NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that data from across the SYMBRAVO (meloxicam and rizatriptan) clinical program will be presented at the 67 Annual Scientific Meeting of the American Headache Society (AHS), being held June 19- 22, 2025, in Minneapolis, Minnesota. Details for the presentations are as follows: Title: Efficacy of SYMBRAVO ...

Summary of Viatris (VTRS) FY Conference Call - June 09, 2025 Company Overview - **Company**: Viatris (VTRS) - **Key Executives Present**: Scott Smith (CEO), Doretta Mistras (CFO), Corinne Lagoff (CCO), Philippe Martin (Head of R&D) [2][3] Core Industry Insights - **Industry**: Pharmaceutical and Biotechnology - **Market Dynamics**: Viatris operates in a competitive landscape with a focus on both branded (60%) and generic (40%) products, with a significant portion of branded products being past loss of exclusivity (LOE) [11][12] Key Points and Arguments 1. **Base Business Performance**: The base business is described as strong, with eight to nine consecutive quarters of operational revenue growth, despite some manufacturing issues at the Indoor plant [4][6] 2. **Capital Allocation Strategy**: Viatris has been actively buying back shares, totaling over $300 million, while also focusing on dividends and business development [5][63] 3. **Pipeline Development**: The company has a robust pipeline with 11 programs in Phase III, all showing positive results, including products for anxiety, pain, and eye care [6][10] 4. **Strategic Review**: An enterprise-wide strategic review is underway to optimize operations and ensure the right personnel are in place for future growth [7][9] 5. **FDA Resubmission**: The Indoor facility is on track for FDA re-inspection mid-year, with remediation efforts progressing ahead of schedule [8][32] 6. **Tariff Concerns**: Potential pharmaceutical tariffs could impact the generic market significantly, with 90% of dispensed products being generics, yet only accounting for 1% of total healthcare costs [19][22] 7. **Impact of Legislation**: The company has limited exposure to recent legislative changes, as 99% of its portfolio has gone through LOE, indicating minimal current impact but potential future considerations [30][31] 8. **Acute Pain Market Opportunity**: Viatris is developing a fast-acting meloxicam for acute pain, targeting a market of 70-80 million cases annually, with a significant unmet need for non-opioid treatments [43][44] 9. **Ocular Portfolio**: The company is expanding its eye care division, with recent positive Phase III data for a product addressing dim light disturbances post-surgery, indicating a potential first FDA-approved treatment for this condition [72][74] Additional Important Insights - **Market Size**: The acute pain market in the U.S. is valued at approximately $44 billion, highlighting the significant revenue potential for Viatris's new product [46] - **Patient Education**: For the emergency therapeutic option for heart attacks, Viatris is focusing on patient education to ensure timely self-administration of the treatment [60][61] - **Future Growth**: The company aims for sustainable revenue and EBITDA growth in 2026 and beyond, with a focus on innovative products and capital allocation strategies [10][12] This summary encapsulates the key themes and insights from the Viatris FY Conference Call, providing a comprehensive overview of the company's current status, strategic direction, and market opportunities.

Viatris (VTRS) Q1 2025 Earnings Call May 08, 2025 08:30 AM ET Company Participants Bill Szablewski - Head of Capital MarketScott Smith - Director & CEOPhilippe Martin - Chief R&D OfficerDoretta Mistras - CFOChris Schott - Managing DirectorCorinne Le Goff - Chief Commercial OfficerAshwani Verma - Executive Director - SMID Biotech & BiopharmaUmer Raffat - Senior Managing Director Conference Call Participants David Amsellem - Sr. Research AnalystPavan Patel - Analyst Operator Please also note today's event is ...

Viatris (VTRS) Q1 2025 Earnings Call May 08, 2025 08:30 AM ET Speaker0 Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Bill Cyblowski, Head of Capital Markets. Please go ahead. Speaker1 Good morning, everyone. Welcome to our Q1 twenty twenty five earnings call. With us today is our CEO, Scott Smith CFO, Doretta Mistras Chief R and D Officer, Philippe Martin and Chief Commercial Officer, Karine Lagasse. During today's call, we will be making forward looking ...

Q1 2025 Earnings May 8, 2025 1 This document contains proprietary information of Viatris Inc. Unauthorized use, duplication, dissemination or disclosure to third parties is strictly prohibited. © 2025 Viatris Inc. All Rights Reserved. VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris company. Forward Looking Statements This presentation contains "forward-looking statements". These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of ...

Delivers Total Revenues in Line With Expectations Demonstrating Strength of the Base Business Makes Significant Pipeline Progress With Three Positive Phase 3 Data Readouts  Returns More Than $450 Million in Capital to Shareholders Year-to-Date and Reaffirms 2025 Capital Allocation Priorities PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today reported first quarter 2025 financial results and reaffirmed its 2025 outlook[1].Executive Commentary View PDF Viatris Reports First Quarte ...

All Primary and Secondary Endpoints Were Met in Both Phase 3 StudiesIn Both Acute Pain Models, MR-107A-02 Demonstrated Statistically Significant and Clinically Meaningful Improvement in Pain Compared to Placebo, Significant Reduction in Opioid Usage and Superior Pain Control Versus the Opioid ArmTargeting New Drug Application Submission to U.S. FDA by End of 2025PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive results from its Phase 3 ...