Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference held on November 10, 2025 Key Points Industry and Market Performance - Axsome Therapeutics operates in the biotechnology sector, focusing on treatments for mental health and neurological disorders [1] - The company reported a strong Q3 performance with total net sales of **$171 million**, driven by their leading product for Major Depressive Disorder (MDD) which generated **$136 million**, reflecting a **69% year-over-year growth** and **14% quarter-over-quarter growth** [4][5] Product Pipeline and Development - Axsome has several products in various stages of development: - **AXS-05** for MDD - **AXS-12** for narcolepsy - Ongoing Phase III programs for other indications [3] - The company is expanding its earlier stage pipeline and has launched a direct-to-consumer (DTC) campaign to enhance product visibility [3][5] Direct-to-Consumer Campaign - The DTC campaign launched in early September has already shown positive early metrics, including increased Google searches and new prescriptions (NBRxs) [8][10] - NBRxs increased from **2,000 per week** to **2,800**, attributed largely to the DTC efforts [9][10] - The company is taking a disciplined approach to DTC spending, ensuring that sales in Q4 will meet or exceed the additional DTC expenditures [11][12] Market Access and Sales Force Expansion - Axsome has improved its gross-to-net dynamics, achieving a discount in the high **40s%** and covering **85% of total lives** [18][19] - The sales force currently consists of **300 representatives**, with plans for expansion upon receiving approval for additional indications [20][21] Regulatory and Approval Process - Axsome is preparing for an NDA submission for Alzheimer's Disease Agitation (ADA), with a robust package that includes three positive controlled trials and a standalone safety database [24][25] - The company has received breakthrough therapy designation and is eligible for priority review, although they are modeling a standard review timeline [32][33] Competitive Landscape - The market for Alzheimer's Disease treatments is evolving, with competitors like Rexulti showing growth rates of **20% to 25%** [39][40] - Despite the presence of approved products, a significant portion of patients are still treated off-label, indicating room for growth in formalized treatment protocols [42][43] Financial Outlook - Axsome achieved cash flow positivity for the first time, with approximately **$1 million** positive cash flow from operations in Q3 [60] - The company anticipates operating leverage moving into Q4 and next year, with revenue growth of **14%** and operating expenses growing at **5.5%** [61] Future Projections - Axsome projects peak sales for its products, including **$500 million to $1 billion** for Cymbravo and **$300 million to $500 million** for Sunosi [51][57] - The company is focused on maintaining a disciplined approach to its investments while preparing for potential growth in the ADA market [58][61] Conclusion - Axsome Therapeutics is positioned for significant growth with a strong product pipeline, effective marketing strategies, and a disciplined financial approach. The upcoming regulatory submissions and market expansions are critical to the company's future success.

Summary of Aytu Biopharma Conference Call Company Overview - Aytu Biopharma is a specialty pharmaceutical company founded in 2015, focusing on ADHD and pediatric products, with a revenue of approximately $66 million, of which $58 million is from ADHD products [4][5] - The company has a program called Aytu Rx Connect, partnering with 1,000 pharmacies to ensure patients have access to prescriptions at a maximum cost of $50 [6] New Product Launch - Aytu Biopharma is preparing to launch a new product, ExuA, for major depressive disorder (MDD), which is a $22 billion market [8] - ExuA is a novel treatment that targets the 5-HT1A receptor, differentiating it from existing SSRIs and SNRIs that often cause side effects like sexual dysfunction and weight gain [9][10] - The product is expected to launch by December 2025, with initial sales to wholesalers and a more significant revenue impact anticipated by June 2026 [32] Market Dynamics - The MDD market sees 340 million prescriptions annually in the U.S., with SSRIs and SNRIs accounting for about 60% of these [12] - Competitors like Trintellix, Avelity, and Spravato have seen growth but share similar side effects that ExuA aims to avoid [13][14] - Government payers are required to cover depression treatments, which could account for 30-40% of the market for ExuA [19] Financial Performance - For the fiscal year 2025, Aytu reported $66.4 million in revenue and an adjusted EBITDA of $9.2 million, marking three consecutive years of positive adjusted EBITDA [36] - The company raised $15 million in June 2025 to support the launch of ExuA, with a cash balance of $31 million as of June 30, 2025 [39][40] Strategic Initiatives - Aytu is focusing on refining sales territories and engaging with psychiatrists, as 60% of their current psychiatrist contacts overlap with the target market for ExuA [18] - The company is also working on branding and promotional strategies to effectively communicate the benefits of ExuA to clinicians [20] Investor Outlook - The management believes ExuA could quickly become a $50 million business within a year of launch, based on the number of prescriptions and the product's unique selling points [42] - The company is exploring ways to extend the patent life of ExuA, which currently has a five-year runway [52][53] Key Takeaways - Aytu Biopharma is positioned for growth with the upcoming launch of ExuA, targeting a significant market opportunity in MDD while leveraging its existing ADHD business [5][8] - The company has a solid financial foundation and strategic plans in place to maximize the potential of its new product [36][39]

Summary of Axsome Therapeutics (AXSM) 2025 Conference Call Company Overview - **Company**: Axsome Therapeutics (AXSM) - **Date of Conference**: May 13, 2025 - **Key Speakers**: Mark Jacobsen (COO), Nick Pizzi (CFO), Jason Gerber (Analyst) Key Points Industry and Product Launches - **Avelity (MDD)**: - The company is over two years into the launch and is experiencing a growth trajectory with ongoing initiatives to drive further growth [4][5] - Expansion of the field force to approximately 300 representatives was completed in Q1, expected to impact new prescriptions (NBRx) positively [5][8] - The company anticipates a national patient-provider program (PPP) campaign in the second half of the year to further catalyze growth [6] - **Symbravo (Migraine)**: - Launch is targeted for June 2025, with preparations underway and field force training in progress [36][37] - Peak sales expectations are between $500 million to $1 billion, compared to Avelity's $1 billion to $3 billion for MDD [35] Financial Performance and Projections - **Revenue Growth**: - Revenue growth is outpacing operating expense growth, with expectations for continued operating leverage into 2025 and 2026 [9] - The company is currently at 63% coverage in the commercial space, with a goal to exceed 80% [14][15] - Gross to net (GTN) in Q1 was in the mid-50s, expected to remain constant throughout the year despite seasonality [16] Market Dynamics and Competitive Landscape - **Payer Negotiations**: - The company is pleased with ongoing discussions with payers, aiming for long-term value rather than immediate coverage [13][14] - The efficacy of Avelity is a key factor in negotiations, with a strategy focused on maintaining net pricing [13] - **Market Access**: - Anticipated access in the Medicare Part D channel for Avelity, with expectations of around 70% coverage for total prescriptions [28] - The company is assessing potential targeting in long-term care facilities, which could enhance market penetration [31] Clinical Development and Regulatory Updates - **Alzheimer's Agitation Label Expansion**: - The company is preparing for a supplemental NDA (sNDA) submission in Q3 2025, with positive feedback from the FDA on the clinical program [22][24] - Three positive studies have been completed, supporting the filing [25] - **AXS-12 for Narcolepsy**: - The company plans to file for AXS-12 in the second half of 2025, with a robust clinical data package from multiple studies [47][48] Strategic Considerations - **Long-term Strategy**: - The company emphasizes a long-term approach to product value and market positioning, particularly in the context of evolving payer dynamics and competitive pressures [13][19] - The expansion of the field force is seen as a critical component for enhancing engagement with primary care clinicians [18] Additional Insights - **Market Segmentation**: - The company recognizes the distinct market dynamics for migraine treatments compared to MDD, with different refill patterns and prescribing behaviors [38][39] - There is a focus on ensuring that the product reaches patients effectively, with considerations for market access dynamics and clinician experiences [42][44] Conclusion - Axsome Therapeutics is positioned for growth with strategic initiatives in place for its key products, Avelity and Symbravo. The company is actively engaging with payers and preparing for significant product launches while maintaining a focus on long-term value and market access.

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]