Financial Performance Q1 2025 - Total Revenues were $3.3 billion, a decrease of 11% compared to Q1 2024[16, 74] - Adjusted EBITDA was $923 million, a decrease of 23% compared to Q1 2024[16, 74] - Adjusted EPS was $0.50, a decrease of 25% compared to Q1 2024[16, 74] - Free Cash Flow was $493 million, or $535 million excluding transaction costs[17] Impact of Indore Facility - The FDA issued a warning letter and import alert related to the oral finished dose manufacturing facility in Indore, India, leading to an estimated revenue impact of ~$140 million in Q1 2025[8, 94] - The estimated full-year 2025 revenue impact is ~$500 million, with an adjusted EBITDA impact of ~$385 million, including ~$100 million in penalties and supply disruptions[2, 94] - The estimated 2025 net sales impact by region is approximately $300 million in North America, $75 million in Europe, and $125 million in Emerging Markets[2] Financial Guidance 2025 - Total Revenues are projected to be between $13.5 billion and $14 billion[99] - Adjusted EBITDA is projected to be between $3.89 billion and $4.19 billion[99] - Adjusted EPS is projected to be between $2.16 and $2.30[99] - Free Cash Flow is projected to be between $1.8 billion and $2.2 billion[99] R&D Pipeline Update - Positive Phase 3 readouts were achieved for novel fast-acting meloxicam and XULANE LO[18] - A positive Phase 3 readout for EFFEXOR® for generalized anxiety disorder was achieved, and an sNDA was filed in Japan[18] - Selatogrel and cenerimod enrollment are on track[18] - The company is advancing 11 Phase 3 programs[22] Capital Allocation - The company returned >$450 million of capital to shareholders YTD, including >$300 million in share repurchases and ~$143 million in dividends paid[18, 111] - The company expects $500 million-$650 million in total share repurchases in 2025[2]

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]

Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety EndpointsResults Demonstrated Potential Best-In-Class Patch Performance New Drug Application Submission to U.S. FDA Anticipated in the Second Half of 2025PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of investigational XULANE LO low dose weekly ...

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]

NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Viatris Inc. (NASDAQ: VTRS) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Viatris, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/viatris-inc. Investors have until June 3, 2025, to ask the Court to be appointed to lead the case. ...

PITTSBURGH, May 7, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today announced that on May 5, 2025, its Board of Directors declared a quarterly dividend of $0.12 per share for each issued and outstanding share of the Company's common stock. The dividend is payable on June 16, 2025, to shareholders of record as of the close of business on May 23, 2025. About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands ...

Core Viewpoint - Viatris Inc. is undergoing a Board refreshment process, announcing the retirement of directors Rajiv Malik and Harry Korman, and the appointment of Frank D'Amelio and Michael Severino, M.D. to its Board of Directors [1][7][10] Group 1: Board Changes - Frank D'Amelio and Michael Severino, M.D. have been appointed as new members of Viatris' Board of Directors [1][2] - Rajiv Malik and Harry Korman will retire from the Board at the end of their current terms in December 2025 [1][10] Group 2: New Board Members' Background - Frank D'Amelio has 20 years of experience as a public company CFO, most recently at Pfizer, where he oversaw corporate finance functions and global supply during the COVID-19 pandemic [3][4] - Michael Severino, M.D. is currently the CEO of Tessera Therapeutics and has held significant roles at AbbVie and Amgen, focusing on drug development and management [5][6] Group 3: Statements from Leadership - Melina Higgins, Chair of Viatris' Board, expressed enthusiasm for the new appointments, highlighting their extensive experience in the pharmaceutical industry [7] - Scott A. Smith, CEO of Viatris, emphasized the value of D'Amelio's financial expertise and Severino's drug development background for the company's future [7][8] Group 4: Company Overview - Viatris Inc. is a global healthcare company that aims to bridge the gap between generics and brands, providing access to high-quality medicines for approximately 1 billion patients annually [9]

NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Viatris Inc. ("Viatris" or the "Company") (NASDAQ: VTRS) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Viatris investors who were adversely affected by alleged securities fraud between August 8, 2024 and February 26, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/viatris-inc-lawsuit-submission- ...

NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, announces that a complaint has been filed in the United States District Court for the Western District of Pennsylvania on behalf of investors who purchased or acquired the securities of Viatris, Inc. (“Viatris” or the “Company”) (NASDAQ: VTRS) between August 8, 2024 and February 26, 2025, inclusive, alleging violations of the Securities Exchange Act of 1934 against the Company and certain of i ...

NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Viatris Inc. (NASDAQ: VTRS) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Viatris, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/viatris-inc. Investors have until June 3, 2025, to ask the Court to be appointed to lead the case. ...