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Cover and table of contents

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q


☑			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 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)

(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

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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

The number of shares of common stock outstanding, par value $0.01 per share, of the registrant as of November 3, 2021 was 1,209,393,416.

Table of Contents

VIATRIS INC. AND SUBSIDIARIES

INDEX TO FORM 10-Q

For the Quarterly Period Ended

September 30, 2021


		Page
	PART I — FINANCIAL INFORMATION
ITEM 1.	Condensed Consolidated Financial Statements (unaudited)
	Condensed Consolidated Statements of Operations — Three and Nine Months Ended September 30, 2021 and 2020	7
	Condensed Consolidated Statements of Comprehensive Earnings (Loss) — Three and Nine Months Ended Sept ember 30, 2021 and 2020	8
	Condensed Consolidated Balance Sheets — September 30, 2021 and December 31, 2020	9
	Condensed Consolidated Statements of Equity — Three and Nine Months Ended September 30, 2021 and 2020	10
	Condensed Consolidated Statements of Cash Flows — Nine Months Ended September 30, 2021 and 2020	12

	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	79

ITEM 4.	Controls and Procedures	79

	PART II — OTHER INFORMATION
ITEM 1.	Legal Proceedings	80

ITEM 1A.	Risk Factors	81



ITEM 6.	Exhibits	82

SIGNATURES		83

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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			2003 Long-Term Incentive Plan
2020 Form 10-K			Viatris’ annual report on Form 10-K for the fiscal year ended December 31, 2020, as amended
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
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
APIs			Active pharmaceutical ingredients
ASC			Accounting Standards Codification
Aspen			Aspen Global Incorporated
ASU			Accounting Standards Update
Biogen			Biogen MA Inc. and Biogen International GmbH, collectively
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
CAT			Competition Appeals Tribunal
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
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
COVID-19			Novel coronavirus disease of 2019
DCGI			Drug Controller General of India
Developed Markets segment			Viatris’ business segment that includes our operations primarily in the following markets: North America and Europe

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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
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
EU			European Union
Exchange Act			Securities Exchange Act of 1934, as amended
Exchange Offer			The offer to exchange the Unregistered Upjohn 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
FDA			U.S. Food and Drug Administration
Form 10-Q			This quarterly report on Form 10-Q for the quarterly period ended September 30, 2021
Greater China segment			Viatris’ business segment that includes our operations primarily in the following markets: China, Taiwan and Hong Kong
Gx			Generic drugs
IPR			Inter Partes review
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
LIBOR			London Interbank Offered Rate
Lilly			Eli Lilly and Company
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
MPI			Mylan Pharmaceutical 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. Senior 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.
NASDAQ			The NASDAQ Stock Market

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NDA			New drug application
NHS			National Health Services
Note Securitization Facility			The note securitization facility entered into in July 2021 for borrowings up to $200 million and expiring in August 2022
OTC			Over-the-counter
Pfizer			Pfizer Inc.
Plan			Viatris Inc. 2020 Stock Incentive Plan
PMS			Pharmascience Inc.
PSUs			Performance awards
PTAB			U.S. Patent Trial and Appeal Board
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 Unregistered Upjohn Notes in a similar aggregate principal amount and with terms substantially identical to the Unregistered Upjohn 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
restricted stock awards			The Company’s nonvested restricted stock and restricted stock unit awards, including PSUs
RICO			Racketeer Influenced and Corrupt Organizations Act
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 Notes			The Registered Upjohn Notes, the Utah Senior Notes and the Mylan Inc. Senior 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
Teva			Teva Pharmaceutical Industries Ltd.
TSA			Transition service agreements
U.K.			United Kingdom
Unregistered 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 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.
U.S.			United States
U.S. GAAP			Accounting principles generally accepted in the U.S.

Table of Contents


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
USD Term Loan Agreement			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 Senior Notes			The 3.150% Senior Notes due 2021, 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 Agreement			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

Table of Contents

PART I — FINANCIAL INFORMATION

VIATRIS INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(Unaudited; in millions, except per share amounts)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Revenues:
Net sales	$	4,520.5	$	2,948.1	$	13,482.3	$	8,232.2
Other revenues	16.1		24.0		62.4		90.3
Total revenues	4,536.6		2,972.1		13,544.7		8,322.5
Cost of sales	2,962.5		1,813.6		9,515.6		5,232.2
Gross profit	1,574.1		1,158.5		4,029.1		3,090.3
Operating expenses:
Research and development	152.1		129.8		483.9		400.3
Selling, general and administrative	1,055.0		658.4		3,446.3		1,983.2
Litigation settlements and other contingencies, net	9.4		18.9		55.3		36.5
Total operating expenses	1,216.5		807.1		3,985.5		2,420.0
Earnings from operations	357.6		351.4		43.6		670.3
Interest expense	151.9		117.3		488.0		353.4
Other expense (income), net	5.8		(7.5)		16.1		24.6
Earnings (loss) before income taxes	199.9		241.6		(460.5)		292.3
Income tax (benefit) provision	(111.6)		55.9		544.8		46.4
Net earnings (loss)	$	311.5	$	185.7	$	(1,005.3)	$	245.9
Earnings (loss) per share attributable to Viatris Inc. shareholders
Basic	$	0.26	$	0.36	$	(0.83)	$	0.48
Diluted	$	0.26	$	0.36	$	(0.83)	$	0.48
Weighted average shares outstanding:
Basic	1,209.3		516.9		1,208.6		516.8
Diluted	1,212.6		517.7		1,208.6		517.3

See Notes to Condensed Consolidated Financial Statements

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VIATRIS INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Earnings (Loss)

(Unaudited; in millions)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Net earnings (loss)	$	311.5	$	185.7	$	(1,005.3)	$	245.9
Other comprehensive (loss) earnings, before tax:
Foreign currency translation adjustment	(407.4)		687.7		(967.9)		483.1
Change in unrecognized gain (loss) and prior service cost related to defined benefit plans	0.8		(1.6)		74.1		3.4
Net unrecognized gain (loss) on derivatives in cash flow hedging relationships	11.8		32.5		27.5		(0.2)
Net unrecognized gain (loss) on derivatives in net investment hedging relationships	168.4		(114.7)		318.4		(119.7)
Net unrealized (loss) gain on marketable securities	(0.1)		—		(0.8)		0.8
Other comprehensive (loss) earnings, before tax	(226.5)		603.9		(548.7)		367.4
Income tax provision (benefit)	40.4		2.8		65.2		(6.0)
Other comprehensive (loss) earnings, net of tax	(266.9)		601.1		(613.9)		373.4
Comprehensive earnings (loss)	$	44.6	$	786.8	$	(1,619.2)	$	619.3

See Notes to Condensed Consolidated Financial Statements

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VIATRIS INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited in millions, except share and per share amounts)


	September 30, 2021		December 31, 2020
ASSETS
Assets
Current assets:
Cash and cash equivalents	$	756.6	$	844.4
Accounts receivable, net	4,345.5		4,843.8
Inventories	4,081.9		5,471.9
Prepaid expenses and other current assets	2,124.4		1,707.4
Total current assets	11,308.4		12,867.5
Property, plant and equipment, net	3,114.0		3,459.9
Intangible assets, net	26,987.0		29,683.2
Goodwill	12,169.5		12,347.0
Deferred income tax benefit - noncurrent	1,451.9		2,147.9
Other assets	1,039.6		1,047.5
Total assets	$	56,070.4	$	61,553.0

LIABILITIES AND EQUITY
Liabilities
Current liabilities:
Accounts payable	$	1,659.6	$	1,904.2
Short-term borrowings	1,706.9		1,100.9
Income taxes payable	198.0		288.6
Current portion of long-term debt and other long-term obligations	1,908.1		2,308.5
Other current liabilities	4,631.3		4,960.7
Total current liabilities	10,103.9		10,562.9
Long-term debt	19,854.3		22,429.2
Deferred income tax liability	2,918.0		3,123.7
Other long-term obligations	2,052.9		2,483.1
Total liabilities	34,929.1		38,598.9
Equity
Viatris Inc. shareholders’ equity
Common stock — par value $0.01 per share as of September 30, 2021 and December 31, 2020:
Shares authorized: 3,000,000,000 as of September 30, 2021 and December 31, 2020
Shares issued and outstanding: 1,209,378,962 and 1,206,895,644 as of September 30, 2021 and December 31, 2020	12.1		12.1
Additional paid-in capital	18,514.1		18,438.8
Retained earnings	4,087.0		5,361.2
Accumulated other comprehensive loss	(1,471.9)		(858.0)




Total equity	21,141.3		22,954.1

Total liabilities and equity	$	56,070.4	$	61,553.0

See Notes to Condensed Consolidated Financial Statements

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VIATRIS INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Equity

(Unaudited; in millions, except share amounts)


				Additional Paid-In Capital		Retained Earnings					Accumulated Other Comprehensive Loss		Total Equity
	Common Stock					Treasury Stock
	Shares	Cost				Shares		Cost
Balance at June 30, 2021	1,209,212,338	$	12.1	$	18,489.9	$	3,909.9	—	$	—	$	(1,205.0)	$	21,206.9
Net earnings	—	—		—		311.5		—	—		—		311.5
Other comprehensive loss, net of tax	—	—		—		—		—	—		(266.9)		(266.9)
Issuance of restricted stock and stock options exercised, net	166,624	—		—		—		—	—		—		—
Taxes related to the net share settlement of equity awards	—	—		(0.8)		—		—	—		—		(0.8)
Share-based compensation expense	—	—		25.0		—		—	—		—		25.0
Cash dividends declared, $0.11 per common share	—	—		—		(134.4)		—	—		—		(134.4)





Balance at September 30, 2021	1,209,378,962	$	12.1	$	18,514.1	$	4,087.0	—	$	—	$	(1,471.9)	$	21,141.3

				Additional Paid-In Capital		Retained Earnings					Accumulated Other Comprehensive Loss		Total Equity
	Common Stock					Treasury Stock
	Shares	Cost				Shares		Cost
Balance at December 31, 2020	1,206,895,644	$	12.1	$	18,438.8	$	5,361.2	—	$	—	$	(858.0)	$	22,954.1
Net loss	—	—		—		(1,005.3)		—	—		—		(1,005.3)
Other comprehensive loss, net of tax	—	—		—		—		—	—		(613.9)		(613.9)
Issuance of restricted stock and stock options exercised, net	2,483,318	—		—		—		—	—		—		—
Taxes related to the net share settlement of equity awards	—	—		(13.4)		—		—	—		—		(13.4)
Share-based compensation expense	—	—		88.7		—		—	—		—		88.7
Cash dividends declared, $0.11 per common share	—	—		—		(268.9)		—	—		—		(268.9)





Balance at September 30, 2021	1,209,378,962	$	12.1	$	18,514.1	$	4,087.0	—	$	—	$	(1,471.9)	$	21,141.3

See Notes to Condensed Consolidated Financial Statements

Table of Contents


				Additional Paid-In Capital		Retained Earnings					Accumulated Other Comprehensive Loss		Total Equity
	Ordinary Shares (1)					Treasury Stock
	Shares	Cost				Shares		Cost
Balance at June 30, 2020	541,545,308	$	6.1	$	8,673.2	$	6,091.5	24,598,074	$	(999.7)	$	(2,024.9)	$	11,746.2
Net earnings	—	—		—		185.7		—	—		—		185.7
Other comprehensive earnings, net of tax	—	—		—		—		—	—		601.1		601.1
Issuance of restricted stock and stock options exercised, net	4,747	—		—		—		—	—		—		—

Share-based compensation expense	—	—		15.1		—		—	—		—		15.1



Other	—	—		—		(0.2)		—	—		—		(0.2)
Balance at September 30, 2020	541,550,055	$	6.1	$	8,688.3	$	6,277.0	24,598,074	$	(999.7)	$	(1,423.8)	$	12,547.9

				Additional Paid-In Capital		Retained Earnings					Accumulated Other Comprehensive Loss		Total Equity
	Ordinary Shares (1)					Treasury Stock
	Shares	Cost				Shares		Cost
Balance at December 31, 2019	540,746,871	$	6.1	$	8,643.5	$	6,031.1	24,598,074	$	(999.7)	$	(1,797.2)	$	11,883.8
Net earnings	—	—		—		245.9		—	—		—		245.9
Other comprehensive earnings, net of tax	—	—		—		—		—	—		373.4		373.4
Issuance of restricted stock and stock options exercised, net	803,184	—		0.6		—		—	—		—		0.6
Taxes related to the net share settlement of equity awards	—	—		(5.6)		—		—	—		—		(5.6)
Share-based compensation expense	—	—		49.8		—		—	—		—		49.8



Other	—	—		—		—		—	—		—		—
Balance at September 30, 2020	541,550,055	$	6.1	$	8,688.3	$	6,277.0	24,598,074	$	(999.7)	$	(1,423.8)	$	12,547.9

(1) Ordinary Shares prior to November 16, 2020.

See Notes to Condensed Consolidated Financial Statements

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VIATRIS INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(Unaudited; in millions)


	Nine Months Ended
	September 30,
	2021		2020
Cash flows from operating activities:
Net (loss) earnings	$	(1,005.3)	$	245.9
Adjustments to reconcile net (loss) earnings to net cash provided by operating activities:
Depreciation and amortization	3,756.7		1,263.0
Share-based compensation expense	88.7		49.8
Deferred income tax expense (benefit)	728.6		(210.4)
Loss from equity method investments	52.2		37.4
Other non-cash items	288.2		134.3
Litigation settlements and other contingencies, net	50.0		43.6
Changes in operating assets and liabilities:
Accounts receivable	69.1		(27.3)
Inventories	(351.1)		(532.4)
Accounts payable	(108.4)		(99.7)
Income taxes	(675.3)		115.2
Other operating assets and liabilities, net	(399.6)		176.2
Net cash provided by operating activities	2,493.8		1,195.6
Cash flows from investing activities:
Cash received from acquisitions	277.0		—
Capital expenditures	(259.8)		(126.1)
Purchase of marketable securities	(26.3)		(96.1)
Proceeds from the sale of marketable securities	26.0		38.6
Payments for product rights and other, net	(28.2)		(97.3)
Proceeds from sale of assets and subsidiaries	96.5		—
Proceeds from sale of property, plant and equipment	16.1		2.1
Net cash provided by (used in) investing activities	101.3		(278.8)
Cash flows from financing activities:
Proceeds from issuance of long-term debt	1,710.1		33.2
Payments of long-term debt	(4,200.7)		(588.9)
Change in short-term borrowings, net	606.1		0.3
Cash dividends paid	(266.0)		—
Taxes paid related to net share settlement of equity awards	(17.1)		(7.1)
Non-contingent payments for product rights	(456.0)		(139.5)
Contingent consideration payments	(28.6)		(48.5)
Payments of financing fees	(6.5)		(1.8)
Proceeds from exercise of stock options	—		0.6
Other items, net	(4.1)		(3.1)
Net cash used in financing activities	(2,662.8)		(754.8)
Effect on cash of changes in exchange rates	(20.6)		14.0
Net (decrease) increase in cash, cash equivalents and restricted cash	(88.3)		176.0
Cash, cash equivalents and restricted cash — beginning of period	850.0		491.1
Cash, cash equivalents and restricted cash — end of period	$	761.7	$	667.1

See Notes to Condensed Consolidated Financial Statements

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VIATRIS INC. AND SUBSIDIARIES

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, 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’ 2020 Form 10-K. The December 31, 2020 condensed consolidated balance sheet was derived from audited financial statements. In accordance with ASC 805, Business Combinations, Mylan is considered the accounting acquirer of the Upjohn Business and all historical financial information of the Company prior to November 16, 2020 represents Mylan’s historical results and the Company’s thereafter. Refer to Note 4 Acquisitions and Other Transactions for additional information.

The interim results of operations and comprehensive earnings (loss) for the three and nine months ended September 30, 2021, and cash flows for the nine months ended September 30, 2021, are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.

**2.**Revenue Recognition and Accounts Receivable

The Company recognizes revenue 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 revenue 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 nine months ended September 30, 2021 and 2020, respectively:


(In millions)	Three Months Ended September 30, 2021
Product Category	Developed Markets		Greater China		JANZ		Emerging Markets		Total
Brands	$	1,522.7	$	566.8	$	299.1	$	414.5	$	2,803.1
Complex Gx and Biosimilars	305.1		—		13.2		13.7		332.0
Generics	828.1		—		193.0		364.3		1,385.4
Total	$	2,655.9	$	566.8	$	505.3	$	792.5	$	4,520.5

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


(In millions)	Nine Months Ended September 30, 2021
Product Category	Developed Markets		Greater China		JANZ		Emerging Markets		Total
Brands	$	4,350.5	$	1,706.9	$	878.5	$	1,293.5	$	8,229.4
Complex Gx and Biosimilars	926.4		—		31.9		35.4		993.7
Generics	2,591.0		2.1		577.8		1,088.3		4,259.2
Total	$	7,867.9	$	1,709.0	$	1,488.2	$	2,417.2	$	13,482.3


(In millions)	Three Months Ended September 30, 2020
Product Category	Developed Markets		Greater China		JANZ		Emerging Markets		Total
Brands	$	1,013.2	$	30.5	$	116.8	$	80.9	$	1,241.4
Complex Gx and Biosimilars	325.8		0.1		8.3		18.1		352.3
Generics	824.2		0.9		157.3		372.0		1,354.4
Total	$	2,163.2	$	31.5	$	282.4	$	471.0	$	2,948.1


(In millions)	Nine Months Ended September 30, 2020
Product Category	Developed Markets		Greater China		JANZ		Emerging Markets		Total
Brands	$	2,760.2	$	67.2	$	335.5	$	213.0	$	3,375.9
Complex Gx and Biosimilars	896.0		0.2		25.2		35.3		956.7
Generics	2,476.1		1.9		445.1		976.5		3,899.6
Total	$	6,132.3	$	69.3	$	805.8	$	1,224.8	$	8,232.2

The following table presents net sales on a consolidated basis for select key products for the three and nine months ended September 30, 2021:


(In millions)	Three months ended September 30, 2021		Nine months ended September 30, 2021

Select Key Global Products
Lipitor ®	$	410.0	$	1,272.9
Norvasc ®	198.4		635.9
Lyrica ®	175.6		555.9
Viagra ®	138.0		412.4
EpiPen® Auto-Injectors	129.5		337.3
Celebrex ®	86.0		257.3
Creon ®	81.1		231.7
Effexor ®	79.5		239.6
Zoloft ®	61.3		208.8
Xalabrands	55.8		172.0

Select Key Segment Products
Influvac ®	$	161.2	$	165.3
Amitiza ®	49.5		147.5
Xanax ®	47.6		141.5
Yupelri ®	39.4		118.1
Dymista ®	35.0		129.9

(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 introductions.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

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 nine months ended September 30, 2021 and 2020, respectively:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In millions)	2021		2020		2021		2020
Gross sales	$	7,739.5	$	4,986.4	$	23,058.8	$	13,868.0
Gross to net adjustments:
Chargebacks	(1,439.3)		(967.0)		(4,112.1)		(2,616.9)
Rebates, promotional programs and other sales allowances	(1,521.6)		(926.3)		(4,656.7)		(2,592.3)
Returns	(87.9)		(76.6)		(289.2)		(193.2)
Governmental rebate programs	(170.2)		(68.4)		(518.5)		(233.4)
Total gross to net adjustments	$	(3,219.0)	$	(2,038.3)	$	(9,576.5)	$	(5,635.8)
Net sales	$	4,520.5	$	2,948.1	$	13,482.3	$	8,232.2

No significant revisions were made to the methodology used in determining these provisions or the nature of the provisions during the three and nine months ended September 30, 2021. Such allowances were comprised of the following at September 30, 2021 and December 31, 2020, respectively:


(In millions)	September 30, 2021		December 31, 2020
Accounts receivable, net	$	1,733.0	$	1,802.9
Other current liabilities	1,395.8		1,211.8
Total	$	3,128.8	$	3,014.7

Accounts receivable, net was comprised of the following at September 30, 2021 and December 31, 2020, respectively:


(In millions)	September 30, 2021		December 31, 2020
Trade receivables, net	$	3,841.5	$	3,891.3
Other receivables	504.0		952.5
Accounts receivable, net	$	4,345.5	$	4,843.8

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 $35.2 million and $153.0 million of accounts receivable as of September 30, 2021 and December 31, 2020, respectively, under these factoring arrangements.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

**3.**Recent Accounting Pronouncements

Adoption of New Accounting Standards

In January 2020, the FASB issued Accounting Standards Update 2020-01, Clarifying the Interactions Between Topic 321, Topic 323, and Topic 815 (“ASU 2020-01”), which clarifies that an entity should consider observable transactions that require it to either apply or discontinue the equity method of accounting for the purposes of applying the measurement alternative in accordance with Topic 321 immediately before applying or upon discontinuing the equity method. In addition, ASU 2020-01 states that for the purpose of applying paragraph 815-10-15-141(a) an entity should not consider whether, upon the settlement of the forward contract or exercise of the purchased option, individually or with existing investments, the underlying securities would be accounted for under the equity method in Topic 323 or the fair value option in accordance with the financial instruments guidance in Topic 825. ASU 2020-01 was effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements and disclosures.

In December 2019, the FASB issued Accounting Standards Update 2019-12, Income Taxes (Topic 740) which is intended to simplify the accounting for income taxes by eliminating certain exceptions and simplifying certain requirements under Topic 740. ASU 2019-12 was effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. ASU 2019-12 includes an update to previous guidance in situations in which an entity incurs a loss on a year-to-date basis that exceeds the anticipated loss for the year. In these situations, previous guidance stipulated that the income tax benefit was limited to the income tax that would exist on the basis of the year-to-date loss. This represented an exception to the guidance in ASC 740-270, and the provisions of ASU 2019-12 include the elimination of this exception which applied to the financial results of the three and nine months ended September 30, 2021. The Company has applied the provisions of ASU 2019-12 on a prospective basis beginning January 1, 2021. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements and disclosures.

Accounting Standard Issued Not Yet Adopted

The following recently issued accounting standard has not been adopted. Refer to Viatris’ 2020 Form 10-K for additional information and its potential impacts.


Accounting Standard Update			Effective Date
ASU 2020-04: Reference Rate Reform (Topic 848) Facilitation of the Effects of Reference Rate Reform on Financial Reporting			January 1, 2023

**4.**Acquisitions and Other Transactions

Upjohn Business Combination Agreement

On July 29, 2019, Mylan, Pfizer, Upjohn Inc., a wholly-owned subsidiary of Pfizer, and certain other affiliated entities entered into a Business Combination Agreement pursuant to which Mylan would combine with the Upjohn Business in a Reverse Morris Trust transaction. The Upjohn Business was a global, primarily off-patent branded and generic established medicines business, which includes 20 primarily off-patent solid oral dose legacy brands, such as Lyrica, Lipitor, Celebrex and Viagra. The Combination was completed on November 16, 2020.

Prior to the Combination and pursuant to a Separation and Distribution Agreement, Pfizer had, among other things, transferred to Viatris substantially all of the assets and liabilities comprising the Upjohn Business (the Separation) and, thereafter, Pfizer had distributed to Pfizer stockholders all of the issued and outstanding shares of Viatris (the Distribution). When the Distribution and Combination were complete, Pfizer stockholders as of the record date of the Distribution owned 57% of the outstanding shares of Viatris common stock and Mylan shareholders as of immediately before the Combination owned 43% of the outstanding shares of Viatris common stock, in each case on a fully diluted basis. Viatris also made a cash payment to Pfizer equal to $12 billion, which was funded with the proceeds of debt incurred by Upjohn prior to the Combination.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

The transaction involved multiple legal entity restructuring transactions and a reverse merger acquisition with Viatris representing the legal acquirer and Mylan representing the accounting acquirer of the Upjohn Business. In accordance with ASC 805, Business Combinations, Mylan is considered the accounting acquirer of the Upjohn Business and Viatris applied purchase accounting to the acquired assets and assumed liabilities of the Upjohn Business as of November 16, 2020. The debt incurred by Upjohn prior to the Combination was a liability assumed in purchase accounting. The fair value of the debt as of November 16, 2020 was $13.08 billion.

The purchase price consists of the issuance of approximately 689.9 million Viatris shares of common stock at a fair value of approximately $10.73 billion based on the closing price of Mylan’s ordinary shares on November 13, 2020, as reported by the NASDAQ. In accordance with U.S. GAAP, the Company used the acquisition method of accounting to account for this transaction. Under the acquisition method of accounting, the assets acquired and liabilities assumed in the transaction have been recorded at their respective estimated fair values at the acquisition date. Acquisition related costs of approximately $602.9 million were incurred during the twelve months ended December 31, 2020, and approximately $149.7 million were incurred during the nine months ended September 30, 2021. Acquisition related costs were recorded primarily in SG&A in the consolidated statements of operations for such periods.

During the nine months ended September 30, 2021, adjustments were made to the preliminary purchase price recorded at November 16, 2020. These adjustments are reflected in the values presented below. The preliminary allocation of the $10.73 billion purchase price to the assets acquired and liabilities assumed under the Combination is as follows:


(In millions)	Preliminary Purchase Price Allocation as of December 31, 2020 (a)		Measurement Period and Other Adjustments (b)		Preliminary Purchase Price Allocation as of September 30, 2021 (as adjusted)
Current assets (excluding inventories and net of cash acquired)	$	2,841.9	$	(7.3)	$	2,834.6
Inventories	2,588.9		(34.2)		2,554.7
Property, plant and equipment	1,394.1		(5.0)		1,389.1
Identified intangible assets	18,040.0		—		18,040.0
Goodwill	2,107.5		218.6		2,326.1
Deferred income tax benefit	1,481.9		247.4		1,729.3
Other assets	792.1		(0.1)		792.0
Total assets acquired	$	29,246.4	$	419.4	$	29,665.8
Current liabilities	2,760.2		418.6		3,178.8
Long-term debt, including current portion	13,076.2		—		13,076.2
Deferred tax liabilities	1,656.9		(1.7)		1,655.2
Other noncurrent liabilities	1,441.5		2.5		1,444.0
Net assets acquired (net of $415.8 of cash acquired)	$	10,311.6	$	—	$	10,311.6

(a)As previously reported in Viatris’ 2020 Form 10-K.

(b)The measurement period adjustments are primarily for 1) certain working capital adjustments, an increase in litigation reserves to reflect facts and circumstances that existed as of the date of the Combination, and other adjustments and 2) the tax implications of these and other adjustments. These adjustments did not have a significant impact on the Company’s previously reported consolidated financial statements and accordingly, the Company has not retrospectively adjusted those consolidated financial statements.

The preliminary fair value estimates for the assets acquired and liabilities assumed were based upon preliminary calculations, valuations and assumptions that are subject to change as the Company obtains additional information during the measurement period (up to one year from the acquisition date). The primary areas subject to change relate to the finalization of the working capital components and income taxes.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

During the year ended December 31, 2020, the Company recorded a step-up in the fair value of inventory of approximately $1.43 billion. During the three and nine months ended September 30, 2021, the Company recorded amortization of the inventory step-up of approximately $238.5 million and $1.19 billion, respectively, which is included in cost of sales in the condensed consolidated statements of operations. The inventory step up has been fully amortized at September 30, 2021. In addition, a step-up in the fair value of property, plant and equipment of approximately $385.0 million was recognized as of September 30, 2021. The related depreciation is being expensed over a service life of five years for machinery and equipment and between 10 and 20 years for buildings.

The identified intangible assets of $18.04 billion are comprised of product rights and are being amortized over a weighted average useful life of 15 years. Significant assumptions utilized in the valuation of identified intangible assets were based on company specific information and projections which are not observable in the market and are thus considered Level 3 measurements as defined by U.S. GAAP. The goodwill of $2.33 billion arising from the Combination consisted largely of the value of the employee workforce and products to be sold in new markets leveraging the combined entity. In addition, an allocation of the goodwill was assigned to the respective segments. None of the goodwill recognized in this transaction is expected to be deductible for income tax purposes.

The Company recorded a fair value adjustment of approximately $759.4 million related to the long-term debt assumed as part of the acquisition. The fair value of long-term debt as of the Combination date was determined by broker or dealer quotations, which is classified as Level 2 in the fair value hierarchy. The total fair value adjustment is being amortized as a reduction to interest expense over the maturity dates of the related debt instruments.

Unaudited Pro Forma Financial Results

The following table presents supplemental unaudited pro forma information for the Combination, as if it had occurred on January 1, 2019. The unaudited pro forma results reflect certain adjustments related to past operating performance and acquisition accounting adjustments, such as increased depreciation and amortization expense based on the fair value of assets acquired, the impact of transaction costs and the related income tax effects. The unaudited pro forma results do not include any anticipated synergies which may be achievable, or have been achieved, subsequent to the closing of the Combination. Accordingly, the unaudited pro forma results are not necessarily indicative of the results that actually would have occurred had the acquisitions been completed on the stated date above, nor are they indicative of the future operating results of Viatris and its subsidiaries.


	Three Months Ended		Nine Months Ended
(Unaudited, in millions, except per share amounts)	September 30, 2020		September 30, 2020
Total revenues	$	4,712.2	$	13,707.0
Net earnings	$	419.1	$	1,642.8
Earnings per share:
Basic	$	0.35	$	1.36
Diluted	$	0.35	$	1.36
Weighted average shares outstanding:
Basic	1,206.8		1,206.7
Diluted	1,207.6		1,207.2

**5.**Share-Based Incentive Plan

Prior to the Distribution, Viatris adopted and Pfizer, in the capacity as Viatris’ sole stockholder at such time, approved the Plan which became effective as of the Distribution. In connection with the Combination, as of November 16, 2020, the Company assumed the Mylan N.V. Amended and Restated 2003 Long-Term Incentive Plan, which had previously been approved by Mylan shareholders. The Plan and 2003 LTIP include (i) 72,500,000 shares of common stock authorized for grant pursuant to the Plan, which may include dividend payments payable in common stock on unvested shares granted under awards, (ii) 6,757,640 shares of common stock to be issued pursuant to the exercise of outstanding stock options granted to participants under the 2003 LTIP and assumed by Viatris in connection with the Combination and (iii) 13,535,627 shares of common stock subject to outstanding equity-based awards, other than stock options, assumed by Viatris in connection with the Combination, or that otherwise remain available for issuance under the 2003 LTIP.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Under the Plan and 2003 LTIP, 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 to four years, and generally expire in ten years.

The following table summarizes stock option and SAR (together, “stock awards”) activity under the Plan and 2003 LTIP:


	Number of Shares Under Stock Awards	Weighted Average Exercise Price per Share
Outstanding at December 31, 2020	6,711,731	$	35.36


Forfeited	(1,002,889)	$	25.24
Outstanding at September 30, 2021	5,708,842	$	37.14
Vested and expected to vest at September 30, 2021	5,615,521	$	37.40
Exercisable at September 30, 2021	5,071,319	$	39.19

As of September 30, 2021, stock awards outstanding, stock awards vested and expected to vest and stock awards exercisable had average remaining contractual terms of 4.9 years, 4.8 years and 4.5 years, respectively. Also, at September 30, 2021, stock awards outstanding, stock awards vested and expected to vest and stock awards exercisable had no aggregate intrinsic value.

A summary of the status of the Company’s restricted stock awards as of September 30, 2021 and the changes during the nine months ended September 30, 2021 are presented below:


	Number of Restricted Stock Awards	Weighted Average Grant-Date Fair Value Per Share
Nonvested at December 31, 2020	12,073,790	$	18.34
Granted	9,850,633	14.42
Released	(3,029,725)	24.94
Forfeited	(1,383,140)	15.42
Nonvested at September 30, 2021	17,511,558	$	15.14

As of September 30, 2021, the Company had $171.8 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 1.8 years. The total intrinsic value of stock awards exercised and restricted stock units released during the nine months ended September 30, 2021 and 2020 was $75.6 million and $19.1 million, respectively.

**6.**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.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

In connection with the Combination, the Company assumed certain post retirement defined benefit pension plans sponsored by Upjohn. The most significant plans include those in Puerto Rico, Ireland and Japan. Upjohn is also the sponsor of one postretirement medical plan in Puerto Rico. As part of the acquisition accounting, the Company recorded the fair value of these plans using assumptions and accounting policies consistent with those historically utilized by Mylan. Upon completion of the Combination, the excess of projected benefit obligation over the plan assets was recognized as a liability and any existing unrecognized actuarial gains or losses and unrecognized service costs or benefits were eliminated in purchase accounting.

Net Periodic Benefit Cost

Components of net periodic benefit cost for the three and nine months ended September 30, 2021 and 2020 were as follows:


	Pension and Other Postretirement Benefits
	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In millions)	2021		2020		2021		2020
Service cost	$	10.8	$	5.3	$	32.5	$	15.9
Interest cost	8.5		2.9		25.7		8.7
Expected return on plan assets	(16.6)		(3.3)		(49.8)		(10.1)
Amortization of prior service costs	(0.1)		—		(0.4)		—
Recognized net actuarial losses	0.4		0.1		1.2		0.4
Settlement gain	—		—		(3.1)		—
Net periodic benefit cost	$	3.0	$	5.0	$	6.1	$	14.9

During the nine months ended September 30, 2021, the Company recognized a settlement gain as a result of cash payments from lump sum elections related to the U.S. and Puerto Rico pension plans.

The Company expects to make total benefit payments of approximately $118.9 million from pension and other postretirement benefit plans in 2021. The Company anticipates making contributions to pension and other postretirement benefit plans of approximately $70.1 million in 2021.

**7.**Balance Sheet Components

Selected balance sheet components consist of the following:

Cash and restricted cash


(In millions)	September 30, 2021		December 31, 2020		September 30, 2020
Cash and cash equivalents	$	756.6	$	844.4	$	664.5
Restricted cash, included in other current and non-current assets	5.1		5.6		2.6
Cash, cash equivalents and restricted cash	$	761.7	$	850.0	$	667.1

Inventories


(In millions)	September 30, 2021		December 31, 2020
Raw materials	$	955.7	$	958.4
Work in process	836.4		1,438.1
Finished goods	2,289.8		3,075.4
Inventories	$	4,081.9	$	5,471.9

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Prepaid expenses and other current assets


(In millions)	September 30, 2021		December 31, 2020
Prepaid expenses	$	237.3	$	267.8

Available-for-sale fixed income securities	38.7		39.1
Fair value of financial instruments	146.5		118.6
Equity securities	49.0		45.8
Other current assets	1,652.9		1,236.1
Prepaid expenses and other current assets	$	2,124.4	$	1,707.4

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

Property, plant and equipment, net


(In millions)	September 30, 2021		December 31, 2020
Machinery and equipment	$	3,070.3	$	3,235.0
Buildings and improvements	1,888.4		1,954.8
Construction in progress	493.1		376.3
Land and improvements	146.0		155.8
Gross property, plant and equipment	5,597.8		5,721.9
Accumulated depreciation	2,483.8		2,262.0
Property, plant and equipment, net	$	3,114.0	$	3,459.9

Other assets


(In millions)	September 30, 2021		December 31, 2020
Equity method investments, clean energy investments	$	11.6	$	47.9
Operating lease right-of-use assets	305.9		323.6
Other long-term assets	722.1		676.0
Other assets	$	1,039.6	$	1,047.5

Accounts payable


(In millions)	September 30, 2021		December 31, 2020
Trade accounts payable	$	1,139.0	$	1,345.7
Other payables	520.6		558.5
Accounts payable	$	1,659.6	$	1,904.2

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Other current liabilities


(In millions)	September 30, 2021		December 31, 2020
Accrued sales allowances	$	1,395.8	$	1,211.8
Legal and professional accruals, including litigation accruals	474.9		362.9
Payroll and employee benefit liabilities	712.0		828.2
Contingent consideration	85.0		100.5
Accrued interest	224.1		90.9
Restructuring	249.7		149.2
Equity method investments, clean energy investments	20.2		47.5
Fair value of financial instruments	47.1		103.6
Operating lease liability	88.9		92.9
Other	1,333.6		1,973.2
Other current liabilities	$	4,631.3	$	4,960.7

Other long-term obligations


(In millions)	September 30, 2021		December 31, 2020
Employee benefit liabilities	$	884.9	$	1,020.4
Contingent consideration	121.9		123.1

Tax related items, including contingencies	399.4		469.5
Operating lease liability	213.7		229.5
Accrued Restructuring	122.0		134.8
Other	311.0		505.8
Other long-term obligations	$	2,052.9	$	2,483.1

**8.**Equity Method Investments

Summarized financial information, in the aggregate, for the Company’s three equity method, clean energy investments on a 100% basis for the three and nine months ended September 30, 2021 and 2020 are as follows:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In millions)	2021		2020		2021		2020
Total revenues	$	94.0	$	113.5	$	293.5	$	288.8
Gross loss	(1.3)		(1.4)		(3.9)		(3.6)
Operating and non-operating expense	4.8		5.2		13.7		14.4
Net loss	$	(6.1)	$	(6.6)	$	(17.6)	$	(18.0)

The Company’s net losses from its equity method investments include amortization expense related to the excess of the cost basis of the Company’s investment over the underlying assets of each individual investee. For the three months ended September 30, 2021 and 2020, the Company recognized net losses from equity method investments of $17.6 million and $2.9 million, respectively. For the nine months ended September 30, 2021 and 2020, the Company recognized net losses from equity method investments of $52.2 million and $37.4 million, respectively, which were recognized as a component of other expense, net in the condensed consolidated statements of operations. The Company recognizes the income tax credits and benefits from the clean energy investments as part of its provision for income taxes.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

During the three months ended September 30, 2020, the Company reduced its long-term obligations for its three investments as a result of lower than anticipated production levels and lower expected future variable debt payments to the respective project sponsor. The Company recognized a net gain of approximately $15 million, which was recognized as a component of the net loss of the equity method investments in the condensed consolidated statements of operations.

The law that provides for IRC Section 45 tax credits expired during the third quarter of 2021 for one of our clean energy investments and is expected to expire in the fourth quarter of 2021 for our other two clean energy investments. We anticipate that the Company’s clean energy investments will wind down operations upon the expiration of the refined coal tax credits at the end of 2021.

**9.**Earnings (Loss) per Share

Basic earnings (loss) per share is computed by dividing net earnings (loss) by the weighted average number of shares outstanding during the period. Diluted earnings (loss) per share is computed by dividing net earnings (loss) 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 earnings (loss) per share attributable to Viatris Inc. are calculated as follows:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In millions, except per share amounts)	2021		2020		2021		2020
Basic earnings (loss) attributable to Viatris Inc. common shareholders
Net earnings (loss) attributable to Viatris Inc. common shareholders	$	311.5	$	185.7	$	(1,005.3)	$	245.9
Shares (denominator):
Weighted average shares outstanding	1,209.3		516.9		1,208.6		516.8
Basic earnings (loss) per share attributable to Viatris Inc. shareholders	$	0.26	$	0.36	$	(0.83)	$	0.48

Diluted earnings (loss) attributable to Viatris Inc. common shareholders
Net earnings (loss) attributable to Viatris Inc. common shareholders	$	311.5	$	185.7	$	(1,005.3)	$	245.9
Shares (denominator):
Weighted average shares outstanding	1,209.3		516.9		1,208.6		516.8
Share-based awards and warrants	3.3		0.8		—		0.5
Total dilutive shares outstanding	1,212.6		517.7		1,208.6		517.3
Diluted earnings (loss) per share attributable to Viatris Inc. shareholders	$	0.26	$	0.36	$	(0.83)	$	0.48

Additional stock awards and restricted stock awards were outstanding during the three and nine months ended September 30, 2021 and 2020, but were not included in the computation of diluted earnings per share for each respective period because the effect would be anti-dilutive. Excluded shares at September 30, 2021 include certain share-based compensation awards whose performance conditions had not been fully met. Such excluded shares and anti-dilutive awards represented 11.4 million shares and 10.8 million shares for the three and nine months ended September 30, 2021, respectively, and 8.8 million shares and 9.8 million shares for the three and nine months ended September 30, 2020, respectively.

The Company paid quarterly cash dividends of $0.11 per share on the Company’s issued and outstanding common stock on June 16, 2021 and September 16, 2021. On November 5, 2021, the Company’s Board of Directors declared a quarterly cash dividend of $0.11 per share on the Company’s issued and outstanding common stock, which will be payable on December 16, 2021 to shareholders of record as of the close of business on November 23, 2021. 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.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

**10.**Goodwill and Intangible Assets

The changes in the carrying amount of goodwill for the nine months ended September 30, 2021 are as follows:


(In millions)	Developed Markets		Greater China		JANZ		Emerging Markets		Total
Balance at December 31, 2020:
Goodwill	$	9,569.5	$	738.3	$	864.0	$	1,560.2	$	12,732.0
Accumulated impairment losses	(385.0)		—		—		—		(385.0)
	9,184.5		738.3		864.0		1,560.2		12,347.0
Measurement period and other adjustments	73.0		67.7		22.5		55.4		218.6
Foreign currency translation	(406.9)		6.3		(49.8)		54.3		(396.1)
	$	8,850.6	$	812.3	$	836.7	$	1,669.9	$	12,169.5
Balance at September 30, 2021:
Goodwill	$	9,235.6	$	812.3	$	836.7	$	1,669.9	$	12,554.5
Accumulated impairment losses	(385.0)		—		—		—		(385.0)
	$	8,850.6	$	812.3	$	836.7	$	1,669.9	$	12,169.5

Intangible assets consist of the following components at September 30, 2021 and December 31, 2020:


(In millions)	Weighted Average Life (Years)	Original Cost		Accumulated Amortization		Net Book Value
September 30, 2021
Product rights, licenses and other (1)	15	$	39,352.4	$	12,445.2	$	26,907.2
In-process research and development		79.8		—		79.8
		$	39,432.2	$	12,445.2	$	26,987.0
December 31, 2020
Product rights, licenses and other (1)	15	$	40,404.1	$	10,801.6	$	29,602.5
In-process research and development		80.7		—		80.7
		$	40,484.8	$	10,801.6	$	29,683.2

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

The Company performed its annual goodwill impairment test as of April 1, 2021 on a quantitative basis for its five reporting units, North America, Europe, Emerging Markets, JANZ, and Greater China. See Note 14, Segment Information, for further discussion. Additionally, the net assets acquired as part of the Combination were included in the respective reporting units and in the annual impairment test for the first time. In estimating each reporting unit’s fair value, the Company performed an extensive valuation analysis, utilizing both income and market-based approaches. 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, market multiples, control premiums, the discount rate, terminal growth rates, operating income before depreciation and amortization, and capital expenditures forecasts.

As of April 1, 2021, the allocation of the Company’s total goodwill was as follows: North America $3.66 billion, Europe $5.15 billion, Emerging Markets $1.58 billion, JANZ $0.82 billion and Greater China $0.70 billion.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

As of April 1, 2021, the Company determined that the fair value of the North America, Emerging Markets and Greater China reporting units was substantially in excess of the respective unit’s carrying value.

For the Europe reporting unit, the estimated fair value exceeded its carrying value by approximately $0.91 billion or 5.8% for the annual goodwill impairment test. As it relates to the income approach for the Europe reporting unit at April 1, 2021, the Company forecasted cash flows for the next 10 years. During the forecast period, the revenue compound annual growth rate was approximately 3.0%. A terminal year value was calculated with a 0.9% revenue growth rate applied. The discount rate utilized was 10.5% and the estimated tax rate was 19.0%. Under the market-based approach, we utilized an estimated range of market multiples of 7.5 to 8.5 times EBITDA plus a control premium of 15.0%. If all other assumptions are held constant, a reduction in the terminal value growth rate by 2.9% or an increase in discount rate by 1.5% would result in an impairment charge for the Europe reporting unit.

For the JANZ reporting unit, the estimated fair value exceeded its carrying value by approximately $0.23 billion or 7.0% for the annual goodwill impairment test. As it relates to the income approach for the JANZ reporting unit at April 1, 2021, the Company forecasted cash flows for the next 10 years. During the forecast period, the revenue compound annual growth rate was approximately negative 1.5%. A terminal year value was calculated with a 0.7% revenue growth rate applied. The discount rate utilized was 8.5% and the estimated tax rate was 30.5%. Under the market-based approach, we utilized an estimated market multiple of 6.0 times EBITDA plus a control premium of 15.0%. If all other assumptions are held constant, a reduction in the terminal value growth rate by 4.2% or an increase in discount rate by 2.0% would result in an impairment charge for the JANZ 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.

Amortization expense, which is classified primarily within cost of sales in the condensed consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020 totaled:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In millions)	2021		2020		2021		2020
Intangible asset amortization expense	$	671.5	$	368.1	$	2,037.5	$	1,070.9
Intangible asset impairment charges	—		—		83.4		—

Total intangible asset amortization expense (including impairment charges)	$	671.5	$	368.1	$	2,120.9	$	1,070.9

On April 30, 2021, the Company completed an agreement to divest a group of OTC products in the U.S. As a result of this transaction, the Company recognized an intangible asset impairment charge of approximately $83.4 million during the nine months ended September 30, 2021.

Intangible asset amortization expense over the remainder of 2021 and for the years ended December 31, 2022 through 2025 is estimated to be as follows:


(In millions)
2021	$	661
2022	2,592
2023	2,428
2024	2,335
2025	2,237

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

11. 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 on 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 to eighteen 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 on 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.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

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 Amount		September 30, 2021		December 31, 2020
Euro
2.250% Euro Senior Notes due 2024	€	1,000.0	€	1,000.0	€	1,000.0
3.125% Euro Senior Notes due 2028	750.0		750.0		750.0

2.125% Euro Senior Notes due 2025	500.0		500.0		500.0
0.816% Euro Senior Notes due 2022	750.0		750.0		750.0
1.023% Euro Senior Notes due 2024	750.0		750.0		750.0
1.362% Euro Senior Notes due 2027	850.0		850.0		850.0
1.908% Euro Senior Notes due 2032	1,250.0		1,250.0		1,250.0
Foreign currency forward contracts	105.6		—		105.6
Euro Total	€	5,955.6	€	5,850.0	€	5,955.6

Yen
YEN Term Loan	¥	40,000.0	¥	40,000.0	¥	—
Yen Total	¥	40,000.0	¥	40,000.0	¥	—

At September 30, 2021, the principal amount of the Company’s outstanding Yen borrowings and the notional amount of the Yen borrowings designated as net investment hedge was $359.4 million.

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.

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.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

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


	Asset Derivatives					Liability Derivatives
(In millions)	Balance Sheet Location	September 30, 2021 Fair Value		December 31, 2020 Fair Value		Balance Sheet Location	September 30, 2021 Fair Value		December 31, 2020 Fair Value

Derivatives designated as hedges:

Foreign currency forward contracts	Prepaid expenses & other current assets	$	55.0	$	28.3	Other current liabilities	$	0.5	$	0.8
Total derivatives designated as hedges		55.0		28.3			0.5		0.8
Derivatives not designated as hedges:
Foreign currency forward contracts	Prepaid expenses & other current assets	91.5		90.3		Other current liabilities	46.6		102.8
Total derivatives not designated as hedges		91.5		90.3			46.6		102.8
Total derivatives		$	146.5	$	118.6		$	47.1	$	103.6

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

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 September 30,				Three months ended September 30,				Three months ended September 30,
(In millions)	Location of Gain/(Loss)	2021		2020		2021		2020		2021		2020



Derivative Financial Instruments in Cash Flow Hedging Relationships (2) :
Foreign currency forward contracts	Net sales (4)	$	—	$	—	$	15.5	$	29.5	$	10.2	$	5.1
Interest rate swaps	Interest expense (4)	—		—		(0.8)		—		(1.1)		(1.2)
Derivative Financial Instruments in Net Investment Hedging Relationships:
Foreign currency borrowings and forward contracts		—		—		130.4		(109.0)		—		—
Derivative Financial Instruments Not Designated as Hedging Instruments:
Foreign currency option and forward contracts	Other expense, net (3)	37.6		9.8		—		—		—		—
Total		$	37.6	$	9.8	$	145.1	$	(79.5)	$	9.1	$	3.9


		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
		Nine months ended September 30,				Nine months ended September 30,				Nine months ended September 30,
(In millions)	Location of Gain/(Loss)	2021		2020		2021		2020		2021		2020
Derivative Financial Instruments in Fair Value Hedge Relationships (1) :
Interest rate swaps	Interest expense (3)	$	—	$	22.1	$	—	$	—	$	—	$	—
2023 Senior Notes (3.125% coupon)	Interest expense (3)	—		(22.1)		—		—		—		—
Derivative Financial Instruments in Cash Flow Hedging Relationships (2) :
Foreign currency forward contracts	Net sales (4)	—		—		32.4		(0.5)		19.9		2.3
Interest rate swaps	Interest expense (4)	—		—		(2.5)		—		(3.2)		(3.4)
Derivative Financial Instruments in Net Investment Hedging Relationships:
Foreign currency borrowings and forward contracts		—		—		329.4		(113.8)		—		—
Derivative Financial Instruments Not Designated as Hedging Instruments:
Foreign currency option and forward contracts	Other expense, net (3)	58.3		22.9		—		—		—		—
Total		$	58.3	$	22.9	$	359.3	$	(114.3)	$	16.7	$	(1.1)

(1)In the first quarter of 2020, the Company terminated interest rate swaps designated as a fair value hedge resulting in net proceeds of approximately $45 million. The amount included in the above tables represents the fair value adjustment recognized at the date the interest rate swaps were settled.

(2)At September 30, 2021, the Company expects that approximately $15.0 million of pre-tax net gains on cash flow hedges will be reclassified from AOCE into earnings during the next twelve months.

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

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

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

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:


	September 30, 2021						December 31, 2020
(In millions)	Level 1		Level 2		Level 3		Level 1		Level 2		Level 3
Recurring fair value measurements
Financial Assets
Cash equivalents:
Money market funds	$	51.5	$	—	$	—	$	0.9	$	—	$	—
Total cash equivalents	51.5		—		—		0.9		—		—
Equity securities:
Exchange traded funds	48.3		—		—		45.1		—		—
Marketable securities	0.7		—		—		0.7		—		—
Total equity securities	49.0		—		—		45.8		—		—
Available-for-sale fixed income investments:
Corporate bonds	—		17.0		—		—		17.8		—
U.S. Treasuries	—		14.3		—		—		14.4		—
Agency mortgage-backed securities	—		1.8		—		—		1.9		—
Asset backed securities	—		5.0		—		—		4.6		—
Other	—		0.6		—		—		0.4		—
Total available-for-sale fixed income investments	—		38.7		—		—		39.1		—
Foreign exchange derivative assets	—		146.5		—		—		118.6		—

Total assets at recurring fair value measurement	$	100.5	$	185.2	$	—	$	46.7	$	157.7	$	—
Financial Liabilities

Foreign exchange derivative liabilities	—		47.1		—		—		103.6		—
Contingent consideration	—		—		206.9		—		—		223.6
Total liabilities at recurring fair value measurement	$	—	$	47.1	$	206.9	$	—	$	103.6	$	223.6

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

For financial assets and liabilities that utilize Level 2 inputs, the Company utilizes both direct and indirect observable price quotes, including the LIBOR yield curve, foreign exchange forward prices and bank price quotes. Below is a summary of valuation techniques for Level 1 and Level 2 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, 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, net, in the condensed consolidated statements of operations.

*•*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

The fair value measurement of contingent consideration is determined using Level 3 inputs. The Company’s contingent consideration represents a component of the total purchase consideration for the respiratory delivery platform and certain other acquisitions. The measurement is calculated using unobservable inputs based on the Company’s own assumptions primarily related to the probability and timing of future development and commercial milestones and future profit sharing payments which are discounted using a market rate of return. At September 30, 2021 and December 31, 2020, discount rates ranging from 2.1% to 10.5% were utilized in the valuations. Significant changes in unobservable inputs could result in material changes to the contingent consideration liability.

A rollforward of the activity in the Company’s fair value of contingent consideration from December 31, 2020 to September 30, 2021 is as follows:


(In millions)	Current Portion (1)		Long-Term Portion (2)		Total Contingent Consideration
Balance at December 31, 2020	$	100.5	$	123.1	$	223.6
Payments	(64.9)		—		(64.9)
Reclassifications	49.4		(49.4)		—
Accretion	—		7.0		7.0
Fair value loss (3)	—		41.2		41.2
Balance at September 30, 2021	$	85.0	$	121.9	$	206.9

(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 other financial assets and liabilities, any future transacted financial asset or liability will be evaluated for the fair value election.

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

**12.**Debt

For additional information, see Note 10 Debt in Viatris’ 2020 Form 10-K.

Short-Term Borrowings

The Company had $1.71 billion and $1.10 billion of short-term borrowings as of September 30, 2021 and December 31, 2020, respectively.


(In millions)	September 30, 2021		December 31, 2020
Commercial paper notes	$	1,132.4	$	651.3
Receivables Facility	374.5		248.4
Note Securitization Facility	200.0		200.0
Other	—		1.2
Short-term borrowings	$	1,706.9	$	1,100.9

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VIATRIS INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Long-Term Debt

A summary of long-term debt is as follows:


($ in millions)	Interest Rate as of September 30, 2021		September 30, 2021		December 31, 2020
Current portion of long-term debt:





2021 Senior Notes (a) **	3.150	%	$	—	$	2,249.7
2022 Euro Senior Notes ****	0.816	%	874.4		—
2022 Senior Notes ***	1.125	%	1,004.4		—

Other			2.3		8.0
Deferred financing fees			(0.1)		(1.4)
Current portion of long-term debt			$	1,881.0	$	2,256.3

Non-current portion of long-term debt:


2022 Euro Senior Notes ****	0.816	%	$	—	$	928.8
2022 Senior Notes ***	1.125	%	—		1,008.8
2023 Senior Notes (b) *	3.125	%	770.0		781.6
2023 Senior Notes *	4.200	%	499.5		499.3
2024 Euro Senior Notes **	2.250	%	1,156.7		1,219.9
2024 Euro Senior Notes ****	1.023	%	889.6		944.6
2025 Euro Senior Notes *	2.125	%	578.3		609.9
2025 Senior Notes ***	1.650	%	764.3		767.1
2026 Senior Notes **	3.950	%	2,241.0		2,239.7
2027 Euro Senior Notes ****	1.362	%	1,033.9		1,097.4
2027 Senior Notes ***	2.300	%	782.1		786.1
2028 Euro Senior Notes **	3.125	%	862.9		909.7
2028 Senior Notes *	4.550	%	748.7		748.6
2030 Senior Notes ***	2.700	%	1,522.4		1,528.0
2032 Euro Senior Notes ****	1.908	%	1,577.7		1,672.6
2040 Senior Notes ***	3.850	%	1,658.7		1,663.3
2043 Senior Notes *	5.400	%	497.3		497.3
2046 Senior Notes **	5.250	%	999.9		999.9
2048 Senior Notes *	5.200	%	747.7		747.7
2050 Senior Notes ***	4.000	%	2,206.2		2,209.3
USD Term Loan			—		600.0
YEN Term Loan			359.4		—

Other			1.7		17.4
Deferred financing fees			(43.7)		(47.8)
Long-term debt			$	19,854.3	$	22,429.2

(a) The 2021 Senior Notes were repaid at maturity in the second quarter of 2021.

(b) In the first quarter of 2020, the Company terminated interest rate swaps designated as a fair value hedge resulting in net proceeds of approximately $45 million. The fair value adjustment is being amortized to interest expense over the remaining term of the notes.

Instrument was issued by Mylan Inc.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

** 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.

In September 2021, Viatris filed a registration statement with the SEC with respect to an offer to exchange $7.45 billion aggregate principal amount of Unregistered Upjohn Notes with Registered Upjohn Notes in the same aggregate principal amount and with terms substantially identical in all material respects, which was declared effective on September 28, 2021. The exchange offer expired on October 28, 2021 and settled on October 29, 2021. More than 99.9% of the aggregate principal amount of each of the Unregistered Upjohn Notes were exchanged for Registered Upjohn Notes.

USD Term Loan, 2020 Revolving Facility, YEN Term Loan and 2021 Revolving Facility

In June 2020, Viatris entered into (i) a $600 million term loan agreement (the “USD Term Loan”) and (ii) a $4.0 billion revolving facility (the “2020 Revolving Facility”) with various syndicates of banks. The USD Term Loan was fully repaid in July 2021.

The USD Term Loan and the 2020 Revolving Facility contained a maximum leverage ratio of 4.25 to 1.00 for the first four full fiscal quarters following the close of the Combination and 3.75 to 1.00 thereafter, except in circumstances as defined in the related credit agreements.

The USD Term Loan and the 2020 Revolving Facility contained customary affirmative covenants for facilities of this type, including among others, covenants pertaining to the delivery of financial statements, notices of default and certain material events, maintenance of corporate existence and rights, property, and insurance and compliance with laws, as well as customary negative covenants for facilities of this type, including limitations on the incurrence of subsidiary indebtedness, liens, mergers and certain other fundamental changes, investments and loans, acquisitions, transactions with affiliates, payments of dividends and other restricted payments and changes in our lines of business.

In July 2021, Viatris entered into (i) a ¥40 billion term loan credit agreement (the “YEN Term Loan”) and (ii) a $4.0 billion revolving credit agreement (the “2021 Revolving Facility”) with various syndicates of banks. The 2021 Revolving Facility amended and restated the 2020 Revolving Facility and proceeds from the 2021 Revolving Facility were used to repay outstanding obligations under the 2020 Revolving Facility. Proceeds from the YEN Term Loan and 2021 Revolving Facility were also used to repay the USD Term Loan in full and the USD Term Loan was terminated. The 2021 Revolving Facility and the YEN Term Loan have substantially identical terms to the 2020 Revolving Facility and USD Term Loan, respectively, with the following exceptions: 1) the maturity of both the YEN Term Loan and the 2021 Revolving Facility is July 2026, 2) the pricing was adjusted to reflect current market prices (which were generally more favorable) and 3) the maximum leverage ratio as of the end of any quarter was set at 4.25 to 1.00 for each quarter ending after June 30, 2021 through and including June 30, 2022, 4.0 to 1.00 for each quarter ending after June 30, 2022 through and including December 31, 2022 and 3.75 to 1.00 thereafter, except in circumstances as defined in the related credit agreement.

The YEN Term Loan and the 2021 Revolving Facility contain customary affirmative covenants for facilities of this type, including among others, those set forth above with respect to the USD Term Loan and the 2020 Revolving Facility.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Fair Value

At September 30, 2021 and December 31, 2020, the aggregate fair value of the Company’s outstanding notes was approximately $22.35 billion and $25.90 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 September 30, 2021 were as follows for each of the periods ending December 31:


(In millions)	Total
2021	$	—
2022	1,869
2023	1,250
2024	2,027
2025	1,329
Thereafter	14,610
Total	$	21,085

**13.**Comprehensive Loss

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


(In millions)	September 30, 2021		December 31, 2020
Accumulated other comprehensive loss:
Net unrealized gain on marketable securities, net of tax	$	0.3	$	1.2
Net unrecognized gain (loss) and prior service cost related to defined benefit plans, net of tax	44.9		(26.1)
Net unrecognized gain (loss) on derivatives in cash flow hedging relationships, net of tax	2.7		(18.0)
Net unrecognized (loss) on derivatives in net investment hedging relationships, net of tax	(90.4)		(353.6)
Foreign currency translation adjustment	(1,429.4)		(461.5)
	$	(1,471.9)	$	(858.0)

Components of accumulated other comprehensive loss, before tax, consist of the following, for the three and nine months ended September 30, 2021 and 2020:

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


	Three Months Ended September 30, 2021
Gains and Losses on Derivatives in Cash Flow Hedging Relationships					Gains and Losses on Net Investment Hedges			Gains and Losses on Marketable Securities			Defined Pension Plan Items			Foreign Currency Translation Adjustment			Totals
(In millions)	Foreign Currency Forward Contracts	Interest Rate Swaps	Total
Balance at June 30, 2021, net of tax			$	(6.2)		$	(220.8)		$	0.4		$	43.6		$	(1,022.0)		$	(1,205.0)
Other comprehensive earnings (loss) before reclassifications, before tax			20.9			168.4			(0.1)			0.5			(407.4)			(217.7)
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	(10.2)		(10.2)															(10.2)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense		1.1	1.1															1.1
Amortization of prior service costs included in SG&A												(0.1)						(0.1)
Amortization of actuarial gain included in SG&A												0.4						0.4
Net other comprehensive earnings (loss), before tax			11.8			168.4			(0.1)			0.8			(407.4)			(226.5)
Income tax provision (benefit)			2.9			38.0			—			(0.5)			—			40.4

Balance at September 30, 2021, net of tax			$	2.7		$	(90.4)		$	0.3		$	44.9		$	(1,429.4)		$	(1,471.9)

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


	Three Months Ended September 30, 2020
Gains and Losses on Derivatives in Cash Flow Hedging Relationships					Gains and Losses on Net Investment Hedges			Gains and Losses on Marketable Securities			Defined Pension Plan Items			Foreign Currency Translation Adjustment			Totals
(In millions)	Foreign Currency Forward Contracts	Interest Rate Swaps	Total
Balance at June 30, 2020, net of tax			$	(55.7)		$	(79.0)		$	1.3		$	(12.4)		$	(1,879.1)		$	(2,024.9)
Other comprehensive earnings (loss) before reclassifications, before tax			36.4			(114.7)			—			(1.7)			687.7			607.7
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	(5.1)		(5.1)															(5.1)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense		1.2	1.2															1.2

Amortization of actuarial loss included in SG&A												0.1						0.1
Net other comprehensive earnings (loss), before tax			32.5			(114.7)			—			(1.6)			687.7			603.9
Income tax provision (benefit)			8.1			(5.7)			(0.1)			0.5			—			2.8

Balance at September 30, 2020, net of tax			$	(31.3)		$	(188.0)		$	1.4		$	(14.5)		$	(1,191.4)		$	(1,423.8)

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


	Nine Months Ended September 30, 2021
Gains and Losses on Derivatives in Cash Flow Hedging Relationships					Gains and Losses on Net Investment Hedges			Gains and Losses on Marketable Securities			Defined Pension Plan Items			Foreign Currency Translation Adjustment			Totals
(In millions)	Foreign Currency Forward Contracts	Interest Rate Swaps	Total
Balance at December 31, 2020, net of tax			$	(18.0)		$	(353.6)		$	1.2		$	(26.1)		$	(461.5)		$	(858.0)
Other comprehensive earnings (loss) before reclassifications, before tax			44.2			318.4			(0.8)			73.3			(967.9)			(532.8)
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	(19.9)		(19.9)															(19.9)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense		3.2	3.2															3.2
Amortization of prior service costs included in SG&A												(0.4)						(0.4)
Amortization of actuarial loss included in SG&A												1.2						1.2
Net other comprehensive earnings (loss), before tax			27.5			318.4			(0.8)			74.1			(967.9)			(548.7)
Income tax provision			6.8			55.2			0.1			3.1			—			65.2

Balance at September 30, 2021, net of tax			$	2.7		$	(90.4)		$	0.3		$	44.9		$	(1,429.4)		$	(1,471.9)

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


	Nine Months Ended September 30, 2020
Gains and Losses on Derivatives in Cash Flow Hedging Relationships					Gains and Losses on Net Investment Hedges			Gains and Losses on Marketable Securities			Defined Pension Plan Items			Foreign Currency Translation Adjustment			Totals
(In millions)	Foreign Currency Forward Contracts	Interest Rate Swaps	Total
Balance at December 31, 2019, net of tax			$	(31.6)		$	(74.3)		$	0.6		$	(17.4)		$	(1,674.5)		$	(1,797.2)
Other comprehensive (loss) earnings before reclassifications, before tax			(1.3)			(119.7)			0.8			3.0			483.1			365.9
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	(2.3)		(2.3)															(2.3)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense		3.4	3.4															3.4

Amortization of actuarial loss included in SG&A												0.4						0.4
Net other comprehensive (loss) earnings, before tax			(0.2)			(119.7)			0.8			3.4			483.1			367.4
Income tax (benefit) provision			(0.5)			(6.0)			—			0.5			—			(6.0)

Balance at September 30, 2020, net of tax			$	(31.3)		$	(188.0)		$	1.4		$	(14.5)		$	(1,191.4)		$	(1,423.8)

**14.**Segment Information

Viatris reports segment information on the basis of markets and geography. In conjunction with the formation of Viatris, the Company has changed its reportable segments, from North America, Europe, and Rest of World, to Developed Markets, Greater China, JANZ, and Emerging Markets. Prior year amounts have been recasted to reflect this segment structure. We have also revised our measure of segment profitability. This approach reflects the Company’s focus on bringing its broad and diversified portfolio of branded, complex generics and biosimilars, and generic 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 China, Taiwan and Hong Kong. Our JANZ segment reflects our operations in Japan, Australia and New Zealand. Our Emerging Markets segment encompasses our operations in countries with developing markets and emerging economies including countries in Asia, the Middle East, South and Central America, Africa and Eastern Europe, and also includes the Company’s anti-retroviral franchise.

The Company’s chief operating decision maker is the Chief Executive Officer, who evaluates the performance of the Company’s segments based on total revenues and segment profitability.

Certain costs are not included in the measurement of segment profitability, such as costs, if any, associated with the following:

◦Intangible asset amortization expense and impairments of intangible assets;

◦R&D expense;

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

◦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) acquisition-related costs, where we incur costs for executing the transaction, integrating the acquired operations and restructuring the combined company; and (iii) other significant items, which are substantive and/or unusual, and in some cases recurring, items (such as restructuring) 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 disposals of assets or businesses, including, as applicable, any associated transition activities.

◦Corporate and other unallocated costs associated with platform functions (such as digital, facilities, legal, finance, human resources, insurance, public affairs and procurement), patient advocacy activities and certain compensation and other corporate costs (such as interest income and expense, and gains and losses on investments, as well as overhead expenses associated with our manufacturing, which include 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.

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

The accounting policies of the segments are the same as those described in Note 2 Summary of Significant Accounting Policies included in the 2020 Form 10-K, and Note 3 Recent Accounting Pronouncements, Adoption of New Accounting Standards included in this Form 10-Q.

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


	Net Sales				Segment Profitability
	Three Months Ended September 30,				Three Months Ended September 30,

(In millions)	2021		2020		2021		2020
Reportable Segments:
Developed Markets	$	2,655.9	$	2,163.2	$	1,302.7	$	1,141.4
Greater China	566.8		31.5		352.5		(24.4)
JANZ	505.3		282.4		216.7		73.4
Emerging Markets	792.5		471.0		362.5		165.3
Total reportable segments	$	4,520.5	$	2,948.1	$	2,234.4	$	1,355.7

Reconciling items:
Intangible asset amortization expense					(671.5)		(368.1)

Globally managed research and development costs					(152.1)		(129.8)
Litigation settlements & other contingencies					(9.4)		(18.9)
Transaction related and other special items					(569.8)		(192.9)
Corporate and other unallocated					(474.0)		(294.6)
Earnings from operations					$	357.6	$	351.4

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


	Net Sales				Segment Profitability
	Nine Months Ended September 30,				Nine Months Ended September 30,

(In millions)	2021		2020		2021		2020
Reportable Segments:
Developed Markets	$	7,867.9	$	6,132.3	$	3,908.0	$	3,179.0
Greater China	1,709.0		69.3		1,123.9		(19.3)
JANZ	1,488.2		805.8		586.3		208.4
Emerging Markets	2,417.2		1,224.8		1,084.5		393.5
Total reportable segments	$	13,482.3	$	8,232.2	$	6,702.7	$	3,761.6

Reconciling items:
Intangible asset amortization expense					(2,037.5)		(1,070.9)
Intangible asset impairment charges					(83.4)		—
Globally managed research and development costs					(483.9)		(400.3)
Litigation settlements & other contingencies					(55.3)		(36.5)
Transaction related and other special items					(2,483.9)		(626.7)
Corporate and other unallocated					(1,515.1)		(956.9)
Earnings from operations					$	43.6	$	670.3

**15.**Restructuring

2020 Restructuring Program

During the fourth quarter of 2020, Viatris announced a significant global restructuring program in order to achieve synergies and ensure that the organization is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers, and other stakeholders. Viatris’ restructuring initiative incorporates and expands on the restructuring program announced by Mylan N.V. earlier in 2020 as part of its business transformation efforts. The Company expects to optimize its commercial capabilities and enabling functions, and close, downsize or divest up to 15 manufacturing facilities globally that are deemed to be no longer viable either due to surplus capacity, challenging market dynamics or a shift in its product portfolio toward more complex products. As a result, Viatris expects that up to 20% of its global workforce may be impacted upon completion of the restructuring initiative.

For the committed restructuring actions, the Company expects to incur total pre-tax charges ranging between $1.1 billion and $1.4 billion. Such charges are expected to include between $350 million and $450 million of non-cash charges mainly related to accelerated depreciation and asset impairment charges, including inventory write-offs. The remaining estimated cash costs of between $750 million and $950 million are expected to be primarily related to severance and employee benefits expense, as well as other costs, including those related to contract terminations and decommissioning costs.

Charges for restructuring and ongoing cost reduction initiatives are recorded in the period the Company commits to a restructuring or cost reduction plan, or executes specific actions contemplated by the plan and all criteria for liability recognition have been met.

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The following table summarizes the restructuring charges and the reserve activity for the 2020 restructuring program from December 31, 2020 to September 30, 2021:


(In millions)	Employee Related Costs		Other Exit Costs		Total
Balance at December 31, 2020:	$	262.6	$	4.8	$	267.4
Charges (1)	161.6		152.0		313.6

Cash payment	(49.2)		(1.1)		(50.3)
Utilization	—		(151.0)		(151.0)
Foreign currency translation	(3.3)		0.1		(3.2)
Balance at March 31, 2021:	371.7		4.8		376.5
Charges (1)	169.0		82.9		251.9

Reimbursable restructuring charges	26.4		—		26.4
Cash payment	(74.7)		(2.1)		(76.8)
Utilization	—		(80.8)		(80.8)
Foreign currency translation	1.6		(0.1)		1.5
Balance at June 30, 2021:	494.0		4.7		498.7
Charges (1)	64.2		108.6		172.8
Cash payment	(189.2)		(21.8)		(211.0)
Utilization	—		(87.3)		(87.3)
Foreign currency translation	(2.6)		—		(2.6)
Balance at September 30, 2021:	$	366.4	$	4.2	$	370.6

(1) For the three months ended September 30, 2021, total restructuring charges in Developed Markets, JANZ, Emerging Markets, and Corporate/Other were approximately $138.7 million, $27.4 million, $4.5 million, and $2.2 million respectively. For the nine months ended September 30, 2021, total restructuring charges in Developed Markets, Greater China, JANZ, Emerging Markets, and Corporate/Other were approximately $520.3 million, $5.3 million, $136.4 million, $50.8 million, and $25.5 million, respectively.

At September 30, 2021 and December 31, 2020, accrued liabilities for restructuring and other cost reduction programs were primarily included in other current liabilities and other long-term obligations in the condensed consolidated balance sheets.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

**16.**Collaboration and Licensing Agreements

We periodically enter into collaboration and licensing agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products. Our significant collaboration and licensing agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic biologic compounds, insulin analog products and respiratory products, among other 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. Refer to Note 11 Financial Instruments and Risk Management for further discussion of contingent consideration. Our potential maximum development milestones not accrued for at September 30, 2021 totaled approximately $341 million*.* We estimate that the amounts that may be paid through the end of 2021 to be approximately $13 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.

There have been no significant changes to our collaboration and licensing agreements as disclosed in our 2020 Form 10-K.

**17.**Income Taxes

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 2015 through 2018 are open years under examination. The years 2012, 2013 and 2014 have one matter open, and a Tax Court petition was filed regarding the matter and a trial was held in December 2018 and is discussed further below.

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 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 Australia, the tax authorities have issued notices of assessments to the Company for the years ended December 2009 to December 2019, subject to additional interest and penalties, concerning our tax position with respect to certain intercompany transactions. We intend to challenge these assessments in court in the event our objections are not sustained.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

In France, the tax authorities have issued notices of assessments to the Company for the years ended December 2013 to December 2016 concerning our tax position with respect to (i) certain intercompany transactions and (ii) whether income earned by a Company entity not domiciled in France should be subject to French tax. We have resolved our position concerning certain intercompany transactions with the tax authorities. Concerning the remaining issue, we anticipate it will become the subject of litigation before the French tax courts in which the tax authorities will seek unpaid taxes, penalties, and interest.

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 assessments remain in the audit phase where we are challenging them before the tax authorities while we are challenging some of the other assessments in the Indian tax courts.

The Company has recorded a net reserve for uncertain tax positions of $319.2 million, including interest and penalties, in connection with its international audits at September 30, 2021. The reserve balance at September 30, 2021 reflects the impact of current year settlement payments. 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 2013 through 2020, with several state audits currently in progress. The Company’s major international taxing jurisdictions remain open from 2012 through 2020.

Tax Court Proceedings

The Company's U.S. federal income tax returns for 2012 through 2014 had been subject to proceedings in U.S. Tax Court involving a dispute with the IRS regarding whether certain costs related to ANDAs were eligible to be expensed and deducted immediately or required to be amortized over longer periods. A trial was held in U.S. Tax Court in December 2018 and on April 27, 2021, the Court affirmed Mylan’s position and held that patent litigation expenses related to ANDAs are immediately deductible.

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.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

**18.**Litigation

The Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax 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 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 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

The Company has been named as a defendant in indirect purchaser class actions relating to the pricing and/or marketing of the EpiPen® Auto-Injector. The plaintiffs in these cases asserted violations of various federal and state antitrust and consumer protection laws, RICO as well as common law claims. A former Mylan N.V. officer and other non-Viatris affiliated companies are also defendants in some of the class actions. Plaintiffs’ seek monetary damages, attorneys’ fees and costs. These lawsuits were filed in various federal and state courts and, except for a small number, have either been dismissed or transferred into a MDL in the U.S. District Court for the District of Kansas and have been consolidated. The District Court certified an antitrust class that applies to 17 states and a RICO class. On June 23, 2021, the Court granted – in substantial part –the Company’s and former Mylan N.V. officer’s motion for summary judgment by dismissing certain antitrust claims and the RICO claims, which included RICO claims asserted against the former Mylan N.V. officer. Plaintiffs’ motions for reconsideration and to certify an interlocutory appeal of the summary judgment decision with respect to the RICO claims were denied. On July 8, 2021, the Company filed a motion to decertify the class action with respect to the remaining antitrust theory,

which concerns a patent settlement between Pfizer and Teva and other alleged actions regarding the launch of Teva’s generic epinephrine auto-injector. A trial on the remaining antitrust theory against the Company is currently scheduled to begin on January 24, 2022. Plaintiffs are asserting damages of approximately $1.0 billion on the remaining antitrust theory, which is subject to multipliers under certain state laws. The Company believes that it acted lawfully, is continuing to defend itself vigorously, and intends to vigorously contest all remaining aspects of Plaintiffs’ case, including their asserted damages.

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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, after Plaintiffs’ then operative complaint was dismissed with an option to file a limited amended complaint, Plaintiffs filed an amended complaint asserting federal antitrust claims which are based on allegations that are similar to those in the putative indirect purchaser class actions discussed above. Plaintiffs’ seek monetary damages, declaratory relief, attorneys’ fees and costs.

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. These actions have been consolidated. Plaintiffs’ seek monetary damages, attorneys’ fees and costs.

On April 24, 2017, Sanofi Aventis U.S., LLC (“Sanofi”) filed a lawsuit against the Company in the U.S. District Court for the District of New Jersey. This lawsuit has been transferred into the aforementioned MDL and alleges exclusive dealing and anti-competitive marketing practices in violation of the antitrust laws in connection with the sale and marketing of the EpiPen® Auto-Injector. Sanofi seeks monetary damages, declaratory relief, attorneys’ fees and costs. The Court granted the Company’s motion for summary judgment and dismissed Sanofi’s claims. Sanofi’s appeal is pending.

The Company has a total accrual of approximately $10.0 million related to this matter at September 30, 2021, 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 and/or stock price in future periods.

Drug Pricing Matters

Department of Justice

On December 3, 2015, the Company received a subpoena from the Antitrust Division of the DOJ seeking information relating to the marketing, pricing, and sale of certain of our generic products and any communications with competitors about such products. On September 8, 2016, the Company, as well as certain employees and a member of senior management, received subpoenas from the DOJ seeking similar information. Related search warrants also were executed.

On May 10, 2018, the Company received a civil investigative demand from the Civil Division of the DOJ seeking information relating to the pricing and sale of its generic drug products.

We are fully cooperating with these investigations, which we believe are related to a broader industry-wide investigation of the generic pharmaceutical industry.

Civil Litigation

Beginning in 2016, the Company, along with other manufacturers, has been named as a defendant in lawsuits 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. They allege harm under federal and state laws, including federal and state antitrust laws, state consumer protection laws and unjust enrichment claims. Some of the lawsuits also name as defendants the Company’s 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 Court has ordered certain plaintiffs’ complaints regarding two single-drug product cases to proceed as bellwethers. The Company is named in those plaintiffs’ complaints that regard one of the two individual drug products.

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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 originally 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 has been transferred to the aforementioned MDL proceeding in the EDPA. The operative complaint includes attorneys general of forty-seven 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 of thirty-seven states and the Commonwealth of Puerto Rico against certain individuals, including the Company’s President, with respect to a single drug product. The amended complaint seeks declaratory and injunctive relief, disgorgement, attorneys’ fees and costs, and certain states seek monetary damages, civil penalties, and restitution.

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. On November 1, 2019, the complaint was amended, adding additional states as plaintiffs. The operative complaint is brought by attorneys general of forty-eight states, certain territories and the District of Columbia. The amended complaint also includes claims asserted by attorneys general of forty-three states and certain territories against several individuals, including a Company sales employee. The amended complaint seeks declaratory and injunctive relief, disgorgement, attorneys’ fees and costs, and certain states seek monetary damages, civil penalties, and restitution. This lawsuit has been 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 of forty-seven states, certain territories and the District of Columbia. The amended complaint seeks declaratory and injunctive relief, disgorgement, attorneys’ fees and costs, and certain states seek monetary damages, civil penalties, and restitution. This lawsuit has been transferred to the aforementioned MDL proceeding in the EDPA and has been ordered to proceed as a bellwether.

Securities Related Litigation

Purported class action complaints were filed in October 2016 against Mylan N.V. and Mylan Inc. (collectively “Mylan”), certain of Mylan’s former directors and officers, and certain of the Company’s current directors and officers (collectively, for purposes of this paragraph, the “defendants”) in the United States District Court for the Southern District of New York (“SDNY”) on behalf of certain purchasers of securities of Mylan on the NASDAQ. The complaints alleged that defendants 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. On March 20, 2017, a consolidated amended complaint was filed alleging substantially similar claims, but adding allegations that defendants made false or misleading statements and omissions of purportedly material fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs.

The operative complaint is the third amended consolidated complaint, which was filed on June 17, 2019, and contains the allegations as described above against Mylan, certain of Mylan’s former directors and officers, and certain of the Company’s current directors, officers, and employees (collectively, for purposes of this paragraph, the “defendants”). A class has been certified covering all persons or entities that purchased Mylan common stock between February 21, 2012 and May 24, 2019 excluding defendants, certain of the Company’s current directors and officers, former directors and officers of Mylan, members of their immediate families and their legal representatives, heirs, successors or assigns, and any entity in which defendants have or had a controlling interest. Plaintiffs seek damages and costs and expenses, including attorneys’ fees and expert costs. On September 22, 2021, Defendants filed a motion for summary judgment seeking to dismiss the case in its entirety, which remains pending.

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On April 30, 2017, a similar lawsuit was filed in the Tel Aviv District Court (Economic Division) in Israel, which has been stayed pending a decision in the SDNY class action litigation.

On February 14, 2020, the Abu Dhabi Investment Authority filed a complaint against Mylan in the SDNY asserting allegations pertaining to EpiPen® Auto-Injector and certain generic drugs under the federal securities laws that overlap with those asserted in the third amended complaint identified above. The Abu Dhabi Investment Authority’s complaint seeks monetary damages as well as the plaintiff’s fees and costs.

On February 26, 2019, MYL Litigation Recovery I LLC (“MYL Plaintiff”) (an assignee of entities that purportedly purchased stock of Mylan N.V.) filed an additional complaint in the SDNY against Mylan, certain of Mylan’s former officers and directors, and an officer of the Company asserting allegations pertaining to EpiPen® Auto-Injector under the federal securities laws that overlap in part with those asserted in the third amended complaint identified above. On May 6, 2020, MYL Plaintiff filed an amended complaint including additional allegations in connection with purportedly anticompetitive conduct with respect to EpiPen® Auto-Injector.

MYL Plaintiff subsequently filed a summons on October 30, 2020, naming Mylan, certain of Mylan’s former officers and directors, and certain of the Company’s current officers, directors, and employees in New York State Court, County of New York, claiming investment losses suffered as a result of purportedly false and misleading statements in connection with allegedly anticompetitive conduct concerning generic pharmaceuticals. The parties have resolved both matters filed by MYL Plaintiff and they have been dismissed with prejudice.

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 an officer and 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 on behalf of certain purchasers of securities of Mylan N.V. The amended complaint alleges that defendants made false or misleading statements and omissions of purportedly material fact, in violation of federal securities laws, in connection with disclosures relating to the Morgantown manufacturing plant and inspections at the plant by the FDA. Plaintiff seeks certification of a class of purchasers of Mylan N.V. securities between February 16, 2016 and May 7, 2019. The complaint seeks monetary damages, as well as the plaintiff’s fees and costs.

On February 15, 2021, a complaint was filed 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 current director and officer of the Company, and current employees of the Company. The Complaint asserts claims which are based on allegations that are similar to those in the SDNY and the Western District of Pennsylvania complaints identified above. Plaintiffs seek compensatory damages, costs and expenses and attorneys’ fees.

On October 28, 2021, the Company and certain of its officers and directors were named as defendants in a putative class action lawsuit filed in the Court of Common Pleas of Allegheny County, Pennsylvania on behalf of former Mylan shareholders who received Company common stock in connection with the Combination. A non-Viatris affiliated company and persons were also named as defendants. The complaint alleges violations of Sections 11, 12(a)(2), and 15 of the Securities Act of 1933 for purportedly failing to disclose or misrepresenting material information in the registration statement and related prospectus issued in connection with the Combination. Plaintiffs seek monetary damages, reasonable costs and expenses, and certain other equitable and injunctive relief.

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.

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In November 2019, the Company received a subpoena from the New York Department of Financial Services as part of an industry-wide inquiry into the effect of opioid prescriptions on New York health insurance premiums. The Company is fully cooperating with this subpoena request.

European Commission Proceedings

Perindopril

On July 9, 2014, the Commission issued a decision finding that the Company as well as several other companies, had violated EU competition rules relating to the product Perindopril and fined the Company approximately €17.2 million. The Company paid approximately $21.7 million related to this matter during the fourth quarter of 2014. The decision was affirmed on appeal by the General Court of the EU and is now on appeal to the CJEU. The Company has received a notice from an organization representing health insurers in the Netherlands stating an intention to commence follow-on litigation and asserting monetary damages.

Citalopram

On June 19, 2013, the Commission issued a decision finding that the Company as well as several other companies, had violated EU competition rules relating to the product Citalopram and fined the Company approximately €7.8 million, jointly and severally with Merck KGaA. The decision was affirmed on appeal by the General Court of the EU and the CJEU. The Commission’s matter as to the Company is now closed. The Company has received notices from European NHS and health insurers stating an intention to commence follow-on litigation and asserting monetary damages. The NHS England and Wales has instituted litigation against all parties to the Commission’s decision, including the Company.

The Company has also sought indemnification from Merck KGaA with respect to the €7.8 million portion of the fine for which Merck KGaA and the Company were held jointly and severally liable. Merck KGaA has counterclaimed against the Company seeking the same indemnification. In June 2018, the Frankfurt Regional Court issued a judgment ordering the Company to indemnify Merck KGaA with respect to the amount for which the parties were held jointly and severally liable. The parties have resolved this matter.

The Company has accrued approximately €11.2 million as of September 30, 2021 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.

U.K. Competition and Markets Authority

Paroxetine

On August 12, 2011, the Company received notice that the Office of Fair Trading (now the “CMA”) opened an investigation regarding possible infringement of the Competition Act 1998 and Articles 101 and 102 of the Treaty on the Functioning of the EU, with respect to alleged agreements related to Paroxetine. The CMA issued a decision on February 12, 2016, finding that the Company, Merck KGaA, and other companies were liable for infringing EU and U.K. competition rules. The CMA issued a penalty to Merck KGaA of approximately £5.8 million, for which the Company is jointly and severally liable for approximately £2.7 million. On appeal, the CAT affirmed the CMA’s decision but reduced the penalty to Merck KGaA to approximately £3.9 million, and reduced the amount for which the Company is jointly and severally liable to approximately £2.05 million. The CMA’s matter as to the Company is now closed.

The Company has also received a notice from the NHS England and Wales stating an intention to commence follow- on litigation and asserting monetary damages.

The Company has accrued approximately £8.8 million as of September 30, 2021 related to this matter. It is reasonably possible that the Company 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.

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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 $103.6 million as of September 30, 2021 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 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 class actions 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. Similar lawsuits pertaining to valsartan have been filed in other countries. The Company has also received claims and inquiries related to these products, as well as 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 Company was not named as a defendant in the amended master complaints, though it was still named in certain short form personal injury complaints. The end-payor plaintiffs and certain of the plaintiffs named in the short form personal injury complaints in the ranitidine matter have filed appeals to the U.S. Court of Appeals for the Eleventh Circuit.

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. Since 2016, certain cases in the MDL were remanded to certain state courts. In 2017, the District Court granted Pfizer’s motion for summary judgment, dismissing all of the cases pending in the MDL. In June 2018, this dismissal was affirmed by the U.S. Court of Appeals for the Fourth Circuit. The state court proceedings remain pending in various jurisdictions, including in California, Missouri, and New York. On January 27, 2021, the California Court granted Pfizer’s motion to exclude the opinions of plaintiffs’ only general causation expert in connection with his opinions involving the three lowest doses of Lipitor (10, 20 and 40 mg). The Company’s motion for summary judgment in connection with the 10, 20, and 40 mg plaintiffs was granted, resulting in their dismissal.

Viagra

Since April 2016, an MDL has been pending in the U.S. District Court for the Northern District of California, in which plaintiffs allege that they developed melanoma and/or the exacerbation of melanoma purportedly as a result of the ingestion of Viagra. Additional cases filed against Eli Lilly and Company (“Lilly”) with respect to Cialis have also been consolidated in the MDL. Plaintiffs seek compensatory and punitive damages. In January 2020, the District Court granted Pfizer’s and Lilly’s motion to exclude all of plaintiffs’ general causation opinions. As a result, in April 2020, the District Court entered summary judgment in favor of defendants and dismissed all of plaintiffs’ claims. In April 2020, plaintiffs filed a notice of appeal in the U.S. Court of Appeals for the Ninth Circuit. The parties have reached a settlement in principle.

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Dilantin

Since 2018, a number of individual and multi-plaintiff lawsuits have been filed against Pfizer and related entities in various federal and state courts, alleging that the plaintiffs developed cerebellar atrophy as a result of the ingestion of Dilantin. Plaintiffs seek compensatory and punitive damages. The cases are in various stages, from the initial pleading stage to discovery, and some at the bellwether case selection phase. The parties have reached a settlement in principle.

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 including but not limited to the matters described below. 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 and/or stock price.

The Company has accrued approximately $304.0 million as of September 30, 2021 for its intellectual property 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.

Insulin Glargine

On October 24, 2017, Sanofi and affiliated entities (collectively for the purposes of this section, “Sanofi”), sued Mylan GmbH and other Mylan entities in the U.S. District Court for the District of New Jersey asserting that Mylan GmbH’s new drug application for insulin glargine injection 100 Units/mL vials and prefilled injection pens (SEMGLEE® vial and pens) infringed 18 U.S. patents. 2 of the 18 patents covered the insulin glargine formulation. Both of these patents have been held invalid and all appeals have concluded. These two patents were the only patents asserted against the SEMGLEE® vial product.

The 16 other asserted patents relate to a pen injection device (“device patents”) and were asserted only against the SEMGLEE® pen injection device. Prior to trial, Sanofi dismissed 12 of those device patents from the case and granted the Company a covenant not to sue with respect to them. On June 17, 2019, following the District Court’s claim construction order, the District Court entered judgment of non-infringement with respect to the asserted claims of three of the four remaining device patents (U.S. Patent Numbers 8,603,044, 8,679,069, 8,992,486).

Only one device patent remained for trial (U.S. Patent Number 9,526,844). On March 9, 2020, the District Court issued an opinion after trial finding all asserted claims of the ‘844 patent not infringed and invalid for lack of written description. Sanofi’s appeal is pending.

On September 10, 2018, Mylan Pharmaceuticals Inc. (“MPI”) filed IPR petitions challenging five device patents (the ‘844, ‘044, ‘069, ‘486, and ‘008 patents). On April 2, 2020 and May 29, 2020, the PTAB issued final written decisions in the IPR proceedings finding all challenged claims unpatentable except for two claims of the ‘008 patent for which Sanofi granted the Company a covenant not to sue as described above. Sanofi’s appeals of all these IPR decisions are pending.

On March 26, 2021, the PTAB issued a final written decision in an IPR proceeding in which MPI challenged an additional Sanofi device patent (U.S. Patent Number RE47,614) and found all challenged claims unpatentable. Sanofi’s appeal is pending.

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On June 11, 2020, the FDA approved the SEMGLEE® vial and pen products, which MPI began selling on August 31, 2020.

Dimethyl Fumarate

On June 30, 2017, Biogen MA Inc. and Biogen International GmbH (collectively, “Biogen”) sued MPI in the U.S. District Court for the Northern District of West Virginia asserting that MPI’s abbreviated new drug application for dimethyl fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate (generic for Tecfidera®) infringed six U.S. patents that Biogen had listed in the Orange Book: 6,509,376, 7,320,999, 7,619,001, 7,803,840, 8,759,393, and 8,399,514. All patents except for the ‘514 expired during the litigation and were dismissed from the case.

After a trial involving only the ’514 patent on June 18, 2020, the District Court issued a judgment finding all claims of the ’514 patent invalid for lack of adequate written description. Biogen’s appeal is pending.

On July 13, 2018, MPI filed an IPR petition challenging the ’514 patent based only on obviousness. On February 5, 2020, the PTAB issued a final written decision finding the claims not obvious. MPI’s appeal is pending.

On August 17, 2020, the FDA approved MPI’s dimethyl fumarate delayed-release capsules, which MPI began selling on August 18, 2020.

Lyrica - United Kingdom

Beginning in 2014, Pfizer was involved in patent litigation in the English courts concerning the validity of its Lyrica pain use patent. In 2015, the High Court of Justice in London ordered that the NHS England issue guidance for prescribers and pharmacists directing the prescription and dispensing of Lyrica by brand when pregabalin was prescribed for the treatment of neuropathic pain and entered a preliminary injunction against certain Sandoz group companies preventing the sale of Sandoz’s full label pregabalin product. Pfizer undertook to compensate certain generic companies and NHS entities for losses caused by these orders, which remained in effect until patent expiration in July 2017. In November 2018, the U.K. Supreme Court ruled that all the relevant claims directed to neuropathic pain were invalid.

Dr. Reddy’s Laboratories filed a claim for monetary damages, interest, and costs in May 2020, followed by the Scottish Ministers and fourteen Scottish Health Boards (together, NHS Scotland) in July 2020. In September 2020, Teva, Sandoz, Ranbaxy, Actavis, and the Secretary of State for Health and Social Care, together with 32 other NHS entities (together, NHS England, Wales, Scotland and Northern Ireland) filed their claims. The claims filed by Sandoz and Ranbaxy have been resolved.

Lyrica - Canada

In June 2014, Pharmascience Inc. (“PMS”) commenced an action against Pfizer Canada Inc., Warner-Lambert Company and Warner-Lambert Company LLC (the Pfizer Canada Defendants) seeking damages in connection with an earlier unsuccessful patent litigation brought by the Pfizer Canada Defendants involving pregabalin. PMS claims lost profit damages from November 30, 2010, the date it received tentative regulatory approval for its pregabalin product, to February 13, 2013, the date Pfizer’s patent case against PMS was dismissed. The parties have reached a settlement in principle to resolve the matter.

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 $8.9 million accrued related to these various other legal proceedings at September 30, 2021.

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Next: Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS