Viatris Inc Stock

Viatris Inc. (Viatris) operates as a healthcare company worldwide.

With a global workforce of approximately 38,000, the company has industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise complemented by a strong commitment to quality and an unparalleled geographic footprint to deliver high-quality medicines to patients in more than 165 countries and territories. As of December 31, 2023, Viatris’ portfolio included more than 1,400 approved molecules across a wide range of key therapeutic areas, including globally recognized iconic and key brands and generics, including complex products, and the company operated approximately 40 manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs.

Viatris has announced various strategic initiatives, transactions and business arrangements, including the company’s two-phased strategic vision. In Phase 1 of this strategy, the company has focused on stabilizing the base business, delivering on its pipeline, reducing debt, maintaining an investment grade credit rating and returning capital to shareholders.

During the first quarter of 2023, the company completed the acquisition of Oyster Point Pharma, Inc. (Oyster Point) that focuses on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.

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.

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, generics, including complex products, and OTC products.

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’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 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 its 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 also working with its partners on novel and complex products, such as its BOTOX (onabotulinumtoxinA) biosimilar and Glatiramer Acetate Depot, a long-acting injection version of the approved glatiramer acetate.

Global Healthcare Gateway Built to Fuel Growth and Partnerships

The company’s Global Healthcare Gateway is open for business. The company’s platform, which allows existing and new partners to access its many established strengths to reach patients they may not have the resources to reach on their own, connects more people with even more products and services. The company is actively engaging with potential partners to help them accelerate possibilities of using their own healthcare assets to reach more patients by leveraging its 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. Through its Global Healthcare Gateway, the company connects more people with even more products and services to advance access and health.

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 manufacturing of APIs and finished dosage forms is performed by a combination of internal and external manufacturing operations. 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. While many of these key facilities are owned, Viatris also leases certain facilities from third parties.

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 2023, the company’s customers included 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. To best meet customers’ needs, the company manages its business on a geographic basis.

In addition to being dynamic, the pharmaceutical industry is complex. 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.

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.

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 its portfolio. The company also expects to expand further beyond its scope into more innovative products, including NCEs and 505(b)(2)s. 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 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. 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. 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 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 and may cost less, providing patients and the healthcare system important savings and medicine options which are essential to making healthcare accessible. National health authorities inspect the company’s facilities around the world to ensure that generic manufacturing, packaging and testing sites pass the same quality standards as those of brand drugs. Gx products typically are sold under their INNs. INNs facilitate the identification of pharmaceutical substances or APIs. Each INN is unique and globally recognized. A nonproprietary name also is known as a generic 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, for example. The company’s complex products are considered generics and are included within its generics revenue category.

Market Types

Viatris focuses its sales and marketing efforts on the people who make key decisions around pharmaceutical prescribing, dispensing or buying. Decision-makers vary by country or region, reflecting law and custom, giving rise to different types of pharmaceutical markets. Many countries feature a mix of or hybrids of various market types, though the company may focus on just one type in a particular country. 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. In exchange, the chosen supplier’s product is placed on the payer’s formulary, or list of covered prescriptions. Often, a supplier’s drug is the only one available in an entire class of drugs. Large sales forces are not needed to reach these decision-makers. 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. Large sales forces are not needed to reach the decision-makers representing these organizations. Examples of countries served by Viatris that are mainly distribution markets are the U.S. generics business, the U.K. and Norway.

The allocation of the company’s sales and marketing resources reflects the characteristics of these different market types.

In the case of OTC products, consumers are the decision-makers. OTC products are commonly sold via retail channels, such as pharmacies, drugstores and supermarkets. This makes their sale and marketing comparable to other retail businesses, with broad advertising and trade-channel promotion. Consumers often are loyal to well-known OTC brands. For this reason, suppliers of OTC products, Viatris included, must invest the time and resources needed to build strong OTC brand names.

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 operates through four segments: Developed Markets, Greater China, JANZ, and Emerging Markets.

Developed Markets segment comprises the company’s operations primarily in North America and Europe.

Greater China segment includes the company’s operations in China, Taiwan and Hong Kong.

JANZ segment reflects the company’s operations in Japan, Australia and New Zealand.

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.

Developed Markets

The Developed Markets segment includes the company’s operations primarily in North America and Europe. The company’s business in North America is driven mainly by its operations in 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.

New product launches are an important growth driver. Important recent launches include lenalidomide and Breyna in the U.S.

While its 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 fifth year and includes more than 330 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 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 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. 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, Effexor and Dymista.

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 34,000 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 also 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 3,300 patents filed globally.

Research and Development (R&D) Expense

The company’s R&D expense for the year ended December 31, 2023, was $805.2 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.