of 14.09% [4] - For the upcoming quarter, Axsome has an Earnings ESP of -7.22% and a Zacks Rank 3, with a consensus estimate for a loss per share of $1 [6] - Revenue growth is anticipated from strong sales of its products Auvelity and Sunosi, along with an update on the commercialization plans for the newly FDA-approved Symbravo [7][8] Halozyme Therapeutics (HALO) - Halozyme has a mixed earnings surprise history, beating estimates in three of the last four quarters with an average surprise of 14.86% [9] - The company has an Earnings ESP of 0.00% and a Zacks Rank 3, with a consensus estimate for earnings per share at $1.16 [10] - Revenue is expected to be driven by higher royalty payments from Roche and JNJ, along with increased collaboration revenues and sales of its proprietary products [11][12] Amicus Therapeutics (FOLD) - Amicus has a mixed earnings track record, beating estimates in three of the last four quarters with an average surprise of 27.09% [13] - The company has an Earnings ESP of -16.67% and a Zacks Rank 3, with a consensus estimate for earnings per share at 10 cents [14] - Revenue growth is likely driven by strong demand for its Fabry disease drug, Galafold, and sales from its Pompe disease combo drug [14][15] BioMarin Pharmaceutical (BMRN) - BioMarin has an impeccable earnings track record, beating estimates in each of the last four quarters with an average surprise of 28.7% [16] - The company has an Earnings ESP of -1.48% and a Zacks Rank 2, with a consensus estimate for earnings per share at 73 cents [16] - Sales of its achondroplasia drug, Voxzogo, are expected to be the primary revenue contributor, along with increased sales of other marketed products [17][18] Insmed (INSM) - Insmed has a disappointing earnings track record, beating estimates only once in the last four quarters with an average negative surprise of 16.48% [18] - The company has an Earnings ESP of +1.62% and a Zacks Rank 3, with a consensus estimate for a loss per share of $1.15 [19] - Revenue is expected to be driven by sales of its only marketed drug, Arikayce, which has seen continued growth in demand [20]

Core Viewpoint - Axsome Therapeutics has experienced a significant stock increase of 55% year-to-date, raising questions about its long-term performance potential and investment viability [1] Recent Developments - Axsome settled a patent lawsuit with Teva Pharmaceutical regarding Auvelity, a treatment for major depressive disorder, resulting in a 25% stock surge in one day [2] - The settlement prevents Teva from launching a generic version of Auvelity until at least 2038, providing a substantial advantage for Axsome and its shareholders [3] Product Line and Financial Outlook - Axsome's product lineup includes Auvelity, Sunosi for narcolepsy, and the newly approved Symbravo for migraines, contributing to strong revenue growth [4] - The company anticipates product revenue of $385.2 million for 2024, representing a 42% increase from the previous year's total revenue of $270.6 million [4][5] Clinical and Regulatory Progress - Axsome plans to submit Auvelity for FDA approval as a treatment for Alzheimer's disease agitation in the second half of the year, following mixed results from phase 3 trials [6][7] - The investigational drug AXS-12 has successfully completed a phase 3 study for narcolepsy and received orphan drug designation from the FDA [8] Future Prospects - Axsome expects late-stage clinical trial results for Sunosi in major depressive disorder and ADHD in early 2025, along with regulatory submissions for AXS-14 in fibromyalgia [9] - The company could launch at least one new product and gain a key indication for Auvelity within the next 18 months, with potential for additional new medicines in the following three years [10]

Core Viewpoint - Axsome Therapeutics' stock has seen a significant increase following the settlement of a key litigation, which enhances its market position and attractiveness to potential partners [1][2][3]. Group 1: Stock Performance - Axsome's shares rose by 4.1% as of 10:20 a.m. ET, with an earlier peak of 5.6%, contrasting with declines in the S&P 500 and Nasdaq Composite [1]. Group 2: Legal Settlement - The company settled a lawsuit with Teva Pharmaceuticals, which had sought FDA approval for a generic version of Axsome's drug Auvelity, thus protecting Axsome's exclusive rights for approximately 14 years [2]. Group 3: Analyst Reactions - Mizuho's analyst Graig Suvannavejh raised Axsome's price target from $137 to $195 per share, citing reduced uncertainty and increased attractiveness for strategic partnerships [3]. - Following the settlement, other analysts on Wall Street have also revised their price targets positively for Axsome [4].

Axsome Therapeutics (AXSM) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended December 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The earnings report, which is expected to be released on February 18, 2025, might help the stock move higher if these key numbers are be ...