Viatris Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout 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.
Sep 30, 2024 · Filed Nov 7, 2024
VTRS$19.91+5.0%Stored close · as of Nov 6, 2026
Contents
Item 1. Condensed Consolidated Financial Statements (unaudited)
| Condensed Consolidated Statements of Operations — Three and Nine Months Ended September 30, 2024 and 2023 | 6 | |
| Condensed Consolidated Statements of Comprehensive Earnings (Loss) — Three and Nine Months Ended September 30, 2024 and 2023 | 7 | |
| Condensed Consolidated Balance Sheets — September 30, 2024 and December 31, 2023 | 8 | |
| Condensed Consolidated Statements of Equity — Three and Nine Months Ended September 30, 2024 and 2023 | 9 | |
| Condensed Consolidated Statements of Cash Flows — Nine Months Ended September 30, 2024 and 2023 | 11 | |
| Notes to Condensed Consolidated Financial Statements | 13 | |
| ITEM 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 53 |
|---|---|---|
| ITEM 3. | Quantitative and Qualitative Disclosures About Market Risk | 75 |
| ITEM 4. | Controls and Procedures | 75 |
| PART II — OTHER INFORMATION | ||
| ITEM 1. | Legal Proceedings | 76 |
| ITEM 1A. | Risk Factors | 76 |
| ITEM 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 76 |
| ITEM 5. | Other Information | 76 |
| ITEM 6. | Exhibits | 77 |
| SIGNATURES | 78 | |
Glossary of Defined Terms
Unless the context requires otherwise, references to “Viatris,” “the Company,” “we,” “us” or “our” in this Form 10-Q (defined below) refer to Viatris Inc. and its subsidiaries. We also have used several other terms in this Form 10-Q, most of which are explained or defined below. Some amounts in this Form 10-Q may not add due to rounding.
| 2003 LTIP | Mylan N.V. Amended and Restated 2003 Long-Term Incentive Plan |
|---|---|
| 2020 Incentive Plan | Viatris Inc. 2020 Stock Incentive Plan |
| 2021 Revolving Facility | The $4.0 billion revolving facility dated as of July 1, 2021, by and among Viatris, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent and which was amended and restated in September 2024 |
| 2024 Revolving Facility | The $3.5 billion revolving facility dated as of September 27, 2024, by and among Viatris, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent |
| Adjusted EBITDA | Non-GAAP financial measure that the Company believes is appropriate to provide information to investors - EBITDA (defined below) is further adjusted for share-based compensation expense, litigation settlements, and other contingencies, net, restructuring and other special items |
| ANDA | Abbreviated New Drug Application |
| AOCE | Accumulated other comprehensive earnings |
| API | Active pharmaceutical ingredients |
| ARV | Antiretroviral medicines |
| ASC | Accounting Standards Codification |
| ASU | Accounting Standards Update |
| Biocon | Biocon Limited |
| Biocon Biologics | Biocon Biologics Limited, a majority owned subsidiary of Biocon |
| Biocon Biologics Transaction | The transaction between Viatris and Biocon Biologics pursuant to which Viatris contributed its biosimilars portfolio, composed of the Biocon collaboration programs, biosimilars to Humira®, Enbrel®, and Eylea®, as well as related assets and liabilities to Biocon Biologics |
| Biocon Agreement | The transaction agreement between Viatris and Biocon Biologics, dated February 27, 2022, relating to the Biocon Biologics Transaction, as amended from time to time |
| Business Combination Agreement | Business Combination Agreement, dated as of July 29, 2019, as amended from time to time, among Viatris, Mylan, Pfizer and certain of their affiliates |
| CAMT | U.S. corporate alternative minimum tax |
| CCPS | Compulsory convertible preferred shares |
| Code | The U.S. Internal Revenue Code of 1986, as amended |
| Combination | Refers to Mylan combining with Pfizer's Upjohn Business in a Reverse Morris Trust transaction to form Viatris on November 16, 2020 |
| Commercial Paper Program | The $1.65 billion unsecured commercial paper program entered into as of November 16, 2020 by Viatris, as issuer, Mylan Inc., Utah Acquisition Sub Inc. and Mylan II B.V., as guarantors, and certain dealers from time to time |
| Developed Markets segment | Viatris’ business segment that includes our operations primarily in the following markets: North America and Europe |
| Distribution | Pfizer's distribution to Pfizer stockholders all the issued and outstanding shares of Upjohn Inc. |
| DOJ | U.S. Department of Justice |
| EBITDA | Non-GAAP financial measure that the Company believes is appropriate to provide information to investors - U.S. GAAP net earnings (loss) adjusted for income tax provision (benefit), interest expense and depreciation and amortization |
| EDPA | U.S. District Court for the Eastern District of Pennsylvania |
| Emerging Markets segment | Viatris’ business segment that includes, but is not limited to, our operations primarily in the following markets: Parts of Asia, the Middle East, South and Central America, Africa, and Eastern Europe |
|---|---|
| EPS | Earnings per share |
| EU | European Union |
| Exchange Act | Securities Exchange Act of 1934, as amended |
| FASB | Financial Accounting Standards Board |
| FDA | U.S. Food and Drug Administration |
| Form 10-Q | This quarterly report on Form 10-Q for the quarterly period ended September 30, 2024 |
| GA Depot | Long-acting glatiramer acetate depot product |
| Global Systemically Important Banks | Financial institutions that are considered systemically important by the Financial Stability Board |
| Greater China segment | Viatris’ business segment that includes our operations primarily in the following markets: China, Taiwan and Hong Kong |
| Gx | Generic drugs |
| Idorsia | Idorsia Pharmaceuticals Ltd. |
| Idorsia Transaction | The transaction between Viatris and Idorsia pursuant to which Viatris acquired the development programs and certain personnel related to selatogrel and cenerimod from Idorsia in exchange for an upfront payment to Idorsia of $350 million, potential development and regulatory milestone payments, certain contingent payments of tiered sales milestones, as well as potential contingent tiered sales royalties |
| IPR&D | In-process research and development |
| IRS | U.S. Internal Revenue Service |
| IT | Information technology |
| JANZ segment | Viatris’ business segment that includes our operations in the following markets: Japan, Australia and New Zealand |
| Mapi | Mapi Pharma Ltd. |
| Maximum Leverage Ratio | The maximum consolidated leverage ratio financial covenant requiring maintenance of a maximum ratio of consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters as defined in the related credit agreements from time to time |
| MDL | Multidistrict litigation |
| Mylan | Mylan N.V. and its subsidiaries |
| Mylan Inc. U.S. Dollar Notes | The 4.550% Senior Notes due 2028, 5.400% Senior Notes due 2043 and 5.200% Senior Notes due 2048 issued by Mylan Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan II B.V., Viatris Inc. and Utah Acquisition Sub Inc. |
| NASDAQ | The NASDAQ Stock Market |
| NDA | New drug application |
| Note Securitization Facility | The note securitization facility entered into in August 2023 for borrowings up to $200 million, which expired in August 2024 and was not renewed |
| OTC | Over-the-counter |
| OTC Business | Viatris’ OTC business that the Company divested to Cooper Consumer Health SAS in July 2024, including two manufacturing sites located in Merignac, France, and Confienza, Italy, and an R&D site in Monza, Italy. This excludes the Company’s rights for Viagra®, Dymista® (which, in certain limited markets, are sold as OTC products), and select OTC products in certain markets. |
| OTC Transaction | On October 1, 2023, Viatris announced it had received an offer for the divestiture of its OTC Business. In January 2024, we exercised our option to accept the offer and entered into a definitive transaction agreement with respect to such OTC Transaction. The OTC Transaction closed in July 2024. |
| Oyster Point | Oyster Point Pharma, Inc. |
| Pfizer | Pfizer Inc. |
| PSUs | Performance awards |
| R&D | Research and development |
| Receivables Facility | The $400 million accounts receivable facility entered into in August 2020 and expiring in April 2025 |
|---|---|
| Registered Upjohn Notes | The 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on October 29, 2021 registered with the SEC in exchange for the corresponding Unregistered Upjohn U.S. Dollar Notes in a similar aggregate principal amount and with terms substantially identical to the corresponding Unregistered Upjohn U.S. Dollar Notes and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. |
| Respiratory Delivery Platform | Pfizer’s proprietary dry powder inhaler delivery platform |
| Restricted Stock Awards | The Company’s nonvested restricted stock and restricted stock unit awards, including PSUs |
| RICO | Racketeer Influenced and Corrupt Organizations Act |
| SARs | Stock appreciation rights |
| SDNY | U.S. District Court for the Southern District of New York |
| SEC | U.S. Securities and Exchange Commission |
| Securities Act | Securities Act of 1933, as amended |
| Senior U.S. Dollar Notes | The Upjohn U.S. Dollar Notes, the Utah U.S. Dollar Notes and the Mylan Inc. U.S. Dollar Notes, collectively |
| Separation and Distribution Agreement | Separation and Distribution Agreement between Viatris and Pfizer, dated as of July 29, 2019, as amended from time to time |
| SG&A | Selling, general and administrative expenses |
| stock awards | Stock options and SARs |
| Teva | Teva Pharmaceutical Industries Ltd. |
| TSA | Transition services agreements, including related distribution services |
| U.K. | United Kingdom |
| U.S. | United States |
| U.S. GAAP | Accounting principles generally accepted in the U.S. |
| Unregistered Upjohn U.S. Dollar Notes | The 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on June 22, 2020 by Upjohn Inc. (now Viatris Inc.) in a private offering exempt from the registration requirements of the Securities Act and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. |
| Upjohn | Upjohn Inc., a wholly owned subsidiary of Pfizer prior to the Distribution, that combined with Mylan and was renamed Viatris Inc. |
| Upjohn Business | Pfizer’s off-patent branded and generic established medicines business that, in connection with the Combination, was separated from Pfizer and combined with Mylan to form Viatris |
| Upjohn Distributor Markets | Select geographic markets that were part of the Combination that are smaller in nature and in which we had no established infrastructure prior to or following the Combination and that the Company has divested or intends to divest |
| Upjohn U.S. Dollar Notes | Senior unsecured notes denominated in U.S. dollars and originally issued by Upjohn Inc. or Viatris Inc. pursuant to an indenture dated June 22, 2020 and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. |
| Utah Acquisition Sub | Utah Acquisition Sub Inc., a Delaware corporation and an indirect wholly owned subsidiary of Viatris |
| Utah U.S. Dollar Notes | The 3.950% Senior Notes due 2026 and 5.250% Senior Notes due 2046 issued by Utah Acquisition Sub Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan Inc., Viatris Inc. and Mylan II B.V. |
| Viatris | Viatris Inc., formerly known as Upjohn Inc. prior to the completion of the Combination |
| YEN Term Loan Facility | The ¥40 billion term loan agreement dated as of July 1, 2021, among Viatris, the guarantors from time to time party thereto, the lenders from time to time party thereto and Mizuho Bank, Ltd., as administrative agent |
PART I — FINANCIAL INFORMATION
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.