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Viatris is a global healthcare company whose breadth and scale we believe make it uniquely positioned to address healthcare needs globally. 10-K, Item 1
18 paragraphs in Risk Factors of the 10-K filed Feb 26, 2026 with nothing like them in the 10-K filed Feb 27, 2025. Quoted exactly. Paragraphs that were only edited are under 10-K change.
Compared with the Risk Factors in the latest 10-K of the other 59 Health care companies: a paragraph with at least half its words the same at another company is called similar, and the companies are listed under it. A paragraph most of them have is marked boilerplate. No line means no other company has one like it. This counts text; it does not say how serious a risk is.
◦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
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◦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.
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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.
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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.
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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.
In addition, we may be restricted in our ability to adapt, or may be unable or unsuccessful in adapting, to these impacts and challenges due to, among other things, the terms of our current customer, supply or distribution agreements, or the need to obtain regulatory approval prior to making any changes to our manufacturing locations, processes or suppliers. Existing, announced, and future tariffs, trade agreements, or domestic sourcing requirements, as well as potential exemptions, could also provide our competitors with an advantage to the extent such future impacts disproportionately affect us compared with them.
The impact of any adopted, announced, new or proposed tariffs, trade restrictions or domestic sourcing requirements on our business continues to be subject to a number of factors that we cannot predict, including, but not limited to, the scope, nature, amount, effective date and duration of any such measures. Furthermore, general uncertainty related to adopted, new or potential tariffs, trade restrictions and domestic sourcing requirements has in the past reduced and could in the future further reduce global economic activity, thereby resulting in additional adverse impacts to us.
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additional changes in legislative or regulatory priorities and personnel may transpire at the state or federal level, or what the ultimate impact may be.
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Our manufacturing operations involve handling chemicals, pressurized systems, and complex equipment and electrical systems, which expose us to inherent health and safety risks. These include accidents, fires, explosions, chemical spills, and employee exposure to hazardous substances. Such incidents have in the past and could in the future result in serious injury, property damage, regulatory investigations, or significant operational disruptions. We have implemented systems and procedures across our facilities designed to prevent, prepare for and respond to such incidents. However, if our systems,
procedures or other risk management efforts are not effective, our facilities may be adversely affected, and operations would experience significant impact or disruption.
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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,
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Much of our development effort is focused on technically difficult-to-formulate products and/or products that require advanced manufacturing technology. We conduct R&D primarily to enable us to gain approval for, manufacture, and market
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In India, the DPDP Act forms the personal information protection and regulatory requirements for organizations who process any personal information within the country. The DPDP Act is currently in the initial phase of implementation with a 12-18 month phased compliance timeline for organizations although there are current discussions regarding shortening this timeline. The DPDP Act focuses on data minimization, purpose limitation, and user consent and includes a requirement for a Data Protection Officer. While similar to other data protection laws such as the GDPR, several requirements are unique to the DPDP Act such as registered consent managers and a lack of available legal bases for processing personal information without consent. These requirements, along with other requirements unique to the DPDP Act, will require us to enhance our data privacy processes and practices accordingly.
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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.
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In addition to the risks inherent in all information technology systems—including cybersecurity, data confidentiality, system integrity, and availability—the unique characteristics of AI can amplify existing risks and introduce new risks. These include an elevated risk of intellectual property loss or infringement, whether through inadvertent disclosure, unauthorized training on proprietary data, or improper use of third-party content. AI tools lower the barrier to access and replication, increasing the likelihood of intellectual property leakage, copyright violations, and regulatory non-compliance. Additionally, ML or AI-based systems may be subject to novel cybersecurity risks, including attempts to manipulate model outputs, poison data, or extract sensitive information, which could compromise the confidentiality, integrity, or availability of our systems and data.
AI-specific risks also include so-called “hallucinations,” where systems generate inaccurate, misleading, or fabricated outputs that may not be readily detectable, potentially affecting business decisions, customer trust, and regulatory posture. Model performance is highly dependent on the quality, completeness, and appropriateness of underlying data. Flawed algorithms, biased or insufficient datasets, or controversial data practices may lead to unreliable outcomes and reputational harm.
The deployment of AI in regulated environments presents additional complexity. Requirements related to validation, documentation, explainability, data lineage, and change control may lengthen implementation timelines, increase costs, or trigger regulatory scrutiny, audit findings, or enforcement actions. As regulatory expectations continue to mature globally, organizations must ensure that AI adoption aligns with existing compliance obligations and risk management frameworks.
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If tax authorities determine that the intercompany pricing applied to our cross-border arrangements is inconsistent with the arms’ length standard or otherwise ineffective, our tax liabilities could increase.
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18 paragraphs in the 10-Q filed Nov 5, 2026 with nothing like them in the 10-Q filed Aug 6, 2026 (at least half the words must differ; new numbers alone do not count). Quoted exactly, grouped by the item heading above them. This is text that changed, not a judgement of how serious it is.
On October 8, 2026, the Company entered into the Pacira Merger Agreement with Pacira under which Viatris has agreed to acquire all of the outstanding Pacira Shares for $ 36.50 per share in cash, representing an aggregate equity value of $ 1.65 billion. Pacira brings two established, high-margin, patent-protected, in-market U.S. products - EXPAREL® (bupivacaine liposome injectable suspension) and ZILRETTA® (triamcinolone acetonide extended-release injectable suspension). Viatris plans to leverage its intellectual property expertise and proven ability to extend product lifecycles and sustain meaningful sales after the entry of competition to maximize the long-term value of the Pacira portfolio and expects to expand the products' reach across select markets within its global infrastructure.
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On October 30, 2026, the Company commenced the Pacira Offer to purchase all of the issued and outstanding Pacira Shares for $ 36.50 per share in cash, net of applicable withholding taxes and without interest, upon the terms and subject to the conditions set forth in the related Pacira Merger Agreement. The Pacira Offer and withdrawal rights will expire at one minute after 11:59 p.m., Eastern Time, on November 16, 2026, unless the Pacira Offer is extended or earlier terminated in accordance with the Pacira Merger Agreement. Following completion of the Pacira Offer, Viatris will acquire all remaining Pacira Shares not tendered in the Pacira Offer through the Pacira Merger for the same consideration. The Company expects to fund the transaction primarily from excess cash with the remainder from short-term borrowings.
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The transaction, which was unanimously approved by the boards of directors of both companies, is subject to customary closing conditions, including the tender of a majority of the outstanding Pacira Shares and expiration of the applicable regulatory waiting period. The transaction is expected to close by the end of November 2026.
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Number of Stock Options Weighted Average Exercise Price per Share Outstanding at December 31, 2025 2,460,805 $34.21 Exercised (37,393) 9.91 Forfeited (605,947) 43.25 Outstanding at September 30, 2026 1,817,465 $31.70 Vested and expected to vest at September 30, 2026 1,817,465 $31.70 Exercisable at September 30, 2026 1,817,465 $31.70
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Number of Restricted Stock Awards Weighted Average Grant-Date Fair Value Per Share Nonvested at December 31, 2025 32,916,111 $ 10.59 Granted 14,565,838 13.69 Released (15,618,994) 10.90 Forfeited (2,752,042) 11.32 Nonvested at September 30, 2026 29,110,913 $ 11.90
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($ in millions) Interest Rate as of September 30, 2026 September 30, December 31,
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Trials have been scheduled to begin in two other bellwether cases involving the Company in August 2027 and January 2028.
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• the possibility that the Company may not complete the proposed acquisition of Pacira within the timeframe it anticipates or at all and, if completed, the possibility that the Company may not realize the anticipated benefits, synergies and operating efficiencies of the proposed acquisition;
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On October 8, 2026, the Company entered into the Pacira Merger Agreement with Pacira under which Viatris has agreed to acquire all of the outstanding Pacira Shares for $36.50 per share in cash, representing an aggregate equity value of $1.65 billion. Pacira brings two established, high-margin, patent-protected, in-market U.S. products - EXPAREL® (bupivacaine liposome injectable suspension) and ZILRETTA® (triamcinolone acetonide extended-release injectable suspension). Viatris plans to leverage its intellectual property expertise and proven ability to extend product lifecycles and sustain meaningful sales after the entry of competition to maximize the long-term value of the Pacira portfolio and expects to expand the products' reach across select markets within its global infrastructure.
Read in the 10-Q ↗
On October 30, 2026, the Company commenced the Pacira Offer to purchase all of the issued and outstanding Pacira Shares for $36.50 per share in cash, net of applicable withholding taxes and without interest, upon the terms and subject to the conditions set forth in the related Pacira Merger Agreement. The Pacira Offer and withdrawal rights will expire at one minute after 11:59 p.m., Eastern Time, on November 16, 2026, unless the Pacira Offer is extended or earlier terminated in accordance with the Pacira Merger Agreement. Following completion of the Pacira Offer, Viatris will acquire all remaining Pacira Shares not tendered in the Pacira Offer through the Pacira Merger for the same consideration. The Company expects to fund the transaction primarily from excess cash with the remainder from short-term borrowings.
Read in the 10-Q ↗
The transaction, which was unanimously approved by the boards of directors of both companies, is subject to customary closing conditions, including the tender of a majority of the outstanding Pacira Shares and expiration of the applicable regulatory waiting period. The transaction is expected to close by the end of November 2026.
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In September 2026, the Company received notice from the FDA that the inspection classification of the facility was OAI, which could lead to enforcement actions, including a warning letter or import alert. In October 2026, out of an abundance of caution, the Company voluntarily suspended manufacturing at the facility to focus on remediation activities. The Company expects to resume production at the facility during the first quarter of 2027. The foregoing manufacturing suspension is expected to result in incremental costs associated with the Company’s remediation activities, operational inefficiencies, reduced production volumes and delays in production during the affected period. The Company currently anticipates the negative impact of these supply disruptions to be approximately $100 million to total revenues in the fourth quarter of 2026. Also, due to timing of the expected ramp up needed to get the facility back to full production in 2027, the Company currently does not expect to recover the lower revenues from 2026 in 2027.
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Nine Months Ended September 30, 2026 Compared to Nine Months Ended September 30, 2025
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• cash proceeds from the CCPS settlement and the sale of the Biocon equity shares of $779.8 million; and
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During the third quarter of 2026, the Company implemented a new ERP system for entities outside of the U.S. The Company has modified and will continue to modify its internal controls relating to its business and financial processes throughout the entire ERP system implementation, which is expected through the end of calendar year 2026. While the Company believes that this new system and the related changes to internal controls will ultimately strengthen its ICFR, there are inherent risks in implementing any new ERP system and the Company will continue to evaluate and test control changes in order to provide certification as of its fiscal year ending December 31, 2026 on the effectiveness of its ICFR.
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We may not complete the proposed acquisition of Pacira within the timeframe we anticipate or at all and, if completed, we may not realize the anticipated benefits, synergies and operating efficiencies of the proposed acquisition.
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The completion of the acquisition of Pacira is subject to a number of conditions, including (i) that there have been validly tendered (and not validly withdrawn) prior to the expiration of the Pacira Offer a number of Pacira Shares that, together with the number of Pacira Shares then owned by us, if any, would represent at least one Pacira Share more than 50% of the total number of Pacira Shares then issued and outstanding, (ii) the accuracy of the representations and warranties of Pacira contained in the Pacira Merger Agreement, subject to customary materiality thresholds and qualifications, (iii) Pacira’s compliance with, or performance of, in all material respects, its covenants and agreements required to be complied with or performed by it under the Pacira Merger Agreement at or prior to the time of acceptance for payment of Pacira Shares validly tendered and not validly withdrawn, (iv) the expiration or termination of the waiting period (or any extension thereof) applicable to the Pacira Offer under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, (v) the absence of any legal restraint that prohibits or makes illegal the consummation of the Pacira Offer or the Pacira Merger and (vi) other customary conditions set forth in the Pacira Merger Agreement. No assurance can be given that a sufficient number of Pacira Shares will be tendered or that the other required conditions to closing will be satisfied, or when such conditions may be satisfied. The failure to satisfy all of the required conditions could delay the completion of the acquisition for a significant period of time or prevent it from occurring at all. In addition, the Pacira workforce is expected to provide U.S. innovative commercial, market access, medical affairs and global R&D capabilities that are highly complementary to our existing infrastructure and portfolio. Any delay in
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completing the acquisition or, following its completion, any underperformance of the acquired business relative to our expectations, our inability to successfully integrate the acquired business or our inability to retain the talent necessary to provide expected capabilities could cause us not to realize some or all of the anticipated benefits, synergies and operating efficiencies of the acquisition or cause us to realize them on a different timeline than expected. The occurrence of any one or more of the above risks could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price.
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Item 1A of the 10-Q filed Nov 5, 2026 against Item 1A of the 10-K filed Feb 26, 2026.
A 10-Q repeats only the risks that changed, so a 10-K paragraph that is missing from it is not counted as removed.
Added is a paragraph with nothing like it in the 10-K, Reworded a sentence that is in both with several words changed,
Quiet changes a sentence in both where one to four words changed and one is a hedge or a modal
(cut words struck through, new words highlighted and underlined).
Text on the page, not a score; each links to the filing at sec.gov.
What the 10-Q itself says about its risk factors:
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Except as set forth below, there have been no material changes in the Company’s risk factors from those disclosed in Viatris’ 2025 Form 10-K.
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