Viatris Inc

Viatris is a global healthcare company focused on addressing healthcare needs worldwide, supplying high-quality medicines to approximately 1 billion patients annually ¹. The company operates in over 165 countries and territories with more than 30,000 employees ². Its portfolio includes generics (including complex products), globally recognized iconic brands, and an expanding range of innovative medicines ³. Viatris is headquartered in the U.S., with global centers in Pittsburgh, Pennsylvania, Shanghai, China, and Hyderabad, India ⁴.

Viatris' business model is centered on providing access to high-quality, trusted medicines globally, regardless of geography or circumstance. The company covers a broad range of therapeutic areas, including cardiovascular health and oncology, offering treatment options across more than 10 major therapeutic areas ⁵. It also focuses on easing the burden of noncommunicable diseases and fighting infectious diseases like HIV/AIDS, hepatitis, and tuberculosis ⁶. Viatris aims to advance sustainable operations and innovative solutions, leveraging its global operating platform of 27 manufacturing, packaging, and distribution sites, robust global technical resources, and a strong global commercial team ⁷. The company actively seeks partnerships and collaborations with other pharmaceutical companies, non-profit organizations, and government agencies to promote sustainable access to treatment and build resilient healthcare systems ⁸.

Viatris operates through four reportable segments: Developed Markets, Greater China, JANZ (Japan, Australia, and New Zealand), and Emerging Markets ⁹. The Developed Markets segment, comprising North America and Europe, reported net sales of $8.514 billion in 2025 ¹⁰. The Greater China segment, including mainland China, Taiwan, and Hong Kong, generated net sales of $2.3325 billion in 2025 ¹¹. The JANZ segment, covering Japan, Australia, and New Zealand, had net sales of $1.1938 billion in 2025 ¹². The Emerging Markets segment, encompassing over 125 countries in Asia, Africa, Eastern Europe, Latin America, and the Middle East, as well as the ARV franchise, recorded net sales of $2.2101 billion in 2025 ¹³.

For the fiscal year ended December 31, 2025, Viatris reported total revenues of $14.2999 billion ¹⁴, a decrease of $439.4 million ¹⁵ or 3% ¹⁶ from $14.7393 billion ¹⁷ in 2024. Net sales for 2025 were $14.2504 billion ¹⁸, down $442.4 million ¹⁹ or 3% ²⁰ from $14.6928 billion ²¹ in the prior year. Gross profit for 2025 was $5.0135 billion ²², with a gross margin of 35% ²³, compared to $5.6236 billion ²⁴ and 38% ²⁵ in 2024. Operating loss was $2.6631 billion ²⁶ in 2025, a significant change from operating earnings of $10.1 million ²⁷ in 2024. The company reported a net loss of $3.5149 billion ²⁸ and diluted loss per share of $3.00 ²⁹ in 2025, compared to a net loss of $634.2 million ³⁰ and diluted loss per share of $0.53 ³¹ in 2024. Cash and cash equivalents stood at $1.3224 billion ³² as of December 31, 2025, and total long-term debt was $12.4806 billion ³³.

Year-over-year, total revenues decreased by 3% ³⁴, primarily due to the inclusion of net sales in the prior year related to divestitures that closed during 2024 and the Indore Impact ³⁵. On a constant currency basis, net sales from the remaining business decreased by approximately $142.1 million ³⁶, or 1% ³⁷, driven by net base business erosion of approximately $465.8 million ³⁸, of which approximately $370 million ³⁹ related to the Indore Impact. This was partially offset by new product sales of approximately $323.7 million ⁴⁰. Developed Markets net sales decreased by 5% ⁴¹, Greater China net sales increased by 8% ⁴², JANZ net sales decreased by 11% ⁴³, and Emerging Markets net sales decreased by 2% ⁴⁴. Gross margin contracted from 38% ⁴⁵ in 2024 to 35% ⁴⁶ in 2025, primarily due to an increase in cost of sales ⁴⁷.

In 2025, Viatris advanced its innovative pipeline with five positive Phase 3 data readouts, including for EFFEXOR® in Japan, meloxicam for acute pain, a low dose estrogen weekly dermal patch for contraception, MR-142 for night driving impairment, and MR-141 for presbyopia ⁴⁸. The company launched its Iron Sucrose Injection, USP, in the U.S. ⁴⁹ and received the first approval for Inpefa® (sotagliflozin) in the United Arab Emirates, with a launch in early 2026 ⁵⁰. Viatris acquired Aculys Pharma in October 2025, gaining exclusive development and commercialization rights in Japan for pitolisant and in Japan and certain other Asia-Pacific markets for Spydia® Nasal Spray ⁵¹. The company returned over $1 billion ⁵² of capital to shareholders in 2025, including approximately $500 million ⁵³ in share repurchases and $561 million ⁵⁴ in dividends. Substantial progress was made on remediation activities at the oral finished dose manufacturing facility in Indore, India, following an FDA warning letter and import alert ⁵⁵. In December 2025, Viatris entered into definitive agreements to sell its equity stake in Biocon Biologics for $815.0 million ⁵⁶, consisting of $400.0 million ⁵⁷ in cash and $415.0 million ⁵⁸ in newly issued equity shares of Biocon ⁵⁹.

Viatris initiated an enterprise-wide strategic review (EWSR) in 2025 to build a more focused, efficient, and future-ready organization, positioning the company for sustained growth beginning in 2026 ⁶⁰. As a result of this review, the company committed to and began implementing restructuring activities on February 26, 2026 ⁶¹. These activities are expected to optimize commercial capabilities, enabling functions, R&D, medical affairs, regulatory activities, and sourcing, manufacturing, and supply chain activities, including inventory optimization ⁶². The company anticipates a global workforce reduction of up to approximately 10% ⁶³ and expects these restructuring activities, along with associated costs and savings, to be completed primarily over the next three years ⁶⁴.

The company expects to incur total pre-tax charges ranging between $700 million and $850 million ⁶⁵ for the committed restructuring activities of the EWSR. These charges are anticipated to include between $50 million and $100 million ⁶⁶ of non-cash charges, mainly related to accelerated depreciation and asset impairment charges, including inventory write-offs ⁶⁷. The remaining estimated cash costs, between $650 million and $750 million ⁶⁸, are expected to be primarily related to severance and employee benefits expense, as well as other costs such as contract terminations, vendor consolidations, product transfer costs, and network-related simplification and modernization costs ⁶⁹. Management believes the potential savings related to these committed restructuring activities will be between $600 million and $700 million ⁷⁰ once fully implemented, with most of these savings expected to improve operating cash flow ⁷¹.

Viatris has identified three strategic imperatives to drive future growth: driving its base business, fueling its innovative portfolio, and modernizing for sustainable growth ⁷². To drive its base business, the company plans to execute successful launches, focus on supply chain continuity, evolve its generics portfolio towards more profitable, higher-margin products, and strengthen its established brands portfolio ⁷³. The company aims to fuel its innovative portfolio by advancing a pipeline of late-stage and in-market growth assets sourced both internally and externally ⁷⁴. This includes patent-protected, innovative assets such as selatogrel and cenerimod, 505(b)(2) products like fast-absorbing meloxicam for acute pain and a low dose estrogen weekly patch for contraception, and potential first-to-market generics for Abilify Maintena®, Injectafer®, Ozempic®, and Wegovy™ ⁷⁵. The company intends to increase its R&D investment and grow inorganically through business development ⁷⁶. Modernizing for sustainable growth involves strengthening technology, data, and talent capabilities ⁷⁷.

The company anticipates regulatory responses on several products in 2026, including its low dose estrogen weekly patch for contraception, which has an FDA target action date of July 30, 2026 ⁷⁸, and MR-141 (phentolamine ophthalmic solution 0.75%) for presbyopia, with an anticipated FDA action during the second half of 2026 ⁷⁹. Inpefa® (sotagliflozin) was launched in the United Arab Emirates in early 2026 ⁸⁰, and regulatory submissions have been filed in Saudi Arabia, Canada, Australia, and New Zealand ⁸¹. The Japanese NDAs for pitolisant for narcolepsy and obstructive sleep apnea syndrome are under review by the Japan Pharmaceuticals and Medical Devices Agency ⁸².

Regarding operational outlook, manufacturing at the oral solid dose manufacturing facility in Nashik, India, has been temporarily suspended due to a fire in mid-February 2026, with operations currently expected to resume in April 2026 ⁸³. The company believes it has insurance coverages for losses, including for assets and business interruption ⁸⁴. The facility in Indore, India, which received an FDA warning letter and import alert in 2024, is anticipated to be ready for reinspection in 2026 ⁸⁵.

Planned capital allocation for the 2026 calendar year includes capital expenditures expected to be approximately $350 million to $450 million ⁸⁶. Viatris intends to continue paying quarterly cash dividends to its shareholders, with a dividend of $0.12 per share ⁸⁷ declared on February 23, 2026, payable on March 18, 2026 ⁸⁸. The Board of Directors has authorized a $2 billion ⁸⁹ share repurchase program, with $1.0 billion ⁹⁰ remaining available as of February 26, 2026 ⁹¹.

The company faces structural headwinds and execution risks, including potential continued or additional drug pricing reduction pressures, general uncertainty related to the timing of responses and approvals from the FDA due to evolving regulatory priorities and associated changes to agency operations, and the potential for adverse impacts from future tariffs and trade restrictions ⁹². In China, additional pricing and volume pressure for pharmaceutical products sold in the hospital channel is expected to continue during 2026 ⁹³. The implementation of the Inflation Reduction Act, including drug price negotiation, inflation penalties, and Part D redesign, could negatively affect certain Viatris portfolio products ⁹⁴. The ongoing conflicts in the Middle East and between Russia and Ukraine, along with related trade controls, sanctions, supply chain disruptions, and staffing challenges, have impacted and may continue to impact the company's ability to market or sell pharmaceuticals and the ability of regulators to conduct inspections ⁹⁵.

Viatris operates in a complex and rapidly changing environment, facing significant macroeconomic, competitive, regulatory, geopolitical, and operational risks. The global economy's volatility, including inflation, increased interest rates, and rising energy costs, may adversely affect the industry, business, partners, and suppliers, potentially leading to reduced consumer and customer spending or decreased governmental/third-party payor coverage ⁹⁶. The pharmaceutical industry is highly competitive, with Viatris facing competition from larger manufacturers and the rapid entry of generic products after patent expiration, which can lead to substantial and rapid declines in branded product sales ⁹⁷. For example, market exclusivity for Amitiza® 24 µg in Japan may be lost in June 2026 ⁹⁸. Regulatory risks are substantial, as the industry is heavily regulated by authorities like the FDA and EMA, and non-compliance can result in fines, penalties, product recalls, or suspension of production ⁹⁹. The FDA issued a warning letter and import alert related to the Indore, India, manufacturing facility in December 2024, restricting the distribution of 11 products into the U.S. and negatively impacting sales in other regions, with an estimated negative impact to total revenues of approximately $370 million ¹⁰⁰ for the year ended December 31, 2025 ¹⁰¹. Geopolitical events, such as the ongoing conflicts in the Middle East and between Russia and Ukraine, pose risks including trade controls, sanctions, supply chain disruptions, and challenges to manufacturing and sales ¹⁰². Operationally, a significant portion of manufacturing capacity relies on a limited number of facilities and third-party suppliers, making the company vulnerable to disruptions, as demonstrated by the temporary suspension of manufacturing at the Nashik, India, facility due to a fire in February 2026 ¹⁰³. The company also faces significant indebtedness, with approximately $12.4806 billion ¹⁰⁴ in long-term debt as of December 31, 2025 ¹⁰⁵, and approximately $259 million ¹⁰⁶ of floating rate debt as of December 31, 2025 ¹⁰⁷, making it vulnerable to interest rate increases; a one percentage point increase in the average interest rate on this floating rate debt would increase combined interest expense by approximately $2.6 million ¹⁰⁸ per year ¹⁰⁹.

Management's message to shareholders emphasizes Viatris' mission to empower people worldwide to live healthier at every stage of life, leveraging its global footprint, extensive portfolio, supply chain, and scientific expertise to address healthcare needs globally. The executive management team is focused on ensuring the company is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers, and other key stakeholders. Management has initiated an enterprise-wide strategic review (EWSR) in 2025 to build a more focused, efficient, and future-ready organization, positioning the company for sustained growth beginning in 2026. As a result of the EWSR, the company has committed to and begun implementation of certain restructuring activities, expecting to incur total pre-tax charges ranging between $700 million and $850 million ¹¹⁰, with potential savings of $600 million to $700 million ¹¹¹ once fully implemented. The three strategic priorities emphasized for the period ahead are to drive the base business by executing successful launches, focusing on supply chain continuity, evolving the generics portfolio towards higher-margin products, and strengthening established brands; to fuel the innovative portfolio by advancing a pipeline of late-stage and in-market growth assets sourced internally and externally; and to modernize for sustainable growth by strengthening technology, data, and talent capabilities. Management anticipates capital expenditures for the 2026 calendar year to be approximately $350 million to $450 million ¹¹². The Board of Directors declared a quarterly cash dividend of $0.12 per share ¹¹³ on February 23, 2026, payable on March 18, 2026 ¹¹⁴, and noted that $1.0 billion ¹¹⁵ remains available under the $2 billion ¹¹⁶ share repurchase program as of February 26, 2026 ¹¹⁷.