VTRS 10-K & 10-Q changes, risk factors and insider trading

◦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,our acquisitionsenterprise-wide orstrategic review and other potential corporate transactions.

◦ThereViatris’ arerestructuring ongoingactivities risksmay not achieve their intended goals and uncertaintiesmay associatedpresent withsignificant our recent divestitures, one or more ofchallenges, 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 may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives and priorities, including divestitures,our acquisitionsenterprise-wide orstrategic review and other potential corporate transactions.

Implementing these and otherour 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. TheseOur 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 more 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.

ThereViatris’ arerestructuring ongoingactivities risksmay not achieve their intended goals and uncertaintiesmay associatedpresent withsignificant our recent divestitures, one or more ofchallenges, 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.

AnyIf ofour restructuring activities are unsuccessful, if the risksestimated describedcosts aboveare higher than anticipated, or if we are unable to realize the anticipated cost savings and other benefits, there could havebe a material adverse effect on ourViatris’ 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.

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. TheseIn addition, integration and restructuring processesactivities have in the past and may in the future require Viatris’ senior management to devote considerable amounts of time to these processes,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 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.

We operate in a challenging environment, with significant pressures on the pricing of our products and on our ability to obtain and maintain satisfactory rates of reimbursement for our products by governments, insurers and other payors. We face numerous cost-containment measures by governments and other payors, including certain government-imposed industry-wide price reductions, caps on price increases, mandatory rebates or pricing, international reference pricing (i.e., the practice of a country linking its regulated medicine prices to those of other countries), VBP, tender systems, shifting of the payment burden to patients through higher co-payments, and requirements for increased transparency on pricing, all of which may have an adverse impact on the pricing of our products. In addition, rates of inflation have increased and may continue to increase pressure on governments, insurers and other payors to implement additional cost containment measures. 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.

In addition, there have been executive orders, legislation, and legislative and regulatory proposals, including in connection with government programs such as Medicare, concerning drug prices and related issues, including the perceived need to bring more transparency to drug pricing, reviewing the relationship between pricing and manufacturer patient programs, and reforming government program reimbursement methodologies for drugs. 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.

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 CongressCongress, the Administration, 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,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. The implementation of the Inflation Reduction Act, including the drug price negotiation provision, inflation penalties, and Part D redesign is currently underway and could negatively affect certain Viatris portfolio products based on future pricing decisions, changes in the Consumer Price Index for All Urban Consumers (CPI-U), and the potential for shifting payor preferences based on the Part D redesign and requirements to cover drugs selected for negotiation.

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,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 givenCongressionally thatappropriated therefunds isused aby newthe presidentialFDA administrationor user fees, or heightened levels of staff departures at key regulatory agencies, could lead to increased regulatory uncertainty and changedelayed inapprovals controlfor ofNDAs Congress.and ANDAs. Significant additional reforms to the U.S. healthcare system, including changes to the ACA, Medicare and Medicaid, modifications to the Inflation Reduction Act, or changes to other laws or regulatory frameworks in other markets in which we operate, that reduce our revenues or increase our costs 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.

•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. 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;

•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;

•increasedimposition tariffsof onadopted, thenew, importannounced or exportproposed oftariffs, ourtrade restrictions or domestic sourcing requirements, including but not limited to products, ingredientsingredients, orand inputs into(such ouras products, or API, including potentially significant reciprocal tariffsAPI) on products sold between the U.S. and other countries as a result of recent trade policy shifts in the U.S. and other countries;

•changing or increasing requirements related to the domestic or regional manufacture of pharmaceutical products, or other country of origin policies, in the U.S., EU, and other jurisdictions globally, including changes in U.S. government procurement laws for pharmaceutical products related to compliance with the Trade Agreements Act or country of origin policies, or changes in U.S. agency procurement policies for pharmaceutical products manufactured in India or ChinaChina, or changes in relevant customs, import, and export laws;

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 significant asset impairments and/or related charges.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. Any such charges could cause a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.

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. Counterfeit medicines may contain harmful substances, the wrong API, an incorrect dose of API or no API at all, depriving patients of the therapeutic benefit of such medicines. However, to distributors and users, counterfeit products may be visually indistinguishable from the authentic version.

Many of our products are not protected by patent rights or have limited patent life and will soon lose patent protection. Loss of patent protection for a product typically is followed promptly with the launch of generic products. As a result, sales of many of these products decline or stop growing over time, and decline faster than projected once patent protection is lost. 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.

We also face increasing competition from lower-cost generic products and other branded products. As we focus on developing or acquiring innovative, best-in-class, patent-protected assets, competition from manufacturers of generic or biosimilar drugs, including from generic versions of competitors’ branded products that lose their market exclusivity, has been and will continue to be a major challenge for our patent-protected and branded products. Generic competitors are also becoming more aggressive in terms of pricing in many of the regions in which Viatris operates. In China, for example, we face strong competition from certain generic manufacturers, which havehas resulted and may in the future result in price cuts and volume loss on some of Viatris’ branded products.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. We also face competition in the U.S., the EU and other mature markets that have a robust generics market and favorable regulatory conditions for generics. In addition, legislative proposals emerge from time to time in various jurisdictions to further encourage the early and rapid approval of generic drugs. Any such proposal that is enacted into law could increase competition and worsen this negative effect on our branded sales.

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, 20242025 and 2023,2024, Viatris’ top ten products in terms of sales, in the aggregate, represented approximately 33%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.

The global economy continues to experience significant volatility, and the economic environment may become less favorable. For example, if the U.S. governmentor another country 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. 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. This has led, or could lead, to reduced consumer and customer spending, reduced or eliminated governmental or third-party payor coverage or reimbursement or reduced spending on healthcare, including but not limited to pharmaceutical products. While generic drugs present an alternative to higher-priced branded products, our sales could be negatively impacted if patients forego obtaining healthcare, patients and customers reduce spending or purchases, or if governments or third-party payors reduce or eliminate coverage or reimbursement amounts for pharmaceuticals or impose price or other controls adversely impacting the price or availability of pharmaceuticals (whether for generics, branded products or both). 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. 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. For the pharmaceutical industry and the healthcare systems in the markets in which we participate, regulatory restrictions and the pricing dynamics of our products generally make it difficult to pass on such costs to customers. 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,costs whichhave hasin resultedthe past, and may in the future, result in significant economic volatility and central banks tightening their monetary policies and increasing interest rates.volatility. These macroeconomic pressures combined with the volatility in foreign exchange rates, including the strengthening of the U.S. dollarDollar versus the other currencies in which we operate, has in the past and may in the future, negatively impact our results of operations.

We are subject globally to various laws and regulations concerning, among other things, the environment, climate change, water, waste, chemicals and employee health and safety. These requirements include regulation of the handling, manufacture, transportation, storage, use and disposal of materials and wastes, including the discharge of regulated materials and emissions into the environment. We are also subject to related permitting, record-keeping, reporting and registration requirements. In the normal course of our business, we are exposed to risks relating to possible releases of hazardous substances into the environment, which could cause environmental or property damage or personal injuries, and which could result in (i) our noncompliance with such environmental and occupational health and safety laws, regulations and permits and (ii) regulatory enforcement actions or claims for personal injury and property damage against us. 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. 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. The substantial unexpected costs we may incur 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. Environmental and occupational health and safety laws and regulations are also complex and subject to change, and our related capital expenditures and costs for compliance may increase substantially in the future as a result of such changes, the development and manufacturing of a new product or increased development or manufacturing activities at any of our facilities. We may be required to expend significant funds and our manufacturing activities could be delayed or suspended or we may lose the ability to purchase or use certain materials, or face restrictions on the amounts of materials we may use or purchase, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.

The pharmaceutical industry is subject to regulation by various governmental authorities in the jurisdictions in which we operate, including the U.S., EU, China and India. For instance, we must comply with applicable laws and requirements of the FDA and other regulatory agencies, including foreign authorities, with respect to the research, development, manufacture, quality, safety, effectiveness, approval, labeling, tracking, tracing, authentication, storage, record-keeping, reporting, pharmacovigilance, sale, distribution, import, export, marketing, advertising, and promotion of pharmaceutical products. We are committed to conducting our business, including the sale and marketing of our products, in compliance with all applicable laws and regulations. These laws and regulations, however, are numerous, complex and continue to evolve, and it is possible that a governmental authority may challenge our activities, or that an employee or agent could violate these laws and regulations without our knowledge. 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,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 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. In addition, we are subject to regulations in various jurisdictions, including the Federal Drug Supply Chain Security Act in the U.S., the Falsified Medicines Directive in the EU and several other such regulations in other countries that require us to develop electronic systems to serialize, track, trace and authenticate units of our products through the supply chain and distribution system. Compliance with these regulations has in the past and may in the future result in increased expenses for us or impose greater administrative burdens on our organization, and failure to meet these requirements could result in fines or other penalties.

Although we have established internal quality and regulatory compliance programs and policies, there is no guarantee that these programs and policies, as currently designed, will meet regulatory agency standards in the future or will prevent instances of non-compliance with applicable laws and regulations. Additionally, despite our compliance efforts, we or our partners have in the past and may in the future receive notices of manufacturing and quality-related observations following inspections by regulatory authorities around the world, as well as official agency correspondence regarding compliance. For example, in December 2024 the FDA issued a warning letter and import alert related to our oral finished dose manufacturing facility in Indore, India. The warning letter and import alert restrict our ability to distribute certain products into the U.S. and have also negatively impacted our ability to sell products made at this facility to customers in other regions. WeThe currentlywarning expectletter aand negativeimport impactalert fromat theour Indore actionsfacility onnegatively impacted our financial condition, results of operations and cash flows in fiscal year 2025, and,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 in 2025 as well as future periods.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 facilitiesfacilities, partners, or suppliers to cease or limit production; or suspend, vary, or withdraw related marketing authorization. Reductions in personnel at the FDA or other health agencies as a result of changing legislative or regulatory priorities could result in slower response times or reduced resources and, as a result, review of regulatory submissions, inspections, resolution of warning letters or import alerts, approval of new products and other timelines important to our business may be materially impacted, which could have a material adverse effect on our business.

This Form 10-K contains “forward-looking statements”. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about the goals or outlooks with respect to the Company’s strategic initiatives and priorities, including but not limited to divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions; the anticipated benefits and synergies of such divestitures, acquisitions, strategic alliances, collaborations,initiatives or other transactions,priorities or restructuring programsactivities; future opportunities for the Company and its products; the outcomes of clinical trials and research studies; R&D and new product development; and any other statements regarding the Company’s future operations, financial or operating results, capital allocation, dividend policy and payments, share repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, imperatives, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock value, and other expectations and targets for future periods. Forward-looking statements may often be identified by the use of words such as “will”, “may”, “could”, “should”, “would”, “project”, “believe”, “anticipate”, “expect”, “plan”, “estimate”, “forecast”, “potential”, “pipeline”, “intend”, “continue”, “target”, “seek” and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to:

•the possibility that the Company may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives and priorities (including divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions) or accelerate its growth by building on the strength of its base business with an expanding portfolio of innovative, best-in-class, patent-protected assets;

•the possibility that the Company may be unable to achieve the intended or expected benefits,benefits goals,of outlooks,its synergies,enterprise-wide growthstrategic opportunitiesreview and operatingrelated efficienciescost-saving in connection with divestitures, acquisitions, strategic alliances, collaborations, or other transactions, orand restructuring programs,activities within the expected timeframestimeframe or at all;

•the potential impact of natural or man-made disasters, public health outbreaks, epidemics,fires, pandemics,accidents, weather, unrest or socialother disruptionemergencies in regions where we or our partners or suppliers operate;

•any regulatory, legal or other impediments to the Company’s ability to bring new products to market, including but not limited to “at-risk launches”market;

•uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential for adverse impacts from future tariffs and trade policies,restrictions, inflation rates and global exchange rates; and

Viatris’ executive management team is focused on ensuring that the Company is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers and other key stakeholders. The Company operates in more than 165 countries and territories with approximatelymore 32,000than 30,000 employees. The Company has 2627 manufacturingmanufacturing, packaging, and packagingdistribution sites worldwide, more than 1,400 approved molecules, and what we believe is industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise. Viatris’ portfolio consists of generics (including complex products), globally recognized iconic brands, and an expanding portfolio of innovative medicines. Viatris is headquartered in the U.S., with global centers in Pittsburgh, Pennsylvania, Shanghai, China and Hyderabad, India.

The process of obtaining regulatory approval to manufacture and market new branded and generic pharmaceutical products is rigorous, time consuming, costly, and inherently unpredictable. Complex generic products are often more difficult, costly and time-consuming to receive regulatory approval for and bring to market.market compared with commodity generic pharmaceutical products. Any delay in regulatory approval could impact the commercial or financial success of a product. Regulatory approval, if and when obtained, may be limited in scope. Even if regulatory approvals for new products are obtained, the success of those products is dependent upon market acceptance.

For branded products, the majority of the product’s commercial value is usually realized during the period in which the product has market exclusivity. In the U.S. and some other countries, when market exclusivity expires and generic versions of a product are approved and marketed, there can often be very substantial and rapid declines in the branded product’s sales. For example, generic entry may occur for Amitiza® 24 μg may occur in Japan in DecemberJune 20252026 upondepending expirationon the outcome of patent exclusivity.litigation.

Additionally, a number of markets in which we operate outside of the U.S. have implemented, or may implement, tender systems for generic pharmaceuticals in an effort to lower prices. Generally speaking, tender systems can have an unfavorable impact on sales and profitability. Under such tender systems, manufacturers submit bids that establish prices for generic pharmaceutical products. Upon winning the tender, the winning company will receive priority placement for a period of time. The tender system often results in companies underbidding one another by proposing lowlower pricing in order to win the tender. Sales continue to be negatively affected by the impact of tender systems in certain countries.

In addition to the impact of competition, government pricing actions and other measures designed to reduce healthcare costs, our results of operations, cash flows and financial condition could also be affected by other risks of doing business internationally, including the impact of inflation, elections, geopolitical events, including the ongoing conflicts in the Middle East and between Russia and Ukraine and related trade controls, sanctions, supply chain disruptions and staffing challenges and other economic considerations, supplylonger chainreview, disruptions,response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies, the potential for adverse impacts from future tariffs and trade restrictions, foreign currency exchange fluctuations, public health epidemics, changes in intellectual property legal protections and other regulatory changes.

Indore Manufacturing FacilityFacilities

Following an inspection by the FDA at our oral finished dose manufacturing facility in Indore, India in 2024, the FDA has issued a warning letter,letter and an import alert related to this facility. The import alert affects 11 actively distributed products that will no longer be accepted into the U.S. until the warning letter is lifted. It makes exceptions, subject to certain conditions, for four products based on shortage concerns. Following recently concluded discussions with the FDA, the Company does not expect additional product exceptions to be granted by the FDA.

Following the substance of FDA’s original inspection observations, the Company immediately implemented a comprehensive remediation plan at the site. TheDuring necessary2025, correctivewe andmade preventivesubstantial actionsprogress areon wellour underway,remediation activities at the facility, including but not limited to related personnel actions. Additionally, we have engaged independent third-party subject matter experts to support the remediation plan.

We have been in regular communication with the FDA during this process and will continue to work to ensure that the FDA is satisfied with the steps we have taken to resolve all the points raised. Our responses to the warning letter and import alert were submitted within the required time periods. The facility will be subject to a reinspection by the FDA. The timing of the reinspection will be determined by the FDA; however, we anticipate that the facility will be ready for reinspection in 2026.

While product continues to be shipped from the Indore facility to markets outside the U.S., someas expected, we have also experienced a negative impact in other markets,markets during 2025, including the ARV business in Emerging Markets and select generic products in Europe, is anticipated.Europe. The Company currently estimates theestimated negative impact to 2025 total revenues tofor bethe year ended December 31, 2025 versus the year ended December 31, 2024 was approximately $500 million and to 2025 earnings from operations to be approximately $385$370 million.

On March 15, 2024, the Company acquired exclusive global development and commercialization rights to two Phase 3 assets from Idorsia, as well as the potential to add additional innovative assets in the future. Under the terms of the original agreements, the development programs and certain personnel for selatogrel and cenerimod were transferred to Viatris from Idorsia in exchange for an upfront payment to Idorsia of $350 million, potential contingent milestone payments (including $300 million payable upon the achievement of certain development and regulatory milestones, and $2.1 billion payable upon the achievement of certain tiered sales milestones), as well as potential contingent tiered sales royalties. Viatris has worldwide commercialization rights for both selatogrel and cenerimod (excluding,which excluded, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region). A joint development committee was formed to oversee the development of the ongoing Phase 3 programs through regulatory approval. The agreements also provideprovided Viatris a right of first refusal and a right of first negotiation for certain other assets in Idorsia’s pipeline. Viatris and Idorsia are both contractually obligated to contribute to the development costs for both programs, which are expected to be incurred through 2026.2027. There are risks and uncertainties associated with the timely and successful completion of these programs, including but not limited to the high cost and uncertainty of conducting clinical trials (particularly with respect to new and/or complex or innovative drugs), obtaining approval by relevant regulatory bodies and our partner’s financial condition. Refer to Note 4 Acquisitions and Other Transactions included in Part II, Item 8 of this Form 10-K for more information.

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 above. Under the terms of the letter agreement, Viatris will receivereceived additional territory rights in Japan, South Korea and certain other countries in the Asia-Pacific region for cenerimod, a $250 million reduction in contingent milestone payments, including $200 million of development milestones, and additional personnel to expedite transitioning the development programs to Viatris in exchange for Viatris assuming $100 million of Idorsia’s obligation to contribute to development costs. In addition, the letter agreement provides for the replacement of the joint development committee has been replaced with a transition committee to oversee the transition of both development programs to Viatris.

A detailed discussion of the Company’s financial results can be found below in the section titled “Results of Operations.” As part of this discussion, we also report sales performance using the non-GAAP financial measures of “constant currency” net sales and total revenues. These measures provide information on the change in net sales and total revenues assuming that foreign currency exchange rates had not changed between the prior and current period. The comparisons presented at constant currency rates reflect comparative local currency sales at the prior year’s foreign exchange rates. We routinely evaluate our net sales and total revenues performance at constant currency so that salesthese results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities, and believe that this presentation also provides useful information to investors for the same reason.

(3)Reductions were driven primarily by the inclusion of net sales in the prior year period related to divestitures that have closed during 20232024 and 2024.the Indore Impact.

(4)For the year ended December 31, 2024,2025, other revenues in Developed Markets, Greater China, JANZ, and Emerging Markets were approximately $32.0$38.1 million, $1.3 million, $3.5$3.9 million, and $9.7$7.5 million, respectively.

Net sales decreased by approximately $732.2$478.0 million, or 5%,3%, due to the inclusion of net sales in the prior year period related to divestitures that have closed during 2023 and 2024. The decrease in net sales was also partially driven by the unfavorablefavorable impact of foreign currency translation ofwas approximately $239.5$177.7 million, or 2%,1%, primarily reflecting changes in the U.S. Dollar as compared to the currencies of subsidiaries in Japan,the China, and countries in Emerging Markets.EU. On a constant currency basis, net sales from the remaining business increaseddecreased by approximately $276.1$142.1 million, or 2%,1%, for the year ended December 31, 20242025 compared to the prior year period, driven by net base business erosion of approximately $465.8 million, of which approximately $370 million related to the Indore Impact. This decrease was partially offset by new product sales, primarily in Developed Markets, of approximately $582.4$323.7 million. New product sales include new products launched in 20242025 and the carryover impact of new products, including business development, launched within the last twelve months. The increase was partially offset by base business erosion of approximately $306.3 million.

From time to time, a limited number of our products may represent a significant portion of our net sales, gross profit and net earnings. Generally, this is due to the timing of new product introductions, seasonality, and the amount, if any, of additional competition in the market. Our top ten products in terms of net sales, in the aggregate, represented approximately 36% and 33% for each of the years ended December 31, 20242025 and 2023.2024, respectively.

Net sales from Developed Markets decreased by $322.5$415.4 million, or 3%,5%, for the year ended December 31, 20242025 when compared to the prior year. Net sales decreased by approximately $421.1$372.7 million, or 5%,4%, due to the inclusion of net sales in the prior year period related to divestitures that have closed during 2023 and 2024. The favorable impact of foreign currency translation was approximately $5.3$213.2 million, or less than 1%.2%. Constant currency net sales from the remaining business increaseddecreased by approximately $93.3$255.9 million, or 1%,3%, driven primarily by new product sales throughout Developed Markets, including Breyna™ and lisdexamfetamine in the U.S. This increase was partially offset by anticipated lower net sales of certain existing productsproducts, withinincluding lenalidomide and everolimus in the U.S., including EpiPen® Auto-Injector and Perforomist®, as a result of lowerthe pricingIndore andImpact volumesof dueapproximately to$283 additionalmillion, competitionpartially andoffset increasedby utilizationnew withinproduct government channels.sales. Net sales within North America totaled approximately $3.78$3.39 billion and net sales within Europe totaled approximately $5.15$5.12 billion.

Net sales from Greater China wereincreased essentiallyby flat$166.0 million, or 8%, for the year ended December 31, 20242025 when compared to the prior year. The unfavorable impact of foreign currency translation was approximately $47.2$1.5 million, or 2%.million. Constant currency net sales increased by approximately $53.4$168.2 million, or 2%,8%, when compared to the prior year, driven primarily by increasedstrong volumesgrowth across multiple channels, including e-commerce, retail, and private hospitals, as well as benefits of existingtiming products.of customer purchasing patterns. Divestitures did not have a significant impact on the net sales in either period and the Indore Impact during the yearsyear ended December 31, 20242025 andwas 2023.not significant.

Net sales from JANZ decreased by $78.3$152.4 million, or 5%,11%, for the year ended December 31, 20242025 when compared to the prior year. This decrease was the result of the unfavorable impact of foreign currency translation of approximately $81.4 million, or 6%. Net sales also decreased by approximately $16.4$24.0 million, or 1%,2%, due to the inclusion of net sales in the prior year period related to divestitures that have closed during 20232024. andThe 2024.decrease was also partially driven by the unfavorable impact of foreign currency translation of approximately $15.5 million, or 1%. Constant currency net sales from the remaining business increaseddecreased by approximately $19.5$112.9 million, or 1%,8%, when compared to the prior year, driven primarily by new product sales in Australia. This increase was partially offset by lower net sales of existing products mainly driven by lower pricing in Japan asand aAustralia resultdue ofto government price reductions and additional competition.competition, and by the Indore Impact of approximately $9 million.

Net sales from Emerging Markets decreased by $300.9$40.6 millionmillion, or 12%2%, for the year ended December 31, 20242025 when compared to the prior year. Net sales decreased by approximately $294.6$80.6 million, or 12%,4%, due to the inclusion of net sales in the prior year period related to divestitures that have closed during 2023 and 2024. The decrease in net sales was also partially driven by the unfavorable impact of foreign currency translation of approximately $116.2$18.5 million, or 5%.1%. Constant currency net sales from the remaining business increased by approximately $109.9$58.5 million, or 4%,3%, when compared to the prior year, primarily driven by new products in certain Latin American countries and higher netvolumes salesand pricing of existing products in certain Latin American, Middle Eastern and Asian countries. These increases were partially offset by lower volumes in our ARV business, mainly as a result of the Indore Impact of approximately $77 million.

Cost of sales increased from $8.99 billion for the year ended December 31, 2023 to $9.12 billion for the year ended December 31, 2024.2024 to $9.29 billion for the year ended December 31, 2025. The increase in cost of sales was largely driven by higher costs associated with other special items, which are described further in the section titled Use of Non-GAAP Financial Measures, and by product mix as a result of the Indore Impact. These increases were partially offset by the impact of the decrease in net sales, and lower IPR&D intangible asset impairment charges of $177.1 million.charges. Refer to Note 8 Goodwill and Intangible Assets included in Part II, Item 8 of this Form 10-K for more information. This increase was partially offset by the impact of the decrease in net sales, including as a result of the divestitures that have closed in 2023 and 2024.

Gross profit for the year ended December 31, 20242025 was $5.01 billion and gross margins were 35%. For the year ended December 31, 2024, gross profit was $5.62 billion and gross margins were 38%. For the year ended December 31, 2023, gross profit was $6.44 billion and gross margins were 42%. The changes in gross profit and gross margins are primarily related to the impactincrease in cost of the divestitures and the IPR&D intangible asset impairment charges.sales. Adjusted gross margins were approximately 56% for the year ended December 31, 2025, compared to 58% for the year ended December 31, 2024, essentially flat when compared to the year ended December 31, 2023.2024.

R&D expense for the year ended December 31, 20242025 was $808.7$965.9 million, essentially flat compared to R&D expense of $805.2$808.7 million for the prior year.year, Anan increase inof spend$157.2 onmillion. theThis selatogrel and cenerimod programsincrease was partially offset by lower spending on base business programs. We expect R&D expense to increase in excess of $100 million in 2025 as compared to 2024 primarily as athe result of increasedhigher expenses for the selatogrel and cenerimod development programs.

Acquired IPR&D expense for the year ended December 31, 20242025 was $28.3$48.3 million, compared to $105.5$28.3 million for the prior year, aan decreaseincrease of $77.2$20.0 million. The decreaseincrease was primarily due to an upfront licensing payments to Mapi of $75.0 millionpayment related to additionalthe productsacquisition underof developmentAculys Pharma of $35.0 million recorded during the priorfourth year.quarter of 2025, and an upfront licensing payment for rights to cenerimod in Japan, South Korea and certain countries in the Asia-Pacific region during the first quarter of 2025. This was partially offset by an upfront licensing payment of $25.0 million to Lexicon related to sotagliflozin recorded during the fourth quarter of 2024.

SG&A expense for the year ended December 31, 20242025 was $4.43$3.79 billion, compared to $4.65$4.10 billion for the prior year, a decrease of $224.5$310.5 million. The decrease was primarily due to lower goodwill impairment charges of approximately $259.1 million (refer to Note 8 Goodwill and Intangible Assets included in Part II, Item 8 of this Form 10-K for more information on the goodwill impairment charges recorded in 2023 and 2024), and the impact of the divestitures.divestitures, Partiallyand offsettinglower theseacquisition decreasesand wasdivestiture-related a gain recorded in 2023costs of approximately $156.2$205.7 million on the transaction to divest the Company’s rights to two women’s healthcare products in certain countries.million.

The following table includes the (gains)/losses recognized in litigation settlements and other contingencies, net during the years ended December 31, 20242025 and 2023,2024, respectively:

Also referRefer to Note 194 LitigationAcquisitions and Other Transactions and Note 9 Financial Instruments and Risk Management included in Part II, Item 8 of this Form 10-K for more information.information with respect to the contingent consideration adjustment.

Interest expense for the year ended December 31, 20242025 totaled $550.0$471.3 million, compared to $573.1$550.0 million for the year ended December 31, 2023,2024, a decrease of $23.1$78.7 million. The decrease was primarily due to the impact of 2024 debt repayments, partially offset by the non-cash accretion of the contingent consideration liability related to the Idorsia Transaction.repayments.

This discussion and analysis should be read in conjunction with the Consolidated Financial Statements, the related Notes to Consolidated Financial Statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Viatris’ 2025 Form 10-K, the unaudited interim financial statements and related Notes included in Part I — Item 1 of this Form 10-Q and our other SEC filings and public disclosures. The interim results of operations and comprehensive earnings (loss) earnings for the three and six months ended MarchJune 31,30, 2026, and cash flows for the threesix months ended MarchJune 31,30, 2026 are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.

The Company expects to record charges for costs associated with the restructuring activities of the EWSR. For the committed restructuring activities, the Company expects to incur total pre-tax charges ranging between $700 million and $850 million. Such charges are expected to include between $50 million and $100 million of non-cash charges mainly related to accelerated depreciation and asset impairment charges, including inventory write-offs. The remaining estimated cash costs of between $650 million and $750 million are expected to be primarily related to severance and employee benefits expense, as well as other costs, including those related to contract terminations, vendor consolidations, product transfer costs and network related simplification and modernization costs. In addition, management believes the potential savings related to these committed restructuring activities will be between $600 million and $700 million once fully implemented, with most of these savings expected to improve operating cash flow. During the three and six months ended MarchJune 31,30, 2026, the Company recognized total charges of $77.9$27.3 million and $105.2 million, respectively, in the condensed consolidated statements of operations related to this restructuring program.

In December 2025, the Company entered into definitive agreements with Biocon for the sale of the Company’s equity stake in Biocon Biologics. Under the terms of the definitive agreements, Biocon acquired all of Viatris’ CCPS in Biocon Biologics for total consideration of $815.0 million, consisting of $400.0 million in cash and $415.0 million in newly issued equity shares of Biocon, which are listed and traded on the National Stock Exchange of India. The transaction closed during the first quarter of 2026 and the equity shares of Biocon arewere subject to a six-month lock up period. The Company completed the sale of its equity position in Biocon on July 14, 2026 for pre-tax total consideration of approximately $380 million, and recorded a pre-tax loss of $27.4 million in the third quarter of 2026. The pre-tax sale proceeds include the impacts of an approximate 2.7% block sale discount to market, transaction fees, and the strengthening of the U.S. dollar since the Company obtained the equity in January 2026. In addition, the terms of the definitive agreements accelerate the expiration of biosimilars non-compete restrictions previously placed on Viatris in 2022 in connection with Viatris’ sale of its biosimilars portfolio and related commercial and other capabilities to Biocon Biologics. These restrictions expired immediately at the time of close for all ex-U.S. markets and will expire in November 2026 for the U.S. market. During the three and six months ended June 30, 2026, the Company recognized a (gain)/loss of approximately $(56.3) million and $8.6 million, respectively, as a result of changes in the fair value of the Biocon equity shares.

We have been in regular communication with the FDA during this process and will continue to workworking to ensure thatsatisfy the FDA is satisfied withthat the steps we have taken tohave resolveresolved all the points raised. Our responses to the warning letter and import alert were submitted within the required time periods. The facility will be subject to a reinspection by the FDA. The timing of the reinspection will be determined by the FDA; however, we anticipate that the facility will be ready for reinspection in 2026.

InAs mid-Februarypreviously disclosed, in February 2026, a fire occurred in a service area at the Company'sCompany’s oral solid dose manufacturing facility in Nashik, India. Manufacturing at the facility was temporarily suspended. Recently, we have restarted certain manufacturing activities and currently expect to resume full operations in July 2026.

During the three and six months ended MarchJune 31,30, 2026, the Company recognized total charges of $71.9$14.9 million and $86.8 million, respectively, within Cost of Sales in the condensed consolidated statements of operations primarily related to the write off of inventory and fixed assets damaged in the fire and incremental manufacturing variances. The Company believes it has certain insurance coverages for these losses, including for assets and business interruption. In the event the plant cannot be returned to sustained normal operations or the Company’s insurance coverage is unavailable or inadequate, this event could have a negative impact on our financial position, results of operations and cash flows.

We take very seriously our continued and comprehensive oversight of our entire manufacturing network.network very seriously. Patient safety remainsis our primary and unwavering focus. We will continue to work closely with our customers to mitigate anythe possibleeffects of potential supply disruptions andto meet the needs of the patients we serve.

The table below is a summary of the Company’s financial results for the three and six months ended MarchJune 31,30, 2026 compared to the prior year period:

Three Months Ended MarchJune 31,30, 2026 Compared to Three Months Ended MarchJune 31,30, 2025

(3)For the three months ended MarchJune 31,30, 2026, other revenues in Developed Markets, JANZ, and Emerging Markets were approximately $5.2$9.3 million, $0.1 million, and $2.0$1.5 million, respectively.

For the three months ended MarchJune 31,30, 2026, Viatris reported total revenues of $3.52$3.76 billion, compared to $3.25$3.58 billion for the comparable prior year period, representing an increase of $262.7$174.7 million, or 8%.5%. Total revenues include both net sales and other revenues from third parties. Net sales for the threecurrent months ended March 31, 2026quarter were $3.51$3.75 billion, compared to $3.24$3.57 billion for the comparable prior year period, representing an increase of $266.5$176.9 million, or 8%.5%. Other revenues for the threecurrent months ended March 31, 2026quarter were $7.3$10.9 million, compared to $11.1$13.1 million for the comparable prior year period.

The favorable impact of foreign currency translation was approximately $161.8$49.2 million, or 5%,1%, primarily reflecting changes in the U.S. Dollar as compared to the currencies of subsidiaries in the EU and China. On a constant currency basis, net sales increased by approximately $104.7$127.7 million, or 3%,4%, for the three months ended MarchJune 31,30, 2026 compared to the prior year period. The increase was the result of new product sales, primarily in Developed Markets, of approximately $70.7$101.0 million, and net base business growth,growth primarilyof approximately $26.7 million, driven by strong net sales in Greater China, of approximately $34.0 million.China. New product sales include new products launched in 2026 and the carryover impact of new products, including business development, launched within the last twelve months.

From time to time, a limited number of our products may represent a significant portion of our net sales, gross profit and net earnings. Generally, this is due to the timing of new product introductions, seasonality, and the amount, if any, of additional competition in the market. Our top ten products in terms of net sales, in the aggregate, represented approximately 40%38% and 38%37% for the three months ended MarchJune 31,30, 2026 and 2025, respectively.

Net sales from Developed Markets increased by $129.1$74.4 million, or 7%,4%, for the three months ended MarchJune 31,30, 2026 when compared to the prior year period. The favorable impact of foreign currency translation was approximately $117.7$30.8 million, or 6%.1%. Constant currency net sales increased by approximately $11.4$43.6 million, or 1%,2%, when compared to the prior year periodperiod, driven primarily by new product sales.sales, primarily octreotide acetate in North America, and strong sales of estradiol transdermal systems. This was partially offset by lower net sales of certain existing products, primarily as a result of certain supply constraints andin additional competition.Europe. Net sales within North America totaled approximately $828.1$882.7 million and net sales within Europe totaled approximately $1.19$1.31 billion.

Net sales from Greater China increased by $124.6$124.9 million, or 22%,21%, for the three months ended MarchJune 31,30, 2026 when compared to the prior year period. The favorable impact of foreign currency translation was approximately $25.6$28.6 million, or 5%. Constant currency net sales increased by approximately $99.0$96.3 million, or 18%,16%, when compared to the prior year period, primarily thedriven result ofby strong growth across multiple channels, including e-commerce,e-commerce and retail, anddriven private hospitals, drivenprimarily by increased marketing and selling efforts.

Net sales from JANZ decreased by $2.7$9.6 million, or 1%,3%, for the three months ended MarchJune 31,30, 2026 when compared to the prior year period. The favorabledecrease was primarily driven by the unfavorable impact of foreign currency translation wasof approximately $3.9$8.1 million, or 1%.3%. Constant currency net sales decreased by approximately $6.6$1.5 million, or 2%,essentially flat, when compared to the prior year period, driven primarily by lower net sales of existing products in Japan and Australia due to government price reductions and additional competition.period.

Net sales from Emerging Markets increaseddecreased by $15.5$12.8 million, or 3%,2%, for the three months ended MarchJune 31,30, 2026 when compared to the prior year period. ThisThe increase in net sales was primarily driven by the favorableunfavorable impact of foreign currency translation ofwas approximately $14.6$2.1 million, or 3%.less than 1%. Constant currency net sales weredecreased essentiallyby flat$10.7 million, or 2%, when compared to the prior year period.period, primarily driven by lower ARV volumes related to continued supply constraints. This decrease was partially offset by higher pricing and volumes of existing products in certain Middle Eastern and Asian countries.

Cost of sales increased from $2.09$2.25 billion for the three months ended MarchJune 31,30, 2025 to $2.36$2.30 billion for the three months ended MarchJune 31,30, 2026. The increase in cost of sales was largely driven by the increase in net sales,sales. higherRefer restructuringto costs,Note and4 higherDivestitures costsin associatedPart withI, otherItem special1 items,of whichthis includeForm certain costs10-Q for plantsmore slated for sale or closure or undergoing remediation activities, including $71.9 million related to the write off inventory and fixed assets damaged in the fire at the Nashik manufacturing facility and incremental manufacturing variances.information.

Gross profit for the three months ended MarchJune 31,30, 2026 was $1.16$1.46 billion and gross margins were 33%.39%. For the three months ended MarchJune 31,30, 2025, gross profit was $1.16$1.33 billion and gross margins were 36%.37%. The changes in gross profit and gross margins are primarily relateddriven toby theproduct increase in cost of sales.mix. Adjusted gross margins were approximately 56%57% for the three months ended MarchJune 31,30, 2026, compared to approximately 56%57% for the three months ended MarchJune 31,30, 2025.

A reconciliation between cost of sales, as reported under U.S. GAAP, and adjusted cost of sales and adjusted gross margin for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025 is as follows:

R&D expense for the three months ended MarchJune 31,30, 2026 was $248.6$248.3 million, compared to $222.0$218.8 million for the comparable prior year period, an increase of $26.6$29.5 million. This increase was primarily the result of higher expenses for the selatogrel and cenerimod development programs.

SG&A expense for the threecurrent months ended March 31, 2026quarter was $928.8$1.13 million,billion, compared to $948.1$928.7 million for the comparable prior year period, aan decreaseincrease of $19.3$205.8 million. The decreaseincrease was primarily duedriven by a charge of $177.8 million related to lowerthe restructuringplanned costssale of approximatelythe $30.3product million.rights for Tyrvaya® (refer to Note 4 Divestitures in Part I, Item 1 of this Form 10-Q for more information), and higher non-income related taxes and certain other items.