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