Viatris Inc. (Viatris) is a global healthcare company.
Viatris supplies high-quality medicines to approximately 1 billion patients around the world each year. The company has a global footprint, an extensive portfolio of medicines that is well-diversified across therapeutic areas, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges.
The company operates in mo...
Viatris Inc. (Viatris) is a global healthcare company.
Viatris supplies high-quality medicines to approximately 1 billion patients around the world each year. The company has a global footprint, an extensive portfolio of medicines that is well-diversified across therapeutic areas, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges.
The company operates in more than 165 countries and territories. The company has 26 manufacturing and packaging sites worldwide, more than 1,400 approved molecules, and industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise. Viatris’ portfolio consists of generics (including complex products), globally recognized iconic brands, and an expanding portfolio of innovative medicines.
Business Strategy
The company’s strategies include diversified and growing base business and expanding innovative portfolio.
Business Model and Operations
The company’s business and operating model is deliberately designed and implemented to deliver on its strategy to provide and sustain access to medicine at scale.
The company is convinced that patients and health systems around the world are best served by a healthcare company applying a well-rounded and long-term approach, maintaining viability while working to manage inherent risks and opportunities and continuously striving to advance sustainable operations and responsible practices in a focused way. The company sees healthcare not as it is, but as it should be. The company acts courageously and is uniquely positioned to be a source of stability in a world of evolving healthcare needs. The company does so via Access, Leadership and Partnership.
Access
Viatris provides high-quality, trusted medicines, regardless of geography or circumstance. The company is committed to improving access to high-quality medicines and working to ensure a reliable supply so patients can get the treatments they need, when and where they need them. The company’s global portfolio, supported by its science, medical and manufacturing expertise, delivers global iconic and key brands, and generics, including complex products.
The company is focused on meeting individual needs, whether with a generic medicine, an improved version of an existing medicine, or a truly novel therapeutic solution.
The company produces medicines for patients across a broad range of major therapeutic areas. From cardiovascular health to oncology, Viatris offers quality treatment options across more than 10 major therapeutic areas covering a wide variety of noncommunicable and infectious diseases. The company also offers support services, such as diagnostic clinics, educational seminars and digital tools to help patients better manage their health. The company continues to seek opportunities in various therapeutic areas that moves it forward and leverage the strength of its internal capabilities and global platform.
With the company’s acquisition of selatogrel and licensing agreement for sotagliflozin, it is continuing to build on its strong presence in cardiovascular disease. Viatris collaborates with many organizations to help prevent, diagnose, and treat cardiovascular illnesses. The company’ deep experience in emerging and developed markets affords a tried-and-true method of achieving high impact across the patient experience, from awareness to adherence. In close collaboration with governments, healthcare providers, technology partners and patients, at Viatris work to nurture healthcare systems that can adapt and respond to patients’ ever-changing needs. The company continues to collaborate with medical associations, patient advocacy groups and academia to develop innovative, integrated solutions and programs to help strengthen both the delivery and quality of healthcare.
The company is also a global leader in treating infectious diseases, such as HIV/AIDS, hepatitis, and tuberculosis, and offer an extensive portfolio across these disease states.
Pipeline
The company’s confidence in the future delivery of its pipeline is rooted in the company’s strong historic development programs and list of firsts, including the first FDA approvals of the generic version of Allergan's Restasis and the generic version of Symbicort, Breyna. In addition, the company is working on many other programs, including the potential to be first to market for its generics of Abilify Maintena, Injectafer, Invega Trinza, Ozempic, Venofer and Wegovy. The company is working with its partners in developing patent-protected, innovative assets, such as selatogrel and cenerimod; and on novel and complex products, such as the company’s BOTOX (onabotulinumtoxinA) biosimilar.
Leadership
Viatris is advancing sustainable operations and innovative solutions to improve patient health and support more resilient healthcare systems. Viatris is committed to providing steady leadership in a world that is constantly evolving. The company takes that commitment seriously and know that advancing sustainable operations and innovative solutions to improve patient health requires strong global leadership. The company knows what it takes to reach more patients with more products, and Viatris is uniquely positioned to make a difference through:
Powerful global operating platform, which combines manufacturing and supply chain capabilities. The company has designed its global operations and supply chain to be a reliable and flexible partner for access across the world, constantly adapting to an ever-evolving landscape. Viatris operates approximately 26 manufacturing and packaging sites worldwide that produce oral solid doses, injectables, and products with complex dosage forms on five different continents. Together with a global, flexible and diverse supply chain, the company’s platform strives to mitigate risks of disruption and ensure supply reliability. The company’s responsive global network has helped it maintain a reliable supply of much needed medicines through times of significant volatility. The company is committed to advancing responsible and sustainable operations and work diligently to minimize its environmental footprint across the Viatris network while safeguarding access to medicine.
Robust global technical resources, including thousands of scientists, regulatory experts, clinical, medical and product safety professionals working around the world on innovative therapies and solutions for patients everywhere.
Strong global commercial team, including sales team members and marketing professionals whose goal is to ensure that the company’s products reach customers around the globe.
Diverse and differentiated global portfolio includes products in more than 10 major therapeutic areas, including both infectious diseases and NCDs, and medicines that help treat the top 10 leading causes of death globally, as determined by the WHO. The company is a leading supplier of medicines to the HIV/AIDS community around the world, with a legacy of providing access to high-quality and affordable ARVs in more than 100 countries.
Partnership
Leveraging the company’s collective expertise to connect people to products and services
The company has a strong history of playing a leading role by partnering with other pharmaceutical companies, nonprofit organizations, government agencies, policymakers, trade associations and alliances, industry researchers and patient advocacy groups to promote sustainable access to treatment, build more resilient healthcare systems and drive these issues within its industry on global, regional and local levels. Many of the company’s collaborations focus on access to medicine; public awareness and disease screening; and healthcare professional education and support.
Global Healthcare Gateway Built to Fuel Growth and Partnerships
The company’s Global Healthcare Gateway offers partners ready access to more markets and patients worldwide through the company’s unique global infrastructure and expertise, connecting more people with even more products and services they may not have the resources to reach on their own. The company is actively engaging with potential business partners to help them accelerate possibilities of using their own healthcare assets to reach more markets and patients by leveraging Viatris’ unique global platform – its R&D, supply chain, manufacturing, regulatory, commercial and legal expertise. With the global platforms and infrastructure supporting its innovative Global Healthcare Gateway, the company is enhancing its capital allocation approach to business development, and its organic and inorganic R&D investments through a focused governance structure to ensure the highest level of strategic decision-making.
A recent example of how the company is utilizing its Global Healthcare Gateway is the October 2024 exclusive licensing agreement with Lexicon for sotagliflozin in all markets outside of the U.S. and Europe. This licensing agreement leverages Viatris’ expertise in cardiovascular diseases and is another example of how the company is continuing to expand its innovative portfolio by identifying, vetting and securing highly innovative, patent-protected assets that address significant unmet medical needs.
Licensing and Other Partner Agreements
Viatris periodically enters into commercial licensing and other partner agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products. The result often is that medicines become available sooner and to a significantly larger group of patients.
The company’s significant licensing and other partner agreements are focused on the development, manufacturing, supply and commercialization of multiple, high-value generic compounds, respiratory products, and other complex or innovative products.
Operations
Viatris has developed an end-to-end experience across the total product life cycle, which includes global regulatory licensing, launch, growth and post-approval lifecycle management. The company’s research, development and medical platform seeks to maximize the impact of its existing portfolio by examining whether there is an opportunity for new indications, label extensions, formulations, and market registrations for the company’s products. The company also uses its platform to determine whether there is an opportunity to integrate new products into the company’s portfolio.
After completing the divestiture of the company’s API business in India, it continues to maintain some selective R&D capabilities in API and the company has access to adequate API supplies through a manufacturing and supply agreement with the API business buyer and the company’s arrangements with other manufacturers.
The company’s significant manufacturing, warehousing and distribution activities are located primarily in the U.S., Puerto Rico, Singapore, India, Australia, China, and certain EU countries, including Ireland. In addition, the company maintains administrative facilities around the world. While many of these key facilities are owned, Viatris also leases certain facilities from third parties.
Following an inspection by the FDA at the company’s oral finished dose manufacturing facility in Indore, India in 2024, the FDA has issued a warning letter, and an import alert related to this facility. Following the substance of FDA’s original inspection observations, the company immediately implemented a comprehensive remediation plan at the site. Additionally, the company has engaged independent third-party subject matter experts to support the remediation plan.
Customers and Marketing
The company’s customers include retail and pharmacy establishments, wholesalers and distributors, payers, insurers and governments, and institutions, such as hospitals, among others. In 2024, the company’s customers include McKesson Corporation; Cencora, Inc. (AmerisourceBergen Corporation); and Cardinal Health, Inc.
The company serves its customers through a team of highly skilled sales and marketing professionals, all of whom are focused on establishing Viatris as its customers’ partner of choice. To best meet customers’ needs, the company manages its business on a geographic basis. Certain parts of the company’s business also are affected by seasonality, e.g., due to the timing and severity of peak cough, cold and flu incidence, which can cause variability in sales trends for some of its products.
Products
From cardiovascular health to oncology, Viatris offers quality treatment options across more than 10 major therapeutic areas covering a wide variety of noncommunicable and infectious diseases. The company also offers support services, such as diagnostic clinics, educational seminars and digital tools to help patients better manage their health. The company offers a broad and diverse range of treatment options across all its therapeutic areas, with many categories containing several products in a range of dosage forms, formulations and delivery systems that allow physicians to tailor care for optimal treatment.
Viatris intends to continue building its pipeline and focusing on products with greater complexity while also investing in the lifecycle management of certain key products in the company’s portfolio. The company is also expanding further beyond its scope into more innovative products, including innovative, best-in-class, patent-protected assets that address areas of significant unmet medical need. The company is further enhancing its commercial and scientific capabilities as needed for this future portfolio and intends to increase its R&D investment as well as inorganically grow via business development through its Global Healthcare Gateway.
Viatris markets prescription branded and generic drugs, including complex drugs. Viatris has numerous branded drugs, including iconic brands, as well as several global key brands to help patients manage their health.
Branded generic products are common in many countries outside the U.S., including emerging markets. Brand and branded generic products are more sensitive to promotion than are unbranded generic products. They therefore represent the primary focus of most of the company’s sales representatives and product-level marketing activity. The company’s remaining OTC products, which are sold directly to consumers without a prescription and without reimbursement, are generally sold under a brand name.
Viatris offers a number of these important medicines to patients, including Breyna Inhalation Aerosol, the first FDA-approved generic version of Symbicort, Wixela Inhub, the first generic of ADVAIR DISKUS and glatiramer acetate injection, a generic version of Copaxone. The company’s complex products are considered generics and are included within its generic’s revenue category.
Market Types
Viatris focuses its sales and marketing efforts on the people who make key decisions around pharmaceutical prescribing, dispensing or buying.
In prescription markets, physicians decide which medicines patients will take. Pharmacies then dispense the products as directed. Drug companies employ sales forces to educate doctors about the clinical benefits of their products. Representatives call on individual doctors or group practices; the process is known as detailing. Examples of countries served by Viatris that are mainly prescription markets are the U.S. brand business, China, Turkey, Poland and Mexico.
In substitution markets, pharmacists generally are authorized (and in some cases required) by law to dispense an unbranded or branded generic, if available, in place of a brand-name medicine, or vice versa. Examples of countries served by Viatris that are mainly substitution markets are France, Italy, Spain, Portugal, Japan and Australia.
In tender markets, payers, such as governments or insurance companies, negotiate the lowest price for a drug (or group of drugs) on behalf of their constituents or members. Examples of generic markets served by Viatris that are mainly tender markets are New Zealand, Sweden, South Africa, as well as Germany.
In distribution markets, retailers and wholesalers make drug-purchasing decisions. Examples of countries served by Viatris that are mainly distribution markets are the U.S. generics business, the U.K. and Norway.
For the company’s remaining OTC products, consumers are the decision-makers.
Channel Types
Viatris’ products make their way to patients through a variety of intermediaries, or channels.
Business Segments
The company operates through four segments: Developed Markets, Greater China, JANZ, and Emerging Markets.
Developed Markets
The Developed Markets segment comprises the company’s operations primarily in North America and Europe. The company’s business in North America is driven mainly by operations in the U.S., where the company is one of the largest providers of prescription medicines. The U.S. pharmaceutical industry is very competitive, and the primary means of competition are innovation and development, timely FDA approval, manufacturing and supply chain capabilities, product quality, marketing, portfolio size, customer service, reputation and price. Viatris relies on a flexible and cost-effective supply chain to meet the rapidly changing needs of its customers around a reliable, high-quality supply of pharmaceutical products. Europe, where many governments provide healthcare at a low direct cost to consumers and regulate pharmaceutical prices or patient reimbursement levels, continues to be a highly competitive market, especially in terms of pricing, quality standards, service levels and product portfolio. Viatris’ leadership position in a number of countries provides the company a platform to fulfill the needs of patients, physicians, pharmacies, customers and payors.
Significant products sold by the Developed Markets segment include Lyrica, Lipitor, Creon, Influvac, Wixela Inhub, EpiPen Auto-Injector, Fraxiparine, and Yupelri.
New product launches are an important growth driver. Important recent launches include Breyna and lisdexamfetamine in the U.S., and Rivaroxaban in certain European markets.
While Viatris’ U.S. customer base is extensive, it comprises a small number of very large firms as the pharmaceutical industry has undergone tremendous change and consolidation.
Greater China
The Greater China segment includes the company’s operations in mainland China, Taiwan, and Hong Kong. The Viatris Greater China portfolio predominantly consists of branded LOE products.
Healthcare spending is expected to increase in-line with GDP growth. The VBP policy for LOE molecules is in its sixth year and includes approximately 400 molecules. All major Viatris brands are included in the VBP molecule lists. The company has re-balanced its business to expand its focus on the retail pharmacy and e-commerce channels while maintaining its presence in the hospital channel. Healthcare consumerism, increased spending power, and demand for premium medical products has generated strong growth in these new channels and partially absorbed the reductions seen in the hospital channel due to VBP. Additional pricing and volume pressure for pharmaceutical products sold in the hospital channel is expected to continue during 2025 and could negatively impact the company’s results of operations.
Significant products within the Greater China segment include Lipitor, Norvasc, and Viagra.
JANZ
The JANZ segment consists of the company’s operations in Japan, Australia and New Zealand. In Japan, the National Health Insurance regulates the pricing of pharmaceutical products to healthcare providers. The company sells products in Japan primarily through a network of wholesalers who then sell the products to doctors, hospitals and pharmacies. In Australia, the healthcare system is a mix of public and private healthcare sectors, with Medicare, Australia’s public healthcare system, covering most of the country’s medical costs. The Department of Health oversees healthcare governance, law, and policy while the various state and territory governments administer the system. Most prescription pharmaceutical products are subsidized under the pharmaceutical benefits scheme by the federal government. Pricing of reimbursed pharmaceutical products is regulated by the government and funded via the Medicare levy and through company and patient contributions. The company sells products primarily through the wholesale system, while promoting its products to both physicians and pharmacists.
Significant products within the JANZ segment include AMITIZA, Effexor, Lipacreon, Lyrica, and EpiPen Auto-Injector.
Emerging Markets
The Emerging Markets segment encompasses the company’s presence in more than 125 countries with developing markets and emerging economies, including in Asia, Africa, Eastern Europe, Latin America and the Middle East, as well as the company’s ARV franchise. With healthcare at various stages of development across these markets, the company positioned to not only leverage its large geographical footprint to maximize the similarities between these markets, but also tailor solutions to meet local need. There is demand in this segment for better healthcare to serve a growing population and economic expansion. Many countries in this segment are brand-conscious with generic penetration rates lower than developed markets.
Among Viatris products sold in the segment are Lipitor, Lyrica, Norvasc, Celebrex, and ARVs.
Divestitures
In October 2023, the company received an offer for the divestiture of its OTC Business and had entered into definitive agreements to divest its women’s healthcare business primarily related to oral and injectable contraceptives, its API business in India, its rights to two women’s healthcare products in certain countries, and commercialization rights in the Upjohn Distributor Markets.
In March 2024, the company completed the divestiture of its women's healthcare business, primarily related to its oral and injectable contraceptives, to Insud Pharma, S.L., a leading Spanish multinational pharmaceutical company. The transaction included two manufacturing facilities in India: one in Ahmedabad and one in Sarigam.
In June 2024, the company completed the divestiture of its API business in India to Matrix Pharma Private Limited, a privately held pharmaceutical company based in India. The transaction included three manufacturing sites and an R&D lab in Hyderabad, three manufacturing sites in Vizag and third-party API sales. Viatris retained some selective R&D capabilities in API.
In July 2024, the company completed the divestiture of its OTC Business to Cooper Consumer Health, a leading European OTC drug manufacturer and distributor. The transaction included two manufacturing sites located in Merignac, France, and Confienza, Italy, and an R&D site in Monza, Italy. The company retained the rights for Viagra, Dymista (which, in certain limited markets, are sold as OTC products) and select OTC products in certain markets.
Viatris divested its rights to women’s healthcare products Duphaston and Femoston in certain countries to Theramex HQ UK Limited, a leading global specialty pharmaceutical company dedicated to women's health. The transaction (other than in the U.K., which was sold to Insud Pharma, S.L. in August 2024) closed in December 2023.
The divestitures of the commercialization rights in the majority of the Upjohn Distributor Markets closed during 2023 and 2024.
Intellectual Property
Viatris has an extensive trademark portfolio totaling more than 28,700 trademarks filed globally and routinely apply to register key brand names, generic names, branded generic names, and trade names in numerous countries around the world. The company has more than 2,400 patents filed globally.
Research and Development
The company’s R&D expense was $808.7 million for the year ended December 31, 2024.
Government Regulations
Facilities and records related to the company’s products are subject to periodic inspection by the FDA, the EMA and other regulatory authorities in jurisdictions where its products are marketed. In addition, authorities often conduct pre-approval plant inspections to determine whether the company’s systems and processes comply with GMP and other regulations, and clinical-trial reviews to evaluate regulatory compliance and data integrity.
The company utilizes controlled substances in certain of its products and products in development, and therefore must meet the requirements of the Controlled Substances Act of 1970 and the related regulations administered by the DEA in the U.S., as well as those of similar laws in other countries where the company operates. These laws relate to the manufacture, shipment, storage, sale, and use of controlled substances.
The company is subject to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, Chinese anti-corruption laws and similar anti-corruption laws in other jurisdictions. These laws generally prohibit companies and their intermediaries from engaging in bribery or making other prohibited payments to government officials or others for the purpose of obtaining or retaining business, and some has record keeping requirements.
History
Viatris Inc. was founded in 1961.