AddedRisk Factors
◦The imposition of tariffs on, or other trade restrictions or domestic sourcing requirements in, the territories and countries where we, our partners, suppliers, or customers do business, as well as any retaliatory actions
The 10-K against last year's
200 changes: 35 added, 18 removed, 146 reworded, 1 quiet changes
10-K 0001792044-26-000013 (2026-02-26) vs 10-K 0001792044-25-000008 (2025-02-27)
The redline
The paragraph that changed most in each section
Marked against last year's 10-K:
cut words struck through, new words highlighted and underlined.
Risk Factors 234 words changed in this paragraph; it is 46% similar to last year's version.
As the Company looks to drive its base business by executing successful launches, evolving its generics portfolio over time towards more profitable, higher margin products, strengthening its established brands portfolio, and advancing its portfolio of late-stage and in-market growth assets sourced both internally and externally, it expects to use more capital resources and has entered into, and may in the future enter into, financial commitments in connection with these acquisitions, alliances and collaborations. For example, collaborations, such as, our acquisition of the development programs for selatogrel and cenerimod, which are currently in Phase 3 development. development and our acquisition of Aculys Pharma, including exclusive rights to pitolisant in Japan and Spydia® in Japan and certain other markets in the Asia-Pacific region. In addition, we have in the past and may in the future enter into (i) strategic alliances with partners to develop, manufacture, market and/or distribute certain products, and/or certain components of our products, in various markets and (ii) agreements with our collaboration partners that provide for certain services, as well as cross manufacturing, development and licensing arrangements. We commit substantial efforts and other resources to these various alliances and collaborations There is a risk that the investments made by us in these and other alliances and collaborative arrangements will not generate financial returns. While we believe our relationships with our collaboration partners generally are successful, In addition, our collaboration partners’ financial situation, or disputes or conflicting priorities and regulatory or legal intervention has been or could in the future be a source of delay or uncertainty as to the expected benefits of our strategic alliances and collaborations. 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.
Source: Item 1A, 10-K 0001792044-26-000013 vs Item 1A, 10-K 0001792044-25-000008
Legal Proceedings 165 words changed in this paragraph; it is 46% similar to last year's version.
Beginning in January 2023, certain generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Yupelri® with associated Paragraph IV certifications. The companies assert the invalidity and/or non-infringement of polymorph patents expiring in 2030 and 2031, and a method of use patent expiring in 2039. The companies have not filed Paragraph IV certifications to our compound patents, which currently expire in December 2025, with one compound patent subject to a patent term extension to October 2028. Beginning in February 2023, we brought patent infringement actions against the generic filers in federal district courts, including the U.S. District Court for the District of New Jersey, the U.S. District Court for the District of Delaware, the U.S. District Court for the Middle District of North Carolina, and the U.S. District Court for the Eastern District of Pennsylvania asserting infringement of the patents by the generic companies. The actions filed in Delaware, North Carolina and Pennsylvania have been dismissed and the remaining actions will proceed in New Jersey. filers. The Company has entered into settlement agreements with Teva, Accord, Orbicular, Lupin, and Qilu all but one of the generic filers, granting them licenses to commercialize their generic versions of Yupelri® in April 2039 or earlier depending on certain circumstances. Three One ANDA filers remain filer remains in the litigation. litigation in the U.S. District Court for the District of New
Source: Item 3, via Note 20 – Litigation, 10-K 0001792044-26-000013 vs Item 3, via Note 19 – Litigation, 10-K 0001792044-25-000008
MD&A 128 words changed in this paragraph; it is 68% similar to last year's version.
On March 15, 2024, the Company acquired exclusive global development and commercialization rights to two Phase 3 assets from Idorsia, as well as the potential to add additional innovative assets in the future. Under the terms of the original agreements, the development programs and certain personnel for selatogrel and cenerimod were transferred to Viatris from Idorsia in exchange for an upfront payment to Idorsia of $350 million, potential contingent milestone payments (including $300 million payable upon the achievement of certain development and regulatory milestones, and $2.1 billion payable upon the achievement of certain tiered sales milestones), as well as potential contingent tiered sales royalties. Viatris has worldwide commercialization rights for both selatogrel and cenerimod (excluding, (which excluded, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region). A joint development committee was formed to oversee the development of the ongoing Phase 3 programs through regulatory approval. The agreements also provide Viatris a right of first refusal and a right of first negotiation for certain other assets in Idorsia’s pipeline. Viatris and Idorsia are both contractually obligated to contribute to the development costs for both programs, which are expected to be incurred through 2026. There are risks and uncertainties associated with the timely and successful completion of these programs, including but not limited to the high cost and uncertainty of conducting clinical trials (particularly with respect to new and/or complex or innovative drugs), obtaining approval by relevant regulatory bodies and our partner’s financial condition. Refer to Note 4 Acquisitions and Other Transactions included in Part II, Item 8 of this Form 10-K for more information.
Source: Item 7, 10-K 0001792044-26-000013 vs Item 7, 10-K 0001792044-25-000008
Accounting Policies 57 words changed in this paragraph; it is 71% similar to last year's version.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires expanded income tax disclosures, including greater disaggregation of information in the effective tax rate reconciliation and of income taxes paid. The amendments in ASU 2023-09 are effective for all public entities for fiscal years beginning after December 15, 2024, with early adoption permitted. We adopted this ASU on a prospective basis beginning with the year ended December 31, 2025. Refer to Note 12 Income Taxes for additional information. The Company is currently assessing the impact of the adoption of this ASU 2023-09 did not affect the Company’s financial condition, results of operations or cash flows as the guidance on its consolidated financial statement only requires additional disclosures.
Source: Item 8, Note 2 – Summary of Significant Accounting Policies, 10-K 0001792044-26-000013 vs Item 8, Note 2 – Summary of Significant Accounting Policies, 10-K 0001792044-25-000008
Every change, by type
Sentences and paragraphs added, removed or reworded
Sentences and paragraphs of VTRS's Risk Factors and MD&A, 10-K 2026-02-26 against 10-K 2025-02-27. Each links to the text at sec.gov.
Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier (may, could, will, not, significant, material…). A year or date rolling forward is not counted.
The full word list
adverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, wouldAddedRisk Factors
◦Incorporating ML, AI and other emerging technologies into our products, services and operations may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business, financial condition or results of operations.
AddedRisk Factors
As a result of the EWSR initiated in 2025, the Company has identified three strategic imperatives that will drive our future and position the Company for sustainable growth by (i) driving our base business through executing successful launches, focusing on supply chain continuity, evolving our generics portfolio over time towards more profitable, higher-margin products and strengthening our established brands portfolio (ii) fueling our innovative portfolio through advancing a pipeline of late-stage and in-market growth assets sourced both internally and externally; and (iii) modernizing for sustainable growth through strengthening our technology, data and talent capabilities to enable sustained success in a rapidly evolving healthcare environment.
AddedRisk Factors
With respect to the Biocon Biologics Transaction, in December 2025, Viatris entered into definitive agreements with Biocon for the sale of Viatris’ equity stake in Biocon Biologics for total consideration of $815 million, consisting of $400 million in cash and $415 million in newly issued equity shares of Biocon. The shares are subject to a six-month lock-up period. While the shares are listed and traded on the National Stock Exchange of India, the value of the shares remains subject to market fluctuations and there is no guarantee that Viatris will be able to sell the shares for any particular price.
AddedRisk Factors
The U.S. has imposed or is considering imposing tariffs on certain imports from other countries, including pharmaceutical products, ingredients and inputs, which could significantly impact our cost of doing business. The imposition of adopted, new, announced or proposed tariffs, trade restrictions or domestic sourcing requirements on pharmaceutical imports, including but not limited to products, ingredients, and inputs (such as API), could result in increased costs of goods and prices, disruptions to our supply chain, manufacturing delays, supply shortages, and adverse impacts to clinical trials. These measures could also result in decreased profit margins on certain of our products. Decreased or negative profit margins have in the past, and could in the future, make the production of certain of our products unsustainable, thereby reducing our net sales as well as access for patients.
AddedRisk Factors
In addition, we may be restricted in our ability to adapt, or may be unable or unsuccessful in adapting, to these impacts and challenges due to, among other things, the terms of our current customer, supply or distribution agreements, or the need to obtain regulatory approval prior to making any changes to our manufacturing locations, processes or suppliers. Existing, announced, and future tariffs, trade agreements, or domestic sourcing requirements, as well as potential exemptions, could also provide our competitors with an advantage to the extent such future impacts disproportionately affect us compared with them.
AddedRisk Factors
The impact of any adopted, announced, new or proposed tariffs, trade restrictions or domestic sourcing requirements on our business continues to be subject to a number of factors that we cannot predict, including, but not limited to, the scope, nature, amount, effective date and duration of any such measures. Furthermore, general uncertainty related to adopted, new or potential tariffs, trade restrictions and domestic sourcing requirements has in the past reduced and could in the future further reduce global economic activity, thereby resulting in additional adverse impacts to us.
AddedRisk Factors
additional changes in legislative or regulatory priorities and personnel may transpire at the state or federal level, or what the ultimate impact may be.
Show the other 59
AddedRisk Factors
Our manufacturing operations involve handling chemicals, pressurized systems, and complex equipment and electrical systems, which expose us to inherent health and safety risks. These include accidents, fires, explosions, chemical spills, and employee exposure to hazardous substances. Such incidents have in the past and could in the future result in serious injury, property damage, regulatory investigations, or significant operational disruptions. We have implemented systems and procedures across our facilities designed to prevent, prepare for and respond to such incidents. However, if our systems,
AddedRisk Factors
procedures or other risk management efforts are not effective, our facilities may be adversely affected, and operations would experience significant impact or disruption.
AddedRisk Factors
The FDA and comparable foreign regulatory authorities also regulate the facilities and operational procedures that we use to manufacture our products. We must register our facilities with the FDA and similar regulators in other countries. Products must be manufactured in our facilities in accordance with cGMP or similar standards in each territory in which we manufacture. Compliance with such regulations and with our own quality standards requires substantial expenditures of time,
AddedRisk Factors
Much of our development effort is focused on technically difficult-to-formulate products and/or products that require advanced manufacturing technology. We conduct R&D primarily to enable us to gain approval for, manufacture, and market
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RewordedRisk Factors
RewordedRisk Factors
RewordedRisk Factors
Failure to appropriately respond to this evolving landscape may result in legal liability, regulatory action, loss of trade secrets or other intellectual property, brand and reputational harm, or lead to outcomes with unintended biases or other consequences. consequences, which could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on the way we operate our business, our financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
RewordedRisk Factors
RewordedRisk Factors
We also partner with third parties to develop products, or acquire products under development, including, for instance, our acquisition of the development programs for selatogrel and cenerimod, which are currently in Phase 3 development. development and our acquisition of Aculys Pharma, including exclusive rights to pitolisant in Japan and Spydia® in Japan and certain other markets in the Asia-Pacific region.
RewordedRisk Factors
Any of these events could also result in a loss of confidence from our customers, loss of existing or potential business, and have a material adverse effect on our reputation, business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
RewordedRisk Factors
RewordedRisk Factors
RewordedRisk Factors
These macroeconomic pressures combined with the volatility in foreign exchange rates, including the strengthening of the U.S. dollar versus the other currencies in which we operate, has in the past and may in the future, negatively impact our results of operations.
RewordedRisk Factors
RewordedRisk Factors
In addition, our facilities or the facilities of our third-party suppliers have in the past and may in the future be required to close for periods of time, be required to staff at reduced capacity, or suffer other manufacturing shortages, delays or shutdowns as the result of an outbreak of disease, epidemic or pandemic, fires, accidents, weather, unrest or other emergencies taking place in or near any of our facilities.
RewordedRisk Factors
The GDPR contains establishes a comprehensive data protection requirements in the EU and U.K. and imposes a framework of obligations and restrictions governing that governs the collection, processing, and the transmission of personal information to jurisdictions outside of the EU and U.K.
AddedMD&A
•products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety;
AddedMD&A
•longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies;
AddedMD&A
For more detailed information on the risks and uncertainties associated with Viatris, see the risks described in Part I, Item 1A in this Form 10-K, and our other filings with the SEC. You can access Viatris’ filings with the SEC through the SEC
AddedMD&A
In 2025, the Company initiated an EWSR to enable the Company to build a more focused, efficient and future-ready organization and position the Company for sustained growth beginning in 2026. On February 26, 2026, the Company announced the results of its EWSR, and as a part of the review, committed to and began implementation of certain restructuring activities. These restructuring activities are expected to optimize the Company’s commercial capabilities, enabling functions, R&D, medical affairs and regulatory activities, and sourcing, manufacturing and supply chain activities, including inventory optimization. As a result, the Company expects a global workforce reduction of up to approximately 10%. The Company anticipates that these restructuring activities, as well as associated costs and savings, will be completed primarily over the next three years.
AddedMD&A
The Company expects to record charges for costs associated with the restructuring activities of the EWSR. For the committed restructuring activities, the Company expects to incur total pre-tax charges ranging between $700 million and $850 million. Such charges are expected to include between $50 million and $100 million of non-cash charges mainly related to accelerated depreciation and asset impairment charges, including inventory write-offs. The remaining estimated cash costs of between $650 million and $750 million are expected to be primarily related to severance and employee benefits expense, as well as other costs, including those related to contract terminations, vendor consolidations, product transfer costs and network related simplification and modernization costs. In addition, management believes the potential savings related to these committed restructuring activities will be between $600 million and $700 million once fully implemented, with most of these savings expected to improve operating cash flow.
AddedMD&A
On October 15, 2025, the Company acquired Aculys Pharma, a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions. Viatris received rights to develop and commercialize pitolisant and Spydia®, two assets in the CNS therapy area, further expanding Viatris' portfolio of innovative products in Japan. As part of the transaction, Viatris acquired exclusive development and commercialization rights in Japan for pitolisant, a selective/inverse agonist of the histamine H3 receptor. One indication is for the treatment of excessive daytime sleepiness or
AddedMD&A
cataplexy in adult patients with narcolepsy and the second is for the treatment of excessive daytime sleepiness
AddedMD&A
associated with obstructive sleep apnea syndrome. The Japanese NDAs for both indications have been submitted to the Japan Pharmaceuticals and Medical Devices Agency and are under review by the agency. The transaction also includes exclusive rights in Japan and certain other markets in the Asia-Pacific region for Spydia® Nasal Spray, which was approved in Japan in
AddedMD&A
In December 2025, the Company entered into definitive agreements with Biocon for the sale of the Company’s equity stake in Biocon Biologics. Under the terms of the definitive agreements, Biocon acquired all of Viatris’ CCPS in Biocon Biologics for total consideration of $815.0 million, consisting of $400.0 million in cash and $415.0 million in newly issued equity shares of Biocon, which are listed and traded on the National Stock Exchange of India. The transaction closed during the first quarter of 2026 and the shares are subject to a six-month lock up period. In addition, the terms of the definitive agreements accelerate the expiration of biosimilars non-compete restrictions previously placed on Viatris in 2022 in connection with Viatris’ sale of its biosimilars portfolio and related commercial and other capabilities to Biocon Biologics. These restrictions expired immediately at the time of close for all ex-U.S. markets and will expire in November 2026 for U.S. markets.
AddedMD&A
In mid-February 2026, a fire occurred in a service area at the Company's oral solid dose manufacturing facility in Nashik, India. Manufacturing at the facility has been temporarily suspended and the Company currently expects to resume operations beginning in April 2026. The Company believes it has certain insurance coverages for losses, including for assets and business interruption. In the event the plant cannot be returned to normal operations or the Company’s insurance coverage is unavailable or inadequate, this event could have a negative impact on our financial position, results of operations and cash flows.
AddedMD&A
In conjunction with an interim goodwill impairment test performed as of March 31, 2025, the Company recorded a goodwill impairment charge of $2.94 billion in the first quarter of 2025, allocated across the North America, Europe, JANZ, and Emerging Markets reporting units. Following that impairment, there was no remaining goodwill in the JANZ reporting unit. The Company also performed its annual goodwill impairment test on April 1, 2025, which resulted in no further impairment charges being recorded. Refer to Note 8 Goodwill and Intangible Assets in Part II, Item 8 of this Form 10-K for more information.
AddedMD&A
The increase was primarily driven by a loss of $534.8 million recorded in the current year period as a result of changes in the fair value of the CCPS in Biocon Biologics, compared to a net gain in the prior year period of $(373.5) million, lower interest income of $56.6 million, and lower TSA income of $30.5 million. The reduction in the fair value of the CCPS in Biocon Biologics was primarily the result of the Company entering into definitive agreements with Biocon for the sale of the Company’s equity stake in Biocon Biologics. Under the terms of the definitive agreements, Biocon acquired all of Viatris’ CCPS in Biocon Biologics for total consideration of $815.0 million.
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RewordedMD&A
Such forward-looking statements may include, without limitation, statements about the goals or outlooks with respect to the Company’s strategic initiatives and priorities, including but not limited to divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions; the anticipated benefits and synergies of such divestitures, acquisitions, strategic alliances, collaborations, initiatives or other transactions, priorities or restructuring programs; activities; future opportunities for the Company and its products; the outcomes of clinical trials and any other statements regarding the Company’s future operations, financial or operating results, capital allocation, dividend policy and payments, share repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock value, and other expectations and targets for future periods. research studies;
RewordedMD&A
RewordedMD&A
RewordedMD&A
(2) a gain on the extinguishment of debt of $16.5 million; and (3) charges of $184.6 million recorded in the prior year related to the impairment of our equity investment in Mapi and advances for GA Depot inventory (refer to Note 18 19 Licensing and Other Partner Agreements included in Part II, Item 8 of this Form 10-K for more information). information); and (3) a gain on debt extinguishments of $16.5 million recorded in the prior year.
RewordedMD&A
In addition to the impact of competition, government pricing actions and other measures designed to reduce healthcare costs, our results of operations, cash flows and financial condition could also be affected by other risks of doing business internationally, including the impact of inflation, elections, geopolitical events, including the ongoing conflicts in the Middle East and between Russia and Ukraine and related trade controls, sanctions, supply chain disruptions and staffing challenges and other economic considerations, supply chain disruptions, longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies, the potential for adverse impacts from future tariffs and trade restrictions, foreign currency exchange fluctuations, public health epidemics, changes in intellectual property legal protections and other regulatory changes.
RewordedMD&A
Constant currency net sales from the remaining business increased decreased by approximately $19.5 $112.9 million, or 1%, 8%, when compared to the prior year, driven primarily by new product lower net sales of existing products in Australia. Japan and Australia due to government price reductions and additional competition, and by the Indore Impact of approximately $9 million.
RewordedMD&A
On a constant currency basis, net sales from the remaining business increased decreased by approximately $276.1 $142.1 million, or 2%, 1%, for the year ended December 31, 2024 2025 compared to the prior year period, driven by new product sales, primarily in Developed Markets, net base business erosion of approximately $582.4 million. $465.8 million, of which approximately $370 million related to the Indore Impact.
RewordedMD&A
GAAP diluted (loss) earnings per share $ (3,514.9) $(3.00) $ (634.2) $(0.53) $ 54.7 $0.05 $ 2,078.6 $1.71 Purchase accounting amortization (primarily included in cost of sales) (a) 2,470.3 2,581.1 2,421.5 2,721.3 Impairment of goodwill (included in SG&A) (b) 2,936.8 321.0 580.1 117.0 Litigation settlements and other contingencies, net (68.5) 350.9 111.6 4.4 Interest expense (primarily amortization of premiums and discounts on long term debt) (38.6) (23.0) (42.4) (48.7) Acquisition and divestiture-related costs (primarily included in cost of sales and SG&A) (c) 208.2 361.0 377.9 475.7 Loss (gain) on divestitures of businesses (included in other expense (income), net) (d) 101.0 399.4 239.9 (1,754.1) Restructuring-related Restructuring costs (e) 170.0 211.1 125.2 86.9 Share-based compensation expense 177.7 146.1 180.7 116.5 Other special items included in:
RewordedMD&A
RewordedMD&A
The decrease increase in net cash provided by operating activities was principally due to the timing of cash payments and collections, partially offset by lower operating earnings, including as a result of divestitures that closed in 2023 and 2024, higher transaction costs associated with divestitures, and the timing of cash payments and collections. Indore Impact.
RewordedMD&A
Constant currency net sales increased by approximately $53.4 $168.2 million, or 2%, 8%, when compared to the prior year, driven primarily by increased volumes strong growth across multiple channels, including e-commerce, retail, and private hospitals, as well as benefits of existing products. timing of customer purchasing patterns.
RewordedMD&A
Other expense (income), expense, net for the year ended December 31, 2024 2025 totaled $530.6 million, compared to $83.3 million of expense, compared to $(9.8) million of income for the year ended December 31, 2023, a decrease 2024, an increase of $93.1 $447.3 million.
Quiet changesMD&A
Under the terms of the letter agreement, Viatris will receive received additional territory rights in Japan, South Korea and certain other countries in the Asia-Pacific region for cenerimod, a $250 million reduction in contingent milestone payments, including $200 million of development milestones, and additional personnel to expedite transitioning the development programs to Viatris in exchange for Viatris assuming $100 million of Idorsia’s obligation to contribute to development costs.