Cover and table of contents

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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, 2021


☐			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. ☑

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, 2021, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $17,237,737,213.

The number of shares of common stock outstanding, par value $0.01 per share, of the registrant as of February 22, 2022 was 1,209,576,280.

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, 2021


		Page
PART I
ITEM 1.	Business	9
ITEM 1A.	Risk Factors	20
ITEM 1B.	Unresolved Staff Comments	52
ITEM 2.	Properties	52
ITEM 3.	Legal Proceedings	52
ITEM 4.	Mine Safety Disclosures	52

PART II
ITEM 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	53
ITEM 6.	[Reserved]	54
ITEM 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	55
ITEM 7A.	Quantitative and Qualitative Disclosures about Market Risk	77
ITEM 8.	Financial Statements and Supplementary Data	78
ITEM 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	148
ITEM 9A.	Controls and Procedures	148
ITEM 9B.	Other Information	148
ITEM 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	148

PART III
ITEM 10.	Directors, Executive Officers and Corporate Governance	149
ITEM 11.	Executive Compensation	149
ITEM 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	149
ITEM 13.	Certain Relationships and Related Transactions, and Director Independence	149
ITEM 14.	Principal Accounting Fees and Services	149

PART IV
ITEM 15.	Exhibits and Consolidated Financial Statement Schedules	150
Signatures		159

Glossary of Defined Terms

Unless the context requires otherwise, references to “Viatris,” “the Company,” “we,” “us” or “our” in this 2021 Form 10-K (defined below) refer to Viatris Inc. and its subsidiaries. We also have used several other terms in this 2021 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			2003 Long-Term Incentive Plan
2020 Revolving Facility			The revolving credit facility available pursuant to the revolving credit agreement, dated as of June 16, 2020, 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 repaid in full in July 2021
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
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
ANDA			Abbreviated New Drug Application
AOCE			Accumulated other comprehensive earnings
API			Active pharmaceutical ingredients
ARV			Antiretroviral medicines
ASC			Accounting Standards Codification
Aspen			Aspen Global Incorporated
ASU			Accounting Standards Update
BEAT			Base Erosion Anti-Abuse Tax
Biocon			Biocon Limited
Biocon Biologics			Biocon Biologics Limited, a majority owned subsidiary of Biocon
Biocon Biologics Transaction			The pending transaction between Viatris and Biocon Biologics pursuant to which Viatris will contribute its biosimilar products and programs to Biocon Biologics in exchange for cash consideration and a convertible preferred equity interest in Biocon Biologics
Biocon Agreement			The agreement between Viatris and Biocon Biologics, dated February 28, 2022, relating to the Biocon Biologics Transaction
Biogen			Biogen MA Inc. and Biogen International GmbH, collectively
BPCIA			Biologics Price Competition and Innovation Act of 2009
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
CARES Act			Coronavirus Aid, Relief, and Economic Security Act
cGMP			Current Good Manufacturing Practices
CIA			Corporate Integrity Agreement, dated August 16, 2017, entered into between the OIG-HHA, Mylan Inc. and Mylan Specialty L.P.
CJEU			European Court of Justice


clean energy investments			Used to define the three equity method investments the Company has in limited liability companies that own refined coal production plants whose activities qualify for income tax credits under Section 45 of the Code
CMA			Competition and Markets Authority
CMS			Centers for Medicare & Medicaid Services
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
Commission			European Commission
Contribution			Pfizer's contribution of the Upjohn Business to Viatris
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
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
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
ERP system			Enterprise resource planning system
EU			European Union
EURIBOR			Euro Interbank Offered Rate
Exchange Act			Securities Exchange Act of 1934, as amended
Exchange Offer			The offer to exchange the Unregistered Upjohn U.S. Dollar Notes for the Registered Upjohn Notes, which was conducted pursuant to a registration statement filed with the SEC in September 2021 by Viatris Inc., Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. and declared effective on September 28, 2021. The exchange offer expired on October 28, 2021 and settled on October 29, 2021.
FASB			Financial Accounting Standards Board
FCA			Financial Conduct Authority in the U.K.


FDA			U.S. Food and Drug Administration
FKB			Fujifilm Kyowa Kirin Biologics Co. Ltd
Form 10-K			This annual report on Form 10-K for the fiscal year ended December 31, 2021
FTC			U.S. Federal Trade Commission
GDPR			The EU’s General Data Protection Regulation
GILTI			Global intangible low-taxed income
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
INN			International NonProprietary Name
IPR			Inter Partes review
IPR&D			In-process research and development
IRS			U.S. Internal Revenue Service
IRS Ruling			The private letter ruling issued by the IRS to Pfizer with respect to the Combination, dated as of March 17, 2020
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
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 II			Mylan II B.V., a company incorporated under the laws of the Netherlands and an indirect wholly owned subsidiary of Viatris, in which legacy Mylan merged with and into
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 4.200% Senior Notes due 2023, 3.125% Senior Notes due 2023, 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.
Mylan Securitization			Mylan Securitization LLC
NASDAQ			The NASDAQ Stock Market
NCDs			noncommunicable diseases


NDA			New drug application
NHI			National Health Insurance of Japan
NHS			National Health Services
NOLs			Net Operating Losses
Note Securitization Facility			The note securitization facility entered into in July 2021 for borrowings up to $200 million and expiring in August 2022
OIG-HHS			Office of Inspector General of the Department of Health and Human Services
OTC			Over-the-counter
PBM			Pharmacy benefit managers
PCAOB			Public Company Accounting Oversight Board
Pfizer			Pfizer Inc.
Pfizer Distribution Payments			Payments made by Pfizer using the proceeds of the $12 billion cash distribution to (a) repurchase Pfizer common stock, (b) make pro rata special cash distributions to its stockholders and/or (c) repay or repurchase debt (including principal, interest and associated premiums and fees) held by third party lenders
Plan			Viatris Inc. 2020 Stock Incentive Plan
PMS			Pharmascience Inc.
PPACA			Patient Protection and Affordable Care Act
Profit Sharing 401(k) Plan			401(k) retirement plan with a profit sharing component for non-union represented employees
PSUs			Performance awards
PTAB			U.S. Patent Trial and Appeal Board
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 2022
Registered Upjohn Notes			The 1.125% Senior Notes due 2022, 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 and Utah Acquisition Sub Inc.
respiratory delivery platform			Pfizer’s proprietary dry powder inhaler delivery platform
Restoration Plan			The Company’s 401(k) Restoration Plan
restricted stock awards			The Company’s nonvested restricted stock and restricted stock unit awards, including PSUs
Revance			Revance Therapeutics, Inc.
RICO			Racketeer Influenced and Corrupt Organizations Act
ROU asset			Right-of-use asset
RSUs			The Company's unvested restricted stock unit awards
Sanofi			Sanofi-Aventis U.S., LLC
SARs			Stock Appreciation Rights
SDA			Separation and Distribution Agreement between Viatris and Pfizer, dated as of July 29, 2019, as amended from time to time
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 Registered 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 Act			December 2017 U.S. Tax Cuts and Jobs Act
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
Tax Opinion			The tax opinion issued by Pfizer’s tax counsel, David Polk & Wardwell LLP, with respect to the Combination
Teva			Teva Pharmaceutical Industries Ltd.
Theravance Biopharma			Theravance Biopharma, Inc.
TSA			Transition service agreements
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 1.125% Senior Notes due 2022, 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 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 Euro Notes			Senior unsecured notes denominated in euros and issued by Upjohn Finance B.V. pursuant to an indenture dated June 23, 2020
Upjohn Senior Notes			The Upjohn U.S. Dollar Notes together with the Upjohn Euro Notes
Upjohn U.S. Dollar Notes			Senior unsecured notes denominated in U.S. dollars and issued by Upjohn Inc. pursuant to an indenture dated June 22, 2020
URP			Universal reimbursement pricing
USD Term Loan Facility			The $600 million delayed draw term loan credit agreement, dated as of June 16, 2020 by and among Viatris, Mizuho Bank, Ltd. and MUFG Bank, Ltd., as administrative agent, and repaid in full in July 2021
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.
WHO			World Health Organization
YEN Term Loan Facility			The ¥40 billion term loan agreement dated as of July 1, 2021, by and among Viatris, Mizuho Bank, Ltd. and MUFG Bank, Ltd., as administrative agent

PART I

Next: Item 1. Business