Cover and table of contents
27K characters. Original on sec.gov · Markdown
Cover and table of contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
| ☑ | Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 | ||||
| For the Fiscal Year Ended December 31, 2023 |
OR
| ☐ | Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 | ||||
| For the transition period from to |
Commission file number 001-39695
VIATRIS INC.
(Exact name of registrant as specified in its charter)
| Delaware | 83-4364296 | |||||||
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
1000 Mylan Boulevard, Canonsburg, Pennsylvania, 15317
(Address of principal executive offices)(Zip Code)
(724) 514-1800
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class: | Trading Symbol(s) | Name of Each Exchange on Which Registered: | ||||||||||||
| Common Stock, par value $0.01 per share | VTRS | The NASDAQ Stock Market |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☑ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☑
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☑ | Accelerated filer | ☐ | |||||||||||||||||
| Non-accelerated filer | ☐ | Smaller reporting company | ☐ | |||||||||||||||||
| Emerging growth company | ☐ | |||||||||||||||||||
| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ |
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☑
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☑
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2023, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $11,936,712,582.
The number of shares of common stock outstanding, par value $0.01 per share, of the registrant as of February 22, 2024 was 1,187,569,149.
INCORPORATED BY REFERENCE
| Document | Part of Form 10-K into Which Document is Incorporated | ||||
| An amendment to this Form 10-K will be filed no later than 120 days after the close of registrant’s fiscal year. | III |
VIATRIS INC.
INDEX TO FORM 10-K
For the Year Ended December 31, 2023
Glossary of Defined Terms
Unless the context requires otherwise, references to “Viatris,” “the Company,” “we,” “us” or “our” in this 2023 Form 10-K (defined below) refer to Viatris Inc. and its subsidiaries. We also have used several other terms in this 2023 Form 10-K, most of which are explained or defined below. Some amounts in this Form 10-K 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 | ||||
| 505(b)(2) | A streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for which the applicant has not obtained right of reference. | ||||
| AbbVie | AbbVie Inc. | ||||
| ACA | Patient Protection and Affordable Care Act, as amended by the Health Care and Education and Reconciliation Act | ||||
| 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 | ||||
| AI | Artificial intelligence | ||||
| ANDA | Abbreviated New Drug Application | ||||
| Announced Divestitures | All of the following transactions: on October 1, 2023, Viatris announced it had received an offer for the divestiture of its OTC Business and had entered into definitive agreements to divest its women’s healthcare business and, separately, in another transaction, its rights to two women’s healthcare products in certain countries, its API business in India and commercialization rights in the Upjohn Distributor Markets | ||||
| AOCE | Accumulated other comprehensive earnings | ||||
| API | Active pharmaceutical ingredient | ||||
| 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 | ||||
| cGMP | Current Good Manufacturing Practices | ||||
| CIRP | Cybersecurity Incident Response Plan | ||||
| CIRT | Cybersecurity Incident Response Team | ||||
| clean energy investments | Used to define the three equity method investments the Company had in limited liability companies that owned refined coal production plants whose activities qualify for income tax credits under Section 45 of the Code | ||||
| 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 | ||||
| COPD | Chronic obstructive pulmonary disease |
| COSO | Committee of Sponsoring Organizations of the Treadway Commission | ||||
| COVID-19 | Novel coronavirus disease of 2019 | ||||
| CP Notes | Unsecured, short-term commercial paper notes issued pursuant to the Commercial Paper Program | ||||
| DEA | U.S. Drug Enforcement Agency | ||||
| DEI | Diversity, equity, and inclusion | ||||
| Developed Markets segment | Viatris’ business segment that includes our operations primarily in the following markets: North America and Europe | ||||
| DGCL | Delaware General Corporation Law | ||||
| Distribution | Pfizer's distribution to Pfizer stockholders all the issued and outstanding shares of Upjohn Inc. | ||||
| DOJ | U.S. Department of Justice | ||||
| DRIP | Dividend Reinvestment and Share Purchase Plan | ||||
| EBITDA | Non-GAAP financial measure that the Company believes is appropriate to provide information to investors - U.S. GAAP net earnings (loss) adjusted for net contribution attributable to equity method investments, income tax provision (benefit), interest expense and depreciation and amortization | ||||
| EDPA | U.S. District Court for the Eastern District of Pennsylvania | ||||
| EMA | European Medicines Agency | ||||
| 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 | ||||
| EPD Business | Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business, prior to its acquisition by Mylan in February 2015 | ||||
| EU | European Union | ||||
| Exchange Act | Securities Exchange Act of 1934, as amended | ||||
| Famy Life Sciences | Famy Life Sciences Private Limited | ||||
| FASB | Financial Accounting Standards Board | ||||
| FDA | U.S. Food and Drug Administration | ||||
| Form 10-K | This annual report on Form 10-K for the fiscal year ended December 31, 2023 | ||||
| GA Depot | Long-acting glatiramer acetate depot product | ||||
| GDPR | The EU’s General Data Protection Regulation | ||||
| 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 | ||||
| Hatch-Waxman Act | Drug Price Competition and Patent Term Restoration Act of 1984 | ||||
| HIPAA | Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act | ||||
| HIV/AIDS | Human immunodeficiency virus infection and acquired immune deficiency syndrome | ||||
| Idorsia | Idorsia Pharmaceuticals Ltd. | ||||
| INN | International NonProprietary Name | ||||
| 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 | ||||
| LAMA | Long-acting muscarinic antagonist | ||||
| LIBOR | London Interbank Offered Rate | ||||
| Lilly | Eli Lilly and Company | ||||
| LOE | Loss of exclusivity | ||||
| 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 | ||||
| Momenta | Momenta Pharmaceuticals, Inc. | ||||
| MPI | Mylan Pharmaceuticals Inc. | ||||
| Mylan | Mylan N.V. and its subsidiaries | ||||
| Mylan Inc. Euro Notes | The 2.125% Senior Notes due 2025 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. | ||||
| 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 | ||||
| NCDs | noncommunicable diseases | ||||
| NCEs | New Chemical Entities | ||||
| NDA | New drug application | ||||
| NHS | National Health Services | ||||
| Note Securitization Facility | The note securitization facility entered into in August 2023 for borrowings up to $200 million and expiring in August 2024 | ||||
| OECD | The Organisation for Economic Co-operation and Development | ||||
| OTC | Over-the-counter | ||||
| OTC Business | Viatris’ OTC business that the Company has agreed to divest to Cooper Consumer Health SAS, 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. | ||||
| Oyster Point | Oyster Point Pharma, Inc. | ||||
| PBMs | Pharmacy benefit managers | ||||
| PCAOB | Public Company Accounting Oversight Board | ||||
| Pending Announced Divestitures | The remaining Announced Divestitures that have not been consummated | ||||
| Pfizer | Pfizer Inc. | ||||
| Profit Sharing 401(k) Plan | 401(k) retirement plan with a profit sharing component for non-union represented employees | ||||
| PSUs | Performance awards | ||||
| QCE | Quality consistency evaluation | ||||
| R&D | Research and development | ||||
| Receivables Facility | The $400 million accounts receivable entered into in August 2020 and expiring in April 2025 | ||||
| Registered Upjohn Notes | The 1.650% Senior Notes due 2025, 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on October 29, 2021 registered with the SEC in exchange for the corresponding Unregistered Upjohn U.S. Dollar Notes in a similar aggregate principal amount and with terms substantially identical to the corresponding Unregistered Upjohn U.S. Dollar Notes and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. | ||||
| 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 | ||||
| Revance | Revance Therapeutics, Inc. |
| 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 | ||||
| RICO | Racketeer Influenced and Corrupt Organizations Act | ||||
| ROU asset | Right-of-use asset | ||||
| Sanofi | Sanofi-Aventis U.S., LLC | ||||
| 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 | Pfizer's transfer to Upjohn of substantially all the assets and liabilities comprising the Upjohn Business | ||||
| 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 | ||||
| SOFR | Secured overnight financial rate | ||||
| stock awards | Stock options and SARs | ||||
| Tax Matters Agreement | The agreement entered into by Pfizer and Viatris in connection with the Separation and the Distribution that governs the parties’ respective rights, responsibilities and obligations with respect to taxes, including taxes arising in the ordinary course of business and taxes, if any, incurred as a result of any failure of the Distribution or certain related transactions to qualify as tax-free transactions | ||||
| Teva | Teva Pharmaceutical Industries Ltd. | ||||
| Theravance Biopharma | Theravance Biopharma, Inc. | ||||
| TSA | Transition services agreement | ||||
| 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 1.650% Senior Notes due 2025, 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on 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 intends to divest | ||||
| Upjohn Euro Notes | Senior unsecured notes denominated in euros and issued by Upjohn Finance B.V. pursuant to an indenture dated June 23, 2020 | ||||
| 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. | ||||
| URP | Universal reimbursement pricing | ||||
| Utah Acquisition Sub | Utah Acquisition Sub Inc., a Delaware corporation and an indirect wholly owned subsidiary of Viatris | ||||
| Utah Euro Notes | The 2.250% Senior Notes due 2024 and 3.125% Senior Notes due 2028 issued by Utah Acquisition Sub Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan Inc., Viatris Inc. and Mylan II B.V. |
| 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. | ||||
| VA | Department of Veterans Affairs | ||||
| VBP | Volume-based procurement | ||||
| Viatris | Viatris Inc., formerly known as Upjohn Inc. prior to the completion of the Combination | ||||
| Viatris Board | The board of directors of Viatris Inc. | ||||
| Viatris Bylaws | The amended and restated bylaws of Viatris Inc. | ||||
| Viatris Charter | Amended and restated certificate of incorporation of Viatris Inc., as amended | ||||
| WHO | World Health Organization | ||||
| 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