Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $3,300,000,000, down 2% on a divestiture adjusted operational basis, primarily due to the impact of indoor [4][28] - The company returned approximately $450,000,000 in capital to shareholders, with about $300,000,000 through share repurchases and $143,000,000 from dividends [4][8] - Adjusted gross margin was approximately 56%, in line with expectations, but declined compared to the prior year due to price regulations and increased product supply costs [31][32] Business Line Data and Key Metrics Changes - Brand revenues grew by 3%, driven by the expansion of the cardiovascular portfolio in emerging markets and growth in Greater China [28] - The generics business saw a decline, particularly in North America, which decreased by 8% due to indoor impact and competition [29] - Emerging markets experienced a 5% decrease in net sales, primarily due to indoor impact and customer buying patterns affecting the ARV generics business [30] Market Data and Key Metrics Changes - European business grew approximately 1%, with brand portfolio growth led by Creon, Brufen, and the thrombosis portfolio [29] - Greater China net sales grew by 4%, attributed to a diversified model across e-commerce, retail, and private hospitals [30] - The North American market faced challenges, with a significant decline in generics, but new product revenues partially offset this [29] Company Strategy and Development Direction - The company is focused on executing strategic priorities, including significant pipeline progress and remediation of the indoor facility [4][9] - A strategic review is underway to streamline costs and prepare for sustainable revenue and earnings growth [9] - The company aims to prioritize capital return to shareholders while navigating market and policy unpredictability [8][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the fundamentals of the business despite challenges from tariffs and supply chain disruptions [10][37] - The company reaffirmed its outlook for the year, expecting total revenues to be higher in the second half, driven by new product launches and seasonal trends [36][37] - Management highlighted the importance of patient access and ongoing discussions with the administration regarding the generic industry's role [46] Other Important Information - A non-cash goodwill impairment charge of $2,900,000,000 was recorded due to a decline in share price and increased business risk [34] - The company manufactured approximately 8,500,000,000 doses in the U.S. last year, with over 50% of U.S. revenue sourced from domestic manufacturing [12][83] - The company is exploring ways to optimize its global network and increase manufacturing capacity in the U.S. [13] Q&A Session Summary Question: Can you help us frame out how you're thinking about the peak sales opportunity for meloxicam? - Management indicated that the data from Phase three studies is compelling and positions the drug well for a major role in the acute pain market [40][56] Question: How should we think about the company's ability to mitigate the impact of tariffs? - Management is focused on increasing U.S. production and adjusting inventory levels while exploring long-term strategies to mitigate tariff impacts [44][46] Question: Can you elaborate on the volume versus price drivers for key brands in developed markets? - Management noted strong momentum in brand growth in China and Europe, while the generics portfolio was most impacted by indoor [75] Question: What is the expected timing and contribution cadence within the second half from key launches? - Management expects a second half ramp in revenue, with new product launches scheduled for approval in that period [78]

Financial Data and Key Metrics Changes - In Q1 2025, the company reported total revenues of $3,300,000,000, a decrease of 2% on a divestiture adjusted operational basis, primarily due to the impact of indoor [4][26] - The adjusted gross margin was approximately 56%, in line with expectations, but declined compared to the prior year due to price regulations and increased product supply costs [30][31] - A non-cash goodwill impairment charge of $2,900,000,000 was recorded due to a decline in share price and increased business risk [31] Business Line Data and Key Metrics Changes - Brand revenues grew by 3%, driven by the expansion of the cardiovascular portfolio in emerging markets and growth in Greater China and developed markets [27] - The generics business experienced an 8% decline in North America, primarily due to the indoor impact and competition on select products [28] - The European business showed consistent growth of approximately 1%, with the brand portfolio growing by 2% [28] Market Data and Key Metrics Changes - In Greater China, net sales grew by 4%, attributed to a diversified model across e-commerce, retail, and private hospitals [29] - Emerging markets saw a decrease of approximately 5% in net sales, primarily driven by the indoor impact and customer buying patterns affecting the ARV generics business [29] - The company's products are commercialized in 165 countries, with 36 manufacturing, R&D, and packaging sites globally [9][10] Company Strategy and Development Direction - The company is focused on returning capital to shareholders, having returned approximately $450,000,000 in capital, including $300,000,000 through share repurchases [4][7] - A strategic review is underway to streamline costs and prepare for sustainable revenue and earnings growth [8] - The company is committed to increasing U.S. manufacturing capacity and optimizing its global supply chain in response to potential tariffs [10][12] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed the outlook for the year, expecting total revenues to be higher in the second half, approximately 52% of the full-year outlook [34][35] - The company is optimistic about its ability to navigate through periods of volatility and uncertainty in the industry [87] - Management expressed concerns about potential tariffs impacting financial performance and patient access to medications [9][44] Other Important Information - The company has made significant progress in its pipeline, with three positive Phase three data readouts and plans for regulatory submissions in 2025 [5][6] - The company is on track to deliver $450,000,000 to $550,000,000 of new product revenue this year [25] - A new Chief Strategy Officer has joined the executive leadership team, bringing extensive experience in the biotech and pharmaceutical industries [13] Q&A Session Summary Question: Can you help frame the peak sales opportunity for meloxicam and how much existing infrastructure can be leveraged? - Management indicated that the market demand for safer alternatives to opioids is significant, with over 70 million acute pain cases annually in the U.S. [50][51] Question: How should the company mitigate the impact of tariffs on U.S. sales? - Management is exploring various mitigation strategies, including increasing U.S. production and adjusting inventory levels [41][44] Question: Can you elaborate on the brand resilience and generic weakness observed in Q1? - Management noted that brand growth was driven by strong performance in China and Europe, while generics were impacted by the indoor situation [72][73] Question: What is the expected timing and contribution of key launches in the second half? - Management expects new product launches to be slightly more second half weighted, with several key products scheduled for approval [75][76]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________to___________ Commission file number 001-39695 VIATRIS INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpora ...

Viatris (VTRS) came out with quarterly earnings of $0.50 per share, beating the Zacks Consensus Estimate of $0.49 per share. This compares to earnings of $0.67 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 2.04%. A quarter ago, it was expected that this generic drugmaker would post earnings of $0.57 per share when it actually produced earnings of $0.54, delivering a surprise of -5.26%.Over the last four quarters, the company ...

Viatris Reports First Quarter 2025 Results and Reaffirms 2025 Outlook PITTSBURGH – May 8, 2025 – Viatris Inc. (Nasdaq: VTRS) today reported first quarter 2025 financial results and reaffirmed its 2025 outlook[1]. Executive Commentary "2025 is off to a good start as we continue to focus on executing our strategic priorities," said Scott A. Smith, CEO, Viatris. "Our growing pipeline, capital discipline, operational execution, and significant global scope give us confidence in our ability to navigate the perio ...

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]

Core Viewpoint - A lawsuit has been filed against Viatris Inc. and certain senior executives for potential violations of federal securities laws, stemming from misleading statements regarding the company's operational conditions and the impact of a failed FDA inspection [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Western District of Pennsylvania, titled Quinn v. Viatris Inc., et al., No. 25-cv-466, with investors having until June 3, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Viatris securities [2]. Group 2: Company Background and Allegations - Viatris is a global healthcare company that provides medicines to approximately 1 billion patients across over 165 countries [3]. - The complaint claims that Viatris misrepresented its facilities as being in "good operating condition" and suitable for their intended purposes, while downplaying the significance of a Warning Letter issued by the FDA following a failed inspection at its Indore, India facility [3][4]. Group 3: Financial Impact - The failed FDA inspection has had a substantial negative impact on Viatris's financial results, hindering the company from manufacturing and distributing key products, including Lenalidomide [4]. - In the Q4 2024 results released on February 27, 2025, Viatris disclosed that the failed inspection would reduce 2025 revenue by approximately $500 million and earnings from operations by about $385 million [5]. - Following this announcement, Viatris's stock price fell roughly 15%, from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025 [5].