What changed in this filing

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Item 1A. Risk Factors

2026-02-26 compared with 2025-02-27 · 179 added, 142 removed, 677 unchanged (32% of the section changed)

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• 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 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

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.

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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.

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.

◦ 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

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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.

Viatris has announced various strategic initiatives and priorities, transactions and business arrangements.

As the Company moves forward, it will look to accelerate its growth by building on the strength of its base business with an expanding portfolio of innovative, best-in-class, patent-protected assets and will focus on three strategic pillars:

1) diversified and growing base business, 2) financial strength and significant cash flow and 3) expanding innovative portfolio.

Implementing these and other strategic initiatives and priorities has included and may in the future include divestitures, acquisitions, asset purchases, partnerships, collaborations, joint ventures, product rationalization and other investments.

Certain of these transactions and arrangements have been and may in the future be material both from a strategic and financial perspective.

These strategic initiatives and priorities have been, and may continue to be, complex, time-consuming or expensive, may divert management’s and employees’ attention, and expose us to operational ineffectiveness.

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.

Innovative assets are more difficult, costly and time-consuming to develop, receive regulatory approval for and bring to market.

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.

As a result of the EWSR initiated in 2025, the Company has identified three strategic imperatives that will drive our future and position the Company for sustainable growth by (i) driving our base business through executing successful launches, focusing on supply chain continuity, evolving our generics portfolio over time towards more profitable, higher-margin products and strengthening our established brands portfolio (ii) fueling our innovative portfolio through advancing a pipeline of late-stage and in-market growth assets sourced both internally and externally;

and (iii) modernizing for sustainable growth through strengthening our technology, data and talent capabilities to enable sustained success in a rapidly evolving healthcare environment.

As the Company looks to drive its base business by executing successful launches, evolving its generics portfolio over time towards more profitable, higher margin products, strengthening its established brands portfolio, and advancing its portfolio of late-stage and in-market growth assets sourced both internally and externally, it expects to use more capital resources and has entered into, and may in the future enter into, financial commitments in connection with acquisitions, alliances and collaborations, such as, our acquisition of the development programs for selatogrel and cenerimod, which are currently in Phase 3 development and our acquisition of Aculys Pharma, including exclusive rights to pitolisant in Japan and Spydia® in Japan and certain other markets in the Asia-Pacific region.

In addition, we have in the past and may in the future enter into (i) strategic alliances with partners to develop, manufacture, market and/or distribute certain products, and/or certain components of our products, in various markets and (ii) agreements with our collaboration partners that provide for certain services, as well as cross manufacturing, development and licensing arrangements.

We commit substantial efforts and other resources to these various alliances and collaborations There is a risk that the investments made by us in these and other alliances and collaborative arrangements will not generate financial returns.

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.

Implementing our strategic initiatives and priorities has been and may in the future be material both from a strategic and financial perspective.

Our strategic initiatives and priorities have been, and may continue to be, complex, time-consuming or expensive, may divert management’s and employees’ attention, and expose us to operational ineffectiveness.

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.

Innovative and patent protected assets are difficult, costly and time-consuming to develop, receive regulatory approval for and bring to market.

There can be no assurance that we will be able to achieve all of our intended goals or outlooks with respect to such strategies and priorities within the anticipated timeframes or at all, fully realize the expected benefits of any such transactions or arrangements, or successfully manage base business erosion or grow in future periods.

Divestitures, product rationalizations or asset sales have resulted and could in the future result in asset impairments, or reductions to the size or scope of our business, our market share in particular markets or our opportunities and ability to compete with respect to certain markets, therapeutic areas or products.

We may not be successful in separating divested businesses or assets, which could negatively impact our ongoing operations, future earnings and future goals and outlooks.

Please also refer to “ 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.”

We have also entered into strategic alliances with partners, including through our Global Healthcare Gateway®, to develop, manufacture, market and/or distribute certain products, and/or certain components of our products, in various markets.

We have entered into and may in the future enter into agreements with our collaboration partners that provide for certain services, as well as cross manufacturing, development and licensing arrangements.

We commit substantial efforts and other resources to these various alliances and collaborations.

In addition, as the Company looks to accelerate its growth by building on the strength of its base business with an expanding portfolio of innovative, best-in-class, patent-protected assets, it expects to

use more capital resources and has entered into, and may in the future enter into, financial commitments in connection with these alliances and collaborations.

For example, our acquisition of the development programs for selatogrel and cenerimod, which are currently in Phase 3 development.

There is a risk that the investments made by us in these and other alliances and collaborative arrangements will not generate financial returns.

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.

For example, on February [25], 2025, in order to preserve the ongoing continuity of the development programs for selatogrel and cenerimod considering certain capital structuring steps announced by Idorsia to secure its ongoing operations, Viatris and Idorsia entered into a letter agreement to amend certain terms of the original agreements described in Part I, Item 1 Business - About Viatris - Business Strategy of this Form 10-K.

The overall execution of our strategic initiatives and priorities may result in material unanticipated problems, expenses, liabilities, competitive responses, operational inefficiencies, adverse tax consequences, impairment or restructuring charges, loss of customer relationships, difficulty attracting and retaining qualified employees, and diversion of management’s and/or employee’s attention, among other potential adverse consequences.

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Any of the risks described above could 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.

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.

In recent years, the Company has completed several divestitures, including the Biocon Biologics Transaction, the OTC Transaction and other divestitures.

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.

For instance, in connection with our recently completed divestitures, we have entered into transition services and manufacturing and supply agreements pursuant to which we have agreed to provide certain specified services to the respective purchasers, including manufacturing, quality, supply chain, pricing and procurement, regulatory, product safety and risk management, medical affairs, IT, finance, human resources, real estate, commercial development and local commercial operations services.

In addition, in connection with the OTC Transaction and the divestitures of our women’s healthcare business, we entered into distribution agreements.

Our obligations under these agreements have resulted and may in the future result in additional expenses that are borne by us and have diverted and may continue to divert our focus and resources that would otherwise be invested into maintaining or growing our retained business.

In connection with our API business divestiture, we entered into a manufacturing and supply agreement pursuant to which we are purchasing a significant amount of API from the purchaser in that transaction.

Our obligations under the manufacturing and supply agreement may make us more vulnerable to API supply shortages and price volatility.

Please also refer to “ 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.”

With respect to the Biocon Biologics Transaction, a significant portion of the consideration that we received, valued at approximately $1.3 billion on our balance sheet at December 31, 2024, is in the form of equity in Biocon Biologics, which is currently a privately held Indian company.

Although we have negotiated certain “downside” protection regarding the value of that equity in the Biocon Agreement and related documents, such protection does not guarantee any particular liquidity event or our ability to monetize our equity and, even if we are able to successfully liquidate our equity, the downside protection may be inadequate to guarantee a minimum return that we or investors expect.

In addition, we believe the success of the Biocon Biologics business will be highly dependent upon the successful transition of the business to, and ongoing operation of the business by, Biocon Biologics.

If the ongoing operation of the business is not successful, it could have a significant impact on the value of the equity we will own in Biocon Biologics and could negatively impact our business or financial condition.

We have also agreed to indemnify Biocon Biologics and certain of its representatives against certain losses suffered as a result of certain breaches of our representations, warranties, covenants and agreements in the Biocon Agreement and related documents.

Any event that results in a right for Biocon Biologics to seek indemnity from us could result in substantial liability to us and could adversely affect our financial position and results of operations.

We may not be able to realize the anticipated benefits from our divestitures, such as realizing the anticipated proceeds or utilizing the net proceeds for our strategic initiatives and priorities.

We may also face other challenges as a result of

divestitures, including maintaining employee morale and retaining key management and other employees to provide the transition services and to operate our retained business, and managing stranded costs.

As a result of the Biocon Biologics Transaction and our recently completed divestitures, our results of operations, including but not limited to total revenues and cash flows, have been reduced.

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.

As a result of the EWSR initiated in 2025, Viatris has announced related cost-saving and restructuring activities designed to deliver meaningful cost savings primarily over a three year period expected to optimize its commercial capabilities, enabling functions, its R&D, medical and regulatory activities, and its sourcing, manufacturing and supply chain, including inventory optimization.

Implementing these restructuring activities, including anticipated headcount reductions of up to approximately 10% and an anticipated facility closure, could cause an interruption of, or loss of momentum in, the activities of one or more of Viatris’ businesses, difficulty retaining existing employees, or require Viatris’ senior management to devote considerable amounts of time to these processes, which would decrease the time they have to manage and service Viatris’ existing businesses, and develop new products or strategies.

In addition, the restructuring activities could result in total costs and expenses that are greater than anticipated, asset impairments, and reductions to the size or scope of our business, our results of operations, including but not limited to total revenues, and cash flows, our market share in particular markets or our opportunities and ability to compete with respect to certain markets, therapeutic areas or products.

Even if the restructuring activities and related initiatives are successful, we may not achieve anticipated cost savings, opportunities for reinvestment, growth opportunities and other financial and operating benefits within the timeline we anticipate, or at all.

If our restructuring activities are unsuccessful, if the estimated costs are higher than anticipated, or if we are unable to realize the anticipated cost savings 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.

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.

Viatris has completed or is in the process of completing divestitures, product rationalizations and asset sales, and expects to initiate additional divestitures, product rationalizations and asset sales in the future.

Such actions have resulted and could in the future result in asset impairments, as well as reductions to the size or scope of our business, our results of operations (including but not limited to total revenues and cash flows), our market share in particular markets, or our opportunities and ability to compete with respect to certain markets, therapeutic areas or products.

We may not be successful in separating divested businesses or assets, which could negatively impact our ongoing operations, future earnings and future goals and outlooks.

In recent years, the Company has completed several divestitures, including the Biocon Biologics Transaction, the OTC Transaction, the divestiture of our API and women’s healthcare businesses and other divestitures.

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.

Because the businesses or assets we have divested were commingled with Viatris’ other businesses, their financial information must be carved-out of Viatris’ financial and other systems, and this process has increased or will continue to increase the risk of errors in the presentation of our financial results in conformity with U.S.

In addition, we may also face other challenges as a result of divestitures, including maintaining employee morale and retaining key management.

With respect to the Biocon Biologics Transaction, in December 2025, Viatris entered into definitive agreements with Biocon for the sale of Viatris’ equity stake in Biocon Biologics for total consideration of $815 million, consisting of $400 million in cash and $415 million in newly issued equity shares of Biocon.

The shares are subject to a six-month lock-up period.

While the shares are listed and traded on the National Stock Exchange of India, the value of the shares remains subject to market fluctuations and there is no guarantee that Viatris will be able to sell the shares for any particular price.

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.

The integration of acquired businesses as well as restructuring programs have presented and may in the future present significant challenges.

Refer to Note 5 Divestitures included in Part II, Item 8 of this Form 10-K for more information about our divestitures.

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 combination of two or more independent businesses is a complex, costly and time-consuming process and there is a significant degree of difficulty inherent in the integration process.

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• reducing costs associated with transition services, including managing the amount for replacement costs.

Viatris has also in the past undertaken and may in the future undertake restructuring programs in order to achieve synergies and ensure the Company is optimally structured and efficiently resourced.

The process of integrating operations and implementing restructuring initiatives could cause an interruption of, or loss of momentum in, the activities of one or more of Viatris’ businesses.

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.

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.

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.

The process of integrating operations could cause an interruption of, or loss of momentum in, the activities of one or more of Viatris’ businesses.

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.

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.

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.

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 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.

has imposed or is considering imposing tariffs on certain imports from other countries, including pharmaceutical products, ingredients and inputs, which could significantly impact our cost of doing business.

The imposition of adopted, new, announced or proposed tariffs, trade restrictions or domestic sourcing requirements on pharmaceutical imports, including but not limited to products, ingredients, and inputs (such as API), could result in increased costs of goods and prices, disruptions to our supply chain, manufacturing delays, supply shortages, and adverse impacts to clinical trials.

These measures could also result in decreased profit margins on certain of our products.

Decreased or negative profit margins have in the past, and could in the future, make the production of certain of our products unsustainable, thereby reducing our net sales as well as access for patients.

In addition, we may be restricted in our ability to adapt, or may be unable or unsuccessful in adapting, to these impacts and challenges due to, among other things, the terms of our current customer, supply or distribution agreements, or the need to obtain regulatory approval prior to making any changes to our manufacturing locations, processes or suppliers.

Existing, announced, and future tariffs, trade agreements, or domestic sourcing requirements, as well as potential exemptions, could also provide our competitors with an advantage to the extent such future impacts disproportionately affect us compared with them.

The impact of any adopted, announced, new or proposed tariffs, trade restrictions or domestic sourcing requirements on our business continues to be subject to a number of factors that we cannot predict, including, but not limited to, the scope, nature, amount, effective date and duration of any such measures.

Furthermore, general uncertainty related to adopted, new or potential tariffs, trade restrictions and domestic sourcing requirements has in the past reduced and could in the future further reduce global economic activity, thereby resulting in additional adverse impacts to us.

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.

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There is no guarantee that these cost containment measures will be rolled back in the event that inflation rates decrease in the future.

Recent actions by the Administration to establish most-favored-nation drug pricing pilot programs and its entrance into most-favored-nation drug pricing agreements with our competitors, could negatively impact the financial performance of innovative pipeline products and impact the business development environment.

Many markets in which we operate have implemented or may implement tender systems for generic pharmaceuticals in an effort to lower prices.

Under such tender systems, manufacturers submit bids which establish prices for generic pharmaceutical products.

Upon winning the tender, the winning company will receive a preferential reimbursement for a period

Upon winning the tender, the winning company will receive a preferential reimbursement for a period of time.

If our bids do not win, we may not be able to participate in the given market or may lose out on market share.

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Some states have also signed into law programs that compel manufacturers to provide certain medicines at free or reduced costs to certain patients, and additional states are exploring such programs.

Although we continue to expect to see focus on regulating pricing, we cannot predict what, if any, additional changes in legislative or regulatory priorities and personnel may transpire at the state or federal level, particularly given that there is a new presidential administration and change in control of Congress, or what the ultimate impact may be.

Although we continue to expect to see focus on regulating pricing, we cannot predict what, if any,

additional changes in legislative or regulatory priorities and personnel may transpire at the state or federal level, or what the ultimate impact may be.

In the U.S., certain of these pressures are further compounded by increasing consolidation among wholesalers, retailer drug chains, PBMs, private insurers, managed care organizations and other private payors, which can increase their negotiating power.

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Healthcare reform legislation could have a material adverse effect on our business.

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 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 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.

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.

These reforms include government price negotiation for certain high-spend, single-source Medicare drugs, out-of-pocket caps for Medicare beneficiaries using insulin products, and the application of inflation-based rebates for certain Medicare drugs.

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We are unable to predict the future course of federal or state healthcare legislation in the U.S.

or reform or the outcome of challenges to such laws or reforms once passed, particularly given that there is a new presidential administration and change in control of Congress.

or reform or the outcome of challenges to such laws or reforms once passed.

For example, changes to or reductions in subsidies of individual insurance plans on the healthcare exchanges in 2026 have led to a reduction in the number of individuals with health insurance in the U.S., which could lead to correlating reductions in spending on pharmaceuticals and increased reliance on our patient support programs.

Instability related to government funding, particularly Congressionally appropriated funds used by the FDA or user fees, or heightened levels of staff departures at key regulatory agencies, could lead to increased regulatory uncertainty and delayed approvals for NDAs and ANDAs.

Significant additional reforms to the U.S.

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• 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.

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.

• 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.

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.

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;

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• 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;

• 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.

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• 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.

• 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.

• 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;

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;

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In particular, the amount of goodwill and identifiable intangible assets in our consolidated balance sheets is significant as a result of our acquisitions and other transactions, and may increase further following future potential acquisitions, and we have in the past and may in the future decide to sell assets that we determine are not critical to our strategy or execution.

These and other future events or decisions have in the past and may in the future lead to asset impairments and/or related charges.

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.

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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.

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.

Counterfeit products are frequently unsafe or ineffective and can be potentially life-threatening.

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In addition, certain products have experienced or may experience generic competition prior to the expiration of patent terms or associated extensions.

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.

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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.

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.

In many emerging markets, we face increased competition and contracting markets for certain of our ARV products, primarily related to competing therapies.

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Sales of a limited number of our products from time to time represent a significant portion of our revenues, net sales, gross profit, and net earnings.

For each of the years ended December 31, 2024 and 2023, Viatris’ top ten products in terms of sales, in the aggregate, represented approximately 33% of the Company’s net sales.

For the years ended December 31, 2025 and 2024, Viatris’ top ten products in terms of sales, in the aggregate, represented approximately 36% and 33%, respectively, of the Company’s net sales.

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.

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For example, if the U.S.

government defaults on its debt, or the U.S.

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.

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.

A sovereign debt default, economic volatility, governmental financial restructuring efforts and evolving deficit and spending reduction programs could negatively impact the global economy and the pharmaceutical industry.

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Reduced consumer and customer spending, reduced government or third-party payor coverage or reimbursement, or new government controls, may drive us and our competitors to decrease prices, may reduce the ability of customers to pay, or may result in reduced demand for our 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.

While inflationary and other macroeconomic pressures have somewhat eased more recently, we do not expect to see a corresponding reduction in these higher costs and expect such higher costs to negatively impact our results of operations.

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Inflation has also resulted and may continue to result in higher interest rates and increased costs of capital.

In particular, the global economy has recently been impacted by high levels of inflation and rising energy costs, which has resulted in significant economic volatility and central banks tightening their monetary policies and increasing interest rates.

In particular, high levels of inflation and rising energy costs have in the past, and may in the future, result in significant economic volatility.

These macroeconomic pressures combined with the volatility in foreign exchange rates, including the strengthening of the U.S.

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If environmental discharge occurs, or to the extent we discover contamination caused by third parties, including by prior owners and operators of properties we acquire or lease, or by neighboring properties or other offsite sources, we could be liable for cleanup or remediation obligations, damages and fines or have relevant permits, authorizations or registrations modified or revoked, regardless of our responsibility for such contamination.

Our manufacturing operations involve handling chemicals, pressurized systems, and complex equipment and electrical systems, which expose us to inherent health and safety risks.

These include accidents, fires, explosions, chemical spills, and employee exposure to hazardous substances.

Such incidents have in the past and could in the future result in serious injury, property damage, regulatory investigations, or significant operational disruptions.

We have implemented systems and procedures across our facilities designed to prevent, prepare for and respond to such incidents.

However, if our systems,

procedures or other risk management efforts are not effective, our facilities may be adversely affected, and operations would experience significant impact or disruption.

In addition, any non-compliance with environmental and occupational health and safety laws and regulations and permits, or emissions into the environment, whether actual or perceived, may result in significant reputational damage.

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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.

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.

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.

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.

For example, certain jurisdictions and regulatory agencies, including the FDA and EMA, require risk assessments and, if applicable, testing for the presence of nitrosamine impurities in certain drugs.

If such regulatory authorities become aware of new safety information about any of our marketed or investigational products, those authorities may require further inspections, enhancements to manufacturing controls, labeling changes, establishment of a risk evaluation and mitigation strategy or similar strategy, restrictions on a product’s indicated uses or marketing, or post-approval studies or post-market surveillance.

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Products must be manufactured in our facilities in accordance with cGMP or similar standards in each territory in which we manufacture.

Compliance with such regulations and with our own quality standards requires substantial expenditures of time, money, and effort in multiple areas, including training of personnel, record-keeping, production, and quality control and quality assurance.

Compliance with such regulations and with our own quality standards requires substantial expenditures of time,

money, and effort in multiple areas, including training of personnel, record-keeping, production, and quality control and quality assurance.

The FDA and other comparable regulatory authorities, including foreign authorities, periodically inspect our manufacturing facilities for compliance with cGMP or similar standards in the applicable territory.

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and have also negatively impacted our ability to sell products made at this facility to customers in other regions.

We currently expect a negative impact from the Indore actions on our financial condition, results of operations and cash flows in fiscal year 2025, and, if we are unable to resolve any such observations and address regulatory concerns in a timely fashion, our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price could be materially adversely affected in 2025 as well as future periods.

The warning letter and import alert at our Indore facility negatively impacted our financial condition, results of operations and cash flows in fiscal year 2025, and we may not be able to fully recover these lost revenues in current or future periods.

While we continue to work toward finalizing the remediation of the Indore facility to prepare for reinspection by the FDA, if we are unable to resolve any such observations and address regulatory concerns in a timely fashion, our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price could be materially adversely affected.

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;

require one of our manufacturing facilities, partners, or suppliers to cease or limit production;

or suspend, vary, or withdraw related marketing authorization.

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Regulators and policymakers globally are also increasingly focused on addressing drug shortages and expanding transparency across supply chains.

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.

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.

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• obtaining extensions of market exclusivity by conducting clinical trials of brand drugs in pediatric populations or by other methods;

• seeking to obtain new patents on drugs for which patent protection is about to expire.

• seeking to obtain patents on new uses, formulations and processes with respect to drugs for which any original patent protection is about to expire.

In the U.S., some companies have lobbied Congress for amendments to Hatch-Waxman Act that would give them additional advantages over generic competitors.

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Our future revenues and profitability will depend, in part, upon our ability to successfully and timely develop, license, or otherwise acquire and commercialize new products.

For example, in 2026 Viatris is anticipating regulatory responses on several products, including its low dose estrogen weekly patch for contraception and fast-absorbing formulation of meloxicam.

Product development is inherently risky, especially for new drugs for which safety and efficacy have not been established and/or the market is not yet fully developed as well as for complex generic drugs and biosimilars.

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As we look to accelerate our growth by building on the strength of our base business with an expanding portfolio of innovative, best-in-class, patent-protected assets, the development and commercialization process of such products requires substantial time, effort and financial resources.

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.

As a result, our ability to match our production levels and capacity to market demand is imprecise and may result in a failure to meet market demand or satisfy customer requirements for our products or, alternatively, an oversupply of inventory.

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.

Before any prescription drug product, including generic drug products, can be marketed, marketing authorization approval is required by the relevant regulatory authorities and/or national regulatory agencies (for example, the FDA in the U.S., the EMA in the EU and other regulatory authorities).

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We, or a partner or supplier, may be unable to obtain requisite approvals on a timely basis, or at all, for new products that we may develop, license or otherwise acquire.

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.

A regulatory approval may also include post-approval study or risk management requirements that may substantially increase the resources required to market the drug.

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Much of our development effort is focused on technically difficult-to-formulate products and/or products that require advanced manufacturing technology.

We conduct R&D primarily to enable us to gain approval for, manufacture, and market pharmaceuticals in accordance with applicable laws and regulations.

We also partner with third parties to develop products, including, for instance, our acquisition of the development programs for selatogrel and cenerimod, which are currently in Phase 3 development.

In such cases, successful product introductions have in the past and may in the future significantly rely on such partners, including with respect to their financial condition.

We conduct R&D primarily to enable us to gain approval for, manufacture, and market

pharmaceuticals in accordance with applicable laws and regulations.

We also partner with third parties to develop or acquire products under development, including, for instance, our acquisition of the development programs for selatogrel and cenerimod, which are currently in Phase 3 development and our acquisition of Aculys Pharma, including exclusive rights to pitolisant in Japan and Spydia® in Japan and certain other markets in the Asia-Pacific region.

Successful product introductions have in the past and may in the future significantly rely on our partners or collaborators, including with respect to their financial condition.

Typically, expenses related to the development of innovative or complex compounds and the filing of marketing authorization applications for innovative and complex compounds (such as NDAs in the U.S.) are significantly greater than those expenses associated with the development of and filing of marketing authorization applications for most generic products (such as ANDAs in the U.S.

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Also, after we submit a marketing authorization application for a new compound or generic product, the relevant regulatory authority may change standards and/or request that we conduct additional studies or evaluations and, as a result, we may incur approval delays as well as R&D costs in excess of what we anticipated.

For example, we are currently working with Mapi to determine appropriate next steps with respect to a Complete Response letter from the FDA regarding the NDA for GA Depot 40mg.

Clinical testing, particularly with respect to new and/or complex or innovative drugs, is expensive and can take many years to complete, and its outcome is inherently uncertain.

Failure can occur at any time during the clinical trial process.

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.

Failure can occur at any time during the clinical trial process, including after significant investments have been made.

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.

Clinical trials are complex to administer and outcomes are often unpredictable, particularly with respect to new and/or complex or innovative products.

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If we, our partners and suppliers, or our products or brands suffer from negative publicity, are subject to market withdrawal or recall or are proven to be, or are claimed to be, ineffective or harmful to consumers, then this could have a material adverse effect on our reputation and business.

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 addition, if customers, patients or regulatory authorities mistake us, our partners and suppliers, or our products and brands for other companies, products or brands, this could lead to brand confusion, unanticipated regulatory inquiries or proceedings and have a negative impact on our reputation and business.

Viatris’ sales and marketing efforts are anchored by promoting its products to physicians, pharmacists, eye care and other healthcare professionals, clinics and hospitals.

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.

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A substantial portion of our manufacturing capacity, as well as our current production, is attributable to a limited number of manufacturing facilities and certain third-party suppliers.

In recent years, we have closed, downsized and divested a number of our manufacturing facilities globally, which further limits our internal manufacturing capacity and increases our dependence on third-party suppliers.

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.

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.

We have in the past and will in the future close, downsize or divest manufacturing facilities, which further limits our internal manufacturing capacity and increases our dependence on third-party suppliers.

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.

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.

If we or our third-party suppliers face significant manufacturing issues, this could lead to shutdowns, delays or product shortages, or to our being entirely unable to supply certain products to customers for an extended period of time.

In addition, our facilities or the facilities of our third-party suppliers may be required to close for periods of time, be required to staff at reduced capacity, or suffer other manufacturing delays as the result of an outbreak of disease, epidemic or pandemic, in or near any of our facilities.

Such shortages, delays or shutdowns have led and could continue to lead to significant losses of sales revenue, third-party litigation, or negative publicity.

In addition, our facilities or the facilities of our third-party suppliers have in the past and may in the future be required to close for periods of time, be required to staff at reduced capacity, or suffer other manufacturing shortages, delays or shutdowns as the result of an outbreak of disease, epidemic or pandemic, fires, accidents, weather, unrest or other emergencies taking place in or near any of our facilities.

For example, manufacturing at our facility in Nashik, India has been temporarily suspended due to a fire in February 2026.

Such shortages, delays or shutdowns have in the past and could in the future result in significant losses of sales revenue, third-party litigation, or negative publicity.

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 .”

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Our obligations under this manufacturing and supply agreement have made us more dependent on the purchaser of our API business and the success of their business, and made us more vulnerable to API supply shortages and price volatility.

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.

The EU has implemented particularly stringent regulations with respect to manufacturing standards for API imported into Europe that place the certification requirement on the regulatory bodies of the exporting countries.

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Given the size, complexity and global reach of our business, it is important that we attract, motivate and retain qualified management and other key employees in order to develop and commercialize new products, manage our business, and compete effectively.

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.

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.

Current or prospective Viatris employees may have changing expectations around workplace flexibility, and a failure to meet these evolving expectations may result in reduced ability to attract and retain talent.

In addition, current or prospective Viatris employees may experience uncertainty about their future roles at the Company as a result of our strategic initiatives, acquisitions, divestitures, integration activities or restructuring programs.

As a result, we may lose key personnel or may be unable to attract, retain and motivate qualified individuals, or the associated costs may increase.

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There can be no assurance that our submissions will not be found by Centers for Medicare & Medicaid Services or the VA to be incomplete or incorrect.

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.

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 are involved in various legal proceedings and certain government inquiries and may experience unfavorable outcomes of such proceedings or inquiries.

We are or may be involved in various legal proceedings and certain government inquiries or investigations, including, but not limited to, patent infringement, product liability, personal injury, securities fraud, claims with respect to the manufacture, sale, marketing and distribution of opioid products, antitrust matters, breach of contract, consumer protection matters, and claims involving Medicare, Medicaid and/or VA reimbursements, or laws relating to sales, marketing, and pricing practices.

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.

Viatris is subject to investigations and extensive regulation by government agencies in the U.S., China and other developed and emerging markets in which we operate.

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If any of these legal proceedings or inquiries were to result in an adverse outcome, the impact 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.

Moreover, although we maintain a combination of self-insurance and commercial insurance, no reasonable amount of insurance can fully protect against all risks because of the potential liability inherent in the business of producing pharmaceuticals for human consumption.

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We are increasingly dependent on IT and information systems and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

Significant disruptions to our IT and information systems or breaches of information security could adversely affect our business.

Significant disruptions to our IT and information systems or cybersecurity breaches could adversely affect our business.

We are increasingly dependent on sophisticated IT and information systems and infrastructure to operate our business.

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.

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.

If the Company does not successfully establish, maintain and update its IT and information systems, this could result in increased system outages or business disruptions, higher costs and failure to meet our business objectives.

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.

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.

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Insurance may be insufficient or may not cover the financial, legal, business or reputational losses that may result from a breakdown, breach, cybersecurity threat or incident or other compromise of or interruption to our IT and information systems or confidential and other sensitive information.

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.

respect to any particular claim.

Refer to Part I, Item 1C “Cybersecurity” of this Form 10-K for additional information about the Company’s risk management and strategy and governance with respect to cybersecurity threats and incidents.

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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.

The EU’s and U.K.’s GDPR and local implementing regulations also impose significant compliance obligations on our organization.

The GDPR contains data protection requirements in the EU and U.K.

and imposes a framework of obligations and restrictions governing the collection, processing, and the transmission of personal information to jurisdictions outside of the EU and U.K.

The GDPR affords individuals with a series of privacy rights related to the collection, processing, and transmission of their personal information.

The GDPR imposes significant compliance obligations, including required processes and policies governing our collection, transmission, processing and use of individuals personal information.

In addition, the GDPR includes significant penalties for non-compliance, with fines up to the higher of €20 million or 4% of total annual worldwide revenue.

In general, GDPR, and other data protection laws and regulations, could require adaptation of our technologies or practices to satisfy local country data protection requirements and standards.

The EU’s and U.K.’s GDPR, together with related local implementing regulations, impose significant compliance obligations on our organization.

The GDPR establishes a comprehensive data protection framework that governs the collection, processing, and the transmission of personal information to jurisdictions outside of the EU and U.K.

The GDPR also affords individuals with a series of privacy rights relating to their personal information.

GDPR-imposed violations can result in significant penalties for non-compliance, including fines up to the higher of €20 million or 4% of total annual worldwide revenue.

Cybersecurity regulations continue to evolve beyond laws focused specifically on personal information.

In particular, the EU’s NIS2 Directive and related national implementing laws impose additional cybersecurity risk management, governance, and incident reporting obligations on certain in-scope entities and their critical services and systems.

NIS2 also includes significant penalties for non-compliance, including fines up to the higher of €10 million or 2% of total annual worldwide revenue for certain entities, as implemented by applicable national law.

Other recent or proposed legislation aimed at strengthening national cybersecurity protections have focused on more prescriptive requirements for managing risks and vulnerabilities and reporting incidents, going beyond general guidelines.

Another evolving trend is national prohibitions against the use of foreign security software, imposing data sovereignty or prohibitions on cross-border security monitoring, which could require us to adapt our technologies, controls and practices to meet local standards.

In China, the laws and regulations relating to cybersecurity, data privacy and personal information continue to evolve.

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.

These laws and regulations restrict our ability to collect, transfer and use certain personal data, absent an application to and, in some cases, approval from relevant governmental authorities in China.

Additional regulations, guidelines, and measures relating to data privacy and data protection are expected to be adopted, including more guidance from industry sector regulators on the catalogues of important data and publication of implementation rules for certifications for cross-border transfers of personal information out of China, which may contain additional requirements for transferring personal information out of mainland China.

In India, the DPDP Act forms the personal information protection and regulatory requirements for organizations who process any personal information within the country.

The DPDP Act is currently in the initial phase of implementation with a 12-18 month phased compliance timeline for organizations although there are current discussions regarding shortening this timeline.

The DPDP Act focuses on data minimization, purpose limitation, and user consent and includes a requirement for a Data Protection Officer.

While similar to other data protection laws such as the GDPR, several requirements are unique to the DPDP Act such as registered consent managers and a lack of available legal bases for processing personal information without consent.

These requirements, along with other requirements unique to the DPDP Act, will require us to enhance our data privacy processes and practices accordingly.

Other countries in which we operate have, or are developing, laws and regulations governing the collection, use, securing and transmission of personal information as well that may affect our business or require us to adapt our technologies or practices.

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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, 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.

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.

A failure by us, or our third-party vendors, to comply with applicable data privacy and security laws may lead to government enforcement actions and private litigation, which could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on the way we operate our business, our financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.

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.

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.

The rapidly evolving nature of these technologies presents risks and challenges, including with respect to opportunity costs, the establishment of durable governance frameworks, standards and best practices, and uncertainty around return on investment.

For example, algorithms may be flawed;

data sets may be insufficient, of poor quality or contain biased information;

and inappropriate or controversial data practices could impair results.

If the analyses that ML or AI-based software assist in producing are deficient or inaccurate, we could be subjected to competitive harm, potential legal liability and brand or reputational harm.

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.

In addition to the risks inherent in all information technology systems—including cybersecurity, data confidentiality, system integrity, and availability—the unique characteristics of AI can amplify existing risks and introduce new risks.

These include an elevated risk of intellectual property loss or infringement, whether through inadvertent disclosure, unauthorized training on proprietary data, or improper use of third-party content.

AI tools lower the barrier to access and replication, increasing the likelihood of intellectual property leakage, copyright violations, and regulatory non-compliance.

Additionally, ML or AI-based systems may be subject to novel cybersecurity risks, including attempts to manipulate model outputs, poison data, or extract sensitive information, which could compromise the confidentiality, integrity, or availability of our systems and data.

AI-specific risks also include so-called “hallucinations,” where systems generate inaccurate, misleading, or fabricated outputs that may not be readily detectable, potentially affecting business decisions, customer trust, and regulatory posture.

Model performance is highly dependent on the quality, completeness, and appropriateness of underlying data.

Flawed algorithms, biased or insufficient datasets, or controversial data practices may lead to unreliable outcomes and reputational harm.

The deployment of AI in regulated environments presents additional complexity.

Requirements related to validation, documentation, explainability, data lineage, and change control may lengthen implementation timelines, increase costs, or trigger regulatory scrutiny, audit findings, or enforcement actions.

As regulatory expectations continue to mature globally, organizations must ensure that AI adoption aligns with existing compliance obligations and risk management frameworks.

The misuse of AI solutions could also result in unauthorized access and use of personal data of our employees, clinical trial participants, collaborators, or other third parties.

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Compliance with new or changing laws, regulations or industry standards relating to AI may impose significant operational costs and may limit our ability to develop, deploy or use AI technologies.

Failure to appropriately respond to this evolving landscape may result in legal liability, regulatory action, loss of trade secrets or other intellectual property, brand and reputational harm, or lead to outcomes with unintended biases or other consequences, which could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on the way we operate our business, our financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.

Increasing scrutiny and evolving expectations from customers, regulators, governments, investors, lenders, employees, and other stakeholders with respect to our environmental, social and governance practices may impose additional costs on us or expose us to new or additional risks.

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Investor advocacy groups, investment funds and influential investors are also focused on these practices, including those related to the environment, climate change, health and safety, supply chain management, diversity, labor conditions and human rights, both in our own operations and in our supply chain.

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.

business and operations.

In parallel, environmental, social and governance initiatives have become increasingly controversial, and we may also face scrutiny, reputational risk, lawsuits or market access restrictions as a result of our initiatives and disclosures.

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.

Failure to adapt to or comply with government regulations, regulatory requirements or investor or stakeholder expectations and standards could negatively impact our reputation, ability to do business with certain partners, access to investors and capital, and our stock price, and could lead to novel forms of litigation, including shareholder litigation and governmental investigations or enforcement actions, sanctions or fines related to environmental, social and governance matters.

In the EU, evolving “extended producer responsibility” regulations now require companies that manufacture pharmaceutical products to pay a significant portion of the cost of treating urban wastewater to eliminate micropollutants.

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.

In the EU, evolving “extended producer responsibility” regulations have been proposed or adopted with respect to public wastewater treatment and use of plastics, among others.

For example, as currently proposed, companies that manufacture, market, or supply pharmaceutical products will be required to pay a significant portion of the cost of upgrading public wastewater treatment plants across EU member states to treat urban wastewater to eliminate micropollutants.

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, a growing number of our customers, including certain government purchasers, have adopted, or may adopt, procurement policies that include social and environmental requirements, including, for example, requirements to monitor and conduct third party audits, or these customers may seek to include such provisions in their procurement contract terms and conditions.

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Current or future insurance arrangements may not provide protection for costs that may arise from such events, particularly if such events are catastrophic in nature or occur in combination.

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.

These events could have a material adverse effect on the way we operate our business, including the resiliency of our supply chain, our financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.

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A share repurchase program could affect our stock price and increase volatility, and any announcement of a pause in, or termination of, a share repurchase program may result in a decrease in our stock price.

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.

If we are unable to, or choose not to, pay a quarterly dividend or repurchase shares under our share repurchase program, this may have a negative impact on the perception of the Company as an investment opportunity by shareholders or investment analysts, which may in turn negatively impact our stock price.

If the intercompany terms of cross border arrangements that we have among our subsidiaries are determined to be inappropriate or ineffective, our tax liability may increase.

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.

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.

If tax authorities determine that the intercompany pricing applied to our cross-border arrangements is inconsistent with the arms’ length standard or otherwise ineffective, our tax liabilities could increase.

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.

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.

We may not be able to maintain competitive financial flexibility and our corporate tax rate which could adversely affect us and our shareholders.

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We must make material assumptions underlying our expected tax rates, including regarding the effect of certain internal reorganization transactions, intercompany transactions, and divestitures.

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.

Our actual effective tax rate may vary from our expectation and that variance may be material.

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Inflation Reduction Act was signed into law which, among other things, provides for a corporate alternative minimum tax of 15% on adjusted financial statement income and an excise tax of 1% on corporate share repurchases.

In addition, on July 4, 2025, the U.S.

enacted the One Big Beautiful Bill Act, which contains a broad range of tax reform provisions affecting businesses, including permanent extensions of most expiring Tax Cuts and Jobs Act provisions and international tax changes.

Moreover, the rate of tax we pay in other jurisdictions may increase significantly upon the adoption and implementation of the OECD Pillar Two Global Anti-Base Erosion rule, which provides for a minimum 15% tax rate in jurisdictions where adopted.

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Defaults or restructurings in other countries could have a similar adverse impact on our financial condition, results of operations, and cash flows.

In addition, there remains significant international pressure on the Chinese government to adopt a more flexible currency policy, including from the U.S.

government, which designated China as a “currency manipulator” in August 2019 and subsequently removed such designation in January 2020, which could result in greater fluctuation of the Renminbi against the U.S.

From time to time, we may implement currency hedges intended to reduce our exposure to changes in foreign currency exchange rates.

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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

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.

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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.

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.

For instance, during the years ended December 31, 2024 and 2025, the Company recorded significant goodwill and other long-lived asset impairment charges.

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.

Viatris may be adversely affected by disruptions in the credit markets, including disruptions that reduce customers’ access to credit and increase the costs to customers of obtaining credit.

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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.

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.

Further, Viatris had approximately $259 million of floating rate debt as of December 31, 2025.

A one percentage point increase in the average interest rate of this debt would increase the combined interest expense by approximately $2.6 million per year.

Accordingly, a spike in interest rates could adversely affect our results of operations and cash flows.

Accordingly, for both potential new debt issuances and floating rate exposures, a spike in interest rates could adversely affect our results of operations and cash flows.

Viatris has certain material obligations relating to defined benefit pension and termination benefit programs.

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and foreign countries.

Our obligations under these plans are significant and future funding obligations are subject to increased interest rates on asset and liability calculations.

Our obligations under these plans are significant and future funding obligations are subject to increased interest rates on asset and liability calculations and changes in laws, which could materially increase costs to Viatris.

Each of these liabilities and the related future payment obligations could restrict cash available for Viatris’ operations, capital expenditures, acquisitions, dividend payments, share repurchases, and other requirements, and may materially affect Viatris’ financial condition and liquidity.

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

What changed 10-K

Item 1A. Risk Factors