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]

Financial Data and Key Metrics Changes - Total net product revenue for 2024 was $386 million, reflecting high double-digit year-over-year growth for Avelity and Sunosi [7][12] - Total product revenues for Q4 2024 were $118.8 million, representing a year-over-year growth of 6688% [12][13] - 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 [17][18] - The company ended 2024 with $315.4 million in cash and cash equivalents, down from $386.2 million at the end of 2023 [18] Business Line Data and Key Metrics Changes - Avelity net product sales were $291.4 million for the full year 2024, representing a year-over-year growth of 89124% [13][14] - Sunosi net product revenues were $94.3 million for the full year 2024, reflecting a year-over-year growth of 1626% [14][15] - Avelity prescriptions reached approximately 158,000 in Q4 2024, showing a 10% quarter-over-quarter growth and 87% growth compared to Q4 2023 [20][21] - Sunosi total prescriptions were approximately 49,000 in Q4 2024, representing 4% sequential growth and 16% growth versus Q4 2023 [22] Market Data and Key Metrics Changes - Avelity access is 78% of all lives across channels and 63% of lives in commercial [21] - Payer coverage for Sunosi in Q4 was stable at 83% of lives covered across channels [22] Company Strategy and Development Direction - The company aims to commercialize seven products or indications through 2027, focusing on CNS conditions [6][9] - The company plans to submit NDAs for AXS-five and AXS-twelve in the second half of 2025 [9][10] - The launch of Simbravo is anticipated to enhance the company's portfolio in the migraine treatment market [8][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in 2025, supported by sales force expansion and improved market access dynamics [7][19] - The company expects to achieve cash flow positivity based on the current operating plan [18] - Management highlighted the importance of their digital-centric commercialization platform in driving growth [19] Other Important Information - The company completed five pivotal trials and initiated three Phase III trials in 2024, positioning for several important milestones in 2025 [9][11] - The company is actively engaged with payers to expand access for its products in 2025 [21] Q&A Session Summary Question: DTC promotional activities for Avelity and Simbravo - Management plans to launch a broad-based media outreach plan for Avelity in the coming months, considering seasonality in media spending [27][28] Question: Sales force expansion for Avelity - Approximately 40 additional representatives were added to the Avelity sales team, creating potential synergies with the prescriber base for Simbravo [32][34] Question: NDA submission for AXS-five - The submission is a top priority, with updates expected in the second half of the year [35][36] Question: Alzheimer's disease agitation filing - The filing approach has not been confirmed yet, but updates will be provided soon [41][43] Question: Seasonal cadence of scripts and revenues for Avelity - Q1 is expected to be a growth quarter, albeit slower than the previous year, with sales force expansion anticipated to drive growth [52][54] Question: M&A and business development strategy - The company is open to opportunities that complement its pipeline, focusing on both commercial and development-stage assets [58][59] Question: Impact of Medicare Part D restructure on Avelity revenues - No significant impact is expected from the Medicare Part D restructure on Avelity revenues [103][104] Question: Launch trajectory for Simbravo - The company is optimistic about Simbravo's impact on the acute migraine market, with a targeted approach to headache specialists [72][73] Question: Market opportunity for AXS-twelve in narcolepsy - The company sees a compelling market opportunity for AXS-twelve, particularly among patients dissatisfied with existing treatments [100][101]

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' 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].

Company Overview - Axsome Therapeutics (AXSM) is anticipated to report a year-over-year decline in earnings despite higher revenues for the quarter ended December 2024, with a consensus outlook indicating a loss of $0.97 per share, representing a -32.9% change from the previous year [1][3] - Revenues are expected to reach $117.84 million, reflecting a significant increase of 64.7% compared to the same quarter last year [3] Earnings Expectations - The earnings report is scheduled for release on February 18, 2025, and could influence the stock price depending on whether the actual results exceed or fall short of expectations [2] - The consensus EPS estimate has been revised 1.63% lower in the past 30 days, indicating a bearish sentiment among analysts regarding the company's earnings prospects [4][10] Earnings Surprise Prediction - The Zacks Earnings ESP model indicates an Earnings ESP of -4.06% for Axsome, suggesting that the Most Accurate Estimate is lower than the Zacks Consensus Estimate [10][11] - Historically, Axsome has beaten consensus EPS estimates in the last four quarters, with a recent surprise of +2.90% when it reported a loss of $1.34 per share against an expected loss of $1.38 [12][13] Industry Comparison - In contrast, Blueprint Medicines (BPMC), another player in the Zacks Medical - Biomedical and Genetics industry, is expected to report an EPS of $0.51 for the same quarter, marking a +72% year-over-year change, with revenues projected at $147.53 million, up 105% from the previous year [17] - Despite a positive outlook, Blueprint Medicines also faces a challenging Earnings ESP of -72.80%, combined with a Zacks Rank of 3, making it difficult to predict an earnings beat [18]

Shares of Axsome Therapeutics (AXSM) jumped 20.2% on Monday after the company announced that it has entered into a settlement agreement with Teva Pharmaceuticals (TEVA) related to patents for the psychiatry drug, Auvelity.The settlement agreement resolves the patent litigation brought by Axsome on Teva for submitting an abbreviated new drug application to the FDA, seeking marketing approval for a generic version of Auvelity in the United States before applicable patents expire.Auvelity is approved for the t ...