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What changed in Viatris's 10-K2024 vs 2025

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Paragraph-level year-over-year comparison of Viatris's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+560 added522 removedSource: 10-K (2026-02-26) vs 10-K (2025-02-27)

Top changes in Viatris's 2025 10-K

560 paragraphs added · 522 removed · 416 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

114 edited+35 added34 removed58 unchanged
Biggest changeThe Company has also completed certain transactions to simplify and streamline its business, accelerate paydown of debt and unlock value, including the Biocon Biologics Transaction and the recently completed divestitures discussed below. On November 29, 2022, Viatris completed a transaction to contribute its biosimilars portfolio to Biocon Biologics to create a vertically integrated global biosimilars leader.
Biggest changeThe Company has also completed certain divestiture-related transactions to simplify and streamline its business, accelerate paydown of debt and unlock value as discussed below. In November 2022, Viatris completed a transaction to contribute its biosimilars portfolio to Biocon Biologics to create a vertically integrated global biosimilars leader, for a combination of cash and stock in the form of CCPS representing a stake of approximately 12.9% (on a fully diluted basis) in Biocon Biologics. 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.
We have been in regular communication with FDA during this process and will continue to work to ensure that the FDA is satisfied with the steps we have taken to resolve all the points raised. Our responses to the warning letter and import alert were submitted within the required time periods.
We have been in regular communication with the FDA during this process and will continue to work to ensure that the FDA is satisfied with the steps we have taken to resolve all the points raised. Our responses to the warning letter and import alert were submitted within the required time periods.
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.
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®, Breyna™, Influvac®, Wixela Inhub®, EpiPen® Auto-Injector, Fraxiparine®, and Yupelri®. New product launches are an important growth driver.
We are living the Viatris mission internally by providing 100% of all colleagues globally access to Elevate tools and resources including many local programs to further support health and wellbeing, with a focus on mental health through employee assistance programs and our new partnership with Unmind.
We are living the Viatris mission internally by providing 100% of all colleagues globally with access to Elevate tools and resources including many local programs to further support health and wellbeing, with a focus on mental health through employee assistance programs and our partnership with Unmind.
Together with long-term partners including but not limited to, Direct Relief, Save the Children, SBP, World Central Kitchen, and the American Red Cross, the Company has supported medical relief shipments, access to food and long-term rebuilding efforts.
Together with long-term partners including but not limited to, Direct Relief, AmeriCares, Save the Children, SBP, World Central Kitchen, and the American Red Cross, the Company has supported medical relief shipments, access to food and long-term rebuilding efforts.
We also often incur substantial litigation expense as a result of defending or challenging brand patents or exclusivities, which is described further in Note 19 Litigation included in Part II, Item 8 of this Form 10-K. Market Types Viatris focuses its sales and marketing efforts on the people who make key decisions around pharmaceutical prescribing, dispensing or buying.
We also often incur substantial litigation expense as a result of defending or challenging brand patents or exclusivities, which is described further in Note 20 Litigation included in Part II, Item 8 of this Form 10-K. Market Types Viatris focuses its sales and marketing efforts on the people who make key decisions around pharmaceutical prescribing, dispensing or buying.
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.
For this reason, suppliers of OTC products, including Viatris, 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.
With healthcare at various stages of development across these markets, we believe we are positioned to not only leverage our 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.
With healthcare at various stages of development across these markets, we believe we are positioned to not only leverage our large geographical footprint to maximize the similarities between these markets, but also tailor solutions to meet local needs. There is demand in this segment for better healthcare to serve a growing population and economic expansion.
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 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.
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 the hospital channel due to VBP. Additional pricing and volume pressure for pharmaceutical products sold in the hospital channel is expected to continue during 2026 and could negatively impact the Company’s results of operations.
For our remaining 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 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 additional information, see Part I, Item 1A Risk Factors “We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives and priorities, including divestitures, acquisitions or other potential transactions.” , “If we are unable to successfully introduce new products in a timely manner, our future revenue and profitability may be adversely affected.” and “We expend a significant amount of resources on R&D efforts that may not lead to successful product introductions.” 7 Table of Contents Unless otherwise indicated, industry data included in this Item 1 are sourced from IQVIA Holdings Inc. and are for the twelve months ended November 2024 and Viatris product and other company data included in this Item 1 are from internal sources and are as of November 30, 2024.
For additional information, see Part I, Item 1A Risk Factors “We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives and priorities, including divestitures, acquisitions or other potential transactions.” , “If we are unable to successfully introduce new products in a timely manner, our future revenue and profitability may be adversely affected.” and “We expend a significant amount of resources on R&D efforts that may not lead to successful product introductions.” Unless otherwise indicated, industry data included in this Item 1 are sourced from IQVIA Holdings Inc. and are for the twelve months ended November 2025 and Viatris product and other company data included in this Item 1 are from internal sources and are as of November 30, 2025.
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.
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, formulary placement, product quality, marketing, portfolio size, customer service, reputation and price.
Note, however, that pharmacists operating in distribution markets 14 Table of Contents also may be authorized to make substitution decisions when dispensing medicines. 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 our sales and marketing resources reflects the characteristics of these different market types.
Note, however, that pharmacists operating in distribution markets also may be authorized to make substitution decisions when dispensing medicines. 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 our sales and marketing resources reflects the characteristics of these different market types.
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.
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. 17 Table of Contents Institutional pharmacies address the unique needs of hospitals, nursing homes and other such venues.
Following an inspection by the FDA at our 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. The import alert affects 11 actively distributed products that will no longer be accepted into the U.S. until the warning letter is lifted.
Following an inspection by the FDA at our oral finished dose manufacturing facility in Indore, India in 2024, the FDA issued a warning letter and an import alert related to this facility. The import alert affects 11 products that will no longer be accepted into the U.S. until the warning letter is lifted.
Brand drugs include branded generics which are off-patent products that are 13 Table of Contents 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 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.
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. Doing so helps the Company share risks and costs, leverage strengths and scale up commercialization, but usually requires the Company to also share future profits.
As a result, 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. Doing so helps the Company share risks and costs, leverage strengths and scale up commercialization, but usually requires the Company to also share future profits.
Viatris has also received several local accolades in 2024 and previous years, such as Great Place to Work® and Top Employers certifications in multiple countries, among many others.
Viatris has also received several local accolades in 2025 and previous years, such as Great Place to Work® and Top Employers certifications in multiple countries, among many others.
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. 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 our 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.
Viatris 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 our products reach customers around the globe. Increasingly innovative and differentiated pipeline 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.
Viatris’ executive 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 key stakeholders. The Company operates in more than 165 countries and territories with approximately 32,000 employees.
Viatris’ executive 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 key stakeholders. The Company operates in more than 165 countries and territories with more than 30,000 employees.
For additional information, see Part I, Item 1A Risk Factors - We 17 Table of Contents rely on the effectiveness of our patents, trademarks, confidentiality agreements and other measures to protect our intellectual property rights. of this Form 10-K.
For additional information, see Part I, Item 1A Risk Factors - We rely on the effectiveness of our patents, trademarks, confidentiality agreements and other measures to protect our intellectual property rights. of this Form 10-K.
Refer to Note 18 Licensing and Other Partner Agreements included in Part II, Item 8 of this Form 10-K for more information.
Refer to Note 19 Licensing and Other Partner Agreements included in Part II, Item 8 of this Form 10-K for more information.
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, we maintain administrative facilities around the world. While many of these key facilities are owned, Viatris also leases certain facilities from third parties.
The Company’s significant manufacturing, packaging, 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, we maintain 14 Table of Contents administrative facilities around the world. While many of these key facilities are owned, Viatris also leases certain facilities from third parties.
Sustainability To learn about Viatris’ sustainability work, the Company encourages you to read Viatris’ 2023 Sustainability Report: Building Sustainable Access at Scale 1 , published in May 2024.
Sustainability To learn about Viatris’ sustainability work, the Company encourages you to read Viatris’ 2024 Sustainability Report: Building Sustainable Access at Scale 1 , published in May 2025.
Significant products within the Greater China segment include Lipitor®, Norvasc®, and Viagra®. JANZ The JANZ segment consists of our operations in Japan, Australia and New Zealand. In Japan, the National Health Insurance regulates the pricing of pharmaceutical products to healthcare providers.
Significant products within the Greater China segment include Lipitor®, Norvasc®, and Viagra®. 18 Table of Contents JANZ The JANZ segment consists of our operations in Japan, Australia and New Zealand. In Japan, the National Health Insurance regulates the pricing of pharmaceutical products to healthcare providers.
While committed to generics and specialty products, over the last several years, a greater portion of the Company’s investments has been focused on complex or difficult-to-formulate products, such as modified release or complex injectables such as glucagon, rather than on commodity products, such as conventional oral solid dosage forms.
While committed to generics and specialty products, over the last several years, a greater portion of the Company’s investments has been focused on complex or difficult-to-formulate products, including modified release or complex injectables such as iron sucrose injection and glucagon, rather than commodity products such as conventional oral solid dosage forms.
Viatris invests a significant amount of capital and resources in R&D, and this amount is likely to increase as we focus on more complex and innovative products to drive accelerated and durable growth, and build a more durable higher margin portfolio with exclusivity opportunities.
Viatris invests a significant amount of capital and resources in R&D, and this investment is likely to continue or potentially increase as we focus on more complex and innovative products to drive accelerated and durable growth, and build a more durable higher margin portfolio with exclusivity opportunities.
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.
With the global platforms and infrastructure supporting this approach, 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.
We have 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 our industry on global, regional and local levels.
Viatris 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.
As noted above access is fundamental to our mission. It is not an initiative; it is our business model, and it is personal. It begins with our ability to sustainably deliver quality medicines to people, regardless of geography or circumstance.
As noted above, access is fundamental to the Company’s mission. It is not an initiative; it is Viatris’ business model, and it is personal. It begins with Viatris’ ability to sustainably deliver quality medicines to people, regardless of geography or circumstance.
Human Capital Our people Our approximately 32,000 colleagues are passionate about our mission, and together we are building a performance-driven, highly engaging and inclusive culture where diverse perspectives drive access, innovation and our ability to make an impact in the world.
Human Capital Our people Our more than 30,000 colleagues are passionate about our mission, and together we are building a performance-driven, highly engaging and inclusive culture where diverse perspectives drive access, innovation and our ability to make an impact in the world.
Many of our collaborations focus on access to medicine; public awareness and disease screening; and healthcare professional education and support.
Many of the Company’s collaborations focus on access to medicine; public awareness and disease screening; and healthcare professional education and support.
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.
The Company has 27 manufacturing, packaging, and distribution sites worldwide, more than 1,400 approved molecules, and what we believe is 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.
Our goal is to enhance our proven scientific capabilities and current global platform, including our Global Healthcare Gateway®, which allows partners to access our infrastructure and many established strengths to reach patients they may not have the resources to reach on their own, to create a durable and higher-margin portfolio of products.
The Company’s goal is to enhance its proven scientific capabilities and current global platform, which allows partners to access Viatris’ infrastructure and many established strengths to reach patients they may not have the resources to reach on their own, to create a durable and higher-margin portfolio of products.
As a company, Viatris: Covers a broad range of therapeutic areas . We produce 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 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.
Together with a global, flexible and diverse supply chain, our platform strives to mitigate risks of disruption and ensure supply reliability. Our responsive global network has helped us maintain a reliable supply of much needed medicines through times of significant volatility.
Together with a global, flexible and diverse supply chain, the Company’s platform strives to mitigate risks of disruption and ensure supply reliability. Viatris’ responsive global network has helped the Company maintain a reliable supply of much needed medicines through times of significant volatility.
Our research, development and medical platform seeks to maximize the impact of our existing portfolio by examining whether there is an opportunity for new indications, label extensions, formulations, and market registrations for our products.
Our research, development and medical platform seeks to maximize the impact of our existing portfolio by examining whether there is an opportunity for new indications, label extensions, formulations, and market registrations for our products. We also use our platform to determine whether there is an opportunity to integrate new products into our portfolio.
The Company’s product pipeline includes a variety of dosage forms, including oral solid dosage forms, transdermals, injectables, inhalation, and other delivery systems.
The Company’s product pipeline includes a variety of dosage forms, including oral solid dosage forms, transdermals, injectables, inhalation, and other delivery systems, as well as drug delivery devices.
For these and other reasons, the Company’s sales and marketing efforts vary accordingly by product, market and channel type, each of which is described below. See the Application of Critical Accounting Policies section in Part II, Item 7 of this Form 10-K for more information related to customer arrangements.
For these and other reasons, the Company’s sales and marketing efforts vary accordingly by product, market and channel type, each of which is described below. See the Application of Critical Accounting Policies section in Part II, Item 7 of this Form 10-K for more information related to customer arrangements. Products Viatris currently markets branded and generic drugs, including complex drugs.
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’s registered trademarks are renewable indefinitely, and are maintained in accordance with the laws of the countries in which they are registered.
Viatris has an extensive trademark portfolio totaling approximately 27,000 active 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’s registered trademarks are renewable indefinitely, and are maintained in accordance with the laws of the countries in which they are registered.
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.
Building for Growth Through Partnerships Viatris 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.
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 believe that Viatris’ global leadership in all of these areas uniquely positions us to efficiently and effectively serve patients regardless of geography or circumstance.
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 ARV in more than 100 countries. Viatris believes that its global leadership in all of these areas uniquely positions the Company to efficiently and effectively serve patients regardless of geography or circumstance.
We know what it takes to reach more patients with more products, and believe that Viatris is uniquely positioned to make a difference through our: Powerful global operating platform , which combines what we believe to be best-in-class manufacturing and supply chain capabilities.
Viatris knows what it takes to reach more patients with more products, and believes that it is uniquely positioned to make a difference through its: Powerful global operating platform , which combines what it believes to be best-in-class manufacturing and supply chain capabilities.
We also offer support services such as diagnostic clinics, educational seminars and digital tools to help patients better manage their health. We continue to seek opportunities in various therapeutic areas that move the Company forward and leverage the strength of our internal capabilities and global platform. Helps ease the burden of noncommunicable diseases.
It also offers support services such as diagnostic clinics, educational seminars and digital tools to help patients better manage their health. Viatris continues to seek opportunities in various therapeutic areas that move the Company forward and leverage the strength of its internal capabilities and global platform. Helps ease the burden of noncommunicable diseases.
Viatris believes it is well positioned to serve such customers in the Developed Markets due to the scale it has built in terms of R&D, supply chain, and portfolio breadth. 15 Table of Contents Greater China The Greater China segment includes our operations in mainland China, Taiwan, and Hong Kong.
Viatris believes it is well positioned to serve such customers in the Developed Markets due to the scale it has built in terms of R&D, supply chain, and portfolio breadth. Greater China The Greater China segment includes our operations in mainland China, Taiwan, and Hong Kong. The Viatris Greater China portfolio predominantly consists of branded LOE products.
The Company also has an extensive patent portfolio and actively files for patent protection in various countries to protect its brand-name, generic, branded generic, and remaining OTC products, including processes for making and using them. The Company has more than 2,400 patents filed globally.
The Company also has an extensive patent portfolio and actively files for patent protection in various countries to protect its brand-name, generic, branded generic, and OTC products, including processes for making and using them, as well as to protect its drug-delivery technologies. The Company has more than 1,400 patents filed globally.
Generic drugs are therapeutically equivalent versions of brand drugs. Generics generally become available once the patents and other exclusivities on their branded counterparts expire. The generics business is generally characterized by lower margins on higher volumes of a relatively large number of products.
Generics generally become available once the patents and other exclusivities on their branded counterparts expire. The generics business is generally characterized by lower margins on higher volumes of a relatively large number of products.
We believe we are a company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. We are 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 believes it is uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. Viatris is committed to improving access to high-quality medicines and maintaining a reliable supply so patients can get the treatments they need, when and where they need them.
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 26 manufacturing and packaging sites worldwide that produce oral solid doses, injectables, and products with complex dosage forms on five different continents.
Viatris 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 owns 27 manufacturing, packaging, and distribution sites worldwide that produce oral solid doses, injectables, and products with complex dosage forms on five different continents.
The Company is also expanding further beyond its current scope into more innovative products, including innovative, best-in-class, patent-protected assets that address areas of significant unmet medical need.
And that means further expanding beyond the Company’s current scope into more innovative products, including innovative, best-in-class, patent-protected assets that address areas of significant unmet medical need.
Brand and branded generic products are more sensitive to promotion than are unbranded generic products. They therefore represent the primary focus of most of our sales representatives and product-level marketing activity. Our remaining OTC products, which are sold directly to consumers without a prescription and without reimbursement, are generally sold under a brand name.
Brand and branded generic products are more sensitive to promotion than are unbranded generic products. They therefore represent the primary focus of most of our sales representatives and product-level marketing activity. Our branded drugs also include certain OTC products, which are sold directly to consumers without a prescription and without reimbursement. Generic drugs are therapeutically equivalent versions of brand drugs.
Mylan became a publicly traded company in 1973. Mylan’s strategy then led to many acquisitions which played a significant role in the evolution of that company, including Matrix Laboratories Limited (2007); Merck KGaA’s generic and specialty pharmaceutical business (2007); the EPD Business (2015) and Meda AB (publ.) (2016).
Mylan became a publicly traded company in 1973. Mylan’s strategy then led to many acquisitions which played a significant role in the evolution of that company, including Matrix Laboratories Limited (2007); 11 Table of Contents Merck KGaA’s generic and specialty pharmaceutical business (2007); Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business (2015) and Meda AB (publ.) (2016).
While Viatris will continue to diligently pursue important generics opportunities, the Company 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. The Company believes innovative and complex products categories are critical to patient health and are growing at a rapid pace.
While the Company continues to diligently pursue important generics opportunities, it has increasingly focused on limited-competition complex and novel products targeting gaps in care, all with a first-to-market emphasis and serving Viatris’ mission of patient access. Complex product categories are critical to patient health and are growing at a rapid pace.
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. According to the WHO, coronary heart disease is the number one cause of death globally.
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. 12 Table of Contents Helps hearts stay healthier.
Together, with our commitment to provide access to a sustainable, affordable, and diverse portfolio of high-quality medicines and our goal to be a Partner of Choice® for companies big and small, Viatris works to improve access and meet evolving healthcare needs around the world. 10 Table of Contents PARTNERSHIP Leveraging our collective expertise to connect people to products and services.
Together with its commitment to provide access to a sustainable, affordable, and diverse portfolio of high-quality medicines, Viatris works to improve access and meet evolving healthcare needs around the world. 13 Table of Contents PARTNERSHIP Leveraging its collective expertise to connect people to products and services.
In previous years, Viatris has also been included on Forbes’ World’s Best Employers list, USA Today’s America’s Climate Leaders list, 3BL 100 Best Corporate Citizens list, TIME’s World’s Best Companies list, Fast Company’s Most Innovative Companies list, Fortune’s Change the World list, and Newsweek’s America’s Most Responsible Companies list.
In recent years, Viatris has also been included on Forbes’ World’s Top Companies for Women list, Forbes’ World’s Best Employers list, USA Today’s America’s Climate Leaders list, 3BL 100 Best Corporate Citizens list, TIME’s World’s Best Companies list, Fast Company’s Most Innovative Companies list, Fortune’s Change the World list, National Association for Business Resources’ Nation’s Best & Brightest in Wellness list, and Newsweek’s America’s Most Responsible Companies list.
The VBP policy for LOE molecules is now 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.
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.
We continue 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. Fights infectious disease . We are also a global leader in treating infectious diseases such as HIV/AIDS, hepatitis, and tuberculosis, and offer an extensive portfolio across these disease states.
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. Fights infectious disease. Viatris has a long history in the fight against infectious diseases such as HIV/AIDS, hepatitis, and tuberculosis, and offer an extensive portfolio across these disease states.
We take that commitment seriously and know that advancing sustainable operations and innovative solutions to improve patient health requires strong global leadership.
The Company takes that commitment seriously and knows that advancing sustainable operations and innovative solutions to improve patient health requires strong global leadership.
Customers and Marketing Our customers include retail and pharmacy establishments, wholesalers and distributors, payers, insurers and governments, and institutions, such as hospitals, among others.
Customers and Marketing Our customers include retail and pharmacy establishments, wholesalers and distributors, payers, insurers and governments, and institutions, such as hospitals, among others. See “Channel Types” below for more information about our customers.
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.
Important recent launches include iron sucrose injection and octreotide acetate for injectable suspension in the U.S., and pomalidomide, dapagliflozin, atorvastatin/ezetimibe, rivaroxaban, and ferric carboxymaltose 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.
Our colleagues are dedicated to our mission and we continue to build our culture with a focus on colleague experience and engagement; learning and development; career progression; workplace culture; talent attraction and our deep commitment to the health, safety and wellbeing of our colleagues, their families and the communities we serve. 19 Table of Contents We remain committed to building upon our foundations, harmonizing our processes and programs and initiating many firsts for Viatris.
Our colleagues are dedicated to our mission and we continue to build our culture with a focus on colleague experience and engagement; learning and development; career progression; workplace culture; talent attraction and our deep commitment to the health, safety and wellbeing of our colleagues, their families and the communities we serve.
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®. Our current complex products are considered generics and are included within our generics revenue category.
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®, glatiramer acetate injection, a generic version of Copaxone®, and its generic iron sucrose injection.
Key actions and strategies for making progress toward our SBTi climate targets include increasing renewable energy usage, implementing energy-efficiency projects, preventing refrigerant leaks and transitioning to greener refrigerants, using alternative fuels and technologies, and leveraging infrastructure upgrades and utility replacement projects.
Key actions taken by the Company include increasing renewable energy usage, implementing energy-efficiency projects, preventing refrigerant leaks and transitioning to greener refrigerants, using alternative fuels and technologies, and leveraging infrastructure upgrades and utility replacement projects.
After completing the divestiture of our API business in India, we continue to maintain some selective R&D capabilities in API and believe we have access to adequate API supplies through a manufacturing and supply agreement with the API business buyer and our arrangements with other manufacturers.
After completing the divestiture of its API business in India, Viatris continues to maintain some selective R&D capabilities in API and believes it has access to adequate API supplies through a manufacturing and supply agreement with the API business buyer and Viatris’ supply agreements with other manufacturers.
See “Channel Types” below for more information about our customers. 12 Table of Contents The table below displays the percentage of consolidated net sales to our largest customers during the years ended December 31, 2024, 2023 and 2022: Percentage of Consolidated Net Sales 2024 2023 2022 McKesson Corporation * 10 % 11 % Cencora, Inc.
The table below displays the percentage of consolidated net sales to our largest customers during the years ended December 31, 2025, 2024 and 2023: Percentage of Consolidated Net Sales 2025 2024 2023 McKesson Corporation * * 10 % Cencora, Inc. 11 % 12 % 10 % Cardinal Health, Inc. * * 5 % 15 Table of Contents * Net sales represented less than 10% of consolidated net sales during the period.
Furthermore, Viatris colleagues across the globe have done beach cleanups, community fundraisers, and participated in volunteer opportunities to raise money and awareness for patients living with diseases as a part of a larger global initiative called Building Healthier Communities. Business partnerships, collaboration within and across sectors, memberships, and philanthropic collaborations help us serve patients, healthcare systems and communities worldwide.
Furthermore, Viatris colleagues across the globe have supported local care facilities, community cleanups, fundraisers, and participated in volunteer opportunities to raise money and awareness for patients living with diseases as a part of a larger global initiative - Building Healthier Communities.
The Viatris Greater China portfolio predominantly consists of branded LOE products. In China, the recent healthcare reform measures are aimed at controlling the overall healthcare costs, while providing better and broader care to the population. Healthcare spending is expected to increase in-line with GDP growth.
In China, the recent healthcare reform measures are aimed at controlling the overall healthcare costs, while providing better and broader care to the population. Healthcare spending is expected to increase in-line with GDP growth. The VBP policy for LOE molecules is now in its seventh year and includes approximately 490 molecules.
Further, Viatris has well-established safeguards in place to protect our proprietary know-how and trade secrets, both of which the Company considers extremely valuable to its intellectual property portfolio. The Company looks for intellectual property licensing opportunities to or from third parties, related not only to our existing products, but as a means for expanding our product portfolio.
Further, Viatris has well-established safeguards in place to protect our proprietary know-how and trade secrets, both of which the Company considers extremely valuable to its intellectual property portfolio.
Viatris relies on the aforementioned types of intellectual property, as well as our copyrights, trade dress, regulatory exclusivities and contractual protections, to establish a broad scope of intellectual property rights for our product portfolio.
The Company looks for intellectual property licensing opportunities to or from third parties, related not only to our existing products, but as a means for expanding our product portfolio. 20 Table of Contents Viatris relies on the aforementioned types of intellectual property, as well as our copyrights, trade dress, regulatory exclusivities and contractual protections, to establish a broad scope of intellectual property rights for our product portfolio.
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.
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. 19 Table of Contents Any failure or delay by Viatris, its 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.
Our commitment to wellbeing has grown with the launch of our Elevate program focused on the health, purpose and growth of our colleagues. This program is fully supported by an active and engaged employee-led group of ambassadors through the Viatris Elevate Champions network.
This program is fully supported by an active and engaged employee-led group of ambassadors through the Viatris Elevate Champions network.
The insights from our employee listening strategy guide our efforts as we continually strive to create a work environment where people can learn, grow, feel appreciated and make an impact in the world. Health and Safety Protecting the health and safety of our colleagues is essential at Viatris.
We foster listening, inclusion, and mutual respect and encourage colleagues to connect with each other to learn, grow and achieve together. The insights from our employee engagement and listening strategies guide our efforts as we continually strive to create a work environment where people can feel appreciated and make an impact in the world.
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.
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.
Viatris is headquartered in the U.S., with global centers in Pittsburgh, Pennsylvania, Shanghai, China and Hyderabad, India. Viatris has executed various strategic initiatives, transactions and business arrangements over the last few years to return its base business to growth, deliver on its pipeline, reduce debt, maintain an investment grade credit rating and return capital to shareholders.
Viatris has executed various strategic initiatives, transactions and business arrangements over the last few years to return its base business to growth, deliver on its pipeline, reduce debt, and return capital to shareholders.
Viatris remains engaged in promoting environmentally responsible supply chains, including through the Company’s compliance with the AMR Industry Alliance’s Common Antibiotic Manufacturing Standard in its operations and its commitment to the standard’s implementation across Viatris’ external supply chain.
Viatris remains engaged in promoting environmentally responsible and sustainable supply chains, including through the Company’s compliance with the AMR Industry Alliance’s Common Antibiotic Manufacturing Standard in its operations 1 Please note that our website, Sustainability Report and their respective contents are not incorporated by reference into this Form 10-K. 21 Table of Contents and its commitment to the standard’s implementation across Viatris’ external supply chain.
Government Regulation Regulation by governmental authorities is a significant factor in the R&D, production, marketing, sales and distribution of pharmaceuticals. Viatris’ products are subject to robust developmental studies which include analytical determinations of strength, quality, purity as well as rigorous safety and efficacy determinations using preclinical, pharmacokinetic studies and clinical evaluations to gather data to support regulatory review and approval.
Viatris’ products are subject to robust developmental studies which include analytical determinations of strength, quality, purity as well as rigorous safety and efficacy determinations using preclinical, pharmacokinetic studies and clinical evaluations to gather data to support regulatory review and approval. This body of work results in extensive data and scientific information that is incorporated into a given product’s regulatory dossier.
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 Company sells products in Japan primarily through a network of wholesalers who then sell the products to doctors, hospitals and pharmacies.
Environmental Stewardship We are committed to minimizing our impact on the environment while working to safeguard a reliable supply of medicine.
Ultimately, we know we are stronger together, working collaboratively and relentlessly across our company and with the broader global community, in pursuit of access. Environmental Stewardship We are committed to minimizing our impact on the environment while working to safeguard a reliable supply of medicine.
For example, the Company is working on a number of programs including the potential to be first-to-market for our generics of Abilify Maintena®, Injectafer®, Invega Trinza®, Ozempic®, Venofer® and Wegovy™. The Company is also working with its partners on novel and/or complex products such as our biosimilar to BOTOX® (onabotulinumtoxinA).
The Company is working on a number of programs including patent-protected, innovative assets such as selatogrel and cenerimod, and on the potential to be first-to-market for our generics of Abilify Maintena®, Injectafer®, Ozempic®, and Wegovy™.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThis summary is not exhaustive and is qualified by reference to the full set of risk factors set forth in this Part I, Item 1A. Strategic Risks We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives and priorities, including divestitures, acquisitions or other potential transactions. There are ongoing risks and uncertainties associated with our recent divestitures, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. The integration of acquired businesses as well as restructuring programs have presented and may in the future present significant challenges. We have and may continue to experience pressure on the pricing of and reimbursements for certain of our products due to pricing controls, social or government pressure to lower the cost of drugs, and consolidation across the supply chain. We have significant operations globally, which exposes us to the risks inherent in conducting our business internationally. Charges to earnings resulting from acquisitions could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. Operational Risks Current and changing economic conditions, including inflation, may adversely affect our industry, business, partners and suppliers. The pharmaceutical industry is heavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicable laws and regulations. The use of legal, regulatory, and legislative strategies by both brand and generic competitors, including but not limited to “authorized generics” and regulatory petitions, may increase costs associated with the introduction or marketing of our generic products, could delay or prevent such introduction, and could significantly reduce our revenue and profit. If we are unable to successfully introduce new products in a timely manner, our future revenue and profitability may be adversely affected. We expend a significant amount of resources on R&D efforts that may not lead to successful product introductions. Even if our products in development receive regulatory approval, such products may not achieve expected levels of market acceptance. Our business is highly dependent upon market perceptions of us, our products and brands, and the safety and quality of our products and brands, as well as the effectiveness of our sales and marketing activities, and we may be adversely impacted by negative publicity or findings. We have a limited number of manufacturing facilities and certain third-party suppliers produce a substantial portion of our API and products, some of which require a highly exacting and complex manufacturing process. Our future success is highly dependent on our ability to attract, motivate and retain key personnel. Compliance Risks We are subject to the U.S.
Biggest changeThis summary is not exhaustive and is qualified by reference to the full set of risk factors set forth in this Part I, Item 1A. Strategic Risks We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives and priorities, including our enterprise-wide strategic review and other potential corporate transactions. Viatris’ restructuring activities may not achieve their intended goals and may present significant challenges, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. There are risks and uncertainties associated with divestitures, product rationalizations and asset sales, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. The integration of acquired businesses has presented and may in the future present significant challenges, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. The imposition of tariffs on, or other trade restrictions or domestic sourcing requirements in, the territories and countries where we, our partners, suppliers, or customers do business, as well as any retaliatory actions 23 Table of Contents with respect to such actions, could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. We have and may continue to experience pressure on the pricing of and reimbursements for certain of our products due to pricing controls, social or government pressure to lower the cost of drugs, and consolidation across the supply chain. We have significant operations globally, which exposes us to the risks inherent in conducting our business internationally. Charges to earnings resulting from acquisitions could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. Operational Risks Current and changing economic conditions, including inflation, may adversely affect our industry, business, partners and suppliers. The pharmaceutical industry is heavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicable laws and regulations. The use of legal, regulatory, and legislative strategies by both brand and generic competitors, including but not limited to “authorized generics” and regulatory petitions, may increase costs associated with the introduction or marketing of our generic products, could delay or prevent such introduction, and could significantly reduce our revenue and profit. If we are unable to successfully introduce new products in a timely manner, our future revenue and profitability may be adversely affected. We expend a significant amount of resources on R&D efforts that may not lead to successful product introductions. Even if our products in development receive regulatory approval, such products may not achieve expected levels of market acceptance. Our business is highly dependent upon market perceptions of us, our products and brands, and the safety and quality of our products and brands, as well as the effectiveness of our sales and marketing activities, and we may be adversely impacted by negative publicity or findings. We have a limited number of manufacturing facilities and certain third-party suppliers produce a substantial portion of our API and products, some of which require a highly exacting and complex manufacturing process. Our future success is highly dependent on our ability to attract, motivate and retain key personnel. Compliance Risks We are subject to the U.S.
In 2021 and 2022, China amended and, in some cases, adopted new laws and regulations governing the collection, transmission, processing and use of individual personal information, including the Data Security Law, the Cybersecurity Review Measures, the Personal Information Protection Law and the Data Export Security Review Measures.
In 2021 and 2022, China amended and, in some cases, adopted new laws and regulations governing the collection, transmission, processing and use of individual personal data, including the Data Security Law, the Cybersecurity Review Measures, the Personal Information Protection Law and the Data Export Security Review Measures.
Although we believe our cross-border arrangements among our subsidiaries are based upon internationally accepted standards and applicable law, tax authorities in various jurisdictions may disagree with and subsequently challenge the amount of profits taxed in their country, which may result in increased tax liability, including accrued interest and penalties, which would cause our tax expense to increase and could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Although we believe our cross-border arrangements among our subsidiaries are based upon internationally accepted standards and applicable law, tax authorities in various jurisdictions may disagree with and subsequently challenge the amount of profits taxed in their country, which may result in an increased tax liability, including accrued interest and penalties, which would cause our tax expense to increase and could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
The exclusive forum provisions in the Viatris Charter could discourage lawsuits against Viatris and its directors and officers. 48 Table of Contents The Viatris Charter provides that unless Viatris, through approval of the Viatris Board, otherwise consents in writing, the Court of Chancery of the State of Delaware or, if and only if the Court of Chancery of the State of Delaware dismisses such action for lack of subject matter jurisdiction, another state court sitting in the State of Delaware (or, if no state court located within the State of Delaware has jurisdiction, the federal district court for the District of Delaware), will be the sole and exclusive forum for any derivative action or proceeding brought on behalf of Viatris, any action or proceeding asserting a claim of breach of a fiduciary duty owed by any director or officer or other employees of Viatris to Viatris or its stockholders, creditors or other constituents, any action asserting a claim against Viatris or any of its directors, officers or other employees arising pursuant to, or seeking to enforce any right, obligation or remedy under, any provision of the DGCL or the Viatris Charter or the Viatris Bylaws, as each may be amended from time to time, any action or proceeding asserting a claim against Viatris or any of its directors, officers or other employees governed by the internal affairs doctrine or any action or proceeding as to which the DGCL (as it may be amended from time to time) confers jurisdiction on the Court of Chancery of the State of Delaware.
The exclusive forum provisions in the Viatris Charter could discourage lawsuits against Viatris and its directors and officers. 52 Table of Contents The Viatris Charter provides that unless Viatris, through approval of the Viatris Board, otherwise consents in writing, the Court of Chancery of the State of Delaware or, if and only if the Court of Chancery of the State of Delaware dismisses such action for lack of subject matter jurisdiction, another state court sitting in the State of Delaware (or, if no state court located within the State of Delaware has jurisdiction, the federal district court for the District of Delaware), will be the sole and exclusive forum for any derivative action or proceeding brought on behalf of Viatris, any action or proceeding asserting a claim of breach of a fiduciary duty owed by any director or officer or other employees of Viatris to Viatris or its stockholders, creditors or other constituents, any action asserting a claim against Viatris or any of its directors, officers or other employees arising pursuant to, or seeking to enforce any right, obligation or remedy under, any provision of the DGCL or the Viatris Charter or the Viatris Bylaws, as each may be amended from time to time, any action or proceeding asserting a claim against Viatris or any of its directors, officers or other employees governed by the internal affairs doctrine or any action or proceeding as to which the DGCL (as it may be amended from time to time) confers jurisdiction on the Court of Chancery of the State of Delaware.
In the U.S., Congress has recently considered measures to enhance supply chain resiliency and ensure the quality of pharmaceutical products, including expansion of reporting requirements to include API and finished dose manufacturing locations and expanded communication with regulators regarding demand spikes for pharmaceutical products. Compliance with any such requirements may be burdensome or costly.
In the U.S., Congress has considered measures to enhance supply chain resiliency and ensure the quality of pharmaceutical products, including expansion of reporting requirements to include API and finished dose manufacturing locations and expanded communication with regulators regarding demand spikes for pharmaceutical products. Compliance with any such requirements may be burdensome or costly.
The pharmaceutical drug supply is vulnerable to illegal counterfeiting and the presence of counterfeit or IP-infringing products in a growing number of markets, including widespread sales over the internet. Third parties may illegally distribute and sell counterfeit or IP-infringing versions of our products that do not meet our rigorous manufacturing and testing standards.
The pharmaceutical drug supply is vulnerable to illegal counterfeiting and the presence of counterfeit or IP-infringing products in a growing number of markets, including widespread sales over the internet. Third parties may illegally manufacture, distribute and/or sell counterfeit or IP-infringing versions of our products that do not meet our rigorous manufacturing and testing standards.
Negative publicity related to the receipt of a warning letter, import alert, or similar restrictions from the FDA or other regulatory authorities, such as the recent restrictions at our Indore facility, have damaged and could continue to damage our reputation among customers, lead customers to seek other suppliers of our products, or lead to additional inquiries from other regulatory authorities.
Negative publicity related to the receipt of a warning letter, import alert, or similar restrictions from the FDA or other regulatory authorities, such as the restrictions at our Indore facility, have damaged and could continue to damage our reputation among customers, lead customers to seek other suppliers of our products, or lead to additional inquiries from other regulatory authorities.
In recent years, there have been numerous initiatives on the federal and state levels for comprehensive reforms affecting the payment for, the availability of and reimbursement for, healthcare services in the U.S., and it is likely that Congress and state legislatures and health agencies will continue to focus on healthcare reform in the future.
In recent years, there have been numerous initiatives on the federal and state levels for comprehensive reforms affecting the payment for, the availability of and reimbursement for, healthcare services in the U.S., and it is likely that Congress, the Administration, and state legislatures and health agencies will continue to focus on healthcare reform in the future.
After we complete an acquisition, the following factors could result in material charges and adversely affect our operating results and may adversely affect our cash flows: 27 Table of Contents costs incurred to combine the operations of companies we acquire, such as transitional employee expenses and employee retention, redeployment or relocation expenses; liabilities assumed in purchase accounting; impairment of goodwill or intangible assets, including acquired IPR&D; amortization of intangible assets acquired; a reduction in the useful lives of intangible assets acquired; identification of or changes to assumed contingent liabilities, including, but not limited to, litigation reserves, contingent purchase price consideration including fair value adjustments, income tax contingencies and other non-income tax contingencies, after our final determination of the amounts for these contingencies or the conclusion of the measurement period (generally up to one year from the acquisition date), whichever comes first; significant costs to restructure our operations and to reduce our cost structure, including cost related to severance payments, plant shutdowns and costs to achieve anticipated synergies; and charges to our operating results resulting from expenses incurred to effect the acquisition.
After we complete an acquisition, the following factors could result in material charges and adversely affect our operating results and may adversely affect our cash flows: costs incurred to combine the operations of companies we acquire, such as transitional employee expenses and employee retention, redeployment or relocation expenses; liabilities assumed in purchase accounting; impairment of goodwill or intangible assets, including acquired IPR&D; amortization of intangible assets acquired; a reduction in the useful lives of intangible assets acquired; identification of or changes to assumed contingent liabilities, including, but not limited to, litigation reserves, contingent purchase price consideration including fair value adjustments, income tax contingencies and other non-income tax contingencies, after our final determination of the amounts for these contingencies or the conclusion of the measurement period (generally up to one year from the acquisition date), whichever comes first; significant costs to restructure our operations and to reduce our cost structure, including cost related to severance payments, plant shutdowns and costs to achieve anticipated synergies; and charges to our operating results resulting from expenses incurred to effect the acquisition.
Treasury’s Office of Foreign Assets Control, the Iran Threat Reduction and Syria Human Rights Act of 2012 and rules relating to the use of certain “conflict minerals” under Section 1502 of the Dodd-Frank Wall Street Reform and the Consumer Protection Act; sanctions and our interpretation of those sanctions, trade controls, supply chain and staffing challenges as a result of the ongoing conflict between Russia and Ukraine that have impacted and may continue to impact our ability to market or sell pharmaceuticals in either country or subject us to increased government scrutiny, and a significant escalation or expansion of the conflict’s current scope may have a negative impact on our operations and financial results in future periods; instability in the Middle East, especially the ongoing conflict in Israel and Gaza, has impacted and may continue to impact our and our partners’ ability to develop and manufacture products in the region and to transport those products to other markets, and has impacted and may continue to impact the ability of regulators to conduct required inspections at our or our partners’ manufacturing facilities in the region.
Treasury’s Office of Foreign Assets Control, the Iran Threat Reduction and Syria Human Rights Act of 2012 and rules relating to the use of certain “conflict minerals” under Section 1502 of the Dodd-Frank Wall Street Reform and the Consumer Protection Act; 29 Table of Contents sanctions and our interpretation of those sanctions, trade controls, supply chain and staffing challenges as a result of the ongoing conflict between Russia and Ukraine that have impacted and may continue to impact our ability to market or sell pharmaceuticals in either country or subject us to increased government scrutiny, and a significant escalation or expansion of the conflict’s current scope may have a negative impact on our operations and financial results in future periods; instability in the Middle East, especially the conflict in Israel and Gaza, has impacted and may continue to impact our and our partners’ ability to develop and manufacture products in the region and to transport those products to other markets, and has impacted and may continue to impact the ability of regulators to conduct required inspections at our or our partners’ manufacturing facilities in the region.
A significant disruption at any facilities within our internal or third-party supply chain, even on a short-term basis, whether due to the failure of a third-party supplier to fulfill the terms of their agreement with us, labor disruption, adverse quality or compliance observation, other regulatory action, infringement of brand or other third-party intellectual property rights, natural disaster, civil or political unrest, export or import restrictions, or other events could impair our ability to produce and ship products to the market on a timely basis and could, among other consequences, subject us to exposure to claims from customers.
A significant disruption at any facilities within our internal or third-party supply chain, even on a short-term basis, whether due to the failure of a third-party supplier to fulfill the terms of their agreement with us, labor disruption, legal proceedings, adverse quality or compliance observation, other regulatory action, infringement of brand or other third-party intellectual property rights, natural disaster, civil or political unrest, export or import restrictions, or other events could impair our ability to produce and ship products to the market on a timely basis and could, among other consequences, subject us to exposure to claims from customers.
These divestitures have resulted and may in the future result in continued financial and operational exposure to the divested assets or businesses, such as through guarantees or other financial arrangements, indemnification, continued supply and transition services obligations to the divested businesses, stranded costs, or potential litigation.
These divestitures have resulted and may in the future result in continued financial and operational exposure to the divested assets or businesses, such as through guarantees or other financial arrangements, indemnification, continued supply and distribution arrangements, transition services obligations to the divested businesses, stranded costs, or potential litigation.
Our ability to do so also depends in part on how well we maintain a strong, diverse and inclusive workplace culture that is attractive to employees. Competition for qualified personnel in the pharmaceutical industry is intense.
Our ability to do so also depends in part on how well we maintain a strong, diverse, inclusive, and safe workplace culture that is attractive to employees. Competition for qualified personnel in the pharmaceutical industry is intense.
These difficulties may include: diversion of management’s and employees’ attention from the ongoing operations of Viatris to integration and restructuring matters; the challenge of integrating the employees and business cultures; retaining existing customers and suppliers, or obtaining new customers and suppliers; risks associated with managing a larger and more complex company; loss of institutional knowledge or lack of access to IT systems and historical data, including clinical or trial data; the challenge and cost of integrating manufacturing, logistics, IT, communications and other systems; the potential difficulty transitioning acquired assets to the Company and retaining key personnel and other employees; challenges in reducing reliance on transition services, including difficulties in hiring employees or finding suitable replacements, prior to the expiration of any period in which such services are provided; and reducing costs associated with transition services, including managing the amount for replacement costs.
These difficulties may include: diversion of management’s and employees’ attention from the ongoing operations of Viatris to integration and restructuring matters; the challenge of integrating the employees and business cultures; retaining existing customers and suppliers, or obtaining new customers and suppliers; risks associated with managing a larger and more complex company; 26 Table of Contents loss of institutional knowledge or lack of access to IT systems and historical data, including clinical or trial data; the challenge and cost of integrating manufacturing, logistics, IT, communications and other systems; the potential difficulty transitioning acquired assets to the Company and retaining key personnel and other employees; challenges in reducing reliance on transition services, including difficulties in hiring employees or finding suitable replacements, prior to the expiration of any period in which such services are provided; and reducing costs associated with transition services, including managing the amount for replacement costs.
Payment of a cash dividend or share repurchases will reduce the amount of cash available to the Company for other activities, including repayment of debt, investment in the business, R&D, business development activities, or other capital expenditures.
Payment of a cash dividend or share repurchases will reduce the amount of cash available to the Company for other activities, including repayment of debt, investment in the business, R&D, business development activities, acquisitions, or other capital expenditures.
Any of the risks described above could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. Refer to Note 5 Divestitures included in Part II, Item 8 of this Form 10-K for more information about our recently completed divestitures.
Any of the risks described above could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. Refer to Note 5 Divestitures included in Part II, Item 8 of this Form 10-K for more information about our divestitures.
If integration activities or restructuring programs are unsuccessful, if the estimated costs are higher than anticipated, or if we are unable to realize the anticipated synergies and other benefits, there could be a material adverse effect on Viatris’ business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
If integration activities are unsuccessful, if the estimated costs are higher than anticipated, or if we are unable to realize the anticipated synergies and other benefits, there could be a material adverse effect on Viatris’ business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Failure to comply with these laws, regulations or expectations could result in a range of consequences, including, but not limited to, fines, penalties, disgorgement, exclusion from U.S. federal healthcare reimbursement programs, unanticipated compliance expenditures, suspension of review of applications or other submissions, rejection or delay in approval of applications, recall or seizure of products, total or partial suspension of production and/or distribution, our inability to sell products, the return by customers of our products, injunctions, and/or criminal prosecution.
Failure to comply with these laws, regulations or expectations could result in a range of consequences, including, but not limited to, fines, penalties, disgorgement, exclusion from U.S. federal healthcare reimbursement programs, unanticipated compliance expenditures, suspension of review of applications or other submissions, rejection or delay in approval of applications, recall or seizure of products, total or partial suspension of production and/or distribution of certain products or at certain facilities, our inability to sell products, the return by customers of our products, injunctions, and/or criminal prosecution.
Our business could be adversely affected if any regulatory body were to delay, withhold, or withdraw approval of an application; require a recall or other adverse product action; require one of our manufacturing facilities to cease or limit production; or suspend, vary, or withdraw related marketing authorization.
Our business could be adversely affected if any regulatory body were to delay, withhold, or withdraw approval of an application; require a recall or other adverse product action; require one of our manufacturing facilities, partners, or suppliers to cease or limit production; or suspend, vary, or withdraw related marketing authorization.
We, or a collaboration partner, may not have sufficient capital or finances to develop or commercialize a potential product, may not be successful in developing or commercializing such products on a timely basis, or at all, and such products may be less likely or take longer to receive regulatory approval, which could adversely affect our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
We, or a collaboration partner, may 36 Table of Contents not have sufficient capital or finances to develop or commercialize a potential product, may not be successful in developing or commercializing such products on a timely basis, or at all, and such products may be less likely or take longer to receive regulatory approval, which could adversely affect our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
The use of AI solutions by our employees or third parties on which we rely could lead to the public disclosure of confidential information (including personal data or proprietary information) in contravention of our internal policies, data protection or other applicable laws, or contractual requirements.
In addition, the use of ML or AI solutions by our employees or third parties on which we rely could lead to the public disclosure of confidential information (including personal data or proprietary information) in contravention of our internal policies, data protection or other applicable laws, or contractual requirements.
These strategies include, but are not limited to: entering into agreements whereby other generic companies will begin to market an authorized generic, which is the approved brand-name drug without the brand-name on its label, at the same time or after generic competition initially enters the market; launching their own authorized generic product prior to or at the same time or after generic competition initially enters the market; pricing a branded product at a discount equivalent to generic pricing; filing frivolous petitions with the FDA or other regulatory bodies seeking to prevent or delay approvals, including timing the frivolous filings so as to thwart generic competition by causing delays of our product approvals; contracting strategies among pharmaceutical manufacturers and PBMs that could decrease generic or biosimilar utilization and negatively impact our products; 32 Table of Contents seeking to establish regulatory and legal obstacles that would make it more difficult to demonstrate bioequivalence or to meet other requirements for approval, and/or to prevent regulatory agency review of applications; initiating legislative or other efforts to limit the substitution of generic versions of brand pharmaceuticals; filing suits for patent infringement and other claims that may delay or prevent regulatory approval, manufacture, and/or sale of generic products; introducing “next-generation” products prior to the expiration of market exclusivity for the reference product, which often materially reduces the demand for the generic or the reference product for which we seek regulatory approval; persuading regulatory bodies to withdraw the approval of brand-name drugs for which the patents are about to expire and converting the market to another product of the brand company on which longer patent protection exists; obtaining extensions of market exclusivity by conducting clinical trials of brand drugs in pediatric populations or by other methods; and seeking to obtain new patents on drugs for which patent protection is about to expire.
These strategies include, but are not limited to: entering into agreements whereby other generic companies will begin to market an authorized generic, which is the approved brand-name drug without the brand-name on its label, at the same time or after generic competition initially enters the market; launching their own authorized generic product prior to or at the same time or after generic competition initially enters the market; pricing a branded product at a discount equivalent to generic pricing; filing frivolous petitions with the FDA or other regulatory bodies seeking to prevent or delay approvals, including timing the frivolous filings so as to thwart generic competition by causing delays of our product approvals; contracting strategies among pharmaceutical manufacturers and PBMs that could decrease generic or biosimilar utilization and negatively impact our products; seeking to establish regulatory and legal obstacles that would make it more difficult to demonstrate bioequivalence or to meet other requirements for approval, and/or to prevent regulatory agency review of applications; initiating legislative or other efforts to limit the substitution of generic versions of brand pharmaceuticals; filing suits for patent infringement and other claims that may delay or prevent regulatory approval, manufacture, and/or sale of generic products; introducing “next-generation” products prior to the expiration of market exclusivity for the reference product, which often materially reduces the demand for the generic or the reference product for which we seek regulatory approval; persuading regulatory bodies to withdraw the approval of brand-name drugs for which the patents are about to expire and converting the market to another product of the brand company on which longer patent protection exists; obtaining extensions of market exclusivity by conducting clinical trials of brand drugs in pediatric populations or by other methods; and seeking to obtain patents on new uses, formulations and processes with respect to drugs for which any original patent protection is about to expire.
As the legislative and regulatory landscape for data privacy and security continues to evolve around the world, there has been an increasing focus on data privacy and security matters that may affect our business. 41 Table of Contents In the U.S., federal laws include HIPAA, which governs the use, disclosure, and security of protected health information by HIPAA covered entities and business associates.
As the legislative and regulatory landscape for data privacy and security continues to evolve around the world, there has been an increasing focus on data privacy and security matters that may affect our business. In the U.S., federal laws include HIPAA, which governs the use, disclosure, and security of protected health information by HIPAA covered entities and business associates.
Complying with new and changing regulations will likely require us to modify or update certain of our practices, processes, and manufacturing systems, which could require additional investment of time and resources or result in significant costs.
Complying with new, changing, and sometimes divergent regulations will likely require us to modify or update certain of our practices, processes, and manufacturing systems, which could require additional investment of time and resources or result in significant costs.
New or evolving government regulations, including in the EU, have resulted and could continue to result in new or more stringent forms of environmental, social and governance oversight and related costs, including increased greenhouse gas limitations, and the expansion of mandatory and voluntary reporting, due diligence, and disclosure regarding environmental, social and governance matters, which could materially negatively impact our business and operations.
New or evolving government regulations, including in the EU, have resulted and could continue to result in new or more stringent forms of environmental, social and governance oversight and related costs, including increased greenhouse gas limitations, and the expansion of mandatory and voluntary reporting, due diligence, and disclosure regarding environmental, social and governance matters, which could materially negatively impact our 46 Table of Contents business and operations.
We also cannot ensure that any limitation of liability or indemnity provisions in our contracts, including with vendors and service providers, for a cybersecurity threat or incident, security lapse or breach or other security incident would be enforceable or adequate or would otherwise protect us from any liabilities or damages with respect to any particular claim.
We also cannot ensure that any limitation of liability or indemnity provisions in our contracts, including with vendors and service providers, for a cybersecurity threat or incident, security lapse or breach or other security incident would be enforceable or adequate or would otherwise protect us from any liabilities or damages with 44 Table of Contents respect to any particular claim.
If we, or the third-party vendors on which we rely, fail to comply with applicable laws and regulations we could be subject to fines, penalties or sanctions, including criminal penalties. Similar initiatives could increase the cost of developing, implementing or maintaining our IT systems, require us to allocate more resources to compliance initiatives or increase our costs.
If we, or the third-party vendors on which we rely, fail to comply with applicable laws and regulations we could be subject to fines, penalties or sanctions, including criminal penalties. 45 Table of Contents Similar initiatives could increase the cost of developing, implementing or maintaining our IT systems, require us to allocate more resources to compliance initiatives or increase our costs.
In addition, regulations intended to limit greenhouse gas emissions or water usage, such as greenhouse gas emission reduction obligations, carbon pricing, and taxes on emissions, fuel and energy, or to mitigate the 43 Table of Contents impacts of climate change may become more prevalent, which could increase our operating costs and the costs charged by suppliers.
In addition, regulations intended to limit greenhouse gas emissions or water usage, such as greenhouse gas emission reduction obligations, carbon pricing, and taxes on emissions, fuel and energy, or to mitigate the impacts of climate change may become more prevalent, which could increase our operating costs and the costs charged by suppliers.
Our competitors may be able to develop products and processes competitive with or superior to our own for many reasons, including but not limited to the possibility that they may have: proprietary processes or delivery systems; larger or more productive R&D and marketing staff; larger or more efficient production capabilities in a particular therapeutic area; more experience in preclinical testing and human clinical trials; more products; 28 Table of Contents more experience in developing new drugs; or greater financial resources.
Our competitors may be able to develop products and processes competitive with or superior to our own for many reasons, including but not limited to the possibility that they may have: proprietary processes or delivery systems; larger or more productive R&D and marketing staff; larger or more efficient production capabilities in a particular therapeutic area; more experience in preclinical testing and human clinical trials; more products; more experience in developing new drugs; or greater financial resources.
If the volume or pricing of our largest selling products declines in the future, our business, financial condition, results of operations, cash flows, and/or share price could be materially adversely affected. 29 Table of Contents Operational Risks Current and changing economic conditions, including inflation, may adversely affect our industry, business, partners and suppliers.
If the volume or pricing of our largest selling products declines in the future, our business, financial condition, results of operations, cash flows, and/or share price could be materially adversely affected. Operational Risks Current and changing economic conditions, including inflation, may adversely affect our industry, business, partners and suppliers.
It is also possible that we could incur substantial costs if we initiate litigation against others to protect or enforce our intellectual property rights. 38 Table of Contents We may submit patent applications covering the API, formulation, methods of making, and/or methods of use for our branded products and branded product candidates.
It is also possible that we could incur substantial costs if we initiate litigation against others to protect or enforce our intellectual property rights. We may submit patent applications covering the API, formulation, methods of making, and/or methods of use for our branded products and branded product candidates.
The preparation of financial statements in accordance with U.S. GAAP involves making estimates, judgments and assumptions that affect reported amounts of assets, liabilities, revenues, expenses 46 Table of Contents and income. Estimates, judgments and assumptions are inherently subject to change in the future and any necessary revisions to prior estimates, judgments or assumptions could lead to a restatement.
The preparation of financial statements in accordance with U.S. GAAP involves making estimates, judgments and assumptions that affect reported amounts of assets, liabilities, revenues, expenses and income. Estimates, judgments and assumptions are inherently subject to change in the future and any necessary revisions to prior estimates, judgments or assumptions could lead to a restatement.
Such attacks are increasingly sophisticated 40 Table of Contents and are made by groups and individuals with a wide range of motives and expertise, including state and quasi-state actors, criminal groups, “hackers” and others. Evolving work conditions, including work from home protocols, may be less secure and have introduced operational risk, including increased cybersecurity risk.
Such attacks are increasingly sophisticated and are made by groups and individuals with a wide range of motives and expertise, including state and quasi-state actors, criminal groups, “hackers” and others. Evolving work conditions, including work from home protocols, may be less secure and have introduced operational risk, including increased cybersecurity risk.
Even if integration activities and restructuring programs are successful, we may not achieve anticipated synergies, growth opportunities and other financial and operating benefits within the timeline we anticipate, or at all.
Even if integration activities are successful, we may not achieve anticipated synergies, growth opportunities and other financial and operating benefits within the timeline we anticipate, or at all.
For the years ended December 31, 2024 and 2023, Viatris’ top three customers in terms of net sales, in the aggregate, represented approximately 26% and 25%, respectively, of the Company’s consolidated total net sales.
For the years ended December 31, 2025 and 2024, Viatris’ top three customers in terms of net sales, in the aggregate, represented approximately 25% and 26%, respectively, of the Company’s consolidated total net sales.
Any of these events could also result in a loss of confidence from our customers, loss of existing or potential business, and have a material adverse effect on our reputation, business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Any of these events could also result in a loss of confidence from our customers, loss of 39 Table of Contents existing or potential business, and have a material adverse effect on our reputation, business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Bribery Act, Chinese anti-corruption laws and similar worldwide anti-corruption laws, which impose restrictions on certain conduct and may carry substantial fines and penalties. Our competitors, including branded pharmaceutical companies, and/or other third parties, may allege that we or our suppliers are infringing upon their intellectual property, including in an “at risk launch” situation, 21 Table of Contents which could result in substantial monetary damages, impact our ability to launch a product and/or our ability to continue marketing a product, and/or force us to expend substantial resources in resulting litigation, the outcome of which is uncertain. We are involved in various legal proceedings and certain government inquiries and may experience unfavorable outcomes of such proceedings or inquiries. We are increasingly dependent on IT and information systems and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks. Finance Risks There can be no guarantee that we will continue to pay dividends or repurchase shares under our share repurchase program. We may not be able to maintain competitive financial flexibility and our corporate tax rate which could adversely affect us and our shareholders. Currency fluctuations and changes in exchange rates have impacted and could continue to adversely affect our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. We have significant indebtedness, which could lead to adverse consequences or adversely affect our financial position and prevent us from fulfilling our obligations under such indebtedness, and any refinancing of this debt could be at significantly higher interest rates. There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with U.S.
Bribery Act, Chinese anti-corruption laws and similar worldwide anti-corruption laws, which impose restrictions on certain conduct and may carry substantial fines and penalties. Our competitors, including branded pharmaceutical companies, and/or other third parties, may allege that we or our suppliers are infringing upon their intellectual property, including in an “at risk launch” situation, which could result in substantial monetary damages, impact our ability to launch a product and/or our ability to continue marketing a product, and/or force us to expend substantial resources in resulting litigation, the outcome of which is uncertain. We are involved in various legal proceedings and certain government inquiries and may experience unfavorable outcomes of such proceedings or inquiries. We are increasingly dependent on IT and information systems and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks. Incorporating ML, AI and other emerging technologies into our products, services and operations may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business, financial condition or results of operations. Finance Risks There can be no guarantee that we will continue to pay dividends or repurchase shares under our share repurchase program. We may not be able to maintain competitive financial flexibility and our corporate tax rate which could adversely affect us and our shareholders. Currency fluctuations and changes in exchange rates have impacted and could continue to adversely affect our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. We have significant indebtedness, which could lead to adverse consequences or adversely affect our financial position and prevent us from fulfilling our obligations under such indebtedness, and any refinancing of this debt could be at significantly higher interest rates. 24 Table of Contents There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with U.S.
Any failure to comply with the above 39 Table of Contents laws and regulations, and any such penalties or sanctions could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Any failure to comply with the above laws and regulations, and any such penalties or sanctions could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
We face vigorous competition that threatens the commercial acceptance and pricing of our products . The pharmaceutical industry is highly competitive. We face competition from other pharmaceutical manufacturers globally, some of whom are significantly larger than us and have stronger, more well-established reputations than us.
We face vigorous competition that threatens the commercial acceptance and pricing of our products . 31 Table of Contents The pharmaceutical industry is highly competitive. We face competition from other pharmaceutical manufacturers globally, some of whom are significantly larger than us and have stronger, more well-established reputations than us.
These proceedings may involve claims for, or the possibility of, fines, penalties, or damages involving substantial amounts of money or other relief, including but not limited to civil or criminal fines and penalties and exclusion from participation in various government healthcare-related programs.
These proceedings may involve claims for, or the possibility of, fines, penalties, joint and several liability, or damages involving substantial amounts of money or other relief, including but not limited to civil or criminal fines and penalties and exclusion from participation in various government healthcare-related programs.
A significant escalation or expansion of the conflict’s current scope may have a negative impact on our operations and financial results in future periods; changes in laws, regulations, and practices that impact the pharmaceutical industry and/or healthcare systems, including but not limited to imports, exports, manufacturing, quality, cost, pricing, reimbursement, approval, inspection, and delivery of healthcare; changes in policies designed to promote foreign investment, including significant tax incentives, liberalized import and export duties, and preferential rules on foreign investment and repatriation; differing local product preferences and product requirements; adverse changes in the economies in which we or our partners and suppliers operate as a result of a slowdown in overall growth; changes in government or economic policies, elections, or financial, political, or social change or instability that affects the markets or countries in which we or our partners operate; reductions in funding by U.S. governmental agencies for certain products in our Emerging Markets region; changes in employment or labor laws, or wage increases in the countries in which we or our partners and suppliers operate; local, regional and global restrictions on banking and commercial activities in certain markets, especially emerging markets; longer payment cycles and increased exposure to counterparty risk; volatility in international financial markets and increased foreign currency risk; inflation or hyperinflation in certain markets, including Turkey and Egypt; supply disruptions and increases in energy and transportation costs; increased tariffs on the import or export of our products, ingredients or inputs into our products, or API, including potentially significant reciprocal tariffs on products sold between the U.S. and other countries as a result of recent trade policy shifts in the U.S.; changes in U.S. government procurement laws for pharmaceutical products related to compliance with the Trade Agreements Act or country of origin policies, or changes in U.S. agency procurement policies for pharmaceutical products manufactured in India or China; burdens to comply with multiple, changing and potentially conflicting laws, regulations and disclosure requirements, including those relating to environmental, social and governance matters, carbon emissions, health and safety, labor and human rights; natural or man-made disasters, including droughts, floods, earthquakes, hurricanes, wildfires and the impact of climate change in the countries in which we or our partners and suppliers operate; and local disturbances, the outbreak of highly contagious diseases or other health epidemics or pandemics, terrorist attacks, riots, social disruption, wars, or regional hostilities in the countries in which we or our partners and suppliers operate and that could affect the economy, our operations and employees by disrupting operations and communications, making travel and the conduct of our business more difficult, and/or causing our customers to be concerned about our ability to meet their needs.
A significant escalation or expansion of the conflict’s current scope may have a negative impact on our operations and financial results in future periods; changes in laws, regulations, and practices that impact the pharmaceutical industry and/or healthcare systems, including but not limited to imports, exports, manufacturing, quality, cost, pricing, reimbursement, approval, inspection, and delivery of healthcare; changes in policies designed to promote foreign investment, including significant tax incentives, liberalized import and export duties, and preferential rules on foreign investment and repatriation; differing local product preferences and product requirements; adverse changes in the economies in which we or our partners and suppliers operate as a result of a slowdown in overall growth; government shutdowns or changes in government or economic policies, elections, or financial, political, or social change or instability that affects the markets or countries in which we or our partners operate; reductions in funding by U.S. governmental agencies for certain products in our Emerging Markets region; changes in employment or labor laws, or wage increases in the countries in which we or our partners and suppliers operate; local, regional and global restrictions on banking and commercial activities in certain markets, especially emerging markets; longer payment cycles and increased exposure to counterparty risk; volatility in international financial markets and increased foreign currency risk; inflation or hyperinflation in certain markets, including Turkey and Egypt; supply disruptions and increases in energy and transportation costs; imposition of adopted, new, announced or proposed tariffs, trade restrictions or domestic sourcing requirements, including but not limited to products, ingredients, and inputs (such as API) on products sold between the U.S. and other countries as a result of recent trade policy shifts in the U.S. and other countries; changing or increasing requirements related to the domestic or regional manufacture of pharmaceutical products, or other country of origin policies, in the U.S., EU, and other jurisdictions globally, including changes in U.S. government procurement laws for pharmaceutical products related to compliance with the Trade Agreements Act or country of origin policies, changes in U.S. agency procurement policies for pharmaceutical products manufactured in India or China, or changes in relevant customs, import, and export laws; burdens to comply with multiple, changing and potentially conflicting laws, regulations and disclosure requirements, including those relating to environmental, social and governance matters, carbon emissions, health and safety, labor and human rights; natural or man-made disasters, including droughts, floods, earthquakes, hurricanes, wildfires and the impact of climate change in the countries in which we or our partners and suppliers operate; and local disturbances, the outbreak of highly contagious diseases or other health epidemics or pandemics, terrorist attacks, riots, social disruption, wars, or regional hostilities in the countries in which we or our partners and suppliers operate and that could affect the economy, our operations and employees by disrupting operations and communications, making travel and the conduct of our business more difficult, and/or causing our customers to be concerned about our ability to meet their needs.
See also The pharmaceutical industry is heavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicable laws and regulations.” 36 Table of Contents We purchase certain API and other materials and supplies that we use in our manufacturing operations, as well as certain finished products, from many different foreign and domestic suppliers.
See also The pharmaceutical industry is heavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicable laws and regulations .” We purchase certain API and other materials and supplies that we use in our manufacturing operations, as well as certain finished products, from many different foreign and domestic suppliers.
GAAP provisions relating to business acquisition accounting standards, we recognize the identifiable assets acquired, the liabilities assumed, and any noncontrolling interests in acquired companies generally at their acquisition date fair values and, in each case, separately from goodwill.
Under U.S. GAAP provisions relating to business acquisition accounting standards, we recognize the identifiable assets acquired, the liabilities assumed, and any noncontrolling interests in acquired companies generally at their acquisition date fair values and, in each case, separately from goodwill.
The occurrence of any of the above risks could have a material adverse effect on our industry, business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
The occurrence of any of the above risks could cause a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Such impairments or losses have in the past and could in the future materially affect Viatris’ reported net earnings, business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Such impairments or losses have in the past and could in the future materially affect Viatris’ business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
These regulations may significantly increase the cost of producing our pharmaceutical products, limit our ability to supply certain products in certain markets, or may limit our competitiveness, which may adversely impact our market share, business and operations.
These and other similar regulations may significantly increase the cost of producing and supplying our pharmaceutical products, limit our ability to supply certain products in certain markets, or may limit our competitiveness, which may adversely impact our market share, business and operations.
In addition, we have incurred and may in the future incur significant impairment charges or losses. For instance, during the year ended December 31, 2024, the Company recorded significant goodwill and other long-lived asset impairment charges.
In addition, we have incurred and may in the future incur significant impairment charges or losses. For instance, during the years ended December 31, 2024 and 2025, the Company recorded significant goodwill and other long-lived asset impairment charges.
Moreover, if we obtain regulatory approval for a drug, it may be limited, for example, with respect to the indicated uses and delivery methods for which the drug may be marketed, or may include warnings, 33 Table of Contents precautions or contraindications in the labeling, which could restrict our potential market for the drug.
Moreover, if we obtain regulatory approval for a drug, it may be limited, for example, with respect to the indicated uses and delivery methods for which the drug may be marketed, or may include warnings, precautions or contraindications in the labeling, which could restrict our potential market for the drug.
We or 34 Table of Contents our collaboration partners may experience delays in our ongoing or future clinical trials, and we do not know whether planned clinical trials will begin or enroll subjects on time, need additional financing, need to be redesigned, or be completed on schedule, if at all.
We or our collaboration partners may experience delays in our ongoing or future clinical trials, and we do not know whether planned clinical trials will begin or enroll subjects on time, need additional financing, need to be redesigned, or be completed on schedule, if at all.
Foreign Extortion Prevention Act, the U.K. Bribery Act, Chinese anti-corruption laws and similar worldwide anti-corruption laws, which impose restrictions on certain conduct and may carry substantial fines and penalties. 37 Table of Contents We are 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.
Foreign Extortion Prevention Act, the U.K. Bribery Act, Chinese anti-corruption laws and similar worldwide anti-corruption laws, which impose restrictions on certain conduct and may carry substantial fines and penalties. We are 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.
In addition, AI-based solutions, including generative AI, are increasingly being used in the pharmaceutical industry, including by us, and we expect to use other systems and tools that incorporate AI-based technologies in the future.
ML and AI-based solutions, including generative AI, are increasingly being used in the pharmaceutical industry, including by us, and we expect to use other systems and tools that incorporate ML or AI-based technologies in the future.
We have potential tax exposures resulting from the varying application of statutes, regulations, and interpretations which include exposures on intercompany terms of cross-border arrangements among our subsidiaries (including intercompany loans, licenses, sales, and services agreements) in relation to various aspects of our business, including manufacturing, marketing, sales, and delivery functions.
We have potential tax exposures resulting from the varying application of statutes, regulations, and interpretations which include exposures on intercompany pricing of cross-border arrangements among our subsidiaries (including intercompany loans, licenses, sales, and services agreements) in relation to various aspects of our business, including manufacturing, marketing, sales, distribution and enabling functions.
We may miscalculate the risks associated with our strategic initiatives and priorities at the time they are made or not have the resources or ability to access all the relevant information to evaluate them properly, including with regard to the potential of R&D pipelines, manufacturing issues, compliance issues, or the outcome of ongoing legal and other proceedings.
We may miscalculate the risks associated with our strategic initiatives and priorities at the time they are made or not have the resources or ability to access all the relevant information to evaluate them properly, including with regard to the potential of R&D pipelines, manufacturing issues, compliance issues, supply chain continuity, technology, data capabilities, or the outcome of ongoing legal and other proceedings.
Our level of indebtedness could have important consequences, including but not limited to: increasing our vulnerability to general adverse economic and industry conditions; requiring us to dedicate a substantial portion of our cash flow from operations to make debt service payments, or repay debt, thereby reducing the availability of cash flow to fund working capital, capital expenditures, acquisitions and investments, dividend payments or share repurchases, and other general corporate purposes; limiting our flexibility in planning for, or reacting to, challenges and opportunities, and changes in our businesses and the markets in which we operate; limiting our ability to obtain additional financing to fund our working capital, capital expenditures, acquisitions and debt service requirements and other financing needs; increasing our vulnerability to increases in interest rates in general related to any of our indebtedness that bears interest at floating rates or when refinancing maturing debt at higher rates; increasing our exposure to currency fluctuations, since a significant portion of our indebtedness is denominated in currencies other than the U.S. dollar, such as our Euro and Japanese yen denominated debt; and placing us at a competitive disadvantage to our competitors that have less debt.
Our level of indebtedness could have important consequences, including but not limited to: increasing our vulnerability to general adverse economic and industry conditions; 49 Table of Contents requiring us to dedicate a substantial portion of our cash flow from operations to make debt service payments, or repay debt, thereby reducing the availability of cash flow to fund working capital, capital expenditures, acquisitions and investments, dividend payments or share repurchases, and other general corporate purposes; limiting our flexibility in planning for, or reacting to, challenges and opportunities, and changes in our businesses and the markets in which we operate; limiting our ability to obtain additional financing to fund our working capital, capital expenditures, acquisitions and debt service requirements, and other financing needs; increasing our vulnerability to increases in interest rates in general related to any of our indebtedness that bears interest at floating rates or when refinancing maturing debt at higher rates; increasing our exposure to currency fluctuations, since a significant portion of our indebtedness is denominated in currencies other than the U.S.
In addition, while the Board of Directors has authorized a $2 billion share repurchase program, of which $1.5 billion remains available as of February 27, 2025, there is no guarantee with respect to the timing or amount of any future share repurchases, or that we will repurchase the full amount authorized under our current share repurchase program.
In addition, while the Board of Directors has authorized a $2 billion share repurchase program, of which $1.0 billion remains available as of February 26, 2026, there is no guarantee with respect to the timing or amount of any future share repurchases, or that we will repurchase the full amount authorized under our current share repurchase program.
We cannot give any assurance as to what our effective tax rate will be, however, because of, among other reasons, uncertainty regarding the tax policies of the jurisdictions where we operate, potential changes of laws and interpretations thereof, and the potential for tax audits or challenges.
We cannot give any assurance as to what our effective tax rate will be, however, due to uncertainty regarding the tax policies of the jurisdictions where we operate, potential changes of laws and interpretations thereof, the potential for tax audits or challenges, and other complexities.
These integration and restructuring processes have in the past and may in the future require Viatris’ senior management to devote considerable amounts of time to these processes, which has in the past and could in the future decrease the time they have to manage and service Viatris’ businesses, and develop new products or strategies.
In addition, integration activities have in the past and may in the future require Viatris’ senior management to devote considerable amounts of time to these activities, which has in the past and could in the future decrease the time they have to manage and service Viatris’ existing businesses, and develop new products or strategies.
The conflict has also impacted our and our partners’ 26 Table of Contents ability to market or sell pharmaceutical products in the area, and has caused and may continue to cause other disruptions to the supply chain.
The conflict has also impacted our and our partners’ ability to market or sell pharmaceutical products in the area, and has caused and may continue to cause other disruptions to the supply chain.
The number of new vulnerabilities identified to these systems combined with the increased number of systems that reach end of life each year creates an opportunity for successful malicious attacks.
The number of new vulnerabilities identified to these systems combined with the increased number of systems that reach end of life each year creates an opportunity for system failures as well as successful malicious attacks.
In addition, actual or alleged quality deficiencies in the products which we or our suppliers provide, or at our or their manufacturing facilities, including with respect to the recent warning letter and import alert at our Indore facility, have in the past and could in the future adversely impact our manufacturing and supply capabilities, cause supply interruptions, or lead to voluntary market withdrawals or product recalls.
In addition, actual or alleged quality deficiencies in the products which we or our suppliers provide, or at our or their manufacturing facilities, including with respect to warning letters and import alerts, for example at our Indore facility, have in the past and could in the future adversely impact our manufacturing and supply capabilities, cause supply interruptions, or lead to voluntary market withdrawals or product recalls.
There are ongoing risks and uncertainties associated with our recent divestitures, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
There are risks and uncertainties associated with divestitures, product rationalizations and asset sales, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Emerging developments in the U.S. legal landscape relative to the liability of pharmaceutical manufacturers for certain product liabilities claims could increase our exposure to litigation costs and damages, including in connection with third party defense and indemnification demands.
The legal landscape for the liability of pharmaceutical manufacturers for certain product liabilities claims could increase our exposure to litigation costs and damages, including in connection with third party defense and indemnification demands.
The occurrence of any one or more of the above risks could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
The occurrence of any of the above risks could have an adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
Innovative assets are more difficult, costly and time-consuming to develop, receive regulatory approval for and bring to market.
Innovative and patent protected assets are difficult, costly and time-consuming to develop, receive regulatory approval for and bring to market.
Generic competitors are also becoming more aggressive in terms of pricing in many of the regions in which Viatris operates. In China, for example, we face strong competition from certain generic manufacturers, which have resulted and may in the future result in price cuts and volume loss on some of Viatris’ branded products.
Generic competitors are also becoming more aggressive in terms of pricing in many of the regions in which Viatris operates. In China, for example, we face strong competition from certain generic manufacturers, which has resulted and may in the future result in price cuts and volume loss on some of Viatris’ branded products without patent term and/or regulatory protection.
The use of legal, regulatory, and legislative strategies by both brand and generic competitors, including but not limited to “authorized generics” and regulatory petitions, may increase costs associated with the introduction or marketing of our generic products, could delay or prevent such introduction, and could significantly reduce our revenue and profit .
The use of legal, regulatory, and legislative strategies by both brand and generic competitors, including but not limited to “authorized generics” and regulatory petitions, may increase costs associated with the introduction or marketing of our generic products, could delay or prevent such introduction, and could significantly reduce our revenue and profit . 35 Table of Contents Our competitors, both branded and generic, often pursue strategies that could prevent or delay generic alternatives to branded products.
In addition, higher rates of inflation over the past few years have resulted, and may continue to result, in increased costs of labor, raw materials, other supplies and freight and distribution costs, among others.
In addition, higher rates of inflation have resulted, and may continue to result, in increased costs of labor, raw materials, other supplies and freight and distribution costs, among others.
In 2022, then-President Biden signed into law the Inflation Reduction Act, which includes numerous Medicare reforms that will affect reimbursement for certain pharmaceuticals covered by Medicare and modify the Part D and Part B program structure, including shifting the liability for certain prescription drug costs shared between Medicare, pharmaceutical manufacturers, and Part D plans.
In 2022, the Inflation Reduction Act was enacted, which includes numerous Medicare reforms that will affect reimbursement for certain pharmaceuticals covered by Medicare and modify the Part D and Part B program structure, including shifting the liability for certain prescription drug costs shared between Medicare, pharmaceutical manufacturers, and Part D plans.
Under certain circumstances, a regulator may also have the authority to revoke or vary previously granted drug approvals. The safety profile of any product will continue to be closely monitored by the FDA and comparable foreign regulatory authorities after approval.
Under certain circumstances, a regulator may also have the authority to revoke or vary previously granted drug approvals. The safety profile of any product will continue to be closely monitored both by the Company through on-going post-market vigilance programs and by the FDA and comparable foreign regulatory authorities after approval.
In particular, Section 404 of the Sarbanes-Oxley Act of 2002 requires management’s annual review and evaluation of our internal control over financial reporting and attestation as to the effectiveness of these controls by our independent registered public accounting firm.
In the U.S., such regulations include the Sarbanes-Oxley Act of 2002, SEC regulations and the NASDAQ listing standards. In particular, Section 404 of the Sarbanes-Oxley Act of 2002 requires management’s annual review and evaluation of our internal control over financial reporting and attestation as to the effectiveness of these controls by our independent registered public accounting firm.
An adverse decision in a case such as this, or a judicial order preventing us or our suppliers and partners from manufacturing, marketing, selling, and/or other activities necessary to the manufacture and distribution of our products, could result in substantial penalties, and/or have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
An adverse decision in a case such as this, or a judicial order preventing us or our suppliers and partners from manufacturing, marketing, selling, and/or other activities necessary to the manufacture and distribution of our products, could result in substantial penalties, and/or have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. 41 Table of Contents We rely on the effectiveness of our patents, trademarks, confidentiality agreements and other measures to protect our intellectual property rights.
We may not be successful in managing competition from non-branded generics or other alternatives, or in generally managing revenues after loss of exclusivity, and our business may be materially adversely affected. We also face increasing competition from lower-cost generic products and other branded products.
For example, we may lose market exclusivity for Amitiza® 24 μg in Japan in June 2026. We may not be successful in managing competition from non-branded generics or other alternatives, or in generally managing revenues after loss of exclusivity, and our business may be materially adversely affected. We also face increasing competition from lower-cost generic products and other branded products.
Treasury takes measures to avoid such a default, or if there is an assumption that such an event may occur, this could have a negative impact on general economic conditions, including the liquidity of and access to the capital markets.
For example, if the U.S. or another country defaults on its debt, or takes measures to avoid such a default, or if there is an assumption that such an event may occur, this could have a negative impact on general economic conditions, including the liquidity of and access to the capital markets.
These and other future events or decisions have in the past and may in the future lead to asset impairments and/or related charges. Certain impairments may also result from a change in our strategic goals, business direction or other factors relating to the overall business environment.
These and other future events or decisions have in the past and may in the future lead to significant asset impairments and/or related charges, including a goodwill impairment charge of $2.94 billion in 2025. Certain impairments may also result from a change in our strategic goals, business direction or other factors relating to the overall business environment.
We are subject to income taxes in many jurisdictions. Significant analysis and judgment are required in determining our worldwide provision for income taxes. In the ordinary course of business, there are many transactions and calculations where the ultimate tax determination is uncertain.
Significant analysis and judgment are required in determining our worldwide provision for income taxes. In the ordinary course of business, there are many transactions and calculations where the ultimate tax determination is uncertain. We are currently subject to tax audits, investigations and litigations in several jurisdictions, and may be subject to other audits, investigations or litigations in the future.
While we believe our relationships with our collaboration partners generally are successful, our collaboration partners’ financial situation, or disputes or conflicting priorities and regulatory or legal intervention has been or could in the future be a source of delay or uncertainty as to the expected benefits of our strategic alliances and collaborations.
In addition, our collaboration partners’ financial situation, or disputes or conflicting priorities and regulatory or legal intervention has been or could in the future be a source of delay or uncertainty as to the expected benefits of our strategic alliances and collaborations.
In addition, customers may decide to downsize, defer or cancel contracts which could negatively affect our revenue. Recently, interest rates have increased above historical rates paid by Viatris. As such, any debt we refinance in the future may increase, even substantially, our interest expense in future periods.
In addition, customers may decide to downsize, defer or cancel contracts which could negatively affect our revenue. Interest rates continue to be higher than historical rates paid by Viatris. As such, any debt we refinance in 2026 or beyond may increase, even substantially, our interest expense in future periods.
Therefore, Viatris’ sales and marketing force, whether in-house sales representatives or third-party commercial partners, must possess a relatively high level of technical knowledge, up-to-date understanding of industry trends and expertise in the relevant therapeutic areas and products, as well as promotion and 35 Table of Contents communication skills.
Therefore, Viatris’ sales and marketing force, whether in-house sales representatives or third-party commercial partners, must possess a relatively high level of technical knowledge, up-to-date understanding of industry trends and expertise in the relevant therapeutic areas and products, as well as promotion and communication skills. Marketing, advertising and promotions may be expensive and may not achieve their intended benefits.
Failure to comply with cGMP and other regulatory standards at one of our or our partners’ or suppliers’ manufacturing facilities could result in an adverse action brought by the FDA or other regulatory authorities, which has resulted and could in the future result in the receipt of an untitled or warning letter, fines, penalties, disgorgement, unanticipated compliance expenditures, rejection or delay in approval of applications, suspension of review of applications or other submissions, suspension of ongoing clinical trials, recall or seizure of products, total or partial suspension of production and/or distribution, our inability to sell products, the return by customers of our products, orders to suspend, vary, or withdraw marketing authorizations, injunctions, consent decrees, requirements to modify promotional materials or issue corrective information to healthcare practitioners, refusal to permit import or export, criminal prosecution and/or other adverse actions. 31 Table of Contents Although we have established internal quality and regulatory compliance programs and policies, there is no guarantee that these programs and policies, as currently designed, will meet regulatory agency standards in the future or will prevent instances of non-compliance with applicable laws and regulations.
Failure to comply with cGMP and other regulatory standards at one of our or our partners’ or suppliers’ manufacturing facilities could result in an adverse action brought by the FDA or other regulatory authorities, which has resulted and could in the future result in the receipt of an untitled or warning letter, fines, penalties, disgorgement, unanticipated compliance expenditures, rejection or delay in approval of applications, suspension of review of applications or other submissions, suspension of ongoing clinical trials, recall or seizure of products, total or partial suspension of production and/or distribution, our inability to sell products, the return by customers of our products, orders to suspend, vary, or withdraw marketing authorizations, injunctions, consent decrees, requirements to modify promotional materials or issue corrective information to healthcare practitioners, refusal to permit import or export, criminal prosecution and/or other adverse actions.
We may be required to expend significant funds and our manufacturing activities could be delayed or suspended or we may lose the ability to purchase or use certain materials, or face restrictions on the amounts of materials we may use or purchase, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price. 30 Table of Contents The pharmaceutical industry is heavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicable laws and regulations.
We may be required to expend significant funds and our manufacturing activities could be delayed or suspended or we may lose the ability to purchase or use certain materials, or face restrictions on the amounts of materials we may use or purchase, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe conduct initial risk assessments of third-party suppliers and service providers based 50 Table of Contents on various factors and then review and monitor these third-party suppliers and service providers based on their relative assessed level of risk. We also require our suppliers, subcontractors and third-party service providers to agree to cybersecurity-related contractual terms and conditions of purchase.
Biggest changeOur suppliers, 54 Table of Contents subcontractors and third-party service providers, including third-party managed security providers, are subject to cybersecurity obligations and controls. We conduct initial risk assessments of third-party suppliers and service providers based on various factors and then review and monitor these third-party suppliers and service providers based on their relative assessed level of risk.
As part of its information security program, Viatris has adopted a Cybersecurity Incident Response Plan (CIRP) to establish a guide for Viatris’ leadership and incident response stakeholders through an “incident” a single event or a set of anomalous and adverse “events” or, for purposes of the CIRP, a change in a system, technology device or environment that could impact the confidentiality, integrity, availability or safety of Viatris’ data, employees or assets, caused by malicious intent or accident and impacting Viatris’ network, computing systems, digital information, employees or assets.
As part of its cybersecurity program, Viatris has adopted a Cybersecurity Incident Response Plan (CIRP) to establish a guide for Viatris’ leadership and incident response stakeholders through an “incident” a single event or a set of anomalous and adverse “events” or, for purposes of the CIRP, a change in a system, technology device or environment that could impact the confidentiality, integrity, availability or safety of Viatris’ data, employees or assets, caused by malicious intent or accident and impacting Viatris’ network, computing systems, digital information, employees or assets.
The Company’s Disclosure Controls and Procedures also require (i) the Company’s Information Security function to monitor and escalate, as appropriate, cybersecurity incidents or series of related incidents (including with respect to any third party provider to the Company of IT services) and (ii) the Disclosure Committee to determine, without unreasonable delay, the materiality of any such escalated cybersecurity incidents or series of related incidents with input from Global Compliance, Information Security, Legal, Finance and other groups, as appropriate.
The Company’s Disclosure Controls and Procedures also require (i) the Company’s Cybersecurity function to monitor and escalate, as appropriate, cybersecurity incidents or series of related “incidents” (including with respect to any third party provider to the Company of IT services) and (ii) the Disclosure Committee to determine, without unreasonable delay, the materiality of any such escalated cybersecurity incidents or series of related incidents with input from Global Compliance, Global Privacy, Global Security, Legal, Finance and other groups, as appropriate.
The Viatris IT team, led by the Chief Information Officer, is responsible for ongoing security operations such as maintaining firewalls and patch management. In addition, the delivery of many information security programs relies on IT resources to execute the selection, delivery and implementation of security solutions, such as end-point protection and end-of-life protocols.
The Viatris IT team, led by the Chief Information Officer, is responsible for ongoing security operations such as maintaining firewalls and patch management. In addition, the delivery of many cybersecurity programs relies on IT resources to execute the selection, delivery and implementation of security solutions, such as identity and access management, end-point protection and end-of-life protocols.
The CIRP provides an overview of critical actions to take through the incident response lifecycle and contains a severity matrix used to guide the Company’s incident response stakeholders on communication and escalation protocols.
The CIRP provides an overview of critical actions to take throughout the incident response lifecycle and contains a severity matrix used to guide the Company’s incident response stakeholders on communication and escalation protocols.
On a biannual basis, the Compliance and Risk Oversight Committee and chairs of each other Committee of the Viatris Board receive an information security update from the Company’s Chief Information Security Officer & Head of Global Security, the Chief Compliance Officer and the Chief Information Officer.
On a biannual basis, the Compliance and Risk Oversight Committee and chairs of each other Committee of the Viatris Board receive a cybersecurity update from the Company’s Chief Information Security Officer & Head of Global Security, the Chief Compliance Officer and the Chief Information Officer.
ITEM 2. Properties For information regarding properties, refer to Item 1 “Business” in Part I of this Form 10-K. ITEM 3. Legal Proceedings For information regarding legal proceedings, refer to Note 19 Litigation included in Part II, Item 8 of this 10-K.
ITEM 2. Properties For information regarding properties, refer to Item 1 “Business” in Part I of this Form 10-K. ITEM 3. Legal Proceedings For information regarding legal proceedings, refer to Note 20 Litigation included in Part II, Item 8 of this 10-K.
ITEM 1C. Cybersecurity Viatris operates in a complex and rapidly changing environment that involves many potential risks, including IT and cybersecurity risks. Risk management is an enterprise-wide objective and is subject to oversight by the Viatris Board and its committees.
ITEM 1C. Cybersecurity Viatris operates in a complex and rapidly changing environment that involves many potential risks, including IT, information security, cybersecurity, and AI risks. Risk management is an enterprise-wide objective and is subject to oversight by the Viatris Board and its committees.
The Company’s Chief Information Security Officer & Head of Global Security, under the direction of the Company’s Chief Compliance Officer, reports quarterly to an internal risk committee of senior management, which includes the CEO, CFO, Chief Legal Officer, Chief People Officer, Chief Corporate Affairs Officer, Chief Information Officer, Chief Compliance Officer, Chief Quality Officer, Chief Supply Officer, Chief R&D Officer and Regional Presidents, as well as the Viatris Board on the progress of the information security program and overall security status.
The Company’s Chief Information Security Officer & Head of Global Security, under the direction of the Company’s Chief Administrative and Transformation Officer, reports quarterly to an internal risk committee of senior management, which includes the CEO, CFO, Chief Legal Officer, Chief Administrative and Transformation Officer, Chief People and Corporate Affairs Officer, Chief Information Officer, Chief Compliance Officer, Chief Supply Officer, Chief R&D Officer and Regional Presidents, as well as the Viatris Board on the progress of the cybersecurity program and overall security status.
Viatris’ current Chief Information Security Officer & Head of Global Security has over 25 years of experience in information security within the pharmaceutical industry.
Viatris’ current Chief Information Security Officer & Head of Global Security has over 30 years of experience in cybersecurity within the pharmaceutical industry.
Viatris’ information security program includes policies, procedures, cybersecurity awareness communications, testing, and training for employees (including mandatory training programs for system users), system monitoring, risk reduction, vulnerability and patch management and monitoring of external developments. The information security team is responsible for defining and overseeing the execution of the Company’s information security program and strategy.
Viatris’ cybersecurity program includes policies, procedures, awareness communications, testing, and training for employees (including mandatory training programs for privileged users), as well as system monitoring, risk reduction, vulnerability and patch management and monitoring of external threats. The Global Security team is responsible for defining and overseeing the execution of the Company’s cybersecurity program and strategy.
With respect to IT and cybersecurity risks, Viatris maintains an information security program that is aligned with the National Institute of Standards and Technology Cybersecurity Framework, and which is designed to govern, identify, protect, detect, respond to and recover from cybersecurity threats.
With respect to cybersecurity risks, Viatris maintains a cybersecurity program that is aligned with the National Institute of Standards and Technology (NIST) Cybersecurity Framework, designed to govern, identify, protect, detect, respond to and recover from cybersecurity threats.
The CIRP is managed by the Viatris global information security team and is reviewed at least annually. Viatris tests the CIRP through technical exercises semi-annually, reviews the CIRP with executive management annually, and periodically conducts executive tabletop exercises/scenarios.
The CIRP is managed by the Viatris global security team and their managed security service providers and is reviewed at least annually. Viatris tests the CIRP through semi-annual technical exercises and periodically conducts executive tabletop exercises/scenarios.
The CIRT is responsible for determining the potential impacts to the Company, including severity, notifying appropriate parties pursuant to the CIRP and determining whether to engage a third-party incident response vendor, among other responsibilities. Critical incidents require implementation of the global crisis plan and high severity incidents require notification to the executive leadership team once such an incident is confirmed.
The CIRT is responsible for determining the potential impacts to the Company, including type and severity, notifying appropriate parties pursuant to the CIRP and determining whether to engage a third-party incident response vendor, among other responsibilities.
The Company participates in several industry and third-party threat monitoring and information-sharing services, and these engagements provide insight into vulnerabilities and threats which are incorporated into the security operations and IT remediation.
The Company participates in several industry and third-party threat monitoring and information-sharing services, and these engagements provide insight into vulnerabilities and threats which are incorporated into the security operations and IT remediation. Key aspects of the cybersecurity program are also provided by third-party managed security providers, including first- and second-line support for incident response and the Company’s vulnerability assessment process.
The severity of the incident guides the determination of the parties to whom the incident will be escalated, and the Company may decide to seek assistance from a third-party incident response vendor. Viatris’ Cybersecurity Incident Response Team (CIRT) reports to the Chief Information Security Officer & Head of Global Security and has the role of investigating and executing incident protocols.
The severity of the incident guides the determination of the parties to whom the incident will be escalated, and the Company may decide to seek assistance from third-party incident response vendors.
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Key aspects of the information security program are also provided by third-party managed security providers, including first- and second-line support for incident response and the Company’s vulnerability assessment process. Our suppliers, subcontractors and third-party service providers, including third-party managed security providers, are subject to cybersecurity obligations and controls.
Added
Viatris’ Cybersecurity Incident Response Team (CIRT) reports to the Chief Information Security Officer & Head of Global Security and has the role of responding to incidents and executing incident protocols.
Added
Critical incidents require implementation of the global crisis plan and high severity incidents require notification to the executive leadership team once such an incident is confirmed.
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We also require our suppliers, subcontractors and third-party service providers to agree to cybersecurity-related contractual terms and conditions of purchase.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe Company also paid quarterly cash dividends of $0.12 per share on the Company’s issued and outstanding common stock in each of the four quarters of 2023 and 2022. 52 Table of Contents STOCK PERFORMANCE GRAPH Viatris common stock has been listed on the NASDAQ under the symbol “VTRS” since November 17, 2020.
Biggest changeThe Company also paid quarterly cash dividends of $0.12 per share on the Company’s issued and outstanding common stock in each of the four quarters of 2024 and 2023. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS Viatris Inc.
The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from November 16, 2020 to December 31, 2024.
The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from December 31, 2020 to December 31, 2025.
On February 24, 2025, the Company’s Board of Directors declared a quarterly cash dividend of $0.12 per share on the Company’s issued and outstanding common stock, which will be payable on March 18, 2025 to shareholders of record as of the close of business on March 10, 2025.
On February 23, 2026, the Company’s Board of Directors declared a quarterly cash dividend of $0.12 per share on the Company’s issued and outstanding common stock, which will be payable on March 18, 2026 to shareholders of record as of the close of business on March 9, 2026.
ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is traded on the NASDAQ Stock Market under the symbol “VTRS”. As of February 21, 2025, there were approximately 95,287 holders of record of shares of Viatris common stock.
ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is traded on the NASDAQ Stock Market under the symbol “VTRS”. As of February 23, 2026, there were approximately 87,770 holders of record of shares of Viatris common stock.
The Company paid quarterly cash dividends of $0.12 per share on the Company’s issued and outstanding common stock on March 18, 2024, June 14, 2024, September 13, 2024 and December 13, 2024.
The Company paid quarterly cash dividends of $0.12 per share on the Company’s issued and outstanding common stock in March 2025, June 2025, September 2025 and December 2025.
Prior to that time, there was no public market for our common stock. The graph below compares Viatris Inc.’s cumulative total shareholder return on common stock with the cumulative total returns of the S&P 500 index and the Dow Jones US Pharmaceuticals index.
(c) Average price per share includes commissions. 56 Table of Contents STOCK PERFORMANCE GRAPH The graph below compares Viatris Inc.’s cumulative total shareholder return on common stock with the cumulative total returns of the S&P 500 index and the Dow Jones US Pharmaceuticals index.
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November 16, 2020 December 31, 2020 December 31, 2021 December 31, 2022 December 31, 2023 December 31, 2024 Viatris Inc. 100.00 119.67 88.40 75.78 77.34 92.55 S&P 500 100.00 115.21 148.28 121.43 153.35 191.72 Dow Jones U.S. Pharmaceuticals 100.00 104.70 130.85 141.10 141.08 152.31
Added
Issuer purchases of equity securities Period Total Number of Shares Purchased (a) (b) Average Price Paid per Share (c) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (a) (b) Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs (a) October 1 - October 31, 2025 7,126,338 $ 10.14 7,126,338 $ 1,009,421,070 November 1 - November 30, 2025 928,388 10.65 928,388 999,532,092 December 1 - December 31, 2025 — — — 999,532,092 Total 8,054,726 $ 10.20 8,054,726 $ 999,532,092 ____________ (a) Refer to Part II, Item 7.
Added
Management’s Discussion and Analysis of Financial Condition And Results of Operations – Recent Developments of this Form 10-K for additional information regarding the Company’s authorized share repurchase program. During the three months ended December 31, 2025, the Company repurchased approximately 8.1 million shares of common stock at a cost of approximately $82.1 million under this program.
Added
(b) The number of shares purchased is based on the purchase date and not the settlement date.
Added
December 31, 2020 December 31, 2021 December 31, 2022 December 31, 2023 December 31, 2024 December 31, 2025 Viatris Inc. 100.00 73.87 63.32 64.63 77.34 81.26 S&P 500 100.00 128.71 105.40 133.10 166.40 196.16 Dow Jones U.S. Pharmaceuticals 100.00 124.98 134.76 134.75 145.47 185.97 ITEM 6. [Reserved]

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeFactors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives and priorities (including divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions) or accelerate its growth by building on the strength of its base business with an expanding portfolio of innovative, best-in-class, patent-protected assets; the possibility that the Company may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, strategic alliances, collaborations, or other transactions, or restructuring programs, within the expected timeframes or at all; the ongoing risks and uncertainties associated with our recent divestitures; goodwill or impairment charges or other losses; the Company’s failure to achieve expected or targeted future financial and operating performance and results; the potential impact of natural or man-made disasters, public health outbreaks, epidemics, pandemics, or social disruption in regions where we or our partners or suppliers operate; actions and decisions of healthcare and pharmaceutical regulators; changes in relevant laws, regulations and policies and/or the application or implementation thereof, including but not limited to tax, healthcare and pharmaceutical laws, regulations and policies globally; the ability to attract, motivate and retain key personnel; the Company’s liquidity, capital resources and ability to obtain financing; any regulatory, legal or other impediments to the Company’s ability to bring new products to market, including but not limited to “at-risk launches”; success of clinical trials and the Company’s or its partners’ ability to execute on new product opportunities and develop, manufacture and commercialize products; any changes in or difficulties with the Company’s manufacturing facilities, including with respect to inspections, remediation and restructuring activities, supply chain or inventory or the ability to meet anticipated demand; the scope, timing and outcome of any ongoing legal proceedings, including government inquiries or investigations, and the impact of any such proceedings on the Company; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with having significant operations globally; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in the Company’s or its partners’ customer and supplier relationships and customer purchasing patterns, including customer loss and business disruption being greater than expected following an adverse regulatory action, acquisition or divestiture; the impacts of competition, including decreases in sales or revenues as a result of the loss of market exclusivity for certain products; changes in the economic and financial conditions of the Company or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company’s products; 54 Table of Contents uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, tariffs and trade policies, inflation rates and global exchange rates; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with U.S.
Biggest changeFactors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives and priorities; the possibility that the Company may be unable to achieve the intended or expected benefits of its enterprise-wide strategic review and related cost-saving and restructuring activities within the expected timeframe or at all; the possibility that the Company may be unable to achieve intended or expected benefits in connection with divestitures, acquisitions, strategic alliances, collaborations, or other transactions, or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses; success of clinical trials and the Company’s or its partners’ ability to execute on new product opportunities and develop, manufacture and commercialize products; any changes in or difficulties with the Company’s manufacturing facilities, including with respect to short- or long-term shutdowns, inspections, remediation and restructuring activities, supply chain continuity, inventory management, or the ability to meet anticipated demand; the Company’s failure to achieve expected or targeted future financial and operating performance and results; the potential impact of natural or man-made disasters, public health outbreaks, fires, accidents, weather, unrest or other emergencies in regions where we or our partners or suppliers operate; actions and decisions of healthcare and pharmaceutical regulators; changes in relevant laws, regulations and policies and/or the application or implementation thereof, including but not limited to tax, healthcare and pharmaceutical laws, regulations and policies globally; the ability to attract, motivate and retain key personnel; the Company’s liquidity, capital resources and ability to obtain financing; any regulatory, legal or other impediments to the Company’s ability to bring new products to market; products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; the scope, timing and outcome of any ongoing legal proceedings, including government inquiries or investigations, and the impact of any such proceedings on the Company; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with having significant operations globally; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in the Company’s or its partners’ customer and supplier relationships and customer purchasing patterns, including customer loss and business disruption being greater than expected following an adverse regulatory action, acquisition or divestiture; the impacts of competition, including decreases in sales or revenues as a result of the loss of market exclusivity for certain products; changes in the economic and financial conditions of the Company or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company’s products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential for adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with U.S.
The majority of our cash is invested in U.S. government money market funds and in bank deposits. In order to support our global operations, we maintain significant cash and cash equivalents within the banking system with the majority of this at Global Systemically Important Banks.
The majority of our cash is invested in U.S. government money market funds and in bank deposits. In order to support our global operations, we maintain significant cash and cash equivalents within the global banking system with the majority of this at Global Systemically Important Banks.
We routinely evaluate our net sales and total revenues performance at constant currency so that sales results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities, and believe that this presentation also provides useful information to investors for the same reason.
We routinely evaluate our net sales and total revenues performance at constant currency so that these results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities, and believe that this presentation also provides useful information to investors for the same reason.
Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred in certain taxing jurisdictions over the three-year period ended December 31, 2024.
Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred in certain taxing jurisdictions over the three-year period ended December 31, 2025.
We estimate that the amounts that may be paid during the next twelve months to be approximately $33 million. These agreements may also include potential sales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profit share.
We estimate that the amounts that may be paid during the next twelve months to be approximately $163 million. These agreements may also include potential sales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profit share.
Refer to Note 18 Licensing and Other Partner Agreements included in Part II, Item 8 of this Form 10-K for additional information. Application of Critical Accounting Policies Our significant accounting policies are described in Note 2 Summary of Significant Accounting Policies included in Part II, Item 8 of this Form 10-K and are in accordance with U.S. GAAP.
Refer to Note 19 Licensing and Other Partner Agreements included in Part II, Item 8 of this Form 10-K for additional information. Application of Critical Accounting Policies Our significant accounting policies are described in Note 2 Summary of Significant Accounting Policies included in Part II, Item 8 of this Form 10-K and are in accordance with U.S. GAAP.
Long-term Debt Maturity For information regarding our debt agreements and mandatory minimum repayments remaining on the outstanding notional amount of long-term debt at December 31, 2024, refer to Note 10 Debt included in Part II, Item 8 of this Form 10-K.
Long-term Debt Maturity For information regarding our debt agreements and mandatory minimum repayments remaining on the outstanding notional amount of long-term debt at December 31, 2025, refer to Note 10 Debt included in Part II, Item 8 of this Form 10-K.
While the Company believes that it has meritorious defenses with respect to the claims asserted against it and the assumed legal matters referenced above, and intends to vigorously defend its position, the process of resolving these matters is 69 Table of Contents inherently uncertain and may develop over a long period of time, and so it is not possible to predict the ultimate resolution of any such matter.
While the Company believes that it has meritorious defenses with respect to the claims asserted against it and the assumed legal matters referenced above, and intends to vigorously defend its position, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict the ultimate resolution of any such matter.
(2) The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2024 constant currency net sales or revenues to the corresponding amount in the prior year.
(2) The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2025 constant currency net sales or revenues to the corresponding amount in the prior year.
These amounts include items such as: Costs related to formal restructuring programs and actions, including costs associated with facilities to be closed or divested, employee separation costs, impairment charges, accelerated depreciation, incremental manufacturing variances, equipment relocation costs, decommissioning and other restructuring related costs; Certain acquisition and divestiture costs, including costs relating to integration and planning, advisory and legal fees, certain financing related costs, certain reimbursements related to the Company’s obligation to reimburse Pfizer for certain financing and transaction related costs under the Business Combination Agreement and Separation and Distribution Agreement, certain other TSA related set-up and exit costs, and other business transformation and/or optimization initiatives, which are not part of a formal restructuring program, including employee separation and post-employment costs; Other costs, incurred from time to time, related to certain special events or activities that lead to gains or losses, including, but not limited to, incremental manufacturing variances, asset write-downs, including other-than-temporary impairments of investments in equity or debt instruments, or liability adjustments; 63 Table of Contents Certain costs to further develop and optimize our global enterprise resource planning systems, operations and supply chain; Gains or losses from divestitures, including impairments of held for sale assets; and The impact of changes related to uncertain tax positions are excluded from adjusted net earnings and adjusted EPS.
These amounts include items such as: Costs related to formal restructuring programs and actions, including costs associated with facilities to be closed or divested, employee separation costs, impairment charges, accelerated depreciation, incremental manufacturing variances, equipment relocation costs, decommissioning and other restructuring related costs; Certain acquisition and divestiture costs, including costs relating to integration and planning, contractual obligations, including under supply agreements, advisory and legal fees, certain financing related costs, certain reimbursements related to the Company’s obligation to reimburse Pfizer for certain financing and transaction related costs under the Business Combination Agreement and Separation and Distribution Agreement, certain other TSA related set-up and exit costs, and other business transformation and/or optimization initiatives, which are not part of a formal restructuring program, including employee separation and post-employment costs; Other costs, incurred from time to time, related to certain special events or activities that lead to gains or losses, including, but not limited to, incremental manufacturing variances, contractual termination costs, certain remediation activities, asset write-downs, including other-than-temporary impairments of investments in equity or debt instruments, or liability adjustments; Certain costs to further develop and optimize our global enterprise resource planning systems, operations and supply chain; Gains or losses from divestitures, including impairments of held for sale assets; and The impact of changes related to uncertain tax positions are excluded from adjusted net earnings and adjusted EPS.
Under the terms of the letter agreement, Viatris will receive additional territory rights in Japan, South Korea and certain other countries in the Asia-Pacific region for cenerimod, a $250 million reduction in contingent milestone payments, including $200 million of development milestones, and additional personnel to expedite transitioning the development programs to Viatris in exchange for Viatris assuming $100 million of Idorsia’s obligation to contribute to development costs.
Under the terms of the letter agreement, Viatris received additional territory rights in Japan, South Korea and certain other countries in the Asia-Pacific region for cenerimod, a $250 million reduction in contingent milestone payments, including $200 million of development milestones, and additional personnel to expedite transitioning the development programs to Viatris in exchange for Viatris assuming $100 million of Idorsia’s obligation to contribute to development costs.
The following section briefly describes the nature of our provisions for variable consideration and how such provisions are estimated: Chargebacks : the Company has agreements with certain indirect customers, such as independent pharmacies, retail pharmacy chains, managed care organizations, hospitals, nursing homes, governmental agencies and pharmacy benefit managers, which establish contract prices for certain products.
The following section briefly describes the nature of our provisions for variable consideration and how such provisions are estimated: Chargebacks : the Company has agreements with certain indirect customers, such as independent pharmacies, retail pharmacy chains, managed care organizations, hospitals, nursing homes, governmental agencies and PBMs, which establish contract prices for certain products.
When assessing the realizability of deferred tax assets, management considers all available evidence, including historical information, long-term forecasts of future taxable income and possible tax planning strategies. Amounts recorded for valuation allowances can result from a complex series of estimates, assumptions and judgments about future events.
When assessing the realizability of deferred tax assets, management considers all available evidence, including historical information, long-term forecasts of future 79 Table of Contents taxable income and possible tax planning strategies. Amounts recorded for valuation allowances can result from a complex series of estimates, assumptions and judgments about future events.
A variance of 5% between estimated reserves and valuation allowances and actual resolution and realization of these tax items would have an effect on our reserve balance and valuation allowance of approximately $74.5 million. Legal Matters Viatris is involved in various legal proceedings, some of which involve claims for substantial amounts.
A variance of 5% between estimated reserves and valuation allowances and actual resolution and realization of these tax items would have an effect on our reserve balance and valuation allowance of approximately $85.0 million. Legal Matters Viatris is involved in various legal proceedings, some of which involve claims for substantial amounts.
We anticipate our cash requirements related to ordinary course purchases of goods and services will be consistent with our past levels. In the normal course of business, Viatris periodically enters into acquisition, divestiture, collaboration, employment, legal settlement and other agreements which incorporate indemnification provisions.
We anticipate our cash requirements related to ordinary course purchases of goods and services will be consistent with our past levels. 74 Table of Contents In the normal course of business, Viatris periodically enters into acquisition, divestiture, collaboration, employment, legal settlement and other agreements which incorporate indemnification provisions.
Conversely, generic products generally experience less volatility over a longer period of time in Europe as compared to the U.S., primarily due to the role of 55 Table of Contents government oversight of healthcare systems in the region. In addition, U.S. governmental agencies provide funding for certain products in our Emerging Markets region.
Conversely, generic products generally experience less volatility over a longer period of time in Europe as compared to the U.S., primarily due to the role of government oversight of healthcare systems in the region. In addition, U.S. governmental agencies provide funding for certain products in our Emerging Markets region.
GAAP, and adjusted net earnings and adjusted EPS for the periods shown follows: Year Ended December 31, (In millions, except per share amounts) 2024 2023 2022 U.S. GAAP net (loss) earnings and U.S.
GAAP, and adjusted net earnings and adjusted EPS for the periods shown follows: Year Ended December 31, (In millions, except per share amounts) 2025 2024 2023 U.S. GAAP net (loss) earnings and U.S.
GAAP, and adjusted cost of sales and adjusted gross margin for the year ended December 31, 2024 compared to the year ended December 31, 2023 is as follows: Year Ended December 31, (In millions, except %s) 2024 2023 U.S.
GAAP, and adjusted cost of sales and adjusted gross margin for the year ended December 31, 2025 compared to the year ended December 31, 2024 is as follows: Year Ended December 31, (In millions, except %s) 2025 2024 U.S.
The current year and prior year provisions were also impacted by the levels of income and the changing mix at which it is earned in jurisdictions with differing tax rates. 2023 Compared to 2022 Discussions of 2022 items and year-to-year comparisons between 2023 and 2022 are not included in this Form 10-K, and can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
The current year and prior year provisions were also impacted by the levels of income and the changing mix at which it is earned in jurisdictions with differing tax rates. 66 Table of Contents 2024 Compared to 2023 Discussions of 2023 items and year-to-year comparisons between 2024 and 2023 are not included in this Form 10-K, and can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
We and our subsidiaries and affiliates may from time to time, in our sole discretion, purchase, repay, redeem or retire any of our outstanding debt securities (including any publicly-issued debt securities) in privately negotiated or open market transactions, by tender offer or otherwise, or extend or refinance any of our outstanding indebtedness.
We and our subsidiaries and affiliates may from time to time, in our sole discretion, purchase, repay, redeem or retire any of our outstanding debt securities (including any publicly-issued debt securities) in privately negotiated or open market 72 Table of Contents transactions, by tender offer or otherwise, or extend or refinance any of our outstanding indebtedness.
A change of 5% would have an effect on our reserve balance of approximately $63.3 million. Returns : consistent with industry practice, Viatris maintains a return policy that allows customers to return a product, which varies country by country in accordance with local practices, generally within a specified period prior (six months) and subsequent (twelve months) to the expiration date.
A change of 5% would have an effect on our reserve balance of approximately $56.7 million. Returns : consistent with industry practice, Viatris maintains a return policy that allows customers to return a product, which varies country by country in accordance with local practices, generally within a specified period prior (six months) and subsequent (twelve months) to the expiration date.
Such objective evidence limits the ability to consider other subjective evidence such as our projections for future growth. Based on this evaluation and other factors, as of December 31, 2024, a valuation allowance of $1.23 billion has been recorded in order to measure only the portion of the deferred tax asset that more likely than not will be realized.
Such objective evidence limits the ability to consider other subjective evidence such as our projections for future growth. Based on this evaluation and other factors, as of December 31, 2025, a valuation allowance of $1.44 billion has been recorded in order to measure only the portion of the deferred tax asset that more likely than not will be realized.
Viatris’ executive 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 key stakeholders. The Company operates in more than 165 countries and territories with approximately 32,000 employees.
Viatris’ executive 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 key stakeholders. The Company operates in more than 165 countries and territories with more than 30,000 employees.
A change of 5% would have an effect on our reserve balance of approximately $20.0 million. Governmental rebate programs : government reimbursement programs in the U.S. include Medicare, Medicaid, and State Pharmacy Assistance Programs established according to statute, regulations and policy.
A change of 5% would have an effect on our reserve balance of approximately $17.5 million. Governmental rebate programs : government reimbursement programs in the U.S. include Medicare, Medicaid, and State Pharmacy Assistance Programs established according to statute, regulations and policy.
(b) Includes purchase accounting related amortization. (c) See items detailed in the Reconciliation of U.S. GAAP Net (Loss) Earnings to Adjusted Net Earnings. Liquidity and Capital Resources Our primary source of liquidity is net cash provided by operating activities, which was $2.30 billion for the year ended December 31, 2024.
(b) Includes purchase accounting related amortization. (c) See items detailed in the Reconciliation of U.S. GAAP Net (Loss) Earnings to Adjusted Net Earnings. Liquidity and Capital Resources Our primary source of liquidity is net cash provided by operating activities, which was $2.32 billion for the year ended December 31, 2025.
The Company performed its annual goodwill impairment test on a quantitative basis for its five reporting units, North America, Europe, Emerging Markets, JANZ, and Greater China. In estimating each reporting unit’s fair value, the Company performed an extensive valuation analysis, utilizing a discounted cash flow approach.
The Company performed both its interim and annual goodwill impairment tests on a quantitative basis for its five reporting units, North America, Europe, Emerging Markets, JANZ, and Greater China. In estimating each reporting unit’s fair value, the Company performed an extensive valuation analysis, utilizing a discounted cash flow approach.
The Company is in compliance with its covenants at December 31, 2024 and expects to remain in compliance for the next twelve months.
The Company is in compliance with its covenants at December 31, 2025 and expects to remain in compliance for the next twelve months.
This discussion and analysis should be read in conjunction with the consolidated financial statements and the related notes to consolidated financial statements included in Part II, Item 8 in this Form 10-K, and our other SEC filings and public disclosures. This Form 10-K contains “forward-looking statements”.
This discussion and analysis should be read in conjunction with the consolidated financial statements and the related notes to consolidated financial statements included in Part II, Item 8 in this Form 10-K, and our other SEC filings and public disclosures. 57 Table of Contents This Form 10-K contains “forward-looking statements”.
The agreements also provide Viatris a right of first refusal and a right of first negotiation for certain other assets in Idorsia’s pipeline. Viatris and Idorsia are both contractually obligated to contribute to the development costs for both programs, which are expected to be incurred through 2026.
The agreements also provided Viatris a right of first refusal and a right of first negotiation for certain other assets in Idorsia’s pipeline. Viatris and Idorsia are both contractually obligated to contribute to the development costs for both programs, which are expected to be incurred through 2027.
A variance of 5% between estimated and recorded litigation reserves and actual resolution of certain legal matters would have an effect on our litigation reserve balance of approximately $19.2 million. Refer to Note 19 Litigation included in Part II, Item 8 of this Form 10-K for further discussion of litigation matters.
A variance of 5% between estimated and recorded litigation reserves and actual resolution of certain legal matters would have an effect on our litigation reserve balance of approximately $26.7 million. Refer to Note 20 Litigation included in Part II, Item 8 of this Form 10-K for further discussion of litigation matters.
We have entered into employment and other agreements with certain executives and other employees that provide for compensation and certain other benefits. These agreements provide for severance payments under certain circumstances. Licensing and Other Partner Agreements Under our licensing and other partner agreements, our potential maximum development milestones not accrued for at December 31, 2024 totaled approximately $419.4 million.
We have entered into employment and other agreements with certain executives and other employees that provide for compensation and certain other benefits. These agreements provide for severance payments under certain circumstances. Licensing and Other Partner Agreements Under our licensing and other partner agreements, our potential maximum development milestones not accrued for at December 31, 2025 totaled approximately $416 million.
During the forecast period, the revenue compound annual growth rate was approximately negative 0.3%. A terminal year value was calculated with a 1.0% revenue growth rate applied. The discount rate utilized was 8.0% and the estimated tax rate was 30.3%.
During the forecast period, the revenue compound annual growth rate was approximately 3.1%. A terminal year value was calculated with a negative 3.0% revenue growth rate applied. The discount rate utilized was 12.5% and the estimated tax rate was 24.8%.
Borrowings outstanding under the Receivables Facility bear interest at the applicable base rate plus 0.775% and are included as a component of short-term borrowings, while the accounts receivable securing these obligations remain as a component of accounts receivable, net, in our consolidated balance sheets.
Borrowings outstanding under the Receivables Facility bear interest at the applicable base rates plus applicable margins and are included as a component of short-term borrowings, while the accounts receivable securing these obligations remain as a component of accounts receivable, net, in our consolidated balance sheets.
Our top ten products in terms of net sales, in the aggregate, represented approximately 33% for each of the years ended December 31, 2024 and 2023. Net sales are derived from our four reporting segments: Developed Markets, Greater China, JANZ and Emerging Markets.
Our top ten products in terms of net sales, in the aggregate, represented approximately 36% and 33% for the years ended December 31, 2025 and 2024, respectively. Net sales are derived from our four reporting segments: Developed Markets, Greater China, JANZ and Emerging Markets.
At December 31, 2024, our material cash requirements from known contractual and other obligations primarily relate to repayment of outstanding borrowings and interest, open purchase orders, post-employment benefit plans, unrecognized tax benefits, capital expenditures, dividends and leases. For additional information, refer to Notes 2, 7, 10, 12, 14, and 16 included in Part II, Item 8 of this Form 10-K.
At December 31, 2025, our material cash requirements from known contractual and other obligations primarily relate to repayment of outstanding borrowings and interest, open purchase orders, post-employment benefit plans, unrecognized tax benefits, capital expenditures, dividends and leases. For additional information, refer to Notes 7, 10, 12, 13, 15, and 17 included in Part II, Item 8 of this Form 10-K.
Accounts receivable are presented net of allowances relating to these provisions, which were comprised of the following at December 31, 2024 and 2023, respectively: (In millions) December 31, 2024 December 31, 2023 Accounts receivable, net $ 1,547.0 $ 1,483.6 Other current liabilities 989.4 996.3 Total $ 2,536.4 $ 2,479.9 We have not made and do not anticipate making any significant changes to the methodologies that we use to measure provisions for variable consideration; however, the balances within these reserves can fluctuate significantly through the consistent application of our methodologies.
Accounts receivable are presented net of allowances relating to these provisions, which were comprised of the following at December 31, 2025 and 2024, respectively: (In millions) December 31, 2025 December 31, 2024 Accounts receivable, net $ 1,257.4 $ 1,547.0 Other current liabilities 1,011.2 989.4 Total $ 2,268.6 $ 2,536.4 We have not made and do not anticipate making any significant changes to the methodologies that we use to measure provisions for variable consideration; however, the balances within these reserves can fluctuate significantly through the consistent application of our methodologies.
Viatris has worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region). A joint development committee was formed to oversee the development of the ongoing Phase 3 programs through regulatory approval.
Viatris has worldwide commercialization rights for both selatogrel and cenerimod (which excluded, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region). A joint development committee was formed to oversee the development of the 61 Table of Contents ongoing Phase 3 programs through regulatory approval.
Due to the inherent uncertainty involved in making these estimates, assumptions and judgments, actual results could differ materially. Any future increases to the Company’s valuation allowances could materially impact the Company’s consolidated financial condition and results of operations. At December 31, 2024 and 2023, the Company’s net deferred tax assets totaled $753.0 million and $692.9 million, respectively.
Due to the inherent uncertainty involved in making these estimates, assumptions and judgments, actual results could differ materially. Any future increases to the Company’s valuation allowances could materially impact the Company’s consolidated financial condition and results of operations. At December 31, 2025 and 2024, the Company’s net deferred tax assets totaled $1.06 billion and $753.0 million, respectively.
Such forward-looking statements may include, without limitation, statements about the goals or outlooks with respect to the Company’s strategic initiatives and priorities, including but not limited to divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions; the benefits and synergies of such divestitures, acquisitions, strategic alliances, collaborations, or other transactions, or restructuring programs; future opportunities for the Company and its products; and any other statements regarding the Company’s future operations, financial or operating results, capital allocation, dividend policy and payments, share repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock value, and other expectations and targets for future periods.
Such forward-looking statements may include, without limitation, statements about the goals or outlooks with respect to the Company’s strategic initiatives and priorities, including but not limited to divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions; the anticipated benefits of such strategic initiatives or priorities or restructuring activities; future opportunities for the Company and its products; the outcomes of clinical trials and research studies; R&D and new product development; and any other statements regarding the Company’s future operations, financial or operating results, capital allocation, dividend policy and payments, share repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, imperatives, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock value, and other expectations and targets for future periods.
We continually monitor our provision for chargebacks and evaluate our reserve and estimates as additional information becomes available. A change of 5% would have an effect on our reserve balance of approximately $24.7 million. Rebates, promotional programs and other sales allowances : this category includes rebate and other programs to assist in product sales.
We continually monitor our provision for chargebacks and evaluate our reserve and estimates as additional information becomes available. A change of 5% would have an effect on our reserve balance of approximately $22.1 million. 75 Table of Contents Rebates, promotional programs and other sales allowances : this category includes rebate and other programs to assist in product sales.
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.
The Company has 27 manufacturing, packaging, and distribution sites worldwide, more than 1,400 approved molecules, and what we believe is 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.
You can access Viatris’ filings with the SEC through the SEC website at www.sec.gov or through our website, and Viatris strongly encourages you to do so.
You can access Viatris’ filings with the SEC through the SEC 58 Table of Contents website at www.sec.gov or through our website, and Viatris strongly encourages you to do so.
These matters are often complex and have outcomes that are difficult to predict. We have approximately $384 million accrued for legal contingencies at December 31, 2024.
These matters are often complex and have outcomes that are difficult to predict. We have approximately $535 million accrued for legal contingencies at December 31, 2025.
The fair value of finite-lived intangible assets was calculated as the present value of the estimated future net cash flows using a market rate of return. At December 31, 2024 and 2023, the Company’s finite-lived intangible assets totaled $16.26 billion and $18.86 billion, respectively.
The fair value of finite-lived intangible assets was calculated as the present value of the estimated future net cash flows using a market rate of return. At December 31, 2025 and 2024, the Company’s finite-lived intangible assets totaled $14.40 billion and $16.26 billion, respectively.
Refer to the consolidated statements of cash flows in Part II, Item 8 of this Form 10-K for additional details on other significant sources and uses of cash during the years ended December 31, 2024 and 2023. Capital Resources Our cash and cash equivalents totaled $734.8 million at December 31, 2024.
Refer to the consolidated statements of cash flows in Part II, Item 8 of this Form 10-K for additional details on other significant sources and uses of cash during the years ended December 31, 2025 and 2024. Capital Resources Our cash and cash equivalents totaled $1.32 billion at December 31, 2025.
(In millions) Year Ended December 31, 2024 Year Ended December 31, 2023 Revenues $ $ Gross profit Loss from operations (1,206.6) (1,243.8) Net (loss) earnings (634.2) 54.7 Other Commitments The Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax proceedings and litigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in losses, including damages, fines and/or civil penalties, and/or criminal charges against the Company.
(In millions) Year Ended December 31, 2025 Year Ended December 31, 2024 Revenues $ $ Gross profit Loss from operations (1,008.2) (1,206.6) Net loss (3,514.9) (634.2) Other Commitments The Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax proceedings and litigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in losses, including damages, fines and/or civil penalties, and/or criminal charges against the Company.
Complex products are more difficult, costly and time-consuming to receive regulatory approval for and bring to market. Any delay in regulatory approval could impact the commercial or financial success of a product. Regulatory approval, if and when obtained, may be limited in scope.
Complex generic products are often more difficult, costly and time-consuming to receive regulatory approval and bring to market compared with commodity generic pharmaceutical products. Any delay in regulatory approval could impact the commercial or financial success of a product. Regulatory approval, if and when obtained, may be limited in scope.
(3) Reductions were driven primarily by the inclusion of net sales in the prior year period related to divestitures that have closed during 2023 and 2024. (4) For the year ended December 31, 2024, other revenues in Developed Markets, Greater China, JANZ, and Emerging Markets were approximately $32.0 million, $1.3 million, $3.5 million, and $9.7 million, respectively.
(3) Reductions were driven primarily by the inclusion of net sales in the prior year period related to divestitures that have closed during 2024 and the Indore Impact. (4) For the year ended December 31, 2025, other revenues in Developed Markets, JANZ, and Emerging Markets were approximately $38.1 million, $3.9 million, and $7.5 million, respectively.
For the years ended December 31, 2024 and 2022, the Company recorded $177.1 million and $0.6 million, respectively, of impairment charges, which were recorded as a component of amortization expense. There were no IPR&D impairment charges in 2023. At December 31, 2024 and 2023, the Company’s IPR&D assets totaled $814.2 million and $319.4 million, respectively.
For the years ended December 31, 2025 and 2024, the Company recorded $73.9 million and $177.1 million, respectively, of impairment charges, which were recorded as a component of amortization expense. There were no IPR&D impairment charges in 2023. At December 31, 2025 and 2024, the Company’s IPR&D assets totaled $706.0 million and $814.2 million, respectively.
Other Expense (Income), Net Other expense (income), net includes gains and losses from divestitures of businesses, changes in the fair value of equity securities, extinguishment of debt, foreign exchange, expense (income) related to post-employment benefit plans, TSA income, and interest and dividend income.
The decrease was primarily due to the impact of 2024 debt repayments. Other Expense (Income), Net Other expense (income), net includes gains and losses from divestitures of businesses, changes in the fair value of equity securities, extinguishment of debt, foreign exchange, expense (income) related to post-employment benefit plans, TSA income, and interest and dividend income.
Management believes that adjusted net earnings and adjusted EPS are important internal financial metrics related to the ongoing operating performance of the Company, and are therefore useful to investors and that their understanding of our performance is enhanced by these measures.
Management believes that adjusted net earnings and adjusted EPS are important internal financial metrics related to the ongoing operating performance of the Company, and are therefore useful to investors and that their understanding of our performance is enhanced by these measures. Actual internal and forecasted operating results and annual budgets used by management include adjusted net earnings and adjusted EPS.
Net cash provided by operating activities is derived from net (loss) earnings adjusted for non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash, including changes in cash primarily reflecting the timing of cash collections from customers, payments to vendors and employees and tax payments in the ordinary course of business.
Net cash provided by operating activities is derived from net (loss) earnings adjusted for non-cash operating items, including impairment of goodwill and fair value adjustments related to the Biocon Biologics CCPS investment, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash, including changes in cash primarily reflecting the timing of cash collections from customers, payments to vendors and employees and tax payments in the ordinary course of business.
The Company reviews goodwill for impairment annually on April 1st or more frequently if events or changes in circumstances indicate that the carrying value of goodwill may not be recoverable. The Company performed the annual goodwill impairment test as of April 1, 2024.
The Company reviews goodwill for impairment annually on April 1st or more frequently if events or changes in circumstances indicate that the carrying value of goodwill may not be recoverable.
Constant currency net sales from the remaining business increased by approximately $109.9 million, or 4%, when compared to the prior year, primarily driven by new products and higher net sales of existing products in certain Latin American, Middle Eastern and Asian countries.
Constant currency net sales from the remaining business increased by approximately $58.5 million, or 3%, when compared to the prior year, primarily driven by new products in certain Latin American countries and higher volumes and pricing of existing products in certain Middle Eastern and Asian countries.
The following table presents unaudited summarized financial information of Viatris Inc., Mylan Inc., Utah Acquisition Sub Inc., and Mylan II B.V. on a combined basis as of and for the years ended December 31, 2024 and 2023. All intercompany balances have been eliminated in consolidation. This unaudited combined summarized financial information is presented utilizing the equity method of accounting.
The following table presents unaudited summarized financial information of Viatris Inc., Mylan Inc., Utah Acquisition Sub Inc., and Mylan II B.V. on a combined basis as of and for the years ended December 31, 2025 and 2024. All intercompany balances have been eliminated in consolidation.
The Company has a $400 million Receivables Facility which expires in April 2025. As of December 31, 2024, the Company did not have any borrowings outstanding under the Receivables Facility. Under the terms of the Receivables Facility, certain of our accounts receivable secure the amounts borrowed and cannot be used to pay our other debts or liabilities.
As of December 31, 2025, the Company did not have any borrowings outstanding under the Receivables Facility. Under the terms of the Receivables Facility, certain of our accounts receivable secure the amounts borrowed and cannot be used to pay our other debts or liabilities.
While there can be no assurance that current expectations will be realized, capital expenditures for the 2025 calendar year are expected to be approximately $300 million to $400 million.
While there can be no assurance that current expectations will be realized, capital expenditures for the 2026 calendar year are expected to be approximately $350 million to $450 million.
GAAP net (loss) earnings $ (634.2) $ 54.7 $ 2,078.6 Add adjustments: Income tax provision 11.0 148.2 734.6 Interest expense (a) 550.0 573.1 592.4 Depreciation and amortization (b) 2,893.2 2,740.5 3,027.6 EBITDA $ 2,820.0 $ 3,516.5 $ 6,433.2 Add / (deduct) adjustments: Share-based compensation expense 146.1 180.7 116.4 Litigation settlements and other contingencies, net 350.9 111.6 4.4 Loss (gain) on divestitures of businesses 399.4 239.9 (1,754.1) Impairment of goodwill 321.0 580.1 117.0 Restructuring, acquisition and divestiture-related and other special items (c) 632.0 495.3 859.9 Adjusted EBITDA $ 4,669.4 $ 5,124.1 $ 5,776.8 ____________ (a) Includes amortization of premiums and discounts on long-term debt.
GAAP net (loss) earnings $ (3,514.9) $ (634.2) $ 54.7 Add / (deduct) adjustments: Income tax (benefit) provision (150.1) 11.0 148.2 Interest expense (a) 471.3 550.0 573.1 Depreciation and amortization (b) 2,798.3 2,893.2 2,740.5 EBITDA $ (395.4) $ 2,820.0 $ 3,516.5 Add / (deduct) adjustments: Share-based compensation expense 177.7 146.1 180.7 Litigation settlements and other contingencies, net (68.5) 350.9 111.6 Loss on divestitures of businesses 101.0 399.4 239.9 Impairment of goodwill 2,936.8 321.0 580.1 Restructuring, acquisition and divestiture-related and other special items (c) 1,408.4 632.0 495.3 Adjusted EBITDA $ 4,160.0 $ 4,669.4 $ 5,124.1 ____________ (a) Includes amortization of premiums and discounts on long-term debt.
The Company has access to $3.5 billion under the 2024 Revolving Facility which matures in September 2029. Up to $1.65 billion of the 2024 Revolving Facility may be used to support borrowings under our Commercial Paper Program. As of December 31, 2024, the Company did not have any borrowings outstanding under the Commercial Paper Program or the 2024 Revolving Facility.
The Company has access to $3.5 billion under the 2024 Revolving Facility which matures in September 2029. Up to $1.65 billion of the 2024 Revolving Facility may be used to support borrowings under our Commercial Paper Program.
Based on this 74 Table of Contents evaluation, as of December 31, 2024, our reserve for unrecognized tax benefits totaled $255.7 million, of which $182.2 million was recorded in connection with the Combination and is subject to Pfizer’s indemnification obligations to Viatris under the Tax Matters Agreement.
Based on this evaluation, as of December 31, 2025, our reserve for unrecognized tax benefits totaled $263.2 million, of which $170.1 million was recorded in connection with the Combination and is subject to Pfizer’s indemnification obligations to Viatris under the Tax Matters Agreement.
GAAP diluted (loss) earnings per share $ (634.2) $ (0.53) $ 54.7 $ 0.05 $ 2,078.6 $ 1.71 Purchase accounting amortization (primarily included in cost of sales) (a) 2,581.1 2,421.5 2,721.3 Impairment of goodwill (included in SG&A) (b) 321.0 580.1 117.0 Litigation settlements and other contingencies, net 350.9 111.6 4.4 Interest expense (primarily amortization of premiums and discounts on long term debt) (23.0) (42.4) (48.7) Acquisition and divestiture-related costs (primarily included in SG&A) (c) 361.0 377.9 475.7 Loss (gain) on divestitures of businesses (included in other expense (income), net) (d) 399.4 239.9 (1,754.1) Restructuring-related costs (e) 211.1 125.2 86.9 Share-based compensation expense 146.1 180.7 116.5 Other special items included in: Cost of sales (f) 143.0 119.2 255.2 Research and development expense 2.8 2.8 1.0 Selling, general and administrative expense 90.5 (83.5) 68.8 Other expense (income), net (g) (160.2) (24.4) (3.8) Tax effect of the above items and other income tax related items (h) (597.1) (525.6) (41.7) Adjusted net earnings and adjusted EPS $ 3,192.4 $ 2.65 $ 3,537.7 $ 2.93 $ 4,077.1 $ 3.35 Weighted average diluted shares outstanding 1,202.7 1,206.9 1,217.4 Significant items for the year ended December 31, 2024 include the following: (a) Includes IPR&D intangible asset impairment charges of $177.1 million as the Company concluded that certain of its IPR&D assets were fully impaired due to unfavorable clinical results and/or changes in market conditions which led to the termination of the development programs.
GAAP diluted (loss) earnings per share $ (3,514.9) $ (3.00) $ (634.2) $ (0.53) $ 54.7 $ 0.05 Purchase accounting amortization (primarily included in cost of sales) (a) 2,470.3 2,581.1 2,421.5 Impairment of goodwill (b) 2,936.8 321.0 580.1 Litigation settlements and other contingencies, net (68.5) 350.9 111.6 Interest expense (primarily amortization of premiums and discounts on long term debt) (38.6) (23.0) (42.4) Acquisition and divestiture-related costs (primarily included in cost of sales and SG&A) (c) 208.2 361.0 377.9 Loss on divestitures of businesses (included in other expense (income), net) (d) 101.0 399.4 239.9 Restructuring costs (e) 170.0 211.1 125.2 Share-based compensation expense 177.7 146.1 180.7 Other special items included in: Cost of sales (f) 383.2 143.0 119.2 Research and development expense 8.7 2.8 2.8 Selling, general and administrative expense 136.3 90.5 (83.5) Other expense (income), net (g) 536.6 (160.2) (24.4) Tax effect of the above items and other income tax related items (h) (737.5) (597.1) (525.6) Adjusted net earnings and adjusted EPS $ 2,769.3 $ 2.35 $ 3,192.4 $ 2.65 $ 3,537.7 $ 2.93 Weighted average diluted shares outstanding 1,179.4 1,202.7 1,206.9 Significant items for the year ended December 31, 2025 include the following: (a) Includes an IPR&D intangible asset impairment charge of $73.9 million as the Company concluded that one of its IPR&D assets was fully impaired due to unfavorable clinical results which led to the termination of the development program.
During the forecast period, the revenue compound annual growth rate was approximately 2.5%. A terminal year value was calculated with a 2.0% revenue growth rate applied. The discount rate utilized was 10.0% and the estimated tax rate was 15.7%.
During the forecast period, the revenue compound annual growth rate was approximately negative 0.9%. A terminal year value was calculated with a 1.0% revenue growth rate applied. The discount rate utilized was 8.5% and the estimated tax rate was 30.2%.
In addition to the impact of competition, government pricing actions and other measures designed to reduce healthcare costs, our results of operations, cash flows and financial condition could also be affected by other risks of doing business internationally, including the impact of inflation, elections, geopolitical events, including the ongoing conflicts in the Middle East and between Russia and Ukraine and related trade controls, sanctions, supply chain and staffing challenges and other economic considerations, supply chain disruptions, foreign currency exchange fluctuations, public health epidemics, changes in intellectual property legal protections and other regulatory changes.
In addition to the impact of competition, government pricing actions and other measures designed to reduce healthcare costs, our results of operations, cash flows and financial condition could also be affected by other risks of doing business internationally, including the impact of inflation, elections, geopolitical events, including the ongoing conflicts in the Middle East and between Russia and Ukraine and related trade controls, sanctions, supply chain disruptions and staffing challenges and other economic considerations, longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies, the potential for adverse impacts from future tariffs and trade restrictions, foreign currency exchange fluctuations, public health epidemics, changes in intellectual property legal protections and other regulatory changes.
Net sales decreased by approximately $294.6 million, or 12%, due to the inclusion of net sales in the prior year period related to divestitures that have closed during 2023 and 2024. The decrease in net sales was also partially driven by the unfavorable impact of foreign currency translation of approximately $116.2 million, or 5%.
Net sales decreased by approximately $24.0 million, or 2%, due to the inclusion of net sales in the prior year period related to divestitures that closed during 2024. The decrease was also partially driven by the unfavorable impact of foreign currency translation of approximately $15.5 million, or 1%.
Adjusted gross margins were approximately 58% for the year ended December 31, 2024, essentially flat when compared to the year ended December 31, 2023. A reconciliation between cost of sales, as reported under U.S.
Adjusted gross margins were approximately 56% for the year ended December 31, 2025, compared to 58% for the year ended December 31, 2024. 64 Table of Contents A reconciliation between cost of sales, as reported under U.S.
These amounts are included within Accounts payable in the consolidated balance sheets. 67 Table of Contents We are continuously evaluating the potential acquisition of products, as well as companies, as a strategic part of our future growth. Consequently, we may utilize current cash reserves or incur additional indebtedness to finance any such acquisitions, which could impact future liquidity.
We are continuously evaluating the potential acquisition of products, as well as companies, as a strategic part of our future growth. Consequently, we may utilize current cash reserves or incur additional indebtedness to finance any such acquisitions, which could impact future liquidity.
These macroeconomic pressures combined with the volatility in foreign exchange rates, including the strengthening of the U.S. dollar versus certain of the other currencies in which we operate, have impacted and may continue to negatively impact our results of operations.
These macroeconomic pressures combined with the volatility in foreign exchange rates, including the strengthening of the U.S. Dollar versus certain of the other currencies in which we operate, have impacted and may continue to impact our results of operations. We proactively look to manage such macroeconomic pressures by implementing strategies to mitigate and partially offset the impact of these factors.
For information regarding our dividends paid and declared and share repurchase program, refer to Note 2 Summary of Significant Accounting Policies included in Part II, Item 8 of this Form 10-K.
For information regarding our dividends paid and declared and share repurchase program, refer to Note 13 (Loss) Earnings per Share included in Part II, Item 8 of this Form 10-K.
Developed Markets Segment Net sales from Developed Markets decreased by $322.5 million, or 3%, for the year ended December 31, 2024 when compared to the prior year. Net sales decreased by approximately $421.1 million, or 5%, due to the inclusion of net sales in the prior year period related to divestitures that have closed during 2023 and 2024.
Developed Markets Segment Net sales from Developed Markets decreased by $415.4 million, or 5%, for the year ended December 31, 2025 when compared to the prior year. Net sales decreased by approximately $372.7 million, or 4%, due to the inclusion of net sales in the prior year period related to divestitures that closed during 2024.
GAAP cost of sales $ 9,115.7 $ 8,988.3 Deduct: Purchase accounting amortization and other related items (2,581.1) (2,421.6) Acquisition and divestiture-related costs (71.5) (40.7) Restructuring-related costs (115.7) (101.8) Share-based compensation expense (3.7) (2.9) Other special items (143.0) (119.2) Adjusted cost of sales $ 6,200.7 $ 6,302.1 Adjusted gross profit (a) $ 8,538.6 $ 9,124.8 Adjusted gross margin (a) 58 % 59 % ____________ (a) Adjusted gross profit is calculated as total revenues less adjusted cost of sales.
GAAP cost of sales $ 9,286.4 $ 9,115.7 Deduct: Purchase accounting amortization and other related items (2,470.3) (2,581.1) Acquisition and divestiture-related costs (116.8) (71.5) Restructuring costs (67.8) (115.7) Share-based compensation expense (4.0) (3.7) Other special items, including restructuring related costs (383.2) (143.0) Adjusted cost of sales $ 6,244.3 $ 6,200.7 Adjusted gross profit (a) $ 8,055.6 $ 8,538.6 Adjusted gross margin (a) 56 % 58 % ____________ (a) Adjusted gross profit is calculated as total revenues less adjusted cost of sales.
The Company has certain voluntary supply chain finance programs with financial intermediaries which provide participating suppliers the option to be paid by the intermediary earlier than the original invoice due date.
As of December 31, 2025, no amounts were assigned and derecognized. The Company has certain voluntary supply chain finance programs with financial intermediaries which provide participating suppliers the option to be paid by the intermediary earlier than the original invoice due date.
Acquisitions, including Intangible Assets, Goodwill and Contingent Consideration The Company accounts for acquired businesses using the acquisition method of accounting in accordance with the provisions of ASC 805 , Business Combinations , which requires that the assets acquired and liabilities assumed be recorded at the date of acquisition at their respective estimated fair values.
Historically, we have not recorded in any current period any material amounts related to adjustments made to prior period reserves. 76 Table of Contents Acquisitions, including Intangible Assets, Goodwill and Contingent Consideration The Company accounts for acquired businesses using the acquisition method of accounting in accordance with the provisions of ASC 805 , Business Combinations , which requires that the assets acquired and liabilities assumed be recorded at the date of acquisition at their respective estimated fair values.
We have been in regular communication with FDA during this process and will continue to work to ensure that the FDA is satisfied with the steps we have taken to resolve all the points raised.
We have been in regular communication with the FDA during this process and will continue to work to ensure that the FDA is satisfied with the steps we have taken to resolve all the points raised. Our responses to the warning letter and import alert were submitted within the required time periods.
Because this process involves management making estimates with respect to future sales volumes, pricing, new product launches, government reform actions, anticipated cost environment and overall market conditions, and because these estimates form the basis for the determination of whether or not an impairment charge should be recorded, these estimates are considered to be critical accounting estimates. 72 Table of Contents The Company records contingent consideration liabilities resulting from business acquisitions or divestitures at its estimated fair value on the acquisition or divestiture date.
Because this process involves management making estimates with respect to future sales volumes, pricing, new product launches, government reform actions, anticipated cost environment and overall market conditions, and because these estimates form the basis for the determination of whether or not an impairment charge should be recorded, these estimates are considered to be critical accounting estimates.
EBITDA is further adjusted for share-based compensation expense, litigation settlements and other contingencies, net, gain (loss) on divestitures of businesses, impairment of long-lived assets and goodwill, restructuring, acquisition and divestiture-related and other special items to determine adjusted EBITDA. These adjustments are generally permitted under our credit agreement in calculating adjusted EBITDA for determining compliance with our debt covenants.
EBITDA is further adjusted for share-based compensation expense, litigation settlements and other contingencies, net, gain (loss) on divestitures of businesses, impairment of long-lived assets and goodwill, restructuring, acquisition and divestiture-related and other special items to determine adjusted EBITDA.
Each reporting period thereafter, the Company revalues these obligations and records increases or decreases in their fair value as adjustments to litigation settlements and other contingencies, net within the consolidated statements of operations.
The Company records contingent consideration liabilities resulting from business acquisitions or divestitures at its estimated fair value on the acquisition or divestiture date. Each reporting period thereafter, the Company revalues these obligations and records increases or decreases in their fair value as adjustments to litigation settlements and other contingencies, net within the consolidated statements of operations.
Refer to Note 5 Divestitures included in Part II, Item 8 of this Form 10-K for more information. 57 Table of Contents Financial Summary The table below is a summary of the Company’s financial results for the year ended December 31, 2024 compared to the prior year period: Year Ended December 31, (In millions, except per share amounts) 2024 2023 Change Total revenues $ 14,739.3 $ 15,426.9 $ (687.6) Gross profit 5,623.6 6,438.6 (815.0) Earnings from operations 10.1 766.2 (756.1) Net (loss) earnings (634.2) 54.7 (688.9) Diluted (loss) earnings per share $ (0.53) $ 0.05 $ (0.58) A detailed discussion of the Company’s financial results can be found below in the section titled “Results of Operations.” As part of this discussion, we also report sales performance using the non-GAAP financial measures of “constant currency” net sales and total revenues.
Financial Summary The table below is a summary of the Company’s financial results for the year ended December 31, 2025 compared to the prior year period: Year Ended December 31, (In millions, except per share amounts) 2025 2024 Change Total revenues $ 14,299.9 $ 14,739.3 $ (439.4) Gross profit 5,013.5 5,623.6 (610.1) (Loss) earnings from operations (2,663.1) 10.1 (2,673.2) Net loss (3,514.9) (634.2) (2,880.7) Diluted loss per share $ (3.00) $ (0.53) $ (2.47) A detailed discussion of the Company’s financial results can be found below in the section titled “Results of Operations.” As part of this discussion, we also report sales performance using the non-GAAP financial measures of “constant currency” net sales and total revenues.
The tender system often results in companies underbidding one another by proposing low pricing in order to win the tender. Sales continue to be negatively affected by the impact of tender systems in certain countries.
Upon winning the tender, the winning company will receive priority placement for a period of time. The tender system often results in companies underbidding one another by proposing lower pricing in order to win the tender. Sales continue to be negatively affected by the impact of tender systems in certain countries.
Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. Operating Expenses Research and Development Expense R&D expense for the year ended December 31, 2024 was $808.7 million, essentially flat compared to R&D expense of $805.2 million for the prior year.
Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. Operating Expenses Research and Development Expense R&D expense for the year ended December 31, 2025 was $965.9 million, compared to $808.7 million for the prior year, an increase of $157.2 million. This increase was primarily the result of higher expenses for the selatogrel and cenerimod development programs.
In certain European countries, certain rebates are calculated on the governments total pharmaceutical spending or on specific product sale thresholds. We utilize historical data and obtain third party information to determine the adequacy of these accruals. Also, this provision includes price reductions that are mandated by law outside of the U.S.
Outside the U.S., the majority of our pharmaceutical sales are contractually or legislatively governed. In certain European countries, certain rebates are calculated on the government’s total pharmaceutical spending or on specific product sale thresholds. We utilize historical data and obtain third party information to determine the adequacy of these accruals.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

5 edited+0 added1 removed8 unchanged
Biggest changeA 100 basis point change in interest rates on Viatris’ variable rate debt would result in a change in interest expense of approximately $2.6 million per year.
Biggest changeDollar and Euro notes was approximately $11.99 billion. As of December 31, 2025, Viatris’ outstanding variable rate borrowings consist principally of borrowings under the Yen Term Loan Facility of $255.2 million. A 100 basis point change in interest rates on Viatris’ variable rate debt would result in a change in interest expense of approximately $2.6 million per year.
The fair values of these instruments were determined as follows: foreign currency forward-exchange contracts net present values foreign currency denominated receivables, payables, debt and loans changes in exchange rates. In this sensitivity analysis, we assumed that the change in one currency’s rate relative to the U.S.
The fair values of these instruments were determined as follows: foreign currency forward-exchange contracts net present values foreign currency denominated receivables, payables, debt and loans changes in exchange rates. 80 Table of Contents In this sensitivity analysis, we assumed that the change in one currency’s rate relative to the U.S.
As of December 31, 2024, Viatris’ outstanding fixed rate borrowings consist principally of $13.33 billion notional amount of senior U.S. dollar and Euro notes. Generally, the fair value of fixed interest rate debt will decrease as interest rates rise and increase as interest rates fall.
As of December 31, 2025, Viatris’ outstanding fixed rate borrowings consist principally of $13.72 billion notional amount of senior U.S. Dollar and Euro notes. Generally, the fair value of fixed interest rate debt will decrease as interest rates rise and increase as interest rates fall. As of December 31, 2025, the fair value of our outstanding fixed rate senior U.S.
Fair Value Risk The Company’s fair value risk exposure relates primarily to our equity investments that do not have readily determinable fair values, principally the CCPS received as part of the Biocon Biologics Transaction. As of December 31, 2024 and 2023, the carrying value of these investments were approximately $1.35 billion and $1.14 billion, respectively.
Fair Value Risk The Company’s fair value risk exposure relates primarily to our equity investments that do not have readily determinable fair values, principally the CCPS received as part of the Biocon Biologics Transaction. As of December 31, 2025 and 2024, the carrying value of these investments were approximately $815.0 million and $1.35 billion, respectively.
A hypothetical 20 percent decline in the fair value of these investments would have decreased the carrying value and increased other expense (income), net by approximately $270.0 million at December 31, 2024. 76 Table of Contents
A hypothetical 20 percent decline in the fair value of these investments would have decreased the carrying value and increased other expense (income), net by approximately $163.0 million at December 31, 2025. 81 Table of Contents
Removed
As of December 31, 2024, the fair value of our outstanding fixed rate senior U.S. dollar and Euro notes was approximately $11.53 billion. As of December 31, 2024, Viatris’ outstanding variable rate borrowings consist principally of borrowings under the Yen Term Loan Facility of $254.4 million.

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