Core Insights - The article emphasizes a conservative investment strategy, allocating 90% to stable investments and 10% to growth opportunities to achieve balanced returns [1] Valuation Framework - The base valuation framework projects free cash flows over a 9-year period, starting from a baseline year, applying consistent annual growth rates [1] - Cash flows are discounted using a rate calculated through CAPM, considering time value and risk factors, with terminal value calculated for Year 9 [1] - The model assumes steady growth patterns and discount rates that exceed long-term growth to maintain mathematical validity [1] Pharmaceutical Revenue Model - The pharmaceutical revenue model indicates a linear market adoption from 10% initial uptake to full penetration, followed by an 8% yearly decline while maintaining at least 40% of peak levels [1] - Revenue calculations are based on patient numbers, market penetration, and annual treatment costs, with operating and production costs scaling proportionally with sales volume [1] - The final valuation incorporates success probability factors and time-adjusted cash flows using standard discount rates [1]

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 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]

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].

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 ...

Axsome Therapeutics (AXSM) shares soared 20.2% in the last trading session to close at $127.08. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 32.1% gain over the past four weeks.The sudden rise in the stock price was observed after Axsome announced that it has entered into a settlement agreement with Teva Pharmaceuticals regarding the Auvelity (dextromethorphan HBr – bupropion HCl) patent litigation. The settlement agreement re ...