What changed in this filing

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Item 1. Business

2023-02-27 compared with 2022-02-28 · 159 added, 88 removed, 281 unchanged (47% of the section changed)

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One that rests on visionary thinking, determination and best-in-class capabilities that were strategically built to remove barriers across the health spectrum and advance access globally.

Viatris’ seasoned management team is focused on ensuring that the Company is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers and other stakeholders.

With a global workforce of approximately 37,000, the Company has industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise complemented by a strong commitment to quality and unparalleled geographic footprint to deliver high-quality medicines to patients in more than 165 countries and territories.

Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of key therapeutic areas, including globally recognized iconic and key brands, generics, complex generics, and biosimilars.

With a global workforce of approximately 37,000, 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.

Viatris’ portfolio comprises 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.

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On November 16, 2020, Viatris, formerly known as Upjohn, Mylan and Pfizer consummated the combination of Mylan with the Upjohn Business through a Reverse Morris Trust transaction.

In accordance with the terms and conditions of the BCA and SDA, (1) Pfizer contributed the Upjohn Business to Viatris (the “Contribution”), so that the Upjohn Business was separated from the remainder of Pfizer’s businesses (the “Separation”), (2) following the Separation, Pfizer distributed, on a pro rata basis (based on the number of shares of Pfizer common stock held by holders of Pfizer common stock as of the record date of November 13, 2020 (the “Record Date”)), all of the shares of Viatris common stock held by Pfizer to Pfizer stockholders as of the Record Date (the “Distribution”), and (3) immediately following the Distribution, Viatris and Mylan engaged in a strategic business combination transaction (the “Combination”).

In addition, pursuant to the SDA and immediately prior to the Distribution, Viatris made a cash payment to Pfizer equal to $12 billion as partial consideration for the Contribution.

As a result of the Combination, Viatris holds the combined Upjohn Business and Mylan business.

Upon completion of the Distribution and the Combination, holders of Pfizer’s common stock as of the Record Date owned approximately 57% of the outstanding shares of Viatris common stock, and former Mylan shareholders owned approximately 43% of the outstanding shares of Viatris common stock, in each case on a fully diluted, as-converted and as-exercised basis.

In connection with the Combination, on November 16, 2020, Mylan merged with and into Mylan II B.V., a company incorporated under the laws of the Netherlands and an indirect wholly owned subsidiary of Viatris, pursuant to and in accordance with the BCA.

As a result of such merger, Mylan ceased to exist as a separate legal entity.

As a result of the Combination, Viatris held the combined Upjohn Business and Mylan business and Mylan ceased to exist as a separate legal entity after merging with and into Mylan II B.V., an indirect wholly owned subsidiary of Viatris.

In accordance with ASC 805, Business Combinations , Mylan is considered the accounting acquirer of the Upjohn Business and all historical financial information of the Company prior to November 16, 2020 represents Mylan’s historical results and the Company’s thereafter.

Prior to the Separation, the legacy Upjohn Business historically received support services from Pfizer.

Refer to Note 4 Acquisitions and Other Transactions included in Part II.

Item 8 of this Form 10-K for more information.

Prior to the separation of the Upjohn Business from the remainder of Pfizer’s businesses, the legacy Upjohn Business historically received support services from Pfizer.

In connection with the Separation and Combination, Viatris entered into several agreements with Pfizer or its subsidiaries, including among others, transition services and the manufacturing and supply agreements, which in general provide for the performance of certain services or obligations by each of Pfizer and Viatris for the benefit of each other for initial transitional periods following the Combination.

The Company began the process of transitioning certain capabilities in 2021, but expects significant changes to occur in 2022 as a result of further transitioning of services and information and other systems.

For additional information, see “Risk Factors – Viatris could incur operational difficulties or losses if Pfizer is unable to perform under the agreements entered into as part of the Combination, if we are unable to obtain the same types and level of services and resources that historically have been provided to the legacy Upjohn Business by Pfizer, or if we are required to make payments to Pfizer pursuant to indemnities agreed to as part of the Combination.

By the end of 2022, the Company had exited substantially all transition services with Pfizer.

In February 2022, the Company announced plans for certain strategic actions, anchored by a significant global reshaping initiative designed to unlock trapped value and provide the financial flexibility required to deliver on its vision.

The Company also announced that it had entered into a strategic transaction with Biocon Biologics to create what it expects to be a vertically integrated global biosimilars leader, as well as potential plans to divest other select assets no longer considered core to our future strategy to help reshape the Company.

On February 27, 2022, Viatris entered into a definitive agreement with Biocon Biologics to contribute its biosimilars portfolio to Biocon Biologics.

The transaction subsequently closed on November 29, 2022.

Under the terms of the Biocon Agreement, Viatris received $3 billion in consideration in the form of a $2 billion cash payment, adjusted as set forth in the Biocon Agreement, and approximately $1 billion of CCPS representing a stake of approximately 12.9% (on a fully diluted basis) in Biocon Biologics.

Viatris also is entitled to $335 million of additional cash payments in 2024.

In addition, Viatris and Biocon Biologics have agreed to a closing working capital target of $250 million.

An amount of cash equal to all or a portion of the closing working capital target may become payable to Biocon Biologics in connection with certain events in the future, depending on the valuations attributable to such events.

Upon closing of the transaction, the Company recognized a gain on sale of approximately $1.75 billion and has not recognized the results of the business in its consolidated financial statements subsequent to November 29, 2022.

Viatris and Biocon Biologics 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.

The term of the transition services agreement is generally up to two years.

Under the transition services agreement, Viatris is entitled to be reimbursed for its costs (subject to certain caps) plus a markup.

In November 2022, the Company provided an update on the strategic priorities announced in February 2022, including identifying the following businesses no longer considered core to its future strategy that the Company intends to divest:

• API (while retaining some selective development API capabilities);

• Women’s health care, primarily related to our oral and injectable contraceptives.

This does not include all of our women’s health care related products;

as an example, our Xulane® product in the U.S.

• Upjohn Distributor Markets.

During the first quarter of 2023, the Company completed the acquisition of Oyster Point for approximately $425 million in cash, which includes $11 per share paid to Oyster Point stockholders through a tender offer and the repayment of the principal amount of certain debt of Oyster Point.

In addition to the upfront cash consideration, each Oyster Point stockholder received one non-tradeable contingent value right representing up to an additional $2 per share, or approximately $60 million in the aggregate, contingent upon Oyster Point achieving certain metrics based upon full year 2022 performance, which are expected to be determined by the end of the first quarter of 2023.

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.

On November 7, 2022, the Company entered into a definitive agreement to acquire the remaining equity shares of Famy Life Sciences, a private-owned research company with a complementary portfolio of ophthalmology therapies under development, for a consideration of $281 million.

The Company had previously entered into a Master Development Agreement with Famy Life Sciences on December 20, 2019 to grant the Company rights with respect to acquiring certain pharmaceutical products and had additionally acquired shares representing approximately 13.5% equity interest in Famy Life Sciences for $25.0 million during the year ended December 31, 2020.

The transaction to acquire the remaining equity shares of Famy Life Sciences closed during the first quarter of 2023.

Ophthalmology is one of the key therapeutic areas of focus that the Company announced in February 2022.

With the combination of Viatris' global commercial footprint, R&D and regulatory capabilities and supply chain, along with Oyster Point's deep knowledge of the ophthalmology space from a clinical, medical, regulatory and commercial perspective—including a commercial asset, Tyrvaya®, for the treatment of dry eye disease—and Famy Life Sciences' Phase III-ready pipeline, the Company believes it has the foundation to create a leading global ophthalmology franchise, accelerating efforts to address the unmet needs of patients with ophthalmic disease and the eye care professionals who treat them.

The Eye Care division within the company will be led by former Oyster Point CEO, Jeff Nau Ph.D.

Unless otherwise indicated, industry data included in this Item 1 are sourced from IQVIA Holdings Inc.

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Effective as of November 16, 2020, Upjohn changed its name to “Viatris Inc.” and became the parent entity of the combined Upjohn Business and Mylan business.

The Upjohn Business was a global, primarily off-patent branded and generic established medicines business, which included 20 primarily off-patent solid oral dose legacy brands, such as Lyrica®, Lipitor®, Celebrex® and Viagra®.

The Upjohn Business was a global, primarily off-patent branded and generic established medicines business, which included 20 primarily off-patent oral solid dose legacy brands, such as Lyrica®, Lipitor®, Celebrex® and Viagra®.

Mylan was founded in 1961 as a privately-owned company and grew over time into one of the largest manufacturers of generic drugs in the U.S.

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Since the consummation of the Combination, the Viatris management team has been focused on ensuring that the Company is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers and other stakeholders.

This includes our previously disclosed significant global restructuring program, which is described further in Note 17 included in Part II.

Item 8 of this Form 10-K.

Business Model and Operations

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We are 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.

Our global portfolio, supported by our science, medical and manufacturing expertise, delivers global iconic and key brands, complex generics, biosimilars, generics - including complex and branded generics - and over-the-counter products.

Our global portfolio, supported by our science, medical and manufacturing expertise, delivers global iconic and key brands, complex generics, including biosimilars prior to the Biocon Biologics Transaction, generics and OTC products.

We see access as fundamental to empowering people worldwide to live healthier at every stage of life—a powerful concept in challenging times.

It begins with our efforts to sustainably deliver high-quality medicines and health solutions at scale to people, regardless of geography or circumstance.

As a healthcare company born during a global pandemic, Viatris was formed to bridge the traditional divide between generics and brands, aiming to combine the best of both, to more holistically address healthcare needs globally.

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 our unique vantage point, we touch all of life’s moments, from birth to end of life, acute conditions to chronic diseases.

We see across multiple therapeutic areas to the person at the center of their own unique health journey.

We are focused on meeting individual needs, whether with a generic medicine, an improved version of an existing medicine, or a truly novel therapeutic solution.

Ultimately, we know we are stronger together.

Both as a company and as a global community.

Our pursuit of access is relentless.

Because health matters everywhere.

As a company, Viatris:

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We also offer support services such as diagnostic clinics, educational seminars and digital tools to help patients better manage their health.

While we intend to maintain our broad range of therapeutic areas, we have, 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 we believe particularly fit our own internal capabilities while leveraging our global platform.

• Helps ease the burden of noncommunicable diseases.

According to the WHO, NCDs, such as ischemic heart disease, stroke, diabetes, certain cancers and chronic obstructive pulmonary disease, were among the leading causes of death globally as of 2016.

According to the WHO, NCDs, such as ischemic heart disease, stroke, diabetes, certain cancers and chronic obstructive pulmonary disease, are among the leading causes of death globally.

NCDs affect people of every age, gender and socioeconomic status in every corner of the world, and pose a heavy burden on individuals, families and communities.

To overcome this global public health threat, patients worldwide need a partner they can trust – one that not only believes everyone deserves good health, but also has the portfolio, experience and expertise to make this belief a reality.

To overcome this global public health threat, patients

worldwide need a partner they can trust – one that not only believes everyone deserves good health, but also has the portfolio, experience and expertise to make this belief a reality.

• Helps hearts stay healthier.

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An Increasingly Innovative and Differentiated Pipeline

Our confidence in the future delivery of our pipeline is rooted in our strong historic development programs and list of firsts, including the recent approval of the generic version of Allergan's Restasis® and Semglee® (insulin glargine-yfgn), the first interchangeable biosimilar ever approved in the U.S., and the launch of the first biosimilar to Humira® (adalimumab) in Japan.

In addition, we are working on many other programs, including the potential to be first to market for our BOTOX® (onabotulinumtoxinA) and Eylea® (aflibercept) biosimilars.

Our confidence in the future delivery of our pipeline is rooted in our 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, we are working on many other programs, including the potential to be first to market for our generics of Abilify Maintena®, Injectafer®, Invega Trinza®, Ozempic®, Sandostin® LAR Depot, Venofer® and Wegovy™.

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

While we will continue to diligently pursue important generics opportunities, we will increasingly focus on limited-competition complex and novel products targeting gaps in care, all with a first-to-market emphasis and serving our mission of patient access.

Complex products categories are critical to patient health and are growing at a rapid pace.

We believe that Viatris’ early vision and continued commitment has given us one of the deepest complex product pipelines in the industry, and that we are well positioned to capitalize on these growth opportunities in the future.

Complex product categories are critical to patient health and are growing at a rapid pace.

Our goal is to enhance our proven scientific capabilities and current global platform, including our Global Healthcare Gateway®, to create a durable and higher-margin portfolio of products.

And that means further expanding beyond our current scope into more innovative products, including NCEs and global 505(b)(2) products.

As previously mentioned, while we intend to maintain our broad range of therapeutic areas, we have identified three core, global therapeutic areas – ophthalmology, gastrointestinal and dermatology – that we believe particularly fit our own internal capabilities while leveraging our global platform.

Viatris is advancing sustainable operations and innovative solutions to improve patient health.

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• Powerful global operating platform , which combines what we believe to be best-in-class manufacturing and supply chain capabilities.

We have designed our 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 40 manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs on five different continents.

Together with a global, flexible and diverse supply chain, our platform strives to mitigate risks of disruption and ensure supply reliability.

Our efforts to build a responsive global network have helped us maintain a reliable supply of much needed medicines as the fight against the COVID-19 pandemic continues.

We are committed to advancing responsible and sustainable operations and work diligently to minimize our environmental footprint across the Viatris network while safeguarding access to medicine.

Our integrated, comprehensive approach focuses on water, air emissions, waste, climate change and energy.

Our efforts to build a responsive global network have helped us maintain a reliable supply of much needed medicines during the COVID-19 pandemic.

We are committed to advancing responsible and sustainable operations and work diligently to minimize our environmental footprint across the Viatris

network while safeguarding access to medicine.

As discussed above, our API business (other than some selective development API capabilities) is one of the assets we intend to divest.

• Robust global technical resources , including thousands of scientists, regulatory experts and 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 products are shipped to 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 treat 9 out of 10 of the WHO’s leading causes of death.

• Diverse and differentiated global portfolio includes products in more than 10 major therapeutic areas, including both infectious diseases and NCDs and medicines that treat the top 10 of the WHO’s leading causes of death globally.

We are 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.

We also are a leading provider of biosimilars globally, with regulatory approvals for biosimilars in more than 85 countries in the areas of oncology, immunology, endocrinology, ophthalmology and dermatology.

We believe that Viatris’ global leadership in all of these areas uniquely positions us to efficiently and effectively serve patients regardless of geography or circumstance.

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Leveraging our collective expertise to connect people to products and services.

We engage with around 100 trade associations and not-for-profit organizations across more than 40 countries, as well as patient and industry groups and other partners.

Our key collaborations focus on access to medicine;

Partnerships and collaborations are critical, as are policies and strong healthcare systems that allow for healthy competitive environments.

We have a strong history of 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 our industry on global, regional and local levels.

We hold leadership roles in several industry associations and actively engage with more than 100 groups worldwide to this end.

Many of our collaborations focus on access to medicine;

public awareness and disease screening;

and healthcare provider education and support.

and healthcare professional education and support.

Our Global Healthcare Gateway® Built to Fuel Growth and Partnerships

Our 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 our Global Healthcare Gateway®—a platform that allows partners to access our many established strengths to reach patients they may not have the resources to reach on their own—we connect more people with even more products and services.

We are actively engaging with potential partners to help them accelerate possibilities of using their own healthcare assets to reach more patients by leveraging our unique global platform – our R&D, supply chain, manufacturing, regulatory, commercial and legal expertise.

Although the global platforms and infrastructure supporting our innovative Global Healthcare Gateway are not entirely new, what is new is how we are enhancing our capital allocation approach to business development, and our organic and inorganic R&D investments through a focused governance structure to ensure the highest level of strategic decision-making.

With the global platforms and infrastructure supporting our innovative Global Healthcare Gateway®, we are enhancing our capital allocation approach to business development, and our organic and inorganic R&D investments through a focused governance structure to ensure the highest level of strategic decision-making.

Licensing and Other Partner Agreements

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The result often is that medicines become available sooner and to a significantly larger group of patients.

Our significant licensing and other partner agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic biosimilar compounds, insulin analog products and respiratory products, among other complex products.

Our 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.

Refer to Note 19 Licensing and Other Partner Agreements included in Part II.

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We also use our platform to determine whether there is an opportunity to integrate new products into our portfolio.

The manufacturing of APIs and finished dosage forms is performed by a combination of internal and external manufacturing operations.

Internally, many of the products we produce are vertically integrated;

The manufacturing of APIs and finished dosage forms is currently performed by a combination of internal and external manufacturing operations.

Internally, many of the products we produce are currently vertically integrated;

meaning we manufacture both the APIs and finished dosage forms related to those products.

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As a result, we supplement our production footprint through arrangements with other manufacturers.

The Company’s significant manufacturing, warehousing and distribution activities are located primarily in the U.S., Puerto Rico, Singapore, India, Japan, China, and certain E.U.

However, as discussed above, our API business is one of the assets we intend to divest as we continue to move up the value chain and focus on more complex and innovative products to build a more durable, higher-margin portfolio.

We expect to retain some selective development API capabilities and to continue to have access to adequate API supplies through our 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 E.U.

countries, including Ireland.

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This means we focus on responsible conduct and have global policies and procedures to support our work.

We work systematically and diligently to minimize our environmental footprint.

Environmental and human health are interconnected, a relationship underscored by climate change and water stress.

Our integrated, comprehensive approach focuses on water, air emissions, waste, climate change and energy.

Looking ahead, to help ensure we identify and manage risks and opportunities appropriately, we are conducting a climate scenario analysis and intend to establish science-based greenhouse gas reduction targets and strategies, acknowledging the context of the Paris Agreement, as well as goals for water and waste.

While it is impossible to predict accurately the future costs associated with environmental compliance and potential remediation activities, compliance with environmental laws is not expected to require significant capital expenditures and has not had, and is not expected to have, a material adverse effect on our operations or competitive position.

We work systematically and diligently to minimize our environmental footprint while seeking to safeguard stable access to medicine.

In 2022, we launched Viatris’ initial sustainability goals in the areas of access to medicine and health;

diversity, equity & inclusion;

and the environment:

climate change, water risk assessments and waste management.

Our 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, we also completed a climate scenario analysis to help us identify and manage risk and opportunities regarding climate impacts.

While it is very hard to predict accurately the future costs associated with compliance with environmental laws, this is not expected to require significant capital expenditures and has not had, and is not expected to have, a material adverse effect on our operations or competitive position.

Customers and Marketing

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We offer a broad and diverse range of treatment options across all our 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 markets prescription brand drugs, generic drugs, complex generic drugs, biosimilars and APIs.

As the Company looks to the future, its goal is to leverage its proven scientific capabilities to create a durable and higher-margin portfolio of products.

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 our current 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 currently 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.

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In many high-income countries, the brand business often is characterized by higher margins on lower volumes - especially as compared with generic manufacturers.

Viatris has numerous branded drugs, including iconic brands, as well as several global key brands to help patients manage their health.

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.

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Our OTC products, which are sold directly to consumers without a prescription and without reimbursement, are generally sold under a brand name.

As discussed above, our OTC business is one of the assets we intend to divest.

Generic drugs are therapeutically equivalent versions of brand drugs.

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Viatris offers a number of these important medicines to patients, including our Wixela Inhub®, the first generic of ADVAIR DISKUS® and glatiramer acetate injection, a generic version of Copaxone®, for example.

Biosimilars are approved by regulatory authorities as highly similar to the originally approved biologic brand version with no clinically meaningful differences in safety or efficacy.

Biosimilar versions are increasingly available as therapeutic alternatives for patients facing many serious diseases, including diabetes, autoimmune disorders and multiple cancers.

We offer one of the industry’s largest and most diverse global biosimilars franchises with more than 300 marketing authorizations globally focused on the areas of oncology, immunology, endocrinology, ophthalmology and dermatology.

These vital products can help increase access for current and future patients while supporting the sustainability of healthcare systems, and we continue to invest in bringing more to market, as we believe more than two-thirds of the products we will launch in the coming years will be either complex generics or biosimilars.

Biosimilars often are marketed under a brand-name.

Viatris offers one of the industry’s largest and most diverse global biosimilars franchises, including Fulphila®, Ogivri®, Hulio®, and SEMGLEE®.

We believe complex products categories are critical to patient health and are growing at a rapid pace.

APIs are responsible for the therapeutic effects of medicines.

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and proton pump inhibitors.

Our API is sold through a dedicated sales and marketing team primarily to pharmaceutical companies throughout the world.

Our APIs are sold through a dedicated sales and marketing team primarily to pharmaceutical companies throughout the world.

As discussed above, our API business is one of the assets we intend to divest.

We expect to retain some selective development API capabilities and to continue to have access to adequate API supplies through our arrangements with other manufacturers.

Viatris invests significant sums in R&D and in manufacturing capacity.

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Examples of countries served by Viatris that are mainly prescription markets are the U.S.

brand business, Japan, China, Russia, Turkey, Poland and Mexico.

brand business, Japan, 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.

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For this reason, suppliers of OTC products, Viatris included, must invest the time and resources needed to build strong OTC brand names.

As disclosed previously, the OTC business is no longer considered core to our future strategy, and we plan to divest it.

Channel Types

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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 and biosimilars, and generic products to people in markets everywhere.

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.

Our Developed Markets segment comprises our operations primarily in North America and Europe.

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We rely on cost-effective manufacturing processes to meet the rapidly changing needs of our customers around a reliable, high quality supply of generic 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.

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.

Our leadership position in a number of countries provides us 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®, the EpiPen® Auto-Injector, Hulio®, Fraxiparine®, and Yupelri®.

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 SEMGLEE®, Abiraterone, and Cyclosporine Ophthalmic Emulsion in early 2022.

Important recent launches include SEMGLEE®, cyclosporine ophthalmic emulsion, and lenalidomide in the U.S.

While our U.S.

customer base is extensive, it increasingly comprises a small number of very large firms as the pharmaceutical industry has undergone and continues to undergo tremendous change and consolidation.

We believe Viatris is well positioned to serve such customers in the Developed Markets due to the scale we have built in terms of R&D, API and finished-dosage-form manufacturing, and portfolio breadth.

We believe Viatris is well positioned to serve such customers in the Developed Markets due to the scale we have built in terms of R&D, manufacturing, and portfolio breadth.

Greater China

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Significant products within the JANZ segment include AMITIZA®, Lipacreon®, Lyrica®, Norvasc®, and Effexor®.

New product launches are an important growth driver.

Important recent launches include adalimumab biosimilar in Japan.

Emerging Markets

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Among our products sold in the segment are Lipitor®, Lyrica®, Norvasc®, Celebrex®, and ARVs.

New product launches are an important growth driver.

New products sold in the Emerging Markets segment in 2021 include Remdesivir and a number of biosimilars.

Refer to Note 16 Segment Information included in Part II.

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Regulatory approval, if and when obtained, may be limited in scope.

Further, approved drugs, as well as their manufacturers, are subject to ongoing post-marketing review and inspection, which can lead to the discovery of previously unknown problems with products or the manufacturing or quality control procedures used in their production, which may result in restrictions on their manufacture, sale or use or in their withdrawal from the market.

Further, approved drugs, as well as their manufacturers, are subject to ongoing post-marketing review and inspection, which can lead to the discovery of previously unknown attributes of the products or the manufacturing or quality control procedures used in their production, which may impact the marketing of the products or result in restrictions on their manufacture, sale or use or in their withdrawal from the market.

Any failure or delay by us, our suppliers of manufactured drug product, collaborators or licensees, in obtaining and maintaining regulatory approvals could adversely affect the marketing of our products and our ability to receive product revenue, license revenue or profit-sharing payments.

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Research and Development

Our R&D organization, which includes researchers and regulatory and clinical experts, work collaboratively across our different R&D centers around the world, which include technology-focused development sites and global R&D centers.

Our research, development and clinical platform, which includes regulatory activities, seeks to deliver new product opportunities across all of our categories and markets and to evaluate opportunities to expand the scope of our existing product portfolio.

Our R&D organization, which includes developers and regulatory and clinical experts, work collaboratively across our different R&D centers around the world, which include technology-focused development sites and global R&D centers.

Our product pipeline includes a variety of dosage forms, including oral solid dosage forms, transdermals, injectables, inhalation, and other delivery systems.

While committed to generics and specialty products, over the last several years, a greater portion of our investments has been focused on complex or difficult-to-formulate products, such as biosimilars and extended release injectables, rather than on commodity products, such as conventional oral solid dosage forms.

For example, we are working on a number of programs including the potential to be first to market for our BOTOX® (onabotulinumtoxinA) and Eylea® (aflibercept) biosimilars.

While committed to generics and specialty products, over the last several years, a greater portion of our investments has been focused on complex or difficult-to-formulate products, such as biosimilars and modified release injectables, rather than on commodity products, such as conventional oral solid dosage forms.

For example, we are working on a number of programs including the potential to be first to market for our generics of Abilify Maintena®, Injectafer®, Invega Trinza®, Ozempic®, Sandostin® LAR Depot, Venofer® and Wegovy™.

We are also working with our partners on novel and/or complex products such as our biosimilar to BOTOX® (onabotulinumtoxinA) and Glatiramer Acetate Depot, a long-acting injection version of the approved glatiramer acetate.

As previously mentioned, to facilitate our future growth, we expect to expand our current scope of development into more innovative products, including NCEs and global 505(b)(2) products with a particular focus on three therapeutic areas:

ophthalmology, gastrointestinal and dermatology and intend to increase our R&D investment as well as inorganically grow via business development through our Global Healthcare Gateway®.

Intellectual Property

We consider the protection of our intellectual property rights to be extremely valuable, and we act to protect them from infringement by third parties.

We have an extensive trademark portfolio and routinely apply to register key brand-name, generic, branded generic, biosimilar and trade names in numerous countries around the world.

Our registered trademarks are renewable indefinitely, and these registrations are properly maintained in accordance with the laws of the countries in which they are registered.

We also have an extensive patent portfolio and actively file for patent protection in various countries to protect our brand-name, generic, branded generic, biosimilar and OTC products, including processes for making and using them.

We have 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.

Our registered

trademarks are renewable indefinitely, and these registrations are properly maintained in accordance with the laws of the countries in which they are registered.

We also have an extensive patent portfolio and actively file for patent protection in various countries to protect our brand-name, generic, branded generic, and OTC products, including processes for making and using them.

We have more than 3,100 patents filed globally.

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Our people, our culture

Our approximately 37,000 diverse colleagues are fueled by a shared passion, purpose, and genuine care for the patients we serve, and see healthcare not as it is, but as it should be.

Our approximately 37,000 diverse colleagues are fueled by a shared passion, purpose, and genuine care for the patients we serve.

To us, that means empowering patients worldwide to live healthier at every stage of life.

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“The Viatris Way”.

Since Day 1, we have had several accomplishments that lay the foundation for the kind of company we want to be, including:

• Establishing four inaugural Employee Resource Groups (ERGs):

Blacks, Women, LGBTQ+ and Working Parents.

We believe that it is only through the diverse experiences and perspectives of all our colleagues that we can elicit the best ideas, drive innovation, and achieve business results;

• Being recognized on the Forbes® 2021 World’s Best Employers list.

Talent, training and development

The careers of our colleagues make a difference in the lives of patients around the world, and we want those careers to make a difference in their own lives as well.

We provide tools and resources to help colleagues reach new heights.

We are committed to cultivating and acquiring talent, developing capabilities and driving performance.

We are systematically reviewing and developing structures, programs and processes to support colleagues’ professional development and ensure that Viatris contains the appropriate competencies to support our mission.

Diversity and inclusion

Diversity and inclusion, including understanding and embracing what makes individuals unique, are essential to Viatris’ mission.

The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.

Since the launch of Viatris in November 2020, the Company believes it has taken great strides to create an employee experience and culture where colleagues are encouraged to reach their full potential.

We have had several accomplishments that lay the foundation for the kind of company we want to be, including:

• Being recognized on the Forbes® 2022 World’s Best Employers list for the second year in a row, inclusion on lists such as Fortune's Change the World, Newsweek's America's Most Responsible Companies, Capital Magazine's Best Employers in France, a Great Place to Work® certification in India, HR Asia's Best Companies to Work for in Asia (Taiwan), and Top Employers Institute’s certification as one of the 101 top employers in China;

• In 2022, we conducted our first-ever Viatris Voice Survey with approximately 89% of our employees from around the world sharing their perspectives on:

Diversity, Equity & Inclusion (“DE&I”);

Health & Well-Being;

and Transformation & Change.

The survey also marked a milestone in our commitment to creating our culture The Viatris Way:

one that is performance-driven, highly engaging, and inclusive;

• Diverse perspectives drive innovation and our ability to make a difference in the world.

We continue to progress on our commitment to DE&I aiming to engage at least 90% of all colleagues globally in DE&I foundational learning in 2023, and by forming our inaugural Employee Resource Groups (“ERGs”).

We have four forming ERGs including:

EmpoWer advocating for an ecosystem that empowers women to reach their full potential;

VIVID supporting LGBTQ+ employees and allies;

Black colleagues;

and, Caregivers.

Talent, learning and development

Supporting our colleagues in their learning and development can make a difference in the lives of our patients around the world.

We provide the tools and resources to help colleagues achieve their performance and development goals.

We are committed to continuously anticipating, developing and acquiring new capabilities.

We have an extensive learning and development portfolio of resources and programs and we are introducing new focused development programs and resources via our new Viatris Development Principles:

Develop, Invest, Diversify, Innovate, Build and Achieve .

Diversity, equity and inclusion

Understanding and embracing what makes individuals unique is essential to Viatris’ mission.

The diversity we foster within our teams can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.

In 2022, we established initial goals in DE&I in the areas of foundational learning, and increasing diversity in management for women,

Black and Hispanic/LatinX employees.

We look forward to reporting out on our actions and progress going forward in our annual Sustainability Report.

Viatris strives to create a positive, productive work environment where integrity, dignity and mutual respect for all are valued.

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Together, we are building a highly inclusive organization and our goal is to provide a safe, supportive community where employees feel they belong and can use their unique experiences, perspectives and skills to make a difference in the lives of others.

Our ERGs bring colleagues together to listen and learn from each other and raise awareness to change our company and communities for the better, and our Viatris Voice Survey demonstrates positive results in colleague sentiment for engagement and DE&I in addition to other areas of strength.

Health and Safety

We cultivate a culture of health and safety throughout our global workforce by ensuring that our colleagues and contractors are made aware of issues relevant to their work and providing them with the personal protective equipment and knowledge required to perform their jobs safely.

Further, we work to ensure that our systems and processes are designed to identify and reduce health and safety risks or impacts on the communities in which we operate.

Employee well-being and safety

Viatris is committed to providing a safe and healthy workplace for our employees, contractors and visitors.

Viatris is also committed to providing a safe and healthy workplace for our employees, contractors and visitors.

In addressing the COVID-19 pandemic and helping meet urgent global health needs, tens of thousands of dedicated Viatris employees across the world have worked to help ensure a stable supply of much needed treatments.

Because protecting the health and safety of our workforce remains paramount, we continue to align with government directives and the advice of relevant international, national and local health authorities at every Viatris facility around the world.

Many of our colleagues are working in manufacturing facilities, where we have taken extra precautions to protect our site personnel and operations, including implementing social distancing measures, daily health assessments and split shifts where feasible.

Others have traded their desks for kitchen tables and are juggling disrupted family schedules as well as work, like so many, during this time.

We offer a wide range of benefits and programs that are locally customized to meet the unique needs of employees, and regularly offer advice and support to employees working from home.

Approach to restructuring

Viatris is undertaking a global restructuring program intended to ensure that the organization is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers, and other stakeholders.

Any workforce actions taken as part of this restructuring program have been and will continue to be implemented in a way that is consistent with the company’s strong commitment to treating employees fairly and with respect.

Many of our colleagues are working in manufacturing facilities, where we have continued to take extra precautions to protect our site personnel and operations.

In 2021, we issued principles in support of hybrid-remote work to guide the development of local policies where possible.

We offer a wide range of benefits and programs that are locally customized to meet the unique needs of employees, and regularly offer advice and support to our employees including providing resources that support well-being for our colleagues around the world.

Exchange Act Reports

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business