About Viatris Inc

Viatris Inc. (Viatris) operates as a healthcare company worldwide. Viatris’ portfolio includes more than 1,400 approved molecules across a wide range of key therapeutic areas, including globally recognized iconic and key brands, generics, and complex generics, including biosimilars prior to the Biocon Biologics Transaction. The company operates approximately 40 manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs. Viatris and Biocon Biologics (Biocon Biologics Limited) also entered an agreement pursuant to which Viatris is providing commercialization and certain other transition services on behalf of Biocon Biologics, including billings, collections and the remittance of rebates, to ensure business continuity for patients, customers and colleagues. During the first quarter of 2023, the company completed the acquisition of Oyster Point Pharma, Inc. (Oyster Point). Oyster Point is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. Business Model and Operations Access Viatris provides high-quality, trusted medicines, regardless of geography or circumstance. The company is committed to improving access to high-quality medicines while 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, complex generics, including biosimilars prior to the Biocon Biologics Transaction, generics and OTC (over-the-counter) products. The company sees access as fundamental to empowering people worldwide to live healthier at every stage of life—a powerful concept in challenging times. With an extensive portfolio of medicines to meet nearly every health need, a one-of-a-kind global supply chain designed to reach more people with health solutions when and where they need them, and the scientific expertise to address some of the world’s most enduring health challenges, access takes on deeper meaning at Viatris. From its unique vantage point, the company touches all of life’s moments, from birth to end of life, acute conditions to chronic diseases. The company sees across multiple therapeutic areas to the person at the center of their own unique health journey. The company focuses 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. While the company intends to maintain its broad range of therapeutic areas, the company has, as previously announced, identified three core, global therapeutic areas – ophthalmology (as evidenced by the Oyster Point and Famy Life Sciences’ acquisitions), gastrointestinal, and dermatology – that particularly fit its own internal capabilities while leveraging its global platform. The company’s 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, it 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 offers an extensive portfolio across these disease states. Global Healthcare Gateway Built to Fuel Growth and Partnerships The company’s Global Healthcare Gateway is open for business. This was evidenced by the fact the Oyster Point and Famy Life Sciences acquisitions were sourced through the Global Healthcare Gateway. Through its Global Healthcare Gateway—a platform that allows partners to access the company’s many established strengths to reach patients they may not have the resources to reach on their own—it connects more people with even more products and services. Licensing and Other Partner Agreements The company 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 company’s significant licensing and other partner agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic compounds and respiratory products, among other complex 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 its products. The company also uses its platform to determine whether there is an opportunity to integrate new products into its portfolio. The company’s significant manufacturing, warehousing and distribution activities are located primarily in the U.S., Puerto Rico, Singapore, India, Australia, China, and certain E.U. countries, including Ireland. In addition, the company maintains administrative facilities around the world. The company’s suppliers, contract manufacturers, clinical trial partners and other business partners are subject to similar regulations and periodic inspections. The company remains committed to maintaining the highest quality manufacturing standards at its facilities around the world and to continuous assessment and improvement in a time of evolving industry dynamics and regulatory expectations. The company is to advancing sustainable operations and innovative solutions to improve patient health. In 2022, the company launched Viatris’ initial sustainability goals in the areas of access to medicine and health; diversity, equity and inclusion; and the environment: climate change, water risk assessments and waste management. The company’s near-term science-based emissions reduction targets for scope 1, 2 and 3 have been validated and approved by the Science Based Target initiative (SBTi). The SBTi classified Viatris' scope 1 and 2 target ambition and has determined that it is in line with a 1.5°C trajectory, a worldwide goal of limiting global warming. During 2022, the company also completed a climate scenario analysis to help it identify and manage risk and opportunities regarding climate impacts. 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. Its customers include McKesson Corporation; 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. 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 the 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 also expects to expand further beyond its current scope into more innovative products, including NCEs and global 505(b)(2)s. While Viatris intends to maintain its broad range of therapeutic areas, it has identified three core, global therapeutic areas – ophthalmology, gastrointestinal, dermatology — that it believes particularly fit its internal capabilities while leveraging its global platform. 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 brand drugs, generic drugs, complex generic drugs, and APIs. Brand drugs typically are prescription pharmaceuticals that are sufficiently novel as to be protected by patents or other forms of exclusivity. Viatris has numerous branded drugs, including iconic brands, as well as several global key brands to help patients manage their health. Brand drugs include branded generics which are off-patent products that are sold under an approved proprietary name for marketing purposes. Brand products often become branded generics once patent protections or other forms of exclusivity expire. Branded generic products are common in many countries outside the U.S., including emerging markets. The company’s OTC products, which are sold directly to consumers without a prescription and without reimbursement, are generally sold under a brand name. The company’s generic medicines work in the same way and provide the same clinical benefits as their as their brand-name counterparts. The company is one of the world’s largest producers of APIs, providing them to customers in more than 100 countries. The company is the leading producer of API used in generic ARVs, which treat HIV/AIDS. The company also produces API for products in the following areas: antibacterial; central nervous system agents; antihistamines/antiasthmatics; cardiovascular, antivirals; antidiabetics; antifungals; and proton pump inhibitors. The company’s APIs are sold through a dedicated sales and marketing team primarily to pharmaceutical companies throughout the world. Channel Types Viatris’ products make their way to patients through a variety of intermediaries, or channels. Pharmaceutical wholesalers/distributors purchase prescription medicines and other medical products directly from manufacturers for storage in warehouses and distribution centers. The distributors then fill orders placed by healthcare providers and other authorized buyers. Pharmaceutical retailers purchase products directly from manufacturers or wholesalers/distributors. They then sell them to consumers in relatively small quantities for personal use. Institutional pharmacies address the unique needs of hospitals, nursing homes and other such venues. Among the services provided are specialized packaging, including for injectables and unit-dose products, for controlled administration. Mail-order and e-commerce pharmacies receive prescriptions by mail, fax, phone or the internet at a central location; process them in large, mostly automated centers; and mail the drugs to the consumer. Specialty pharmacies focus on managing the handling and service requirements associated with high-cost and more-complex drug therapies, such as those used to treat patients with rare or serious diseases. Business Segments Viatris has four reportable segments: Developed Markets, Greater China, JANZ, and Emerging Markets. The company reports segment information on the basis of markets and geography, which reflects its focus on bringing its broad and diversified portfolio of branded, complex generics, including biosimilars prior to the Biocon Biologics Transaction, and generic products to people in markets everywhere. The company’s Developed Markets segment comprises its operations primarily in North America and Europe. The company’s Greater China segment includes its operations in China, Taiwan and Hong Kong. The company’s JANZ segment reflects its operations in Japan, Australia and New Zealand. The company’s Emerging Markets segment encompasses its 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. 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 the company’s operations the U.S., where it is one of the largest providers of prescription medicines. The company’s leadership position in a number of countries provides it 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. Greater China The Greater China segment includes the company’s operations in mainland China, Taiwan and Hong Kong. Since the closing of the Combination, the Viatris Greater China portfolio is predominantly branded LOE products. 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 have generated strong growth in these new channels and partially absorbed the reductions seen in hospital channel due to VBP. 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 NHI 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, Lipacreon, Lyrica, Norvasc, and Effexor. 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 its ARV franchise. Among the company’s products sold in the segment are Lipitor, Lyrica, Norvasc, Celebrex, and ARVs. Intellectual Property The company has an extensive trademark portfolio totaling more than 35,000 trademarks filed globally and routinely apply to register key brand-name, generic, branded generic, and trade names in numerous countries around the world. The company’s registered trademarks are renewable indefinitely, and these registrations are properly maintained in accordance with the laws of the countries in which they are registered. The company has an extensive patent portfolio and actively file for patent protection in various countries to protect its brand-name, generic, branded generic, and OTC products, including processes for making and using them. The company has more than 3,100 patents filed globally. Research & Development Expense The company’s research and development expense for the year ended December 31, 2022, included $662.2 million. 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 its systems and processes comply with current GMP and other regulations, and clinical-trial reviews to evaluate regulatory compliance and data integrity. History Viatris Inc. was founded in 1961.