Skip to main content

Viatris Inc

For the period ended Jun 30, 2025. Filed Aug 7, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 7, 2025

VTRS$20.49+2.9%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

Notes to Condensed Consolidated Financial Statements

Notes to Condensed Consolidated Financial Statements (Unaudited)

  1. General

The accompanying unaudited condensed consolidated financial statements (“interim financial statements”) of Viatris Inc. and subsidiaries were prepared in accordance with U.S. GAAP and the rules and regulations of the SEC for reporting on Form 10-Q; therefore, as permitted under these rules, certain footnotes and other financial information included in audited financial statements were condensed or omitted. The interim financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the interim results of operations, comprehensive earnings (loss), financial position, equity and cash flows for the periods presented.

These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto in Viatris’ 2024 Form 10-K. The December 31, 2024 condensed consolidated balance sheet was derived from audited financial statements.

The interim results of operations and comprehensive earnings (loss) for the three and six months ended June 30, 2025, and cash flows for the six months ended June 30, 2025, are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.

Certain reclassifications were made to conform the prior period consolidated financial statements to the current period presentation. Charges related to the impairment of goodwill, which were previously presented in Selling, General and Administrative in the condensed consolidated statements of operations, and which were previously presented in Other non-cash itemsin the condensed consolidated statements of cash flows, are now presented in Impairment of Goodwill in the condensed consolidated statements of operations and the condensed consolidated statements of cash flows.

  1. Revenue Recognition and Accounts Receivable

The Company recognizes revenues in accordance with ASC 606, Revenue from Contracts with Customers. Under ASC 606, the Company recognizes net revenue for product sales when control of the promised goods or services is transferred to our customers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Revenues are recorded net of provisions for variable consideration, including discounts, rebates, governmental rebate programs, price adjustments, returns, chargebacks, promotional programs and other sales allowances. Accruals for these provisions are presented in the condensed consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash).

Our net sales may be impacted by wholesaler and distributor inventory levels of our products, which can fluctuate throughout the year due to the seasonality of certain products, pricing, the timing of product demand, purchasing decisions and other factors. Such fluctuations may impact the comparability of our net sales between periods.

Consideration received from licenses of intellectual property is recorded as other revenues. Royalty or profit share amounts, which are based on sales of licensed products or technology, are recorded when the customer’s subsequent sales or usages occur. Such consideration is included in other revenues in the condensed consolidated statements of operations.

The following table presents the Company’s net sales by product category for each of our reportable segments for the three and six months ended June 30, 2025 and 2024, respectively:

(In millions)Three Months Ended June 30, 2025 (a)
Product CategoryDeveloped MarketsGreater ChinaJANZEmerging MarketsTotal
Brands$1,121.4$586.5$160.5$416.1$2,284.5
Generics997.92.4145.2139.01,284.5
Total Viatris$2,119.3$588.9$305.7$555.1$3,569.0
(In millions)Six Months Ended June 30, 2025 (a)
Product CategoryDeveloped MarketsGreater ChinaJANZEmerging MarketsTotal
Brands$2,141.2$1,139.3$302.3$818.6$4,401.4
Generics1,869.85.1279.5256.42,410.8
Total Viatris$4,011.0$1,144.4$581.8$1,075.0$6,812.2
(In millions)Three Months Ended June 30, 2024
Product CategoryDeveloped MarketsGreater ChinaJANZEmerging MarketsTotal
Brands$1,233.8$535.7$198.4$395.2$2,363.1
Generics1,085.43.3151.2182.91,422.8
Total Viatris$2,319.2$539.0$349.6$578.1$3,785.9
(In millions)Six Months Ended June 30, 2024
Product CategoryDeveloped MarketsGreater ChinaJANZEmerging MarketsTotal
Brands$2,412.6$1,077.5$382.5$799.6$4,672.2
Generics2,072.05.4284.9404.92,767.2
Total Viatris$4,484.6$1,082.9$667.4$1,204.5$7,439.4

(a)Amounts for the three and six months ended June 30, 2025 include the Indore Impact and the impact of foreign currency translations and divested businesses compared to the prior year period.

The following table presents net sales on a consolidated basis for select key products for the three and six months ended June 30, 2025 and 2024, respectively:

Three Months Ended June 30,Six Months Ended June 30,
(In millions)2025202420252024
Select Key Global Products
Lipitor ®$387.9$348.4$775.9$737.3
Norvasc ®182.7161.9355.0338.2
EpiPen® Auto-Injectors136.8115.5233.5195.7
Lyrica ®128.1124.3240.7238.5
Viagra ®100.3106.1198.8206.8
Creon ®91.478.2173.8153.2
Celebrex ®70.072.2133.4144.4
Effexor ®63.162.7122.4122.1
Zoloft ®61.158.9121.3116.9
Xalabrands40.745.677.888.1
Select Key Segment Products
Yupelri ®$66.6$54.5$124.9$109.7
Dymista ®48.455.091.2103.2
Amitiza ®41.636.974.969.9
Xanax ®33.935.466.269.9

(a)The Company does not disclose net sales for any products considered competitively sensitive.

(b)Products disclosed may change in future periods, including as a result of seasonality, competition or new product launches.

(c)Amounts for the three and six months ended June 30, 2025 include the impact of foreign currency translations compared to the prior year period.

(d)Refer to intellectual property matters included in Note 17 Litigation for additional information regarding Yupelri® and Amitiza®.

Variable Consideration and Accounts Receivable

The following table presents a reconciliation of gross sales to net sales by each significant category of variable consideration during the three and six months ended June 30, 2025 and 2024, respectively:

Three Months Ended · Six Months Ended
June 30, · June 30,
(In millions)2025 (a)20242025 (a)2024
Gross sales$5,974.8$6,383.9$11,545.0$12,558.5
Gross to net adjustments:
Chargebacks(1,260.6)(1,282.6)(2,418.6)(2,526.8)
Rebates, promotional programs and other sales allowances(918.4)(1,040.5)(1,889.0)(2,088.8)
Returns(47.8)(70.1)(102.1)(130.4)
Governmental rebate programs(179.0)(204.8)(323.1)(373.1)
Total gross to net adjustments$(2,405.8)$(2,598.0)$(4,732.8)$(5,119.1)
Net sales$3,569.0$3,785.9$6,812.2$7,439.4

(a)Amounts for the three and six months ended June 30, 2025 include the Indore Impact and the impact of foreign currency translations and divested businesses compared to the prior year period.

No significant revisions were made to the methodology used in determining these provisions or the nature of the provisions during the three and six months ended June 30, 2025. Such allowances were comprised of the following at June 30, 2025 and December 31, 2024, respectively:

(In millions)June 30,2025December 31,2024
Accounts receivable, net$1,417.8$1,547.0
Other current liabilities1,046.3989.4
Total$2,464.1$2,536.4

Accounts receivable, net was comprised of the following at June 30, 2025 and December 31, 2024, respectively:

(In millions)June 30,2025December 31,2024
Trade receivables, net$2,794.2$2,675.3
Other receivables463.9546.0
Accounts receivable, net$3,258.1$3,221.3

Accounts Receivable Factoring Arrangements

We have entered into accounts receivable factoring agreements with financial institutions to sell certain of our non-U.S. accounts receivable. These transactions are accounted for as sales and result in a reduction in accounts receivable because the agreements transfer effective control over and risk related to the receivables to the buyers. Our factoring agreements do not allow for recourse in the event of uncollectibility, and we do not retain any interest in the underlying accounts receivable once sold. We derecognized $123.0 million and $68.5 million of accounts receivable as of June 30, 2025 and December 31, 2024, respectively, under these factoring arrangements. Additionally, we have a similar arrangement for certain European countries. As of June 30, 2025 and December 31, 2024, we assigned and derecognized approximately $15.4 million and $29.9 million, respectively, of Trade Receivables, Net, which were included in Other Receivables.

  1. Recent Accounting Pronouncements

Accounting Standards and Disclosure Rules Issued Not Yet Adopted

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 would require registrants to provide certain climate-related information in their registration statements and annual reports. The Final Rules would 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 would 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 pending completion of litigation in the U.S. Court of Appeals for the Eighth Circuit. 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. On March 27, 2025, the SEC voted to end its defense of the Final Rules and withdrew its defense of the Final Rules in the pending litigation. The Company continues to monitor the status of the Final Rules.

There were no other significant changes in new accounting standards from those disclosed in Viatris’ 2024 Form 10-K. Refer to Viatris’ 2024 Form 10-K for additional information.

  1. Acquisitions and Other Transactions

Acquisition of Idorsia Products

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 and Idorsia are both contractually obligated to contribute to the development costs for both programs. Viatris has worldwide commercialization rights for both selatogrel and cenerimod (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 provided Viatris a right of first refusal and a right of first negotiation for certain other assets in Idorsia’s pipeline. The transaction expanded our portfolio of innovative assets by adding two Phase 3 assets and combines our financial strength and worldwide operational infrastructure with Idorsia’s proven, highly-productive drug development team and innovation engine.

In accordance with U.S. GAAP, the transaction has been accounted for as a business combination under the acquisition method of accounting. Under the acquisition method of accounting, the assets acquired and liabilities assumed in the transaction were recorded at their respective estimated fair values at the acquisition date. During the six months ended June 30, 2025 and 2024, the Company incurred acquisition-related costs of approximately $7.1 million and $3.9 million, respectively, which were recorded primarily in SG&A in the condensed consolidated statements of operations.

The U.S. GAAP purchase price allocated to the transaction was $695 million, which consisted of $350 million of cash consideration paid and estimated contingent consideration at the date of acquisition valued at approximately $345 million. The fair value of the contingent consideration was valued using a Monte Carlo simulation model using Level 3 inputs. The fair value is sensitive to changes in the forecasts of operating metrics, probability of success, and discount rates. Refer to Note 11, Financial Instruments and Risk Managementfor additional information. The allocation of the purchase price to the assets acquired and liabilities assumed is shown below. There were no measurement period adjustments.

(In millions)
Current assets$2.1
IPR&D675.0
Goodwill19.5
Total assets acquired$696.6
Current liabilities1.6
Net assets acquired$695.0

The amount allocated to IPR&D represents an estimate of the fair value of purchased in-process technology for research projects that, as of the closing date of the acquisition, had not reached technological feasibility and had no alternative future use. The fair value of IPR&D of $675 million was based on the excess earnings method, which utilizes forecasts of expected cash inflows (including estimates for ongoing costs) and other contributory charges. A discount rate of 20% was utilized to discount net cash inflows to present values. IPR&D is accounted for as an indefinite-lived intangible asset and will be subject to impairment testing until completion or abandonment of the projects. Upon successful completion and launch of each product, the Company will make a determination of the estimated useful life of the individual asset. 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 the projects included in IPR&D, 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, and no assurances can be given that the underlying assumptions used to estimate the fair value of IPR&D will not change or the timely completion of each project to commercial success will occur.

The goodwill of $19.5 million arising from the acquisition consisted largely of the value of the employee workforce and the expected value of products, including additional indications, to be developed in the future. All of the goodwill was assigned to the Developed Markets segment. None of the goodwill recognized in this transaction is expected to be deductible for income tax purposes. The acquisition did not have a material impact on the Company’s results of operations since the acquisition date or on a pro forma basis during the three and six months ended June 30, 2024.

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 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. In addition, the joint development committee has been replaced with a transition committee to oversee the transition of both development programs to Viatris. Refer to Note 11 Financial Instruments and Risk Management for additional information on the fair value adjustment to the Idorsia Transaction contingent consideration liability recorded during the six months ended June 30, 2025 as a result of the February 25, 2025 letter agreement.

  1. Divestitures

By the end of 2024, the Company had substantially completed the previously announced divestitures of its OTC Business, its women’s healthcare business primarily related to oral and injectable contraceptives, its API business in India, its rights totwo women’s healthcare products in certain countries, and commercialization rights in the majority of the Upjohn Distributor Markets.

During the three and six months ended June 30, 2025, the Company recorded additional pre-tax charges of approximately $43.8 million and $80.7 million, respectively, related to the divestitures. The additional charges were recorded as a component of Other Expense (Income), Net in the condensed consolidated statements of operations, and were primarily due to an increase in estimated transaction related costs, including the assumption of additional contractual obligations, as well as the impact of working capital and other transaction-related adjustments.

In conjunction with these transactions, Viatris and the respective buyers entered into various agreements to provide a framework for our relationship with the respective buyers after the closing of the divestitures, including transition services agreements, manufacturing and supply agreements, and distribution agreements, some of which include various on-going financial obligations. During the three months ended June 30, 2025 and 2024, the Company recognized TSA income related to all divestitures of approximately $12.4 million and $6.0 million, respectively. During the six months ended June 30, 2025 and 2024, the Company recognized TSA income related to all divestitures of approximately $29.8 million and $19.5 million, respectively. TSA income is recorded as a component of Other Expense (Income), Net.

  1. Share-Based Incentive Plan

Prior to the Distribution, Viatris adopted and Pfizer, in the capacity as Viatris’ sole stockholder at such time, approved the 2020 Incentive Plan (the Viatris Inc. 2020 Stock Incentive Plan) which became effective as of the Distribution. In connection with the Combination, as of November 16, 2020, the Company assumed the 2003 LTIP (Mylan N.V. Amended and Restated 2003 Long-Term Incentive Plan), which had previously been approved by Mylan shareholders. The 2020 Incentive Plan includes 72,500,000 shares of Viatris’ common stock authorized for grant pursuant to the 2020 Incentive Plan, which may include dividend payments payable in common stock on unvested shares granted under awards. No shares remain available for issuance under the 2003 LTIP, however, certain awards remain outstanding under the plan.

The Board approved an amendment to the 2020 Incentive Plan, which was approved by Viatris shareholders on December 6, 2024, to increase the maximum aggregate number of shares of Viatris common stock available for issuance under the 2020 Incentive Plan by 49,000,000.

Under the 2020 Incentive Plan, shares are reserved for issuance to key employees, consultants, independent contractors and non-employee directors of the Company through a variety of incentive awards, including: stock options, SARs, restricted stock and units, PSUs, other stock-based awards and short-term cash awards. Stock option awards are granted with an exercise price equal to the fair market value of the shares underlying the stock options at the date of the grant, generally become exercisable over periods ranging from three tofour years, and generally expire inten years.

The following table summarizes stock awards (stock options and SARs) activity:

Number of Shares Under Stock AwardsWeighted Average Exercise Price per Share
Outstanding at December 31, 20243,350,786$35.94
Exercised(12,291)6.51
Forfeited(515,096)37.04
Outstanding at June 30, 20252,823,399$35.86
Vested and expected to vest at June 30, 20252,821,503$35.88
Exercisable at June 30, 20252,810,777$35.98

As of June 30, 2025, stock awards outstanding, stock awards vested and expected to vest, and stock awards exercisable each had average remaining contractual terms of 2.6 years. Also, at June 30, 2025, stock awards outstanding, stock awards vested and expected to vest, and stock awards exercisable each had aggregate intrinsic values of $0.1 million.

A rollforward of the changes in the Company’s nonvested Restricted Stock Awards (restricted stock and restricted stock unit awards, including PSUs) from December 31, 2024 to June 30, 2025 is presented below:

Number of Restricted Stock AwardsWeighted Average Grant-Date Fair Value Per Share
Nonvested at December 31, 202429,083,934$11.49
Granted19,015,6789.57
Released(12,653,426)10.91
Forfeited(1,621,873)11.44
Nonvested at June 30, 202533,824,313$10.63

As of June 30, 2025, the Company had $236.2 million of total unrecognized compensation expense, net of estimated forfeitures, related to all of its stock-based awards, which we expect to recognize over the remaining weighted average vesting period of 1.7 years. The total intrinsic value of Restricted Stock Awards released and stock options exercised during the six months ended June 30, 2025 and 2024 was $118.8 million and $137.9 million, respectively.

  1. Pensions and Other Postretirement Benefits

Defined Benefit Plans

The Company sponsors various defined benefit pension plans in several countries. Benefits provided generally depend on length of service, pay grade and remuneration levels. Employees in the U.S., Puerto Rico and certain international locations are also provided retirement benefits through defined contribution plans.

The Company also sponsors other postretirement benefit plans including plans that provide for postretirement supplemental medical coverage. Benefits from these plans are provided to employees and their spouses and dependents who meet various minimum age and service requirements. In addition, the Company sponsors other plans that provide for life insurance benefits and postretirement medical coverage for certain officers and management employees.

Net Periodic Benefit Cost

Components of net periodic benefit cost for the three and six months ended June 30, 2025 and 2024 were as follows:

Pension and Other Postretirement Benefits
Three Months Ended · Six Months Ended
June 30,June 30,
(In millions)2025202420252024
Service cost$7.4$7.8$14.9$15.7
Interest cost16.316.732.533.3
Expected return on plan assets(16.8)(16.9)(33.6)(33.8)
Amortization of prior service costs—0.6—1.1
Recognized net actuarial gains(2.9)(4.2)(5.8)(8.5)
Net periodic benefit cost$4.0$4.0$8.0$7.8

The Company is making the minimum mandatory contributions to its defined benefit pension plans in the U.S. and Puerto Rico for the 2025 plan year. The Company expects to make total benefit payments of approximately $112.2 million from pension and other postretirement benefit plans in 2025. The Company anticipates making contributions to pension and other postretirement benefit plans of approximately $68.8 million in 2025.

  1. Balance Sheet Components

Selected balance sheet components consist of the following:

Cash and restricted cash

(In millions)June 30,2025December 31,2024June 30, 2024
Cash and cash equivalents$566.4$734.8$917.2
Restricted cash, included in prepaid expenses and other current assets1.41.31.3
Cash, cash equivalents and restricted cash$567.8$736.1$918.5

Inventories

(In millions)June 30,2025December 31,2024
Raw materials$1,547.4$1,345.9
Work in process531.7527.3
Finished goods2,185.21,980.9
Inventories$4,264.3$3,854.1

Prepaid expenses and other current assets

(In millions)June 30,2025December 31, 2024
Prepaid expenses$179.9$140.9
Available-for-sale fixed income securities39.738.0
Fair value of financial instruments142.4261.6
Equity securities60.155.5
Deferred charge for taxes on intercompany profit665.1526.6
Income tax receivable339.2300.7
Other current assets259.4387.2
Prepaid expenses and other current assets$1,685.8$1,710.5

Prepaid expenses consist primarily of prepaid rent, insurance and other individually insignificant items.

Property, plant and equipment, net

(In millions)June 30,2025December 31, 2024
Machinery and equipment$3,040.1$2,894.7
Buildings and improvements1,519.91,464.3
Construction in progress390.2397.1
Land and improvements117.0113.2
Gross property, plant and equipment5,067.24,869.3
Accumulated depreciation2,424.62,203.2
Property, plant and equipment, net$2,642.6$2,666.1

Other assets

(In millions)June 30,2025December 31, 2024
CCPS in Biocon Biologics950.01,349.8
Operating lease right-of-use assets276.3253.1
Other long-term assets771.6754.0
Other assets$1,997.9$2,356.9

Accounts payable

(In millions)June 30,2025December 31, 2024
Trade accounts payable$1,320.0$1,355.3
Other payables462.6498.4
Accounts payable$1,782.6$1,853.7

Other current liabilities

(In millions)June 30,2025December 31, 2024
Accrued sales allowances$1,046.3$989.4
Payroll and employee benefit liabilities567.8729.3
Legal and professional accruals, including litigation accruals540.8472.8
Contingent consideration37.159.5
Accrued restructuring44.763.4
Accrued interest46.049.9
Fair value of financial instruments377.0125.8
Operating lease liability111.687.1
Other898.81,147.5
Other current liabilities$3,670.1$3,724.7

Other long-term obligations

(In millions)June 30,2025December 31, 2024
Employee benefit liabilities$487.8$467.9
Contingent consideration330.1496.6
Tax related items, including contingencies320.6341.9
Operating lease liability182.0179.3
Accrued restructuring129.7128.5
Other385.0325.0
Other long-term obligations$1,835.2$1,939.2
  1. Loss per Share

Basic loss per share is computed by dividing net loss attributable to holders of Viatris Inc. common stock by the weighted average number of shares outstanding during the period. Diluted loss per share is computed by dividing net loss attributable to holders of Viatris Inc. common stock by the weighted average number of shares outstanding during the period increased by the number of additional shares that would have been outstanding related to potentially dilutive securities or instruments, if the impact is dilutive.

Basic and diluted loss per share attributable to Viatris Inc. are calculated as follows:

Three Months Ended · Six Months Ended
June 30,June 30,
(In millions, except per share amounts)2025202420252024
Basic loss attributable to Viatris Inc. common shareholders (numerator):
Net loss attributable to Viatris Inc. common shareholders$(4.6)$(326.4)$(3,046.6)$(212.5)
Shares (denominator):
Weighted average shares outstanding1,173.01,191.11,182.71,193.1
Basic loss per share attributable to Viatris Inc. shareholders$—$(0.27)$(2.58)$(0.18)
Diluted loss attributable to Viatris Inc. common shareholders (numerator):
Net loss attributable to Viatris Inc. common shareholders$(4.6)$(326.4)$(3,046.6)$(212.5)
Shares (denominator):
Weighted average shares outstanding1,173.01,191.11,182.71,193.1
Share-based awards————
Total dilutive shares outstanding1,173.01,191.11,182.71,193.1
Diluted loss per share attributable to Viatris Inc. shareholders$—$(0.27)$(2.58)$(0.18)

Additional stock awards and Restricted Stock Awards were outstanding during the three and six months ended June 30, 2025 and 2024, but were not included in the computation of diluted loss per share for each respective period because the effect would be anti-dilutive. Excluded shares also include certain PSUs whose performance conditions had not been fully met. Such excluded shares and anti-dilutive awards represented 27.6 million shares and 27.4 million shares for the three and six months ended June 30, 2025, respectively, and 23.2 million shares and 22.7 million shares for the three and six months ended June 30, 2024, respectively.

The Company paid a quarterly dividend of $0.12 per share on the Company’s issued and outstanding common stock on March 18, 2025 and June 16, 2025. On August 4, 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 September 15, 2025 to shareholders of record as of the close of business on August 22, 2025. The declaration and payment of future dividends to holders of the Company’s common stock will be at the discretion of the Board of Directors, and will depend upon factors, including but not limited to, the Company’s financial condition, earnings, capital requirements of its businesses, legal requirements, regulatory constraints, industry practice, and other factors that the Board of Directors deems relevant.

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. The Company subsequently 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. 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 three months ended June 30, 2025, the Company repurchased approximately 20.2 million shares of common stock at a cost of approximately $175.0 million. During the six months ended June 30, 2025 and 2024, the Company repurchased approximately 38.9 million shares of common stock at a cost of approximately $350.4 million, and approximately 19.2 million shares of common stock at a cost of approximately $250 million, respectively, under the program. As of June 30, 2025, the Company had repurchased a total of approximately 79.3 million shares of common stock at a cost of approximately $850.4 million under the program. The share repurchase program does not obligate the Company to acquire any particular amount of common stock.

  1. Goodwill and Intangible Assets

Goodwill

The changes in the carrying amount of goodwill for the six months ended June 30, 2025 are as follows:

(In millions)Developed Markets (1)Greater ChinaJANZ (2)Emerging Markets (3)Total
Balance at December 31, 2024:6,752.9921.5295.11,163.89,133.3
Impairment(2,261.0)—(300.8)(375.0)(2,936.8)
Foreign currency translation527.36.35.712.5551.8
Balance at June 30, 2025:$5,019.2$927.8$—$801.3$6,748.3

(1)Balances as of June 30, 2025 and December 31, 2024 include an accumulated impairment loss of $3.19 billion and $929.0 million, respectively.

(2)Balances as of June 30, 2025 and December 31, 2024 include an accumulated impairment loss of $651.8 million and $351.0 million, respectively.

(3)Balances as of June 30, 2025 and December 31, 2024 include an accumulated impairment loss of $499.0 million and $124.0 million, respectively.

The Company reviews goodwill for impairment annually on April 1st or more frequently if events or changes in circumstances indicate that the carrying value of goodwill may not be recoverable. During the first quarter of 2025, the Company experienced a sharp and sustained decline in its share price and significantly increased uncertainty and volatility in the geopolitical and economic environments in which the Company operates. As a result of these factors, the Company determined that a triggering event had occurred for each of its reporting units and performed an interim goodwill impairment test as of March 31, 2025.

The Company also performed the annual goodwill impairment test as of April 1, 2025. There were no significant changes from the interim goodwill test performed at March 31, 2025 and the results were consistent with the interim goodwill impairment test. Also, no triggering events have been identified since the April 1, 2025 impairment test date.

The Company performed both its interim and annual goodwill impairment tests on a quantitative basis for itsfive reporting units, North America, Europe, Emerging Markets, JANZ, and Greater China. In estimating each reporting unit’s fair value, the Company performed an extensive valuation analysis, utilizing a discounted cash flow approach. The determination of the fair value of the reporting units requires the Company to make significant estimates and assumptions that affect the reporting unit’s expected future cash flows. These estimates and assumptions, utilizing Level 3 inputs, primarily include, but are not limited to, the discount rate, terminal growth rates, operating income before depreciation and amortization, capital expenditures forecasts and control premiums.

For the March 31, 2025 interim goodwill impairment test, when compared to the prior year annual goodwill impairment test completed on April 1, 2024, the significantly increased uncertainty and volatility in the geopolitical and economic environments in which the Company operates increased the Company’s business risks, including, but not limited to, the potential for continued or additional drug pricing reduction pressures, general uncertainty related to timing of responses and approvals from the FDA resulting from evolving regulatory priorities and associated changes to the operations of the agency, and the potential for adverse impacts from future tariffs and trade restrictions. The negative impact of any or all of these factors could be material. The significant increase in business risks and uncertainty led to an increase in discount rate assumptions impacting all reporting units as compared to the April 1, 2024 annual goodwill impairment test.

As of March 31, 2025 (prior to the impairment charges noted below), the allocation of the Company’s total goodwill was as follows: North America $3.09 billion, Europe $3.92 billion, Emerging Markets $1.17 billion, JANZ $0.30 billion and Greater China $0.92 billion.

In conjunction with its March 31, 2025 interim goodwill impairment test, the Company recorded the following impairment charges in the first quarter of 2025:

(In millions)North AmericaEuropeJANZEmerging MarketsTotal
Impairment charge$707.0$1,554.0$300.8$375.0$2,936.8

For the North America reporting unit at March 31, 2025 and April 1, 2025, the Company forecasted cash flows for the next 10 years. During the forecast period, the revenue compound annual growth rate was approximately 3.1%. A terminal year value was calculated with a negative 3.0% revenue growth rate applied. The discount rate utilized was 12.5% and the estimated tax rate was 24.8%.

For the Europe reporting unit at March 31, 2025 and April 1, 2025, the Company forecasted cash flows for the next 10 years. During the forecast period, the revenue compound annual growth rate was approximately 3.3%. A terminal year value was calculated with a 2.0% revenue growth rate applied. The discount rate utilized was 12.0% and the estimated tax rate was 15.8%.

For the Emerging Markets reporting unit at March 31, 2025 and April 1, 2025, the Company forecasted cash flows for the next 10 years. During the forecast period, the revenue compound annual growth rate was approximately 3.5%. A terminal year value was calculated with a 2.0% revenue growth rate applied. The discount rate utilized was 14.5% and the estimated tax rate was 16.7%.

For the JANZ reporting unit at March 31, 2025 and April 1, 2025, the Company forecasted cash flows for the next 10 years. During the forecast period, the revenue compound annual growth rate was approximately negative 0.9%. A terminal year value was calculated with a 1.0% revenue growth rate applied. The discount rate utilized was 8.5% and the estimated tax rate was 30.2%. After the goodwill impairment charge recorded during the first quarter of 2025, there is no remaining goodwill allocated to the JANZ reporting unit.

Following the goodwill impairment charges recorded in these reporting units, since the carrying value of the reporting units is equal to their estimated fair value as of March 31, 2025 and April 1, 2025, if market conditions or the projected results were to negatively change, it may be necessary to record further impairment charges to one or more of these reporting units in future periods. Any such future charges could be material.

For the Greater China reporting unit, the estimated fair value exceeded its carrying value by approximately $322.0 million or 5.8% for both the March 31, 2025 and April 1, 2025 goodwill impairment tests. As it relates to the discounted cash flow approach for the Greater China reporting unit at March 31, 2025 and April 1, 2025, the Company forecasted cash flows for the next 10 years. During the forecast period, the revenue compound annual growth rate was approximately 1.6%. A terminal year value was calculated with a negative 1.5% revenue growth rate applied. The discount rate utilized was 15.0% and the estimated tax rate was 24.7%. If all other assumptions are held constant, a reduction in the terminal value growth rate by 3.5% or an increase in discount rate by 1.0% would result in an impairment charge for the Greater China reporting unit.

In conjunction with its April 1, 2024 annual goodwill impairment test, the Company recorded a goodwill impairment charge of $321.0 million during the second quarter of 2024 related to its JANZ reporting unit. The impairment charge was primarily the result of a 1.0% increase in the discount rate and a 0.5% reduction in the terminal growth rate assumption for the reporting unit.

Due to the inherent uncertainty involved in making these estimates, actual results could differ from those estimates. In addition, changes in underlying assumptions, especially as they relate to the key assumptions detailed, could have a significant impact on the fair value of the reporting units.

Intangible Assets, Net

Intangible assets consist of the following components at June 30, 2025 and December 31, 2024:

(In millions)Weighted Average Life (Years)Original CostAccumulated AmortizationNet Book Value
Product rights, licenses and other (1)13$34,906.3$19,384.4$15,521.9
In-process research and development801.9—801.9
$35,708.2$19,384.4$16,323.8
Product rights, licenses and other (1)13$33,348.5$17,091.8$16,256.7
In-process research and development814.2—814.2
$34,162.7$17,091.8$17,070.9

(1)Represents amortizable intangible assets. Other intangible assets consist principally of customer lists and contractual rights.

On July 18, 2025, the Company announced that a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing. The Company is evaluating the appropriate next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study. The Company has an IPR&D asset of approximately $74 million related to this program.

Amortization expense, intangible asset disposal & impairment charges and IPR&D intangible asset impairment charges (which are included as a component of amortization expense) are classified primarily within Cost of Sales in the condensed consolidated statements of operations and were as follows for the three and six months ended June 30, 2025 and 2024:

Three Months Ended · Six Months Ended
June 30,June 30,
(In millions)2025202420252024
Intangible asset amortization expense$583.3$597.2$1,154.5$1,198.2
IPR&D intangible asset impairment charges2.2102.02.2102.0
Total intangible asset amortization expense (including disposal & impairment charges)$585.5$699.2$1,156.7$1,300.2

Intangible asset amortization expense over the remainder of 2025 and for the years ending December 31, 2026 through 2029 is estimated to be as follows:

(In millions)
2025$1,189
20262,324
20272,103
20281,840
20291,235
  1. Financial Instruments and Risk Management

The Company is exposed to certain financial risks relating to its ongoing business operations. The primary financial risks that are managed by using derivative instruments are foreign currency risk and interest rate risk.

Foreign Currency Risk Management

In order to manage certain foreign currency risks, the Company enters into foreign exchange forward contracts to mitigate risk associated with changes in spot exchange rates of mainly non-functional currency denominated assets or liabilities. The foreign exchange forward contracts are measured at fair value and reported as current assets or current liabilities in the condensed consolidated balance sheets. Any gains or losses on the foreign exchange forward contracts are recognized in earnings in the period incurred in the condensed consolidated statements of operations.

The Company has also entered into forward contracts to hedge forecasted foreign currency denominated sales from certain international subsidiaries and a portion of forecasted intercompany inventory sales denominated in Euro, Japanese Yen, and Chinese Renminbi for up toeighteen months. These contracts are designated as cash flow hedges to manage foreign currency transaction risk and are measured at fair value and reported as current assets or current liabilities in the condensed consolidated balance sheets. Any changes in the fair value of designated cash flow hedges are deferred in AOCE and are reclassified into earnings when the hedged item impacts earnings.

Net Investment Hedges

The Company may hedge the foreign currency risk associated with certain net investment positions in foreign subsidiaries by either borrowing directly in foreign currencies and designating all or a portion of the foreign currency debt as a hedge of the applicable net investment position or entering into foreign currency swaps that are designated as hedges of net investments.

The Company has designated certain Euro and Yen borrowings as a hedge of its investment in certain Euro-functional and Yen-functional currency subsidiaries in order to manage foreign currency translation risk. Borrowings designated as net investment hedges are marked-to-market using the current spot exchange rate as of the end of the period, with gains and losses included in the foreign currency translation component of AOCE until the sale or substantial liquidation of the underlying net investments. In addition, the Company manages the related foreign exchange risk of the Euro and Yen borrowings not designated as net investment hedges through certain Euro and Yen denominated financial assets and forward currency swaps.

The following table summarizes the principal amounts of the Company’s outstanding Euro and Yen borrowings and the notional amounts of the Euro and Yen borrowings designated as net investment hedges:

Notional Amount Designated as a Net Investment Hedge
(In millions)Principal AmountJune 30,2025December 31,2024
1.362% Euro Senior Notes due 2027€850.0€850.0€850.0
3.125% Euro Senior Notes due 2028750.0750.0750.0
1.908% Euro Senior Notes due 20321,250.01,250.01,250.0
Euro Total€2,850.0€2,850.0€2,850.0
Yen
YEN Term Loan¥40,000.0¥40,000.0¥40,000.0
Yen Total¥40,000.0¥40,000.0¥40,000.0

At June 30, 2025, the principal amount of the Company’s outstanding Yen borrowings and the notional amount of the Yen borrowings designated as net investment hedges was $277.7 million.

During the third quarter of 2023, the Company executed fixed-rate cross-currency interest rate swaps with notional amounts totaling Japanese Yen 14.6 billion with settlement dates through 2026. During the second quarter of 2024, the Company executed fixed-rate cross-currency interest rate swaps with notional amounts totaling €500 million with settlement dates through 2026. The transactions hedge a portion of the Company’s net investment in certain Yen- and Euro-functional currency subsidiaries. All changes in the fair value of these derivative instruments, which are designated as net investment hedges, are marked-to-market using the current spot exchange rate as of the end of the period. The portion of these changes related to the excluded component will be amortized in interest expense over the life of the derivative while the remainder will be recorded in AOCE until the sale or substantial liquidation of the underlying net investments. The semiannual net interest payment received related to the fixed-rate component of the cross-currency interest rate swaps will be reflected in operating cash flows. Subsequent to June 30, 2025, the Company terminated its Yen fixed-rate cross-currency interest rate swaps in exchange for $3.4 million in cash proceeds, net of fees.

During the fourth quarter of 2023, the Company executed foreign currency forward contracts with notional amounts totaling €500 million. During the second quarter of 2024, the Company executed additional foreign currency forward contracts with notional amounts totaling €600 million. The transactions hedged a portion of the Company’s net investment in certain Euro functional currency subsidiaries. The contracts were designated as a net investment hedge and matured in July 2024.

In April 2025, the Company executed foreign currency forward contracts with notional amounts totaling Chinese Renminbi 1.42 billion (approximately $200 million) maturing in December 2026 and Chinese Renminbi 695 million (approximately $100 million) maturing in December 2027. The transactions hedge a portion of the Company’s net investment in certain Chinese Renminbi functional currency subsidiaries. The contracts were designated as net investment hedges.

Interest Rate Risk Management

The Company enters into interest rate swaps from time to time in order to manage interest rate risk associated with the Company’s fixed-rate and floating-rate debt. Interest rate swaps that meet specific accounting criteria are accounted for as fair value or cash flow hedges. All derivative instruments used to manage interest rate risk are measured at fair value and reported as current assets or current liabilities in the condensed consolidated balance sheets. For fair value hedges, the changes in the fair value of both the hedging instrument and the underlying debt obligations are included in interest expense. For cash flow hedges, the change in fair value of the hedging instrument is deferred through AOCE and is reclassified into earnings when the hedged item impacts earnings.

Cash Flow Hedging Relationships

The Company’s interest rate swaps designated as cash flow hedges fix the interest rate on a portion of the Company’s variable-rate debt or hedge part of the Company’s interest rate exposure associated with the variability in the future cash flows attributable to changes in interest rates. Any changes in fair value are included in earnings or deferred through AOCE, depending on the nature and effectiveness of the offset. Any ineffectiveness in a cash flow hedging relationship is recognized immediately in earnings in the condensed consolidated statements of operations.

Credit Risk Management

The Company regularly reviews the creditworthiness of its financial counterparties and does not expect to incur a significant loss from the failure of any counterparties to perform under any agreements. The Company is not subject to any obligations to post collateral under derivative instrument contracts. Certain derivative instrument contracts entered into by the Company are governed by master agreements, which contain credit-risk-related contingent features that would allow the counterparties to terminate the contracts early and request immediate payment should the Company trigger an event of default on other specified borrowings. The Company records all derivative instruments on a gross basis in the condensed consolidated balance sheets. Accordingly, there are no offsetting amounts that net assets against liabilities.

The following table summarizes the classification and fair values of derivative instruments in our condensed consolidated balance sheets:

Asset DerivativesLiability Derivatives
(In millions)Balance Sheet LocationJune 30, 2025 Fair ValueDecember 31, 2024 Fair ValueBalance Sheet LocationJune 30, 2025 Fair ValueDecember 31, 2024 Fair Value
Derivatives designated as hedges:
Cross-currency interest rate swapsPrepaid expenses & other current assets$0.1$24.1Other current liabilities$52.7$—
Foreign currency forward contractsPrepaid expenses & other current assets3.939.2Other current liabilities23.3—
Foreign currency forward contracts——Other long-term obligations5.9—
Total derivatives designated as hedges4.063.381.9—
Derivatives not designated as hedges:
Foreign currency forward contractsPrepaid expenses & other current assets138.4198.3Other current liabilities301.0125.8
Total derivatives not designated as hedges138.4198.3301.0125.8
Total derivatives$142.4$261.6$382.9$125.8

The following table summarizes information about the gains/(losses) incurred to hedge or offset operational foreign exchange or interest rate risk:

Amount of Gains/(Losses) Recognized in Earnings · Amount of Gains/(Losses) Recognized in AOCE (Net of Tax) on Derivatives · Amount of Gains/(Losses) Reclassified from AOCE into Earnings
Three months ended June 30,
(In millions)Location of Gain/(Loss)202520242025202420252024
Derivative Financial Instruments in Cash Flow Hedging Relationships (1) :
Foreign currency forward contractsNet sales (3)$—$—$(21.6)$12.9$0.7$10.0
Interest rate swapsInterest expense (3)——(1.0)(1.3)(1.2)(1.6)
Derivative Financial Instruments in Net Investment Hedging Relationships:
Cross-currency interest rate swapsInterest expense (2)3.42.6(40.3)5.1——
Foreign currency forward contractsOther expense (income), net (3)——(4.6)3.31.1—
Non-derivative Financial Instruments in Net Investment Hedging Relationships:
Foreign currency borrowings——(233.0)45.1——
Derivative Financial Instruments Not Designated as Hedging Instruments:
Foreign currency option and forward contractsOther income, net (2)(125.3)68.9————
Total$(121.9)$71.5$(300.5)$65.1$0.6$8.4
Amount of Gains/(Losses) Recognized in Earnings · Amount of Gains/(Losses) Recognized in AOCE (Net of Tax) on Derivatives · Amount of Gains/(Losses) Reclassified from AOCE into Earnings
Six months ended June 30,
(In millions)Location of Gain/(Loss)202520242025202420252024
Derivative Financial Instruments in Cash Flow Hedging Relationships (1) :
Foreign currency forward contractsNet sales (3)$—$—$(34.8)$37.7$10.6$16.6
Interest rate swapsInterest expense (3)——(1.9)(2.5)(2.4)(3.2)
Derivative Financial Instruments in Net Investment Hedging Relationships:
Cross-currency interest rate swapsInterest expense (2)6.83.8(60.1)10.0——
Foreign currency forward contractsOther expense (income), net (3)——(4.6)14.01.1—
Non-derivative Financial Instruments in Net Investment Hedging Relationships:
Foreign currency borrowings——(349.4)162.1——
Derivative Financial Instruments Not Designated as Hedging Instruments:
Foreign currency option and forward contractsOther expense (income), net (2)(235.2)46.1————
Total$(228.4)$49.9$(450.8)$221.3$9.3$13.4

(1)At June 30, 2025, the Company expects that approximately $32.0 million of pre-tax net losses on cash flow hedges will be reclassified from AOCE into earnings during the next twelve months.

(2)Represents the location of the gain/(loss) recognized in earnings on derivatives.

(3)Represents the location of the gain/(loss) reclassified from AOCE into earnings.

Fair Value Measurement

Fair value is based on the price that would be received from the sale of an identical asset or paid to transfer an identical liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, a fair value hierarchy has been established that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

Level 2: Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities.

Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible, as well as considers counterparty credit risk in its assessment of fair value.

Financial assets and liabilities carried at fair value are classified in the tables below in one of the three categories described above:

June 30, 2025December 31, 2024
(In millions)Level 1Level 2Level 3Level 1Level 2Level 3
Recurring fair value measurements
Financial Assets
Cash equivalents:
Money market funds$223.1$—$—$387.7$—$—
Total cash equivalents223.1——387.7——
Equity securities:
Exchange traded funds58.3——54.8——
Marketable securities1.8——0.7——
Total equity securities60.1——55.5——
CCPS in Biocon Biologics——950.0——1,349.8
Available-for-sale fixed income investments:
Corporate bonds—13.7——12.9—
U.S. Treasuries—19.3——17.2—
Agency mortgage-backed securities—2.2——3.2—
Asset backed securities—4.2——4.4—
Other—0.3——0.3—
Total available-for-sale fixed income investments—39.7——38.0—
Foreign exchange derivative assets—142.3——237.5—
Interest rate swap derivative assets—0.1——24.1—
Total assets at recurring fair value measurement$283.2$182.1$950.0$443.2$299.6$1,349.8
Financial Liabilities
Foreign exchange derivative liabilities$—$330.2$—$—$125.8$—
Interest rate swap derivative liabilities—52.7————
Contingent consideration——367.2——556.1
Total liabilities at recurring fair value measurement$—$382.9$367.2$—$125.8$556.1

For financial assets and liabilities that utilize Level 2 inputs, the Company utilizes both direct and indirect observable price quotes, including interest rate yield curves, foreign exchange forward prices and bank price quotes. Below is a summary of valuation techniques for the Company’s financial assets and liabilities:

Cash equivalents — valued at observable net asset value prices.

Equity securities, exchange traded funds — valued at the active quoted market prices from broker or dealer quotations or transparent pricing sources at the reporting date. Unrealized gains and losses attributable to changes in fair value are included in Other Expense (Income), Net in the condensed consolidated statements of operations.

Equity securities, marketable securities — valued using quoted stock prices from public exchanges at the reporting date. Unrealized gains and losses attributable to changes in fair value are included in Other Expense (Income), Net in the condensed consolidated statements of operations.

CCPS in Biocon Biologics — The Company elected the fair value option for the CCPS under ASC 825. Through March 31, 2025, the CCPS were valued using a Monte Carlo simulation model using Level 3 inputs. The fair value of the CCPS is sensitive to changes in the forecasts of operating metrics, changes in volatility and discount rates, and share dilution. During the second quarter of 2025, there was an observable third-party transaction that indicated the fair value of the CCPS was lower than the amount calculated utilizing the Monte Carlo simulation model. Accordingly, the Company recognized a reduction in the fair value of $284.0 million during the second quarter of 2025 based upon this third-party transaction. The fair value is reassessed quarterly and any change in the fair value estimate is recorded in Other Expense (Income), Net in the condensed consolidated statements of operations for that period. During the three months ended June 30, 2025 and 2024, the Company recorded a loss (gain) of $284.0 million and $(282.4) million, respectively, and during the six months ended June 30, 2025 and 2024, the Company recorded a loss (gain) of $399.8 million and $(329.3) million, respectively, as a result of remeasuring the CCPS in Biocon Biologics to fair value. The Company’s CCPS in Biocon Biologics are classified as equity securities and are included in Other Assets in the condensed consolidated balance sheets.

Available-for-sale fixed income investments — valued at the quoted market prices from broker or dealer quotations or transparent pricing sources at the reporting date. Unrealized gains and losses attributable to changes in fair value, net of income taxes, are included in accumulated other comprehensive loss as a component of shareholders’ equity.

Foreign exchange derivative assets and liabilities — valued using quoted forward foreign exchange prices and spot rates at the reporting date. Counterparties to these contracts are highly rated financial institutions.

Contingent Consideration

As of June 30, 2025 and December 31, 2024, the Company had a contingent consideration liability of $288.0 million and $378.0 million, respectively, related to the Idorsia Transaction. During the six months ended June 30, 2025, the Company recorded a fair value adjustment gain related to the Idorsia Transaction contingent consideration liability, primarily as a result of the February 25, 2025 letter agreement entered into that amended certain terms of the original development agreement for selatogrel and cenerimod. Refer to Note 4 Acquisitions and Other Transactions for additional information.

As of June 30, 2025 and December 31, 2024, the Company had a contingent consideration liability of $77.5 million and $176.3 million, respectively, related to the Respiratory Delivery Platform. The measurement of these contingent consideration liabilities is calculated using unobservable Level 3 inputs based on the Company’s own assumptions primarily related to the probability and timing of future events, including the timing of additional potential competition, and payments which are discounted using a market rate of return. At June 30, 2025, discount rates ranging from 8.5% to 18.0%, and at December 31, 2024, discount rates ranging from 9.0% and 19.0% were utilized in the valuations. Significant changes in unobservable inputs could result in material changes to the contingent consideration liabilities.

A rollforward of the activity in the Company’s fair value of contingent consideration from December 31, 2024 to June 30, 2025 is as follows:

(In millions)Current Portion (1)Long-Term Portion (2)Total Contingent Consideration
Balance at December 31, 2024$59.5$496.6$556.1
Payments(19.9)—(19.9)
Reclassifications(2.5)2.5—
Accretion—2.42.4
Fair value gain (3)—(171.4)(171.4)
Balance at June 30, 2025$37.1$330.1$367.2

(1)Included in other current liabilities in the condensed consolidated balance sheets.

(2)Included in other long-term obligations in the condensed consolidated balance sheets.

(3)Included in litigation settlements and other contingencies, net in the condensed consolidated statements of operations.

Although the Company has not elected the fair value option for financial assets and liabilities other than the CCPS, any future transacted financial asset or liability will be evaluated for the fair value election.

  1. Debt

For additional information, see Note 10 Debtin Viatris’ 2024 Form 10-K.

Receivables Facility

The Company has a Receivables Facility for up to an aggregate amount of $600 million which expires in April 2028. Under the terms of the Receivables Facility, certain of our accounts receivable secure the amounts borrowed and cannot be used to pay our other debts or liabilities. The amount that we may borrow at a given point in time is determined based on the amount of qualifying accounts receivable that are present at such point in time. Amounts outstanding under the Receivables Facility are included as a component of short-term borrowings, while the accounts receivable securing these obligations remain as a component of accounts receivable, net, in our condensed consolidated balance sheets.

Long-Term Debt

A summary of long-term debt is as follows:

($ in millions)Interest Rate as of June 30, 2025June 30,2025December 31,2024
Current portion of long-term debt:
2026 Senior Notes **3.950%$1,673.5$—
Other0.80.6
Deferred financing fees(1.2)—
Current portion of long-term debt$1,673.1$0.6
Non-current portion of long-term debt:
2026 Senior Notes **3.950%$—$1,672.8
2027 Euro Senior Notes ****1.362%1,019.5899.4
2027 Senior Notes ***2.300%761.4764.2
2028 Euro Senior Notes **3.125%881.1773.7
2028 Senior Notes *4.550%749.4749.3
2030 Senior Notes ***2.700%1,492.91,497.0
2032 Euro Senior Notes ****1.908%1,560.71,376.2
2040 Senior Notes ***3.850%1,633.61,637.1
2043 Senior Notes *5.400%497.6497.5
2046 Senior Notes **5.250%999.9999.9
2048 Senior Notes *5.200%747.9747.9
2050 Senior Notes ***4.000%2,189.22,191.6
YEN Term Loan FacilityVariable277.7254.4
Other2.22.2
Deferred financing fees(21.5)(24.3)
Long-term debt$12,791.6$14,038.9

*Instrument was issued by Mylan Inc.

**Instrument was originally issued by Mylan N.V.; now held by Utah Acquisition Sub Inc.

***Instrument was issued by Viatris Inc.

****Instrument was issued by Upjohn Finance B.V.

Fair Value

At June 30, 2025 and December 31, 2024, the aggregate fair value of the Company’s outstanding notes was approximately $11.81 billion and $11.53 billion, respectively. The fair values of the outstanding notes were valued at quoted market prices from broker or dealer quotations and were classified as Level 2 in the fair value hierarchy.

Mandatory minimum repayments remaining on the notional amount of outstanding long-term debt at June 30, 2025 were as follows for each of the periods ending December 31:

(In millions)Total
2025$—
20261,953
20271,752
20281,634
2029—
Thereafter8,673
Total$14,012
  1. Comprehensive Loss

Accumulated other comprehensive loss, as reflected in the condensed consolidated balance sheets, is comprised of the following:

(In millions)June 30,2025December 31,2024
Accumulated other comprehensive loss:
Net unrealized loss on available-for-sale fixed income securities, net of tax$(0.6)$(1.2)
Net unrecognized gain and prior service cost related to defined benefit plans, net of tax253.8254.2
Net unrecognized loss on derivatives in cash flow hedging relationships, net of tax(12.8)32.3
Net unrecognized gain on derivatives in net investment hedging relationships, net of tax80.2492.6
Foreign currency translation adjustment(2,985.0)(3,990.8)
$(2,664.4)$(3,212.9)

Components of accumulated other comprehensive loss, before tax, consist of the following, for the three and six months ended June 30, 2025 and 2024:

Three Months Ended June 30, 2025
Gains and Losses on Derivatives in Cash Flow Hedging Relationships · Gains and Losses on Net Investment Hedges · Gains and Losses on Available-for-Sale Fixed Income Securities · Defined Pension Plan Items · Foreign Currency Translation Adjustment · Totals
(In millions) · Foreign Currency Forward Contracts · Interest Rate Swaps · Total
Balance at March 31, 2025, net of tax$9.0$359.1$(0.8)$253.8$(3,492.0)$(2,870.9)
Other comprehensive (loss) earnings before reclassifications, before tax(29.5)(355.2)0.23.4507.0125.9
Amounts reclassified from accumulated other comprehensive (loss) earnings, before tax:
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales(0.7)(0.7)(0.7)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense1.21.21.2
Amortization of actuarial gain included in SG&A(2.9)(2.9)
Net other comprehensive (loss) earnings, before tax(29.0)(355.2)0.20.5507.0123.5
Income tax (benefit) provision(7.2)(76.3)—0.5—(83.0)
Balance at June 30, 2025, net of tax$(12.8)$80.2$(0.6)$253.8$(2,985.0)$(2,664.4)
Six Months Ended June 30, 2025
Gains and Losses on Derivatives in Cash Flow Hedging Relationships · Gains and Losses on Net Investment Hedges · Gains and Losses on Available-for-Sale Fixed Income Securities · Defined Pension Plan Items · Foreign Currency Translation Adjustment · Totals
(In millions) · Foreign Currency Forward Contracts · Interest Rate Swaps · Total
Balance at December 31, 2024, net of tax$32.3$492.6$(1.2)$254.2$(3,990.8)$(3,212.9)
Other comprehensive (loss) earnings before reclassifications, before tax(48.3)(528.9)0.86.11,005.8435.5
Amounts reclassified from accumulated other comprehensive (loss) earnings, before tax:
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales(10.6)(10.6)(10.6)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense2.42.42.4
Amortization of actuarial gain included in SG&A(5.8)(5.8)
Net other comprehensive (loss) earnings, before tax(56.5)(528.9)0.80.31,005.8421.5
Income tax (benefit) provision(11.4)(116.5)0.20.7—(127.0)
Balance at June 30, 2025, net of tax$(12.8)$80.2$(0.6)$253.8$(2,985.0)$(2,664.4)
Three Months Ended June 30, 2024
Gains and Losses on Derivatives in Cash Flow Hedging Relationships · Gains and Losses on Net Investment Hedges · Gains and Losses on Available-for-Sale Fixed Income Securities · Defined Pension Plan Items · Foreign Currency Translation Adjustment · Totals
(In millions) · Foreign Currency Forward Contracts · Interest Rate Swaps · Total
Balance at March 31, 2024, net of tax$13.6$369.6$(1.4)$266.4$(3,589.2)$(2,941.0)
Other comprehensive earnings (loss) before reclassifications, before tax17.168.4—(2.0)(89.7)(6.2)
Amounts reclassified from accumulated other comprehensive earnings (loss), before tax:
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales(10.0)(10.0)(10.0)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense1.61.61.6
Amortization of prior service costs included in SG&A0.60.6
Amortization of actuarial gain included in SG&A(4.2)(4.2)
Net other comprehensive earnings (loss), before tax8.768.4—(5.6)(89.7)(18.2)
Income tax provision (benefit)2.114.8—(0.9)—16.0
Balance at June 30, 2024, net of tax$20.2$423.2$(1.4)$261.7$(3,678.9)$(2,975.2)
Six Months Ended June 30, 2024
Gains and Losses on Derivatives in Cash Flow Hedging Relationships · Gains and Losses on Net Investment Hedges · Gains and Losses on Available-for-Sale Fixed Income Securities · Defined Pension Plan Items · Foreign Currency Translation Adjustment · Totals
(In millions) · Foreign Currency Forward Contracts · Interest Rate Swaps · Total
Balance at December 31, 2023, net of tax$(8.0)$237.1$(1.2)$271.4$(3,246.7)$(2,747.4)
Other comprehensive earnings (loss) before reclassifications, before tax50.8237.5(0.3)(4.4)(432.2)(148.6)
Amounts reclassified from accumulated other comprehensive (loss) earnings, before tax:
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales(16.6)(16.6)(16.6)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense3.23.23.2
Amortization of prior service costs included in SG&A1.11.1
Amortization of actuarial gain included in SG&A(8.5)(8.5)
Net other comprehensive earnings (loss), before tax37.4237.5(0.3)(11.8)(432.2)(169.4)
Income tax provision (benefit)9.251.4(0.1)(2.1)—58.4
Balance at June 30, 2024, net of tax$20.2$423.2$(1.4)$261.7$(3,678.9)$(2,975.2)
  1. Segment Information

Viatris hasfour reportable segments: Developed Markets, Greater China, JANZ, and Emerging Markets. The Company reports segment information on the basis of markets and geography, which reflects its focus on bringing its large and diversified portfolio of branded and generic products, including complex products, to people in markets everywhere. Our Developed Markets segment comprises our operations primarily in North America and Europe. Our Greater China segment includes our operations in mainland China, Taiwan and Hong Kong. Our JANZ segment consists of our operations in Japan, Australia and New Zealand. Our Emerging Markets segment encompasses our presence in more than 125 countries with developing markets and emerging economies including in Asia, Africa, Eastern Europe, Latin America and the Middle East as well as the Company’s ARV franchise.

The Company’s chief operating decision maker (“CODM”) is the Chief Executive Officer, who evaluates the performance of its segments and allocates resources based on total revenues and our measure of segment profit or loss, segment profitability. These financial metrics are used to review operating trends, perform comparisons between periods, and monitor budget and forecast-to-actual variances on a regular basis. Net sales of our business segments exclude intersegment sales as these activities are not regularly reviewed by the CODM and are eliminated in consolidation.

Certain costs and gains are not included in the measurement of segment profitability, or in segment cost of sales, and segment SG&A, as management excludes these costs in assessing segment financial performance. Such costs and gains include:

Intangible asset amortization expense;

Asset impairments (including of goodwill, intangible assets (including IPR&D), and long-lived assets);

R&D and Acquired IPR&D expense;

Net charges or net gains for litigation settlements and other contingencies;

Certain costs related to transactions and events such as: (i) purchase accounting adjustments, where we incur expenses associated with the amortization of fair value adjustments to inventory and property, plant and equipment; (ii) share-based compensation expense; (iii) acquisition-related costs, where we incur costs for executing the transaction, integrating the acquired operations and restructuring the combined company; and (iv) other significant items, which are substantive and/or unusual, and in some cases recurring, items (such as restructuring, including costs associated with facilities to be closed or divested, employee separation costs, impairment charges, accelerated depreciation, incremental manufacturing variances, equipment relocation costs, decommissioning and other restructuring related costs, and certain remediation costs) that are evaluated on an individual basis by management and that either as a result of their nature or size, would not be expected to occur as part of our normal business on a regular basis. Such special items can include, but are not limited to, non-acquisition-related restructuring costs, as well as costs incurred for asset impairments and costs, as well as gains and losses, related to disposals of assets or businesses, including those related to divestitures, and, as applicable, any associated transition activities;

Corporate and other unallocated costs associated with global functions (such as IT, facilities, legal, finance, human resources, insurance, public affairs, compliance, and procurement), patient advocacy activities and certain compensation and other corporate costs (such as certain expenses associated with our manufacturing, including manufacturing variances associated with production) and operations that are not directly assessed to an operating segment as business unit (segment) management does not manage these costs;

Other Expense (Income), Net (including interest and dividend income, gains and losses from investments, business divestitures, and foreign exchange); and

Interest expense.

The Company does not report depreciation expense, total assets and capital expenditures by segment, as such information is not used by the CODM.

The accounting policies of the segments are the same as those described in Note 2 Summary of Significant Accounting Policies included in the 2024 Form 10-K.

Presented in the table below is segment information for the periods identified and a reconciliation of segment information to total consolidated information.

(In millions) · Developed Markets · Greater China · JANZ · Emerging Markets · Total Reportable Segments
Net Sales$2,119.3$588.9$305.7$555.1$3,569.0
Other revenue10.3—1.01.813.1
Total revenue$2,129.6$588.9$306.7$556.9$3,582.1
Less:
Cost of sales1,004.662.5181.7240.41,489.2
Selling, general and administration249.5124.641.378.4493.8
Segment profitability$875.5$401.8$83.7$238.1$1,599.1
Reconciliation of segment profit:
Intangible asset amortization expense(583.3)
Intangible asset (including IPR&D) disposal & impairment charges(2.2)
Research and development(218.8)
Acquired IPR&D—
Litigation settlements & other contingencies, net47.6
Transaction related and other special items(212.8)
Corporate and other unallocated(396.6)
Earnings from operations$233.0
(In millions)Developed MarketsGreater ChinaJANZEmerging MarketsTotal Reportable Segments
Net sales$4,011.0$1,144.4$581.8$1,075.0$6,812.2
Other revenues17.2—2.05.024.2
Total revenues$4,028.2$1,144.4$583.8$1,080.0$6,836.4
Less:
Cost of sales1,930.8123.3358.2453.22,865.5
Selling, general and administration483.8234.679.7152.7950.8
Segment profit$1,613.6$786.5$145.9$474.1$3,020.1
Reconciliation of segment profit:
Intangible asset amortization expense(1,154.5)
Intangible asset (including IPR&D) disposal & impairment charges(2.2)
Impairment of goodwill(2,936.8)
Research and development(440.8)
Acquired IPR&D(10.0)
Litigation settlements and other contingencies, net121.1
Transaction related and other special items(469.3)
Corporate and other unallocated(776.8)
Loss from operations$(2,649.2)
(In millions) · Developed Markets · Greater China · JANZ · Emerging Markets · Total Reportable Segments
Net Sales$2,319.2$539.0$349.6$578.1$3,785.9
Other revenue5.90.40.24.210.7
Total revenue$2,325.1$539.4$349.8$582.3$3,796.6
Less:
Cost of sales1,025.159.2207.3271.61,563.2
Selling, general and administration292.3130.841.278.0542.3
Segment profitability$1,007.7$349.4$101.3$232.7$1,691.1
Reconciliation of segment profit:
Intangible asset amortization expense(597.2)
Intangible asset (including IPR&D) disposal & impairment charges(102.0)
Impairment of goodwill(321.0)
Research and development(204.1)
Acquired IPR&D7.8
Litigation settlements & other contingencies, net(131.0)
Transaction related and other special items(196.4)
Corporate and other unallocated(387.1)
Loss from operations$(239.9)
(In millions)Developed MarketsGreater ChinaJANZEmerging MarketsTotal Reportable Segments
Net sales$4,484.6$1,082.9$667.4$1,204.5$7,439.4
Other revenues13.10.40.56.620.6
Total revenues$4,497.7$1,083.3$667.9$1,211.1$7,460.0
Less:
Cost of sales2,001.5120.4396.7536.93,055.5
Selling, general and administration575.2247.282.6162.01,067.0
Segment profit$1,921.0$715.7$188.6$512.2$3,337.5
Reconciliation of segment profit:
Intangible asset amortization expense(1,198.2)
Intangible asset (including IPR&D) disposal & impairment charges(102.0)
Impairment of goodwill(321.0)
Research and development(403.8)
Acquired IPR&D1.7
Litigation settlements and other contingencies, net(207.8)
Transaction related and other special items(398.7)
Corporate and other unallocated(743.7)
Loss from operations$(36.0)
  1. Licensing and Other Partner Agreements

We periodically enter into licensing and other partner agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products. Our significant licensing and other partner agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple complex products. Under these agreements, we have future potential milestone payments and co-development expenses payable to third parties as part of our licensing, development and co-development programs. Payments under these agreements generally become due and are payable upon the satisfaction or achievement of certain developmental, regulatory or commercial milestones or as development expenses are incurred on defined projects. Milestone payment obligations are uncertain, including the prediction of timing and the occurrence of events triggering a future obligation and are not reflected as liabilities in the condensed consolidated balance sheets, except for obligations reflected as acquisition related contingent consideration, including those related to the Idorsia Transaction. Refer to Note 11 Financial Instruments and Risk Management for further discussion of contingent consideration.

Our potential maximum development milestones not accrued for at June 30, 2025 totaled approximately $398 million. We estimate that the amounts that may be paid through the end of 2025 to be approximately $24 million. These agreements may also include potential sales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profit share. The amounts disclosed do not include sales-based milestones or royalty or profit share obligations on future sales of product as the timing and amount of future sales levels and costs to produce products subject to these obligations is not reasonably estimable. These sales-based milestones or royalty or profit share obligations may be significant depending upon the level of commercial sales for each product.

Mapi

In 2018, the Company entered into an exclusive license and commercialization agreement with Mapi for the development and commercialization on a world-wide basis of GA Depot. Under the terms of the license and commercialization agreement, as of June 30, 2025, Mapi is eligible to receive regulatory approval and commercial launch milestone payments of up to $90.0 million. Additionally, upon commercial launch of GA Depot, Mapi is eligible to receive potential contingent payments, such as tiered royalties and tiered sales-based milestones.

During the first quarter of 2024, the Company was informed that Mapi received a Complete Response Letter (“CRL”) regarding the NDA for GA Depot 40 mg from the FDA. In December 2024, the companies met with the FDA and reviewed the content of the CRL. As a result of the meeting, Viatris and Mapi are discussing and determining the appropriate next steps for the program. In the fourth quarter of 2024, as a result of the additional uncertainty of regulatory and commercial timing and success of GA Depot and the financial condition of Mapi, the Company impaired its equity investment and prepaid assets related to advances for the initial supply of commercial product. Total charges of $184.6 million were recorded during the year ended December 31, 2024 as a component of Other Expense (Income), Net in the consolidated statements of operations.

In December 2023, the Company entered into a letter agreement, as amended, with Mapi for the development and commercialization of certain additional products, which is subject to finalization pending the execution of a definitive agreement. The Company made an initial upfront payment of $75.0 million which was accounted for as Acquired IPR&D expense in the consolidated statements of operations during 2023.

There have been no other significant changes to our licensing and other partner agreements as disclosed in our 2024 Form 10-K.

  1. Income Taxes

Legislative Updates

On July 4, 2025, the U.S. enacted the One Big Beautiful Bill Act (“OBBBA”), which contains a broad range of tax reform provisions affecting businesses, including permanent extensions of most expiring Tax Cuts and Jobs Act provisions and international tax changes. Consistent with ASC 740, Income Taxes, the effects of the changes in legislation are not included in the Company’s results for the three and six months ended June 30, 2025, but will be recognized in the period in which the legislation is enacted. The Company is still evaluating the impacts of the OBBBA, which could affect the Company's effective tax rate and deferred tax assets in 2025 and future periods, and cannot be reasonably determined at this time due to the complexity of the OBBBA and anticipated guidance from the U.S. Department of the Treasury.

On August 16, 2022, the U.S. government enacted the Inflation Reduction Act of 2022 into law, which includes a new corporate alternative minimum tax (“CAMT”) and an excise tax of 1% on the fair market value of net stock repurchases. Both provisions are effective for years after December 31, 2022. The Company reflected the applicable estimated excise tax in treasury stock as part of the cost basis of the stock repurchased and recorded a corresponding liability in Other current liabilities in its condensed consolidated balance sheets as of June 30, 2025 and December 31, 2024. The share repurchase and authorization amounts otherwise disclosed in this Form 10-Q exclude the excise tax. The Company does not anticipate being subject to the 15% CAMT tax in 2025 based on enacted law and regulatory guidance; however, its CAMT status could change in the future, depending on new regulations or regulatory guidance issued by the U.S. Department of the Treasury, including with respect to the OBBBA.

In addition, many countries are actively considering or have proposed or enacted changes to their tax laws based on the Pillar Two Global Anti-Base Erosion Rules (“Pillar Two Rules”) proposed by the Organisation for Economic Co-operation and Development. The Pillar Two Rules impose a global minimum tax of 15%, and under these rules, the Company may be required to pay a “top-up” tax to the extent our effective tax rate in any given country is below 15%. Several countries have enacted the Pillar Two Rules effective January 1, 2024, with many countries postponing implementation to January 1, 2025 or later, if at all. After determining which jurisdictions are not required to calculate a Pillar Two liability as a result of the existing safe harbors, the Company has determined that, while the impact of the Pillar Two Rules in the countries that have enacted such rules effective for tax years ending on or before December 31, 2025 did increase its effective tax rate, the impact is not material to its results for the three and six months ended June 30, 2025. The Company will continue to monitor and evaluate the evolving tax legislation in the jurisdictions in which it operates which could impact future tax provision and financial results, such as the recently announced understanding between the U.S. and the Group of Seven of a side-by-side system that would fully exclude U.S. parented groups from certain provisions of the Pillar Two Rules.

Tax Examinations

The Company is subject to income taxes and tax audits in many jurisdictions. A certain degree of estimation is thus required in recording the assets and liabilities related to income taxes. Tax audits and examinations can involve complex issues, interpretations, and judgments and the resolution of matters that may span multiple years, particularly if subject to litigation or negotiation.

Although the Company believes that adequate provisions have been made for these uncertain tax positions, the Company’s assessment of uncertain tax positions, including those arising from legal entity restructuring transactions in connection with the Combination, is based on estimates and assumptions that the Company believes are reasonable but the estimates for unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes, and variations from such estimates could materially affect the Company’s financial condition, results of operations or cash flows in the period of resolution, settlement or when the statutes of limitations expire.

The Company is subject to ongoing IRS examinations. The years 2020 through 2023 are open years, with 2020 and 2021 under examination.

Several international audits are currently in progress. In some cases, the tax auditors have proposed adjustments or issued assessments to our tax positions, including with respect to intercompany transactions, and we are in ongoing discussions with some of the auditors regarding the validity of their tax positions.

In instances where assessments have been issued, we disagree with these assessments and believe they are without merit and incorrect as a matter of law. As a result, we anticipate that certain of these matters may become the subject of litigation before tax courts where we intend to vigorously defend our position.

In France, the tax authorities have issued notices of assessments to the Company for the years ended December 2013 to December 2015 concerning our tax position with respect to whether income earned by a Company entity not domiciled in France should be subject to French tax. We have commenced litigation before the French tax courts where the tax authorities will seek unpaid taxes, penalties, and interest. A decision is pending.

In India, the tax authorities have issued notices of assessments to the Company seeking unpaid taxes and interest for the financial years covering 2013 to 2018 concerning our tax position with respect to certain corporate tax deductions and certain intercompany transactions. Some of these issues were resolved through the Company entering into an agreement with the tax authorities in March 2023 in respect of the pricing of its international transactions. The Company recorded tax expense of approximately $22.3 million during the year ended December 31, 2023 due to the terms of this agreement. The remaining issues are in the audit phase or are being challenged in the Indian tax courts.

In 2020, the Swedish Tax Authorities (“STA”) asserted an underpayment of tax against Meda A.B. for the tax years 2014 to 2019. The claim was that profits earned by its Luxembourg subsidiary should have been attributed to Meda A.B. The Company appealed the STA’s assessment to the Administrative Court of Stockholm. On September 16, 2022, the Court ruled in favor of Meda A.B. that no tax was due. The STA appealed that decision. On April 10, 2024, the Administrative Court of Appeals overturned the lower Court’s ruling and issued a decision in favor of the STA upholding its original assessment. The amount due including interest and penalties is approximately $18.2 million, which was paid during the second quarter of 2024. The Company’s petition seeking review of the decision to the Supreme Administrative Court was denied and this matter is now closed.

The Company has recorded a net reserve for uncertain tax positions of $263.6 million and $277.0 million, including interest and penalties, in connection with its international audits at June 30, 2025 and December 31, 2024, respectively. In connection with our international tax audits, it is possible that we will incur material losses above the amounts reserved.

The Company’s major U.S. state taxing jurisdictions remain open from fiscal year 2015 through 2023, with several state audits currently in progress. The Company’s major international taxing jurisdictions remain open from 2013 through 2024.

Accounting for Uncertainty in Income Taxes

The impact of an uncertain tax position that is more likely than not of being sustained upon audit by the relevant taxing authority must be recognized at the largest amount that is more likely than not to be sustained. No portion of an uncertain tax position will be recognized if the position has less than a 50% likelihood of being sustained.

  1. Litigation

The Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, and litigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in losses, including damages, fines and/or civil penalties, and/or criminal charges against the Company. These matters are often complex and have outcomes that are difficult to predict.

In addition, in connection with the Combination, the Company has generally assumed liability for, and control of, pending and threatened legal matters relating to the Upjohn Business – including certain matters initiated against Pfizer described below – and has agreed to indemnify Pfizer for liabilities arising out of such assumed legal matters. Pfizer, however, has agreed to retain various matters – including certain specified competition law matters – to the extent they arise from conduct during the pre-Distribution period and has agreed to indemnify the Company for liabilities arising out of such matters.

While the Company believes that it has meritorious defenses with respect to the claims asserted against it and the assumed legal matters referenced above, and intends to vigorously defend its position, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict the ultimate resolution of any such matter. It is possible that an unfavorable resolution of any of the ongoing matters could have a material effect on the Company’s business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares and/or stock price.

Some of these governmental inquiries, investigations, proceedings and litigation matters with which the Company is involved are described below, and unless otherwise disclosed, the Company is unable to predict the outcome of the matter or to provide an estimate of the range of reasonably possible material losses. The Company records accruals for loss contingencies to the extent we conclude it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company is also involved in other pending proceedings for which, in the opinion of the Company based upon facts and circumstances known at the time, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company’s business, financial position, results of operations, cash flows, ability to pay dividends or repurchase shares and/or stock price. If and when any reasonably possible losses associated with the resolution of such other pending proceedings, in the opinion of the Company, become material, the Company will disclose such matters.

Legal costs are recorded as incurred and are classified in SG&A in the Company’s condensed consolidated statements of operations.

EpiPen® Auto-Injector Litigation

On February 14, 2020, the Company, together with other non-Viatris affiliated companies, were named as defendants in a putative direct purchaser class action filed in the U.S. District Court for the District of Kansas relating to the pricing and/or marketing of the EpiPen® Auto-Injector. On September 21, 2021, Plaintiffs filed an amended complaint asserting federal antitrust claims which were based on allegations concerning a patent settlement between Pfizer and Teva and other alleged actions regarding the launch of Teva’s generic epinephrine auto-injector. Plaintiffs sought monetary damages, declaratory relief, attorneys’ fees and costs. In December 2024, the Company reached an agreement and paid $73.5 million to fully resolve this matter. The settlement was approved by the court and contains an express provision disclaiming and denying any wrongdoing by the Company. This matter is now closed.

Beginning in March 2020, the Company, together with other non-Viatris affiliated companies, were named as defendants in putative direct purchaser class actions filed in the U.S. District Court for the District of Minnesota relating to contracts with certain pharmacy benefit managers concerning EpiPen® Auto-Injector. The plaintiffs claim that the alleged conduct resulted in the exclusion or restriction of competing products and the elimination of pricing constraints in violation of RICO and federal antitrust law. Class certification was denied. The case is proceeding with Rochester Drug Company, Dakota Drug, and Morris & Dickson Company as plaintiffs and they seek monetary damages, attorneys’ fees and costs.

In January 2025, the State of Indiana filed a complaint in Superior Court in Marion County, Indiana against the Company and other non-Viatris affiliated companies alleging harm under Indiana state laws, including antitrust and consumer protection laws, and unjust enrichment claims. Indiana generally seeks monetary damages, restitution, disgorgement, civil penalties, injunctive relief, and attorneys’ fees and costs.

In June 2024, the Company received a civil subpoena from the Attorney General of the State of Mississippi seeking information relating to the sales and/or marketing of EpiPen® Auto-Injector. The Company is fully cooperating with this request and has communicated with certain other State Attorneys General regarding related issues.

The issues covered in the Indiana complaint, Mississippi subpoena, and communications with certain other States, generally relate to issues from litigations and/or investigations that have been previously disclosed, including the indirect purchaser class action that was resolved in 2022 and the direct purchaser litigation matters described above.

The Company has a total accrual of approximately $25.0 million related to these matters at June 30, 2025, which is included in other current liabilities in the condensed consolidated balance sheets. Although it is reasonably possible that the Company may incur additional losses from these matters, any amount cannot be reasonably estimated at this time. In addition, the Company expects to incur additional legal and other professional service expenses associated with such matters in future periods and will recognize these expenses as services are received. The Company believes that the ultimate amount paid for these services and claims could have a material effect on the Company's business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares and/or stock price in future periods.

Drug Pricing Matters

Civil Litigation

Beginning in 2016, the Company, along with other manufacturers, has been named as a defendant in lawsuits filed in the United States and Canada generally alleging anticompetitive conduct with respect to generic drugs. The lawsuits have been filed by plaintiffs, including putative classes of direct purchasers, indirect purchasers, and indirect resellers, as well as individual direct and indirect purchasers and certain cities and counties. The lawsuits allege harm under federal laws and the United States lawsuits also allege harm under state laws, including antitrust laws, state consumer protection laws and unjust enrichment claims. Some of the United States lawsuits also name as defendants the Company’s former President, including allegations against him with respect to a single drug product, and one of the Company’s sales employees, including allegations against him with respect to certain generic drugs. The vast majority of the lawsuits have been consolidated in an MDL proceeding in the Eastern District of Pennsylvania (“EDPA”). Plaintiffs generally seek monetary damages, restitution, declaratory and injunctive relief, attorneys’ fees and costs.

The EDPA Court ordered the Clomipramine and Clobetasol direct and indirect purchaser cases to proceed as bellwethers. The Company is named only in the Clomipramine bellwether cases, wherein the EDPA Court certified both direct and indirect purchaser classes. Defendants filed petitions for permission to appeal those class certification decisions, which were granted by the U.S. Court of Appeals for the Third Circuit. These cases have been stayed pending a decision on the Defendants’ class certification appeals. The Defendants’ summary judgment motions remain pending. Plaintiffs are asserting damages of approximately $350 million in each of the Clomipramine bellwether cases, which are subject to trebling under federal law in the direct purchaser case or multipliers under certain state laws in the indirect purchaser case.

The EDPA Court has selected two additional cases to proceed as bellwether cases. The Company is named only in one of those cases, which is a non-class case filed by a direct and indirect purchaser against the Company and other manufacturers. The Company believes that it acted lawfully, is continuing to defend itself vigorously, and intends to vigorously contest all aspects of the cases, including the asserted damages.

Attorneys General Litigation

On December 21, 2015, the Company received a subpoena and interrogatories from the Connecticut Office of the Attorney General seeking information relating to the marketing, pricing and sale of certain of the Company’s generic products and communications with competitors about such products. On December 14, 2016, attorneys general of certain states filed a complaint in the United States District Court for the District of Connecticut against several generic pharmaceutical drug manufacturers, including the Company, alleging anticompetitive conduct with respect to, among other things, a single drug product. The complaint has subsequently been amended, including on June 18, 2018, to add attorneys general alleging violations of federal and state antitrust laws, as well as violations of various states’ consumer protection laws. This lawsuit was transferred to the aforementioned MDL proceeding in the EDPA. The operative complaint includes attorneys general offorty-two states, the District of Columbia and the Commonwealth of Puerto Rico. The Company is alleged to have engaged in anticompetitive conduct with respect to four generic drug products. The amended complaint also includes claims asserted by attorneys general ofthirty-two states and the Commonwealth of Puerto Rico against certain individuals, including the

Company’s former President, with respect to a single drug product. The operative complaint seeks declaratory and injunctive relief, disgorgement, attorneys’ fees and costs, and certain states seek monetary damages, civil penalties, restitution, and other equitable monetary relief. The states’ claim for disgorgement and restitution under federal law, and certain state law claims brought by certain states, have been dismissed.

On May 10, 2019, certain attorneys general filed a new complaint in the United States District Court for the District of Connecticut against various drug manufacturers and individuals, including the Company and one of its sales employees, alleging anticompetitive conduct with respect to additional generic drugs. The complaint was subsequently amended, including on November 22, 2024, to add states as plaintiffs. The operative complaint is brought by attorneys general offorty-four states, certain territories and the District of Columbia. The amended complaint also includes claims asserted by attorneys general offorty states and certain territories against several individuals, including a Company sales employee. The operative complaint seeks declaratory and injunctive relief, disgorgement, attorneys’ fees and costs, and certain states seek monetary damages, civil penalties, restitution, and other equitable monetary relief. This lawsuit was transferred to the aforementioned MDL proceeding in the EDPA.

On June 10, 2020, certain attorneys general filed a new complaint in the United States District Court for the District of Connecticut against drug manufacturers, including the Company, and individual defendants (none from the Company), alleging anticompetitive conduct with respect to additional generic drugs. On September 9, 2021, the complaint was amended, adding an additional state as a plaintiff. The operative complaint is brought by attorneys general offorty-two states, certain territories and the District of Columbia. The operative complaint seeks declaratory and injunctive relief, disgorgement, attorneys’ fees and costs, and certain states seek monetary damages, civil penalties, restitution, and other equitable monetary relief. The states’ claim for disgorgement and restitution under federal law, and certain state law claims brought by certain states, have been dismissed. This lawsuit was transferred to the aforementioned MDL proceeding in the EDPA and was ordered to proceed as a bellwether. The Company has filed motions for summary judgment seeking to dismiss this case in its entirety, which remains pending.

The aforementioned complaints have been transferred back to the U.S. District Court for the District of Connecticut.

Securities Related Litigation

On February 14, 2020, the Abu Dhabi Investment Authority (“ADIA”) filed a complaint against Mylan N.V. and Mylan Inc. (collectively for purposes of this paragraph, “Mylan”) in the United States District Court for the Southern District of New York (“SDNY”) alleging that Mylan made false or misleading statements and omissions of purportedly material fact, in violation of federal securities laws, in connection with disclosures relating to the classification of their EpiPen® Auto-Injector as a non-innovator drug for purposes of the Medicaid Drug Rebate Program and allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs (“ADIA Litigation”). ADIA seeks monetary damages as well as fees and costs. Mylan has filed a motion for summary judgment to dismiss ADIA’s case in its entirety, which is pending. As previously disclosed, the allegations in ADIA’s complaint were the subject of a class action lawsuit filed in the same court in the SDNY against Mylan and certain individuals. In March 2023, the SDNY dismissed the class action lawsuit in its entirety on summary judgment, which was affirmed on appeal and concluded the class action lawsuit.

On June 26, 2020, a putative class action complaint was filed by the Public Employees Retirement System of Mississippi, which was subsequently amended on November 13, 2020, against Mylan N.V., certain of Mylan N.V.’s former directors and officers, and a former officer/current director of the Company (collectively for the purposes of this paragraph, the “defendants”) in the U.S. District Court for the Western District of Pennsylvania (“WDPA”) on behalf of certain purchasers of securities of Mylan N.V. (“WDPA Mylan N.V. Class Action Litigation”). The amended complaint includes allegations that defendants engaged in a scheme and made false or misleading statements and omissions of purportedly material fact, in violation of federal securities laws, in connection with disclosures relating to the Nashik and Morgantown manufacturing plants and inspections at the plants by the FDA. Plaintiff seeks certification of a class of purchasers of Mylan N.V. securities between February 16, 2016 and May 7, 2019. In July 2025, the Court held that Plaintiffs’ misstatements claim as to 1 of the 46 challenged statements, and their scheme claim, may proceed to discovery. The complaint seeks monetary damages, as well as the plaintiff’s fees and costs.

On February 15, 2021, a complaint was filed in the SDNY by Skandia Mutual Life Ins. Co., Lansforsakringar AB, KBC Asset Management N.V., and GIC Private Limited, against the Company, certain of Mylan N.V.’s former directors and officers, a former officer/current director of the Company, and certain former and current employees of the Company (“Skandia Litigation”). The Complaint filed in the Skandia Litigation asserted claims which were based on allegations that were similar to those in the ADIA Litigation and WDPA Mylan N.V. Class Action Litigation. Plaintiffs sought compensatory damages, costs and expenses and attorneys’ fees. The parties reached an agreement that resolves this matter and it is now closed.

Beginning in May 2023, putative class action complaints were filed against the Company and certain of the Company’s current and former officers, directors, and employees in the WDPA on behalf of certain purchasers of securities of the Company. These actions have been consolidated and, on October 23, 2023, a consolidated amended putative class action complaint was filed in the WDPA against the Company, a director, and a former officer and director (“WDPA Viatris Class Action Litigation”). The operative complaint alleges that defendants made false or misleading statements and omissions of material fact, in violation of federal securities laws, in connection with disclosures relating to the Company’s projected financial performance and biosimilars business. Plaintiffs seek certification of a class of purchasers of Company securities between March 1, 2021 and February 25, 2022. Plaintiffs seek monetary damages, reasonable costs and expenses, and certain other relief. On September 20, 2024, the Court granted Defendants’ motion to dismiss all of Plaintiffs’ claims. Plaintiffs have filed an appeal to the United States Court of Appeals for the Third Circuit, which remains pending.

Beginning in August 2023, stockholder derivative actions purportedly on behalf of Viatris were filed in the WDPA against certain of the Company’s current and former officers, directors, and employees alleging that defendants failed to ensure that the Company was making truthful and accurate statements in connection with the disclosures alleged in the WDPA Viatris Class Action Litigation. Viatris is named as a nominal defendant in these derivative actions. Certain of the complaints also assert claims for corporate waste and unjust enrichment. Plaintiffs seek various forms of relief, including damages, disgorgement, restitution, costs and fees.

In April 2025, a putative class action complaint was filed against the Company and certain of the Company’s officers, one of whom is also a director, in the WDPA on behalf of certain purchasers of the Company’s securities. The complaint alleges that defendants made false or misleading statements or omissions of material fact, in violation of federal securities laws, in connection with disclosures relating to regulatory issues and actions concerning the Company’s Indore manufacturing facility. Plaintiffs seek certification of a class of purchasers of Company securities between August 8, 2024 and February 26, 2025. Plaintiffs seek various forms of relief, including damages, costs and fees.

Opioids

The Company, along with other manufacturers, distributors, pharmacies, pharmacy benefit managers, and individual healthcare providers, is a defendant in more than 1,000 cases in the United States and Canada filed by various plaintiffs, including counties, cities and other local governmental entities, asserting civil claims related to sales, marketing and/or distribution practices with respect to prescription opioid products. In addition, lawsuits have been filed as putative class actions including on behalf of children with Neonatal Abstinence Syndrome due to alleged exposure to opioids.

The lawsuits generally seek equitable relief and monetary damages (including punitive and/or exemplary damages) based on a variety of legal theories, including various statutory and/or common law claims, such as negligence, public nuisance and unjust enrichment. The vast majority of these lawsuits have been consolidated in an MDL in the U.S. District Court for the Northern District Court of Ohio.

In April 2025, the Company has reached a nationwide settlement framework to resolve opioid-related claims by States, local governments, and Native American tribes against the Company and certain of its subsidiaries. Under the agreed upon framework, which has been initiated by a process to determine the level of participation in the settlement, the Company would pay up to a maximum of $335 million, consisting of annual payments over anine-year period of between approximately $27.5 and $40 million each, to help support state and local efforts to address opioid-related issues. The settlement framework is not an admission of wrongdoing or liability.

On January 13, 2023, the Company received a civil subpoena from the Attorney General of the State of New York seeking information relating to opioids manufactured, marketed, or sold by the Company and related subject matter. Beginning in January 2024, the Company received similar subpoenas from the Attorneys General of Alaska, Oregon, Utah, Maryland, and Louisiana. The Company is fully cooperating with these subpoena requests. Each of these States will have the option to participate in the settlement framework identified above.

The Company has accrued approximately $335 million in connection with the possible resolution of certain of these matters at June 30, 2025, which is included in other current liabilities in the condensed consolidated balance sheets. Although it is reasonably possible that the Company may incur additional losses from these matters, any amount cannot be reasonably estimated at this time. In addition, the Company expects to incur additional legal and other professional service expenses associated with such matters in future periods and will recognize these expenses as services are received. The Company believes that the ultimate amount paid for these services and claims could have a material effect on the Company's business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares and/or stock price in future periods.

Citalopram

In 2013, the European Commission issued a decision finding that Lundbeck and several generic companies, including Generics [U.K.] Limited (“GUK”), had violated EU competition rules relating to various settlement agreements entered into in 2002 for citalopram. After various appeals, the European Commission’s decision was upheld in March 2021. On March 28, 2023, bodies of the national health authorities in England & Wales filed a case in the U.K. Competition Appeals Tribunal against parties to the citalopram investigation, including GUK, seeking monetary damages, plus interest, purportedly arising from the settlement agreements. GUK, beginning in approximately 2018, has received notices from other health service authorities and insurers asserting an intention to file similar claims. Pursuant to an indemnification agreement, Merck KGaA and GUK have agreed to equally share any damages claimed against Merck KGaA and/or GUK alleged to have been caused by the conduct which is the subject of the European Commission decision.

The Company has accrued approximately €12.2 million as of June 30, 2025 related to this matter. It is reasonably possible that we will incur additional losses above the amount accrued but we cannot estimate a range of such reasonably possible losses at this time. There are no assurances, however, that settlements reached and/or adverse judgments received, if any, will not exceed amounts accrued.

Perindopril

In 2014, the European Commission issued a decision finding that Servier SAS, and certain of its subsidiaries (“Servier”), along with several generic companies, including the Company, had violated EU competition rules relating to various settlement agreements for perindopril. The settlement agreement involving the Company is a 2005 agreement entered into between Servier and Matrix Laboratories Ltd., which the Company acquired in 2007. After various appeals, the European Commission’s decision was upheld in June 2024. The Company satisfied its monetary obligation in 2014.

Bodies of national health authorities in England, Wales, Scotland, and Northern Ireland filed a case in the English High Court against Servier, seeking monetary damages, plus interest, purportedly arising from the settlement agreements. Servier has joined the generic companies, including the Company, as defendants in this litigation. The case has been transferred to the U.K. Competition Appeals Tribunal.

In December 2024, health insurance funds located in the EU filed a case in the Amsterdam District Court against Servier and the generic companies, including the Company, seeking monetary damages, plus interest, purportedly arising from the settlement agreements.

Product Liability

Like other pharmaceutical companies, the Company is involved in a number of product liability lawsuits related to alleged personal injuries arising out of certain products manufactured/or distributed by the Company, including but not limited to those discussed below. Plaintiffs in these cases generally seek damages and other relief on various grounds for alleged personal injury and economic loss.

The Company has accrued approximately $66.8 million as of June 30, 2025 for its product liability matters. It is reasonably possible that we will incur additional losses and fees above the amount accrued but we cannot estimate a range of such reasonably possible losses or legal fees related to these claims at this time. There are no assurances, however, that settlements reached and/or adverse judgments received, if any, will not exceed amounts accrued.

Nitrosamines

The Company, along with numerous other manufacturers, retailers, and others, are parties to litigation relating to alleged trace amounts of nitrosamine impurities in certain products, including valsartan and ranitidine. The vast majority of these lawsuits naming the Company in the United States are pending in two MDLs, namely an MDL pending in the United

States District Court for the District of New Jersey concerning valsartan and an MDL pending in the United States District Court for the Southern District of Florida concerning ranitidine. The lawsuits against the Company in the MDLs include putative and certified classes seeking the refund of the purchase price and other economic and punitive damages allegedly sustained by consumers and end payors as well as individuals seeking compensatory and punitive damages for personal injuries allegedly caused by ingestion of the medications. A similar lawsuit pertaining to valsartan is pending in Israel. Third party payor, consumer and medical monitoring classes were certified in the valsartan MDL. The Company has also received requests to indemnify purchasers of the Company’s API and/or finished dose forms of these products. The original master complaints concerning ranitidine were dismissed on December 31, 2020. The end-payor plaintiff immediately appealed to the U.S. Court of Appeals for the Eleventh Circuit, which affirmed the dismissal. The personal injury and consumer putative class plaintiffs filed amended master complaints. The Company was not named as a defendant in the amended master complaints, though it was still named in certain short form complaints filed by personal injury plaintiffs. The trial court has dismissed all remaining claims against the generic defendants. Certain of the personal injury plaintiffs appealed this dismissal, which remains pending.

Lipitor

A number of individual and multi-plaintiff lawsuits have been filed against Pfizer in various federal and state courts alleging that the plaintiffs developed type 2 diabetes purportedly as a result of the ingestion of Lipitor. Plaintiffs seek compensatory and punitive damages. In February 2014, the federal actions were transferred for consolidated pre-trial proceedings to an MDL in the U.S. District Court for the District of South Carolina. The District Court granted Pfizer’s motion for summary judgment and dismissed all of the federal cases in 2017, which was subsequently affirmed on appeal. Since 2016, certain cases in the MDL were remanded to certain state courts. State court proceedings remain pending in Missouri and New York.

Depo-Provera

Beginning in October 2024, the Company (including Greenstone LLC), Pfizer and certain entities related to Pfizer, and Prasco Labs have been named in a number of lawsuits filed in federal and state courts related to claims pertaining to Depo-Provera. Certain of these lawsuits include allegations that individual plaintiffs developed meningiomas purportedly as a result of the ingestion of Depo-Provera or its authorized generic equivalent and seek compensatory and punitive damages. Putative class complaints seeking relief in the form of medical monitoring for individuals from certain states who have taken Depo-Provera or its authorized generic equivalent, but have not developed meningiomas, have also been filed. In February 2025, the federal lawsuits were transferred for consolidated pre-trial proceedings to an MDL in the U.S. District Court for the Northern District of Florida. Pfizer is the new drug application holder of Depo-Provera and markets and sells the branded version of the product. Greenstone LLC was a subsidiary of Pfizer until the closing of the Combination and sold the authorized generic of Depo-Provera until the closing of the Combination. Concurrently with the closing of the Combination, Pfizer divested the authorized generic of Depo-Provera to Prasco Labs. In June 2025, the MDL court implemented a process whereby, with respect to current and future cases filed against the Company in this MDL, Plaintiffs must show why claims against the Company are appropriate. As a result of this process, the Company has been dismissed without prejudice from all cases pending in this MDL. The Company has also been dismissed without prejudice in certain state court cases. The Company has sought to tender its defense and is seeking indemnification for these claims from Pfizer pursuant to the Separation and Distribution Agreement and Pfizer is seeking cross-indemnification from the Company pursuant to the Separation and Distribution Agreement with respect to the authorized generic product previously sold by Greens tone LLC.

Intellectual Property

The Company is involved in a number of patent litigation lawsuits involving the validity and/or infringement of patents held by branded pharmaceutical manufacturers. The Company uses its business judgment to decide to market and sell certain products, in each case based on its belief that the applicable patents are invalid and/or that its products do not infringe, notwithstanding the fact that allegations of patent infringement(s) or other potential third party rights have not been finally resolved by the courts. The risk involved in doing so can be substantial because the remedies available to the owner of a patent for infringement may include a reasonable royalty on sales or damages measured by the profits lost by the patent owner. If there is a finding of willful infringement, damages may be increased up to three times. Moreover, because of the discount pricing typically involved with bioequivalent products, patented branded products generally realize a substantially higher profit margin than generic and biosimilar products. The Company also faces challenges to its patents, including suits in various jurisdictions pursuant to which generic drug manufacturers, payers, governments, or other parties are seeking damages for allegedly causing delay of generic entry. An adverse decision in any of these matters could have an adverse effect that is material to our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares and/or stock price.

Yupelri

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 method of use patents expiring in 2039. The companies have not filed Paragraph IV certifications to our compound patents, one of which is 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. The Company has entered into settlement agreements with Teva, Accord, Orbicular, Lupin, Qilu, and Eugia granting licenses to commercialize their generic versions of Yupelri® in April 2039 or earlier depending on certain circumstances. Two ANDA filers remain in the litigation.

Tyrvaya

In June 2023, a generic company notified Oyster Point that it had filed an ANDA with the FDA seeking approval to market a generic version of Tyrvaya® with associated Paragraph IV certifications. The generic company asserts the invalidity and/or non-infringement of six Orange Book listed patents that all have expiration dates in October 2035. In July 2023, Oyster Point brought a patent infringement action against the generic filer in the U.S. District Court of the District of New Jersey. In March 2024, Oyster Point filed an amended complaint asserting infringement with respect tofour additional patents that were recently listed in the Orange Book for Tyrvaya® and also have expiration dates in October 2035. This lawsuit automatically stays FDA approval of the generic company’s ANDA until December 6, 2025, or until an adverse court decision, if any, whichever may occur earlier. Oyster Point has selected claims from five of the asserted Orange Book-listed patents for trial, which is scheduled to begin in September 2025.

Amitiza

In September 2023, Sawai Pharmaceutical Co. (“Sawai”) filed challenges with the Japanese Patent Office (“JPO”) asserting invalidity of patent term extensions for the JPP ‘4332353 patent (the ‘353 patent) relevant to Amitiza®, which the Company commercializes in Japan as a licensee of the relevant patents, including the ‘353 patent. Towa Pharmaceutical Co. Ltd. also filed a challenge to the ‘353 patent term extension in January 2024. Separately, in December 2023, Sawai filed an invalidity action with the JPO against the ‘353 patent itself. With the granted extensions, the ‘353 patent has expiration dates for the Company’s 24µg and 12µg strengths of April 2025 and April 2027, respectively. In April 2025 and June 2025, the JPO upheld the validity of the ‘353 patent and the ‘353 patent term extensions, respectively. Sawai has filed appeals against these JPO decisions with the Intellectual Property High Court, which are pending.

Beginning in April 2024, Sawai filed challenges with the JPO with respect to the 12µg strength, asserting invalidity of patent term extensions offive additional patents expiring in October 2025, September 2026, August 2027, November 2027, and December 2028, and challenged the validity of the August 2027 patent itself.

In April 2025, Sawai filed an action before the Tokyo District Court alleging unfair competition and seeking to restrain the Company from communicating with the public and the Japan Ministry of Health Labor and Welfare about the patent coverage for Amitiza.

Ryzumvi

In February 2025, a generic company notified the Company that it had filed an ANDA with the FDA seeking approval to market a generic version of Ryzumvi® with associated Paragraph IV certifications. The generic company asserts the invalidity and/or non-infringement of Orange Book listed patents that have an expiration date of January 31, 2034, and October 25, 2039. In March 2025, the Company brought a patent infringement action against the generic filer in the U.S. District Court for the District of New Jersey. This lawsuit automatically stays FDA approval of the generic company’s ANDA until August 3, 2027, or until an adverse court decision, if any, whichever may occur earlier.

The Company has approximately $5.3 million accrued related to its intellectual property matters at June 30, 2025. It is reasonably possible that we may incur additional losses and fees but we cannot estimate a range of such reasonably possible losses or legal fees related to these claims at this time.

Other Litigation

The Company is involved in various other legal proceedings including commercial, contractual, employment, or other similar matters that are considered normal to its business. The Company has approximately $8 million accrued related to these various other legal proceedings at June 30, 2025.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.