Viatris (VTRS) 10-K risk factor changes: FY2024 vs FY2023
The 2024-12-31 10-K against the 2023-12-31 one, compared heading by heading and sentence by sentence.
Item 1A183 rewritten45 added55 removed538 unchanged
All filing items1,514 rewritten685 added476 removed2,656 unchanged
Summary
counted, not written
- Item 1A lists 42 risk factor headings: 0 new, 7 reworded and 35 unchanged since FY2023. 1 heading from FY2023 no longer appears.
- Sentence by sentence, 685 added, 476 removed, 1,514 rewritten and 2,656 unchanged across 14 items that differ.
New Item 1A headings (0)
No risk factor heading in this filing is absent from FY2023.
Removed Item 1A headings (1)
- There are risks and uncertainties associated with the Announced Divestitures, including the OTC Transaction, 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 stock price.
Reworded Item 1A headings (7)
- We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic
[removed: initiatives,][added: initiatives and priorities,] including divestitures, acquisitions or other potential transactions. - There are ongoing risks and uncertainties associated with
[removed: the Biocon Biologics Transaction,][added: 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 [added: repurchase shares, and/or] stock price. - Failure to comply with applicable environmental and occupational health and safety laws and regulations worldwide could adversely impact our business, financial condition, results of operations, cash flows, ability to pay dividends [added: or repurchase shares,] and/or stock price.
- We are subject to the U.S. Foreign Corrupt Practices Act, [added: U.S. 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.
- Our reporting and payment obligations related to our participation in U.S. federal healthcare programs, including Medicare, Medicaid and the VA, are complex and often involve subjective decisions that could change as a result of new business circumstances, new [added: laws,] regulations or agency guidance, or advice of legal counsel. Any failure to comply with those obligations could subject us to investigation, penalties, and sanctions.
- There can be no guarantee that we will continue to pay dividends or repurchase shares under our
[removed: stock buyback][added: share repurchase] program. - 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 [added: or repurchase shares,] and/or stock price.
A heading is new when no FY2023 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
23 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2024; struck-through words were in FY2023. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
183 rewritten, 45 added, 55 removed, 538 unchanged
Our business, financial condition, results of operations, cash flows, ability to pay [removed: dividends,] [added: dividends or repurchase shares,] and/or stock price could be materially affected by any of these risks, if they occur, or by other factors not currently known to us, or not currently considered to be material.
◦We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic [removed: initiatives,] [added: initiatives and priorities,] including divestitures, acquisitions or other potential transactions.
◦There are [added: ongoing] risks and uncertainties associated with [removed: the Announced Divestitures, including the OTC Transaction,] [added: 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 [added: repurchase shares, and/or] stock price.
[removed: ◦There] [added: There] are ongoing risks and uncertainties associated with [removed: the Biocon Biologics Transaction,] [added: 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 [added: repurchase shares, and/or] stock [removed: price.][added: price.]
◦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 [added: or repurchase shares,] and/or stock price.
◦We are subject to the U.S. Foreign Corrupt Practices Act, [added: U.S. 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.
◦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, [removed: 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.]
◦There can be no guarantee that we will continue to pay dividends or repurchase shares under our [removed: stock buyback] [added: share repurchase] program.
◦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 [added: 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 [removed: initiatives,] [added: initiatives and priorities,] including divestitures, acquisitions or other potential transactions.
Viatris has announced various strategic [removed: initiatives,] [added: initiatives and priorities,] transactions and business [removed: arrangements, including our two-phased strategic vision.][added: arrangements.]
Implementing these and other strategic initiatives [added: and priorities] has included and may in the future include [removed: divestitures (including the Biocon Biologics Transaction and the Announced Divestitures),] [added: 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 [removed: perspective (including but not limited to divestitures that have resulted or will in the future result in reductions to our results of operations (including but not limited to total revenues) and cash flows).][added: perspective.]
These [removed: initiatives, whether we are able to complete them or not,] [added: strategic initiatives and priorities] have [removed: been] [added: been,] and may continue to [removed: be] [added: be,] complex, time-consuming or expensive, may divert [removed: managements’] [added: management’s and employees’] attention, and expose us to operational ineffectiveness.
We may miscalculate the risks associated with our strategic initiatives [added: 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.
[removed: More complex products] [added: Innovative 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 [added: 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.
[removed: Divestitures (including the Biocon Biologics Transaction and the Announced Divestitures),] [added: Divestitures,] product rationalizations or asset sales have [removed: also] resulted and could [removed: continue to] [added: in the future] result in asset impairments, or reductions to the size or scope of our business, our market share in particular markets or our opportunities and ability to compete with respect to certain markets, [added: therapeutic areas or products.]
[removed: Certain] [added: These] divestitures [removed: also] 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.
Please also refer to “*There are [added: ongoing] risks and uncertainties associated with [removed: the Announced Divestitures, including the OTC Transaction,] [added: 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 [added: repurchase shares, and/or] stock price.”*
[removed: In addition, as we intend to move up the value chain during Phase 2 of our two-phased strategic vision, we expect to] use more capital resources and [added: has entered into, and] may [added: in the future] enter [removed: into more] [added: into,] financial commitments in connection with these alliances and collaborations.
There is a risk that the investments made by us in these [added: and other] alliances and collaborative arrangements will not generate financial returns.
While we believe our relationships with our [added: collaboration] partners generally are successful, [added: our collaboration partners’ financial situation, or] disputes or conflicting priorities and regulatory or legal intervention [added: has been or] could [added: in the future] be a source of delay or uncertainty as to the expected benefits of [removed: the obligations.][added: our strategic alliances and collaborations.]
The overall execution of our strategic initiatives [added: and priorities] may result in material unanticipated problems, expenses, liabilities, competitive responses, operational inefficiencies, adverse tax consequences, impairment or restructuring charges, loss of customer relationships, difficulty attracting and retaining qualified employees, and diversion of management’s and/or employee’s attention, among other potential adverse consequences.
In addition, we may have to terminate a strategic alliance, agreement or arrangement, or our partners may be unable to fulfill their [removed: collaboration.][added: operational or other obligations due to their financial condition or otherwise.]
Any of the risks described above could have a material adverse effect on our reputation, business, financial condition, results of operations, cash flows, ability to pay dividends [added: or repurchase shares,] and/or stock price.
[removed: There are risks and uncertainties associated with the Announced Divestitures, including the OTC Transaction,] [added: The occurrence of any] one or more of [removed: which] [added: the above risks] could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or [added: repurchase shares, and/or] stock [removed: price.][added: price.]
[removed: In] [added: For instance, in] connection with [removed: the Announced Divestitures,] [added: our recently completed divestitures,] we have [removed: also agreed, at the closing of the respective transactions, to enter] [added: entered] into transition services and manufacturing and supply agreements pursuant to which we [removed: will] [added: have agreed to] provide [added: certain specified] services to the respective purchasers, including manufacturing, quality, supply chain, pricing and procurement, regulatory, product safety and risk management, medical affairs, IT, finance, human resources, real estate, commercial development and local commercial operations [removed: services, substantially the same as we currently provide to the related businesses, generally for a period of up to 12 months, subject to potential extensions in certain circumstances.][added: services.]
In addition, in connection with the OTC Transaction and the [removed: divestiture] [added: divestitures] of our women’s healthcare business, we [removed: have agreed, at the closing of the respective transactions, to enter] [added: entered] into distribution agreements.
[removed: Once in effect, our] [added: Our] obligations under these agreements [added: have resulted and] may [added: in the future] result in additional expenses that are borne by us and [added: have diverted and] may [added: continue to] divert our focus and resources that would otherwise be invested into maintaining or growing our retained business.
In connection with our API business divestiture, we [removed: have agreed, at the closing of the transaction, to enter] [added: entered] into a manufacturing and supply agreement pursuant to which we [removed: will] purchase a significant amount of API from the purchaser in that transaction.
Our obligations under [removed: the] [added: this] manufacturing and supply agreement [removed: may make] [added: have made] us more [added: dependent on the purchaser of our API business and the success of their business, and made us more] vulnerable to API supply shortages and price volatility.
[removed: Upon the closing of any or all] [added: As a result] of the [removed: Announced Divestitures,] [added: Biocon Biologics Transaction and] our [added: recently completed divestitures, our] results of [removed: operations (including] [added: operations, including] but not limited to total [removed: revenues)] [added: revenues] and cash [removed: flows will be] [added: flows, have been] reduced.
Because the businesses or assets we [removed: divest, including our Biosimilars Business and the Announced Divestitures,] [added: have divested] were [removed: or are] commingled with Viatris’ other businesses, their financial information must be carved-out of Viatris’ financial and other systems, and this process has [removed: impacted] [added: increased] or will [removed: impact] [added: continue to increase] the [removed: reporting] [added: risk] of [removed: our results] [added: errors in the presentation] of [removed: operations,] [added: our] financial [removed: condition, and cash flows.][added: results in conformity with U.S. GAAP.]
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 [added: or repurchase shares,] and/or stock price.
Refer to Note 5 *Divestitures* [added: included] in Part II, Item 8 of this Form 10-K for more information about [removed: the Announced Divestitures.][added: our recently completed divestitures.]
The combination of two or more independent [removed: businesses, including, for example, the Combination and our recent acquisitions of Oyster Point and Famy Life Sciences,] [added: businesses] is a complex, costly and time-consuming process and there is a significant degree of difficulty inherent in the integration process.
- diversion of management’s [added: and employees’] attention from the ongoing operations of Viatris to integration and restructuring matters;
- the potential difficulty [added: transitioning acquired assets to the Company and] retaining key personnel and other employees;
Viatris has [added: 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.
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.
As the Company moves forward, it will look to accelerate its growth by building on the strength of its base business with an expanding portfolio of innovative, best-in-class, patent-protected assets and will focus on three strategic pillars: 1) diversified and growing base business, 2) financial strength and significant cash flow and 3) expanding innovative portfolio.
In addition, as the Company looks to accelerate its growth by building on the strength of its base business with an expanding portfolio of innovative, best-in-class, patent-protected assets, it expects to
For example, our acquisition of the development programs for selatogrel and cenerimod, which are currently in Phase 3 development.
For example, on February \[25\], 2025, in order to preserve the ongoing continuity of the development programs for selatogrel and cenerimod considering certain capital structuring steps announced by Idorsia to secure its ongoing operations, Viatris and Idorsia entered into a letter agreement to amend certain terms of the original agreements described in Part I, Item 1 Business - *About Viatris - Business Strategy* of this Form 10-K.
In recent years, the Company has completed several divestitures, including the Biocon Biologics Transaction, the OTC Transaction and other divestitures.
In connection with our API business divestiture, we entered into a manufacturing and supply agreement pursuant to which we are purchasing a significant amount of API from the purchaser in that transaction.
We may not be able to realize the anticipated benefits from our divestitures, such as realizing the anticipated proceeds or utilizing the net proceeds for our strategic initiatives and priorities.
We may also face other challenges as a result of
divestitures, including maintaining employee morale and retaining key management and other employees to provide the transition services and to operate our retained business, and managing stranded costs.
- loss of institutional knowledge or lack of access to IT systems and historical data, including clinical or trial data;
of time.
The conflict has also impacted our and our partners’
- reductions in funding by U.S. governmental agencies for certain products in our Emerging Markets region;
- 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;
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.
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.
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.
As we look to accelerate our growth by building on the strength of our base business with an expanding portfolio of innovative, best-in-class, patent-protected assets, the development and commercialization process of such products requires substantial time, effort and financial resources.
We also partner with third parties to develop products, including, for instance, our acquisition of the development programs for selatogrel and cenerimod, which are currently in Phase 3 development.
In such cases, successful product introductions have in the past and may in the future significantly rely on such partners, including with respect to their financial condition.
As we look to accelerate our growth by building on the strength of our base business with an expanding portfolio of innovative, best-in-class, patent-protected assets, our related expenses have increased and will likely continue to increase.
In addition, we have incurred and may in the future incur asset impairment charges related to such programs if they are not successful.
For example, we are currently working with Mapi to determine appropriate next steps with respect to a Complete Response letter from the FDA regarding the NDA for GA Depot 40mg.
We or
Clinical trials are complex to administer and outcomes are often unpredictable, particularly with respect to new and/or complex or innovative products.
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.
communication skills.
In recent years, we have closed, downsized and divested a number of our manufacturing facilities globally, which further limits our internal manufacturing capacity and increases our dependence on third-party suppliers.
Likewise, we are impacted by the U.S. Foreign Extortion Prevention Act that criminalizes a foreign government official’s solicitation of improper payments from U.S. companies or individuals in exchange for conferring an improper advantage.
While this law targets improper demands by foreign officials, in many countries in which we operate hospitals are owned and operated by the government, and doctors and other hospital employees with which we do business would be considered foreign officials under these regulations.
In addition, the U.S. Foreign Extortion Prevention Act may increase enforcement of the U.S. Foreign Corrupt Practices Act and other applicable anti-corruption laws and amplify exposure for U.S. companies.
This will be of particular importance as we will look to accelerate our growth by building on the strength of our base business with an expanding portfolio of innovative, best-in-class, intellectual property-protected assets.
Any failure to comply with the above
Such attacks are increasingly sophisticated
In parallel, environmental, social and governance initiatives have become increasingly controversial, and we may also face scrutiny, reputational risk, lawsuits or market access restrictions as a result of our initiatives and disclosures.
In the EU, evolving “extended producer responsibility” regulations now require companies that manufacture pharmaceutical products to pay a significant portion of the cost of treating urban wastewater to eliminate micropollutants.
These regulations may significantly increase the cost of producing our pharmaceutical products, limit our ability to supply certain products in certain markets, or may limit our competitiveness, which may adversely impact our market share, business and operations.
impacts of climate change may become more prevalent, which could increase our operating costs and the costs charged by suppliers.
In Phase 1 of this strategy, we have focused on stabilizing the base business, delivering on our pipeline, reducing debt, maintaining an investment grade credit rating and returning capital to shareholders.
The Company also entered into certain transactions in order to simplify its business, accelerate paydown of debt and unlock shareholder value, including the Biocon Biologics Transaction and the Announced Divestitures.
During Phase 2, the Company anticipates a period of renewed growth and leadership as it intends to move up the value chain by focusing on more complex and innovative products to build a more durable higher margin portfolio, while continuing to explore opportunities to unlock shareholder value.
therapeutic areas or products.
In addition, we may not be able to obtain the required regulatory approvals for a planned divestiture, or may be unable to dispose of businesses that we intend to divest on satisfactory or commercially reasonable terms or within our anticipated timeline, in part because of competition from other companies in pursuing similar transactions in the pharmaceutical industry.
We may also not be able to realize the intended or anticipated benefits from such transactions, such as realizing the anticipated proceeds, deploying the proceeds to pay down our outstanding indebtedness and/or fund other important initiatives, maintaining employee morale and retaining key management and other employees to provide the transition services and to operate our retained business, or may be unable to realize the intended or expected goals, outlooks, synergies or operating efficiencies with respect to such transactions.
On October 1, 2023, we announced we had received an offer for the divestiture of substantially all of our OTC Business (the “OTC Transaction”) and entered into definitive agreements to divest our women’s healthcare business and, separately, in another transaction, our rights to two women’s healthcare products in certain countries, our API business in India and commercialization rights in the Upjohn Distributor Markets (all such transactions, including the OTC Transaction, referred to as the Announced Divestitures).
As of February 28, 2024, we have consummated certain of the Announced Divestitures, including our rights to two women’s healthcare products in certain countries (other than in the U.K., which remains subject to regulatory approval) and commercialization rights in certain of the Upjohn Distributor Markets.
Additionally, we expect to consummate the divestiture of our women’s healthcare business and our API business in India by the end of the first quarter of 2024, in each case subject to satisfaction of certain closing conditions, and in January 2024, we exercised our option to accept the offer in the OTC Transaction and entered into a definitive transaction agreement with respect to such OTC Transaction.
However, there remain a number of risks and uncertainties associated with the Announced Divestitures, including the remaining Announced Divestitures that have not been consummated (all such remaining Announced Divestitures referred to as the Pending Announced Divestitures), including, among other things:
- the Pending Announced Divestitures not being completed on the expected timelines or at all, including but not limited to the inefficiencies and lack of control that may result if the Pending Announced Divestitures are delayed or not implemented effectively, and unforeseen difficulties and expenditures that may arise as a result;
- the risk that the conditions set forth in the definitive agreements with respect to the Pending Announced Divestitures will not be satisfied or waived (including that, with respect to the OTC Transaction, the potential failure of the conditions in that transaction agreement related to obtaining required regulatory and other consents and approvals, which could give rise to the termination of that transaction agreement);
- failure to realize the total transaction values for the Announced Divestitures and/or the expected proceeds for any or all of the Announced Divestitures, including as a result of any purchase price adjustment or a failure to achieve any
conditions to the payment of any contingent consideration (including, with respect to the OTC Transaction, that transaction agreement’s net indebtedness and working capital adjustments as well as the up to €100.0 million in contingent additional cash consideration);
- the possibility that the Company may be unable to realize the intended or expected benefits of, or achieve the intended or expected goals, outlooks, synergies or operating efficiencies with respect to, the Announced Divestitures, including but not limited to as a result of carrying stranded costs;
- the risk that we will incur additional losses related to the Pending Announced Divestitures (with respect to the OTC Transaction, for instance, we recorded an estimated pre-tax loss of $735 million in the fourth quarter of 2023 for the difference between the estimated consideration to be received, less estimated costs to sell the business, and the carrying value of the business to be divested, including an allocation of goodwill (see Note 5 *Divestitures* in Part II, Item 8 of this Form 10-K for more information);
- the cost of continued post-closing activities related to the divestiture of the commercialization rights in the Upjohn Distributor Markets and the risk that if the divestiture of the commercialization rights in the remaining Upjohn Distributor Markets are not completed, the distribution arrangements will expire in accordance with our agreement with Pfizer and the Company will wind down operations in these markets, which may result in significant additional asset write-offs and other costs being incurred; and
- the risk that we may incur losses related to unhedged foreign exchange exposure related to receiving proceeds from the OTC Transaction in Euros.
To the extent that the current market price of our common stock reflects an assumption that the Pending Announced Divestitures will be consummated in the timeframe and manner currently anticipated, and that the Company will prioritize use of net proceeds from the Pending Announced Divestitures for debt paydown, any delay in closing or failure to close the Pending Announced Divestitures could result in a decline in the market price of our common stock.
Similarly, any delay in closing or failure to close the Pending Announced Divestitures could result in damage to our relationships with customers, suppliers and employees and have an adverse effect on our business.
Regarding all of the Announced Divestitures, the attention of our management may be directed toward closing or post-closing matters, and their focus may be diverted from the day-to-day business operations of our company, including from other opportunities that might otherwise be beneficial to us.
Also, we have agreed to indemnify the respective purchasers in the Announced Divestitures and certain of their respective representatives against certain losses suffered as a result of certain breaches of our representations, warranties, covenants and agreements in the applicable transaction agreements and related documents.
Any event that results in a right for the purchaser in any of the Announced Divestitures to seek indemnity from us could result in substantial liability to us and could adversely affect our financial position and results of operations.
Whether the Pending Announced Divestitures are ultimately consummated or not, their pendency could have a number of negative effects on our current business, including potentially disrupting our regular operations, diverting the attention of our workforce and management team, and increasing workforce turnover.
It could also disrupt existing business relationships, make it harder to develop new business relationships, or otherwise negatively impact the way that we operate the business, which could negatively impact Viatris’ results of operations and cash flows during the pendency of the transactions.
In addition, we have expended significant time and resources, and expect to continue to expend significant time and resources, on these transactions, including management time and focus, costs and expenses related to the separation of the businesses from Viatris, the provision of the transition services and other transaction costs.
Many of these expenses must be paid regardless of whether the transactions close, and even if the expected benefits are
not achieved.
These costs may be significant and we currently do not expect to be reimbursed for all such costs.
We may also face other challenges as a result of the Announced Divestitures, including that we may not be able to realize the anticipated benefits from such transactions, such as prioritizing use of net proceeds from these divestitures for debt paydown, maintaining employee morale and retaining key management and other employees to provide the transition services and to operate our retained business, and the inability to effectively minimize liabilities and stranded costs associated with the Pending Announced Divestitures.
This process increases the risk of errors in the presentation of our financial results in conformity with U.S. GAAP.
- loss of institutional knowledge;
In addition, if customers to whom we supply API do not win their tender bids, the amount of API that we sell to them may be reduced.
declines.
political or social stability in and/or diplomatic relations between any countries in which we or our partners and suppliers do business could meaningfully deteriorate.
For instance, with respect to the OTC Transaction, we recorded an estimated pre-tax loss of $735 million in the fourth quarter of 2023 for the difference between the estimated consideration to be received, less estimated costs to sell the business, and the carrying value of the business to be divested, including an allocation of goodwill (see Note 5 *Divestitures* in Part II, Item 8 of this Form 10-K for more information).
For example, Perforomist® lost exclusivity and experienced generic competition in June 2021, and Lyrica’s pediatric exclusivity expired in Japan in July 2022.
customers to switch among products of different pharmaceutical manufacturers, importation by consumers or the introduction of new products by competitors.
As a result, central banks have and continue to tighten their monetary policies and increase interest rates.
If environmental discharge
An excerpt. Shown here: 40 of 183 rewritten, 40 of 45 added and 40 of 55 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2024 filing and the FY2023 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition And Results of Operations
257 rewritten, 99 added, 101 removed, 317 unchanged
Such forward-looking statements may include, without limitation, statements about the goals or outlooks with respect to the Company’s strategic [removed: initiatives,] [added: initiatives and priorities,] including but not limited to [removed: the Company’s two-phased strategic vision and potential and announced] divestitures, [removed: acquisitions] [added: acquisitions, strategic alliances, collaborations,] or other [added: potential] transactions; the benefits and synergies of such divestitures, acquisitions, [added: strategic alliances, collaborations,] or other transactions, or restructuring programs; future opportunities for the Company and its products; and any other statements regarding the Company’s future operations, financial or operating results, capital allocation, dividend policy and payments, [removed: stock] [added: share] repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock [removed: the value of our unique global platform,] [added: value,] and other expectations and targets for future periods.
- 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 [added: and priorities] (including divestitures, acquisitions, [added: strategic alliances, collaborations,] or other potential transactions) or [removed: move up the value chain] [added: accelerate its growth] by [removed: focusing] [added: building] on [removed: more complex and innovative products to build a more durable higher margin portfolio;][added: the strength of its base business with an expanding portfolio of innovative, best-in-class, patent-protected assets;]
- the possibility that the Company may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, [added: strategic alliances, collaborations, or] other transactions, or restructuring programs, within the expected timeframes or at all;
- changes in relevant laws, regulations and policies and/or the application or implementation thereof, including but not limited to tax, healthcare and pharmaceutical laws, regulations and policies [removed: globally (including the impact of recent and potential tax reform in the U.S. and pharmaceutical product pricing policies in China);][added: globally;]
- the effect of any changes in the Company’s or its partners’ customer and supplier relationships and customer purchasing patterns, including customer loss and business disruption being greater than expected following an [added: adverse regulatory action,] acquisition or divestiture;
- uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, [added: tariffs and trade policies,] inflation rates and global exchange rates; and
You can access Viatris’ filings with the SEC through the SEC website at www.sec.gov or through our [removed: website] [added: website,] and Viatris strongly encourages you to do so.
With a mission to empower people worldwide to live healthier at every stage of life, Viatris [removed: provides access at scale, currently supplying] [added: supplies] high-quality medicines to approximately 1 billion patients around the world [removed: annually and touching all of life’s moments, from birth to the end of life, acute conditions to chronic diseases.][added: each year.]
[removed: With our exceptionally] [added: The Company has a global footprint, an] extensive [removed: and diverse] portfolio of [removed: medicines,] [added: medicines that is well-diversified across therapeutic areas,] a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health [removed: challenges, access takes on deep meaning at Viatris.][added: challenges.]
The Company reports segment information on the basis of markets and geography, which reflects its focus on bringing its [removed: broad] [added: large] and diversified portfolio of branded and generic products, including complex products, to people in markets everywhere.
Our Greater China segment includes our operations in [added: mainland] China, Taiwan and Hong Kong.
Our JANZ segment [removed: reflects] [added: consists of] our operations in Japan, Australia and New Zealand.
[added: As such,] the timing of new product introductions can have a significant impact on the Company’s financial results.
Conversely, generic products generally experience less volatility over a longer period of time in Europe as compared to the U.S., primarily due to the role of [removed: government oversight of healthcare systems in the region.]
[removed: *Idorsia Acquisition*][added: *Acquisition of Idorsia Products*]
[removed: On February 28, 2024,] [added: Under] the [removed: Company announced that it will acquire] [added: terms of] the [added: original agreements, the] development programs and certain personnel [removed: related to] [added: for] selatogrel and cenerimod [added: were transferred to Viatris] from Idorsia in exchange for an upfront payment to Idorsia of $350 million, potential [added: contingent milestone payments (including $300 million payable upon the achievement of certain] development and regulatory [removed: milestone payments,] [added: milestones,] and [removed: certain contingent payments] [added: $2.1 billion payable upon the achievement] of [removed: additional] [added: certain tiered] sales [removed: milestone payments and] [added: milestones), as well as potential contingent] tiered sales royalties.
Viatris and Idorsia [removed: will] [added: are] both [added: contractually obligated to] contribute to the development costs for both [removed: programs.][added: programs, which are expected to be incurred through 2026.]
Viatris [removed: will have] [added: has] worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region).
[removed: On] [added: In] October [removed: 1,] 2023, the Company announced it [added: had] received an offer for the divestiture of its OTC [removed: Business,] [added: Business] and [added: had] entered into definitive agreements to divest its women’s healthcare [added: business, its API] business [removed: and, separately,] in [removed: another transaction,] [added: India,] its rights to two women’s healthcare products in certain countries, [removed: its API business in India] and commercialization rights in the Upjohn Distributor Markets.
The divestiture of the women’s healthcare business [removed: is] [added: was] primarily related to our oral and injectable contraceptives and [removed: does] [added: did] not include all of our women’s healthcare related [removed: products; as an example, our Xulane® product in the U.S. is excluded.][added: products.]
The transaction to divest the Company’s rights to two women’s healthcare products in certain countries [added: closed in December 2023] (other than in the [removed: U.K., which remains subject to regulatory approval)] [added: U.K.), and the divestiture of the women’s healthcare business] closed in [removed: December 2023.][added: March 2024.]
Refer to Note 5 *Divestitures* [added: included] in Part II, Item 8 of this Form 10-K for more information.
Refer to Note 4 *Acquisitions and Other Transactions* [added: included] in Part II, Item 8 of this Form 10-K for more information.
The table below is a summary of the Company’s financial results for the year ended December 31, [removed: 2023] [added: 2024] compared to the prior year period:
| (In millions, except per share amounts) | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | Change | | | | | | | | |
| Total revenues | | | $ | [removed: 15,426.9] [added: 14,739.3] | | | | | $ | [removed: 16,262.7] [added: 15,426.9] | | | | | $ | [removed: (835.8)] [added: (687.6)] | | | | | | | |
| Gross profit | | | [removed: 6,438.6] [added: 5,623.6] | | | | | | [removed: 6,497.0] [added: 6,438.6] | | | | | | [removed: (58.4)] [added: (815.0)] | | | | | | | | |
| Earnings from operations | | | [removed: 766.2] [added: 10.1] | | | | | | [removed: 1,614.9] [added: 766.2] | | | | | | [removed: (848.7)] [added: (756.1)] | | | | | | | | |
| [removed: Net] [added: U.S. GAAP net (loss)] earnings | | | [removed: 54.7] | | | [removed: | | | 2,078.6] [added: $] | [added: (634.2)] | | | | | [removed: (2,023.9)] [added: $] | [added: 54.7] | | | | | [added: $] | [added: 2,078.6] | |
| Diluted [added: (loss)] earnings per share | | | $ | [removed: 0.05] [added: (0.53)] | | | | | $ | [removed: 1.71] [added: 0.05] | | | | | $ | [removed: (1.66)] [added: (0.58)] | | | | | | | |
More information about non-GAAP measures used by the Company as part of this discussion, including adjusted cost of sales, adjusted gross margins, adjusted [added: EBITDA, adjusted] net earnings, and adjusted [removed: EBITDA] [added: EPS] (all of which are defined below) [removed: are discussed further] [added: can be found] in [removed: this] Part II, Item 7 under *Results of Operations* and *Results of Operations — Use of Non-GAAP Financial Measures*.
| (In millions, except %s) | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | % Change | | | | | | [removed: 2023] [added: 2024] Currency Impact (1) | | | | | | [removed: 2023] [added: 2024] Constant Currency Revenues | | | | | | Constant Currency % Change (2) | | |
| Total net sales | | | [removed: 15,388.4] [added: 14,692.8] | | | | | | [removed: 16,218.1] [added: 15,388.4] | | | | | | (5) | | % | | | | [removed: 258.9] [added: 239.5] | | | | | | [removed: 15,647.2] [added: 14,932.3] | | | | | | [removed: (4)] [added: (3)] | | % |
| Other revenues [removed: (3)] [added: (4)] | | | [removed: 38.5] [added: 46.5] | | | | | | [removed: 44.6] [added: 38.5] | | | | | | NM | | | | | | [removed: (0.1)] [added: 0.1] | | | | | | [removed: 38.4] [added: 46.6] | | | | | | NM | | |
| Consolidated total revenues [removed: (4)] [added: (3)(5)] | | | $ | [removed: 15,426.9] [added: 14,739.3] | | | | | $ | [removed: 16,262.7] [added: 15,426.9] | | | | | [removed: (5)] [added: (4)] | | % | | | | $ | [removed: 258.8] [added: 239.6] | | | | | $ | [removed: 15,685.6] [added: 14,978.9] | | | | | [removed: (4)] [added: (3)] | | % |
(2)The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from [removed: 2023] [added: 2024] constant currency net sales or revenues to the corresponding amount in the prior year.
[removed: (3)For] [added: (4)For] the year ended December 31, [removed: 2023,] [added: 2024,] other revenues in Developed Markets, [added: Greater China,] JANZ, and Emerging Markets were approximately [removed: $26.1] [added: $32.0] million, [removed: $1.1] [added: $1.3] million, [added: $3.5 million,] and [removed: $11.3] [added: $9.7] million, respectively.
[removed: (4)Amounts] [added: (5)Amounts] exclude intersegment revenue which eliminates on a consolidated basis.
For the year ended December 31, [removed: 2023,] [added: 2024,] the Company reported total revenues of [removed: $15.43] [added: $14.74] billion, compared to [removed: $16.26] [added: $15.43] billion for the comparable prior year period, representing a decrease of [removed: $835.8] [added: $687.6] million, or [removed: 5%.][added: 4%.]
Net sales for the year ended December 31, [removed: 2023] [added: 2024] were [removed: $15.39] [added: $14.69] billion, compared to [removed: $16.22] [added: $15.39] billion for the comparable prior year period, representing a decrease of [removed: $829.7] [added: $695.6] million, or 5%.
- the ongoing risks and uncertainties associated with our recent divestitures;
- goodwill or impairment charges or other losses;
- the potential impact of natural or man-made disasters, public health outbreaks, epidemics, pandemics, or social disruption in regions where we or our partners or suppliers operate;
Viatris is a global healthcare company whose breadth and scale we believe make it uniquely positioned to address healthcare needs globally.
The Company operates in more than 165 countries and territories with approximately 32,000 employees.
The Company has 26 manufacturing and packaging sites worldwide, more than 1,400 approved molecules, and industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise.
Viatris’ portfolio consists of generics (including complex products), globally recognized iconic brands, and an expanding portfolio of innovative medicines.
The process of obtaining regulatory approval to manufacture and market new branded and generic pharmaceutical products is rigorous, time consuming, costly, and inherently unpredictable.
Complex products are more difficult, costly and time-consuming to receive regulatory approval for and bring to market.
Any delay in regulatory approval could impact the commercial or financial success of a product.
Regulatory approval, if and when obtained, may be limited in scope.
Even if regulatory approvals for new products are obtained, the success of those products is dependent upon market acceptance.
government oversight of healthcare systems in the region.
In addition, U.S. governmental agencies provide funding for certain products in our Emerging Markets region.
We expect that any reduction in that funding will have a negative impact on our financial condition, results of operations or cash flows.
For example, generic entry may occur for Amitiza® 24 μg in Japan in December 2025 upon expiration of patent exclusivity.
*Lexicon Licensing Agreement*
In October 2024, the Company entered into an exclusive licensing agreement with Lexicon for sotagliflozin in all markets outside of the U.S. and Europe in exchange for an upfront payment of $25.0 million, and additional potential contingent payments, including regulatory milestones, sales milestones and tiered royalties ranging from low-double-digit to upper-teens on annual net sales.
Viatris will be responsible for all regulatory and commercialization activities for sotagliflozin in the licensed territories.
Lexicon will be responsible for providing clinical and commercial supply of sotagliflozin to Viatris.
The Company accounted for the transaction as an asset acquisition, with the upfront payment expensed as *Acquired IPR&D* in the fourth quarter of 2024.
*Indore Manufacturing Facility*
Following an inspection by the FDA at our oral finished dose manufacturing facility in Indore, India in 2024, the FDA has issued a warning letter, and an import alert related to this facility.
The import alert affects 11 actively distributed products that will no longer be accepted into the U.S. until the warning letter is lifted.
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.
The necessary corrective and preventive actions are well underway, 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 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.
While product continues to be shipped from the Indore facility to markets outside the U.S., some impact in other markets, including the ARV business in Emerging Markets and select generic products in Europe, is anticipated.
The Company currently estimates the negative impact to 2025 total revenues to be approximately $500 million and to 2025 earnings from operations to be approximately $385 million.
We take very seriously our continued and comprehensive oversight of our entire manufacturing network.
Patient safety remains our primary and unwavering focus.
We will work closely with our customers to mitigate any possible supply disruptions and meet the needs of the patients we serve.
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.
A joint development committee was formed to oversee the development of the ongoing Phase 3 programs through regulatory approval.
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.
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.
- with respect to previously announced divestitures that have not been consummated, including the divestiture of substantially all of our OTC Business, such divestitures not being completed on the expected timelines or at all and the risk that the conditions set forth in the definitive agreements with respect to such divestitures will not be satisfied or waived;
- with respect to previously announced divestitures, failure to realize the total transaction values for the divestitures and/or the expected proceeds for any or all such divestitures, including as a result of any purchase price adjustment or a failure to achieve any conditions to the payment of any contingent consideration;
- goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets (including but not limited to announced divestitures that have not yet been consummated);
- the potential impact of public health outbreaks, epidemics and pandemics;
Viatris is a global healthcare company which we believe is uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.
With a global workforce of approximately 38,000, the Company has industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise complemented by a strong commitment to quality and an unparalleled geographic footprint to deliver high-quality medicines to patients in more than 165 countries and territories.
As of December 31, 2023, Viatris’ portfolio comprised more than 1,400 approved molecules across a wide range of key therapeutic areas, including globally recognized iconic and key brands and generics, including complex products, and the Company operated approximately 40 manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs.
As discussed below, Viatris has entered into certain transactions, including the Pending Announced Divestitures.
As such,
For example, depending on certain factors – including decisions by Japanese regulatory and/or patent authorities – generic entry may occur for Amitiza® 24 μg in Japan prior to one of the patents relevant to Amitiza® expiring in April 2025.
The closing of the transaction is subject to certain closing conditions.
The divestitures of the commercialization rights in certain of the Upjohn Distributor Markets closed during 2023.
Additionally, we expect to consummate the divestiture of our women’s healthcare business and our API business in India by the end of the first quarter of 2024, and in January 2024, we exercised our option to accept the offer in the OTC Transaction and entered into a definitive transaction agreement with respect to such OTC Transaction.
We currently expect the OTC Transaction to close by mid-year 2024.
The transactions that have not yet closed remain subject to regulatory approvals, receipt of required consents and other
closing conditions, including, in the case of the API business divestiture, a financing condition.
*Ophthalmology Acquisitions*
During the first quarter of 2023, the Company completed the acquisition of Oyster Point for approximately $427.4 million in cash, which included $11 per share paid to Oyster Point stockholders through a tender offer, payment for vested share-based awards, and the repayment of the Oyster Point debt.
Oyster Point is focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.
On November 7, 2022, the Company entered into a definitive agreement to acquire the remaining equity shares of Famy Life Sciences, a privately-owned research company with a complementary portfolio of ophthalmology therapies under development, for consideration of $281 million.
The transaction to acquire the remaining equity shares of Famy Life Sciences closed during the first quarter of 2023.
*Share Repurchase Program*
On February 28, 2022, the Company announced that its Board of Directors had authorized a share repurchase program for the repurchase of up to $1.0 billion of the Company’s shares of common stock.
Such repurchases may be made from time-to-time at the Company’s discretion and effected by any means, including but not limited to, open market repurchases, pursuant to plans in accordance with Rules 10b5-1 or 10b-18 under the Exchange Act, privately negotiated transactions (including accelerated stock repurchase programs) or any combination of such methods as the Company deems appropriate.
The program does not have an expiration date.
During the year ended December 31, 2023, the Company repurchased approximately 21.2 million shares of common stock at a cost of approximately $250 million.
In February 2024, the Company repurchased approximately 19.2 million shares of common stock at a cost of approximately $250 million.
The Company did not repurchase any shares of common stock under the share repurchase program in 2022.
The share repurchase program does not obligate the Company to acquire any particular amount of common stock.
The Company announced that on February 26, 2024, its Board of Directors authorized a $1.0 billion increase to the Company’s previously announced $1.0 billion share repurchase program.
As a result, the Company’s share repurchase program now authorizes the repurchase of up to $2.0 billion of the Company’s shares of common stock.
The Company had repurchased a total of $500 million in shares through February 28, 2024 under the program.
*2020 Restructuring Program*
During 2020, Viatris announced a significant global restructuring program in order to achieve synergies and ensure that the organization was optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers, and other stakeholders.
As part of the restructuring, the Company optimized its commercial capabilities and enabling functions, and closed, downsized or divested certain manufacturing facilities globally that were deemed to be no longer viable either due to surplus capacity, challenging market dynamics or a shift in its product portfolio toward more complex products.
The actions under the 2020 restructuring program were substantially completed during 2023.
Since the initiation of the 2020 restructuring program, the Company has incurred total pre-tax charges of approximately $1.4 billion through December 31, 2023.
Such charges included approximately $450 million of non-cash charges mainly related to accelerated depreciation and asset impairment charges, including inventory write-offs, and cash costs of approximately $950 million, primarily related to severance and employee benefits expense, as well as other costs, including those related to contract terminations and other plant disposal costs.
| Developed Markets | | | $ | 9,251.9 | | | | | $ | 9,768.9 | | | | | (5) | | % | | | | $ | (85.2) | | | | | $ | 9,166.6 | | | | | (6) | | % |
| Greater China | | | 2,160.4 | | | | | | 2,201.2 | | | | | | (2) | | % | | | | 87.1 | | | | | | 2,247.6 | | | | | | 2 | | % |
An excerpt. Shown here: 40 of 257 rewritten, 40 of 99 added and 40 of 101 removed. The counts are complete. For every sentence, read Item 7. Management’s Discussion and Analysis of Financial Condition And Results of Operations in the FY2024 filing and the FY2023 filing.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
7 rewritten, 0 added, 0 removed, 23 unchanged
- foreign currency denominated receivables, payables, debt and loans — changes in exchange [removed: rates][added: rates.]
As of December 31, [removed: 2023,] [added: 2024,] Viatris’ outstanding fixed rate borrowings consist principally of [removed: $17.33] [added: $13.33] billion notional amount of senior U.S. dollar and Euro notes.
As of December 31, [removed: 2023,] [added: 2024,] the fair value of our outstanding fixed rate senior U.S. dollar and Euro notes was approximately [removed: $15.25] [added: $11.53] billion.
As of December 31, [removed: 2023,] [added: 2024,] Viatris’ outstanding variable rate borrowings consist principally of borrowings under the Yen Term Loan Facility of [removed: $283.6] [added: $254.4] million.
A 100 basis point change in interest rates on Viatris’ variable rate debt would result in a change in interest expense of approximately [removed: $2.9] [added: $2.6] million per year.
As of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] the carrying value of these investments were approximately [removed: $1.14] [added: $1.35] billion and [removed: $1.09] [added: $1.14] billion, respectively.
A hypothetical 20 percent decline in the fair value of these investments would have decreased the carrying value and [added: increased] other [removed: income,] [added: expense (income),] net by approximately [removed: $228.4] [added: $270.0] million at December 31, [removed: 2023.][added: 2024.]
Item 1. Business
140 rewritten, 80 added, 74 removed, 206 unchanged
With a mission to empower people worldwide to live healthier at every stage of life, Viatris [removed: provides access at scale, currently supplying] [added: supplies] high-quality medicines to approximately 1 billion patients around the world [removed: annually and touching all of life’s moments, from birth to the end of life, acute conditions to chronic diseases.][added: each year.]
[removed: With our exceptionally] [added: The Company has a global footprint, an] extensive [removed: and diverse] portfolio of [removed: medicines,] [added: medicines that is well-diversified across therapeutic areas,] a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health [removed: challenges, access takes on deep meaning at Viatris.][added: challenges.]
The Company [added: has] also [removed: entered into] [added: completed] certain transactions [removed: in order] to simplify [added: and streamline] its business, accelerate paydown of debt and unlock [removed: shareholder] value, including the Biocon Biologics Transaction and the [removed: Announced Divestitures.][added: recently completed divestitures discussed below.]
[removed: On] [added: In] October [removed: 1,] 2023, the Company announced it [added: had] received an offer for the divestiture of its OTC [removed: Business,] [added: Business] and [added: had] entered into definitive agreements to divest its women’s healthcare business [removed: and, separately,] [added: primarily related to oral and injectable contraceptives, its API business] in [removed: another transaction,] [added: India,] its rights to two women’s healthcare products in certain countries, [removed: its API business in India] and commercialization rights in the Upjohn Distributor Markets.
[added: -] The divestitures of the commercialization rights in [removed: certain] [added: the majority] of the Upjohn Distributor Markets closed during [removed: 2023.][added: 2023 and 2024.]
[removed: On February 28, 2024,] [added: Under] the [removed: Company announced that it will acquire] [added: terms of] the [added: original agreements, the] development programs and certain personnel [removed: related to] [added: for] selatogrel and cenerimod [added: were transferred to Viatris] from Idorsia in exchange for an upfront payment to Idorsia of $350 million, potential [added: contingent milestone payments (including $300 million payable upon the achievement of certain] development and regulatory [removed: milestone payments,] [added: milestones,] and [removed: certain contingent payments] [added: $2.1 billion payable upon the achievement] of [removed: additional] [added: certain tiered] sales [removed: milestone payments and] [added: milestones), as well as potential contingent] tiered sales royalties.
Viatris and Idorsia [removed: will] [added: are] both [added: contractually obligated to] contribute to the development costs for both programs.
Viatris [removed: will have] [added: has] worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region).
On November 29, 2022, Viatris completed [removed: the] [added: a] transaction to contribute its biosimilars portfolio to Biocon Biologics to create [removed: what it expects to be] a vertically integrated global biosimilars leader.
[removed: Under the terms] [added: A portion] of the [removed: Biocon Agreement, Viatris received $3 billion in] consideration [removed: in the form of a $2 billion cash payment, adjusted as set forth in the] [added: received from] Biocon [removed: Agreement, and] [added: at closing included] approximately $1 billion of CCPS representing a stake of approximately 12.9% (on a fully diluted basis) in Biocon Biologics.
Unless otherwise indicated, industry data included in this Item 1 are sourced from IQVIA Holdings Inc. and are for the twelve months ended November [removed: 2023] [added: 2024] and Viatris product and other company data included in this Item 1 are from internal sources and are as of November 30, [removed: 2023.][added: 2024.]
Effective as of November 16, 2020, Upjohn, Mylan and Pfizer consummated the combination of Mylan with the Upjohn Business through a Reverse Morris Trust transaction, Viatris became the parent entity of the combined Upjohn Business and Mylan business, and Upjohn changed its name to “Viatris [removed: Inc.”.][added: Inc.” As a result of the Combination, Mylan ceased to exist as a separate legal entity after merging with and into Mylan II B.V., an indirect wholly owned subsidiary of Viatris.]
Mylan was founded in 1961 as a privately-owned company and grew over time into one of the largest manufacturers of generic [removed: drugs] [added: medicines] in the U.S. Mylan became a publicly traded company in 1973.
Our [removed: strength is in our diversity and in our] mission [added: is] to empower people worldwide to live healthier at every stage of life.
[removed: Underpinned by Viatris’ relevance and success in meeting evolving healthcare needs, we] [added: We] seek to create value for and together with our key stakeholders – the people who trust our medicines every day, the health systems who rely on us, the people who make up Viatris, our partners and the investors who believe in our ability to execute on our ambitious mission.
We are convinced that patients and [added: health] systems around the world are best served by a healthcare company applying a well-rounded and long-term approach, maintaining viability while working to manage inherent risks and opportunities and continuously striving to advance sustainable operations and responsible practices in a focused way.
[removed: ][added: ]
It begins with [removed: our] [added: the Company’s] ability to sustainably deliver quality medicines to people, regardless of geography or circumstance.
Our global portfolio, supported by our science, medical and manufacturing expertise, delivers global iconic and key brands, [added: and] generics, including complex [removed: products, and OTC] products.
[removed: In addition to the three therapeutic areas identified, we will] [added: We] continue to seek opportunities in [removed: other] [added: various] therapeutic areas that move the Company forward and leverage the strength of our internal capabilities and global platform.
Viatris collaborates with many organizations to help prevent, diagnose, and treat [removed: many] cardiovascular illnesses.
While many important strides have been made to treat these illnesses, there is still more to be done in countries where lack of access to therapeutics, preventative treatment and diagnostics often result in patients not receiving proper care, and those where HIV transmission continues [removed: thirty years] [added: decades] into the epidemic.
[removed: We are] [added: The Company is] also working with [removed: our] [added: its] partners on novel [removed: and] [added: and/or] complex products such as our [removed: BOTOX® (onabotulinumtoxinA)] biosimilar [removed: and Glatiramer Acetate Depot, a long-acting injection version of the approved glatiramer acetate.][added: to BOTOX® (onabotulinumtoxinA).]
While [removed: we] [added: Viatris] will continue to diligently pursue important generics opportunities, [removed: we] [added: the Company] will increasingly focus on limited-competition complex and novel products targeting gaps in care, all with a first-to-market emphasis and serving our mission of patient access.
And that means further expanding beyond our current scope into more innovative products, including [removed: NCEs and 505(b)(2) products.][added: innovative, best-in-class, patent-protected assets that address areas of significant unmet medical need.]
[removed: ][added: ]
[removed: We have] [added: The Company has] designed [removed: our] [added: its] global operations and supply chain to be a reliable and flexible partner for access across the world, constantly adapting to an ever-evolving landscape.
[removed: As of December 31, 2023,] Viatris [removed: operated] [added: operates] approximately [removed: 40] [added: 26] manufacturing [added: and packaging] sites worldwide that produce oral solid doses, injectables, [added: and products with] complex dosage forms [removed: and APIs] on five different continents.
Our responsive global network has helped us maintain a reliable supply of much needed medicines [removed: throughout] [added: through] times of significant volatility.
- Robust global technical resources, including thousands of scientists, regulatory [removed: experts and] [added: experts, clinical,] medical and product safety professionals working around the world on innovative therapies and solutions for patients everywhere.
- Strong global commercial team, including sales team members and marketing professionals whose goal is to ensure that [added: our] products [removed: are shipped to] [added: reach] customers around the globe.
- Diverse and differentiated global portfolio includes products in more than 10 major therapeutic areas, including both infectious diseases and [removed: NCDs] [added: NCDs,] and medicines that [added: help] treat the top 10 leading causes of death globally, as determined by the WHO.
[removed: ][added: ]
We have a strong history of [added: playing a leading role by] partnering with other pharmaceutical companies, nonprofit organizations, government agencies, policymakers, trade associations and alliances, industry researchers and patient advocacy groups to promote sustainable access to treatment, build more resilient healthcare systems and drive these issues within our industry on global, regional and local levels.
[removed: Our Global] [added: Global] Healthcare Gateway® Built to Fuel Growth and Partnerships
[removed: We are] [added: The Company is] actively engaging with potential [added: business] partners to help them accelerate possibilities of using their own healthcare assets to reach more [added: markets and] patients by leveraging [removed: our] [added: Viatris’] unique global platform – [removed: our] [added: its] R&D, supply chain, manufacturing, regulatory, commercial and legal expertise.
With the global platforms and infrastructure supporting [removed: our] [added: its] innovative Global Healthcare Gateway®, [removed: we are] [added: the Company is] enhancing [removed: our] [added: its] capital allocation approach to business development, and [removed: our] [added: its] organic and inorganic R&D investments through a focused governance structure to ensure the highest level of strategic decision-making.
[removed: We] [added: Viatris] periodically [removed: enter] [added: enters] into commercial licensing and other partner agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products.
Doing so helps [removed: us] [added: the Company] share risks and costs, leverage strengths and scale up commercialization, but usually requires [removed: us] [added: the Company] to also share future profits.
[removed: Our] [added: The Company’s] significant licensing and other partner agreements are [removed: primarily] focused on the development, manufacturing, supply and commercialization of multiple, high-value generic [removed: compounds and] [added: compounds,] respiratory products, [removed: among] [added: and] other complex [added: or innovative] products.
Viatris is a global healthcare company whose breadth and scale we believe make it uniquely positioned to address healthcare needs globally.
The Company operates in more than 165 countries and territories with approximately 32,000 employees.
The Company has 26 manufacturing and packaging sites worldwide, more than 1,400 approved molecules, and industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise.
Viatris’ portfolio consists of generics (including complex products), globally recognized iconic brands, and an expanding portfolio of innovative medicines.
Viatris has executed various strategic initiatives, transactions and business arrangements over the last few years to return its base business to growth, deliver on its pipeline, reduce debt, maintain an investment grade credit rating and return capital to shareholders.
The Company has substantially completed all of these divestitures:
- In March 2024, the Company completed the divestiture of its women's healthcare business, primarily related to its oral and injectable contraceptives, to Insud Pharma, S.L., a leading Spanish multinational pharmaceutical company.
The transaction included two manufacturing facilities in India: one in Ahmedabad and one in Sarigam.
- In June 2024, the Company completed the divestiture of its API business in India to Matrix Pharma Private Limited, a privately held pharmaceutical company based in India.
The transaction included three manufacturing sites and an R&D lab in Hyderabad, three manufacturing sites in Vizag and third-party API sales.
Viatris retained some selective R&D capabilities in API.
- In July 2024, the Company completed the divestiture of its OTC Business to Cooper Consumer Health, a leading European OTC drug manufacturer and distributor.
The transaction included two manufacturing sites located in Merignac, France, and Confienza, Italy, and an R&D site in Monza, Italy.
- Viatris divested its rights to women’s healthcare products Duphaston® and Femoston® in certain countries to Theramex HQ UK Limited, a leading global specialty pharmaceutical company dedicated to women's health.
The transaction (other than in the U.K., which was sold to Insud Pharma, S.L. in August 2024) closed in December 2023.
*Business Strategy*
The Company has laid out three strategic pillars to accelerate growth and shareholder return:
- Diversified & Growing Base Business: We believe the Company’s continued success in its base business comes from its large and diversified portfolio of generics and off-patent brands that extends across markets and therapeutic areas.
Here the Company has a clear legacy of deep product knowledge and extensive commercialization and development expertise.
We believe it is important that Viatris maintains a strong focus on growing its base business over the long-term.
- Financial Strength & Significant Cash Flow: We believe the Company’s strong balance sheet and sector-leading cash flow generation differentiate it from sector peers.
The Company expects to continue to deliver on its long-term financial strategy to return capital to shareholders through dividends and share repurchases, while making investments in its business and maintaining its commitment to its investment grade debt rating.
- Expanding Innovative Portfolio: This represents the Company’s continuous efforts to identify, vet and secure innovative, best-in-class, patent-protected assets in areas of unmet medical need in which it can be successful.
By expanding our innovative portfolio, we believe the Company has the potential to drive accelerated and durable revenue growth over the long-term.
As part of expanding our innovative portfolio, 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.
The collaboration includes selatogrel, a potential life-saving self-administered medicine for patients with a history of acute myocardial infarction (AMI), or heart attack, and builds on Viatris' existing global cardiovascular franchise and specialty infrastructure, as well as its knowledge, leadership, and distribution capabilities for self-administered medication for acute life-threatening conditions.
The collaboration also includes cenerimod, a novel immunology asset that has the potential to be a first-in-class oral therapy for the treatment of systemic lupus erythematosus (SLE), the most common form of lupus.
Through lifecycle management, this asset also has the potential for broad application across multiple autoimmune diseases in a specialist-driven category with attractive market dynamics for oral therapies and could be a cornerstone asset in Viatris' immunology portfolio.
A joint development committee was formed to oversee the development of the ongoing Phase 3 programs through regulatory approval.
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 receive additional territory rights in Japan, South Korea and certain other countries in the Asia-Pacific region for cenerimod, a $250 million reduction in contingent milestone payments, including $200 million of development milestones, and additional personnel to expedite transitioning the development programs to Viatris in exchange for Viatris assuming $100 million of Idorsia’s obligation to contribute to development costs.
In addition, the letter agreement provides for the replacement of the joint development committee with a transition committee to oversee the transition of both development programs to Viatris.
For additional information, see Part I, Item 1A Risk Factors – *“We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives and priorities, including divestitures, acquisitions or other potential transactions.”*, *“If we are unable to successfully introduce new products in a timely manner, our future revenue and profitability may be adversely affected.”* and *“We expend a significant amount of resources on R&D efforts that may not lead to successful product introductions.”*
At Viatris, we have a relentless focus on delivering access at scale.
Our strength is in our diversity.
With our acquisition of selatogrel and licensing agreement for sotagliflozin, we are continuing to build on our strong presence in cardiovascular disease.
While we continue to diligently pursue important generics opportunities, we have increasingly focused on limited-competition complex and novel products targeting gaps in care, all with a first-to-market emphasis and serving our mission of patient access.
The Company’s Global Healthcare Gateway® offers partners ready access to more markets and patients worldwide through the Company’s unique global infrastructure and expertise, connecting more people with even more products and services they may not have the resources to reach on their own.
A recent example of how the Company is utilizing its Global Healthcare Gateway® is the October 2024 exclusive licensing agreement with Lexicon for sotagliflozin in all markets outside of the U.S. and Europe.
This licensing agreement leverages Viatris’ expertise in cardiovascular diseases and is another example of how the Company is continuing to expand its innovative portfolio by identifying, vetting and securing highly innovative, patent-protected assets that address significant unmet medical needs.
Viatris is a global healthcare company which we believe is uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.
With a global workforce of approximately 38,000, the Company has industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise complemented by a strong commitment to quality and an unparalleled geographic footprint to deliver high-quality medicines to patients in more than 165 countries and territories.
As of December 31, 2023, Viatris’ portfolio comprised more than 1,400 approved molecules across a wide range of key therapeutic areas, including globally recognized iconic and key brands and generics, including complex products, and the Company operated approximately 40 manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs.
As discussed below, Viatris has entered into certain transactions, including the Pending Announced Divestitures.
Viatris has announced various strategic initiatives, transactions and business arrangements, including our two-phased strategic vision.
In Phase 1 of this strategy, we have focused on stabilizing the base business, delivering on our pipeline, reducing debt, maintaining an investment grade credit rating and returning capital to shareholders.
During Phase 2, the Company anticipates a period of renewed growth and leadership as it intends to move up the value chain by focusing on more complex and innovative products to build a more durable higher margin portfolio, while continuing to explore opportunities to unlock shareholder value.
The divestiture of the women’s healthcare business is primarily related to our oral and injectable contraceptives and does not include all of our women’s healthcare related products; as an example, our Xulane® product in the U.S. is excluded.
The transaction to divest the Company’s rights to two women’s healthcare products in certain countries (other than in the U.K., which remains subject to regulatory approval) closed in December 2023.
Additionally, we expect to consummate the divestiture of our women’s healthcare business and our API business in India by the end of the first quarter of 2024, and in January 2024, we exercised our option to accept the offer in the OTC Transaction and entered into a definitive transaction agreement with respect to such OTC Transaction.
We currently expect the OTC Transaction to close by mid-year 2024.
The transactions that have not yet closed remain subject to regulatory approvals, receipt of required consents and other closing conditions, including, in the case of the API business divestiture, a financing condition.
Under the terms of the agreements, Viatris expects to receive gross proceeds of up to approximately $2.17 billion for the OTC Business and up to approximately $1.4 billion for the remaining divestitures.
Upon closing of the divestitures of the women’s healthcare and API businesses, the Company expects to record gains for the differences between the expected consideration to be received and the carrying values of the businesses to be divested.
The OTC, API and women’s healthcare businesses are deemed businesses for U.S. GAAP accounting purposes.
As such, the assets and liabilities include an allocation of goodwill.
The sale of the rights to two women’s healthcare products in certain countries was accounted for as an asset sale.
In conjunction with these transactions, Viatris and the respective buyers have entered or will enter into various agreements to provide a framework for our relationship with the respective buyers after the closing of the divestitures, including TSAs, manufacturing and supply agreements, and distribution agreements, as necessary.
The closing of the transaction is subject to certain closing conditions.
During the first quarter of 2023, the Company completed the acquisition of Oyster Point for approximately $427.4 million in cash, which included $11 per share paid to Oyster Point stockholders through a tender offer, payment for vested share-based awards, and the repayment of the Oyster Point debt.
Oyster Point is focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.
On November 7, 2022, the Company entered into a definitive agreement to acquire the remaining equity shares of Famy Life Sciences, a privately-owned research company with a complementary portfolio of ophthalmology therapies under development, for consideration of $281 million.
The transaction to acquire the remaining equity shares of Famy Life Sciences closed during the first quarter of 2023.
Ophthalmology is one of the key therapeutic areas of focus of the Company.
With the combination of Viatris' global commercial footprint, R&D and regulatory capabilities and supply chain, along with Oyster Point's deep knowledge of the ophthalmology space from a clinical, medical, regulatory and commercial perspective—including Tyrvaya®—and Famy Life Sciences' Phase III-ready pipeline, the Company believes it has the foundation to create a leading global ophthalmology franchise, accelerating efforts to address the unmet needs of patients with ophthalmic disease and the eye care professionals who treat them.
Viatris also is entitled to $335 million of additional cash payments in 2024.
In addition, Viatris and Biocon Biologics have agreed to a closing working capital target of $250 million, of which $220 million was paid during 2023.
The remaining amount may become payable to Biocon Biologics in connection with certain events in the future, depending on the valuations attributable to such events.
Upon closing of the transaction, the Company recognized a gain on sale of approximately $1.75 billion and has not recognized the results of the business in its consolidated financial statements subsequent to November 29, 2022.
At the time of closing of the Biocon Biologics Transaction, Viatris and Biocon Biologics also entered an agreement pursuant to which Viatris was providing commercialization and certain other transition services on behalf of Biocon Biologics, including billings, collections and the remittance of rebates, to ensure business continuity for patients, customers and colleagues.
Biocon Biologics had substantially exited all transition services with Viatris as of December 31, 2023.
As a result of the Combination, Mylan ceased to exist as a separate legal entity after merging with and into Mylan II B.V., an indirect wholly owned subsidiary of Viatris.
Viatris is a new kind of healthcare company - a Next-Gen Hybrid Pharmaceutical Company with a relentless focus on delivering access at scale that has been built for the future of healthcare.
Viatris empowers people worldwide to live healthier at every stage of life.
It is not an initiative; it is our business model, and it is personal.
We believe we are a company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.
As discussed above, the Company has entered into a definitive agreement to divest its OTC Business.
While we intend to maintain our broad range of therapeutic areas, we have, as previously announced, identified three core, global therapeutic areas – ophthalmology, gastrointestinal, and dermatology – that we believe particularly fit our own internal capabilities while leveraging our global platform.
As discussed above, the Company has entered into a definitive agreement to divest its API business in India.
We hold leadership roles in several industry associations and actively engage with more than 100 groups worldwide to this end.
An excerpt. Shown here: 40 of 140 rewritten, 40 of 80 added and 40 of 74 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2024 filing and the FY2023 filing.
Item 3. Legal Proceedings
1 rewritten, 0 added, 0 removed, 0 unchanged
For information regarding legal proceedings, refer to Note 19 *Litigation* included in [added: Part II,] Item 8 [removed: in Part II] of this 10-K.
Cover and table of contents
42 rewritten, 10 added, 21 removed, 190 unchanged
| | | | For the Fiscal Year Ended December 31, [removed: 2023] [added: 2024] | | |
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, [removed: 2023,] [added: 2024,] the last business day of the registrant’s most recently completed second fiscal quarter, was approximately [removed: $11,936,712,582.][added: $12,661,582,065.]
The number of shares of common stock outstanding, par value $0.01 per share, of the registrant as of February [removed: 22, 2024] [added: 21, 2025] was [removed: 1,187,569,149.][added: 1,193,688,749.]
For the Year Ended December 31, [removed: 2023][added: 2024]
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Unless the context requires otherwise, references to “Viatris,” “the Company,” “we,” “us” or “our” in this [removed: 2023] [added: 2024] Form 10-K (defined below) refer to Viatris Inc. and its subsidiaries.
We also have used several other terms in this [removed: 2023] [added: 2024] Form 10-K, most of which are explained or defined below.
| Adjusted EBITDA | | | Non-GAAP financial measure that the Company believes is appropriate to provide information to investors - EBITDA (defined below) is further adjusted for share-based compensation expense, litigation settlements, and other contingencies, net, [removed: restructuring] [added: gain (loss) on divestitures of businesses, impairment of long-lived assets] and [added: goodwill, restructuring, acquisition and divestiture-related and] other special items | | |
| API | | | Active pharmaceutical [removed: ingredient] [added: ingredients] | | |
| Distribution | | | Pfizer's distribution to Pfizer stockholders [added: of] all the issued and outstanding shares of Upjohn Inc. | | |
| EBITDA | | | Non-GAAP financial measure that the Company believes is appropriate to provide information to investors - U.S. GAAP net earnings (loss) adjusted for [removed: net contribution attributable to equity method investments,] income tax provision (benefit), interest expense and depreciation and amortization | | |
| Form 10-K | | | This annual report on Form 10-K for the fiscal year ended December 31, [removed: 2023] [added: 2024] | | |
| Greater China segment | | | Viatris’ business segment that includes our operations primarily in the following markets: [added: mainland] China, Taiwan and Hong Kong | | |
| [removed: Momenta] [added: Lexicon Pharmaceuticals, Inc.] | | | [removed: Momenta Pharmaceuticals, Inc.] [added: Lexicon] | | |
| [removed: Mylan Inc.] [added: Utah] Euro Notes | | | The [removed: 2.125%] [added: 3.125%] Senior Notes due [removed: 2025] [added: 2028] issued by [removed: Mylan] [added: Utah Acquisition Sub] Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan [removed: II B.V.,] [added: Inc.,] Viatris Inc. and [removed: Utah Acquisition Sub Inc.] [added: Mylan II B.V.] | | |
| OTC Business | | | Viatris’ OTC business that the Company [removed: has agreed to divest] [added: divested] to Cooper Consumer Health [removed: SAS,] [added: SAS in July 2024,] including two manufacturing sites located in Merignac, France, and Confienza, Italy, and an R&D site in Monza, Italy. This excludes the Company’s rights for Viagra®, Dymista® (which, in certain limited markets, are sold as OTC products), and select OTC products in certain markets. | | |
| OTC Transaction | | | On October 1, 2023, Viatris announced it had received an offer for the divestiture of its OTC Business. [added: In January 2024, we exercised our option to accept the offer and entered into a definitive transaction agreement with respect to such OTC Transaction. The OTC Transaction closed in July 2024.] | | |
| Receivables Facility | | | The $400 million accounts receivable [added: facility] entered into in August 2020 and expiring in April 2025 | | |
| Registered Upjohn Notes | | | The [removed: 1.650% Senior Notes due 2025,] 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on October 29, 2021 registered with the SEC in exchange for the corresponding Unregistered Upjohn U.S. Dollar Notes in a similar aggregate principal amount and with terms substantially identical to the corresponding Unregistered Upjohn U.S. Dollar Notes and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. | | |
| [added: 2021] Revolving Facility | | | The $4.0 billion revolving facility dated as of July 1, 2021, by and among Viatris, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent [added: and which was amended and restated in September 2024] | | |
| ITEM 1C. | | | [Cybersecurity](#i294e6e3112ae4c32a7f27a2ec714b350_55) | | | [50](#i294e6e3112ae4c32a7f27a2ec714b350_55) | | |
| [Signatures](#i294e6e3112ae4c32a7f27a2ec714b350_256) | | | | | | [160](#i294e6e3112ae4c32a7f27a2ec714b350_256) | | |
| 2024 Revolving Facility | | | The $3.5 billion revolving facility dated as of September 27, 2024, by and among Viatris, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent | | |
| Adjusted EPS | | | Adjusted net earnings per diluted share | | |
| CODM | | | Chief operating decision maker | | |
| EPS | | | Earnings per share | | |
| Idorsia Transaction | | | The transaction between Viatris and Idorsia pursuant to which Viatris acquired the development programs and certain personnel related to selatogrel and cenerimod from Idorsia in exchange for an upfront payment to Idorsia of $350 million, potential development and regulatory milestone payments, certain contingent payments of tiered sales milestones, as well as potential contingent tiered sales royalties | | |
| | | | | | |
| | | | | | |
| TSA | | | Transition services agreements, including related distribution services | | |
| --- | --- | --- | --- | --- | --- |
| ITEM 1C. | | | [C](#i0b0d5c23417c472eb84c46f5f45cb005_2192)[ybersecurity](#i0b0d5c23417c472eb84c46f5f45cb005_2192) | | | [50](#i0b0d5c23417c472eb84c46f5f45cb005_2192) | | |
| [Signatures](#i0b0d5c23417c472eb84c46f5f45cb005_256) | | | | | | [161](#i0b0d5c23417c472eb84c46f5f45cb005_256) | | |
| AbbVie | | | AbbVie Inc. | | |
| Announced Divestitures | | | All of the following transactions: on October 1, 2023, Viatris announced it had received an offer for the divestiture of its OTC Business and had entered into definitive agreements to divest its women’s healthcare business and, separately, in another transaction, its rights to two women’s healthcare products in certain countries, its API business in India and commercialization rights in the Upjohn Distributor Markets | | |
| clean energy investments | | | Used to define the three equity method investments the Company had in limited liability companies that owned refined coal production plants whose activities qualify for income tax credits under Section 45 of the Code | | |
| COVID-19 | | | Novel coronavirus disease of 2019 | | |
| CP Notes | | | Unsecured, short-term commercial paper notes issued pursuant to the Commercial Paper Program | | |
| DEI | | | Diversity, equity, and inclusion | | |
| DRIP | | | Dividend Reinvestment and Share Purchase Plan | | |
| Gx | | | Generic drugs | | |
| LAMA | | | Long-acting muscarinic antagonist | | |
| Lilly | | | Eli Lilly and Company | | |
| NCEs | | | New Chemical Entities | | |
| NHS | | | National Health Services | | |
| Note Securitization Facility | | | The note securitization facility entered into in August 2023 for borrowings up to $200 million and expiring in August 2024 | | |
| Pending Announced Divestitures | | | The remaining Announced Divestitures that have not been consummated | | |
| Sanofi | | | Sanofi-Aventis U.S., LLC | | |
| SOFR | | | Secured overnight financial rate | | |
| TSA | | | Transition services agreement | | |
| Utah Euro Notes | | | The 2.250% Senior Notes due 2024 and 3.125% Senior Notes due 2028 issued by Utah Acquisition Sub Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan Inc., Viatris Inc. and Mylan II B.V. | | |
An excerpt. Shown here: 40 of 42 rewritten, all 10 added and all 21 removed. The counts are complete. For every sentence, read Cover and table of contents in the FY2024 filing and the FY2023 filing.
Item 1C. Cybersecurity
18 rewritten, 1 added, 1 removed, 16 unchanged
Our internal audit function coordinates cross functionally to [removed: periodically complete] [added: maintain] the Company’s enterprise risk assessment, including the identification of key and emerging risks, and reviews and refreshes this analysis quarterly with executive management.
For each key or emerging risk identified, the Company establishes risk monitoring ownership, [removed: evaluating risk mitigation opportunities and collecting] [added: from which] quarterly updates [added: are collected] for executive management and the Viatris Board’s Compliance and Risk Oversight Committee.
With respect to IT and cybersecurity risks, Viatris maintains an information security program that is aligned with the National Institute of Standards and Technology Cybersecurity [removed: Framework standards,] [added: Framework,] and which is designed to [added: govern,] identify, protect, detect, respond to and recover from cybersecurity threats.
In addition, the delivery of many information security programs relies on IT resources to execute the [added: selection,] delivery and implementation of security solutions, such as end-point protection and end-of-life protocols.
The Company’s Chief Information Security Officer & Head of Global Security, under the direction of the Company’s Chief Compliance Officer, reports quarterly to [removed: the Risk Management Team,] [added: an internal risk committee of senior management,] which includes the CEO, [removed: President,] CFO, [removed: General Counsel,] Chief [removed: Human Relations] [added: Legal] Officer, [removed: Head of] [added: Chief People Officer, Chief] Corporate [removed: Affairs, Regional Presidents,] [added: Affairs Officer,] Chief Information [removed: Officer and] [added: Officer,] Chief Compliance Officer, [added: Chief Quality Officer, Chief Supply Officer, Chief R&D Officer] and [added: Regional Presidents, as well as] the Viatris Board on the progress of the information security program and overall security status.
Viatris’ current Chief Information Security Officer & Head of Global Security has over [removed: 20] [added: 25] years of experience in information security within the pharmaceutical industry.
As part of [removed: this] [added: its information security] program, Viatris has adopted a Cybersecurity Incident Response Plan [removed: (referred to as CIRP)] [added: (CIRP)] to establish a guide for Viatris’ leadership and incident response stakeholders through an “incident” [removed: (a] [added: – a] single event or a set of anomalous and adverse “events” [removed: (for] [added: or, for] purposes of the CIRP, a change in a [removed: system or] [added: system,] technology device [added: or environment] that could impact the confidentiality, integrity, [removed: and] availability [added: or safety] of Viatris’ [removed: data and technology assets)] [added: data, employees or assets,] caused by malicious intent or [removed: by] accident [added: and] impacting Viatris’ network, computing systems, [removed: or] digital [removed: information).][added: information, employees or assets.]
The CIRP is managed by the [added: Viatris global] information security team and is reviewed at least annually.
Viatris tests the CIRP through technical exercises [removed: at least] semi-annually, reviews the CIRP with executive management annually, and periodically conducts executive tabletop exercises/scenarios.
Viatris’ Cybersecurity Incident Response Team [removed: (referred to as CIRT)] [added: (CIRT)] reports to the Chief Information Security Officer & Head of Global Security and has the role of investigating and executing incident protocols.
The CIRT is [removed: generally] responsible for determining the potential impacts to the Company, including severity, notifying appropriate parties pursuant to the CIRP and determining whether to engage a third-party incident response vendor, among other responsibilities.
Critical [added: incidents require implementation of the global crisis plan] and high severity incidents require [removed: the engagement of] [added: notification to] the [removed: senior] [added: executive] leadership [added: team] once such an incident is confirmed.
The Company participates in several industry and third-party threat monitoring and information-sharing services, and these engagements provide insight into vulnerabilities and threats which are incorporated into the security operations [removed: scanning][added: and IT remediation.]
Key aspects of the information security program are also provided by third-party managed security providers, including [removed: but not limited to] first- and second-line support for incident response and the Company’s vulnerability assessment process.
[removed: We conduct initial risk assessments of third-party suppliers and service providers based] on various factors and then review and monitor these third-party suppliers and service providers based on their relative assessed level of risk.
In the event of a severe cybersecurity incident, such as a ransomware attack or other incident that has a severe adverse effect on Viatris’ operations, critical systems or sensitive data, or which may cause severe reputational damage, executive management may determine that [added: it] is necessary to notify the Viatris Board or the Compliance and Risk Oversight Committee about such a cybersecurity incident immediately.
We and our suppliers, partners, customers and vendors have in the past [added: experienced] and will [added: in the future] likely continue to experience cybersecurity threats and incidents, including attacks on and compromises of our systems.
For additional information regarding how cybersecurity threats are reasonably likely to materially affect our business, financial condition, results of operations, cash flows, ability to pay [removed: dividends] [added: dividends, repurchase shares,] and/or stock price, see Part I, Item 1A [removed: “Risk] [added: Risk] Factors – “*We are increasingly dependent on IT and [added: information systems and] our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.”* of this Form 10-K.
We conduct initial risk assessments of third-party suppliers and service providers based
as well as shared with the IT team for remediation.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
11 rewritten, 2 added, 5 removed, 6 unchanged
As of February [removed: 22, 2024,] [added: 21, 2025,] there were approximately [removed: 103,200] [added: 95,287] holders of record of shares of Viatris common stock.
The Company paid quarterly cash dividends of $0.12 per share on the Company’s issued and outstanding common stock on March [removed: 17, 2023,] [added: 18, 2024,] June [removed: 16, 2023,] [added: 14, 2024,] September [removed: 15, 2023] [added: 13, 2024] and December [removed: 15, 2023.][added: 13, 2024.]
On February [removed: 26, 2024,] [added: 24, 2025,] the Company’s Board of Directors declared a quarterly cash dividend of $0.12 per share on the Company’s issued and outstanding common stock, which will be payable on March 18, [removed: 2024] [added: 2025] to shareholders of record as of the close of business on March [removed: 11, 2024.][added: 10, 2025.]
The Company [added: also] paid quarterly cash dividends of $0.12 per share on the Company’s issued and outstanding common stock [removed: on March 16, 2022, June 16, 2022, September 16, 2022] [added: in each of the four quarters of 2023] and [removed: December 16,] 2022.
The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from November 16, 2020 to December 31, [removed: 2023.][added: 2024.]
![Stock Performance Chart JPEG [removed: 2023] [added: 2024] v3.
[removed: jpg.jpg](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/vtrs-20231231_g4.jpg)][added: jpeg.jpg](https://www.sec.gov/Archives/edgar/data/1792044/000179204425000008/vtrs-20241231_g4.jpg)]
| | | | November 16, 2020 | | | | | | December 31, 2020 | | | | | | December 31, 2021 | | | | | | December 31, 2022 | | | | | | December 31, 2023 | | | [added: | | | December 31, 2024 | | |]
| Viatris Inc. | | | 100.00 | | | | | | 119.67 | | | | | | 88.40 | | | | | | 75.78 | | | | | | 77.34 | | | [added: | | | 92.55 | | |]
| S&P 500 | | | 100.00 | | | | | | 115.21 | | | | | | 148.28 | | | | | | 121.43 | | | | | | 153.35 | | | [added: | | | 191.72 | | |]
| Dow Jones U.S. Pharmaceuticals | | | 100.00 | | | | | | 104.70 | | | | | | 130.85 | | | | | | 141.10 | | | | | | 141.08 | | | [added: | | | 152.31 | | |]
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
The Company paid quarterly cash dividends of $0.11 per share on the Company’s issued and outstanding common stock on June 16, 2021, September 16, 2021 and December 16, 2021.
The historical share price data has been revised to reflect updated source information.
The revisions are not significant to previously reported amounts.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
Item 8. Financial Statements And Supplementary Data
731 rewritten, 435 added, 202 removed, 1,249 unchanged
| [Management’s Report on Internal Control over Financial [removed: Reporting](#i0b0d5c23417c472eb84c46f5f45cb005_127)] [added: Reporting](#i294e6e3112ae4c32a7f27a2ec714b350_124)] | | | [removed: [80](#i0b0d5c23417c472eb84c46f5f45cb005_127)] [added: [78](#i294e6e3112ae4c32a7f27a2ec714b350_124)] | | |
| [Reports of Independent Registered Public Accounting [removed: Firm](#i0b0d5c23417c472eb84c46f5f45cb005_130)] [added: Firm](#i294e6e3112ae4c32a7f27a2ec714b350_127)] (PCAOB ID No. 34) | | | [removed: [81](#i0b0d5c23417c472eb84c46f5f45cb005_130)] [added: [79](#i294e6e3112ae4c32a7f27a2ec714b350_127)] | | |
| [Consolidated Balance Sheets as of December 31, [removed: 202](#i0b0d5c23417c472eb84c46f5f45cb005_136)[3](#i0b0d5c23417c472eb84c46f5f45cb005_136) [and 20](#i0b0d5c23417c472eb84c46f5f45cb005_136)[2](#i0b0d5c23417c472eb84c46f5f45cb005_136)[2](#i0b0d5c23417c472eb84c46f5f45cb005_136)] [added: 2024 and 2023](#i294e6e3112ae4c32a7f27a2ec714b350_133)] | | | [removed: [85](#i0b0d5c23417c472eb84c46f5f45cb005_136)] [added: [83](#i294e6e3112ae4c32a7f27a2ec714b350_133)] | | |
| [Consolidated Statements of Operations for the Years Ended December 31, [removed: 202](#i0b0d5c23417c472eb84c46f5f45cb005_139)[3](#i0b0d5c23417c472eb84c46f5f45cb005_139)[, 202](#i0b0d5c23417c472eb84c46f5f45cb005_139)[2](#i0b0d5c23417c472eb84c46f5f45cb005_139) [and 2021](#i0b0d5c23417c472eb84c46f5f45cb005_139)] [added: 2024, 2023 and 2022](#i294e6e3112ae4c32a7f27a2ec714b350_139)] | | | [removed: [86](#i0b0d5c23417c472eb84c46f5f45cb005_139)] [added: [84](#i294e6e3112ae4c32a7f27a2ec714b350_139)] | | |
| [Consolidated Statements of [removed: Comprehensive Earnings (Loss) for] [added: Comprehensive](#i294e6e3112ae4c32a7f27a2ec714b350_142) [(Loss)](#i294e6e3112ae4c32a7f27a2ec714b350_142) [Earnings](#i294e6e3112ae4c32a7f27a2ec714b350_142) [for] the Years Ended December 31, [removed: 202](#i0b0d5c23417c472eb84c46f5f45cb005_142)[3](#i0b0d5c23417c472eb84c46f5f45cb005_142)[, 202](#i0b0d5c23417c472eb84c46f5f45cb005_142)[2](#i0b0d5c23417c472eb84c46f5f45cb005_142) [and 20](#i0b0d5c23417c472eb84c46f5f45cb005_142)[21](#i0b0d5c23417c472eb84c46f5f45cb005_142)] [added: 2024, 2023 and 2022](#i294e6e3112ae4c32a7f27a2ec714b350_142)] | | | [removed: [87](#i0b0d5c23417c472eb84c46f5f45cb005_142)] [added: [85](#i294e6e3112ae4c32a7f27a2ec714b350_142)] | | |
| [Consolidated Statements of Equity for the Years Ended December 31, [removed: 202](#i0b0d5c23417c472eb84c46f5f45cb005_145)[3](#i0b0d5c23417c472eb84c46f5f45cb005_145)[, 202](#i0b0d5c23417c472eb84c46f5f45cb005_145)[2](#i0b0d5c23417c472eb84c46f5f45cb005_145) [and 20](#i0b0d5c23417c472eb84c46f5f45cb005_145)[21](#i0b0d5c23417c472eb84c46f5f45cb005_145)] [added: 2024, 2023 and 2022](#i294e6e3112ae4c32a7f27a2ec714b350_145)] | | | [removed: [88](#i0b0d5c23417c472eb84c46f5f45cb005_145)] [added: [86](#i294e6e3112ae4c32a7f27a2ec714b350_145)] | | |
| [Consolidated Statements of Cash Flows for the Years Ended December 31, [removed: 202](#i0b0d5c23417c472eb84c46f5f45cb005_148)[3](#i0b0d5c23417c472eb84c46f5f45cb005_148)[, 202](#i0b0d5c23417c472eb84c46f5f45cb005_148)[2](#i0b0d5c23417c472eb84c46f5f45cb005_148) [and 20](#i0b0d5c23417c472eb84c46f5f45cb005_148)[21](#i0b0d5c23417c472eb84c46f5f45cb005_148)] [added: 2024, 2023 and 2022](#i294e6e3112ae4c32a7f27a2ec714b350_148)] | | | [removed: [89](#i0b0d5c23417c472eb84c46f5f45cb005_148)] [added: [87](#i294e6e3112ae4c32a7f27a2ec714b350_148)] | | |
| [Notes to Consolidated Financial [removed: Statements](#i0b0d5c23417c472eb84c46f5f45cb005_151)] [added: Statements](#i294e6e3112ae4c32a7f27a2ec714b350_151)] | | | [removed: [90](#i0b0d5c23417c472eb84c46f5f45cb005_151)] [added: [88](#i294e6e3112ae4c32a7f27a2ec714b350_151)] | | |
As a result of this assessment, management has concluded that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2023] [added: 2024] based on the criteria in *Internal Control - Integrated Framework (2013)* issued by COSO.
Deloitte & Touche LLP’s opinion on the Company’s internal control over financial reporting appears on page [removed: 84] [added: 82] of this Annual Report on Form 10-K.
We have audited the accompanying consolidated balance sheets of Viatris Inc. and subsidiaries (the "Company") as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] the related consolidated statements of operations, comprehensive [removed: earnings (loss),] [added: (loss) earnings,] equity, and cash flows, for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] and the related notes and the schedule listed in the Index at Item 15 (collectively referred to as the "financial statements").
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] in conformity with accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in *Internal Control — Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February [removed: 28, 2024,] [added: 27, 2025,] expressed an unqualified opinion on the Company's internal control over financial reporting.
Goodwill – Viatris Inc. [removed: Europe, JANZ,] [added: Europe] and [removed: Emerging Markets] [added: JANZ] Reporting Units – Refer to Note 8 to the financial statements.
The Company performed an annual goodwill impairment test as of April 1, [removed: 2023.][added: 2024.]
As of April 1, [removed: 2023,] [added: 2024,] the Company had approximately [removed: $10.6] [added: $9.7] billion of consolidated goodwill, [removed: $4.47 billion, $1.34] [added: $3.86] billion and [removed: $0.68] [added: $0.62] billion of which was allocated to its [removed: Europe, Emerging Markets] [added: Europe] and JANZ reporting units, respectively.
The Company performed its valuation analysis, using an income-based approach, to determine the fair value of its [removed: Europe, Emerging Markets] [added: Europe] and JANZ reporting units.
Given that the [removed: Europe, Emerging Markets,] [added: Europe] and JANZ reporting unit’s revenues are sensitive to changes in consumer demand, the approval of new product launches, the expansion of existing products into new jurisdictions (which have differentiated distribution and commercialization models throughout the regions), and the impact of business development activity, auditing management’s judgments regarding forecasts of future revenues, and the selection of the discount rates and terminal growth rates required a high degree of auditor judgment and an increased extent of effort, including the need to involve our fair value specialists.
Our audit procedures related to the forecasts of future revenues (“forecasts”), and the selection of the discount rates and terminal growth rates for the [removed: Europe, Emerging Markets,] [added: Europe] and the JANZ reporting units included the following procedures, among others:
- We evaluated management’s ability to accurately forecast future revenues of the [removed: Europe, Emerging Markets,] [added: Europe] and JANZ reporting units by comparing actual results to management’s historical forecasts.
The returns reserve at [removed: MPI] [added: Mylan Pharmaceuticals Inc. (MPI)] represents a significant component of the global sales returns reserve as of December 31, [removed: 2023.][added: 2024.]
We have audited the internal control over financial reporting of Viatris, Inc. and subsidiaries (the “Company”) as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in *Internal Control - Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in *Internal Control - Integrated Framework (2013)* issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, [removed: 2023,] [added: 2024,] of the Company and our report dated February [removed: 28, 2024,] [added: 27, 2025,] expressed an unqualified opinion on those financial statements.
| [added: (In millions)] | | | December 31, [added: 2024 | | | | | | December 31,] 2023 | | | | | | December 31, 2022 | | |
| Cash and cash equivalents | | | $ | [added: 734.8 | | | | | $ |] 991.9 | | | | | $ | 1,259.9 | |
| Accounts receivable, net | | | [removed: 3,700.4] [added: 3,221.3] | | | | | | [removed: 3,814.5] [added: 3,700.4] | | |
| Inventories | | | [removed: 3,469.7] [added: 3,854.1] | | | | | | [removed: 3,519.5] [added: 3,469.7] | | |
| Prepaid expenses and other current assets | | | [removed: 2,028.1] [added: 1,710.5] | | | | | | [removed: 1,811.2] [added: 2,028.1] | | |
| Assets held for sale | | | [removed: 2,786.0] [added: —] | | | | | | [removed: 230.3] [added: 2,786.0] | | |
| Total current assets | | | [removed: 12,976.1] [added: 9,520.7] | | | | | | [removed: 10,635.4] [added: 12,976.1] | | |
| Property, plant and equipment, net | | | [removed: 2,759.6] [added: 2,666.1] | | | | | | [removed: 3,024.5] [added: 2,759.6] | | |
| Intangible assets, net | | | [removed: 19,181.1] [added: 17,070.9] | | | | | | [removed: 22,607.1] [added: 19,181.1] | | |
| Goodwill | | | [removed: 9,867.1] [added: 9,133.3] | | | | | | [removed: 10,425.8] [added: 9,867.1] | | |
| Deferred income tax benefit | | | [removed: 692.9] [added: 753.0] | | | | | | [removed: 925.9] [added: 692.9] | | |
| Other assets | | | [removed: 2,208.7] [added: 2,356.9] | | | | | | [removed: 2,403.5] [added: 2,208.7] | | |
| Total assets | | | $ | [removed: 47,685.5] [added: 41,500.9] | | | | | $ | [removed: 50,022.2] [added: 47,685.5] | |
| Accounts payable | | | $ | [removed: 1,938.2] [added: 1,853.7] | | | | | $ | [removed: 1,766.6] [added: 1,938.2] | |
| Income taxes payable | | | [removed: 226.8] [added: 192.7] | | | | | | [removed: 279.6] [added: 226.8] | | |
| Current portion of long-term debt and other long-term obligations | | | [removed: 1,943.4] [added: 8.3] | | | | | | [removed: 1,259.1] [added: 1,943.4] | | |
The fair value of the Europe reporting unit exceeded its carrying value by approximately $0.88 billion, or 7.9% as of April 1, 2024.
The Company recorded a goodwill impairment charge of $321.0 million during the second quarter related to the JANZ reporting
unit.
February 27, 2025
February 27, 2025
| | | | 19,139.8 | | | | | | 20,719.2 | | |
| Issuance of restricted stock and stock options exercised, net | | | 11,918,687 | | | | | | 0.1 | | | | | | 10.6 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | 10.7 | | | | | |
| Common stock repurchase | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 19,244,142 | | | | | | (252.5) | | | | | | — | | | | | | | | | | | | (252.5) | | | | | |
| Issuance of common stock | | | 218,313 | | | | | | — | | | | | | 2.5 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | 2.5 | | | | | |
| Balance at December 31, 2024 | | | 1,234,131,491 | | | | | | $ | 12.3 | | | | | $ | 18,921.6 | | | | | $ | 3,418.8 | | | | | 40,483,663 | | | | | | $ | (504.3) | | | | | $ | (3,212.9) | | | | | | | | | | | $ | 18,635.5 | | | | |
| Net (loss) earnings | | | $ | (634.2) | | | | | $ | 54.7 | | | | | $ | 2,078.6 | |
| Acquired IPR&D | | | 12.3 | | | | | | 100.4 | | | | | | 46.4 | | |
| Purchases of IPR&D | | | (12.3) | | | | | | (100.4) | | | | | | (46.4) | | |
Viatris is a global healthcare company whose breadth and scale we believe make it uniquely positioned to address healthcare needs globally.
The Company operates in more than 165 countries and territories with approximately 32,000 employees.
The Company has 26 manufacturing and packaging sites worldwide, more than 1,400 approved molecules, and industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise.
Viatris’ portfolio consists of generics (including complex products), globally recognized iconic brands, and an expanding portfolio of innovative medicines.
Beginning in 2024, upfront and milestone payments related to externally developed IPR&D projects acquired directly in a transaction other than a business combination, which were previously included in cash flows from operating activities in the consolidated statements of cash flows, are now classified as cash flows from investing activities.
The adjustments resulted in an increase to net cash provided by operating activities and an increase to net cash used in investing activities of $100.4 million for the year ended December 31, 2023, and in an increase to net cash provided by operating activities and a decrease to net cash provided by investing activities of $46.4 million for the year ended December 31, 2022.
Effective October 1, 2024, we classified Egypt as highly inflationary and began to utilize the U.S. dollar as our functional currency in Egypt, which historically utilized the Egyptian pound as the functional currency.
| Net (loss) earnings attributable to Viatris Inc. common shareholders | | | $ | (634.2) | | | | | $ | 54.7 | | | | | $ | 2,078.6 | |
| Weighted average shares outstanding | | | 1,193.3 | | | | | | 1,200.3 | | | | | | 1,212.1 | | |
ASU
The standard requires retrospective application to all prior periods presented.
Refer to Note 15 *Segment Information* for additional information.
In March 2024, the SEC adopted final rules under SEC Release No. 34-99678 and No. 33-11275, “The Enhancement and Standardization of Climate-Related Disclosures for Investors” (the “Final Rules”), which will require registrants to provide certain climate-related information in their registration statements and annual reports.
The Final Rules require, among other things, disclosure in the notes to the audited financial statements of the effects of severe weather events and other natural conditions, subject to certain thresholds, as well as amounts related to carbon offsets and renewable energy credits or certificates in certain circumstances.
The Final Rules will also require disclosure outside of the financial statements of material scope 1 and scope 2 greenhouse gas emissions, among other climate-related disclosures.
In April 2024, the SEC stayed the effectiveness of the Final Rules and the timing of the effectiveness of these disclosure requirements remains uncertain.
Prior to the effectiveness of the Final Rules being stayed, the disclosure requirements of the Final Rules were scheduled to begin phasing in for the Company for fiscal year 2025.
The Company is currently monitoring the status of the Final Rules and assessing their impact on its consolidated financial statement disclosures.
In November 2024, the FASB issued ASU 2024-03, *Disaggregation of Income Statement Expenses*, which requires entities to disclose specified information about certain costs and expenses, including amounts of purchases of inventory, employee compensation, depreciation, and intangible asset amortization.
The Company is currently assessing the impact of the adoption of this guidance on its consolidated financial statement disclosures.
| Brands | | | 4,731.6 | | | | | | 2,156.7 | | | | | | 744.2 | | | | | | 1,567.8 | | | | | | 9,200.3 | | |
| Generics | | | 4,197.8 | | | | | | 9.8 | | | | | | 602.0 | | | | | | 682.9 | | | | | | 5,492.5 | | |
| Total Viatris | | | $ | 8,929.4 | | | | | $ | 2,166.5 | | | | | $ | 1,346.2 | | | | | $ | 2,250.7 | | | | | $ | 14,692.8 | |
(b)Amounts reflected in the above tables include net sales attributable to divested businesses until the date of disposition.
| Net sales | | | $ | 14,692.8 | | | | | $ | 15,388.4 | | | | | $ | 16,218.1 | |
(a)Amounts reflected in the above table include net sales attributable to divested businesses until the date of disposition.
| Chargebacks | | | $ | 530.3 | | | | | $ | 5,008.7 | | | | | | | | | | | $ | (5,043.6) | | | | | $ | (1.5) | | | | | $ | 493.9 | |
The fair values of the Europe, Emerging Markets and the JANZ reporting units
exceeded their carrying values by approximately $0.54 billion, or 3.9%, $0.51 billion, or 7.7%, and $0.15 billion, or 5.5%, respectively, as of April 1, 2023 and, therefore, no impairments were recognized.
February 28, 2024
| | | | 20,719.2 | | | | | | 21,072.3 | | |
| Balance at December 31, 2020 | | | 1,206,895,644 | | | | | | $ | 12.1 | | | | | $ | 18,438.8 | | | | | $ | 5,361.2 | | | | | — | | | | | | $ | — | | | | | $ | (858.0) | | | | | | | | | | | $ | 22,954.1 | | | | |
| Issuance of restricted stock, net | | | 2,611,819 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | — | | | | | |
| Loss from equity method investments | | | — | | | | | | — | | | | | | 61.9 | | |
Viatris is a global healthcare company which we believe is uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.
As of December 31, 2023, Viatris’ portfolio comprised more than 1,400 approved molecules across a wide range of key therapeutic areas, including globally recognized iconic and key brands and generics, including complex products, and the Company operated approximately 40 manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs.
Investments in equity method affiliates are recorded at cost and adjusted for the Company’s share of the affiliates’ cumulative results of operations, capital contributions and distributions.
Investments in entities are accounted for using the equity method of accounting when the ability to exercise significant influence over the operating and financial decisions of the investee is maintained.
The Company paid quarterly cash dividends of $0.11 per share on the Company’s issued and outstanding common stock on June 16, 2021, September 16, 2021, and December 16, 2021.
On May 6, 2022, the Company announced that its Board of Directors had authorized a DRIP.
In February 2024, the Company repurchased approximately 19.2 million shares of common stock at a cost of approximately $250 million.
In September 2022, the FASB issued ASU 2022-04, *Liabilities—Supplier Finance Programs (Subtopic 405-50),* which requires entities to provide qualitative and quantitative disclosures about their supplier finance programs, including a rollforward of related obligations.
We adopted this ASU effective January 1, 2023, with the exception of the amendment on rollforward information, which will be adopted in our fiscal year beginning on January 1, 2024 as set forth in ASU 2022-04.
In October 2021, the FASB issued Accounting Standards Update 2021-08, *Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers*, which requires entities (acquirers) to recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC Topic 606.
Entities can apply the provisions of ASU 2020-04 immediately, as applicable, and generally the provisions of the guidance are available through December 31, 2024 as entities transition away from reference rates that are expected to be discontinued.
| Brands | | | 5,759.2 | | | | | | 2,207.8 | | | | | | 1,197.1 | | | | | | 1,677.2 | | | | | | 10,841.3 | | |
| Generics | | | 4,669.5 | | | | | | 5.0 | | | | | | 830.3 | | | | | | 1,467.5 | | | | | | 6,972.3 | | |
| Total Viatris | | | $ | 10,428.7 | | | | | $ | 2,212.8 | | | | | $ | 2,027.4 | | | | | $ | 3,144.7 | | | | | $ | 17,813.6 | |
(b)Amounts for the years ended December 31, 2022 and 2021 include approximately $601.1 million and $607.3 million, respectively, related to the biosimilars business which was contributed to Biocon Biologics in November 2022.
The Company has not recognized the results of the biosimilars business in its consolidated financial statements subsequent to November 29, 2022.
(c)As a result of the contribution of the biosimilars business to Biocon Biologics in November 2022, *Complex Gx and Biosimilars*, which were previously presented as a separate line item, are now included within *Generics.* Reclassifications were made to prior periods to conform to the current period presentation.
(a)Amounts for the years ended December 31, 2022 and 2021 include the biosimilars business which was contributed to Biocon Biologics in November 2022.
| Chargebacks | | | $ | 523.4 | | | | | $ | 5,457.9 | | | | | $ | (8.1) | | | | | $ | (5,443.6) | | | | | $ | 0.7 | | | | | $ | 530.3 | |
| Returns | | | 513.4 | | | | | | 223.2 | | | | | | (26.2) | | | | | | (286.8) | | | | | | 1.8 | | | | | | 425.4 | | |
| Governmental rebate programs | | | 366.5 | | | | | | 766.0 | | | | | | 8.7 | | | | | | (726.3) | | | | | | 6.4 | | | | | | 421.3 | | |
| Total | | | $ | 2,687.5 | | | | | $ | 10,304.7 | | | | | $ | (5.0) | | | | | $ | (10,528.0) | | | | | $ | 20.7 | | | | | $ | 2,479.9 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
The acquired IPR&D projects are in various stages of completion and the estimated costs to complete these projects total approximately $120 million, which are expected to be incurred through 2024.
Idorsia
The closing of the transaction is subject to certain closing conditions.
The transaction to divest the Company’s rights to two women’s healthcare products in certain countries (other than in the U.K., which remains subject to regulatory approval) closed in December 2023.
We currently expect the OTC Transaction to close by mid-year 2024.
The transactions that have not yet closed remain subject to regulatory approvals, receipt of required consents and other closing conditions, including, in the case of the API business divestiture, a financing condition.
Under the terms of the agreements, Viatris expects to receive gross proceeds of up to approximately $2.17 billion for the OTC Business and up to approximately $1.4 billion for the remaining divestitures.
Upon closing of the divestitures of the women’s healthcare and API businesses, the Company expects to record gains for the differences between the expected consideration to be received and the carrying values of the businesses to be divested.
provide a framework for our relationship with the respective buyers after the closing of the divestitures, including TSAs, manufacturing and supply agreements, and distribution agreements, as necessary.
Viatris expects to consummate the divestiture of its women’s healthcare business by the end of the first quarter of 2024, subject to the satisfaction of certain closing conditions.
An excerpt. Shown here: 40 of 731 rewritten, 40 of 435 added and 40 of 202 removed. The counts are complete. For every sentence, read Item 8. Financial Statements And Supplementary Data in the FY2024 filing and the FY2023 filing.
Item 9A. Controls and Procedures
4 rewritten, 0 added, 0 removed, 1 unchanged
An evaluation was performed under the supervision and with the participation of the Company’s management, including the Principal Executive Officer and the Principal Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of December 31, [removed: 2023.][added: 2024.]
Management has not identified any changes in the Company’s internal control over financial reporting (“ICFR”) that occurred during the fourth quarter of [removed: 2023] [added: 2024] that have materially affected, or are reasonably likely to materially affect, the Company’s ICFR.
Management’s Report on ICFR is on page [removed: 80,] [added: 78,] which is incorporated herein by reference.
The effectiveness of the Company’s ICFR as of December 31, [removed: 2023] [added: 2024] has been audited by Deloitte & Touche LLP (PCAOB ID No. 34), an independent registered public accounting firm, as stated in their report on page [removed: 84,] [added: 82,] which is incorporated herein by reference.
Item 9B. Other Information
0 rewritten, 1 added, 2 removed, 1 unchanged
During the three months ended December 31, 2024, no director or “officer” of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.
On November 28, 2023, JoEllen Lyons Dillon, a director of the Company, adopted a written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act.
The plan provides for the sale of up to 20,000 shares of the Company’s common stock until all such shares are sold or March 4, 2025, whichever comes first.
Item 10. Directors, Executive Officers and Corporate Governance
0 rewritten, 3 added, 0 removed, 5 unchanged
*Insider Trading Policies and Procedures*
We have adopted a Global Insider Trading Policy and Insider Trading Policy Additional Procedures governing the purchase, sale, and/or other dispositions of our securities by our directors, officers, and employees, as well as by Viatris itself, that we believe are reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to us.
A copy of our Global Insider Trading Policy and Insider Trading Policy Additional Procedures is filed as Exhibit 19 to this Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
1 rewritten, 2 added, 2 removed, 7 unchanged
The following table shows information about the securities authorized for issuance under Viatris’ equity compensation plans as of December 31, [removed: 2023:][added: 2024:]
| Equity compensation plans approved by security holders | | | 32,434,720 | | | | | | $ | 14.02 | | | | | 67,843,687 | | |
| Total | | | 32,434,720 | | | | | | $ | 14.02 | | | | | 67,843,687 | | |
| Equity compensation plans approved by security holders | | | 35,256,116 | | | | | | $ | 14.29 | | | | | 29,265,309 | | |
| Total | | | 35,256,116 | | | | | | $ | 14.29 | | | | | 29,265,309 | | |
Item 15. Exhibits, Consolidated Financial Statement Schedules
119 rewritten, 7 added, 13 removed, 86 unchanged
| [removed: [2.1(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520212083/d159300dex991.htm#toc781435_29)] [added: [2.1(a)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520212083/d159300dex991.htm#toc781435_29)] | | | | | | Business Combination Agreement, dated as of July 29, 2019, by and among Pfizer Inc., Upjohn Inc., Utah Acquisition Sub Inc., Mylan N.V., Mylan I B.V. and Mylan II B.V., included as Annex A to the Information Statement included as Exhibit 99.1 to the Report on Form 8-K filed by Upjohn Inc. with the SEC on August 6, 2020, and incorporated herein by reference.^ | | |
| [removed: [2.1(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520157465/d904458dex21.htm)] [added: [2.1(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520157465/d904458dex21.htm)] | | | | | | Amendment No. 1, dated as of May 29, 2020, to the Business Combination Agreement, dated as of July 29, 2019, by and among Pfizer Inc., Upjohn Inc., Utah Acquisition Sub Inc., Mylan N.V., Mylan I B.V. and Mylan II B.V., included as Annex B to the Information Statement included as Exhibit 99.1 to the Report on Form 8-K filed by Upjohn Inc. with the SEC on August 6, 2020, and incorporated herein by reference.^ | | |
| [removed: [2.2(a)](http://www.sec.gov/Archives/edgar/data/0001623613/000119312519205031/d775236dex22.htm)] [added: [2.2(a)](https://www.sec.gov/Archives/edgar/data/0001623613/000119312519205031/d775236dex22.htm)] | | | | | | Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., filed as Exhibit 2.2 to the Report on Form 8-K filed by Mylan N.V. with the SEC on July 29, 2019, and incorporated herein by reference.^ | | |
| [removed: [2.2(b)](http://www.sec.gov/Archives/edgar/data/0001623613/000162361320000018/mylex2120200331-10q.htm)] [added: [2.2(b)](https://www.sec.gov/Archives/edgar/data/0001623613/000162361320000018/mylex2120200331-10q.htm)] | | | | | | Amendment No. 1, dated as of February 18, 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., filed by Mylan N.V. as Exhibit 2.1 to Form 10-Q for the quarter ended March 31, 2020, and incorporated herein by reference. | | |
| [removed: [2.2(c)](http://www.sec.gov/Archives/edgar/data/0001623613/000119312520157416/d830428dex22.htm)] [added: [2.2(c)](https://www.sec.gov/Archives/edgar/data/0001623613/000119312520157416/d830428dex22.htm)] | | | | | | Amendment No. 2, dated as of May 29, 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., filed as Exhibit 2.2 to the Report on Form 8-K filed by Mylan N.V. with the SEC on June 1, 2020, and incorporated herein by [removed: reference. ^] [added: reference.^] | | |
| [removed: [2.2(d)](http://www.sec.gov/Archives/edgar/data/0001792044/000119312520298226/d56774dex26.htm)] [added: [2.2(d)](https://www.sec.gov/Archives/edgar/data/0001792044/000119312520298226/d56774dex26.htm)] | | | | | | Amendment No. 3, dated as of September 18, 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., filed as Exhibit 2.6 to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by [removed: reference. ^] [added: reference.^] | | |
| [removed: [2.2(e)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex27.htm)] [added: [2.2(e)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex27.htm)] | | | | | | Amendment No. 4, dated as of November 15, 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., filed as Exhibit 2.7 to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by [removed: reference. ^] [added: reference.^] | | |
| [removed: [2.3(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312522058054/d265304dex21.htm)] [added: [2.3(a)](https://www.sec.gov/Archives/edgar/data/1792044/000119312522058054/d265304dex21.htm)] | | | | | | Transaction Agreement, dated as of February 27, 2022, by and among Biocon Biologics Limited and Viatris Inc., filed as Exhibit 2.1 to the Report on Form 8-K filed by Viatris Inc. with the SEC on February 28, 2022, and incorporated herein by reference.^ | | |
| [removed: [2.3(b)](http://www.sec.gov/Archives/edgar/data/1792044/000095015722001253/ex2-1.htm)] [added: [2.3(b)](https://www.sec.gov/Archives/edgar/data/1792044/000095015722001253/ex2-1.htm)] | | | | | | Amendment No. 1 to Transaction Agreement, dated as of November 28, 2022, by and between Biocon Biologics Limited and Viatris Inc., filed as Exhibit 2.1 to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 29, 2022, and incorporated herein by reference.^ | | |
| [removed: [2.3(c)](http://www.sec.gov/Archives/edgar/data/1792044/000179204423000024/ex_21xvtrsx20230630.htm)] [added: [2.3(c)](https://www.sec.gov/Archives/edgar/data/1792044/000179204423000024/ex_21xvtrsx20230630.htm)] | | | | | | Omnibus Amendment No. 1, effective as of May 17, 2023, by and among Viatris Inc., Biocon Biologics UK Limited, Biosimilar Collaborations Ireland Limited, Biosimilars Newco Limited, and Biocon Biologics Limited, filed by Viatris Inc. as Exhibit 2.1 to Form 10-Q for the quarter ended June 30, 2023, and incorporated herein by reference. | | |
| [removed: [2.3(d)](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_23dxvtrsx10-kx12312023.htm)] [added: [2.3(e)](https://www.sec.gov/Archives/edgar/data/1792044/000179204425000008/ex_23exvtrsx20241231.htm)] | | | | | | Omnibus Amendment No. [removed: 2,] [added: 3,] effective as of December [removed: 19, 2023,] [added: 24, 2024,] by and among Viatris Inc., Biocon Biologics UK Limited, [added: Biosimilar Collaborations Ireland Limited,] Biosimilars Newco Limited, and Biocon Biologics Limited.^ | | |
| [removed: [2.4(a)](http://www.sec.gov/Archives/edgar/data/1792044/000179204423000033/ex_21xvtrsx20230930.htm)] [added: [2.4(a)](https://www.sec.gov/Archives/edgar/data/1792044/000179204423000033/ex_21xvtrsx20230930.htm)] | | | | | | Put Option Agreement, dated October 1, 2023, between Cooper Consumer Health SAS and Viatris Inc., filed by Viatris Inc. as Exhibit 2.1 to Form 10-Q for the quarter ended September 30, 2023, and incorporated herein by reference.^ | | |
| [removed: [2.4(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312524019472/d619190dex21.htm)] [added: [2.4(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312524019472/d619190dex21.htm)] | | | | | | Transaction Agreement, dated as of January 29, 2024, by and among Cooper Consumer Health SAS, Cooper Consumer Health IT S.r.l., Viatris Inc., Viatris Italia S.r.l. and Ipex AB, filed [removed: by Viatris Inc.] as Exhibit 2.1 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on January 30, 2024, and [removed: incorporate] [added: incorporated] herein by reference. ^ | | |
| [removed: [3.1(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex31.htm)] [added: [3.1(a)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex31.htm)] | | | | | | Amended and Restated Certificate of Incorporation of Upjohn Inc., effective as of November 13, 2020, filed as Exhibit 3.1 to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [removed: [3.1(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex33.htm)] [added: [3.1(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex33.htm)] | | | | | | Certificate of Amendment of Amended and Restated Certificate of Incorporation of Upjohn Inc., effective as of November 16, 2020, filed as Exhibit 3.3 to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [3.1(c)](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_31cxvtrsx20231231x10-k.htm) | | | | | | Certificate of Amendment of Amended and Restated Certificate of Incorporation of Viatris Inc., effective as of December 15, [removed: 2023.] [added: 2023, filed by Viatris Inc. as Exhibit 3.1(c) to Form 10-K for the fiscal year ended December 31, 2023, and incorporated herein by reference.] | | |
| [3.1(d)](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_31dxvtrsx20231231x10-k.htm) | | | | | | Certificate of Amendment of Amended and Restated Certificate of Incorporation of Viatris Inc., effective as of December 15, [removed: 2023.] [added: 2023, filed by Viatris Inc. as Exhibit 3.1(d) to Form 10-K for the fiscal year ended December 31, 2023, and incorporated herein by reference.] | | |
| [removed: [3.2](http://www.sec.gov/Archives/edgar/data/1792044/000119312523296654/d662898dex31.htm)] [added: [3.2](https://www.sec.gov/Archives/edgar/data/1792044/000119312523296654/d662898dex31.htm)] | | | | | | Amended and Restated Bylaws of Viatris Inc., effective as of December 15, 2023, filed as Exhibit 3.1 to the Report on Form 8-K filed by Viatris Inc. with the SEC on December 15, 2023, and incorporated herein by reference. | | |
| [removed: [4.1(a)](http://www.sec.gov/Archives/edgar/data/69499/000006949912000042/exhibit_41xindenture.htm)] [added: [4.1(a)](https://www.sec.gov/Archives/edgar/data/69499/000006949912000042/exhibit_41xindenture.htm)] | | | | | | Indenture, dated December 21, 2012, between and among Mylan Inc., as issuer, the guarantors named therein, and The Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K filed by Mylan Inc. with the SEC on December 24, 2012, and incorporated herein by reference. | | |
| [removed: [4.1(b)](http://www.sec.gov/Archives/edgar/data/1623613/000119312515068819/d882101dex44.htm)] [added: [4.1(b)](https://www.sec.gov/Archives/edgar/data/1623613/000119312515068819/d882101dex44.htm)] | | | | | | First Supplemental Indenture, dated February 27, 2015, between and among Mylan Inc., as issuer, Mylan N.V., as guarantor, and The Bank of New York Mellon, as trustee, to the Indenture, dated December 21, 2012, filed as Exhibit 4.4 to the Report on Form 8-K filed by Mylan N.V. with the SEC on February 27, 2015, and incorporated herein by reference. | | |
| [removed: [4.1(c)](http://www.sec.gov/Archives/edgar/data/1623613/000162361315000009/myl_ex43bx20150331-10q.htm)] [added: [4.1(c)](https://www.sec.gov/Archives/edgar/data/1623613/000162361315000009/myl_ex43bx20150331-10q.htm)] | | | | | | Second Supplemental Indenture, dated March 12, 2015, between and among Mylan Inc., as issuer, Mylan N.V., as parent, and The Bank of New York Mellon, as trustee, to the Indenture, dated December 21, 2012, filed by Mylan N.V. as Exhibit 4.3(b) to Form 10-Q for the quarter ended March 31, 2015, and incorporated herein by reference. | | |
| [removed: [4.1(d)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex46.htm)] [added: [4.1(d)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex46.htm)] | | | | | | Third Supplemental Indenture dated November 16, 2020, by and among Mylan Inc., Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V. and the Bank of New York Mellon, as trustee, to the Indenture dated December 21, 2012, by and between Mylan Inc. and the Bank of New York Mellon, as trustee, filed as Exhibit 4.6 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [removed: [4.2(a)](http://www.sec.gov/Archives/edgar/data/69499/000110465913087739/a13-20314_5ex4d1.htm)] [added: [4.2(a)](https://www.sec.gov/Archives/edgar/data/69499/000110465913087739/a13-20314_5ex4d1.htm)] | | | | | | Indenture, dated November 29, 2013, between Mylan Inc. and The Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K filed by Mylan Inc. with the SEC on November 29, 2013, and incorporated herein by reference. | | |
| [removed: [4.2(b)](http://www.sec.gov/Archives/edgar/data/69499/000110465913087739/a13-20314_5ex4d2.htm)] [added: [4.2(b)](https://www.sec.gov/Archives/edgar/data/69499/000110465913087739/a13-20314_5ex4d2.htm)] | | | | | | First Supplemental Indenture, dated November 29, 2013, between Mylan Inc. and The Bank of New York Mellon, as trustee, filed as Exhibit 4.2 to the Report on Form 8-K filed by Mylan Inc. with the SEC on November 29, 2013, and incorporated herein by reference. | | |
| [removed: [4.2(c)](http://www.sec.gov/Archives/edgar/data/1623613/000119312515068819/d882101dex46.htm)] [added: [4.2(c)](https://www.sec.gov/Archives/edgar/data/1623613/000119312515068819/d882101dex46.htm)] | | | | | | Second Supplemental Indenture, dated February 27, 2015, among Mylan Inc., as issuer, Mylan N.V., as guarantor, and The Bank of New York Mellon, as trustee, to the Indenture, dated November 29, 2013, filed as Exhibit 4.6 to the Report on Form 8-K filed by Mylan N.V. with the SEC on February 27, 2015, and incorporated herein by reference. | | |
| [removed: [4.2(d)](http://www.sec.gov/Archives/edgar/data/1623613/000162361315000009/myl_ex45bx20150331-10q.htm)] [added: [4.2(d)](https://www.sec.gov/Archives/edgar/data/1623613/000162361315000009/myl_ex45bx20150331-10q.htm)] | | | | | | Third Supplemental Indenture, dated March 12, 2015, between and among Mylan Inc., as issuer, Mylan N.V., as parent, and The Bank of New York Mellon, as trustee, to the Indenture, dated November 29, 2013, filed by Mylan N.V. as Exhibit 4.5(b) to Form 10-Q for the quarter ended March 31, 2015, and incorporated herein by reference. | | |
| [removed: [4.2(e)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex47.htm)] [added: [4.2(e)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex47.htm)] | | | | | | Fourth Supplemental Indenture dated November 16, 2020, by and among Mylan Inc., Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V. and the Bank of New York Mellon, as trustee, to the Indenture dated November 29, 2013, by and between Mylan Inc. and the Bank of New York Mellon, as trustee, filed as Exhibit 4.7 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [removed: [4.3(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312516622620/d207286dex41.htm)] [added: [4.3(a)](https://www.sec.gov/Archives/edgar/data/1623613/000119312516622620/d207286dex41.htm)] | | | | | | Indenture, dated as of June 9, 2016, among Mylan N.V., as issuer, Mylan Inc., as guarantor, and The Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K filed by Mylan N.V. with the SEC on June 15, 2016, and incorporated herein by reference. | | |
| [removed: [4.3(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex44.htm)] [added: [4.3(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex44.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and the Bank of New York Mellon, as trustee, to the Indenture dated June 9, 2016, by and among Mylan N.V., Mylan Inc. and the Bank of New York Mellon, as trustee, filed as Exhibit 4.4 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [removed: [4.4(a)](http://www.sec.gov/Archives/edgar/data/1623613/000162361317000007/exhibit49.htm)] [added: [4.4(a)](https://www.sec.gov/Archives/edgar/data/1623613/000162361317000007/exhibit49.htm)] | | | | | | Indenture, dated November 22, 2016, among Mylan N.V., as issuer, Mylan, Inc., as guarantor and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, registrar and calculation agent, filed by Mylan N.V. as Exhibit 4.9 to Form 10-K for the fiscal year ended December 31, 2016, and incorporated herein by reference. | | |
| [removed: [4.4(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex45.htm)] [added: [4.4(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex45.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, and registrar, to the Indenture dated November 22, 2016, by and among Mylan N.V., Mylan Inc. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, registrar and calculation agent, filed as Exhibit 4.5 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [removed: [4.5(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312518111603/d560332dex41.htm)] [added: [4.5(a)](https://www.sec.gov/Archives/edgar/data/1623613/000119312518111603/d560332dex41.htm)] | | | | | | Indenture, dated as of April 9, 2018, among Mylan Inc., as issuer, Mylan N.V., as guarantor, and the Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K filed by Mylan N.V. with the SEC on April 9, 2018, and incorporated herein by reference. | | |
| [removed: [4.5(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex48.htm)] [added: [4.5(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex48.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Mylan Inc., Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V. and the Bank of New York Mellon, as trustee, to the Indenture dated April 9, 2018, by and among Mylan Inc., Mylan N.V. and the Bank of New York Mellon, as trustee, filed as Exhibit 4.8 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [removed: [4.6(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312518172116/d566535dex41.htm)] [added: [4.6(a)](https://www.sec.gov/Archives/edgar/data/1623613/000119312518172116/d566535dex41.htm)] | | | | | | Indenture, dated as of May 23, 2018, among Mylan Inc., as issuer, Mylan N.V., as guarantor, and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent and registrar, filed as Exhibit 4.1 to the Report on Form 8-K filed by Mylan N.V. with the SEC on May 23, 2018, and incorporated herein by reference. | | |
| [removed: [4.7(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex41.htm)] [added: [4.7(a)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex41.htm)] | | | | | | Indenture, dated as of June 22, 2020, between Upjohn Inc., as issuer, and The Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K filed by Upjohn Inc. with the SEC on June 26, 2020, and incorporated herein by reference. | | |
| [removed: [4.7(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex41.htm)] [added: [4.7(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex41.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and the Bank of New York Mellon, as trustee, to the Indenture dated June 22, 2020, by and among Viatris Inc. and the Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [removed: [4.8(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex49.htm)] [added: [4.8(a)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex49.htm)] | | | | | | Indenture, dated as of June 23, 2020, among Upjohn Finance B.V., as issuer, Upjohn Inc., as guarantor, and Citibank, N.A., London Branch, as trustee, transfer agent, paying agent and registrar, filed as Exhibit 4.9 to the Report on Form 8-K filed by Upjohn Inc. with the SEC on June 26, 2020, and incorporated herein by reference. | | |
| [removed: [4.8(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex42.htm)] [added: [4.8(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex42.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Upjohn Finance B.V., Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, and registrar, to the Indenture dated June 23, 2020, by and among Upjohn Finance B.V., Viatris Inc. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, and registrar, filed as Exhibit 4.2 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [4.9](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_49xvtrsx20231231x10-k.htm) | | | | | | Description of Viatris Inc. Securities Registered Under Section 12 of the Exchange [removed: Act.] [added: Act, filed by Viatris Inc. as Exhibit 4.9 to Form 10-K for the fiscal year ended December 31, 2023, and incorporated herein by reference.] | | |
| [removed: [10.1(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520167802/d781435dex101.htm)] [added: [10.1(a)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520167802/d781435dex101.htm)] | | | | | | Viatris Inc. 2020 Stock Incentive Plan, included as Exhibit 10.1 to Amendment No. 1 to Form 10 filed by Upjohn Inc. with the SEC on February 6, 2020, and incorporated herein by reference.* | | |
| Year ended December 31, 2024 | | | $ | 118.8 | | | | | 17.4 | | | | | | — | | | | | | (28.6) | | | | | | $ | 107.6 | |
| Year ended December 31, 2024 | | | $ | 421.4 | | | | | 925.4 | | | | | | 1.0 | | | | | | (114.4) | | | | | | $ | 1,233.4 | |
| [10.1(b)](https://www.sec.gov/Archives/edgar/data/1792044/000179204425000008/ex_101bxvtrsx20241231.htm) | | | | | | Amendment to the Viatris Inc. 2020 Stock Incentive Plan dated December 6, 2024.* | | |
| [19](https://www.sec.gov/Archives/edgar/data/1792044/000179204425000008/ex_19xvtrsx20241231.htm) | | | | | | Viatris Inc. Global Insider Trading Policy and Insider Trading Policy Additional Procedures. | | |
| | | | | | | | | |
| /s/ ROGÉRIO VIVALDI COELHO | | | | | | Director | | |
| Rogério Vivaldi Coelho | | | | | | | | |
| Year ended December 31, 2021 | | | $ | 159.9 | | | | | 16.0 | | | | | | — | | | | | | (21.4) | | | | | | $ | 154.5 | |
| Year ended December 31, 2021 | | | $ | 443.6 | | | | | 82.2 | | | | | | 260.8 | | | | | | (6.2) | | | | | | $ | 780.4 | |
| [10.1](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_1013xvtrsx20231231x10-k.htm)[3](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_1013xvtrsx20231231x10-k.htm) | | | | | | Offer Letter with Theodora (Doretta) Mistras, dated December 15, 2023.* | | |
| [10.1](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_1014xvtrsx20231231x10-k.htm)[4](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_1014xvtrsx20231231x10-k.htm) | | | | | | Retirement and Operating Consulting Agreement and Release with Rajiv Malik, dated October 20, 2023.* | | |
| [10.1](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_1015xvtrsx20231231x10-k.htm)[5](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_1015xvtrsx20231231x10-k.htm) | | | | | | Separation Agreement and Release with Anthony Mauro, dated October 20, 2023.* | | |
| [10.1](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_1016xvtrsx20231231x10-k.htm)[6](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_1016xvtrsx20231231x10-k.htm) | | | | | | Separation Agreement and Release with Sanjeev Narula, dated December 15, 2023.* | | |
| [10.28](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000011/mylex102920191231-10k.htm) | | | | | | 2007 Supplemental Health Insurance Plan for Certain Key Employees of Mylan Laboratories Inc., adopted as of January 29, 2007, filed by Mylan N.V. as Exhibit 10.29 to the Form 10-K for the fiscal year ended December 31, 2019 and incorporated herein by reference.* | | |
| [10.30](http://www.sec.gov/Archives/edgar/data/69499/000006949914000007/myl_ex1038x20131231-10k.htm) | | | | | | Amended and Restated Form of Indemnification Agreement between Mylan Inc. and each Director, filed by Mylan Inc. as Exhibit 10.38 to Form 10-K for the fiscal year ended December 31, 2013, and incorporated herein by reference.* | | |
| [10.33](http://www.sec.gov/Archives/edgar/data/1792044/000119312521206477/d50384dex102.htm) | | | | | | Term Loan Credit Agreement, dated as of July 1, 2021, among Viatris, the guarantors from time to time party thereto, the lenders from time to time party thereto and Mizuho Bank, Ltd., as administrative agent, filed as Exhibit 10.2 to the Report on Form 8-K filed by Viatris Inc. with the SEC on July 1, 2021, and incorporated herein by reference. ^ | | |
| [10.35](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex101.htm) | | | | | | Settlement Agreement with the U.S. Department of Justice and two relators finalizing the Medicaid drug rebate settlement, dated August 16, 2017, filed as Exhibit 10.1 to the Report on Form 8-K filed by Mylan N.V. with the SEC on August 21, 2017, and incorporated herein by reference. | | |
| [10.36](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex102.htm) | | | | | | Corporate Integrity Agreement between the Office of Inspector General of the Department of Health and Human Services and Mylan Inc. and Mylan Specialty L.P., dated August 16, 2017, filed as Exhibit 10.2 to the Report on Form 8-K filed by Mylan N.V. with the SEC on August 21, 2017, and incorporated herein by reference. | | |
| [10.37(a)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000035/ex102myl10-q09302020.htm) | | | | | | Asset Purchase Agreement, dated as of September 7, 2020, between Aspen Global Incorporated and Mylan Ireland Limited, filed by Mylan N.V. as Exhibit 10.2 to the Form 10-Q for the quarter ended September 30, 2020, and incorporated herein by reference.^ | | |
| [97](https://www.sec.gov/Archives/edgar/data/1792044/000179204424000008/ex_97xvtrsx20231231x10-k.htm) | | | | | | Viatris Inc. Incentive-Based Compensation Recovery Policy, effective December 1, 2023. | | |
An excerpt. Shown here: 40 of 119 rewritten, all 7 added and all 13 removed. The counts are complete. For every sentence, read Item 15. Exhibits, Consolidated Financial Statement Schedules in the FY2024 filing and the FY2023 filing.