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Viatris
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Viatris Inc. is an American global pharmaceutical and healthcare corporation headquartered in Canonsburg, Pennsylvania. The corporation was formed through the merger of Mylan and Upjohn, a legacy division of Pfizer, on November 16, 2020.[2]

Key Information

The name of the corporation comes from the Latin words via, meaning path, and tris, which means three, referring to the path to three main objectives the corporation set: expanding access to medicines, meeting patient needs through innovation, and earning the trust of the healthcare community.[3][4]

Viatris ranked 254th on the 2021 Fortune 500 rankings of the largest United States corporations based on its 2020 total revenue.[5]

History

[edit]

On November 16, 2020, Upjohn merged with Mylan in a Reverse Morris Trust transaction and changed its name to Viatris.[1][2] At that time, Michael Goettler became chief executive officer.[6][3]

Following the combination, the company began trading on the NASDAQ using the ticker symbol VTRS.[2]

In December 2020, the company announced a cost-reducing restructuring plan that would impact up to 20% of its global workforce, or 9,000 jobs at its facilities around the world.[7][8][9]

In 2021, Viatris was ranked 5th by Fortune on its annual "Change the World" list for having "transformed the treatment of HIV around the world in the [previous] five years through the first low-cost antiretroviral drug for first-line treatment of HIV and a children's version in the form of fruit-flavored tablets that dissolve in liquid.[10]

In February 2022, Viatris announced an agreement where it will contribute to Biocon Biologics its biosimilars portfolio and related commercial and operational capabilities in exchange for up to $3.335 billion, including a stake of at least 12.9% in Biocon Biologics.[11] The transaction was completed in November 2022.[12] In November 2022, the business agreed to acquire Oyster Point Pharma and Famy Life Sciences for an aggregate of $700–750 million to create an ophthalmology division.[13][14] The acquisitions closed in January 2023.[15][16]

In 2022 and 2024, Viatris was recognized by Forbes as one of the world's best employers[17] and by Newsweek as one of America's most responsible companies.[18][19]

On April 1, 2023, Scott A. Smith became Viatris' CEO, succeeding Michael Goettler. Smith previously served on the company's board since 2022. [20]

In April 2023, Viatris was recognized by LinkedIn as one of the 25 best companies to work for in India,[21] and one of the 25 best companies offering career development in Ireland.[22]

In May 2023, USA Today included Viatris in its list of 400 US companies that have reduced their greenhouse gas emissions intensity from 2019 to 2021. [23]

In June 2023, Viatris was named to the Forbes Global 2000 list of the world's largest companies.[24]

In October 2023, Viatris reached agreements to divest from almost all of its OTC business, its women’s healthcare business, and its India-based active pharmaceutical ingredients business for a total of about $3.6 billion.[25]

In late December 2024, Viatris disclosed that the U.S. FDA had issued a warning letter and an import alert concerning the company's drug-making facility in Indore, India. The import alert affects 11 actively distributed products, which will no longer be accepted into the U.S. until the warning letter is lifted, while four products were conditionally exempted due to shortages. The violations cited by the FDA included subpar quality control and improper management of manufacturing defect. In response, the company announced that it has taken corrective and preventative actions.[26][27][28]

Predecessors

[edit]

The following is an illustration of the company's major mergers and acquisitions and historical predecessors:

Viatris Acquisitions
  • Viatris
    • Merger of Mylan and Upjohn
    • Famy Life Sciences (Acq 2023)
    • Oyster Point Pharma (Acq 2023)

Products

[edit]
Viatris Pharmaceutical Plant in Istanbul. 27 May 2023.

The company produces and sells a variety of medicines, with 1,400 approved therapeutic molecules in its portfolio.[29] It owns brands (like Viagra, Xanax, Lipitor),[6][30] generics, including branded and complex generics, biosimilars,[31][32] and over-the-counter (OTC) drugs and active pharmaceutical ingredients. Viatris products cover therapeutic areas including cardiovascular, infectious disease, oncology, immunology, CNS and anesthesia, women's healthcare, diabetes and metabolism, gastroenterology, respiratory and allergy, and dermatology.[32][33]

The following products have been newly launched or received regulatory approvals since Viatris was established include:

Partnerships

[edit]

Following the formation of Viatris, the company became a member of the Biosimilars Forum, a trade organization that advocates for greater biosimilar usage.[31]

Viatris partnered with the American College of Cardiology, the NCD Alliance, and the World Heart Federation to create the NCD Academy, a platform to help fight non-communicable diseases around the world.[43][44]

In December 2020, the company worked with Sesame Workshop to create resources to help children and their caregivers manage their social and emotional needs impacted by the COVID-19 pandemic.[45][46]

In April 2021, the company partnered with Atomo Diagnostics and Unitaid to expand access to HIV self-testing to 135 countries and lower the price of the tests by around 50%.[47][48]

In February 2024, Viatris entered into an agreement with Idorsia to collaborate on global research and development and the commercialization rights to Phase 3 pharmaceuticals selatogrel, a cardiac medication, and cenerimod, a novel immunology medication used to treat systemic lupus erythematosus. The agreement includes the potential to add more assets in the future.[49][50][51]

References

[edit]
[edit]
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Viatris

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Viatris Inc. is an American multinational pharmaceutical company headquartered in , formed on November 16, 2020, through the merger of N.V. and , a legacy division of .
The company operates as a global healthcare entity with centers in , , and Hyderabad, serving over 165 markets and focusing on developing and delivering generic drugs, biosimilars, branded pharmaceuticals, and over-the-counter products to address unmet medical needs in areas such as , infectious diseases, and .
In 2024, Viatris reported total revenues of approximately $14.7 billion and employed around 32,000 people worldwide, emphasizing expanded access to medicines in emerging markets while navigating competitive pressures in the generics sector.
Notable aspects include its broad portfolio of over 1,400 approved molecules and ongoing efforts to launch complex generics and biosimilars, though it has encountered challenges such as regulatory hurdles and pricing dynamics inherited from predecessor entities.

Company Overview

Viatris Inc. was established through the merger of N.V., a global pharmaceutical company, and Inc., the off-patent medicines division of Inc. The transaction was announced on July 29, 2019, and structured as an all-stock Reverse Morris Trust, under which spun off to its stockholders, who then exchanged their shares for shares, effectively merging the entities while providing tax efficiency. This structure allowed to divest its legacy portfolio without incurring significant tax liabilities, with the combined company adopting the name Viatris to reflect its focus on global access to medicines. The merger received final regulatory approval on , 2020, and closed on , 2020, marking the official launch of Viatris as an independent entity. Post-closing, Mylan's shareholders owned approximately 49% of Viatris, while Pfizer's spin-off shareholders held the remaining 51%, preserving the tax-deferred nature of the deal. The formation integrated Mylan's generics expertise with 's branded and portfolio, creating a with over 40 manufacturing sites and presence in more than 165 markets. Viatris Inc. is incorporated in the State of as a , with its principal executive offices located at 1000 Mylan Boulevard, 15317. As a publicly traded entity listed on the Global Select Market under the ticker "VTRS," it operates under a standard framework, including a and seven standing committees such as , compensation, and , each governed by written charters to oversee , , and compliance. This structure emphasizes oversight, with the board retaining authority to engage external advisors for duties.

Leadership and Headquarters

Viatris Inc. is headquartered at 1000 Mylan Boulevard in Canonsburg, Pennsylvania, United States, a location inherited from its predecessor Mylan N.V. following the 2020 merger with Upjohn. The company maintains global centers in Pittsburgh, Pennsylvania; Shanghai, China; and Hyderabad, India, supporting operations across more than 165 markets. Scott A. Smith serves as chief executive officer, a position he has held since April 1, 2023, bringing over 35 years of experience in biotechnology and pharmaceuticals. Doretta Mistras is chief financial officer, overseeing financial strategy and operations. Other key executives include Andrew Enrietti, appointed chief administrative and transformation officer on August 19, 2025; Paul Campbell, executive vice president and chief legal officer; Corinne Le Goff, executive vice president and president of developed markets; Philippe Martin, executive vice president and president of greater China; Peter McCormick, executive vice president and chief information and digital officer; Burt Park, executive vice president and president of Japan and Asia Pacific; and Lara Ramsburg, executive vice president, global product strategy and supply chain. The board of directors, which provides strategic oversight, includes recent appointees such as Frank D'Amelio and Michael Severino, M.D., added on May 5, 2025, and David Simmons, appointed on August 5, 2025, reflecting ongoing efforts to bolster expertise in pharmaceuticals, finance, and capital markets.

Core Mission and Strategic Priorities

Viatris's core mission is to empower people worldwide to live healthier at every stage of life by providing access at scale to high-quality, trusted medicines, irrespective of geography, , or economic status. This mission, articulated upon the company's formation in November 2020, emphasizes five key pillars: access, leadership in sustainable operations and innovative solutions for unmet needs, partnerships to amplify impact, innovation through science and technology to enhance patient outcomes, and unwavering commitment to manufacturing and product quality standards. The approach prioritizes broad accessibility over premium pricing models typical in innovator pharmaceuticals, leveraging a portfolio of generics, biosimilars, and select branded products to serve diverse markets, particularly in emerging economies where over 60% of its revenue originates. Strategic priorities for Viatris, as outlined in recent financial guidance and executive communications, center on driving commercial execution, advancing the pipeline, and pursuing accretive in-market opportunities to enhance long-term value creation. In 2025, these efforts include optimizing the base business for growth—evidenced by 2% operational revenue increase excluding divestitures in 2024—and leveraging financial flexibility for targeted investments, such as the completion of non-core asset divestitures like the over-the-counter (OTC) business in July 2024 to streamline focus on high-margin segments. The company positions its strategy around three pillars: a diversified and expanding core portfolio, robust financial health enabling disciplined capital allocation, and a of opportunities in biosimilars and complex generics, with Phase 2 planning extending through 2028 emphasizing and sustainable access initiatives aligned with U.N. . This framework reflects a post-merger from predecessor entities' focuses—Mylan's generics scale and Upjohn's legacy branded products—toward integrated that prioritize affordability and reliability over aggressive in novel therapies, as evidenced by selective R&D investments yielding advancements like approvals rather than broad-spectrum new . Such priorities have supported consistent execution, with CEO Scott A. Smith noting in Q1 2025 results a "good start" tied to these focuses amid market challenges in select regions.

Historical Background

Predecessor Entities: Mylan and Upjohn

Pharmaceuticals was established in 1961 in , by Milan "Mike" Puskar and Donald "Don" , two former U.S. Army colleagues, initially as a distributor of generic drugs to improve access in underserved areas. By 1963, operations relocated to , where the company began manufacturing its first products, including vitamins in 1965. Incorporated as Laboratories Inc. in in 1970, it shifted emphasis toward generic pharmaceuticals, aiming by 1976 to become a leader in producing drugs under their chemical names rather than branded equivalents. Mylan's expansion included significant R&D investments, such as the 1984 launch of Maxzide, an antihypertensive medication developed after five years of clinical trials and a $5 million outlay, marking a milestone in its generic portfolio. The company grew into a global generics powerhouse, operating in over 165 countries and pioneering products like the first generic version of EpiPen. By the late , Mylan focused on specialty and branded generics, biosimilars, and affordable medicines, positioning it for strategic combinations amid industry consolidation. The Company originated in 1886 in , founded by physician William E. Upjohn and his brother Henry as the Upjohn Pill and Granule Company, innovating friable pill manufacturing to enhance drug dissolution and efficacy. It expanded into steroids and other therapeutics, becoming a major player in pharmaceuticals with global reach by the mid-20th century. In 1995, Upjohn merged with Sweden's AB to form ; this entity was acquired by in 2003, integrating Upjohn's legacy into Pfizer's operations. Within , the division managed off-patent branded and generic medicines, emphasizing established products in areas like , cardiovascular health, and . By 2019, Pfizer announced the spin-off of Upjohn to merge with , creating Viatris as a standalone entity focused on global access to medicines, with the deal valuing at approximately $35 billion and closing in November 2020. retained 57% ownership post-merger, reflecting Upjohn's scale in mature markets like and established portfolios.

The 2020 Merger Process

The merger between N.V. and Inc.'s Business, announced on July 29, 2019, advanced through critical stages in 2020 to form Viatris Inc. The transaction employed a Reverse Morris Trust structure, enabling a tax-free spin-off of to shareholders, followed by 's merger with , resulting in shareholders owning approximately 57% of the combined entity and shareholders owning 43%. On February 27, 2020, and finalized appointments to the Viatris , including executives from both companies, signaling progress toward integration while the deal remained on track for a mid-2020 close pending regulatory and shareholder approvals. shareholders overwhelmingly approved the combination on June 30, 2020, satisfying a key condition for consummation. Regulatory scrutiny focused on antitrust concerns in overlapping generic and off-patent drug markets. The granted approval on September 15, 2020, conditional on divestitures of specified assets, with entering agreements for buyers acceptable to the Commission. The U.S. cleared the merger on October 30, 2020, requiring divestitures of products in 39 markets to preserve competition, along with prior approval for future acquisitions in those areas. Additional clearances included from Australia's ACCC on September 10, 2020, subject to undertakings. Pfizer set November 13, 2020, as the record date for the Upjohn spin-off distribution to its shareholders. The transaction closed on , 2020, with Viatris commencing operations as the parent entity of the combined businesses, headquartered in , and listed on under the ticker VTRS. The merger was projected to yield annual cost synergies of approximately $1 billion by 2023 through operational efficiencies and .

Post-Merger Evolution and Key Milestones

Following the merger's completion on , 2020, Viatris prioritized operational integration and cost efficiencies, launching a global restructuring program projected to deliver approximately $1 billion in annual run-rate synergies by streamlining manufacturing, , and administrative functions across its combined footprint. This initial phase emphasized realizing value from the Mylan-Upjohn union while addressing overlapping assets and regulatory footprints in over 160 countries. By the end of 2021, the company reported progress toward these targets, supported by strong financial performance that met or exceeded guidance for revenue and adjusted EBITDA. In February 2022, Viatris concluded a comprehensive strategic review, shifting focus to portfolio reshaping by divesting non-core assets and concentrating resources on high-growth segments such as biosimilars, , and complex generics. A key outcome was the formation of a global biosimilars with Biologics, combining portfolios to enhance commercialization and development capabilities. This evolution continued through targeted acquisitions and divestitures, enabling the company to reduce complexity from legacy portfolios inherited from predecessors, including low-margin over-the-counter products and select sites, while bolstering differentiated offerings. By mid-2024, these efforts culminated in the completion of all previously announced divestitures, marking a streamlined structure oriented toward sustainable access and innovation in underserved therapeutic areas. Key milestones in this period include:
  • November 7, 2022: Announcement of acquisitions to establish a leading franchise, including Oyster Point Pharma for $500 million and Xiidra from for up to $1.75 billion; transactions closed in January 2023, adding dry eye disease treatments to the portfolio.
  • 2023–2024: Execution of multiple divestitures, such as rights to two women's healthcare products and select manufacturing facilities, alongside the over-the-counter business sale finalized on July 2, 2024, to eliminate non-strategic exposures and improve focus.
  • October 15, 2025: Completion of the acquisition of Aculys Pharma, granting exclusive rights to (for ) in and Spydia (for ) in and certain other markets, extending geographic reach in and consumer health-adjacent segments.

Business Operations

Product Categories and Portfolio

Viatris's product portfolio encompasses branded medicines, generic drugs, and over-the-counter (OTC) products, comprising more than 1,400 approved molecules marketed in over 165 countries. The company's offerings focus on increasing access to treatments for noncommunicable and infectious diseases across more than 10 major therapeutic areas, including cardiovascular health, disorders, , , women's healthcare, , , , and respiratory conditions. This diversified approach stems from the 2020 merger of and Pfizer's business, which combined established brands with extensive generic capabilities. Branded products include approximately 20 iconic brands and several global key brands, such as Lipitor (, a for management and cardiovascular risk reduction), Lyrica (, used for and ), Norvasc (amlodipine, an antihypertensive), Celebrex (celecoxib, a nonsteroidal anti-inflammatory for ), Revatio (, for pulmonary arterial ), Dilantin (, an ), Caduet (amlodipine/ combination), Inspra (, for ), and Nitrostat (, for ). These brands generated $9.2 billion in sales in 2024, though the category experienced a 6% decline year-over-year due to patent expirations and market competition. Viatris also maintains an antiretroviral franchise for treatment within its infectious disease portfolio. In the generics segment, Viatris ranks as one of the world's largest manufacturers, offering over 7,500 products including standard generics, complex generics (such as injectables and topicals), and branded generics to address affordability and access barriers. This category contributed sales amid a 2% decline in , driven by efforts in complex sterile products, oral solids, and transdermals, with a focus on therapeutic areas like , , and for future growth. Viatris divested its biosimilars business in November 2022, selling the portfolio—including assets like Fulphila () and Ogivri ()—to Biologics for up to $3.335 billion in a cash-and-stock transaction, allowing Viatris to streamline operations toward generics and brands. OTC products complement the portfolio by providing accessible consumer health options, though specific revenue breakdowns emphasize the dominance of prescription brands and generics. The overall portfolio supports , with generics and similar products saving U.S. healthcare systems $445 billion in 2023 alone through competition.

Global Manufacturing and Supply Chain

Viatris operates approximately 40 manufacturing sites worldwide, producing oral solid doses, injectables, complex dosage forms, and active pharmaceutical ingredients (APIs). These facilities are distributed across geographically diverse locations to support reliable supply to over 165 markets and territories. In Europe alone, the company maintains 11 manufacturing plants across six countries, complemented by six research and development facilities. The company's is designed for flexibility and resilience, incorporating a broad network of internal alongside strategic partnerships for production. Viatris employs a 24-month horizon, rigorous supplier monitoring, and processes to mitigate disruptions. Additional measures include , IT systems for tracking, and protocols to prevent product diversion, ensuring compliance and availability. Global centers in Pittsburgh, Pennsylvania (), Shanghai (), and Hyderabad () oversee operations, with manufacturing presence spanning multiple continents. This diversified approach emphasizes strong supplier relationships and investments in to secure access to . In 2023, these efforts supported production across five continents, aligning with Viatris's focus on addressing unmet needs in diverse markets.

Research, Development, and Pipeline

Viatris maintains 10 (R&D) centers worldwide, encompassing technology-focused sites and global hubs dedicated to advancing complex generics, biosimilars, and other high-barrier-to-entry products. The company's R&D efforts emphasize moving up the through investments in areas such as biosimilars and insulin analogs, respiratory therapies, complex sterile injectables, topicals and transdermals, complex oral solids, and over-the-counter formulations. For the twelve months ending June 30, 2025, Viatris reported R&D expenses of $846 million, reflecting a 3.41% year-over-year increase amid strategic expansions including an amended global collaboration with Idorsia that added approximately $100 million in incremental R&D commitments. In early 2025, Viatris achieved three positive Phase 3 data readouts, including results for a novel formulation targeting acute . Subsequent milestones included positive top-line results from the Phase 3 LYNX-2 of MR-142 for keratorefractive patients in June 2025, alongside an ongoing Phase 3 evaluation of MR-139 for reported in July 2025. The company anticipates six Phase 3 readouts throughout 2025, focusing on late-stage assets in , pain, and other therapeutic categories to bolster its portfolio of complex injectables and generics. These efforts align with Viatris's broader strategy of developing difficult-to-manufacture products, as evidenced by recent approvals like the first generic iron injection in the U.S. in August 2025 from its robust injectable pipeline.

Financial Profile

Viatris derives its revenue principally from the development, manufacturing, and commercialization of generic, branded, and pharmaceutical products, with sales categorized into (legacy differentiated products such as Lipitor, Norvasc, Lyrica, and Viagra) and Generics (including complex generics, injectables, and biosimilars). Revenue is reported across four geographic segments: Developed Markets (primarily U.S. and , encompassing mature markets with focus on generics and select brands), Greater China (via joint ventures emphasizing branded products like Lipitor), JANZ (, , , featuring regulated generics and brands), and Emerging Markets (diverse generics portfolio in regions like and ). New product launches, including biosimilars and complex generics, represent a growing subset, contributing $582 million in 2024 through items like iron sucrose and . In , total revenues reached $14.7 billion, reflecting a 5% reported decline from $15.4 billion in 2023, driven by generic erosion and divestitures such as non-core assets. Segment net sales broke down as follows:
Segment2024 Net Sales ($M)Change from 2023
Developed Markets8,929-3%
2,1670%
JANZ1,346-5%
Emerging Markets2,251-12%
Total14,693-5%
Despite the headline decline, divestiture-adjusted operational grew 2% year-over-year, supported by gains in generics and new product momentum across segments. Brands faced pricing pressures from , while generics benefited from launches offsetting expirations. Post-2020 merger peaked at approximately $18 billion in 2022 before trending downward amid intensified generic , headwinds, and strategic divestitures to streamline the portfolio. Operational metrics, however, indicate resilience: 2024's 2% core growth followed similar patterns in prior years, with new products mitigating base business erosion from off- drugs. For 2025, Viatris projects total revenues of $13.5–$14 billion, anticipating a ~1% divestiture-adjusted base decline offset by $450–$550 million in new product revenues from launches like and expanded biosimilars. This trajectory underscores a shift toward higher-margin complex products amid ongoing commoditization in standard generics.

Profitability and Cost Management

Following the November 2020 merger, Viatris implemented a multi-phase cost management strategy aimed at realizing at least $1 billion in annual run-rate synergies, primarily through optimization, efficiencies, footprint rationalization, and administrative overhead reductions. These efforts, outlined in the company's integration plan, included one-time cash costs estimated at $1.5 billion in 2021 to achieve the targets, with progress reported as on track by late for full realization by the end of 2023. The synergies formed Phase 1 of Viatris's broader operational plan, involving global such as workforce reductions and facility consolidations, which reduced the overall cost base and supported repayment of $3.7 billion in alone. In that year, expenses totaled $211.1 million, alongside an enterprise-wide to identify further savings opportunities, emphasizing streamlined global infrastructure amid competitive pressures in generics and biosimilars. These measures contributed to adjusted profitability, with fiscal year 2024 adjusted EBITDA reaching $4.7 billion on $14.7 billion in revenue, yielding an approximate 32% margin, while adjusted gross margin improved to 57.9%. U.S. GAAP results reflected a net loss of $634 million, attributable to non-cash charges including amortization of merger-related intangible assets and inventory fair-value step-ups in cost of sales, which elevated reported cost of sales to $9.1 billion before adjustments.
PeriodRevenue ($B)Adjusted EBITDA ($B)Adjusted Gross Margin (%)GAAP Net Earnings/Loss ($M)
FY 202414.74.757.9(634)
Q2 20253.581.0856.6(4.6)
In Q2 2025, cost discipline sustained adjusted net earnings of $726 million and of $241 million excluding transaction costs, despite a 6% decline from generic erosions. 2025 guidance projects adjusted EBITDA of $3.89 billion to $4.19 billion on anticipated s of $13.5 billion to $14.0 billion, reflecting expectations that ongoing efficiencies will offset market headwinds.

Stock Performance and Investor Relations

Viatris Inc. (VTRS) trades on the Global Select Market. Following the November 16, 2020, merger completion, shares opened in the range of approximately $12–$14, adjusted for the transaction, but have since declined amid generics pricing pressures, patent expirations, and integration expenses. As of October 20, 2025, the stock closed at $10.31, with a of about $12.14 billion and a 52-week trading range of $6.85 to $13.55. Post-merger performance has been volatile and predominantly negative in early years, with annual total returns of -25.32% in and -18.39% in , reflecting revenue declines and competitive erosion in legacy portfolios. A rebound occurred in 2024 with +19.67% returns, driven by cost controls and select launches, though 2025 year-to-date returns fell -18.73% amid broader market headwinds and operational challenges.
YearTotal Return (%)
2021-25.32
2022-18.39
2024+19.67
2025 (YTD)-18.73
Viatris emphasizes returns via s and repurchases to offset . The board declared a quarterly of $0.12 per share on August 4, 2025, payable to s of record, equating to an annualized payout of $0.48 and a forward yield of 4.64%. In 2024, the company returned $825 million in capital to s while repaying $3.7 billion in debt, and it announced prioritization of such returns in 2025. As of Q2 2025, over $630 million had been distributed year-to-date, including $350 million in share buybacks. Investor relations are managed through the official website (investor.viatris.com), offering SEC filings, transcripts, historic price data, an investment return calculator, and a toolkit for reinvestment and direct purchase plans. The function conducts quarterly calls, investor days, and presentations to disclose financial results, pipeline updates, and strategic shifts, with contact available for analysts and institutional holders.

Strategic Partnerships

Key Alliances and Joint Ventures

In February 2024, Viatris entered into a major with Idorsia Ltd., securing exclusive global rights to develop and commercialize two Phase 3 assets: selatogrel, a subcutaneous receptor inhibitor intended as a potential self-administered treatment for acute in high-risk patients, and cenerimod, a selective S1P1 for systemic lupus erythematosus (SLE). The agreement also provides Viatris with options to include additional innovative molecules from Idorsia's pipeline, aiming to bolster Viatris's portfolio in and through shared development costs and expertise. In February 2025, the was expanded to grant Viatris additional territory rights, reflecting ongoing alignment on commercialization strategies. Prior to the 2020 merger forming Viatris, its predecessor maintained a longstanding alliance with Biologics for the development, manufacturing, and commercialization of , including products like Semglee (), the first interchangeable approved by the FDA in the United States. This partnership, initiated in 2009, contributed significantly to Viatris's early revenue but concluded with Biocon's acquisition of Viatris's global assets in November 2022 for up to $3.335 billion in cash and equity, including Viatris's 24.5% stake in Biocon Biologics. Post-transaction, Viatris agreed to provide transitional commercial and manufacturing services in select markets for up to two years, preserving some operational continuity while allowing Viatris to refocus on core generics and established brands. Viatris also participates in a collaborative agreement with Revance Therapeutics, established in February 2018, to develop and commercialize an investigational to onabotulinumtoxinA, targeting aesthetic and therapeutic neuromodulator markets. This alliance leverages Revance's expertise in formulations alongside Viatris's global manufacturing and distribution capabilities, though progress remains in preclinical and regulatory stages as of 2023. These partnerships underscore Viatris's strategy of leveraging external to address gaps, particularly in high-value therapeutic areas, while mitigating R&D risks through shared investments.

Licensing Deals and Market Expansions

In October 2024, Viatris entered an exclusive licensing agreement with Pharmaceuticals for , a dual SGLT1/2 inhibitor indicated for glycemic control in patients. The deal grants Viatris commercialization rights in all markets outside the and , including high-growth regions in , , and , supported by a $25 million upfront payment, potential regulatory and sales milestones exceeding $1 billion, and tiered royalties on net sales. This arrangement leverages Viatris' established distribution networks in emerging markets to address unmet needs in cardiometabolic therapies, where sotagliflozin's approval history in Europe and the U.S. provides a foundation for regulatory filings elsewhere. In February 2024, Viatris announced a global research and development collaboration with Idorsia, securing exclusive worldwide rights to develop and commercialize two Phase 3 assets: selatogrel, a subcutaneous receptor inhibitor for acute , and cenerimod, a selective S1P1 receptor modulator for systemic . The agreement involves an upfront payment of $350 million, with additional milestones potentially totaling over $5 billion across both programs, plus royalties, and options for two further Idorsia pipeline candidates. This partnership expands Viatris' footprint in specialty pharmaceuticals, particularly and , by integrating innovative molecules into its generics-led model for broader market penetration beyond traditional low-cost segments. Viatris has also advanced market access through biosimilars partnerships, notably its ongoing collaboration with Biologics initiated prior to the 2020 Mylan-Upjohn merger and formalized in a transaction agreement. This includes co-commercialization of products like Ogivri (trastuzumab-dttb), enabling expansions into price-sensitive markets such as , , and via localized manufacturing and regulatory approvals. These deals align with Viatris' emphasis on emerging markets, which accounted for a significant portion of its growth , by combining licensing with efficiencies to compete against local generics producers. Overall, such agreements have facilitated entry into over 165 countries, prioritizing biosimilars and complex generics to capture share in underserved therapeutic areas.

Antitrust Scrutiny and Settlements

The formation of Viatris through the merger of N.V. and Inc.'s Business Unit, completed on November 16, 2020, underwent antitrust review by the U.S. (FTC). The FTC alleged that the transaction would harm competition in seven existing U.S. markets by reducing the number of suppliers and delay or eliminate entry in three future generic markets by diminishing incentives for development. To address these concerns, the FTC required divestiture of rights and assets related to six products—amlodipine besylate/ calcium tablets, chewable tablets, HCl capsules, HCTZ tablets, gatifloxacin ophthalmic solution, and injectable solution—along with Mylan's tablets, all to Prasco, LLC. Additionally, the consent order mandated prior FTC approval for any acquisition of interests in sodium tablets, tablets, or tartrate tablets by , , or Viatris, with serving as a to ensure supply continuity. The final order was approved by a 3-2 FTC vote on January 28, 2021. Post-merger, Viatris's subsidiary faced scrutiny in a U.S. Department of (DOJ) investigation into alleged price-fixing and bid-rigging in the industry, launched in 2020 and targeting multiple companies. On July 2, 2024, the DOJ notified Viatris that and its former president, Rajiv , were no longer subjects of interest in the probe, effectively clearing them without charges or settlement. Viatris has resolved multiple antitrust class-action lawsuits stemming from EpiPen pricing and market practices, inherited from . In February 2022, Viatris agreed to pay $264 million to settle claims by direct and indirect purchasers that Mylan unlawfully monopolized the epinephrine auto-injector market through exclusive rebate deals with pharmacy benefit managers and delays in generic competition, without admitting liability; the settlement received final approval in July 2022. Separately, in January 2025, Viatris settled for $73.5 million with drug wholesalers alleging conspiracy with and others to suppress generic EpiPen entry and inflate prices, again denying wrongdoing; final approval was granted in May 2025. These resolutions followed allegations of anticompetitive conduct but did not result in findings of liability.

Patent and IP Challenges

Viatris, formed from the 2020 merger of and Pfizer's division, has engaged in extensive patent litigation under the Hatch-Waxman Act, primarily challenging originator patents to facilitate launches while occasionally defending against infringement claims on its own . These disputes often involve abbreviated new drug applications (ANDAs), where Viatris files Paragraph IV certifications contesting patent validity or non-infringement, triggering 30-month stays on FDA approval. The company's strategy emphasizes inter partes review (IPR) proceedings at the U.S. Patent and Trademark Office to invalidate weak patents, aligning with its advocacy against "patent abuse" in the pharmaceutical sector. A notable series of challenges targeted (GLP-1) receptor agonists. In July 2025, a U.S. District Court in ruled that Viatris's proposed generic (the active ingredient in 's Wegovy) did not infringe a key Novo patent covering administration "without another therapeutic agent," dismissing the infringement claim due to claim construction issues. This followed a October 2024 settlement with resolving a related Ozempic patent dispute, allowing potential generic entry post-exclusivity periods. However, has pursued separate infringement suits against Viatris for other formulations, highlighting ongoing risks in high-value markets. Viatris has secured multiple invalidations of patents on respiratory and neurological drugs. In November 2022, the company prevailed in invalidating AstraZeneca's patent for Symbicort, marking the fourth such ruling in related litigation and clearing paths for generic budesonide-formoterol inhalers. Similarly, the U.S. Federal Circuit in an unspecified recent appeal upheld a district court decision invalidating Biogen's Tecfidera patent, enabling earlier generic dimethyl fumarate entry for multiple sclerosis. In April 2024, Viatris and partner Schertenleib invalidated an Allergan patent for the glaucoma drug Lumigan (bimatoprost) at the Paris Central Division of the Unified Patent Court. Defensive challenges have arisen in manufacturing and formulation disputes. Johnson & Johnson and Momenta Pharmaceuticals sued Viatris in May 2022, alleging infringement of patents related to the production process for its generic Copaxone (glatiramer acetate) for multiple sclerosis, targeting partnerships with Indian manufacturers Natco and Gland Pharma. In February 2024, the Paris Court of Appeal upheld a preliminary injunction against Viatris's generic version of MSD's Januvia (sitagliptin), finding probable infringement of a supplementary protection certificate and prohibiting launch pending full trial. Viatris also revived inter partes review challenges with Teva in April 2024 against the final U.S. patent on Janssen's long-acting schizophrenia injectable Invega Sustenna (paliperidone palmitate), potentially accelerating generic competition. These litigations underscore Viatris's reliance on robust IP strategies to balance innovation protection for its off-patent portfolio—such as legacy brands—with aggressive generic challenges, though outcomes vary by jurisdiction and claim specificity, influencing market entry timelines and revenue projections. The company maintains that respecting "legitimate, valid" IP rights while contesting tactics supports broader access to medicines.

Compliance with Health Regulations

Viatris operates under stringent health regulations enforced by agencies such as the U.S. Food and Drug Administration (FDA), which mandates compliance with Current Good Manufacturing Practice (CGMP) standards for pharmaceutical production. The company maintains a Comprehensive Compliance Program (CCP) designed to ensure adherence to applicable laws, including those governing manufacturing, , and across its global facilities. Despite these measures, Viatris has encountered significant regulatory challenges. On December 19, 2024, the FDA issued a warning letter to Viatris citing CGMP violations at its , manufacturing facility, including inadequate investigations of out-of-specification (OOS) results, failures such as unapproved alterations and deletions in laboratory records, and insufficient unit oversight. These issues stemmed from FDA inspections revealing patterns of laboratory discrepancies and deviations not thoroughly addressed, prompting concerns over the reliability of and release processes. The 2024 warning letter triggered an on , 2024, prohibiting entry of 11 actively distributed products from the site into the U.S. market until compliance is demonstrated and the alert lifted, though four products received temporary exemptions due to supply shortages. Viatris acknowledged the deficiencies and committed to a remediation plan involving extended evaluations and corrective actions, while estimating revenue impacts from the restrictions. This follows a prior on July 27, 2023, to Laboratories Limited Unit 8 (a Viatris entity), addressing similar CGMP lapses in controls and data handling, though the firm had partially responded to earlier notices. These enforcement actions underscore ongoing scrutiny of Viatris's integrity, particularly in overseas facilities, where deviations have risked and . The FDA continues to monitor remediation efforts, with potential for further restrictions if violations persist.

Controversies and Debates

EpiPen Pricing Practices and Outcomes

In 2007, Mylan acquired the rights to EpiPen from Merck, at which point the list price for a two-pack of the epinephrine auto-injectors was approximately $94. Over the subsequent decade, Mylan implemented multiple price increases, with the list price rising to over $600 by mid-2016, representing a roughly 550% escalation despite the underlying epinephrine costing less than $1 per dose. These hikes included annual increases of around 10% from 2010 to 2013, followed by sharper rises totaling over 100% from late 2013 to mid-2016, amid limited generic due to FDA approval delays and protections on the auto-injector delivery . The price trajectory drew widespread criticism in 2016, particularly after campaigns highlighted affordability barriers for reliant on the device for treatment, leading to congressional hearings where CEO defended the increases as necessary to support research, rebates to insurers (which covered about 80% of costs), and investments. Critics, including U.S. senators, labeled the strategy as price gouging, pointing to Mylan's dominant 90% U.S. and rises—such as Bresch's pay increasing over 600% to $18.9 million from 2007 to 2015—correlating with the hikes. In response, launched an authorized generic version in December 2016 at about half the brand price (around $300 for a two-pack) and expanded assistance programs, though brand list prices remained elevated. Legal repercussions followed, with settling False Claims Act allegations in 2017 for $465 million over misclassifying EpiPen as a non-innovator drug to underpay rebates, without admitting liability. , formed from Mylan's 2020 merger with , faced further antitrust suits alleging pay-for-delay deals with generics like Teva to block competition; these resolved via a $264 million class-action settlement in 2022 and a $73.5 million direct-purchaser deal approved in 2025. , which manufactured EpiPen under agreement, separately settled consumer claims for $345 million in 2021 related to alleged . Post-controversy, Viatris maintained EpiPen's market position with savings cards offering up to $300 in out-of-pocket reductions for eligible commercially insured patients, while generics from competitors like Amneal and Kaleo (Auvi-Q) entered but captured limited share due to supply issues and perceived reliability differences. The EpiPen patents expired in 2025, anticipated to spur broader and potential price reductions, as epinephrine auto-injector costs have historically reflected delivery device rather than raw drug expenses.

Employment and Facility Restructuring Impacts

Following the November merger of and Pfizer's business to form Viatris, the company initiated a global optimization program in aimed at achieving $1 billion in annual cost savings by 2023 through facility rationalization and workforce reductions. This restructuring encompassed closing, divesting, or downsizing up to 15 sites worldwide, with potential job cuts of up to 9,000 positions, representing approximately 20% of Viatris's global workforce of around 45,000 at the time. The initiative targeted redundant capacities in oral solid dose and other operations, with initial sites including facilities in ; , ; and . In , Viatris closed its Chestnut Ridge oral solid dose plant, eliminating 1,500 jobs after manufacturing ceased on July 31, 2021, with full site closure operations extending into subsequent years. The layoffs contributed to economic strain in the region, a factory town historically reliant on , prompting local concerns over community impacts such as reduced household incomes and strained public services. Similarly, the Baldoyle facility shut down shortly after the merger, resulting in 440 job losses as part of early post-merger integration efforts to consolidate duplicative operations. Subsequent actions included the July 2024 announcement to wind down the Little Island plant in Cork, , by early 2028, affecting over 200 employees, with most retained through the phase-out period to complete ongoing production. In the United States, Viatris planned to close its , manufacturing facility in 2025, leading to 75 layoffs. These measures, implemented via a mix of direct layoffs, attrition, and site transfers, reflected Viatris's strategy to streamline supply chains and enhance efficiency amid competitive pressures in the generics sector, though they drew criticism for accelerating job losses in manufacturing-dependent locales without commensurate local reinvestment.

Broader Critiques on Pricing vs. Market Incentives

Critics of pharmaceutical pricing practices, including those inherited by Viatris from , contend that market incentives often incentivize companies to exploit limited for essential drugs, leading to escalations that burden patients despite low marginal production costs. The EpiPen auto-injector, priced at about $94 for a two-pack in 2007 and raised to $609 by 2016, exemplifies this dynamic, where Mylan's dominance—stemming from competitors' product recalls and FDA regulatory hurdles for device approvals—enabled repeated increases averaging over 20% annually, prompting accusations of prioritizing profits over accessibility for patients. Such cases fuel broader arguments that patent evergreening, complex delivery mechanisms, and approval delays create monopolies, distorting market signals and resulting in prices disconnected from underlying costs or value, as evidenced by bipartisan congressional scrutiny of EpiPen's near-monopoly status and Mylan's $1 billion in 2015 U.S. revenue from the product. Viatris has faced similar critiques in biosimilars, such as its interchangeable (Semglee), where dual-pricing strategies—high list prices paired with deep rebates to pharmacy benefit managers (PBMs)—are said to warp incentives, inflating costs for uninsured patients while benefiting payers through opaque rebate flows that do not fully pass savings to consumers. Defenders of market-driven pricing counter that these dynamics reflect necessary incentives for investing in reliable , liability coverage, and market expansion—such as Mylan's for state laws mandating EpiPen stockpiles in schools, which boosted but required upfront costs—arguing that prices to large payers rose far less (e.g., only about 10% annually for EpiPen amid rebates) than list prices, with true gouging mitigated by eventual generic entry that slashed costs post-2018. Empirical patterns in generics markets, including Viatris' portfolio, show prices eroding 80-90% upon multiple competitors entering, suggesting regulatory barriers rather than inherent market failures primarily delay affordability, though PBM rebate systems complicate transparency and out-of-pocket costs. These tensions highlight causal realities: inelastic demand for life-saving drugs amplifies pricing power absent , yet interventions like price caps risk underincentivizing supply for low-margin essentials, as seen in historical shortages tied to thin generics profits; Viatris advocates pro-competitive settlements to accelerate entry, aligning incentives with access while critiquing policies like Medicaid's generics penalties that deter production. Overall, while critiques emphasize ethical lapses in monopoly exploitation, evidence underscores that robust —facilitated by streamlined regulations—better aligns market incentives with affordability than ex post , which may exacerbate shortages without addressing root barriers.

Societal and Economic Impact

Contributions to Generic Drug Access

Viatris, formed from the 2020 merger of Mylan and Upjohn, operates a diversified portfolio exceeding 1,400 approved molecules, with generics comprising a core component that supports affordability by offering bioequivalent alternatives to branded drugs across therapeutic areas such as cardiovascular, oncology, and infectious diseases. This portfolio reaches patients in over 165 countries, enabling scale in low- and middle-income markets where cost barriers limit treatment. The company's emphasis on complex generics, including injectables and ophthalmics, addresses gaps in supply for high-cost therapies, contributing to broader market competition that has historically reduced U.S. drug spending by associating generics with 90% of prescriptions while accounting for only 13.1% of total costs in 2023. Key product launches underscore Viatris's role in accelerating generic entry. In February 2022, it secured the first U.S. FDA approval for generic Restasis (cyclosporine ophthalmic emulsion 0.05%), a treatment for dry eye disease, following nearly a decade of development and legal challenges to overcome patent and regulatory hurdles, thereby introducing a lower-cost option previously priced at premiums under brand exclusivity. Similarly, in August 2025, Viatris gained approval for the first generic iron sucrose injection (100 mg/5 mL and 200 mg/10 mL strengths), designated as a competitive generic therapy (CGT) by the FDA, which grants 180-day exclusivity to incentivize rapid market entry for this essential anemia treatment used in chronic kidney disease patients. These approvals exemplify Viatris's investment in bioequivalence studies and manufacturing scale-up, directly expanding access in hospital and outpatient settings. Beyond product development, Viatris pursues systemic initiatives to sustain generic availability. Through its Global Healthcare Gateway, launched to foster partnerships with smaller firms, the company facilitates distribution and registration of generics in underserved regions, aiming to bridge supply gaps without compromising standards. In April 2024, Viatris donated over 7 million doses of medicines to , targeting humanitarian needs in areas with limited infrastructure, which bolsters short-term access while generics form the backbone of long-term affordability. Additionally, Viatris advocates for reforms, including to curb last-minute branded label changes that delay generic approvals, as evidenced by its support for U.S. measures enhancing FDA efficiency in 2023. These efforts align with the company's model of sustainable access, prioritizing empirical reliability over short-term pricing tactics.

Criticisms and Policy Implications

Viatris has faced scrutiny over manufacturing quality issues at its overseas facilities, exemplified by a U.S. issued on December 19, 2024, citing significant violations of current good manufacturing practices (CGMP) for finished pharmaceuticals produced at its , plant. This led to an import alert blocking 11 products from U.S. entry, though four were exempted due to ongoing shortages, highlighting tensions between regulatory enforcement and drug supply stability. The action is projected to reduce Viatris's 2025 revenues by approximately $500 million, underscoring vulnerabilities in its reliance on global supply chains for generic production. Critics, including financial analysts, have pointed to inherent flaws in Viatris's , which combines complex generics, biosimilars, and branded drugs, as overly exposed to regulatory risks, erosion from , and macroeconomic pressures that erode margins. Such concerns are amplified by the company's post-merger , which included plans to divest or downsize up to 15 facilities and potentially affect up to 9,000 jobs by the end of , raising questions about long-term operational resilience and workforce impacts. These issues carry broader policy implications for the sector, where consolidation—as seen in Viatris's 2020 formation from and —can diminish competition and exacerbate supply vulnerabilities. The U.S. required divestitures in seven overlapping generic markets to mitigate anticompetitive harms during the merger approval, illustrating the need for rigorous antitrust oversight to preserve market entry and pricing discipline. Policymakers must weigh scale benefits for global access against risks of oligopolistic structures, as evidenced by multimarket contacts among large generics firms correlating with higher regulated prices. Additionally, policies like the Medicaid generics penalty, which applies brand-like rebates to generics upon minor price increases, have been faulted for destabilizing low-margin markets, deterring investment in essential medicines and contributing to shortages. Viatris advocates reforming such measures to incentivize domestic and sustainable manufacturing, arguing that excessive price controls and transparency burdens on generics undermine supply security without addressing root causes like buyer consolidation. Empirical patterns in drug shortages, often tied to thin margins and manufacturing exits, suggest policies should prioritize quality incentives and supply chain diversification over punitive pricing mechanisms to enhance societal access without compromising safety.

Future Outlook and Challenges

Viatris anticipates modest revenue growth in , with guidance projecting total revenues between $13.5 billion and $14 billion, reflecting divestiture-adjusted operational declines of around 2% in early quarters alongside base business stabilization. The company emphasizes strategic priorities including pipeline advancement in s and complex generics, operational execution, and capital allocation toward shareholder returns, with late-stage product launches expected to bolster performance in the latter half of the year and beyond. Analysts forecast long-term growth of approximately 85.9% annually, driven by efficiency gains and expansions, though revenue expansion remains limited to 1.3% per annum amid a consensus hold rating and average price target of $11.17. Key challenges include persistent revenue pressures from generic competition, patent expirations, and divestitures, which contributed to a 6% reported decline in second-quarter 2025 revenues to $3.6 billion. Operational disruptions, such as issues at the facility in , have introduced uncertainty, potentially exacerbating short-term supply constraints and risks in a highly scrutinized global pharmaceutical environment. revised Viatris' outlook to negative in May 2025 while affirming its 'BBB' rating, citing modest forecasts of $13.5 billion for the year and vulnerability to restrictions or tariffs not factored into guidance. Broader market dynamics, including pricing reforms and heightened antitrust oversight in the generics sector, further complicate prospects, with the company pursuing a "Phase 2" consolidation strategy aimed at positioning for stronger growth in 2026 through cost optimizations yielding benefits from 2025 onward.

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