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 67th 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 SYMBRA ...

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 ...

Core Insights - Viatris Inc. reported first quarter 2025 financial results, reaffirming its 2025 outlook, with total revenues of $3.25 billion, down 11% year-over-year, primarily due to the negative Indore Impact [1][6][12] - The company experienced a significant non-cash goodwill impairment charge of $2.9 billion, leading to a U.S. GAAP net loss of $3.04 billion for the quarter [12][27][38] - Viatris continues to focus on capital allocation, returning over $450 million to shareholders year-to-date, including over $300 million in share repurchases [4][14] Financial Performance - Total revenues for Q1 2025 were $3,254.3 million, down from $3,663.4 million in Q1 2024, reflecting an 11% decrease [6][38] - Total net sales decreased to $3,243.2 million from $3,653.5 million, also an 11% decline [6][38] - Gross profit was reported at $1,161.2 million, down 23% from $1,504.0 million in the previous year [8][38] - Adjusted EBITDA for the quarter was $923 million, a decrease of 23% compared to $1,193.4 million in Q1 2024 [8][12] Market Segments - Developed markets saw a revenue decline of 13%, while emerging markets experienced a 17% drop [6] - Greater China reported a 2% increase in revenues, indicating some resilience in that market [6] - Brands net sales decreased by 8%, while generics saw a 16% decline, reflecting the expected negative Indore Impact [6][12] Pipeline and Product Development - The company achieved positive results from three Phase 3 studies, including EFFEXOR® for anxiety disorder and a novel formulation of meloxicam for acute pain [12][35] - Viatris plans to submit a New Drug Application (NDA) for the new meloxicam formulation by the end of 2025 [35] - The company expects to generate approximately $450 million to $550 million in new product revenues in 2025 [12][35] Capital Allocation Strategy - Viatris reaffirmed its commitment to returning capital to shareholders, with expectations of $500 million to $650 million in total share repurchases for 2025 [14][16] - Year-to-date, the company has returned over $450 million to shareholders, including dividends and share repurchases [4][14] Financial Guidance - The company estimates U.S. GAAP net cash provided by operating activities for 2025 to be between $2.2 billion and $2.5 billion, with a midpoint of approximately $2.35 billion [16][26] - Financial guidance for 2025 remains unchanged, excluding the impact of divestiture-related taxes and transaction costs [16][18]

Core Insights - Viatris Inc. announced positive results from its Phase 3 trials for MR-107A-02, a fast-acting formulation of meloxicam, demonstrating significant pain relief compared to placebo and reduced opioid usage [1][2][3] - The company plans to submit a New Drug Application to the U.S. FDA by the end of 2025 based on these results [1][5] Group 1: Study Results - Both Phase 3 trials met primary endpoints, showing statistically significant and clinically meaningful improvement in pain management [2][4] - In the herniorrhaphy trial, the least squares mean difference in pain intensity (SPID0-48h) between MR-107A-02 and placebo was 50.1 (95% CI: 35.4, 64.8; p<0.001), while in the bunionectomy trial, it was 82.7 (95% CI: 62.0, 103.4; p<0.001) [4] - MR-107A-02 resulted in a higher percentage of opioid-free patients: 72.6% in herniorrhaphy versus 58.6% in placebo (p=0.002) and 56.9% in bunionectomy versus 33.1% in placebo (p<0.001) [4] Group 2: Efficacy and Safety - The treatment was well tolerated, with adverse events comparable to placebo, and no deaths reported [4] - The drug showed superior pain control compared to the opioid comparator (tramadol) in both surgical models, with faster onset of pain relief [4][3] Group 3: Future Plans - Viatris aims to present full results from the Phase 3 studies at upcoming conferences, including PAINWeek 2025 [5] - The company is building on previous Phase 2 data from dental pain studies to support its application for MR-107A-02 [5][10]