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 ...

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 ...