Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Date of Conference**: March 02, 2026 - **Key Personnel**: COO Mark Jacobson, CFO Nick Pizzie Core Business and Financial Performance - **AUVELITY Performance**: Generated $155 million in the last quarter, annualizing over $600 million after 13 quarters from launch [3][4] - **Sales Force Expansion**: Plans to increase field force from 300 to 600 representatives to enhance market penetration, particularly in anticipation of Alzheimer's disease agitation [3][4] - **Operating Leverage**: Revenues outpaced operating expenses by a ratio of 3:1 in 2025, with expectations for continued leverage in 2026 [4] Product Pipeline and Development - **Robust Pipeline**: Currently has 5 product candidates across 9 indications, with AXS-05 for Alzheimer's disease agitation being a key focus [5] - **PDUFA Date**: AXS-05 has a PDUFA date set for April 30, 2026, with pre-launch activities already underway [5][12] - **Clinical Trials**: Positive results from randomized withdrawal studies and head-to-head placebo-controlled studies for AXS-05, with significant safety data collected [15][16] Market Insights - **Market Penetration**: Currently at 0.2% of the total antidepressant market, indicating substantial growth potential [8] - **Patient Demographics**: Over 7 million Alzheimer's patients in the U.S., with an estimated 70% experiencing agitation, representing a significant treatment opportunity [20] - **Direct-to-Consumer Campaign**: Launched a national DTC campaign in September, with plans to continue through 2026, aiming to enhance product adoption [10][11] Competitive Landscape - **Comparison with Rexulti**: Acknowledged as the only approved product for Alzheimer's agitation, but differences in mechanism and sales strategy noted [31][32] - **Market Access**: Anticipated 100% coverage in government channels for Alzheimer's agitation, similar to MDD, which could facilitate script writing [34] Additional Products and Future Opportunities - **Simbravo Launch**: Targeted approach with a sales team focused on headache centers, showing early positive feedback [35][36] - **AXS-12 for Narcolepsy**: NDA submission expected soon, with peak sales potential estimated between $500 million to $1 billion [40][42] - **Sunosi Expansion**: Positive Phase 3 data in adult ADHD, with plans for pediatric studies, indicating a significant market opportunity [43][44] - **AXS-14 for Fibromyalgia**: Currently conducting a new study following an RTF from the FDA, with expectations for compelling data in an underserved market [51][53] Conclusion - Axsome Therapeutics is positioned for significant growth with a robust pipeline and strategic expansions in sales force and market access. The upcoming PDUFA date for AXS-05 and ongoing clinical trials for other products highlight the company's commitment to addressing unmet medical needs in various therapeutic areas.

As filed with the Securities and Exchange Commission on December 18, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Registration No. 333- FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MIRA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Florida 2834 85-3354547 (I.R.S. Employer Identification No.) 855 N Wolfe Stre ...