UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
Quarterly Report UnderPursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
For the quarterly period ended September 30, 20202021
COMMISSION FILE NUMBER 001-6351
ELI LILLY AND COMPANY
(Exact name of Registrant as specified in its charter)
Indiana 35-0470950
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
Lilly Corporate Center, Indianapolis, Indiana 46285
(Address and zip code of principal executive offices)
Registrant’s telephone number, including area code (317) 276-2000
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of Each ClassTrading SymbolSymbolsName of Each Exchange On Which Registered
Common Stock (no par value)LLYNew York Stock Exchange
1.000% Notes due 2022LLY22New York Stock Exchange
7 1/8% Notes due 2025LLY25New York Stock Exchange
1.625% Notes due 2026LLY26New York Stock Exchange
2.125% Notes due 2030LLY30New York Stock Exchange
0.625% Notes due 2031LLY31New York Stock Exchange
0.500% Notes due 2033LLY33New York Stock Exchange
6.77% Notes due 2036LLY36New York Stock Exchange
1.625% Notes due 2043LLY43New York Stock Exchange
1.700% Notes due 2049LLY49ANew York Stock Exchange
1.125% Notes due 2051LLY51New York Stock Exchange
1.375% Notes due 2061LLY61New York Stock Exchange
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 registrantRegistrant 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 registrantRegistrant was required to submit and post 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 a “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
  Emerging growth company
If an emerging growth company, indicate by check mark if the registrantRegistrant 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 registrantRegistrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes No
The number of shares of common stock outstanding as of October 26, 202022, 2021:
Class Number of Shares Outstanding
Common 956,581,598956,592,393 



Eli Lilly and Company
Form 10-Q
For the Quarter Ended September 30, 20202021
Table of Contents
Page
2


Forward-Looking Statements
This Quarterly Report on Form 10-Q includesand our other publicly available documents include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act), and are subject to the safe harbor created thereby under the Private Securities Litigation Reform Act of 1995. In particular, information appearing under “Management's Discussion and Analysis of Results of Operations and Financial Condition” includes forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts, and generally can generally be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,” “intend,” “anticipate,” “plan,” “continue,” or similar expressions.expressions or future or conditional verbs.
In particular, information appearing under “Management's Discussion and Analysis of Results of Operations and Financial Condition” includes forward-looking statements. Forward-looking statements inherently involve many risks and uncertainties that could cause actual results to differ materially from those projectedexpressed in theseforward-looking statements. Where, in any forward-looking statement, we (Lilly or the Company) express an expectation or belief as to future results or events, it is based on management's current plans and expectations, expressed in good faith and believed to have a reasonable basis. However, we can give no assurance that any such expectation or belief will result or will be achieved or accomplished. Investors therefore should not place undue reliance on forward-looking statements. The following include some but not all of the factors that could cause actual results or events to differ materially from those anticipated:
the impact of the evolving COVID-19 pandemic and the global response thereto;
uncertainties related to our efforts to develop potential treatments for COVID-19;
the significant costs and uncertainties in the pharmaceutical research and development process, including with respect to the timing and process of anticipatedobtaining regulatory approvalsapprovals;
the impact of acquisitions and launchesbusiness development transactions and related integration costs;
the expiration of newintellectual property protection for certain of our products and competition from generic and/or biosimilar products;
market uptake of recently launched products;our ability to protect and enforce patents and other intellectual property;
changes in patent law or regulations related to data package exclusivity;
competitive developments affecting current products and our pipeline;
the expirationmarket uptake of intellectual property protection for certainrecently launched products;
information technology system inadequacies, breaches, or operating failures;
unauthorized access, disclosure, misappropriation, or compromise of confidential information or other data stored in our IT systems, networks, and facilities, or those of third parties with whom we share our data;
unexpected safety or efficacy concerns associated with our products;
litigation, investigations, or other similar proceedings involving past, current, or future products or commercial activities as we are largely self-insured;
issues with product supply and regulatory approvals stemming from manufacturing difficulties or disruptions, including as a result of regulatory actions relating to our ability to protectfacilities;
reliance on third-party relationships and enforce patents andoutsourcing arrangements;
regulatory changes or other intellectual property;developments;
regulatory actions regarding currently marketed products;
continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and access to pharmaceuticals;
regulatory compliance problemsdevaluations in foreign currency exchange rates or government investigations;
regulatory actions regarding currently marketed products;
unexpected safety or efficacy concerns associated with our products;
issues with product supply stemming from manufacturing difficulties or disruptions;
regulatory changes or other developments;
changes in patent law or regulations related to data-package exclusivity;
litigation, investigations, or other similar proceedings involving past, current, or future products or commercial activities as we are largely self-insured;
unauthorized disclosure, misappropriation, or compromise of trade secrets or other confidential data stored in our information systems, networks,interest rates, and facilities, or those of third parties with whom we share our data;inflation;
changes in tax law, including the impact of United States tax reform legislation enacted in December 2017 and related guidance,rates, or events that differ from our assumptions related to tax positions;
changes in foreign currency exchange rates, interest rates, and inflation;
asset impairments and restructuring charges;
the impact of global macroeconomic conditions and trade disruptions or disputes;
changes in accounting and reporting standards promulgated by the Financial Accounting Standards Board and the Securities and Exchange Commission (SEC);
acquisitions and business development transactions and related integration costs;
information technology system inadequacies or operating failures;
the impact of the evolving COVID-19 pandemic and the global response thereto;
reliance on third-party relationships and outsourcing arrangements; and
the impact of global macroeconomic conditions.regulatory compliance problems or government investigations.
More information on factors that could cause actual results or events to differ materially from those anticipated is included from time to time in our reports filed with the SEC, including in Part II, Item 1A of this Form 10-Q, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, and in our Annual Report on Form 10-K for the year ended December 31, 2019,2020, particularly under the caption “Risk Factors”.
3


All forward-looking statements speak only as of the date of this reportQuarterly Report on Form 10-Q and are expressly qualified in their entirety by the cautionary statements included in or incorporated by reference into this report.Quarterly Report on Form 10-Q. Except as is required by law, we expressly disclaim any obligation to publicly release any revisions to forward-looking statements to reflect events after the date of this report.Quarterly Report on Form 10-Q.
34


PART I. Financial Information
Item 1. Financial Statements
Consolidated Condensed Statements of Operations
(Unaudited)
ELI LILLY AND COMPANY AND SUBSIDIARIES
(Dollars and shares in millions, except per-share data)
 
Three Months Ended September 30,Nine Months Ended September 30, Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019 2021202020212020
Revenue (Note 2)Revenue (Note 2)$5,740.6 $5,476.6 $17,099.8 $16,205.5 Revenue (Note 2)$6,772.8 $5,740.6 $20,318.5 $17,099.8 
Costs, expenses, and other:Costs, expenses, and other:Costs, expenses, and other:
Cost of salesCost of sales1,326.4 1,175.0 3,763.5 3,438.6 Cost of sales1,430.8 1,326.4 5,262.6 3,763.5 
Research and developmentResearch and development1,465.4 1,380.9 4,247.7 4,013.6 Research and development1,708.9 1,465.4 5,066.5 4,247.7 
Marketing, selling, and administrativeMarketing, selling, and administrative1,569.1 1,412.3 4,567.3 4,515.7 Marketing, selling, and administrative1,577.9 1,569.1 4,839.6 4,567.3 
Acquired in-process research and development (Note 3)Acquired in-process research and development (Note 3)0 77.7 294.1 239.6 Acquired in-process research and development (Note 3)174.0 — 498.3 294.1 
Asset impairment, restructuring, and other special charges (Note 6)101.4 161.3 423.9 
Other–net, (income) expense (Note 12)(158.9)24.9 (694.9)(28.7)
Asset impairment, restructuring, and other special charges (Note 5)Asset impairment, restructuring, and other special charges (Note 5) 101.4 211.6 161.3 
Other–net, (income) expense (Note 11)Other–net, (income) expense (Note 11)635.9 (158.9)124.3 (694.9)
4,303.4 4,070.8 12,339.0 12,602.7 5,527.5 4,303.4 16,002.9 12,339.0 
Income before income taxesIncome before income taxes1,437.2 1,405.8 4,760.8 3,602.8 Income before income taxes1,245.3 1,437.2 4,315.6 4,760.8 
Income taxes (Note 8)228.8 151.9 683.9 460.6 
Net income from continuing operations1,208.4 1,253.9 4,076.9 3,142.2 
Net income from discontinued operations (Note 5)0 0 3,680.5 
Income taxes (Note 7)Income taxes (Note 7)135.2 228.8 460.0 683.9 
Net incomeNet income$1,208.4 $1,253.9 $4,076.9 $6,822.7 Net income$1,110.1 $1,208.4 $3,855.6 $4,076.9 
Earnings per share:Earnings per share:Earnings per share:
Earnings from continuing operations - basic$1.33 $1.37 $4.49 $3.35 
Earnings from discontinued operations - basic0 0 3.92 
Earnings per share - basic$1.33 $1.37 $4.49 $7.27 
BasicBasic$1.22 $1.33 $4.25 $4.49 
Earnings from continuing operations - diluted$1.33 $1.37 $4.47 $3.33 
Earnings from discontinued operations - diluted0 0 3.91 
Earnings per share - diluted$1.33 $1.37 $4.47 $7.24 
DilutedDiluted$1.22 $1.33 $4.23 $4.47 
Shares used in calculation of earnings per share:Shares used in calculation of earnings per share:Shares used in calculation of earnings per share:
BasicBasic907.2913.9907.5938.2Basic906.7907.2907.7907.5
DilutedDiluted911.4918.5911.9942.4Diluted910.8911.4911.7911.9
See notes to consolidated condensed financial statements.
45


Consolidated Condensed Statements of Comprehensive Income (Loss)
(Unaudited)
ELI LILLY AND COMPANY AND SUBSIDIARIES
(Dollars in millions)
 
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Net income$1,208.4 $1,253.9 $4,076.9 $6,822.7 
Other comprehensive income (loss) from continuing operations, net of tax (Note 11)127.8 (134.0)(31.5)(51.1)
Other comprehensive income from discontinued operations, net of tax (Note 11)0 0 56.8 
Other comprehensive income (loss), net of tax (Note 11)127.8 (134.0)(31.5)5.7 
Comprehensive income$1,336.2 $1,119.9 $4,045.4 $6,828.4 
Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Net income$1,110.1 $1,208.4 $3,855.6 $4,076.9 
Other comprehensive income (loss), net of tax (Note 10)114.4 127.8 323.7 (31.5)
Comprehensive income$1,224.5 $1,336.2 $4,179.3 $4,045.4 
See notes to consolidated condensed financial statements.

56


Consolidated Condensed Balance Sheets
ELI LILLY AND COMPANY AND SUBSIDIARIES
(Dollars in millions)
September 30, 2020December 31, 2019September 30, 2021December 31, 2020
AssetsAssets(Unaudited) Assets(Unaudited) 
Current AssetsCurrent AssetsCurrent Assets
Cash and cash equivalents (Note 7)$3,595.3 $2,337.5 
Short-term investments (Note 7)35.0 101.0 
Accounts receivable, net of allowances of $26.4 (2020) and $22.4 (2019)
4,886.7 4,547.3 
Cash and cash equivalents (Note 6)Cash and cash equivalents (Note 6)$3,788.2 $3,657.1 
Short-term investments (Note 6)Short-term investments (Note 6)37.1 24.2 
Accounts receivable, net of allowances of $24.1 (2021) and $25.9 (2020)
Accounts receivable, net of allowances of $24.1 (2021) and $25.9 (2020)
5,914.3 5,875.3 
Other receivablesOther receivables958.1 994.2 Other receivables1,110.7 1,053.7 
InventoriesInventories3,555.4 3,190.7 Inventories3,907.4 3,980.3 
Prepaid expenses and otherPrepaid expenses and other3,209.4 2,538.9 Prepaid expenses and other3,050.6 2,871.5 
Total current assetsTotal current assets16,239.9 13,709.6 Total current assets17,808.3 17,462.1 
Investments (Note 7)2,476.2 1,962.4 
Investments (Note 6)Investments (Note 6)3,350.5 2,966.8 
GoodwillGoodwill3,726.4 3,679.4 Goodwill3,884.1 3,766.5 
Other intangibles, netOther intangibles, net7,588.6 6,618.0 Other intangibles, net7,887.7 7,450.0 
Deferred tax assetsDeferred tax assets2,555.3 2,572.6 Deferred tax assets2,625.6 2,830.4 
Property and equipment, net of accumulated depreciation of $9,600.5 (2020) and $9,161.6 (2019)
8,281.1 7,872.9 
Property and equipment, net of accumulated depreciation of $9,962.8 (2021) and $9,570.7 (2020)
Property and equipment, net of accumulated depreciation of $9,962.8 (2021) and $9,570.7 (2020)
8,920.4 8,681.9 
Other noncurrent assetsOther noncurrent assets3,078.5 2,871.2 Other noncurrent assets3,710.4 3,475.4 
Total assetsTotal assets$43,946.0 $39,286.1 Total assets$48,187.0 $46,633.1 
Liabilities and EquityLiabilities and EquityLiabilities and Equity
Current LiabilitiesCurrent LiabilitiesCurrent Liabilities
Short-term borrowings and current maturities of long-term debtShort-term borrowings and current maturities of long-term debt$587.5 $1,499.3 Short-term borrowings and current maturities of long-term debt$1,563.0 $8.7 
Accounts payableAccounts payable1,430.1 1,405.3 Accounts payable1,566.8 1,606.7 
Employee compensationEmployee compensation795.6 915.5 Employee compensation836.6 997.2 
Sales rebates and discountsSales rebates and discounts5,745.2 4,933.6 Sales rebates and discounts7,185.6 5,853.0 
Dividends payableDividends payable0 671.5 Dividends payable 770.6 
Income taxes payableIncome taxes payable1,173.5 160.6 Income taxes payable203.5 495.1 
Other current liabilitiesOther current liabilities2,245.0 2,189.4 Other current liabilities2,326.5 2,750.3 
Total current liabilitiesTotal current liabilities11,976.9 11,775.2 Total current liabilities13,682.0 12,481.6 
Other LiabilitiesOther LiabilitiesOther Liabilities
Long-term debtLong-term debt16,334.6 13,817.9 Long-term debt15,522.4 16,586.6 
Accrued retirement benefits (Note 9)3,435.5 3,698.2 
Accrued retirement benefits (Note 8)Accrued retirement benefits (Note 8)3,878.8 4,094.5 
Long-term income taxes payableLong-term income taxes payable3,392.7 3,607.2 Long-term income taxes payable3,768.5 3,837.8 
Deferred tax liabilitiesDeferred tax liabilities2,107.7 2,187.5 Deferred tax liabilities1,632.5 2,099.9 
Other noncurrent liabilitiesOther noncurrent liabilities1,702.6 1,501.0 Other noncurrent liabilities1,748.7 1,707.5 
Total other liabilitiesTotal other liabilities26,973.1 24,811.8 Total other liabilities26,550.9 28,326.3 
Commitments and Contingencies (Note 10)
Commitments and Contingencies (Note 9)Commitments and Contingencies (Note 9)00
Eli Lilly and Company Shareholders’ EquityEli Lilly and Company Shareholders’ EquityEli Lilly and Company Shareholders’ Equity
Common stockCommon stock598.1 598.8 Common stock598.2 598.2 
Additional paid-in capitalAdditional paid-in capital6,698.8 6,685.3 Additional paid-in capital6,758.0 6,778.5 
Retained earningsRetained earnings7,154.0 4,920.4 Retained earnings9,639.4 7,830.2 
Employee benefit trustEmployee benefit trust(3,013.2)(3,013.2)Employee benefit trust(3,013.2)(3,013.2)
Accumulated other comprehensive loss (Note 11)(6,555.1)(6,523.6)
Accumulated other comprehensive loss (Note 10)Accumulated other comprehensive loss (Note 10)(6,172.7)(6,496.4)
Cost of common stock in treasuryCost of common stock in treasury(55.7)(60.8)Cost of common stock in treasury(52.7)(55.7)
Total Eli Lilly and Company shareholders’ equityTotal Eli Lilly and Company shareholders’ equity4,826.9 2,606.9 Total Eli Lilly and Company shareholders’ equity7,757.0 5,641.6 
Noncontrolling interestsNoncontrolling interests169.1 92.2 Noncontrolling interests197.1 183.6 
Total equityTotal equity4,996.0 2,699.1 Total equity7,954.1 5,825.2 
Total liabilities and equityTotal liabilities and equity$43,946.0 $39,286.1 Total liabilities and equity$48,187.0 $46,633.1 
See notes to consolidated condensed financial statements.
67


Consolidated Condensed Statements of Equity
(Unaudited)
ELI LILLY AND COMPANY AND SUBSIDIARIES
Equity of Eli Lilly and Company ShareholdersEquity of Eli Lilly and Company Shareholders

(Dollars in millions, except per-share data, and shares in thousands)

(Dollars in millions, except per-share data, and shares in thousands)
Common StockAdditional
Paid-in
Capital
Retained
Earnings
Employee Benefit TrustAccumulated Other Comprehensive LossCommon Stock in TreasuryNoncontrolling Interests
(Dollars in millions, except per-share data, and shares in thousands)
Common StockAdditional
Paid-in
Capital
Retained
Earnings
Employee Benefit TrustAccumulated Other Comprehensive Loss
Common Stock in Treasury(1)
Noncontrolling Interests
SharesAmountSharesAmountSharesAmountSharesAmount
Balance at July 1, 2019965,957 $603.7 $6,534.5 $4,318.1 $(3,013.2)$(5,600.5)541 $(62.1)$76.8 
Net income1,253.9 4.6 
Other comprehensive loss, net of tax(134.0)
Balance at July 1, 2020Balance at July 1, 2020956,953 $598.1 $6,629.4 $6,617.2 $(3,013.2)$(6,682.9)487 $(55.7)$179.1 
Net income (loss)Net income (loss)1,208.4 (4.8)
Other comprehensive income, net of taxOther comprehensive income, net of tax127.8 
Retirement of treasury shares(5,391)(3.3)(596.6)(5,391)600.0 
Purchase of treasury shares5,391 (600.0)
Cash dividends declared per share: $0.74Cash dividends declared per share: $0.74(671.6)
Issuance of stock under employee stock plans, netIssuance of stock under employee stock plans, net10 — (1.3)(11)1.3 Issuance of stock under employee stock plans, net25 — (2.3)
Stock-based compensationStock-based compensation75.5 Stock-based compensation71.7 
OtherOther6.5 (1.6)Other(5.2)
Balance at September 30, 2019960,576 $600.4 $6,608.7 $4,981.9 $(3,013.2)$(5,734.5)530 $(60.8)$79.8 
Balance at September 30, 2020Balance at September 30, 2020956,978 $598.1 $6,698.8 $7,154.0 $(3,013.2)$(6,555.1)487 $(55.7)$169.1 
Balance at July 1, 2020956,953 $598.1 $6,629.4 $6,617.2 $(3,013.2)$(6,682.9)487 $(55.7)$179.1 
Balance at July 1, 2021Balance at July 1, 2021957,038 $598.1 $6,669.2 $8,530.1 $(3,013.2)$(6,287.1)463 $(52.7)$219.1 
Net income (loss)Net income (loss)1,208.4 (4.8)Net income (loss)1,110.1 (22.6)
Other comprehensive income, net of taxOther comprehensive income, net of tax127.8 Other comprehensive income, net of tax114.4 
Cash dividends declared per share: $0.74(671.6)
Issuance of stock under employee stock plans, netIssuance of stock under employee stock plans, net25  (2.3)Issuance of stock under employee stock plans, net14 0.1 (1.3)
Stock-based compensationStock-based compensation71.7 Stock-based compensation90.1 
OtherOther(5.2)Other(0.8)0.6 
Balance at September 30, 2020956,978 $598.1 $6,698.8 $7,154.0 $(3,013.2)$(6,555.1)487 $(55.7)$169.1 
Balance at September 30, 2021Balance at September 30, 2021957,052 $598.2 $6,758.0 $9,639.4 $(3,013.2)$(6,172.7)463 $(52.7)$197.1 
(1) As of September 30, 2020,2021, there was $1.00 billionwere $500.0 million remaining under our $8.00 billion share repurchase program authorized in June 2018.
See notes to consolidated condensed financial statements.
7


Equity of Eli Lilly and Company Shareholders

(Dollars in millions, except per-share data, and shares in thousands)
Common StockAdditional
Paid-in
Capital
Retained
Earnings
Employee Benefit TrustAccumulated Other Comprehensive LossCommon Stock in TreasuryNoncontrolling Interests
SharesAmountSharesAmount
Balance at January 1, 20191,057,639 $661.0 $6,583.6 $11,395.9 $(3,013.2)$(5,729.2)604 $(69.4)$1,080.4 
Net income6,822.7 25.7 
Other comprehensive income (loss), net of tax(5.3)11.0 
Cash dividends declared per share: $1.29(1,171.6)
Retirement of treasury shares(100,018)(62.4)(12,065.1)(100,018)12,127.5 
Purchase of treasury shares35,017 (4,100.0)
Issuance of stock under employee stock plans, net2,955 1.8 (205.7)(74)8.6 
Stock-based compensation230.8 
Acquisition of common stock in exchange offer65,001 (8,027.5)
Deconsolidation of Elanco(1,028.9)
Other(8.4)
Balance at September 30, 2019960,576 $600.4 $6,608.7 $4,981.9 $(3,013.2)$(5,734.5)530 $(60.8)$79.8 
Balance at January 1, 2020958,056 $598.8 $6,685.3 $4,920.4 $(3,013.2)$(6,523.6)530 $(60.8)$92.2 
Net income4,076.9 95.9 
Other comprehensive loss, net of tax(31.5)
Cash dividends declared per share: $1.48(1,345.6)
Retirement of treasury shares(3,627)(2.3)(497.7)(3,627)500.0 
Purchase of treasury shares (1)
3,627 (500.0)
Issuance of stock under employee stock plans, net2,549 1.6 (206.4)(43)5.1 
Stock-based compensation220.3 
Other(0.4)(19.0)
Balance at September 30, 2020956,978 $598.1 $6,698.8 $7,154.0 $(3,013.2)$(6,555.1)487 $(55.7)$169.1 
(1) As of September 30, 2020, there was $1.002018 and $5.00 billion remaining under our $8.00$5.00 billion share repurchase program authorized in June 2018.May 2021.
See notes to consolidated condensed financial statements.

8


Equity of Eli Lilly and Company Shareholders

(Dollars in millions, except per-share data, and shares in thousands)
Common StockAdditional
Paid-in
Capital
Retained
Earnings
Employee Benefit TrustAccumulated Other Comprehensive Loss
Common Stock in Treasury(1)
Noncontrolling Interests
SharesAmountSharesAmount
Balance at January 1, 2020958,056 $598.8 $6,685.3 $4,920.4 $(3,013.2)$(6,523.6)530 $(60.8)$92.2 
Net income4,076.9 95.9 
Other comprehensive loss, net of tax(31.5)
Cash dividends declared per share: $1.48(1,345.6)
Retirement of treasury shares(3,627)(2.3)(497.7)(3,627)500.0 
Purchase of treasury shares3,627 (500.0)
Issuance of stock under employee stock plans, net2,549 1.6 (206.4)(43)5.1 
Stock-based compensation220.3 
Other(0.4)(19.0)
Balance at September 30, 2020956,978 $598.1 $6,698.8 $7,154.0 $(3,013.2)$(6,555.1)487 $(55.7)$169.1 
Balance at January 1, 2021957,077 $598.2 $6,778.5 $7,830.2 $(3,013.2)$(6,496.4)487 $(55.7)$183.6 
Net income3,855.6 25.2 
Other comprehensive income, net of tax323.7 
Cash dividends declared per share: $1.70(1,542.9)
Retirement of treasury shares(2,467)(1.5)(498.5)(2,467)500.0 
Purchase of treasury shares2,467 (500.0)
Issuance of stock under employee stock plans, net2,442 1.5 (287.1)(24)3.0 
Stock-based compensation267.5 
Other(0.9)(5.0)(11.7)
Balance at September 30, 2021957,052 $598.2 $6,758.0 $9,639.4 $(3,013.2)$(6,172.7)463 $(52.7)$197.1 
(1) As of September 30, 2021, there were $500.0 million remaining under our $8.00 billion share repurchase program authorized in June 2018 and $5.00 billion remaining under our $5.00 billion share repurchase program authorized in May 2021.
See notes to consolidated condensed financial statements.

9


Consolidated Condensed Statements of Cash Flows
(Unaudited)
ELI LILLY AND COMPANY AND SUBSIDIARIES
(Dollars in millions)
 
Nine Months Ended September 30,Nine Months Ended September 30,
20202019 20212020
Cash Flows from Operating ActivitiesCash Flows from Operating ActivitiesCash Flows from Operating Activities
Net incomeNet income$4,076.9 $6,822.7 Net income$3,855.6 $4,076.9 
Adjustments to Reconcile Net Income to Cash Flows from Operating Activities:Adjustments to Reconcile Net Income to Cash Flows from Operating Activities:Adjustments to Reconcile Net Income to Cash Flows from Operating Activities:
Gain related to disposition of Elanco (Note 5)0 (3,680.5)
Depreciation and amortizationDepreciation and amortization956.4 891.9 Depreciation and amortization1,101.9 956.4 
Change in deferred income taxesChange in deferred income taxes66.2 (23.4)Change in deferred income taxes(709.8)66.2 
Debt extinguishment loss (Note 6)Debt extinguishment loss (Note 6)405.2 — 
Stock-based compensation expenseStock-based compensation expense220.3 230.8 Stock-based compensation expense267.5 220.3 
Net investment gainsNet investment gains(909.5)(177.6)Net investment gains(271.1)(909.5)
Acquired in-process research and development (Note 3)Acquired in-process research and development (Note 3)294.1 239.6 Acquired in-process research and development (Note 3)498.3 294.1 
Other changes in operating assets and liabilities, net of acquisitions and divestituresOther changes in operating assets and liabilities, net of acquisitions and divestitures(232.2)(1,763.7)Other changes in operating assets and liabilities, net of acquisitions and divestitures(548.1)(232.2)
Other non-cash operating activities, netOther non-cash operating activities, net212.2 333.1 Other non-cash operating activities, net504.7 212.2 
Net Cash Provided by Operating ActivitiesNet Cash Provided by Operating Activities4,684.4 2,872.9 Net Cash Provided by Operating Activities5,104.2 4,684.4 
Cash Flows from Investing ActivitiesCash Flows from Investing ActivitiesCash Flows from Investing Activities
Net purchases of property and equipmentNet purchases of property and equipment(933.2)(707.4)Net purchases of property and equipment(1,018.4)(933.2)
Proceeds from sales and maturities of short-term investmentsProceeds from sales and maturities of short-term investments118.8 116.3 Proceeds from sales and maturities of short-term investments46.6 118.8 
Purchases of short-term investmentsPurchases of short-term investments(11.4)(34.1)Purchases of short-term investments(27.9)(11.4)
Proceeds from sales of noncurrent investmentsProceeds from sales of noncurrent investments574.1 498.4 Proceeds from sales of noncurrent investments537.2 574.1 
Purchases of noncurrent investmentsPurchases of noncurrent investments(223.7)(196.7)Purchases of noncurrent investments(710.1)(223.7)
Cash paid for acquisitions, net of cash acquired (Note 3)Cash paid for acquisitions, net of cash acquired (Note 3)(849.3)(6,917.7)Cash paid for acquisitions, net of cash acquired (Note 3)(747.4)(849.3)
Purchases of in-process research and developmentPurchases of in-process research and development(276.4)(319.6)Purchases of in-process research and development(460.6)(276.4)
Other investing activities, netOther investing activities, net16.3 (480.7)Other investing activities, net(2.7)16.3 
Net Cash Used for Investing ActivitiesNet Cash Used for Investing Activities(1,584.8)(8,041.5)Net Cash Used for Investing Activities(2,383.3)(1,584.8)
Cash Flows from Financing ActivitiesCash Flows from Financing ActivitiesCash Flows from Financing Activities
Dividends paidDividends paid(2,017.1)(1,822.6)Dividends paid(2,313.5)(2,017.1)
Net change in short-term borrowingsNet change in short-term borrowings(914.3)1,058.9 Net change in short-term borrowings(1.5)(914.3)
Proceeds from issuance of long-term debtProceeds from issuance of long-term debt2,062.3 4,448.3 Proceeds from issuance of long-term debt2,410.8 2,062.3 
Repayments of long-term debtRepayments of long-term debt(276.3)(600.3)Repayments of long-term debt(1,905.3)(276.3)
Purchases of common stockPurchases of common stock(500.0)(4,100.0)Purchases of common stock(500.0)(500.0)
Other financing activities, netOther financing activities, net(200.2)(195.2)Other financing activities, net(295.3)(200.2)
Net Cash Used for Financing ActivitiesNet Cash Used for Financing Activities(1,845.6)(1,210.9)Net Cash Used for Financing Activities(2,604.8)(1,845.6)
Effect of exchange rate changes on cash and cash equivalentsEffect of exchange rate changes on cash and cash equivalents3.8 (54.9)Effect of exchange rate changes on cash and cash equivalents15.0 3.8 
Net increase (decrease) in cash and cash equivalents1,257.8 (6,434.4)
Cash and cash equivalents at January 1 (2019 includes $677.5 of discontinued operations)2,337.5 7,998.2 
Net increase in cash and cash equivalentsNet increase in cash and cash equivalents131.1 1,257.8 
Cash and cash equivalents at January 1Cash and cash equivalents at January 13,657.1 2,337.5 
Cash and Cash Equivalents at September 30Cash and Cash Equivalents at September 30$3,595.3 $1,563.8 Cash and Cash Equivalents at September 30$3,788.2 $3,595.3 
See notes to consolidated condensed financial statements.


910


Notes to Consolidated Condensed Financial Statements
(Tables present dollars in millions, except per-share data)
Note 1: Basis of Presentation and Change in Accounting Principle
Basis of Presentation
We have prepared the accompanying unaudited consolidated condensed financial statements in accordance with the requirements of Form 10-Q and, therefore, they do not include all information and footnotes necessary for a fair presentation of financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States (GAAP). In our opinion, the consolidated condensed financial statements reflect all adjustments (including those that are normal and recurring) that are necessary for a fair presentation of the results of operations for the periods shown. In preparing financial statements in conformity with GAAP, we must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses, and related disclosures at the date of the financial statements and during the reporting period. Actual results could differ from those estimates.
The information included in this Quarterly Report on Form 10-Q should be read in conjunction with our consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2019.2020. We issue our financial statements by filing them with the Securities and Exchange Commission and have evaluated subsequent events up to the time of the filing of ourthis Quarterly Report on Form 10-Q.
All per-share amounts, unless otherwise noted in the footnotes, are presented on a diluted basis,basis; that is, based on the weighted-average number of outstanding common shares outstanding plus the effect of incremental shares from our stock-based compensation programs.
We operate as a single operating segment engaged in the discovery, development, manufacturing, marketing, and sales of pharmaceutical products worldwide. A global research and development organization and a supply chain organization are responsible for the discovery, development, manufacturing, and supply of our products. Regional commercial organizations market, distribute, and sell the products. The business is also supported by global corporate staff functions. Our determination that we operate as a single segment is consistent with the financial information regularly reviewed by the chief operating decision maker for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods.
Change in Accounting Principle for Retirement Benefit Plan Assets
Effective during the third quarter of 2020, we adopted a voluntary change in our method of applying an accounting principle for certain of our retirement benefit plans. Refer to Note 9 for additional information.


1011


Note 2: Revenue
The following table summarizes our revenue recognized in our consolidated condensed statements of operations:
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019 2021202020212020
Net product revenueNet product revenue$5,281.1 $4,982.0 $15,762.3 $14,843.0 Net product revenue$6,189.0 $5,281.1 $18,579.5 $15,762.3 
Collaboration and other revenue (1)
Collaboration and other revenue (1)
459.5 494.6 1,337.5 1,362.5 
Collaboration and other revenue (1)
583.8 459.5 1,739.0 1,337.5 
RevenueRevenue$5,740.6 $5,476.6 $17,099.8 $16,205.5 Revenue$6,772.8 $5,740.6 $20,318.5 $17,099.8 
(1) Collaboration and other revenue associated with prior period transfers of intellectual property was $62.1 million and $136.1 million during the three and nine months ended September 30, 2021, respectively, and $31.5 million and $101.5 million during the three and nine months ended September 30, 2020, respectively, and $67.9 million and $163.0 million during the three and nine months ended September 30, 2019, respectively.
We recognize revenue primarily from two different types of contracts, product sales to customers (net product revenue) and collaborations and other arrangements. Revenue recognized from collaborations and other arrangements includes our share of profits from the collaboration, as well as royalties, upfront and milestone payments we receive under these types of contracts. See Note 4 for additional information related to certain of our collaborations and other arrangements. Collaboration and other revenue disclosed above includes the revenue from the TrajentaJardiance®and and JardianceTrajenta® families of products resulting from our collaboration with Boehringer Ingelheim discussed in Note 4. Substantially all of the remainder of collaboration and other revenue is related to contracts accounted for as contracts with customers.
Adjustments to Revenue
Adjustments to increase (decrease) revenue recognized as a result of changes in estimates for our most significant U.S.United States (U.S.) sales returns, rebates, and discounts liability balances for products shipped in previous periods were approximately (1 percent) andless than 1 percent of U.S. revenue during each of the three and nine months ended September 30, 2020, respectively,2021, and approximately 2(1) percent and 31 percent of U.S. revenue duringfor the three and nine months ended September 30, 2019,2020, respectively.
Contract Liabilities
Our contract liabilities result from arrangements where we have received payment in advance of performance under the contract and do not include sales returns, rebates, and discounts. Changes in contract liabilities are generally due to either receipt of additional advance payments or our performance under the contract.
The following table summarizes contract liability balances:
 September 30, 2020December 31, 2019
Contract liabilities$289.5 $264.6 

 September 30, 2021December 31, 2020
Contract liabilities$278.4 $276.8 
During the three and nine months ended September 30, 20202021 and 2019,2020, revenue recognized from contract liabilities as of the beginning of the respective year was not material. Revenue expected to be recognized in the future from contract liabilities as the related performance obligations are satisfied is not expected to be material in any one year.







1112


Disaggregation of Revenue
The following table summarizes revenue by product for the three months ended September 30, 20202021 and 2019:2020:
Three Months Ended September 30,Three Months Ended September 30,
20202019 20212020
United States (U.S.)(1)
Outside U.S.Total
U.S.(1)
Outside U.S.TotalU.S.Outside U.S.TotalU.S.Outside U.S.Total
Revenue—to unaffiliated customers:Revenue—to unaffiliated customers:Revenue—to unaffiliated customers:
Diabetes:Diabetes:Diabetes:
Trulicity®
Trulicity®
$791.2 $315.4 $1,106.6 $755.5 $256.0 $1,011.5 
Trulicity®
$1,201.4 $398.8 $1,600.1 $791.2 $315.4 $1,106.6 
Humalog® (2)(1)
Humalog® (2)(1)
390.1 266.9 656.9 356.2 292.6 648.9 
Humalog® (2)(1)
347.3 279.4 626.7 390.1 266.9 656.9 
Jardiance (3)(2)
Jardiance (3)(2)
163.3 147.5 310.8 140.6 100.1 240.7 
Jardiance (3)(2)
221.2 169.2 390.4 163.3 147.5 310.8 
Humulin®
Humulin®
214.0 91.9 305.9 218.2 103.6 321.8 
Humulin®
193.4 93.4 286.7 214.0 91.9 305.9 
Basaglar®
Basaglar®
178.5 69.7 248.2 202.4 60.8 263.2 
Basaglar®
114.7 78.1 192.8 178.5 69.7 248.2 
Trajenta (4)
19.4 72.3 91.7 60.1 95.4 155.5 
Other DiabetesOther Diabetes42.0 20.8 62.9 51.4 19.3 70.7 Other Diabetes65.0 112.2 177.4 61.4 93.1 154.6 
Total DiabetesTotal Diabetes1,798.5 984.5 2,783.0 1,784.4 927.8 2,712.3 Total Diabetes2,143.0 1,131.1 3,274.1 1,798.5 984.5 2,783.0 
Oncology:Oncology:Oncology:
Alimta®
Alimta®
291.9 286.1 578.0 282.4 225.9 508.2 
Alimta®
297.2 159.8 457.0 291.9 286.1 578.0 
Verzenio®
Verzenio®
199.6 135.9 335.5 158.9 75.5 234.4 
Cyramza®
Cyramza®
94.5 158.2 252.7 82.5 157.5 240.0 
Cyramza®
84.8 168.6 253.4 94.5 158.2 252.7 
Verzenio®
158.9 75.5 234.4 124.8 32.4 157.2 
Erbitux®
Erbitux®
122.5 14.0 136.4 113.8 14.8 128.6 
Erbitux®
114.0 20.3 134.3 122.5 14.0 136.4 
Tyvyt®
Tyvyt®
 125.6 125.6 — 84.4 84.4 
Other OncologyOther Oncology14.7 117.1 131.9 36.7 76.6 113.4 Other Oncology35.3 65.1 100.3 14.7 32.7 47.5 
Total OncologyTotal Oncology682.5 650.9 1,333.4 640.2 507.2 1,147.4 Total Oncology730.9 675.3 1,406.1 682.5 650.9 1,333.4 
Immunology:Immunology:Immunology:
Taltz®
Taltz®
326.2 128.3 454.5 250.6 89.4 340.0 
Taltz®
422.2 170.9 593.1 326.2 128.3 454.5 
Olumiant®(3)
Olumiant®(3)
14.5 147.5 162.0 12.1 102.5 114.6 
Olumiant®(3)
194.0 212.9 406.9 14.5 147.5 162.0 
Other ImmunologyOther Immunology6.1 4.5 10.6 Other Immunology 4.9 4.9 6.1 4.5 10.6 
Total ImmunologyTotal Immunology346.8 280.3 627.1 262.8 191.8 454.6 Total Immunology616.2 388.7 1,004.9 346.8 280.3 627.1 
Neuroscience:Neuroscience:Neuroscience:
Emgality®
Emgality®
99.9 40.1 140.0 81.4 10.1 91.5 
Cymbalta®
Cymbalta®
11.1 175.5 186.6 10.3 168.3 178.6 
Cymbalta®
7.0 125.1 132.0 11.1 175.5 186.6 
Zyprexa®
Zyprexa®
21.2 91.5 112.7 11.2 94.2 105.4 
Zyprexa®
13.0 88.7 101.7 21.2 91.5 112.7 
Emgality®
81.4 10.1 91.5 45.8 1.9 47.7 
Other NeuroscienceOther Neuroscience26.7 53.2 79.9 27.3 67.7 95.0 Other Neuroscience24.7 51.6 76.5 26.7 53.2 79.9 
Total NeuroscienceTotal Neuroscience140.4 330.3 470.7 94.6 332.1 426.7 Total Neuroscience144.6 305.5 450.2 140.4 330.3 470.7 
Other:Other:Other:
COVID-19 Antibodies (4)
COVID-19 Antibodies (4)
215.5 1.6 217.1 — — — 
Forteo®
Forteo®
144.6 122.3 266.9 175.1 195.7 370.7 
Forteo®
109.6 91.3 200.9 144.6 122.3 266.9 
Cialis®
Cialis®
15.1 147.3 162.5 30.9 153.4 184.3 
Cialis®
(6.5)137.4 130.9 15.1 147.3 162.5 
OtherOther33.5 63.6 97.0 72.2 108.4 180.6 Other36.3 52.4 88.8 33.5 63.6 97.0 
Total OtherTotal Other193.2 333.2 526.4 278.2 457.5 735.6 Total Other354.9 282.7 637.7 193.2 333.2 526.4 
RevenueRevenue$3,161.4 $2,579.3 $5,740.6 $3,060.2 $2,416.4 $5,476.6 Revenue$3,989.6 $2,783.3 $6,772.8 $3,161.4 $2,579.3 $5,740.6 
Numbers may not add due to rounding.
(1) U.S. revenue includes revenue in Puerto Rico.
(2) Humalog revenue includes insulin lispro.
(3)(2) Jardiance revenue includes Glyxambi®, Synjardy®, and Trijardy® XR.
(3) Olumiant revenue includes sales for baricitinib, for treatment in hospitalized COVID-19 patients, that were made pursuant to Emergency Use Authorization (EUA).
(4) Trajenta revenue includes JentaduetoCOVID-19 antibodies include sales for bamlanivimab administered alone as well as sales for bamlanivimab and etesevimab administered together and were made pursuant to EUAs.
®
.

1213




The following table summarizes revenue by product for the nine months ended September 30, 20202021 and 2019:2020:
Nine Months Ended September 30,Nine Months Ended September 30,
20202019 20212020
U.S. (1)
Outside U.S.Total
U.S. (1)
Outside U.S.TotalU.S.Outside U.S.TotalU.S.Outside U.S.Total
Revenue—to unaffiliated customers:Revenue—to unaffiliated customers:Revenue—to unaffiliated customers:
Diabetes:Diabetes:Diabetes:
TrulicityTrulicity$2,673.2 $892.5 $3,565.7 $2,213.2 $706.5 $2,919.7 Trulicity$3,465.7 $1,122.5 $4,588.2 $2,673.2 $892.5 $3,565.7 
Humalog (2)(1)
Humalog (2)(1)
1,070.4 837.4 1,907.8 1,201.0 856.3 2,057.3 
Humalog (2)(1)
1,009.0 842.3 1,851.3 1,070.4 837.4 1,907.8 
Jardiance (2)
Jardiance (2)
566.8 492.1 1,058.9 453.0 387.3 840.3 
HumulinHumulin642.5 292.7 935.2 639.6 302.5 942.1 Humulin633.5 290.3 923.8 642.5 292.7 935.2 
BasaglarBasaglar638.7 203.7 842.3 632.8 172.6 805.4 Basaglar423.3 226.8 650.1 638.7 203.7 842.3 
Jardiance (3)
453.0 387.3 840.3 408.4 267.9 676.2 
Trajenta (4)
64.5 197.2 261.7 171.9 269.5 441.4 
Other DiabetesOther Diabetes120.7 57.2 177.9 119.7 65.6 185.4 Other Diabetes185.7 302.6 488.3 185.2 254.4 439.6 
Total DiabetesTotal Diabetes5,663.0 2,868.0 8,530.9 5,386.6 2,640.9 8,027.5 Total Diabetes6,284.0 3,276.6 9,560.6 5,663.0 2,868.0 8,530.9 
Oncology:Oncology:Oncology:
AlimtaAlimta933.4 743.8 1,677.2 905.8 679.3 1,585.1 Alimta911.9 714.7 1,626.6 933.4 743.8 1,677.2 
VerzenioVerzenio582.1 363.7 945.8 430.0 201.1 631.1 
CyramzaCyramza277.6 470.8 748.4 247.4 432.7 680.1 Cyramza266.3 496.3 762.5 277.6 470.8 748.4 
Verzenio430.0 201.1 631.1 323.5 77.0 400.6 
ErbituxErbitux356.1 40.6 396.7 364.1 42.3 406.4 Erbitux357.7 45.9 403.7 356.1 40.6 396.7 
TyvytTyvyt 340.2 340.2 — 205.9 205.9 
Other OncologyOther Oncology26.0 324.1 350.1 83.1 202.2 285.1 Other Oncology83.7 169.9 253.6 26.0 118.2 144.2 
Total OncologyTotal Oncology2,023.1 1,780.4 3,803.5 1,923.9 1,433.5 3,357.3 Total Oncology2,201.7 2,130.7 4,332.4 2,023.1 1,780.4 3,803.5 
Immunology:Immunology:Immunology:
TaltzTaltz942.9 350.3 1,293.2 699.6 246.7 946.3 Taltz1,071.6 493.8 1,565.4 942.9 350.3 1,293.2 
Olumiant(3)Olumiant(3)39.0 407.7 446.7 29.2 269.9 299.1 Olumiant(3)236.5 572.6 809.1 39.0 407.7 446.7 
Other ImmunologyOther Immunology13.2 8.1 21.3 Other Immunology15.2 14.5 29.7 13.2 8.1 21.3 
Total ImmunologyTotal Immunology995.1 766.1 1,761.2 728.8 516.6 1,245.4 Total Immunology1,323.3 1,080.9 2,404.2 995.1 766.1 1,761.2 
Neuroscience:Neuroscience:Neuroscience:
CymbaltaCymbalta30.5 546.5 576.9 38.7 491.2 529.9 Cymbalta30.3 454.0 484.3 30.5 546.5 576.9 
EmgalityEmgality313.5 102.2 415.7 229.3 23.6 252.9 
ZyprexaZyprexa41.5 266.2 307.7 29.8 287.2 317.0 Zyprexa28.3 264.5 292.8 41.5 266.2 307.7 
Emgality229.3 23.6 252.9 91.8 4.5 96.3 
Other NeuroscienceOther Neuroscience53.4 165.7 219.2 89.9 239.5 329.4 Other Neuroscience81.0 154.0 235.0 53.4 165.7 219.2 
Total NeuroscienceTotal Neuroscience354.7 1,002.0 1,356.7 250.2 1,022.4 1,272.6 Total Neuroscience453.1 974.7 1,427.8 354.7 1,002.0 1,356.7 
Other:Other:Other:
COVID-19 Antibodies (4)
COVID-19 Antibodies (4)
949.5 226.7 1,176.2— — — 
ForteoForteo386.7 405.2 791.9 473.8 570.6 1,044.4 Forteo330.1 287.7 617.8 386.7 405.2 791.9 
CialisCialis64.6 421.6 486.2 209.3 483.4 692.7 Cialis(3.1)541.8 538.7 64.6 421.6 486.2 
OtherOther144.2 225.2 369.4 230.9 334.6 565.6 Other96.5 164.3 260.8 144.2 225.2 369.4 
Total OtherTotal Other595.5 1,052.0 1,647.5 914.0 1,388.6 2,302.7 Total Other1,373.0 1,220.5 2,593.5 595.5 1,052.0 1,647.5 
RevenueRevenue$9,631.4 $7,468.5 $17,099.8 $9,203.5 $7,002.1 $16,205.5 Revenue$11,635.1 $8,683.4 $20,318.5 $9,631.4 $7,468.5 $17,099.8 
Numbers may not add due to rounding.
(1) U.S. revenue includes revenue in Puerto Rico.
(2) Humalog revenue includes insulin lispro.
(3)(2) Jardiance revenue includes Glyxambi, Synjardy, and Trijardy XR.
(3) Olumiant revenue includes sales for baricitinib, for treatment in hospitalized COVID-19 patients, that were made pursuant to EUA.
(4) Trajenta revenue includes Jentadueto.COVID-19 antibodies include sales for bamlanivimab administered alone as well as sales for bamlanivimab and etesevimab administered together and were made pursuant to EUAs.
.

1314


The following table summarizes revenue by geographical area:
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
20202019202020192021202020212020
Revenue—to unaffiliated customers (1):
Revenue—to unaffiliated customers (1):
Revenue—to unaffiliated customers (1):
U.S. (2)
U.S. (2)
$3,161.4 $3,060.2 $9,631.4 $9,203.5 
U.S. (2)
$3,989.6 $3,161.4 $11,635.1 $9,631.4 
EuropeEurope1,046.7 923.4 2,984.4 2,752.0 Europe1,098.6 1,046.7 3,629.6 2,984.4 
JapanJapan660.1 641.5 1,919.1 1,838.4 Japan595.0 660.1 1,832.2 1,919.1 
ChinaChina289.1 264.1 796.2 706.2 China400.3 289.1 1,285.0 796.2 
Other foreign countriesOther foreign countries583.2 587.3 1,768.7 1,705.5 Other foreign countries689.4 583.2 1,936.7 1,768.7 
RevenueRevenue$5,740.6 $5,476.6 $17,099.8 $16,205.5 Revenue$6,772.8 $5,740.6 $20,318.5 $17,099.8 
Numbers may not add due to rounding.
(1) Revenue is attributed to the countries based on the location of the customer.
(2) U.S. revenue includes revenue in Puerto Rico.

Note 3: Acquisitions
In January 2021 and February 2020, and 2019, we completed the acquisitions of Prevail Therapeutics Inc. (Prevail) and Dermira, Inc. (Dermira) and Loxo Oncology, Inc. (Loxo), respectively. These transactions, as further discussed in this note below in Acquisitions of Businesses, were accounted for as business combinations under the acquisition method of accounting. Under this method, the assets acquired and liabilities assumed were recorded at their respective fair values as of the acquisition date in our consolidated condensed financial statements. The determination of estimated fair value required management to make significant estimates and assumptions. The excess of the purchase price over the fair value of the acquired net assets, where applicable, has been recorded as goodwill. The results of operations of these acquisitions are included in our consolidated condensed financial statements from the date of acquisition.
We also acquired assets in development which are further discussed in this note below in Asset Acquisitions. Upon each acquisition, the cost allocated to acquired in-process research and development (IPR&D) charges related to these compounds werewas immediately expensed because the compoundscompound had no alternative future use. We recognized acquired IPR&D charges of $174.0 million and $498.3 million for the three and nine months ended September 30, 2021, respectively, and $294.1 million for the nine months ended September 30, 2020. There were 0no acquired IPR&D charges recognized in the three months ended September 30, 2020. We recognized $294.1 million of acquired IPR&D charges for the nine months ended September 30, 2020. We recognized $77.7 million and $239.6 million of acquired IPR&D charges for the three and nine months ended September 30, 2019, respectively.
Acquisitions of Businesses
DermiraPrevail Acquisition
Overview of Transaction
In February 2020,January 2021, we acquired all shares of DermiraPrevail for a purchase price that included $22.50 per share in cash (or an aggregate of approximately $849.3$747.4 million, net of cash acquired. acquired) plus 1 non-tradable contingent value right (CVR) per share. The CVR entitles Prevail stockholders up to an additional $4.00 per share in cash (or an aggregate of approximately $160 million) payable, subject to certain terms and conditions, upon the first regulatory approval of a Prevail product in one of the following countries: U.S., Japan, United Kingdom, Germany, France, Italy or Spain. To achieve the full value of the CVR, such regulatory approval must occur by December 31, 2024. If such regulatory approval occurs after December 31, 2024, the value of the CVR will be reduced by approximately 8.3 cents per month until December 1, 2028, at which point the CVR will expire without payment.
Under the terms of the agreement, we acquired lebrikizumab,potentially disease-modifying AAV9-based gene therapies for patients with neurodegenerative diseases. The acquisition establishes a novel, investigational, monoclonal antibodynew modality for drug discovery and development, extending our research efforts through the creation of a gene therapy program that is being evaluatedanchored by Prevail’s portfolio of assets. The lead gene therapies in clinical development that we acquired were PR001 for the treatment of moderate-to-severe atopic dermatitis. Lebrikizumab waspatients with Parkinson’s disease with GBA1 mutations and neuronopathic Gaucher disease and PR006 for patients with frontotemporal dementia with GRN mutations. Both PR001 and PR006 were granted Fast Track designation from the U.S. Food and Drug Administration (FDA). We also acquired Qbrexza
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® (glycopyrronium) cloth, a medicated cloth approved by the FDA for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating).
Assets Acquired and Liabilities Assumed
Our access to DermiraPrevail information was limited prior to the acquisition. As a consequence, we are in the process of determining fair values and tax bases of a significant portion of the assets acquired and liabilities assumed, including the identification and valuation of intangible assets long-term debt, and tax exposures. The final determination of these amounts will be completed as soon as possible but no later than one year from the acquisition date. The final determination may result in asset and liability fair values and tax bases that differ from the preliminary estimates and require changes to the preliminary amounts recognized. Preliminary
The following table summarizes the preliminary amounts recognized for assets acquired and liabilities assumed as of the acquisition date:
Estimated Fair Value at January 22, 2021
Cash$90.5 
Acquired IPR&D(1)
824.0
Goodwill(2)
118.8
Deferred tax liabilities(98.0)
Other assets and liabilities, net(31.5)
Acquisition date fair value of consideration transferred903.8
Less:
     Cash acquired(90.5)
     Fair value of CVR liability(3)
(65.9)
Cash paid, net of cash acquired$747.4 
(1) Acquired IPR&D intangibles primarily relate to PR001.
(2) The goodwill recognized from this acquisition is not deductible for tax purposes.
(3) See Note 6 for a discussion on the estimation of the CVR liability.
Pro forma information has not been included as this acquisition did not have a material impact on our consolidated condensed statements of operations for the three and nine months ended September 30, 2021 and 2020.
Dermira Acquisition
Overview of Transaction
In February 2020, we acquired all shares of Dermira for a purchase price of approximately $849.3 million, net of cash acquired. Under the terms of the agreement, we acquired lebrikizumab, a novel, investigational, monoclonal antibody being evaluated for the treatment of moderate-to-severe atopic dermatitis. Lebrikizumab was granted Fast Track designation from the FDA. We also acquired Qbrexza® (glycopyrronium) cloth, a medicated cloth approved by the FDA for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating). During the nine months ended September 30, 2021, we sold the rights to Qbrexza. See Note 5 for additional information.
Assets Acquired and Liabilities Assumed
The fair values recognized related to the assets acquired and liabilities assumed in this acquisition included goodwill of $46.8$86.8 million, other intangibles of $1.24$1.20 billion primarily related to lebrikizumab, deferred income tax liabilities of $55.0$49.5 million, and long-term debt of $375.5 million. After the acquisition, we repaid $276.2 million of long-term debt assumed as part of our acquisition of Dermira.

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Loxo Acquisition
Overview of Transaction
In February 2019, we acquired all shares of Loxo for a purchase price of $6.92 billion, net of cash acquired. The accelerated vesting of Loxo employee equity awards was recognized as transaction expense included in asset impairment, restructuring, and other special charges during the nine months ended September 30, 2019 (see Note 6).
Under the terms of the agreement, we acquired a pipeline of investigational medicines, including selpercatinib (LOXO-292), an oral RET inhibitor, and LOXO-305, an oral BTK inhibitor. In the second quarter of 2020, the FDA approved selpercatinib (Retevmo®) under its Accelerated Approval regulations and continued approval may be
contingent upon verification and description of clinical benefit in confirmatory trials. At the time of approval, we reclassified our $4.60 billion intangible asset for selpercatinib (Retevmo) from indefinite-lived intangible assets to finite-lived intangible assets and began amortizing straight line over its estimated useful life.
Assets Acquired and Liabilities Assumed
The following table summarizes the amounts recognized for assets acquired and liabilities assumed in the acquisition of Loxo as of the acquisition date:
Estimated Fair Value at February 15, 2019
Acquired IPR&D (1)
$4,670.0 
Finite-lived intangibles (2)
980.0 
Deferred income taxes(1,032.8)
Other assets and liabilities - net(26.4)
Total identifiable net assets4,590.8 
Goodwill(3)
2,326.9 
Total consideration transferred - net of cash acquired$6,917.7 
(1)$4.60 billion of the acquired IPR&D relates to selpercatinib (LOXO-292).
(2)Contract-based intangibles (primarily related to Vitrakvi®) which are being amortized to cost of sales on a straight-line basis over their estimated useful lives, were expected to have a weighted average useful life of approximately 12 years from the acquisition date.
(3)The goodwill recognized from this acquisition is attributable primarily to future unidentified projects and products and the assembled workforce for Loxo and is not deductible for tax purposes.























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Asset Acquisitions
The following table and narrative summarizesummarizes our asset acquisitions during the nine months ended September 30, 20202021 and 2019:2020:
CounterpartyCompound(s) or TherapyAcquisition Month
Phase of Development (1)
Acquired IPR&D Expense
Precision Biosciences, Inc.Potential in vivo therapies for genetic disordersJanuary 2021Pre-clinical$107.8
Merus N.V.CD3-engaging T-cell re-directing bispecific antibodies for the potential treatment of cancerJanuary 2021Pre-clinical46.5
Asahi Kasei Pharma CorporationAK1780, an orally bioavailable P2X7 receptor antagonist for the potential treatment of chronic pain conditionsJanuary 2021Phase I20.0
Rigel Pharmaceuticals, Inc.R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for the potential treatment of autoimmune and inflammatory diseasesMarch 2021Phase I125.0
MiNA Therapeutics LimitedPre-clinical targets that could lead to potential new medicinesMay 2021Pre-clinical25.0
Protomer Technologies Inc.Glucose-sensing insulin programJuly 2021Pre-clinical57.3
Kumquat Biosciences Inc.Pre-clinical small molecules that stimulate tumor-specific immune responsesJuly 2021Pre-clinical55.0
Lycia Therapeutics, Inc.Several potential modalities across a spectrum of therapeutic areas and diseasesAugust 2021Pre-clinical35.0
ProQR Therapeutics N.V.Pre-clinical targets that could lead to potential new medicines for genetic disorders in the liver and nervous systemSeptember 2021Pre-clinical26.7
Sitryx Therapeutics LimitedPre-clinical targets that could lead to potential new medicines for autoimmune diseasesMarch 2020Pre-clinical$52.3 
AbCellera Biologics Inc. (AbCellera)(2)
Neutralizing antibodies for the treatment and prevention of COVID-19March 2020Pre-clinical25.0 
Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences)Neutralizing antibodies for the treatment and prevention of COVID-19May 2020Pre-clinical20.0 
UndisclosedPetra Pharma Corporation (Petra)
Pre-clinical targetMutant-selective PI3Kα inhibitor that could lead to potential new medicine
May 2020Pre-clinical174.8 
Evox Therapeutics Ltd.LimitedPre-clinical research collaborationtargets for the potential treatment of neurological disordersJune 2020Pre-clinical22.0 
AC Immune SATau aggregation inhibitor small molecules for the potential treatment of Alzheimer's disease and other neurodegenerative diseases
January 2019 & September 2019(3)
Pre-clinical$127.1 
ImmuNext, Inc.Novel immunometabolism targetMarch 2019Pre-clinical40.0 
Avidity Biosciences, Inc.Potential new medicines in immunology and other select indicationsApril 2019Pre-clinical25.0 
Centrexion Therapeutics CorporationCNTX-0290, a novel, small molecule somatostain receptor type 4 agonistJuly 2019Phase I47.5 
(1) The phase of development presented is as of the date of the arrangement and represents the phase of development of the most advanced asset acquired, where applicable.
(2) We recognized thean acquired IPR&D expense of $25.0 million in May 2020 upon closing of the transaction.
(3)We recognized acquired IPR&D expense of $96.9 million in January 2019 upon entering into a license agreement and $30.2 millionin September 2019 upon entering into an amendment to the license agreement.

In connection with these arrangements, our partners may be entitled to future royalties and/or commercial milestones based on sales should products be approved for commercialization and/or milestones based on the successful progress of compounds through the development process.
Subsequent Events
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In October 2020, we completed the global expansion of our strategic alliance for Tyvyt® (sintilimab injection) with Innovent Biologics, Inc. (Innovent). We and Innovent currently co-commercialize Tyvyt in China. Under the terms of the expanded license agreement, we obtained an exclusive license for Tyvyt for geographies outside of China and plan to pursue registration of Tyvyt in the U.S. and other markets. As a result of the transaction, we will record an acquired IPR&D charge of $200.0 million in the fourth quarter of 2020 associated with the upfront payment due to Innovent. Innovent will be eligible to receive up to $825.0 million in success-based regulatory and sales-based milestones, as well as tiered double digit royalties on net sales for geographies outside of China. Both companies will also retain the right to study Tyvyt in combination with other medicines as part of their own clinical programs.
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In October 2020, we acquired Disarm Therapeutics, Inc. (Disarm), a privately-held biotechnology company creating a new class of disease-modifying therapeutics for patients with axonal degeneration. Under the terms of the agreement, we acquired Disarm for an upfront payment of $135.0 million and up to $1.23 billion in additional future payments for potential development, success-based regulatory and sales-based milestones. The accounting impact of this acquisition and the results of the operations of Disarm will be included in our consolidated financial statements beginning in the fourth quarter of 2020.


Note 4: Collaborations and Other Arrangements
We often enter into collaborative and other similar arrangements to develop and commercialize drug candidates. Collaborative activities may include research and development, marketing and selling (including promotional activities and physician detailing), manufacturing, and distribution. These arrangements often require milestone andas well as royalty or profit-share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development, as well as expense reimbursements from or payments to the collaboration partner. See Note 2 for amounts of collaboration and other revenue recognized from these types of arrangements.
Operating expenses for costs incurred pursuant to these arrangements are reported in their respective expense line item, net of any payments due to or reimbursements due from our collaboration partners, with such reimbursements being recognized at the time the party becomes obligated to pay. Each collaboration is unique in nature, and our more significant arrangements are discussed below.
Boehringer Ingelheim Diabetes Collaboration
We and Boehringer Ingelheim have a global agreement to jointly develop and commercialize a portfolio of diabetes compounds. Currently included in the collaboration are Boehringer Ingelheim’s oral diabetes products: Trajenta, Jentadueto, Jardiance, Glyxambi, Synjardy, and Trijardy XR, Trajenta, and Jentadueto® as well as our basal insulin, Basaglar. Jentadueto is included in the Trajenta product family. Glyxambi, Synjardy, and Trijardy XR are included in the Jardiance product family. Jentadueto is included in the Trajenta product family.
The table below summarizes the net amount of significant milestones capitalized (deferred) capitalizedat September 30, 2021 and December 31, 2020 for the compounds included in this collaboration:
Product Family
Milestones
(Deferred) Capitalized (1)
Trajenta (2)
$446.4 
Jardiance (3)
289.0 
Basaglar(250.0)
Net Milestones Capitalized (Deferred) (1) as of:
Product FamilySeptember 30, 2021December 31, 2020
Jardiance (2)
$141.1 $156.2 
Trajenta (3)
95.1 114.6 
Basaglar(154.0)(168.0)
(1) In connection with the regulatory approvals of Basaglar inJardiance and Trajenta, milestone payments made were capitalized as intangible assets and are being amortized to cost of sales through the U.S., Europe, and Japan,term of the collaboration. In connection with the regulatory approvals of Basaglar, milestone payments received were recorded as contract liabilities and are being amortized through the term of the collaboration (2029) to collaboration and other revenue. In connection with the regulatory approvals of Trajenta and Jardiance, milestone payments made were capitalized as intangible assets and are being amortized to cost of sales through the term of the collaboration. This represents the cumulative amounts that have been capitalized (deferred) or capitalized from the start of this collaboration through the end of the reporting period.period, net of amount amortized.
(2)The collaboration agreement with Boehringer Ingelheim for Jardiance ends upon expiration of the compound patent and any supplementary protection certificates or extensions thereto.
(3) The collaboration agreement with Boehringer Ingelheim for Trajenta ends upon expiration of the compound patent and any supplementary protection certificates or extensions thereto.
(3) The collaboration agreement withFor the Jardiance product family, we and Boehringer Ingelheim for Jardiance ends upon expiration ofshare equally the compound patentongoing development and any supplementary protection certificates or extensions thereto.
Through December 31, 2019,commercialization costs in the most significant markets, and we and Boehringer Ingelheim shared equally the ongoing development costs, commercialization costs, and agreed upon gross margin for any product resulting from the collaboration. We recorded our portion of the gross margin associated with Boehringer Ingelheim's products as collaboration and other revenue. We recorded our sales of Basaglar to third parties as net product revenue with the payments made to Boehringer Ingelheim for their portion of the gross margin recorded as cost of sales. For all compounds under this collaboration, we recordedrecord our portion of the development and commercialization costs as research and development expense and marketing, selling, and administrative expense, respectively. Each company was entitled to potential performance payments depending on the sales of the molecules it contributes to the collaboration. These performance payments may have resulted in the owner of the molecule retaining a greater share of the agreed upon gross margin of that product. Subject to achieving these thresholds, in a given period, our reported revenue for Trajenta and Jardiance may have been reduced by any performance payments we made
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related to these products. Similarly, performance payments we may have received related to Basaglar effectively reduced Boehringer Ingelheim's share of the gross margin, which reduced our cost of sales.
Effective January 1, 2020, we and Boehringer Ingelheim modernized the alliance. In the most significant markets, we and Boehringer Ingelheim share equally the ongoing development costs and commercialization costs for the Jardiance product family. We receive a royalty on net sales of Boehringer Ingelheim's products in the most significant markets and recognize the royalty as collaboration and other revenue. Boehringer Ingelheim is entitled to potential performance payments depending on the net sales of the Jardiance product family; therefore, our reported revenue for Jardiance may be reduced by any potential performance payments we make related to this product family. Beginning January 1, 2021, the royalty received by us related to the Jardiance product family may also be increased or decreased depending on whether net sales for this product family exceed or fall below certain thresholds. We pay to Boehringer Ingelheim a royalty on net sales for Basaglar in the U.S. We record our sales of Basaglar to third parties as net product revenue with the royalty payments made to Boehringer Ingelheim recorded as cost of sales. For the Jardiance product family, we record our portion of the development and commercialization costs as research and development expense and marketing, selling, and administrative expense, respectively. Boehringer Ingelheim is entitled to potential performance payments depending on the net sales of the Jardiance product family; therefore, our reported revenue for Jardiance may be reduced by any potential performance payments we make related to this product. Beginning January 1, 2021, the royalty received by us related to the Jardiance product family may also be increased or decreased depending on whether net sales for this product family exceed or fall below certain thresholds.
The following table summarizes our net product revenue recognized with respect to Basaglar and collaboration and other revenue recognized with respect to the Jardiance and Trajenta families of products:products and our net product revenue recognized with respect to Basaglar:
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Product FamilyProduct Family2021202020212020
JardianceJardiance$390.4 $310.8 $1,058.9 $840.3 
BasaglarBasaglar$248.2 $263.2 $842.3 $805.4 Basaglar192.8 248.2 650.1 842.3 
Jardiance310.8 240.7 840.3 676.2 
TrajentaTrajenta91.7 155.5 261.7 441.4 Trajenta96.1 91.7 279.9 261.7 
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Olumiant
We have a worldwide license and collaboration agreement with Incyte Corporation (Incyte), which provides us the development and commercialization rights to its Janus tyrosine kinase (JAK) inhibitor compound, now known as Olumiant (baricitinib), and certain follow-on compounds, for the treatment of inflammatory and autoimmune diseases. In the first half of 2020, the agreement was amended to include the potential treatment of COVID-19. Incyte has the right to receive tiered, double digit royalty payments on future global net sales with rates ranging up to 20 percent. The agreement calls for payments by us to Incyte associated with certain development, success-based regulatory, and sales-based milestones. In 2020, the agreement was amended to include the treatment of COVID-19, with Incyte obtaining the right to receive an additional royalty ranging up to the low teens on global net sales for the treatment of COVID-19 that exceed a specified aggregate global net sales threshold.
In connection with the regulatory approvals of Olumiant in the U.S., Europe, and Japan, milestone payments of $180.0$210.0 million were capitalized as intangible assets as of September 30, 2021 and December 31, 2020 and are being amortized to cost of sales through the term of the collaboration. This represents the cumulative amounts that have been capitalized from the start of this collaboration through the end of theeach reporting period.
As of September 30, 2020,2021, Incyte is eligible to receive up to $130.0$100.0 million of additional payments from us contingent upon certain development and success-based regulatory milestones. Incyte is also eligible to receive up to $150.0 million of potential sales-based milestones.
We record our sales of Olumiant, including sales of baricitinib that were made pursuant to EUA, to third parties as net product revenue with the royalty payments made to Incyte recorded as cost of sales. The following table summarizes our net product revenue recognized with respect to Olumiant:
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Olumiant$162.0 $114.6 $446.7 $299.1 
Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Olumiant$406.9 $162.0 $809.1 $446.7 
COVID-19 antibodies
In 2020, we entered into a worldwide license and collaboration agreement with AbCellera to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19, including bamlanivimab, for which we hold development and commercialization rights. AbCellera has the right to receive tiered royalty payments on global net sales of bamlanivimab with percentages ranging in the mid-teens to mid-twenties. Royalty payments made to AbCellera are recorded as cost of sales.
In 2020, we entered into a license and collaboration agreement with Junshi Biosciences to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19, including etesevimab, for which we hold development and commercialization rights outside of mainland China and the Special Administrative Regions of Hong Kong and Macau, and for which Junshi Biosciences currently maintains all rights in mainland China and the Special Administrative Regions of Hong Kong and Macau. Junshi Biosciences has the right to receive royalty payments in the mid-teens on our net sales of etesevimab. Junshi Biosciences also has the right to receive certain development, success-based regulatory and sales-based milestones. In connection with the regulatory authorizations of etesevimab (for administration with bamlanivimab) as well as achievement of a sales-based milestone, milestone payments of $95.0 million were capitalized as intangible assets as of September 30, 2021 and are being amortized to cost of sales over the estimated useful life of etesevimab. As of September 30, 2021, Junshi Biosciences is eligible to receive up to $100.0 million of potential sales-based milestones.
Pursuant to EUAs, we recognized $217.1 million and $1.18 billion of net product revenue associated with our sales of our COVID-19 antibodies during the three and nine months ended September 30, 2021, respectively.
Sintilimab Injection
We have a collaboration agreement with Innovent Biologics, Inc. (Innovent) to jointly develop and commercialize sintilimab injection in China, where it is branded and trademarked as Tyvyt. In 2019, we and Innovent began co-commercializing Tyvyt in China. In 2020, we obtained an exclusive license for sintilimab injection from Innovent for geographies outside of China. Innovent, with collaboration from us, has filed the initial registration of sintilimab injection in the U.S., and we will pursue initial registration of sintilimab injection in other markets and all other subsequent registrations of sintilimab injection. We have exclusive commercialization rights outside of China.
In connection with a regulatory approval for Tyvyt in China in the second quarter of 2021, we capitalized a milestone payment of $40.0 million as an intangible asset which is being amortized to cost of sales through the term of the collaboration.
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As of September 30, 2021, Innovent is eligible to receive up to $825.0 million for geographies outside of China and up to $195.0 million in China in success-based regulatory and sales-based milestones. Innovent is also eligible to receive tiered double digit royalties on net sales for geographies outside of China.
We record our sales of Tyvyt to third parties as net product revenue, with payments made to Innovent for its portion of the gross margin reported as cost of sales. We report as collaboration and other revenue our portion of the gross margin for Tyvyt sales made by Innovent to third parties. The following table summarizes our revenue recognized in China with respect to Tyvyt:
Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Tyvyt$125.6 $84.4 $340.2 $205.9 
Tanezumab
We have a collaboration agreement with Pfizer Inc. (Pfizer) to jointly develop and globally commercialize tanezumab for the treatment of osteoarthritis pain and cancer pain. The companies equally shareIn October 2021, we and Pfizer discontinued the ongoingglobal clinical development costsprogram of tanezumab for the treatment of osteoarthritis pain and if successful, incancer pain following the U.S. will co-commercialize and equally share in gross margin and certain commercialization expenses. Asreceipt of a result of an amendment to the agreement in the third quarter of 2020, Pfizer will be responsible for commercialization activities and costs outside the U.S., and Lilly has the right to receive tiered royalties in percentagesComplete Response Letter from the high teens to mid-twentiesFDA and a negative opinion from the European Medicines Agency's Committee for net sales in Japan as well as low double digit
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royalties on annual net sales greater than $150.0 million in all other territories outside of the U.S. and Japan. As of September 30, 2020, Pfizer is eligible to receive up to $147.5 million in success-based regulatory milestones based on current development plans and up to $1.23 billion in a series of sales-based milestones, contingent upon the commercial success of tanezumab.Medicinal Products for Human Use.
Lebrikizumab
As a result of our acquisition of Dermira, we have a worldwide licensing agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc. (collectively Roche), which provides us the global development and commercialization rights to lebrikizumab. Roche has the right to receive tiered royalty payments on future global net sales ranging in percentages from high single digits to high teens if the product is successfully commercialized. As of September 30, 2020,2021, Roche is eligible to receive up to $180.0 million of payments from us contingent upon the achievement of success-based regulatory milestones and up to $1.03 billion in a series of sales-based milestones, contingent upon the commercial success of lebrikizumab.
As a result of our acquisition of Dermira, we have a license agreement with Almirall, S.A. (Almirall), under which Almirall licensed the rights to develop and commercialize lebrikizumab for the treatment or prevention of dermatology indications, including, but not limited to, atopic dermatitis in Europe. We have the right to receive tiered royalty payments on future net sales in Europe ranging in percentages from low double digits to low twenties if the product is successfully commercialized. As of September 30, 2020,2021, we are eligible to receive additional payments of $85.0 million from Almirall contingent upon the achievement of success-based regulatory milestones and up to $1.25 billion in a series of sales-based milestones, contingent upon the commercial success of lebrikizumab.
As of September 30, 2021 and December 31, 2020, $36.2$15.3 million wasand $29.7 million, respectively, were recorded as a contract liabilityliabilities on the consolidated condensed balance sheetsheets and isare expected to be recognized as collaboration and other revenue over the remaining Phase III development period. During the three and nine months ended September 30, 2021 and 2020, milestones received and collaboration and other revenue recognized were not material.

Petra
Note 5: Discontinued Operations
On March 11, 2019, we completed the disposition of our remaining 80.2 percent ownership of Elanco Animal Health (Elanco) common stock through a tax-free exchange offer. As a result of our acquisition of Petra, we have presented Elanco as discontinued operations in our consolidated condensed financial statements for all periods presented.
Revenue and net income from discontinued operations forare required to make milestone payments to Petra shareholders contingent upon the nine months ended September 30, 2019 were $580.0 million and $3.68 billion, respectively. Net income from discontinued operations for the nine months ended September 30, 2019 included an approximate $3.7 billion gain relatedoccurrence of certain future events linked to the dispositionsuccess of Elanco.
The gain related to the dispositionmutant-selective PI3Kα inhibitor. Our more significant, near term milestones include a development milestone of Elancoapproximately $205 million in the consolidated condensed statement2022 contingent upon initiation of cash flows included the operating resultsits Phase I trial and a further development milestone of Elanco through the disposition date, which were not material. Net cash flowsapproximately $164 million in 2023 contingent upon achieving clinical proof of our discontinued operations for operating and investing activities for the nine months ended September 30, 2019 were not material.
We entered into a transitional services agreement (TSA) with Elanco in order to facilitate the orderly transfer of various services to Elanco. The TSA relates primarily to administrative services, which are generally to be provided over 24 months from March 11, 2019, the disposition date. This agreement is not material and does not confer upon us the ability to influence the operating and/or financial policies of Elanco subsequent to the disposition date.concept.
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Note 6:5: Asset Impairment, Restructuring, and Other Special Charges
The components of the charges included in asset impairment, restructuring, and other special charges in our consolidated condensed statements of operations are described below.
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
20202019202020192021202020212020
SeveranceSeverance$144.4 $$154.2 $(3.6)Severance$ $144.4 $11.5 $154.2 
Asset impairment (recovery) and other special chargesAsset impairment (recovery) and other special charges(43.0)7.1 427.5 Asset impairment (recovery) and other special charges (43.0)200.1 7.1 
Total asset impairment, restructuring, and other special chargesTotal asset impairment, restructuring, and other special charges$101.4 $$161.3 $423.9 Total asset impairment, restructuring, and other special charges$ $101.4 $211.6 $161.3 

Asset impairment, restructuring, and other special charges recognized during the nine months ended September 30, 2021 were primarily related to an intangible asset impairment of $108.1 million resulting from the sale of the rights to Qbrexza, as well as acquisition and integration costs associated with the acquisition of Prevail.
Severance costs recognized during the three and nine months ended September 30, 2020 were incurred as a result of actions taken worldwide to reduce our cost structure. Substantially all of the severance costs incurred during the three and nine months ended September 30, 2020 are expectedhave been paid.
We recognized a net inventory impairment charge related to be paid in the next 12 months.
Asset impairment and other special charges recognizedour COVID-19 antibodies of $435.1 million during the nine months ended September 30, 2019consisted2021 in cost of $400.7 million relatedsales in our consolidated condensed statements of operations. As part of our response to the acquisitionCOVID-19 pandemic, and at the request of Loxo, substantially allthe U.S. and international governments, we invested in large-scale manufacturing of which was associatedCOVID-19 antibodies at risk, in order to ensure rapid access to patients around the world. As the COVID-19 pandemic has continued to evolve during 2021, we incurred a net inventory impairment charge primarily due to the combination of changes to current and forecasted demand from U.S. and international governments, including changes to our agreement with the accelerated vestingU.S. government, and near-term expiry dates of Loxo employee equity awards.COVID-19 antibodies.

Note 7:6: Financial Instruments
Financial instruments that potentially subject us to credit risk consist principally of trade receivables and interest-bearing investments. Wholesale distributors of life science products account for a substantial portion of our trade receivables; collateral is generally not required. We seek to mitigate the risk associated with this concentration through our ongoing credit-review procedures and insurance. A large portion of our cash is held by a few major financial institutions. We monitor our exposures with these institutions and do not expect any of these institutions to fail to meet their obligations. In accordance with documented corporate risk-management policies, we monitor the amount of credit exposure to any one financial institution or corporate issuer. We are exposed to credit-related losses in the event of nonperformance by counterparties to risk-management instruments but do not expect any counterparties to fail to meet their obligations given their high credit ratings.
We consider all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. The cost of these investments approximates fair value.
Our equity investments are accounted for using three different methods depending on the type of equity investment:
Investments in companies over which we have significant influence but not a controlling interest are accounted for using the equity method, with our share of earnings or losses reported in other-net, (income) expense.
For equity investments that do not have readily determinable fair values, we measure these investments at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. Any change in recorded value is recorded in other-net, (income) expense.
Our public equity investments are measured and carried at fair value. Any change in fair value is recognized in other-net, (income) expense.
We review equity investments other than public equity investments for indications of impairment and observable price changes on a regular basis.
21


Our derivative activities are initiated within the guidelines of documented corporate risk-management policies and are intended to offset losses and gains on the assets, liabilities, and transactions being hedged. Management reviews the correlation and effectiveness of our derivatives on a quarterly basis.
For derivative instruments that are designated and qualify as fair value hedges, the derivative instrument is marked to market, with gains and losses recognized currently in income to offset the respective losses and gains recognized on the underlying exposure. For derivative instruments that are designated and qualify as cash flow hedges, gains and losses are reported as a component of accumulated other comprehensive loss and reclassified into earnings in
20


the same period the hedged transaction affects earnings. For derivative and non-derivative instruments that are designated and qualify as net investment hedges, the foreign currency translation gains or losses due to spot rate fluctuations are reported as a component of accumulated other comprehensive loss. Derivative contracts that are not designated as hedging instruments are recorded at fair value with the gain or loss recognized in earnings during the period of change.
We may enter into foreign currency forward or option contracts to reduce the effect of fluctuating currency exchange rates (principally the euro, British pound, and Japanese yen). Foreign currency derivatives used for hedging are put in place using the same or like currencies and duration as the underlying exposures. Forward and option contracts are principally used to manage exposures arising from subsidiary trade and loan payables and receivables denominated in foreign currencies. These contracts are recorded at fair value with the gain or loss recognized in other–net, (income) expense. We may enter into foreign currency forward and option contracts and currency swaps as fair value hedges of firm commitments. Forward contracts generally have maturities not exceeding 12 months. At September 30, 2020,2021, we had outstanding foreign currency forward commitments to purchase 367.5707.3 million U.S. dollars and sell 312.3604.5 million euro, commitments to purchase 2.562.54 billion euro and sell 3.012.98 billion U.S. dollars, commitments to purchase 302.3151.6 million U.S. dollars and sell 31.81980.0 million Chinese yuan, commitments to purchase 144.7 million U.S. dollars and sell 16.13 billion Japanese yen, and commitments to purchase 226.2155.5 million British pounds and sell 290.7212.6 million U.S. dollars, which will all settlehave settlement dates within 30180 days.
Foreign currency exchange risk is also managed through the use of foreign currency debt and cross-currency interest rate swaps. Our foreign currency-denominated notes had carrying amounts of $5.74$8.08 billion and $5.49$6.02 billion as of September 30, 20202021 and December 31, 2019,2020, respectively, of which $4.29$5.95 billion and $4.10$4.50 billion have been designated as, and are effective as, economic hedges of net investments in certain of our euro-denominated foreign operations as of September 30, 20202021 and December 31, 2019,2020, respectively. At September 30, 2020,2021, we had outstanding cross currencycross-currency swaps with notional amounts of $3.16$2.69 billion swapping U.S. dollars to euro and $1.00 billion swapping Swiss francs to U.S. dollars which have settlement dates ranging through 2028. Our cross-currency interest rate swaps, for which a majority convert a portion of our U.S. dollar-denominated floating ratefixed-rate debt to foreign-denominated floating ratefixed-rate debt, have also been designated as, and are effective as, economic hedges of net investments.
In the normal course of business, our operations are exposed to fluctuations in interest rates which can vary ourthe costs of financing, investing, and operating. We seek to address a portion of these risks through a controlled program of risk management that includes the use of derivative financial instruments. The objective of controlling these risks is to limit the impact of fluctuations in interest rates on earnings. Our primary interest-rate risk exposure results from changes in short-term U.S. dollar interest rates. In an effort to manage interest-rate exposures, we strive to achieve an acceptable balance between fixed- and floating-rate debt and investment positions and may enter into interest rate swaps or collars to help maintain that balance.
Interest rate swaps or collars that convert our fixed-rate debt to a floating rate are designated as fair value hedges of the underlying instruments. Interest rate swaps or collars that convert floating-rate debt to a fixed rate are designated as cash flow hedges. Interest expense on the debt is adjusted to include the payments made or received under the swap agreements. Cash proceeds from or payments to counterparties resulting from the termination of interest rate swaps are classified as operating activities in our consolidated condensed statements of cash flows. At September 30, 2020,2021, substantially all of our total long-term debt is at a fixed rate. We have converted approximately 912 percent of our long-term fixed-rate notes to floating rates through the use of interest rate swaps.
We also may enter into forward-starting interest rate swaps, which we designate as cash flow hedges, as part of any anticipated future debt issuances in order to reduce the risk of cash flow volatility from future changes in interest rates. The change in fair value of these instruments is recorded as part of other comprehensive income (loss), and upon completion of a debt issuance and termination of the swap, is amortized to interest expense over the life of the underlying debt. As of September 30, 2020,2021, the total notional amounts of forward-starting interest rate contracts in designated cash flow hedging instruments were $1.75 billion, which have settlement dates ranging between 2023 and 2025.
22


In May 2020,September 2021, we issued $1.00 billioneuro-denominated notes consisting of 2.25 percent fixed-rate notes due in May 2050, with interest to be paid semi-annually. We used the net proceeds from the sale of these notes for general corporate purposes, including the repayment of outstanding commercial paper.
In August 2020, we issued $850.0€600.0 million of 2.500.50 percent fixed-rate notes due in September 20602033, with interest to be paid annually. The net proceeds from the offering will be used to fund, in whole or in part, eligible projects designed to advance one or more of our environmental, social, and an additional $250.0governance objectives.
In September 2021, we issued euro-denominated notes consisting of €500.0 million of our 2.251.125 percent fixed-rate notes due in May 2050,September 2051 and €700.0 million of 1.375 percent fixed-rate notes due in September 2061, with interest to be paid semi-annually.annually, and British pound-denominated notes consisting of £250.0 million of 1.625 percent fixed-rate notes due in September 2043, with interest to be paid annually. We paid $1.91 billion of the net cash proceeds from the offering to purchase and redeem certain higher interest rate U.S. dollar-denominated notes with an aggregate principal amount of $1.50 billion, resulting in a debt extinguishment loss of $405.2 million. This loss was included in other-net, (income) expense in our consolidated statement of operations during the three and nine months ended September 30, 2021. The $1.50 billion principal amount of higher interest rate U.S. dollar-denominated notes that were redeemed primarily included $541.8 million of 3.95 percent notes due 2049, $408.7 million of 4.15 percent notes due 2059, and $219.4 million of 3.375 percent notes due 2029. We used the remaining net proceeds from the sale of these notesoffering to prefund certain 2022 debt maturities and for general corporate purposes, including the repayment of outstanding commercial paper.
21


purposes.
The Effect of Risk-Management Instruments on the Consolidated Condensed Statements of Operations
The following effects of risk-management instruments were recognized in other–net, (income) expense:
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Fair value hedges:
Effect from hedged fixed-rate debt$(14.0)$49.5 $110.4 $148.1 
Effect from interest rate contracts14.0 (49.5)(110.4)(148.1)
Cash flow hedges:
Effective portion of losses on interest rate contracts reclassified from accumulated other comprehensive loss4.1 2.8 12.3 10.6 
Cross-currency interest rate swaps(30.2)47.4 (54.6)2.9 
Net (gains) losses on foreign currency exchange contracts not designated as hedging instruments(54.2)52.6 (82.8)93.0 
Total$(80.3)$102.8 $(125.1)$106.5 

Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Fair value hedges:
Effect from hedged fixed-rate debt$(10.1)$(14.0)$(60.5)$110.4 
Effect from interest rate contracts10.1 14.0 60.5 (110.4)
Cash flow hedges:
Effective portion of losses on interest rate contracts reclassified from accumulated other comprehensive loss4.2 4.1 12.5 12.3 
Cross-currency interest rate swaps10.0 (30.2)58.1 (54.6)
Net (gains) losses on foreign currency exchange contracts not designated as hedging instruments50.8 (54.2)110.6 (82.8)
Total$65.0 $(80.3)$181.2 $(125.1)
During the three and nine months ended September 30, 20202021 and 2019,2020, the amortization of losses related to the portion of our risk management hedging instruments, fair value hedges, and cash flow hedges that was excluded from the assessment of effectiveness was not material.
23


The Effect of Risk-Management Instruments on Other Comprehensive Income (Loss)
The effective portion of risk-management instruments that was recognized in other comprehensive income (loss) is as follows:
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Net investment hedges:
    Foreign currency-denominated notes$(181.1)$89.3 $(186.0)$112.6 
    Cross-currency interest rate swaps(110.4)89.0 (55.4)123.1 
Cash flow hedges:
    Forward-starting interest rate swaps99.6 (32.7)(231.9)(44.4)
    Cross-currency interest rate swaps6.6 16.6 (58.3)(20.8)

Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Net investment hedges:
    Foreign currency-denominated notes$119.0 $(181.1)$268.8 $(186.0)
    Cross-currency interest rate swaps66.7 (110.4)170.8 (55.4)
Cash flow hedges:
    Forward-starting interest rate swaps19.4 99.6 149.3 (231.9)
    Cross-currency interest rate swaps3.1 6.6 22.5 (58.3)
During the next 12 months, we expect to reclassify $16.7$16.4 million of pretax net losses on cash flow hedges from accumulated other comprehensive loss to other–net, (income) expense. During the three and nine months ended September 30, 20202021 and 2019,2020, the amounts excluded from the assessment of hedge effectiveness recognized in other comprehensive income (loss) were not material.

22
24


Fair Value of Financial Instruments
The following tables summarize certain fair value information at September 30, 20202021 and December 31, 20192020 for assets and liabilities measured at fair value on a recurring basis, as well as the carrying amount and amortized cost of certain other investments: 
  Fair Value Measurements Using    Fair Value Measurements Using 
Carrying
Amount
Cost (1)
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant Other
Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Fair
Value
Carrying
Amount
Cost (1)
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant Other
Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Fair
Value
September 30, 2020
September 30, 2021September 30, 2021
Cash equivalentsCash equivalents$2,374.2 $2,374.2 $2,374.2 $0 $0 $2,374.2 Cash equivalents$2,373.8 $2,373.8 $2,373.8 $ $ $2,373.8 
Short-term investments:Short-term investments:Short-term investments:
U.S. government and agency securitiesU.S. government and agency securities$11.8 $11.7 $11.8 $0 $0 $11.8 U.S. government and agency securities$11.3 $11.1 $11.3 $ $ $11.3 
Corporate debt securitiesCorporate debt securities5.5 5.5 0 5.5 0 5.5 Corporate debt securities6.8 6.7  6.8 — 6.8 
Mortgage-backed securitiesMortgage-backed securities0.2 0.2  0.2  0.2 
Asset-backed securitiesAsset-backed securities3.6 3.6 0 3.6 0 3.6 Asset-backed securities3.3 3.2  3.3  3.3 
Other securitiesOther securities14.1 14.1 0 0 14.1 14.1 Other securities15.5 15.5 6.6  8.9 15.5 
Short-term investmentsShort-term investments$35.0 Short-term investments$37.1 
Noncurrent investments:Noncurrent investments:Noncurrent investments:
U.S. government and agency securitiesU.S. government and agency securities$73.2 $68.5 $73.2 $0 $0 $73.2 U.S. government and agency securities$129.9 $129.0 $129.9 $ $ $129.9 
Corporate debt securitiesCorporate debt securities137.5 128.0 0 137.5 0 137.5 Corporate debt securities219.7 215.0  219.7  219.7 
Mortgage-backed securitiesMortgage-backed securities104.3 99.2 0 104.3 0 104.3 Mortgage-backed securities110.7 107.9  110.7  110.7 
Asset-backed securitiesAsset-backed securities25.4 24.8 0 25.4 0 25.4 Asset-backed securities19.7 19.6  19.7  19.7 
Other securitiesOther securities97.8 31.4 0 0 97.8 97.8 Other securities105.6 21.6   105.6 105.6 
Marketable equity securitiesMarketable equity securities1,258.4 275.2 1,258.4 0 0 1,258.4 Marketable equity securities1,482.8 420.5 1,482.8   1,482.8 
Equity investments without readily determinable fair values (2)
Equity investments without readily determinable fair values (2)
339.5 
Equity investments without readily determinable fair values (2)
556.3 
Equity method investments (2)
Equity method investments (2)
440.1 
Equity method investments (2)
725.8 
Noncurrent investmentsNoncurrent investments$2,476.2 Noncurrent investments$3,350.5 
December 31, 2019
December 31, 2020December 31, 2020
Cash equivalentsCash equivalents$1,025.4 $1,025.4 $1,025.4 $$$1,025.4 Cash equivalents$2,097.9 $2,097.9 $2,097.9 $— $— $2,097.9 
Short-term investments:Short-term investments:Short-term investments:
U.S. government and agency securitiesU.S. government and agency securities$7.2 $7.2 $7.2 $$$7.2 U.S. government and agency securities$9.9 $9.9 $9.9 $— $— $9.9 
Corporate debt securitiesCorporate debt securities81.4 81.1 81.4 81.4 Corporate debt securities2.8 2.8 — 2.8 — 2.8 
Asset-backed securitiesAsset-backed securities2.6 2.6 2.6 2.6 Asset-backed securities1.2 1.2 — 1.2 — 1.2 
Other securitiesOther securities9.8 9.8 9.8 9.8 Other securities10.3 10.3 — — 10.3 10.3 
Short-term investmentsShort-term investments$101.0 Short-term investments$24.2 
Noncurrent investments:Noncurrent investments:Noncurrent investments:
U.S. government and agency securitiesU.S. government and agency securities$77.2 $76.3 $77.2 $$$77.2 U.S. government and agency securities$78.7 $74.3 $78.7 $— $— $78.7 
Corporate debt securitiesCorporate debt securities271.1 267.8 271.1 271.1 Corporate debt securities137.0 126.8 — 137.0 — 137.0 
Mortgage-backed securitiesMortgage-backed securities101.1 99.6 101.1 101.1 Mortgage-backed securities106.4 101.4 — 106.4 — 106.4 
Asset-backed securitiesAsset-backed securities30.0 29.6 30.0 30.0 Asset-backed securities24.3 23.7 — 24.3 — 24.3 
Other securitiesOther securities60.0 27.4 60.0 60.0 Other securities110.5 31.8 — — 110.5 110.5 
Marketable equity securitiesMarketable equity securities718.6 254.4 718.6 718.6 Marketable equity securities1,664.2 311.6 1,664.2 — — 1,664.2 
Equity investments without readily determinable fair values (2)
Equity investments without readily determinable fair values (2)
405.0 
Equity investments without readily determinable fair values (2)
373.9 
Equity method investments (2)
Equity method investments (2)
299.4 
Equity method investments (2)
471.8 
Noncurrent investmentsNoncurrent investments$1,962.4 Noncurrent investments$2,966.8 
(1) For available-for-sale debt securities, amounts disclosed represent the securities' amortized cost.
(2) Fair value disclosures are not applicable for equity method investments and investments accounted for under the measurement alternative for equity investments.
2325


  Fair Value Measurements Using 
Carrying
Amount
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant
Other Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Fair
Value
Short-term commercial paper borrowings
September 30, 2020$(579.9)$0 $(578.8)$0 $(578.8)
December 31, 2019(1,494.2)(1,491.6)(1,491.6)
Long-term debt, including current portion
September 30, 2020$(16,342.2)$0 $(16,148.2)$0 $(16,148.2)
December 31, 2019(13,823.0)(15,150.0)(15,150.0)
  Fair Value Measurements Using 
Carrying
Amount
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant
Other Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Fair
Value
Long-term debt, including current portion
September 30, 2021$(17,085.4)$ $(18,354.9)$ $(18,354.9)
December 31, 2020(16,595.3)— (19,038.9)— (19,038.9)
2426


 Fair Value Measurements Using   Fair Value Measurements Using 
Carrying
Amount
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant
Other Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Fair
Value
Carrying
Amount
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant
Other Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Fair
Value
September 30, 2020
September 30, 2021September 30, 2021
Risk-management instruments:Risk-management instruments:Risk-management instruments:
Interest rate contracts designated as fair value hedges:Interest rate contracts designated as fair value hedges:Interest rate contracts designated as fair value hedges:
Other receivablesOther receivables$8.5 $ $8.5 $ $8.5 
Other noncurrent assetsOther noncurrent assets$182.4 $0 $182.4 $0 $182.4 Other noncurrent assets87.2 $ 87.2 $ 87.2 
Other noncurrent liabilitiesOther noncurrent liabilities(2.2) (2.2) (2.2)
Interest rate contracts designated as cash flow hedges:Interest rate contracts designated as cash flow hedges:Interest rate contracts designated as cash flow hedges:
Other noncurrent assetsOther noncurrent assets21.1 0 21.1 0 21.1 Other noncurrent assets77.3  77.3  77.3 
Other noncurrent liabilities(201.8)0 (201.8)0 (201.8)
Cross-currency interest rate contracts designated as net investment hedges:Cross-currency interest rate contracts designated as net investment hedges:Cross-currency interest rate contracts designated as net investment hedges:
Other receivablesOther receivables2.2 0 2.2 0 2.2 Other receivables18.7  18.7  18.7 
Other noncurrent assetsOther noncurrent assets34.1 0 34.1 0 34.1 Other noncurrent assets38.7  38.7  38.7 
Other current liabilitiesOther current liabilities(30.3)0 (30.3)0 (30.3)Other current liabilities(17.0) (17.0) (17.0)
Other noncurrent liabilitiesOther noncurrent liabilities(43.6)0 (43.6)0 (43.6)Other noncurrent liabilities(9.5) (9.5) (9.5)
Cross-currency interest rate contracts designated as cash flow hedges:Cross-currency interest rate contracts designated as cash flow hedges:Cross-currency interest rate contracts designated as cash flow hedges:
Other noncurrent assetsOther noncurrent assets5.5  5.5  5.5 Other noncurrent assets10.8  10.8  10.8 
Other noncurrent liabilitiesOther noncurrent liabilities(26.4)0 (26.4)0 (26.4)Other noncurrent liabilities(23.0) (23.0) (23.0)
Foreign exchange contracts not designated as hedging instruments:Foreign exchange contracts not designated as hedging instruments:Foreign exchange contracts not designated as hedging instruments:
Other receivablesOther receivables8.5 0 8.5 0 8.5 Other receivables5.5  5.5  5.5 
Other current liabilitiesOther current liabilities(16.4)0 (16.4)0 (16.4)Other current liabilities(25.7) (25.7) (25.7)
Contingent consideration liability:Contingent consideration liability:
Other noncurrent liabilitiesOther noncurrent liabilities(70.7)  (70.7)(70.7)
December 31, 2019
December 31, 2020December 31, 2020
Risk-management instruments:Risk-management instruments:Risk-management instruments:
Interest rate contracts designated as fair value hedges:Interest rate contracts designated as fair value hedges:Interest rate contracts designated as fair value hedges:
Other noncurrent assetsOther noncurrent assets72.0 72.0 72.0 Other noncurrent assets158.9 — 158.9 — 158.9 
Interest rate contracts designated as cash flow hedges:Interest rate contracts designated as cash flow hedges:Interest rate contracts designated as cash flow hedges:
Other noncurrent assetsOther noncurrent assets43.3 43.3 43.3 Other noncurrent assets38.1 — 38.1 — 38.1 
Other noncurrent liabilitiesOther noncurrent liabilities(97.8)— (97.8)— (97.8)
Cross-currency interest rate contracts designated as net investment hedges:Cross-currency interest rate contracts designated as net investment hedges:Cross-currency interest rate contracts designated as net investment hedges:
Other noncurrent assets45.1 45.1 45.1 
Other current liabilitiesOther current liabilities(21.4)(21.4)(21.4)Other current liabilities(92.6)— (92.6)— (92.6)
Other noncurrent liabilitiesOther noncurrent liabilities(5.7)(5.7)(5.7)Other noncurrent liabilities(97.2)— (97.2)— (97.2)
Cross-currency interest rate contracts designated as cash flow hedges:Cross-currency interest rate contracts designated as cash flow hedges:Cross-currency interest rate contracts designated as cash flow hedges:
Other noncurrent assetsOther noncurrent assets3.0 3.0 3.0 Other noncurrent assets34.4 — 34.4 — 34.4 
Other noncurrent liabilitiesOther noncurrent liabilities(20.1)(20.1)(20.1)Other noncurrent liabilities(2.9)— (2.9)— (2.9)
Foreign exchange contracts not designated as hedging instruments:Foreign exchange contracts not designated as hedging instruments:Foreign exchange contracts not designated as hedging instruments:
Other receivablesOther receivables18.4 18.4 18.4 Other receivables41.1 — 41.1 — 41.1 
Other current liabilitiesOther current liabilities(11.9)(11.9)(11.9)Other current liabilities(15.2)— (15.2)— (15.2)
2527


Risk-management instruments above are disclosed on a gross basis. There are various rights of setoff associated with certain of the risk-management instruments above that are subject to enforceable master netting arrangements or similar agreements. Although various rights of setoff and master netting arrangements or similar agreements may exist with the individual counterparties to the risk-management instruments above, individually, these financial rights are not material.
We determine our Level 1 and Level 2 fair value measurements based on a market approach using quoted market values, significant other observable inputs for identical or comparable assets or liabilities, or discounted cash flow analyses. Level 3 fair value measurements for other investment securities are determined using unobservable inputs, including the investments' cost adjusted for impairments and price changes from orderly transactions. The fairFair values ofare not readily available for certain equity method investments and investments measured under the measurement alternative for equity investments that do not have readily determinable fair values are not readily available.alternative. As of September 30, 2020,2021, we had approximately $615$781 million of unfunded commitments to invest in venture capital funds, which we anticipate will be paid over a period of up to 10 years.
Contingent consideration liability relates to our liability arising in connection with the CVR issued as a result of the Prevail acquisition. The fair value of the CVR liability was estimated using a discounted cash flow analysis and Level 3 inputs, including projections representative of a market participant's view of the expected cash payment associated with the first potential regulatory approval of a Prevail compound in the applicable countries based on probabilities of technical success, timing of the potential approval events for the compounds, and an estimated discount rate. See Note 3 for additional information related to the CVR arrangement.
The table below summarizes the contractual maturities of our investments in debt securities measured at fair value as of September 30, 2020:2021:
 Maturities by Period
  TotalLess Than
1 Year
1-5
Years
6-10
Years
More Than
10 Years
Fair value of debt securities$361.2 $20.9 $110.2 $94.0 $136.1 

 Maturities by Period
  TotalLess Than
1 Year
1-5
Years
6-10
Years
More Than
10 Years
Fair value of debt securities$501.6 $21.6 $157.8 $153.4 $168.8 
The net gains (losses) recognized in our consolidated condensed statements of operations for equity securities were $142.5$(246.8) million and $884.7$270.1 million for the three and nine months ended September 30, 2020,2021, respectively, and $26.4$141.7 million and $182.4$905.1 million for the three and nine months ended September 30, 2019,2020, respectively. The net gains/losses recognized during the three and nine months ended September 30, 20202021 and 20192020 on equity securities sold during the respective periods were not material.
We adjust our equity investments without readily determinable fair values based upon changes in the equity instruments' values resulting from observable price changes in orderly transactions for an identical or similar investment of the same issuer. Downward adjustments resulting from an impairment are recorded based upon impairment considerations, including the financial condition and near term prospects of the issuer, general market conditions, and industry specific factors. Adjustments recorded during the three and nine months ended September 30, 20202021 and 20192020 were not material.
A summary of the amount of unrealized gains and losses in accumulated other comprehensive loss and the fair value of available-for-sale securities in an unrealized gain or loss position and the amount of unrealized gains and losses in accumulated other comprehensive loss follows: 
September 30, 2020December 31, 2019
Unrealized gross gains$20.8 $10.3 
Unrealized gross losses0.8 4.0 
Fair value of securities in an unrealized gain position335.4 429.5 
Fair value of securities in an unrealized loss position25.7 141.1 

September 30, 2021December 31, 2020
Unrealized gross gains$12.5 $20.9 
Unrealized gross losses4.0 0.5 
Fair value of securities in an unrealized gain position293.4 348.9 
Fair value of securities in an unrealized loss position208.1 11.4 
We periodically assess our investment in available-for-sale securities for other-than-temporary impairment losses. Other-than-temporary impairment losses were not material in the three and nine months ended September 30, 2020 and 2019.
For debt securities, thecredit losses. The amount of credit losses are determined by comparing the difference between the present value of future cash flows expected to be collected on these securities and the amortized cost. Factors considered in assessing credit losses include the position in the capital structure, vintage and amount of collateral, delinquency rates, current credit support, and geographic concentration. CreditImpairment and credit losses related to debtavailable-for-sale securities were not material infor the three and nine months ended September 30, 2021 and 2020.
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As of September 30, 2020,2021, the available-for-sale securities in an unrealized loss position include primarily fixed-rate debt securities of varying maturities, which are sensitive to changes in the yield curve and other market conditions. Approximately 9497 percent of the fixed-rate debt securities in a loss position are investment-grade debt securities. As of September 30, 2020,2021, we do not intend to sell, and it is not more likely than not that we will be required to sell, the
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securities in a loss position before the market values recover or the underlying cash flows have been received, and there is no indication of default on interest or principal payments for any of our debt securities.
Activity related to our available-for-sale securities was as follows:
 Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Proceeds from sales$14.0 $46.5 $246.8 $365.9 
Realized gross gains on sales0.4 0.9 4.0 4.7 
Realized gross losses on sales0.2 8.2 2.0 

 Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Proceeds from sales$49.6 $14.0 $137.3 $246.8 
Realized gross gains on sales0.4 0.4 2.2 4.0 
Realized gross losses on sales0.3 0.2 1.1 8.2 
Realized gains and losses on sales of available-for-sale investments are computed based upon specific identification of the initial cost adjusted for any other-than-temporary declines in fair value that were recorded in earnings.
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 $708.1$617.4 million and $678.8$754.9 million of accounts receivable as of September 30, 20202021 and December 31, 2019,2020, respectively, under these factoring arrangements. The costs of factoring such accounts receivable on our consolidated condensed results of operations for the three and nine months ended September 30, 20202021 and 20192020 were not material.

Note 8:7: Income Taxes
The effective tax rate was 10.9 percent for the three months ended September 30, 2021, compared with 15.9 percent for the three months ended September 30, 2020, compared with 10.8 percent2020. The lower effective tax rate for the three months ended September 30, 2019.2021 was primarily due to the income tax impact of a debt extinguishment loss and unfavorable mark-to-market adjustments on investments in equity securities, partially offset by a lower net discrete tax benefit compared to the three months ended September 30, 2020. The effective tax rate was 10.7 percent for the nine months ended September 30, 2021, compared with 14.4 percent for the nine months ended September 30, 2020, compared with 12.8 percent2020. The lower effective tax rate for the nine months ended September 30, 2019. The2021 was primarily due to the income tax impacts of a net inventory impairment charge related to our COVID-19 antibodies and a debt extinguishment loss, as well as higher effective tax rates foracquired IPR&D charges and lower favorable mark-to-market adjustments on investments in equity securities compared to the three and nine months ended September 30, 2020, were driven primarilypartially offset by a mix of earnings in higher tax jurisdictions and a lower net discrete tax benefit compared to the same periodnine months ended September 30, 2020.
The U.S. examination of tax years 2016-2018 began in 2019.
During the fourth quarter of 2019 the Internal Revenue Service began its examination of tax years 2016-2018. Because this examination is still in the early stages of information gathering, theand remains ongoing. The resolution of thethis audit period will likely extend beyond the next 12 months.
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Note 9:8: Retirement Benefits
Net pension and retiree health benefit (income) cost included the following components:
Defined Benefit Pension PlansDefined Benefit Pension Plans
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019 2021202020212020
Components of net periodic benefit cost:Components of net periodic benefit cost:Components of net periodic benefit cost:
Service costService cost$81.7 $62.4 $243.4 $187.8 Service cost$92.5 $81.7 $277.8 $243.4 
Interest costInterest cost106.6 121.0 319.0 364.4 Interest cost84.5 106.6 253.6 319.0 
Expected return on plan assetsExpected return on plan assets(229.5)(208.9)(671.4)(630.2)Expected return on plan assets(237.5)(229.5)(712.7)(671.4)
Amortization of prior service costAmortization of prior service cost1.1 1.5 3.2 4.5 Amortization of prior service cost1.0 1.1 3.2 3.2 
Recognized actuarial lossRecognized actuarial loss58.4 70.9 286.5 213.6 Recognized actuarial loss121.9 58.4 366.3 286.5 
Net periodic benefit costNet periodic benefit cost$18.3 $46.9 $180.7 $140.1 Net periodic benefit cost$62.4 $18.3 $188.2 $180.7 
Retiree Health Benefit PlansRetiree Health Benefit Plans
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019 2021202020212020
Components of net periodic benefit income:Components of net periodic benefit income:Components of net periodic benefit income:
Service costService cost$10.2 $9.1 $30.6 $27.2 Service cost$12.4 $10.2 $37.0 $30.6 
Interest costInterest cost10.9 14.5 32.8 43.5 Interest cost8.1 10.9 24.4 32.8 
Expected return on plan assetsExpected return on plan assets(40.3)(35.9)(115.1)(107.8)Expected return on plan assets(36.5)(40.3)(109.6)(115.1)
Amortization of prior service benefitAmortization of prior service benefit(21.9)(15.7)(51.6)(47.2)Amortization of prior service benefit(14.9)(21.9)(44.7)(51.6)
Recognized actuarial lossRecognized actuarial loss0.7 0.4 2.1 1.3 Recognized actuarial loss0.8 0.7 2.4 2.1 
Net periodic benefit incomeNet periodic benefit income$(40.4)$(27.6)$(101.2)$(83.0)Net periodic benefit income$(30.1)$(40.4)$(90.5)$(101.2)
We contributed approximately $20 million to satisfy minimum funding requirements to our defined benefit pension and retiree health benefit plans during the nine months ended September 30, 2020. We contributed $200 million in discretionary funding during the nine months ended September 30, 2020. During the remainder of 2020, we expect to make contributions of approximately $5 million to our defined benefit pension and retiree health plans to satisfy minimum funding requirements.
Effective during the third quarter of 2020, we adopted a voluntary change in our method of applying an accounting principle for certain of our retirement benefit plans. The new accounting method changes the computation of expected returns on U.S. Dollar denominated investment grade debt securities and derivatives in such plans from a calculated value that includes changes in the fair values over a period of five years to actual fair value. This change in accounting principle is preferable because changes in the fair value of this class of assets will be amortized into net periodic pension and retiree health cost sooner. No change is being made to the accounting principle for the other classes of pension assets. The impact of the adoption of this change in accounting method was not material to our historical and current financial statements.
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Note 10:9: Contingencies
We are a party toinvolved in various lawsuits, claims, government investigations and other legal actionsproceedings that arise in the ordinary course of business. These claims or proceedings can involve various types of parties, including governments, competitors, customers, suppliers, service providers, licensees, employees, or shareholders, among others. These matters may involve patent infringement, antitrust, securities, pricing, sales and government investigations.marketing practices, environmental, commercial, contractual rights, licensing obligations, health and safety matters, consumer fraud, employment matters, product liability and insurance coverage, among others. The most significantresolution of these matters often develops over a long period of time and expectations can change as a result of new findings, rulings, appeals or settlement arrangements. Legal proceedings that are significant or that we believe could become significant or material are described below.
We believe the legal proceedings in which we are named as defendants are without merit and we are defending against them vigorously. It is not possible to determine the final outcome of these matters, and we cannot reasonably estimate the maximum potential exposure or the range of possible loss in excess of amounts accrued for any of these matters; however, we believe that except as noted below with respect to the U.S. Alimta patent litigation, the resolution of all such matters will not have a material adverse effect on our consolidated financial position or liquidity, but could possibly be material to our consolidated results of operations in any one accounting period.
Litigation accruals, environmental liabilities, and the related estimated insurance recoverables are reflected on a gross basis as liabilities and assets, respectively, on our consolidated condensed balance sheets. With respect to the product liability claims currently asserted against us, we have accrued for our estimated exposures to the extent they are both probable and reasonably estimable based on the information available to us. We accrue for certain product liability claims incurred but not filed to the extent we can formulate a reasonable estimate of their costs. We estimate these expenses based primarily on historical claims experience and data regarding product usage. Legal defense costs expected to be incurred in connection with significant product liability loss contingencies are accrued when both probable and reasonably estimable.
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Because of the nature of pharmaceutical products, it is possible that we could become subject to large numbers of additional product liability and related claims in the future. Due to a very restrictive market for product liability insurance, we are self-insured for product liability losses for all our currently and previously marketed products.
Patent Litigation
Alimta Patent Litigation and Administrative Proceedings
A number of manufacturers are seeking approvals in the U.S., a number of countries in Europe, and Japan to market generic forms of Alimta prior to the expiration of our vitamin regimen patents, alleging that those patents are invalid, not infringed, or both. We believe our Alimta vitamin regimen patents are valid and enforceable against these generic manufacturers. However, it is not possible to determine the ultimate outcome of the proceedings, and accordingly, we can provide no assurance that we will prevail. An unfavorable outcome in the U.S. could have a material adverse impact on our future consolidated results of operations, liquidity, and financial position. We expect that a loss of exclusivity for Alimta in any of the below jurisdictions would result in a rapid and severe decline in future revenue for the product in the relevant market.
U.S. Patent Litigation
Alimta (pemetrexed) is protected by a vitamin regimen patent until November 2021, plus pediatric exclusivity through May 2022. In June 2018, the U.S. District Court for the Southern District of Indiana ruled in our favor in 2 cases, finding Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc.'s (collectively, Dr. Reddy) and Hospira, Inc.'s (Hospira) proposed products using an alternative form of pemetrexed (the active ingredient in Alimta) would infringe our method of use patent under the doctrine of equivalents. In August 2019, the U.S. Court of Appeals for the Federal Circuit affirmed that ruling, and in November 2019, the appeals court denied Dr. Reddy and Hospira’s petition for a rehearing. In June 2020, the U.S. Supreme Court denied Dr. Reddy and Hospira’s petitions to review the case and this litigation has ended.
We have 1 additional lawsuit pending in federal court in which we allege infringement against Apotex Inc. (Apotex) in response to its application to market products using alternative forms of pemetrexed. In December 2019, the U.S. District Court for the Southern District of Indiana granted our motion for summary judgment of infringement under the doctrine of equivalents against Apotex. Apotex has appealed that ruling to the U.S. Court of Appeals for the Federal Circuit, with argument scheduled in November 2020. We had filed a similar lawsuit against Actavis LLC in the U.S. District Court for the Southern District of Indiana, which has been administratively closed.
In December 2019, we settled a lawsuit we filed against Eagle Pharmaceuticals, Inc. (Eagle) in response to its application to market a product using an alternative form of pemetrexed. Per the settlement agreement, Eagle has a limited initial entry into the market with its product starting February 2022 (up to an approximate three-week supply) and subsequent unlimited entry starting April 2022.
European Patent Litigation
LegalIn Europe, Alimta was protected by the vitamin regimen patent through June 2021. Despite the recent patent expiration, a number of legal proceedings are ongoing regarding our Alimta patents in various national courts throughout Europe. We are aware that several companies have received approval to market generic versions of pemetrexed in major European markets (including generics currently on the market at risk in France and the Netherlands) and that additional generic competitors may choose to launch at risk. Following a final decision in the Supreme Court of Germany in July 2020 overturning the lower court and upholding the validity of our Alimta patent, several generics that were on the market at risk left. We have removed the remaining generics from the market by obtaining preliminary injunctions in our favor. In September 2020, the Paris Court of First Instance in France issued a final decision upholding the validity of our Alimta patent and found infringement by Fresenius Kabi’s (Kabi) pemetrexed product. The court issued an injunction against Kabi and provisionally awarded us damages. We will continue to pursue injunctions to remove remaining generics from the market in France. In late October 2020, the Court of Appeal of the Netherlands ruled in Lilly's favor and reinstated an order against Kabi prohibiting it from continuing to market its generic pemetrexed product in the Netherlands. Kabi's generic pemetrexed product was the only at risk generic on the market in the Netherlands.
Our vitamin regimen patents have also been challenged in other smaller European jurisdictions. We will continue to seek to remove any generic pemetrexed products launched at risk in other European markets, seek damages with respect to such launches, and defend our patents against validity challenges.
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Japanese Administrative Proceedings
NaN separate sets of demands for invalidation of our 2 Japanese vitamin regimen patents, involving several companies, have been filed with the Japanese Patent Office (JPO). The JPO has rejected demands for invalidation by Sawai Pharmaceutical Co., Ltd. and Nipro Corporation, and both rejections have been affirmed on appeal. In October 2020, the JPO issued notices closing the last remaining set of demands brought by Hospira, and Hospira has requested withdrawal of its demands for invalidation. These patents provide intellectual property protection for Alimta until June 2021. Notwithstanding our patents, generic versions of Alimta received regulatory approval in Japan starting in February 2016. We do not currently anticipate that generic versions of Alimta will proceed to pricing approvalinitiated prior to our patent’s expiration.
Jardiance Patent Litigation
Boehringer Ingelheim, our partner in marketing and development of Jardiance, initiated U.S. patent litigation in the U.S. District Court of Delaware involving Jardiance, Glyxambi, and Synjardy in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act). Several companies submitted Abbreviated New Drug Applications seeking approval to market generic versions of Jardiance prior to the expiration of the relevant patents, alleging certain patents, including in some allegations the compound patent, are invalid or would not be infringed. Trial is scheduled for April 2021.
Taltz Patent Litigation
We were ongoingnamed as a defendant in litigation filed by Genentech, Inc. (Genentech) in Germany seeking a ruling that Genentech’s patent would be infringed by our continued sales of Taltz in Germany. After it sold its patent rights to Novartis Pharma AG (Novartis) in June 2020, Genentech withdrew its infringement litigation and Novartis subsequently filed litigation against us in Germany asserting infringement based on sales of Taltz. We expect a trial to assess Novartis’ German infringement claims to take place in May 2021. We are also named in litigation in the U.K. in which Genentech asserted similar claims regarding its corresponding U.K. patent. We believe these lawsuits are without merit and are defending against them vigorously..
Emgality Patent Litigation
We haveIn September 2018, we were been named as a defendant in litigation filed by Teva Pharmaceuticals International GMBH and Teva Pharmaceuticals USA, Inc. (collectively, Teva) in the U.S. District Court for the District of Massachusetts seeking a ruling that various claims in 9 different Teva patents would be infringed by our launch and continued sales of Emgality for the prevention of migraine in adults. We believe this lawsuitTrial is without merit andexpected in March 2022. In June 2021, we were named as a defendant in a second litigation filed by Teva in the U.S. District Court for the District of Massachusetts seeking a ruling that 2 of Teva’s patents, which are defending against it vigorously. directed toward use of the active ingredient in Emgality to treat migraine, would be infringed by our continued sales of Emgality.
Separately, the U.S. Patent and Trademark Office (USPTO)Office's Patent Trial and Appeal Board (PTAB) granted our request to initiate an inter partes review (IPR) to reexamine the validity of the 9 Teva patents asserted against us in the litigation. In February 2020, the USPTOPTAB ruled in our favor and found that the claims asserted against us in 6 of Teva's 9 patents were invalid. In March 2020, the USPTOPTAB ruled against us on the remaining 3 Teva patents, finding that we failed to show that the remaining 3 patents were unpatentable based on the subset of invalidity arguments available in an IPR proceeding. We haveIn April 2020, we appealed the USPTO’sPTAB’s March 2020 ruling, and Teva appealed the PTAB’s February 2020 ruling to the U.S. Court of Appeals for the Federal Circuit. In August 2021, the appeals court affirmed all 9 of the PTAB's decisions. Neither Lilly nor Teva appealed the rulings and accordingly those decisions are final, and the parties have agreed to a stipulation which removes the 6 invalidated patents from the district court litigation. This IPR matter is now closed.
Jardiance Patent Litigation
In November 2018, Boehringer Ingelheim (BI), our partner in marketing and development of Jardiance, initiated U.S. patent litigation in the U.S. District Court of Delaware alleging infringement arising from submissions of Abbreviated New Drug Applications (ANDA) by a number of generic companies seeking approval to market generic versions of Jardiance, Glyxambi, and Synjardy in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act). Particularly with respect to Jardiance, the generic companies' ANDAs seek approval to market generic versions of Jardiance prior to the expiration of the relevant patents, and allege that certain patents, including in some allegations the compound patent, are invalid or would not be infringed. We are not a party to this litigation. This litigation has been stayed.
Taltz Patent Litigation
In April 2021, we petitioned the High Court of Ireland to declare invalid the patent that Novartis Pharma AG (Novartis) purchased from Genentech, Inc. in 2020. Novartis responded by filing a claim against us alleging patent infringement related to our commercialization of Taltz and seeking damages for past infringement and an injunction against future infringement. This matter is ongoing.
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In April 2021 and June 2021, Novartis petitioned the Court of Rome Intellectual Property Division and the Commercial Court of Vienna, respectively, in preliminary injunction infringement proceedings against us related to our commercialization of Taltz. In June 2021, the Court of Rome Intellectual Property Division dismissed Novartis’ preliminary injunction action. Novartis has appealed the USPTO’sruling and in October 2021 the panel hearing Novartis' appeal appointed a technical expert to assess the merits of the case. Both matters are ongoing.
Zyprexa Canada Patent Litigation
Beginning in the mid-2000’s, several generic companies in Canada challenged the validity of our Zyprexa compound patent. In 2012, the Canadian Federal Court of Appeals denied our appeal of a lower court's decision that certain patent claims were invalid for lack of utility. In 2013, Apotex Inc. and Apotex Pharmachem Inc. (collectively, Apotex) brought claims against us in the Ontario Superior Court of Justice at Toronto for damages related to our enforcement of the Zyprexa compound patent under Canadian regulations governing patented drugs. Apotex seeks compensation based on novel legal theories under the Statute of Monopolies, Trade-Mark Act, and common law. In March 2021, the Ontario Superior Court granted our motion for summary judgement, thereby dismissing Apotex’s case. Apotex appealed that ruling to the Court of Appeal for Ontario in April 2021 and a hearing is scheduled for February 2022.
Product Liability Litigation
Actos® Product Liability
We are named along with Takeda Chemical Industries, Ltd. and Takeda affiliates (collectively, Takeda) as a defendant in 4 purported product liability class actions in Canada related to Actos, which we commercialized with Takeda in Canada until 2009, including 1 in Ontario filed December 2011 (Casseres et al. v. Takeda Pharmaceutical North America, Inc., et al.), 1 in Quebec filed July 2012 (Whyte et al. v. Eli Lilly et al.), 1 in Saskatchewan filed November 2017 (Weiler v. Takeda Canada Inc. et al.), and 1 in Alberta filed January 2013 (Epp v. Takeda Canada Inc. et al.). In general, plaintiffs in these actions alleged that Actos caused or contributed to their bladder cancer. An agreement to settle these actions became effective in May 2021, and the settlement claims administration process is ongoing. The lawsuits have been dismissed or discontinued.
Byetta® Product Liability
We are named as a defendant in approximately 570 Byetta product liability lawsuits in the U.S. which were initiated in March 2009 and involve approximately 805 plaintiffs. Approximately 55 of these lawsuits, covering about 285 plaintiffs, are filed in California state court and coordinated in a Los Angeles Superior Court. Approximately 515 of the lawsuits, covering about 515 plaintiffs, are filed in federal court, the majority of which are coordinated in a multi-district litigation (MDL) in the U.S. District Court for the Southern District of California. NaN lawsuits, representing approximately 2 plaintiffs, have also been filed in various state courts. Approximately 565 of the lawsuits, involving approximately 800 plaintiffs, contain allegations that Byetta caused or contributed to the plaintiffs' cancer (primarily pancreatic cancer or thyroid cancer); while 6 plaintiffs allege Byetta caused or contributed to pancreatitis. In addition, 1 case alleges that Byetta caused or contributed to ampullary cancer. The federal and state trial courts granted summary judgment in favor of us and our co-defendants on the claims alleging pancreatic cancer. The plaintiffs appealed those rulings.
In November 2017, the U.S. Court of Appeals for the Ninth Circuit reversed the U.S. District Court for the Southern District of California's grant of summary judgment in the MDL based on that court's discovery rulings and remanded the cases back to the U.S. District Court for further proceedings. In March 2021, the U.S. District Court granted summary judgment for the defendants. In April 2021, the plaintiffs filed a notice of appeal to the U.S. Court of Appeals for the Ninth Circuit, but we have now been dismissed from that appeal. Certain plaintiffs have agreed to dismiss their lawsuits in exchange for a waiver of costs, and individual plaintiffs have begun dismissing their claims based upon this agreement. Approximately 160 of the MDL pancreatic lawsuits have been dismissed as of October 2021. In the state court actions, in November 2018, the California Court of Appeal reversed the Los Angeles County Superior Court of California’s grant of summary judgment based on that court's discovery rulings and remanded for further proceedings. In April 2021, the Los Angeles County Superior Court of California granted summary judgment for the defendants and the parties await entry of the order of judgment.
We are aware of approximately 20 additional claimants who have not yet filed suit. These additional claims allege damages for pancreatic cancer or thyroid cancer.
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Cialis Product Liability
We are named as a defendant in approximately 350 Cialis product liability lawsuits in the U.S. which were first initiated in August 2015. These cases, many of which were originally filed in various federal courts, contain allegations that Cialis caused or contributed to the plaintiffs' cancer (melanoma). In December 2016, the Judicial Panel on Multidistrict Litigation (JPML) granted the plaintiffs' petition to have filed cases and an unspecified number of future cases coordinated into a federal multidistrict litigation (MDL) in the U.S. District Court for the Northern District of California, alongside an existing coordinated proceeding involving Viagra®. The JPML ordered the transfer of the existing cases to the now-renamed MDL In re: Viagra (Sildenafil Citrate) and Cialis (Tadalafil) Products Liability Litigation. In April 2020, ruling. We believe thesethe MDL court granted summary judgment to the defendants on all of the claims are without merit and are defendingbrought against them vigorously.by the plaintiffs. In May 2020, plaintiffs filed an appeal in the U.S. Court of Appeals for the Ninth Circuit. The districtplaintiffs’ appeal was administratively closed until August 2021 pending completion of a procedure to resolve the claims in this litigation. The court litigation will proceedhas entered an extension until February 2022 to finalize resolution of all claims.
Jardiance Product Liability
First initiated in parallelJanuary 2019, we and Boehringer Ingelheim Pharmaceuticals, Inc., a subsidiary of BI, have been named as a defendant in approximately 95 product liability lawsuits in the U.S., mostly in Stamford Superior Court in Connecticut, alleging that Jardiance caused or contributed to plaintiffs’ Fournier’s gangrene. Our agreement with BI calls for BI to defend and indemnify us against any damages, costs, expenses, and certain other losses with respect to product liability claims in accordance with the IPR appeals.terms of the agreement. All pending cases have been paused to allow for settlement negotiations.
Environmental Proceedings
Under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly known as "Superfund," we have been designated as one of several potentially responsible parties with respect to the cleanup of fewer than 10 sites. Under Superfund, each responsible party may be jointly and severally liable for the entire amount of the cleanup.
Other Matters
340B Litigation and Investigations
We are the plaintiff in a lawsuit filed in January 2021 in the U.S. District Court for the Southern District of Indiana against the U.S. Department of Health and Human Services (HHS), the Secretary of HHS, the Health Resources and Services Administration (HRSA), and the Administrator of HRSA. The lawsuit challenges the HHS's December 30, 2020 advisory opinion stating that drug manufacturers are required to deliver discounts under the 340B program to all contract pharmacies. We seek a declaratory judgment that the defendants violated the Administrative Procedures Act and the U.S. Constitution, a preliminary injunction enjoining implementation of the administrative dispute resolution process created by defendants and, with it, their application of the advisory opinion, and other related relief. In March 2021, the court entered an order preliminarily enjoining the government’s enforcement of the administrative dispute resolution process against us. In May 2021, HRSA notified us that it determined that our policy was contrary to the 340B statute. In response, in May 2021, we filed a motion for preliminary injunction and temporary restraining order requesting that the U.S. District Court for the Southern District of Indiana enjoin defendants from taking any action against us relating to the 340B drug pricing program until after the court issues a final judgment on the aforementioned litigation. In May 2021, the court denied our motion for a temporary restraining order but deferred resolution of our motion for preliminary injunction. In June 2021, the defendants withdrew the HHS December 30, 2020 advisory opinion. In July 2021, the court held oral argument on the parties’ cross motions for summary judgment, the defendants’ motion to dismiss, and our motion for preliminary injunction related to HRSA’s May 2021 enforcement letter. This matter is ongoing.
In January 2021, we, along with other pharmaceutical manufacturers, were named as a defendant in a petition currently pending before the HHS Administrative Dispute Resolution Panel. Petitioner seeks declaratory and other injunctive relief related to the 340B program. As described above, the U.S. District Court for the Southern District of Indiana has entered a preliminary injunction enjoining the government’s enforcement of this administrative dispute resolution process against us.
In July 2021, we, along with Sanofi-Aventis U.S., LLC (Sanofi), Novo Nordisk Inc. (Novo Nordisk), and AstraZeneca Pharmaceuticals LP, were named as a defendant in a purported class action lawsuit filed in the U.S. District Court for the Western District of New York by Mosaic Health, Inc. alleging antitrust and unjust enrichment claims related to the defendants' 340B distribution programs.
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We received a civil investigative subpoena in February 2021 from the Office of the Attorney General for the State of Vermont relating to the sale of pharmaceutical products to Vermont covered entities under the 340B program. We are cooperating with this subpoena.
Branchburg Manufacturing Facility
In May 2021, we received a subpoena from the United States Department of Justice requesting the production of certain documents relating to our manufacturing site in Branchburg, New Jersey. We are cooperating with the subpoena.
Brazil Litigation – Cosmopolis Facility
Labor Attorney Litigation
OurFirst initiated in 2008, our subsidiary in Brazil, Eli Lilly do Brasil Limitada (Lilly Brasil), is named in a lawsuit brought by the Labor Attorney for the 15th Region in the Labor Court of Paulinia, State of Sao Paulo, Brazil, alleging possible harm to employees and former employees caused by exposure to heavy metals at a former Lilly Brasil manufacturing facility in Cosmopolis, Brazil, operated by the company between 1977 and 2003. In May 2014, the labor court judge ruled against Lilly Brasil, ordering it to undertake several actions of unspecified financial impact, including paying lifetime health coverage for the employees and contractors who worked at the Cosmopolis facility more than six months during the affected years and their children born during and after this period. We appealed this decision. In July 2018, the appeals court affirmed the labor court's ruling with a liquidated award of 300 million Brazilian real (for moral damages, donation of equipment, and creation of a foundation) which, adjusted for inflation and interest using the total financial impactcurrent Central Bank of the ruling estimated to beBrazil's special system of clearance and custody rate (SELIC), is approximately 500950 million Brazilian real (approximately $90$175 million as of September 30, 2020)2021). The appeals court restricted the broad health coverage awarded by the labor court to health problems that claimants could show arose from exposure to the alleged contamination. In August 2019, Lilly Brasil filed an appeal to the superior labor court. In September 2019, the appeals court stayed a number of elements of its prior decision, including the obligation to
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provide health coverage for contractors, their children, and children of employees who worked at the Cosmopolis facility, pending the determination of Lilly Brasil’s appeal to the superior labor court. The cost of any such health coverage has not been determined. In June 2021, the appeals court published its decision on the admissibility of Lilly Brasil’s appeal, admitting the majority of the elements of the appeal to proceed; elements not proceeding are subject to an interlocutory appeal to the appeals court filed in June 2021.
In June 2019, the Labor Attorney filed an application in the labor court for enforcement of the healthcare coverage granted by the appeals court in its July 2018 ruling and requested restrictions on Lilly Brasil’s assets in Brazil. In July 2019, the labor court issued a ruling requiring either a freeze of Lilly Brasil’s immovable property or, alternatively, a security deposit or lien of 500 million Brazilian real. Lilly Brasil filed a writ of mandamus challenging this ruling, but the court has stayed its decision on this writ and instead directed the parties to attend conciliation hearings, a process that concluded unsuccessfully in September 2020. The laborConsequently, the partial stay of the proceedings relating to Lilly Brasil's application to appeal in the main proceedings has been lifted and in June 2021, the court also stayedreduced the security deposit or lien to 100 million Brazilian real from the 500 million Brazilian real referred to above. In addition, the Labor Attorney’sAttorney's application to enforcefor preliminary enforcement of the previousJuly 2018 healthcare coverage ruling until after the appeals court ruled on the various motions pending before it.was granted. As the conciliation hearings have been unsuccessful, we have filed a brief to strike the Labor Attorney’s application to enforce the previous healthcare coverage. Lilly Brasil is currently awaiting a determination as to whether its application seeking leave to appeal to the superior labor court has been successful.
We believe all of these lawsuits are without merit and are defending against them vigorously.
Individual Former Employee Litigation
We are also named in approximately 30 lawsuits filed in the same labor court by individual former employees making similar claims. These lawsuits are each at various stages in the litigation process, with judgments being handed down in approximately half of the lawsuits, nearly all of which are on appeal in the labor courts.
China NDRC Antitrust Matter
The competition authority in China has investigated our distributor pricing practices in China in connection with a broader inquiry into pharmaceutical industry pricing. We believe allhave cooperated with this investigation.
Eastern District of thesePennsylvania Pricing (Average Manufacturer Price) Inquiry
In November 2014, we, along with another pharmaceutical manufacturer, were named as co-defendants in United States et al. ex rel. Streck v. Takeda Pharm. Am., Inc., et al., which was filed in November 2014 and unsealed in the U.S. District Court for the Northern District of Illinois. The complaint alleges that the defendants should have treated certain credits from distributors as retroactive price increases and included such increases in calculating average manufacturer prices. Trial is scheduled for April 2022.
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Health Choice Alliance
We are named as a defendant in a lawsuit filed in June 2017 in the U.S. District Court for the Eastern District of Texas seeking damages under the federal anti-kickback statute and state and federal false claims acts for certain patient support programs related to our products Humalog, Humulin, and Forteo. In September 2019, the U.S. District Court granted the U.S. Department of Justice’s motion to dismiss the relator’s second amended complaint. In January 2020, the relator appealed the District Court’s dismissal to the U.S. Court of Appeals for the Fifth Circuit. In July 2021, the U.S. Court of Appeals for the Fifth Circuit affirmed the dismissal of the lawsuit.We are also named as a defendant in 2 similar lawsuits are without meritfiled in Texas and are defending against them vigorously.New Jersey state courts in October 2019 seeking damages under the Texas Medicaid Fraud Prevention Act and New Jersey Medicaid False Claims Act, respectively. In November 2020, the Texas state court action was stayed pending a final determination with respect to the aforementioned federal lawsuit. In April 2021, the New Jersey state court action was dismissed with prejudice and in June 2021, the relator filed a notice of appeal to the Appellate Division of the New Jersey Superior Court, appealing the state court’s decision.
Pricing Litigation, Investigations, and Inquiries
Litigation
We,In December 2017, we, along with Sanofi-Aventis U.S. LLC (Sanofi)Sanofi and Novo Nordisk Inc. (Novo Nordisk) arewere named as defendants in a consolidated purported class action lawsuit, In re. Insulin Pricing Litigation, in the U.S. District Court for the District of New Jersey relating to insulin pricing seeking damages under various state consumer protection laws and the Federal Racketeer Influenced and Corrupt Organization Act (federal RICO Act). Separately, in February 2018, we, along with Sanofi and Novo Nordisk, arewere named as defendants in MSP Recovery Claims, Series, LLC et al. v. Sanofi Aventis U.S. LLC et al., in the same court, seeking damages under various state consumer protection laws, common law fraud, unjust enrichment, and the federal RICO Act. In both In re. Insulin Pricing Litigation and the MSP Recovery Claims litigation, the court dismissed claims under the federal RICO Act and certain state laws. AlsoIn April 2021, the plaintiffs in the same court,In re. Insulin Pricing Litigation amended their complaint to allege additional state law claims for civil conspiracy and violations of state RICO statutes.Also, we, along with Sanofi, Novo Nordisk, CVS, Express Scripts, and Optum, have been sued in a purported class action, FWK Holdings, LLC v. Novo Nordisk Inc., et al., ,filed in the same court in November 2020, for alleged violations of the federal RICO Act as well as the New Jersey RICO Act and anti-trustantitrust law. That same group of defendants, along with Medco Health and United Health Group, also have been sued in other purported class actions in the same court, Rochester Drug Co-Operative Inc. v. Eli Lilly & Co. et al. and Value Drug Co. v. Eli Lilly & Co. et al.,both initiated in March 2020, for alleged violations of the federal RICO Act. In September 2020, the U.S. District Court for the District of New Jersey granted plaintiffs’ motion to consolidate FWK Holdings, LLC v. Novo Nordisk Inc., et al., Rochester Drug Co-Operative Inc. v. Eli Lilly & Co. et al., and Value Drug Co. v. Eli Lilly & Co. et al.In July 2021, the U.S. District Court for the District of New Jersey dismissed the 3 antitrust claims alleged by plaintiffs in the consolidated litigation and denied dismissal of the RICO claims.
TheIn October 2018, the Minnesota Attorney General’s Office has initiated litigation against us, Sanofi, and Novo Nordisk, State of Minnesota v. Sanofi-Aventis U.S. LLC et al., in the U.S. District Court for the District of New Jersey, alleging unjust enrichment, violations of various Minnesota state consumer protection laws, and the federal RICO Act. In March 2021, the U.S. District Court for the District of New Jersey dismissed with prejudice the Minnesota Attorney General’s federal RICO claims and false advertising claims under state law; the consumer fraud and other related state law claims remain ongoing. Additionally, in May 2019, the Kentucky Attorney General’s Office filed a complaint against us, Sanofi, and Novo Nordisk, Commonwealth of Kentucky v. Novo Nordisk, Inc. et al., in Kentucky state court, alleging violations of the Kentucky consumer protection law, false advertising, and unjust enrichment. In November 2019, Harris County in Texas initiated litigation against us, Sanofi, Novo Nordisk, Express Scripts, CVS, Optum, and Aetna, County of Harris Texas v. Eli Lilly & Co., et al., in federal court in the Southern District of Texas alleging violations of the federal RICO Act, federal and state anti-trust law, and the state deceptive trade practices-consumer protection act. Harris County also allegesact, and common law claims such as fraud, unjust enrichment, and civil conspiracy. Harris County also alleged violations of federal and state antitrust law, but voluntarily dismissed them. This lawsuit relates to our insulin products as well as Trulicity.
We believe allIn June 2021, the City of these claims are without meritMiami, Florida initiated litigation against us, Sanofi, Novo Nordisk, ESI, CVS/Caremark/Aetna, and are defendingOptum, asserting state law antitrust, common law fraud, money had and received, unjust enrichment, and civil conspiracy claims. In June 2021, the Mississippi Attorney General’s Office initiated litigation against them vigorously.us, Sanofi, Novo Nordisk, Evernorth/ESI, CVS/Caremark, and United/Optum in the Hinds County, Mississippi Chancery Court, alleging state law consumer protection, unjust enrichment, and civil conspiracy claims.
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Investigations, Subpoenas, and Inquiries
We have received a subpoena from the New York and Vermont Attorney General’s OfficeGeneral Offices and civil investigative demands from the Washington, New Mexico, and Colorado Attorney General Offices relating to the pricing and sale of our insulin products. The Offices of the Attorney General in Mississippi, Washington D.C., California, Florida, Hawaii, and Nevada have requested information relating to the pricing and sale of our insulin products. We also received interrogatories and a subpoena from the California Attorney General's Office regarding our competition in the long-long-acting insulin market, which was subsequently withdrawn in June 2021.
31


acting insulin market. We received two requestsa request in January 2019 from the House of Representatives’ Committee on EnergyOversight and CommerceReform seeking commercial information and a request from the Senate’s Committee on Health, Education, Labor, and Pensions, seeking certain informationbusiness records related to the pricing of insulin products, among other issues. We also received requests from the House of Representatives’Senate Finance Committee and the Senate Committee on OversightHealth, Education, Labor, and ReformPensions, and separate requests from the Senate’sHouse Committee on Finance, which seek detailedEnergy and Commerce majority and minority members.  Those requests sought pricing and other commercial information and business records. regarding Lilly’s insulin products. In January 2021, the Senate Finance Committee released a report summarizing the findings of its investigation.
We are cooperating with all of these aforementioned investigations, subpoenas, and inquiries.
Product Liability InsuranceResearch Corporation Technologies, Inc.
BecauseIn April 2016, we were named as a defendant in litigation filed by Research Corporation Technologies, Inc. (RCT) in the U.S. District Court for the District of Arizona. RCT is seeking damages for breach of contract, unjust enrichment, and conversion related to processes used to manufacture certain products, including Humalog and Humulin. Both parties moved for summary judgment and a hearing on the naturemotions took place in August 2021. In October 2021, the Court issued a summary judgment decision finding in favor of pharmaceutical products, it is possible that weRCT on certain issues, including with respect to a disputed royalty. Potential damages payable under the litigation, if finally awarded after an appeal, could become subjectbe material but are not currently reasonably estimable. We intend to large numbers of additional product liabilityappeal the summary judgment decision and related claims in the future. Due to a very restrictive market for product liability insurance, we are self-insured for product liability losses for all our currently and previously marketed products.findings. A trial date has not been set.
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Note 11:10: Other Comprehensive Income (Loss)
The following tables summarize the activity related to each component of other comprehensive income (loss) during the three months ended September 30, 20202021 and 2019:2020:
(Amounts presented net of taxes)(Amounts presented net of taxes)Foreign Currency Translation Gains (Losses)Unrealized Net Gains (Losses) on SecuritiesDefined Benefit Pension and Retiree Health Benefit PlansEffective Portion of Cash Flow HedgesAccumulated Other Comprehensive Loss(Amounts presented net of taxes)Foreign Currency Translation Gains (Losses)Unrealized Net Gains (Losses) on SecuritiesDefined Benefit Pension and Retiree Health Benefit PlansEffective Portion of Cash Flow HedgesAccumulated Other Comprehensive Loss
Balance at July 1, 2020$(1,722.5)$15.1 $(4,454.9)$(520.6)$(6,682.9)
Balance at July 1, 2021Balance at July 1, 2021$(1,516.2)$9.1 $(4,569.9)$(210.1)$(6,287.1)
Other comprehensive income (loss) before reclassificationsOther comprehensive income (loss) before reclassifications30.3 0.8 (19.6)82.9 94.4 Other comprehensive income (loss) before reclassifications(8.0)(2.4)18.6 16.8 25.0 
Net amount reclassified from accumulated other comprehensive lossNet amount reclassified from accumulated other comprehensive loss0 (0.2)30.3 3.3 33.4 Net amount reclassified from accumulated other comprehensive loss 0.1 86.0 3.3 89.4 
Net other comprehensive income (loss)Net other comprehensive income (loss)30.3 0.6 10.7 86.2 127.8 Net other comprehensive income (loss)(8.0)(2.3)104.6 20.1 114.4 
Balance at September 30, 2020$(1,692.2)$15.7 $(4,444.2)$(434.4)$(6,555.1)
Balance at September 30, 2021Balance at September 30, 2021$(1,524.2)$6.8 $(4,465.3)$(190.0)$(6,172.7)
(Amounts presented net of taxes)(Amounts presented net of taxes)Foreign Currency Translation Gains (Losses)Unrealized Net Gains (Losses) on SecuritiesDefined Benefit Pension and Retiree Health Benefit PlansEffective Portion of Cash Flow HedgesAccumulated Other Comprehensive Loss(Amounts presented net of taxes)Foreign Currency Translation Gains (Losses)Unrealized Net Gains (Losses) on SecuritiesDefined Benefit Pension and Retiree Health Benefit PlansEffective Portion of Cash Flow HedgesAccumulated Other Comprehensive Loss
Balance at July 1, 2019$(1,570.0)$4.5 $(3,763.3)$(271.7)$(5,600.5)
Balance at July 1, 2020Balance at July 1, 2020$(1,722.5)$15.1 $(4,454.9)$(520.6)$(6,682.9)
Other comprehensive income (loss) before reclassificationsOther comprehensive income (loss) before reclassifications(192.0)1.5 21.3 (12.7)(181.9)Other comprehensive income (loss) before reclassifications30.3 0.8 (19.6)82.9 94.4 
Net amount reclassified from accumulated other comprehensive lossNet amount reclassified from accumulated other comprehensive loss0.6 45.1 2.2 47.9 Net amount reclassified from accumulated other comprehensive loss— (0.2)30.3 3.3 33.4 
Net other comprehensive income (loss)Net other comprehensive income (loss)(192.0)2.1 66.4 (10.5)(134.0)Net other comprehensive income (loss)30.3 0.6 10.7 86.2 127.8 
Balance at September 30, 2019$(1,762.0)$6.6 $(3,696.9)$(282.2)$(5,734.5)
Balance at September 30, 2020Balance at September 30, 2020$(1,692.2)$15.7 $(4,444.2)$(434.4)$(6,555.1)
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The following tables summarize the activity related to each component of other comprehensive income (loss) during the nine months endedSeptember 30, 20202021 and 2019:2020:
(Amounts presented net of taxes)Foreign Currency Translation Gains (Losses)Unrealized Net Gains (Losses) on SecuritiesDefined Benefit Pension and Retiree Health Benefit PlansEffective Portion of Cash Flow HedgesAccumulated Other Comprehensive Loss
Balance at January 1, 2021$(1,427.5)$14.8 $(4,751.0)$(332.7)$(6,496.4)
Other comprehensive income (loss) before reclassifications(96.7)(8.8)27.2 132.8 54.5 
Net amount reclassified from accumulated other comprehensive loss 0.8 258.5 9.9 269.2 
Net other comprehensive income (loss)(96.7)(8.0)285.7 142.7 323.7 
Balance at September 30, 2021$(1,524.2)$6.8 $(4,465.3)$(190.0)$(6,172.7)
(Amounts presented net of taxes)Foreign Currency Translation Gains (Losses)Unrealized Net Gains (Losses) on SecuritiesDefined Benefit Pension and Retiree Health Benefit PlansEffective Portion of Cash Flow HedgesAccumulated Other Comprehensive Loss
Balance at January 1, 2020$(1,678.0)$4.9 $(4,638.6)$(211.9)$(6,523.6)
Other comprehensive income (loss) before reclassifications(14.2)7.6 4.6 (232.3)(234.3)
Net amount reclassified from accumulated other comprehensive loss— 3.2 189.8 9.8 202.8 
Net other comprehensive income (loss)(14.2)10.8 194.4 (222.5)(31.5)
Balance at September 30, 2020$(1,692.2)$15.7 $(4,444.2)$(434.4)$(6,555.1)
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Continuing Operations
(Amounts presented net of taxes)Foreign Currency Translation Gains (Losses)Unrealized Net Gains (Losses) on SecuritiesDefined Benefit Pension and Retiree Health Benefit PlansEffective Portion of Cash Flow HedgesDiscontinued OperationsAccumulated Other Comprehensive Loss
Balance at January 1, 2020$(1,678.0)$4.9 $(4,638.6)$(211.9)$0 $(6,523.6)
Other comprehensive income (loss) before reclassifications(14.2)7.6 4.6 (232.3)0 (234.3)
Net amount reclassified from accumulated other comprehensive loss0 3.2 189.8 9.8 0 202.8 
Net other comprehensive income (loss)(14.2)10.8 194.4 (222.5)0 (31.5)
Balance at September 30, 2020$(1,692.2)$15.7 $(4,444.2)$(434.4)$0 $(6,555.1)
Continuing Operations
(Amounts presented net of taxes)Foreign Currency Translation Gains (Losses)Unrealized Net Gains (Losses) on SecuritiesDefined Benefit Pension and Retiree Health Benefit PlansEffective Portion of Cash Flow HedgesDiscontinued OperationsAccumulated Other Comprehensive Loss
Balance at January 1, 2019 (1)
$(1,569.7)$(22.1)$(3,852.7)$(238.9)$(56.8)$(5,740.2)
Other comprehensive income (loss) before reclassifications(192.3)26.7 19.0 (51.7)(27.2)(225.5)
Net amount reclassified from accumulated other comprehensive loss2.0 136.8 8.4 84.0 231.2 
Net other comprehensive income (loss)(192.3)28.7 155.8 (43.3)56.8 5.7 
Balance at September 30, 2019$(1,762.0)$6.6 $(3,696.9)$(282.2)$$(5,734.5)
(1) Accumulated other comprehensive loss as of January 1, 2019 consists of $5.73 billion of accumulated other comprehensive loss attributable to controlling interest and $11.0 million of accumulated other comprehensive loss attributable to noncontrolling interest.

The tax effects on the net activity related to each component of other comprehensive income (loss) were as follows:
Three Months Ended September 30,Nine Months Ended September 30,
Tax benefit (expense)2020201920202019
Foreign currency translation gains/losses$46.0 $(5.1)$34.9 $(17.1)
Unrealized net gains/losses on securities(0.2)(0.5)(3.0)(7.4)
Defined benefit pension and retiree health benefit plans11.8 (17.4)(32.8)(42.2)
Effective portion of cash flow hedges(22.9)2.7 59.1 11.4 
Benefit (provision) for income taxes allocated to other comprehensive income (loss) items$34.7 $(20.3)$58.2 $(55.3)

Three Months Ended September 30,Nine Months Ended September 30,
Tax benefit (expense)2021202020212020
Foreign currency translation gains/losses$(39.0)$46.0 $(92.3)$34.9 
Unrealized net gains/losses on securities0.8 (0.2)3.8 (3.0)
Defined benefit pension and retiree health benefit plans(28.2)11.8 (79.7)(32.8)
Effective portion of cash flow hedges(5.4)(22.9)(37.9)59.1 
Benefit (provision) for income taxes allocated to other comprehensive income (loss) items$(71.8)$34.7 $(206.1)$58.2 
Except for the tax effects of foreign currency translation gains and losses related to our foreign currency-denominated notes, cross-currency interest rate swaps, and other foreign currency exchange contracts designated as net investment hedges (see Note 7)6), income taxes were not provided for foreign currency translation. Generally, the assets and liabilities of foreign operations are translated into U.S. dollars using the current exchange rate. For those operations, changes in exchange rates generally do not affect cash flows; therefore, resulting translation adjustments are made in shareholders' equity rather than in the consolidated condensed statements of operations.
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Reclassifications out of accumulated other comprehensive loss were as follows:
Details about Accumulated Other Comprehensive Loss ComponentsDetails about Accumulated Other Comprehensive Loss ComponentsThree Months Ended September 30,Nine Months Ended September 30,Affected Line Item in the Consolidated Condensed Statements of OperationsDetails about Accumulated Other Comprehensive Loss ComponentsThree Months Ended September 30,Nine Months Ended September 30,Affected Line Item in the Consolidated Condensed Statements of Operations
Details about Accumulated Other Comprehensive Loss ComponentsThree Months Ended September 30,Nine Months Ended September 30,Affected Line Item in the Consolidated Condensed Statements of Operations
20202019202020192021202020212020
Amortization of retirement benefit items:Amortization of retirement benefit items:Amortization of retirement benefit items:
Prior service benefits, netPrior service benefits, net$(20.8)$(14.2)$(48.4)$(42.7)Other–net, (income) expensePrior service benefits, net$(13.9)$(20.8)$(41.5)$(48.4)Other–net, (income) expense
Actuarial losses, netActuarial losses, net59.1 71.3 288.6 214.9 Other–net, (income) expenseActuarial losses, net122.7 59.1 368.7 288.6 Other–net, (income) expense
Total before taxTotal before tax38.3 57.1 240.2 172.2 Total before tax108.8 38.3 327.2 240.2 
Tax benefitTax benefit(8.0)(12.0)(50.4)(35.4)Income taxesTax benefit(22.8)(8.0)(68.7)(50.4)Income taxes
Net of taxNet of tax30.3 45.1 189.8 136.8 Net of tax86.0 30.3 258.5 189.8 
Other, net of taxOther, net of tax3.1 2.8 13.0 10.4 Other–net, (income) expenseOther, net of tax3.4 3.1 10.7 13.0 Other–net, (income) expense
Reclassifications from continuing operations (net of tax)33.4 47.9 202.8 147.2 
Reclassifications from discontinued operations (net of tax)0 0 84.0 Net income from discontinued operations
Total reclassifications for the period (net of tax)$33.4 $47.9 $202.8 $231.2 
Total reclassifications, net of taxTotal reclassifications, net of tax$89.4 $33.4 $269.2 $202.8 
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Note 12:11: Other–Net, (Income) Expense
Other–net, (income) expense consisted of the following:
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019 2021202020212020
Interest expenseInterest expense$89.6 $107.4 $270.4 $304.7 Interest expense$83.6 $89.6 $258.4 $270.4 
Interest incomeInterest income(5.8)(17.3)(27.2)(67.2)Interest income(7.0)(5.8)(18.0)(27.2)
Net investment (gains) losses on equity securities (Note 6)Net investment (gains) losses on equity securities (Note 6)246.8 (141.7)(270.1)(905.1)
Retirement benefit plansRetirement benefit plans(114.0)(52.2)(194.5)(157.9)Retirement benefit plans(72.6)(114.0)(217.1)(194.5)
Other income(128.7)(13.0)(743.6)(108.3)
Debt extinguishment loss (Note 6)Debt extinguishment loss (Note 6)405.2 — 405.2 — 
Other (income) expenseOther (income) expense(20.1)13.0 (34.1)161.5 
Other–net, (income) expenseOther–net, (income) expense$(158.9)$24.9 $(694.9)$(28.7)Other–net, (income) expense$635.9 $(158.9)$124.3 $(694.9)
For the three and nine months ended September 30, 2020, other income is primarily related to net gains on investments (see Note 7).
3439


Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition

Results of Operations

(Tables present dollars in millions, except per-share data)
General
Management’s discussion and analysis of results of operations and financial condition is intended to assist the reader in understanding and assessing significant changes and trends related to the results of operations and financial position of our consolidated company. This discussion and analysis should be read in conjunction with the consolidated condensed financial statements and accompanying footnotes in Part I, Item 1 of Part I of this Quarterly Report on Form 10-Q. Certain statements in this Part I, Item 2 of Part I of this Quarterly Report on Form 10-Q constitute forward-looking statements. Various risks and uncertainties, including those discussed in "Forward-Looking Statements" and "Risk Factors" in Part II, Item 1A of this Quarterly Report on Form 10-Q and “Risk Factors” in Part I, Item 1A “Risk Factors,” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2019,2020, may cause our actual results, financial position, and cash generated from operations to differ materially from these forward-looking statements.
Executive Overview
This section provides an overview of our financial results, recent product and late-stage pipeline developments, and other matters affecting our company and the pharmaceutical industry. Earnings per share (EPS) data are presented on a diluted basis.
COVID-19 Pandemic
In response to the COVID-19 pandemic, we have been focused on the following: maintaining a reliable supply of our medicines; reducing the strain on the medical system; developing potential treatments for COVID-19; keepingprotecting the health, safety, and well-being of our employees safe;employees; supporting our communities; and ensuring affordability of and access to our medicines, particularly insulin.
Our consolidated operating results during the nine months ended September 30, 2020 were negatively impacted by the COVID-19 pandemic, including as a result of decreases in new prescriptions. The COVID-19 pandemic could continue to have a negative impact on our business in the future depending upon the duration and depth of the effects of the pandemic. We have experienced negative impacts to our underlying business due to the COVID-19 pandemic, including decreases in new prescriptions, as a result of fewer patient visits to physician’s offices to begin or change treatment and changes in payer segment mix, and the increased use of patient affordability programs in the United States (U.S.) due to rising unemployment.. Additionally, we have experienced, and may continue to experience if the COVID-19 pandemic undergoes resurgent or more severe waves, decreased demand as a result of temporarily haltinglack of normal access and fewer in-person interactions by patients and our employees with the healthcare system. Prescriptions in most of our therapeutic areas have returned to pre-COVID-19 pandemic levels in the U.S., and healthcare systems in most of our major markets have largely resumed normal operations as of September 30, 2021. While a majority of in-person interactions by our employees with the healthcare providerssystem have resumed, we may decide to halt such activity in the future and, potentialin those cases, expect to resume such interactions as it is safe to do so and in compliance with applicable guidance and requirements. We may experience additional pricing pressures resulting from the fiscalfinancial strain of the COVID-19 pandemic on government-funded healthcare systems around the world. In addition, if the COVID-19 pandemic experiences resurgent or more severe waves, our ability to commercialize some assets in our product pipeline could be delayed or otherwise adversely affected.
We remain committed to discovering and developing new treatments forSince the patients we serve. At the beginningstart of the pandemic we paused new clinical trial startshave worked with a variety of organizations, including governmental agencies, to facilitate access to our COVID-19 therapies in various countries. The U.S. Food and enrollment in new trials in order to reduce the strain on the medical system, and in recent months we have resumed this activity in the majority of our clinical trials. The clinical trials for molecules in our late-stage pipeline are continuing, and currently we do not expect further delays as a result of COVID-19. In addition, we have made meaningful progress in developing potential COVID-19 treatments, including bamlanivimab (LY-CoV555), etesevimab (LY-CoV016), and baricitinib. We have submitted requests forDrug Administration (FDA) granted Emergency Use AuthorizationAuthorizations (EUA) for bamlanivimab monotherapy inand bamlanivimab and etesevimab administered together for higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19 and for baricitinib in combinationfor treatment with or without remdesivir in hospitalized COVID-19 patients. In April 2021, the FDA subsequently revoked the EUA for bamlanivimab alone. In the third quarter of 2021, the FDA expanded the EUA for bamlanivimab and etesevimab administered together to include post-exposure prophylaxis in certain individuals for the prevention of SARS-CoV-2 infection.
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We are actively working with a varietyhave, and will continue to, face unique risks and uncertainties in our development, manufacture, and uptake of organizations,potential treatments for COVID-19, including governmental agencies,vulnerability to facilitatesupply chain disruptions, higher manufacturing costs, difficulties in manufacturing appropriate quantities of our therapies, heightened regulatory scrutiny of our manufacturing practices, restrictions on administration that limit widespread and timely access to our potentialtherapies, and risks related to handling, return, and/or refund of product after delivery by us. Expedited authorization processes, including our EUA for bamlanivimab and etesevimab administered together, have allowed restricted distribution of products with less than typical safety and efficacy data, and additional data that become available have and may further call into question the safety or effectiveness of our COVID-19 treatmentstherapies. Additionally, the availability of superior or competitive therapies, including therapies that can be administered more easily, or preventative measures, such as vaccines, coupled with the transient nature of pandemics, have and could further negatively impact or eliminate demand for our COVID-19 therapies. Mutations or the spread of other variants of the coronavirus have in various countries. However, unexpected delayssome cases impacted the effectiveness of our COVID-19 therapies, and may further render our therapies more or less effective or ineffective. In addition, evolving regulatory priorities have intensified governmental scrutiny of our operations, including our compliance with Good Manufacturing Practices (cGMP), quality assurance, and similar regulations relating to our manufacture of COVID-19 therapies and other medicines. Any of these risks could prevent us from recouping our substantial investments in the timingresearch, development, and manufacture of our clinical trials,COVID-19 therapies. These risks could also affect other aspects of our business, including potentially resulting in delays or denials in regulatory reviews, could adversely affect our ability to commercialize some assets in our product pipeline if the current pandemic continues for a protracted period.approval or launch of other products.
Our ability to continue to operate without any significant negative impacts will in part depend on our ability to protect our employees and our supply chain. We have taken steps to protect our employees worldwide, with particular measures in place for those working in our manufacturing sites and distribution facilities. ForEffective November 2021, we are requiring COVID-19 vaccinations as a condition of employment in the nine months ended September 30, 2020, we wereU.S. and Puerto Rico. We have been able to largely maintain our normal operations. However, uncertainty resulting from the COVID-19 pandemic and its effects, including as may relate to our COVID-19 vaccination policy, could have an adverse impact on our manufacturing operations, global supply chain, and distribution systems, which could impact our ability to produce and distribute our products and the ability of third parties on which we rely to fulfill their obligations to us, and could increase our expenses. In addition, we are resuming in-person promotional activities when determined safe to do so.expenses if the COVID-19 pandemic experiences resurgent or more severe waves.
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Although the COVID-19 pandemic has had an impactaffected our operations and the demand for our products, it has not negatively impacted our liquidity position. We expect to continue to generate cash flows to meet our short-term liquidity needs and to have access to liquidity via the short-term and long-term debt markets. As part of our response to the COVID-19 pandemic, and at the request of the U.S. and international governments, we invested in large-scale manufacturing of COVID-19 antibodies at risk, in order to ensure rapid access to patients around the world. As the COVID-19 pandemic has continued to evolve during 2021, we have incurred a net inventory impairment charge related to our COVID-19 antibodies during the nine months ended September 30, 2021, primarily due to the combination of changes to current and forecasted demand from the U.S. and international governments, including changes to our agreement with the U.S. government, and near-term expiry dates of COVID-19 antibodies. We have also not observed any materialcould experience additional impairments of our assets, including inventory related to our COVID-19 antibodies, or a significant changechanges in the fair value of our assets due to the COVID-19 pandemic.pandemic, including as a result of the factors discussed above.
The degree to which the COVID-19 pandemic will continue to impact our future business operations, financial results and liquidity will depend on future developments, is highly uncertain, and cannot be predicted due to, among other things, the duration and spread of additional COVID-19 outbreaks, their severity, the actions to contain the virus or treat its impact, and how quickly and to what extent normal economic and operating conditions resume. Should the COVID-19 pandemic and any associated recession or depression continue for a prolonged period, our results of operations, financial condition, liquidity, and cash flows could be materially impacted by lower revenues and profitability and a lower likelihood of effectively and efficiently developing and launching new medicines. See “Risk Factors” in Part II,I, Item 1A of this Quarterlyour Annual Report on Form 10-Q10-K for the year ended December 31, 2020 for additional information on risk factors that could impact our results.
Elanco Animal Health (Elanco) Disposition
41

On March 11, 2019, we completed the disposition of our remaining 80.2 percent ownership of Elanco common stock through a tax-free exchange offer. As a result, we recognized a gain on the disposition of approximately $3.7 billion in the first quarter of 2019 and now operate as a single segment. See Note 5 to the consolidated condensed financial statements for further discussion.

Financial Results
The following table summarizes our key operating results:
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
20202019Percent Change20202019Percent Change20212020Percent Change20212020Percent Change
RevenueRevenue$5,740.6 $5,476.6 5$17,099.8 $16,205.5 6Revenue$6,772.8 $5,740.6 18$20,318.5 $17,099.8 19
Gross marginGross margin4,414.2 4,301.6 313,336.3 12,766.9 4Gross margin5,342.0 4,414.2 2115,055.9 13,336.3 13
Gross margin as a percent of revenueGross margin as a percent of revenue76.9 %78.5 %78.0 %78.8 %Gross margin as a percent of revenue78.9 %76.9 %74.1 %78.0 %
Operating expensesOperating expenses$3,034.5 $2,793.2 9$8,815.0 $8,529.3 3Operating expenses$3,286.8 $3,034.5 8$9,906.1 $8,815.0 12
Acquired in-process research and development (IPR&D)Acquired in-process research and development (IPR&D) 77.7 NM294.1 239.6 23Acquired in-process research and development (IPR&D)174.0 — NM498.3 294.1 69
Asset impairment, restructuring, and other special chargesAsset impairment, restructuring, and other special charges101.4 — NM161.3 423.9 (62)Asset impairment, restructuring, and other special charges 101.4 NM211.6 161.3 31
Net income from continuing operations1,208.4 1,253.9 (4)4,076.9 3,142.2 30
Net incomeNet income1,208.4 1,253.9 (4)4,076.9 6,822.7 (40)Net income1,110.1 1,208.4 (8)3,855.6 4,076.9 (5)
EPS from continuing operations1.33 1.37 (3)4.47 3.33 34
EPSEPS1.33 1.37 (3)4.47 7.24 (38)EPS1.22 1.33 (8)4.23 4.47 (5)
NM - not meaningful
Revenue increased for the three and nine months ended September 30, 20202021, primarily driven by increase in volume, partially offset by a decrease in realized prices.increased volume. Operating expenses, defined as the sum of research and development and marketing, selling, and administrative expenses, increased for the three andmonths ended September 30, 2021, primarily driven by higher development expenses for late-stage assets. Operating expenses increased for the nine months ended September 30, 2020,2021, primarily due todriven by higher development expenses for late-stage assets and higher research and development andexpenses for COVID-19 therapies, as well as higher marketing expenses. The decrease in net income and EPS for the three months ended September 30, 2020 was primarily driven by higher operating expenses and higher asset impairment, restructuring, and other special charges, partially offset by higher other income primarily due to higher net gains on investment securities and higher gross margin. The decrease in net income and EPS for the nine months ended September 30, 20202021 was primarily driven by approximately $3.7 billion gain recognized on the disposition of Elancohigher operating expenses and a reduction in the first quarter of 2019,other-net, (income) expense, partially offset by higher other income and higher gross margin.
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The following highlighted items also affect comparisons of our financial results for the three and nine months ended September 30, 20202021 and 2019:2020:
2021
Cost of Sales (See Note 5 to the consolidated condensed financial statements)
We recognized a net inventory impairment charge related to our COVID-19 antibodies of $435.1 million for the nine months ended September 30, 2021. As part of our response to the COVID-19 pandemic, and at the request of the U.S. and international governments, we invested in large-scale manufacturing of COVID-19 antibodies at risk, in order to ensure rapid access to patients around the world. As the COVID-19 pandemic has continued to evolve during 2021, we incurred a net inventory impairment charge primarily due to the combination of changes to current and forecasted demand from U.S. and international governments, including changes to our agreement with the U.S. government, and near-term expiry dates of COVID-19 antibodies.
Acquired IPR&D (See Note 3 to the consolidated condensed financial statements)
We recognized acquired IPR&D charges of $174.0 million and $498.3 million for the three and nine months ended September 30, 2021, respectively. The charges for the three months ended September 30, 2021 were related to business development transactions with Protomer Technologies Inc. (Protomer), Kumquat Biosciences Inc. (Kumquat), Lycia Therapeutics, Inc. (Lycia), and ProQR Therapeutics N.V. (ProQR). The charges for the nine months ended September 30, 2021 also included charges related to business development transactions with Rigel Pharmaceuticals, Inc. (Rigel), Precision BioSciences, Inc. (Precision), Merus N.V. (Merus), MiNA Therapeutics Limited (MiNA), and Asahi Kasei Pharma Corporation (Asahi).
Asset Impairment, Restructuring, and Other Special Charges (See Note 5 to the consolidated condensed financial statements)
We recognized charges of $211.6 million for the nine months ended September 30, 2021, primarily related to an intangible asset impairment resulting from the sale of the rights to Qbrexza®, as well as acquisition and integration costs associated with the acquisition of Prevail Therapeutics Inc. (Prevail).
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Other-Net, (Income) Expense (See Note 6 to the consolidated condensed financial statements)
We recognized a debt extinguishment loss of $405.2 million related to the repurchase of debt for the three and nine months ended September 30, 2021.
We recognized net investment (losses) gains on equity securities of ($246.8 million) and $270.1 million for the three and nine months ended September 30, 2021, respectively.
2020
Acquired IPR&D (Note(See Note 3 to the consolidated condensed financial statements)
We recognized acquired IPR&D charges of $294.1 million for the nine months ended September 30, 2020, related to both the acquisition of a pre-clinical stage companyPetra Pharma Corporation (Petra), as well as collaborationsbusiness development transactions with Sitryx Therapeutics Limited (Sitryx), AbCellera Biologics Inc. (AbCellera), Evox Therapeutics LtdLimited (Evox), and Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences).
Asset Impairment, Restructuring, and Other Special Charges (Note 6(See Note 5 to the consolidated condensed financial statements)
We recognized charges of $101.4 million and $161.3 million for the three and nine months ended September 30, 2020, respectively. The charges for the three and nine months ended September 30, 2020 wererespectively, primarily related to severance costs incurred as a result of actions taken worldwide to reduce our cost structure.
2019
Acquired IPR&D (Note 3 to the consolidated condensed financial statements)
We recognized acquired IPR&D charges of $77.7 million and $239.6 million for the three and nine months ended September 30, 2019, respectively. The charge for the three months ended September 30, 2019 was related to the collaborations with Centrexion Therapeutics Corporation (Centrexion) and AC Immune SA (AC Immune). The charges for the nine months ended September 30, 2019 also included charges related to collaborations with ImmuNext, Inc. (ImmuNext) and Avidity Biosciences, Inc. (Avidity).
Asset Impairment, Restructuring, and Other Special Charges (NoteOther-Net, (Income) Expense (See Note 6 to the consolidated condensed financial statements)
We recognized chargesnet investment gains on equity securities of $423.9$141.7 million and $905.1 million for the three and nine months ended September 30, 2019 primarily associated with the accelerated vesting of Loxo Oncology, Inc. (Loxo) employee equity awards as a result of the closing of the acquisition of Loxo.
Net Income from Discontinued Operations (Note 5 to the consolidated condensed financial statements)
We recognized a gain related to the disposition of Elanco of approximately $3.7 billion for the nine months ended September 30, 2019.2020, respectively.
Late-Stage Pipeline
Our long-term success depends to a great extent on our ability to continue tocontinually discover or acquire, develop, and developcommercialize innovative pharmaceutical products and acquire or collaborate on moleculesnew medicines. We currently in development by other biotechnology or pharmaceutical companies. We have approximately 40 potential new drugs45 candidates in human testingclinical development or under regulatory review, and a larger number of projects in preclinical research.the discovery phase.
The following new molecular entities (NMEs) and diagnostic agent have been approved by regulatory authorities in at least one of the major geographies for use in the conditions described. The first quarter in which the NMEs and diagnostic agent initially were approved in any major geography for any indication is shown in parentheses:
Flortaucipir** (Tauvid) (Q2 2020)—a positron emission tomography (PET) tracer intended to image tau (or neurofibrillary) tangles in the brain, which are an indicator of Alzheimer's disease.
Galcanezumab* (Emgality®) (Q3 2018)—a once-monthly subcutaneously injected calcitonin gene-related peptide (CGRP) antibody for the treatment of migraine prevention and the treatment of episodic cluster headache. Refer to Note 10 to the consolidated condensed financial statements for discussion of the legal proceedings involving Teva Pharmaceuticals International GMBH and Teva Pharmaceuticals USA, Inc.
Lasmiditan (Reyvow®) (Q4 2019)—an oral 5-HT1F agonist for the acute treatment of migraine.
Nasal glucagon* (Baqsimi®) (Q3 2019)—a glucagon nasal powder formulation for the treatment of severe hypoglycemia in patients with diabetes ages four years and above.
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Selpercatinib (Retevmo®) (Q2 2020)—an oral drug for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase, specifically thyroid cancer and lung cancer.
Ultra-rapid Lispro* (Lyumjev®) (Q1 2020)—an ultra-rapid insulin for the treatment of type 1 and type 2 diabetes.
The following NME has been submitted for regulatory review in at least one of the major geographies for potential use in the conditions described. The first quarter in which the NME initially was submitted in any major geography for any indication is shown in parentheses:
Tanezumab* (Q4 2019)—an anti-nerve growth factor monoclonal antibody for the treatment of osteoarthritis pain (in collaboration with Pfizer Inc. (Pfizer)).
The following NMEs are currently in Phase III clinical trial testing for potential use in the conditions described below buttrials or have not yet been submitted for regulatory review or have received first regulatory approval for any indication. The first quarter in which each NME initially entered Phase IIIthe U.S., Europe, or was acquired for any indication is shownJapan in parentheses:
Bamlanivimab (Q3 2020) - a monoclonal antibody directed against2021. In addition, the spike protein of SARS-CoV-2 for the prevention and treatment of COVID-19.
Lebrikizumab* (acquired in Q1 2020)—a monoclonal antibody designed for the treatment of moderate-to-severe atopic dermatitis (in collaboration with Almirall, S.A. in Europe).
Mirikizumab* (Q2 2018)—a monoclonal antibody designed for the treatment of autoimmune diseases.
Solanezumab* (Q2 2009)—an anti-amyloid beta monoclonal antibody for the treatment of preclinical Alzheimer’s disease.
Tirzepatide* (Q4 2018)—a long-acting, combination therapy of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 for the treatment of type 2 diabetes and obesity.
The following NME istable includes certain NMEs currently in potential registrationalPhase I or Phase II clinical trial testing for potential use in the condition described below but has not yet been submitted for regulatory approval for any indication. The first quarter in which the NME initially entered potential registrational Phase II clinical trial testing is shown in parentheses:
Etesevimab* (Q3 2020) - a neutralizing antibody in combination with bamlanivimab for the treatment of COVID-19.
*    Biologic molecule subject to the U.S. Biologics Price Competition and Innovation Act
**    Diagnostic agent
trials. The following table reflects the status of the recently approved products,these NMEs, and diagnostic agent set forth above, as well asincluding certain other developments to our late-stage pipeline since January 1, 2020:2021.
CompoundIndicationU.S.EuropeJapanStatusDevelopments
EndocrinologyCOVID-19 Therapies
BaqsimiBamlanivimab administered aloneSevere hypoglycemiaCOVID-19
LaunchedEmergency Use Authorization(1)
Approved in JapanAnnounced in the first quarter of 2020. Launched2021 that a Phase III trial met the primary and all key secondary endpoints. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion in the first quarter of 2021. In the second quarter of 2021 the FDA revoked the EUA for bamlanivimab alone in the U.S.
Bamlanivimab and etesevimab administered togetherCOVID-19Emergency Use AuthorizationAnnounced in the first quarter of 2021 that Phase III trials met the primary and all key secondary endpoints. Additional Phase III trial is ongoing. The FDA granted EUA for higher-risk patients recently diagnosed with mild-to-moderate COVID-19 in the first quarter of 2021. In the third quarter of 2021 the FDA expanded the EUA to include post-exposure prophylaxis in certain individuals for the prevention of SARS-CoV-2 infection. The EMA's CHMP issued a positive scientific opinion in the first quarter of 2021. Submitted in Europe in the first quarter of 2021. Announced a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses in the third quarter of 2021.
Bamlanivimab, etesevimab and bebtelovimab (LY-CoV1404) administered togetherCOVID-19Phase IIPhase II trial initiated in the second quarter of 2020. Launched in Japan in October 2020.
TirzepatideType 2 diabetesPhase IIIPhase III trials are ongoing.
ObesityPhase IIIPhase III trials are ongoing.
LyumjevType 1 and 2 diabetesLaunchedApproved in Europe and Japan in the first quarter of 2020. Approved in the U.S. in the second quarter of 2020. Launched in Japan in the second quarter of 2020. Launched in the U.S. and Europe in the third quarter of 2020.2021.
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CompoundIndicationU.S.EuropeJapanStatusDevelopments
VIR-7831 and bamlanivimab administered together(2)
COVID-19Phase IIPhase II trial initiated in the first quarter of 2021.
Endocrinology
TirzepatideType 2 diabetesSubmittedAnnounced in the first and second quarters of 2021 that Phase III trials met the primary and key secondary endpoints. Submitted in the U.S. using a priority review voucher and in Europe in October 2021. Additional Phase III trials are ongoing.
Heart failure with preserved ejection fractionPhase IIIPhase III trial initiated in the second quarter of 2021.
ObesityPhase III trials are ongoing.
Nonalcoholic steatohepatitisPhase IIPhase II trial is ongoing.
Basal Insulin-FcType 1 and 2 diabetesPhase IIPhase II trials are ongoing.
GGG Tri-AgonistObesityPhase IIPhase II trials initiated in the second quarter of 2021.
Type 2 diabetes
GLP-1R NPAObesityPhase IIPhase II trials initiated in the third quarter of 2021.
Type 2 diabetes
Immunology
BamlanivimabCOVID-19Phase IIIIn developmentPhase III trials were initiated during the third quarter of 2020. Submitted an initial request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization for monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.
EtesevimabCOVID-19In developmentIn combination with bamlanivimab, potential registrational Phase II trial was initiated during the third quarter of 2020.
Lebrikizumab(3)
Atopic dermatitisPhase III
AcquiredGranted FDA Fast Track designation(4). Announced in the Dermira acquisition in February 2020. Granted Fast Track Designation(1) by the FDA.third quarter of 2021 that Phase III trials met primary and all key secondary endpoints. Additional Phase III trials are ongoing.
MirikizumabCrohn's DiseasediseasePhase IIIPhase III trials are ongoing.
PsoriasisPhase IIIUlcerative colitisAnnounced in the thirdfirst quarter of 20202021 that a Phase III trialstrial met the primary and all key secondary endpoints. Additional Phase III
trials are ongoing.
PsoriasisNot pursuing submissionAnnounced in the second quarter of 2021 that we do not plan to pursue submission.
CXCR1/2 Ligands Monoclonal AntibodyHidradenitis suppurativaPhase IIPhase II trial is ongoing.
IL-2 ConjugateSystemic lupus erythematosusPhase IIPhase II trial is ongoing.
Ulcerative colitisPhase IIIII trial initiated in the second quarter of 2021.
PD-1 MAB AgonistRheumatoid arthritisPhase III trials are ongoing.IIPhase II trial initiated in the first quarter of 2021.
Neuroscience
EmgalityDonanemabCluster headacheEarly Alzheimer’s diseaseLaunchedSubmission initiated
Not approvedAnnounced in the first quarter of 2021 that a Phase II trial met the primary endpoint and that we expanded a Phase II trial to become a Phase III trial. Granted FDA Breakthrough Therapy designation
Not pursuing approval(5)European Medicines Agency did not approve in the second quarter of 2020. We do not plan to pursue approval in Europe.
Migraine preventionLaunchedSubmittedSubmitted to Japanese regulatory authorities in the first quarter of 2020.
TauvidAlzheimer's disease diagnosticApprovedNot pursuing approvalApproved2021. Initiated a rolling submission in the U.S. for accelerated approval in the secondthird quarter of 2020.
ReyvowAcute treatment of migraineLaunched2021. Additional Phase III trials are ongoing.Received Schedule V classification from the Drug Enforcement Agency and launched in the U.S. in the first quarter of 2020.
SolanezumabPreclinical Alzheimer's diseasePhase IIIAnnounced in the first quarter of 2020 that a Phase III trial for people with dominantly inherited Alzheimer's disease (DIAD) did not meet the primary endpoint. We do not plan to pursue submission for DIAD. Phase III trial is ongoing for Anti-Amyloid Treatment in Asymptomatic Alzheimer's.ongoing.
Epiregulin/TGFα MABChronic painPhase IIPhase II trials are ongoing.
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CompoundIndicationU.S.EuropeJapanStatusDevelopments
GBA1 Gene Therapy (PR001)Parkinson's diseasePhase II
Acquired in the Prevail acquisition in the first quarter of 2021. Granted FDA Fast Track designation(4). Phase II trials are ongoing.
GRN Gene Therapy (PR006)Frontotemporal dementiaPhase II
PACAP38 AntibodyChronic painPhase IIPhase II trial is ongoing.
SSTR4 AgonistChronic painPhase IIPhase II trials are ongoing.
TRPA1 AntagonistPainPhase IIPhase II trials initiated in October 2021.
Tanezumab(6)
Osteoarthritis painSubmittedDiscontinuedPhase IIIIn October 2021, in collaboration with Pfizer, we submitted todiscontinued the global clinical development program following receipt of a Complete Response Letter from the FDA and a negative opinion from the EMA's CHMP.
Cancer pain
ZagotenemabAlzheimer’s diseaseDiscontinuedAnnounced in October 2021 that a Phase II trial did not meet the fourth quarter of 2019, submittedprimary endpoint and we will discontinue development.
Oncology
Selpercatinib (Retevmo®)
Thyroid cancer
Launched(7)
Launched in Europe in the first quarter of 2020, and intend to pursue submission2021. Approved in Japan in 2020. The FDA intends to hold an Advisory Committee meeting, which is expected to occurthe third quarter of 2021. Phase III trials are ongoing.
Lung cancer
Sintilimab injection(8)
Lung cancerSubmittedIn collaboration with Innovent, submitted in March 2021, to discuss the submission.U.S. in the second quarter of 2021.
Cancer painImlunestrantER+HER2-metastic breast cancerPhase IIIPhase III trial is ongoing.initiated in October 2021.
Oncology
RetevmoPirtobrutinib (LOXO-305)Thyroid cancerLaunchedSubmittedChronic lymphocytic leukemiaPhase III
Granted accelerated approval(2) by the FDA based on Phase II data and launchedIII trials initiated in the U.S.first and third quarters of 2021.
Mantle cell lymphomaPhase IIIPhase III trial initiated in the second quarter of 2020. Phase III trials are ongoing.2021.
Lung cancerLaunchedSubmittedB-cell malignanciesPhase IIIIIPhase II trial initiated in the second quarter of 2021.
(1)EUAs remain active for certain countries outside of the U.S.
(2) In collaboration with Vir Biotechnology, Inc. and GlaxoSmithKline plc.
(3) The In collaboration with Almirall, S.A. (Almirall) in Europe.
(4) Fast Track Designationdesignation is designed to expedite the development and review of new therapies to treat serious conditions and address unmet medical needs.
(2)(5) Breakthrough Therapy designation is designed to expedite the development and review of potential medicines that are intended to treat a serious condition where preliminary clinical evidence indicates that the treatment may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
(6) In collaboration with Pfizer, Inc (Pfizer).
(7) Continued approval may be contingent on verification and description of clinical benefit in confirmatory Phase III trials.
(8) In collaboration with Innovent Biologics, Inc. (Innovent).
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Our pipeline also contains several new indication line extension (NILEX) products. The following certain NILEX products are currently in Phase II or Phase III clinical testing, have been submitted for regulatory review, or have received first regulatory approval in the U.S., Europe, or Japan for use in the indication described in 2021. The following table reflects the status of certain NILEX products, including certain other developments since January 1, 2021:
CompoundIndicationStatusDevelopments
Endocrinology
Empagliflozin (Jardiance®)(1)
Heart failure with reduced ejection fractionLaunchedLaunched in the U.S. and Europe in the third quarter of 2021.
Heart failure with preserved ejection fractionSubmitted
Granted FDA Fast Track designation(2). In the third quarter of 2021 the FDA granted Breakthrough Therapy designation(3). Announced in the third quarter of 2021 that a Phase III trial met the primary endpoint. Submitted in the U.S. and Europe in October 2021.
Chronic kidney diseasePhase III
Granted FDA Fast Track designation(2). Phase III trials are ongoing.
Immunology
Baricitinib (Olumiant®)
Atopic dermatitisLaunchedLaunched in Europe and Japan. Announced in the third quarter of 2021 that the FDA will not meet the Prescription Drug User Fee Act action date for the submission in the U.S.
COVID-19
Emergency Use Authorization(4)
Announced in the second quarter of 2021 that a Phase III trial evaluating baricitinib 4 mg once daily plus standard of care did not meet the primary endpoint, but did result in a significant reduction in death. In the third quarter of 2021, the FDA broadened the EUA for baricitinib to allow for treatment with or without remdesivir.
Alopecia areataSubmitted
Granted FDA Breakthrough Therapy designation(3). Announced in the first, second and third quarters of 2021 that Phase III trials met the primary and all key secondary endpoints. Submitted in Europe and Japan in the third quarter of 2021. We intend to submit to the FDA by the end of 2021.
Systemic lupus erythematosusPhase IIIPhase III trials are ongoing.
Oncology
Abemaciclib (Verzenio®)
HR+, HER2- Adjuvant breast cancerLaunchedAnnounced in the first quarter of 2021 patient-reported outcomes in combination with standard adjuvant endocrine therapy. Submitted in Japan in the first quarter of 2021. Launched in the U.S. in October 2021.
HR+, HER2+ Adjuvant breast cancerPhase IIIPhase III trial initiated in the second quarter of 2021.
Prostate cancerPhase IIIPhase III trial initiated in the third quarter of 2021.
(1) In collaboration with Boehringer Ingelheim.
(2) Fast Track designation is designed to expedite the development and review of new therapies to treat serious conditions and address unmet medical needs.
(3) Breakthrough Therapy designation is designed to expedite the development and review of potential medicines that are intended to treat a serious condition where preliminary clinical evidence indicates that the treatment may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
(4) The FDA granted EUA for treatment with or without remdesivir in hospitalized COVID-19 patients.
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Other Matters
Patent Matters
We depend on patents or other forms of intellectual property protection for most of our revenue, cash flows, and earnings.
Our formulationvitamin regimen patents for ForteoAlimta®expired in December 2018, and our use patents expired in August 2019 in major European marketscountries and the U.S. Both the formulation patentJapan in June 2021. We have faced, and the use patent expired in August 2019 in Japan. We expect further volume decline as a result of the entry ofremain exposed to, generic and biosimilar competition following the loss of patent exclusivity in these markets.major European countries and Japan, which has eroded revenue and is likely to continue to rapidly and severely erode revenue from current levels. In the aggregate,U.S., we expect that the decline in revenue will have a material adverse effect on our consolidated results of operations and cash flows.
Thevitamin regimen patent for Alimta® vitamin regimen patents, which we expect to provide us with patent protection for Alimta through June 2021 in Japan and major European countries, and through May 2022 in the U.S., have been challenged in each of these jurisdictions. In the U.S., most challenges have been finally resolved in our favor and one remains in active litigation. We2022. However, we and Eagle Pharmaceuticals, Inc. (Eagle) reached an agreement in December 2019 to settle all pending U.S. patent litigation, allowing Eagle a limited initial entry into the market with its product starting February 2022 (up to an approximate three-week supply) and subsequent unlimited entry starting April 2022. An unfavorable outcome to patent challenges in the U.S. could have a material adverse impact on our future consolidated results of operations, liquidity, and financial position.
We are aware that several companies have received approval to market generic versions of pemetrexed in major European markets (including generics currently on the market at risk in France and the Netherlands) and that additional generic competitors may choose to launch at risk. Following a final decision in the Supreme Court of Germany in July 2020 overturning the lower court and upholding the validity of our Alimta patent, several generics that were on the market at risk in Germany left. We have removed the remaining generics from the market in Germany by obtaining preliminary injunctions in our favor. In September 2020, the Paris Court of First Instance in France issued a final decision upholding the validity of our Alimta patent and found infringement by Fresenius Kabi’s (Kabi) pemetrexed product. The court issued an injunction against Kabi and provisionally awarded us damages. We will continue to pursue injunctions to remove remaining generics from the market in France. In late October 2020, the Court of Appeal of the Netherlands ruled in Lilly's favor and reinstated an order against Kabi prohibiting it from continuing to market its generic pemetrexed product in the Netherlands. Kabi's generic pemetrexed product was the only at risk generic on the market in the Netherlands. Although we will continue to seek to remove any such products in other European countries, generic product entry is resulting in some loss in revenue in these jurisdictions. Our vitamin regimen patents have also been challenged in other smaller European jurisdictions.
We expect that furtherthe entry of generic competition for Alimtain the U.S. following the loss of effective patent protectionexclusivity will cause a rapid and severe decline in future revenue for the product.and will have a material adverse effect on our consolidated results of operations and cash flows. See Note 109 to the consolidated condensed financial statements for a more detailed account of the legal proceedings currently pending in the U.S., Europe, and Japan regarding, among others, our Alimta patents.
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TheOur compound patent for Humalog® (insulin lispro) has expired in major markets. Global regulators have different legal pathways to approve similar versions of insulin lispro. A competitor launched a similar version of insulin lispro in certain European markets in 2017 and in the U.S. in the second quarter of 2018. While it is difficult to estimate the severity of the impact of insulin lispro products entering the market, we do not expect and have not experienced a rapid and severe decline in revenue; however, we expect additional pricing pressure and some loss of market share that would continue over time.
Our formulation and use patents for Forteo® have expired in major markets. We expect further decline in revenue as a result of the entry of generic and biosimilar competition due to the loss of patent exclusivity in major markets.
Our compound patent protection for Cymbalta® expired in Japan in January 2020. We expect genericshave faced, and remain exposed to, enter the market in mid-2021. We expect that the entry of generic competition will cause a rapid and severe decline infollowing the loss of exclusivity, which has eroded revenue and that the decline inis likely to continue to rapidly and severely erode revenue will have a material adverse effect on our consolidated results of operations and cash flows.from current levels.
Foreign Currency Exchange Rates
As a global company with substantial operations outside the U.S., we face foreign currency risk exposure from fluctuating currency exchange rates, primarily the U.S. dollar against the euro, Japanese yen, and Japanese yen.Chinese yuan. While we manage a portion of these exposures through hedging and other risk management techniques, significant fluctuations in currency rates can have a substantial impact, either positive or negative, on our revenue, cost of sales, and operating expenses. While there is uncertainty in the future movements in foreign exchange rates, fluctuations in these rates could negativelyadversely impact our future consolidated results of operations and cash flows.
Trends Affecting Pharmaceutical Pricing, Reimbursement, Access, and AccessOther Regulatory Matters
U.S.
In the U.S., publicGlobal concern over access to and affordability of pharmaceuticalspharmaceutical products continues to drive the regulatory and legislative debate. These policy and political issues increase the risk that taxes, fees, rebates, or other cost control measures may be enacted to manage federal and state budgets. Key health policy initiatives affecting biopharmaceuticals include:
the Coronavirus Aid, Relief and Economic Security (CARES) Act and subsequent stimulus bills that focus on ensuring availability and access to lifesaving drugs during a public health crisis,
foreign reference pricing in Medicare and private insurance,
modifications to Medicare Parts B and D,
provisions that would allow the Department of Health and Human Services to negotiate prices for biologics and drugs in Medicare,
a reduction in biologic data exclusivity,
proposals related to Medicaid prescription drug coverage and manufacturer drug rebates,
proposals that would require biopharmaceutical manufacturers to disclose proprietary drug pricing information, and
state-level proposals related to prescription drug prices and reducing the cost of pharmaceuticals purchased by government health care programs.

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On July 24, 2020 and September 13, 2020, U.S. President Donald Trump signed Executive Orders related to the 340B Prescription Drug Program, rebate reform in Medicare Part D, drug importation including insulin, and foreign reference pricing in Medicare Part B and Part D. If implemented, these Executive Orders could have a material adverse impact on our future consolidated results of operations, liquidity, and financial position. On September 1, 2020, Lilly announced it would distribute all 340B ceiling priced products directly to covered entities and their child sites only. Lilly provides 340B discounts to a contract pharmacy only if it is a wholly owned subsidiary of a covered entity, if a covered entity does not have an in-house pharmacy or, in the case of insulin, if the subject covered entity and its contract pharmacies agree to pass along the discount to patients without any markup for dispensing fees and without billing insurance or collecting duplicate discounts. Lilly has been transparent with regulators on its distribution activity and continues to comply with all 340B program requirements. Certain covered entities and their trade associations have threatened litigation, questioning whether Lilly’s program, and similar actions by other manufacturers, violate 340B program requirements. On October 9, 2020, three covered entities sued the Department of Health and Human Services (HHS) and the Health Resources and Services Administration seeking to compel the agencies to take enforcement action against Lilly and three other companies, among other requested relief. On October 21, 2020, a trade association representing certain covered entities sued HHS seeking to compel the agency to promulgate administrative dispute resolution regulations. The cases are pending and the impact of these cases and any subsequent litigation is uncertain.

California and several other states have enacted legislation related to prescription drug pricing transparency and it is unclear the effect this legislation will have on our business. Several states passed importation legislation, including Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont. Specifically, several of these states are actively working with the Administration to implement an importation program from Canada as early as 2020. We are currently reviewing this state legislation,debate, as well as corresponding proposed federal rulemaking and guidance publishedworldwide cost containment efforts by governmental authorities.Such measures may include the Departmentuse of Health and Human Services and the FDA, the impactmandated discounts, price reporting requirements, mandated reference prices, restrictive formularies, changes to available intellectual property protections, as well as other efforts. In addition, consolidation of which is uncertain at this time. Minnesota recently passed legislation requiring the establishment of two insulin patient assistance programs, effective July 1, 2020, the impact of which has been minimal to date and which we are continuing to assess.
In the private sector, consolidation and integration among healthcare providers is also a major factorpayors in the competitive marketplaceU.S. has significantly impacted the market for pharmaceuticals. Health plans,pharmaceuticals by increasing payor leverage in negotiating manufacturer price concessions and pharmacy benefit managers, wholesalers,reimbursement rates. We expect that these actions may intensify and other supply chain stakeholders have been consolidating into fewer, larger entities, increasingly through vertical integration, thus enhancing their purchasing strength and importance. Payers typically maintain formularies which specify coverage (the conditions under which drugs are included on a plan's formulary) and reimbursement (the associated out-of-pocket cost to the consumer). Formulary placement can lead to reduced usage of a drug for the relevant patient population due to coverage restrictions,could particularly affect certain products, such as prior authorizations and formulary exclusions, or due to reimbursement limitations that result in higher consumer out-of-pocket cost, such as non-preferred co-pay tiers, increased co-insurance levels and higher deductibles. Consequently, pharmaceutical companies compete for formulary placement not only on the basis of product attributes such as greater efficacy, fewer side effects, or greater patient ease of use, but also by providing rebates. Value-based agreements are another tool which may be utilized between payers and pharmaceutical companies as formulary placement and pricing are negotiated. Price is an increasingly important factor in formulary decisions, particularly in treatment areas in which the payer has taken the position that multiple branded products are therapeutically comparable. These downward pricing pressures could continue to negatively affect future consolidated results of operations. In addition to formulary placement, changes in insurance designs continue to drive greater consumer cost sharing through high deductible plans and higher co-insurance or co-pays (including co-pay accumulator and maximizer programs). We continue to invest in patient affordability solutions (resulting in lower revenue) in an effort to assist patients in affording their medicines.
The main coverage expansion provisions of the Affordable Care Act (ACA) are currently in effect through both state-based exchanges and the expansion of Medicaid. A trend has been the prevalence of benefit designs containing high out-of-pocket costs for patients, particularly for pharmaceuticals. In addition to the coverage expansions, many employers in the commercial market continue to evaluate strategies such as private exchanges and wider use of consumer-driven health plans to reduce their healthcare liabilities over time. Federal legislation, litigation, or administrative actions to repeal or modify some or all of the provisions of the ACA could have a material adverse effect on our consolidated results of operations and cash flows. At the same time, the broader paradigm shift towards performance-based reimbursement and the launch of several value-based purchasing initiatives have placed demands on the pharmaceutical industry to offer products with proven real-world outcomes data and a favorable economic profile.
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International
International operations also are generally subject to extensive price and market regulations. Cost-containment measures exist in a number of countries, including additional price controls and mechanisms to limit reimbursement for our products. Such policies are expected to increase in impact and reach, given the pressures on national and regional health care budgets that come from a growing, aging population and ongoing economic challenges. As additional reforms are finalized, we will assess their impact on future revenues. In addition, governments in many emerging markets are becoming increasingly active in expanding health care system offerings. Given the budget challenges of increasing health care coverage for citizens, policies may be proposed that promote generics and biosimilars only and reduce current and future access to branded human pharmaceutical products. The COVID-19 pandemic is also creating additional pressure on health systems worldwide. As a result, cost containment and other measures may intensifyinsulin, as governments manage and emerge from the pandemic.pandemic, which could adversely affect our business. It is not possible to predict the potential adverse impact to us or the general pharmaceutical industry of continued cost containment efforts.
In addition, evolving regulatory priorities have intensified governmental scrutiny of our operations and our industry, including with respect to cGMP, quality assurance, and similar regulations, and increased focus on business combinations in our industry. Any regulatory issues concerning these matters could lead to regulatory and legal actions, product recalls and seizures, fines and penalties, interruption of production leading to product shortages, import bans or denials of import certifications, delays or denials in the approvals of new products pending resolution of the issues, impediments to the completion of business combinations, and reputational harm, any of which would adversely affect our business.
See “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020. See also Note 9 to the consolidated condensed financial statements.
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Tax Matters
We are subject to income taxes and various other taxes in the U.S. and in many foreign jurisdictions; therefore, changes in both domestic and international tax laws or regulations could adversely affect our effective tax rate, results of operations, and cash flows. Countries around the world, including the U.S., are actively considerconsidering and enactenacting tax law changes. Tax proposals introduced by Congress and the Biden administration contain significant changes, including increases to the tax rates at which both domestic and foreign income of U.S. companies would be taxed. Further, actions taken with respect to tax-related matters by associations such as the Organisation for Economic Co-operation and Development and the European Commission could influence tax policy in countries in which we operate. ModificationsIn addition, global tax authorities routinely examine our tax returns and are expected to U.S. and foreign tax laws or regulations are frequently enacted andbecome more aggressive in their examinations of profit allocations among jurisdictions, which could result in material impacts toadversely impact our future consolidated results of operations and financial position.cash flows.
Acquisitions
We strategically invest in external research and technologies that we believe to complement and strengthen our own efforts. These investments can take many forms, including acquisitions, strategic alliances, collaborations, investments, and licensing arrangements, collaborations, and acquisitions.arrangements. We view our business development activity as an important way to achieve our strategies, as we seek to bolster our pipeline and enhance shareholder value. We continue tocontinuously evaluate business development transactions that have the potential to strengthen our business.
In 2019, we acquired all shares of Loxo for a purchase price of $6.92 billion, net of cash acquired. Under the terms of the agreement, we acquired a pipeline of investigational medicines, including selpercatinib (Retevmo), an oral RET inhibitor, and LOXO-305, an oral BTK inhibitor. In the second quarter of 2020, the FDA approved selpercatinib (Retevmo) under its Accelerated Approval regulations and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
In February 2020, we acquired all shares of Dermira, Inc. for a purchase price of $849.3 million, net of cash acquired. Under the terms of the agreement, we acquired lebrikizumab, a novel, investigational, monoclonal antibody being evaluated for the treatment of moderate-to-severe atopic dermatitis. Lebrikizumab was granted Fast Track designation from the FDA. We also acquired Qbrexza® cloth, a medicated cloth for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating). During the nine months ended September 30, 2021, we sold the rights to Qbrexza. See Note 5 to the consolidated condensed financial statements for additional information.
In January 2021, we acquired all shares of Prevail for a purchase price that included $22.50 per share in cash (or an aggregate of $747.4 million, net of cash acquired) plus one non-tradable contingent value right (CVR) per share. The CVR entitles Prevail stockholders up to an additional $4.00 per share in cash (or an aggregate of approximately $160 million) payable, subject to certain terms and conditions, upon the first regulatory approval of a Prevail product in one of the following countries: U.S., Japan, United Kingdom, Germany, France, Italy, or Spain. Under the terms of the agreement, we acquired a gene therapy program for patients with neurodegenerative diseases.
See Note 3 to the consolidated condensed financial statements for further discussion regarding our recent acquisitions.
Legal Matters
Information regarding contingencies relating to certain legal proceedings can be found in Item 1, "Legal Proceedings," of Part II of this Quarterly Report on Form 10-Q and is incorporated here by reference.
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                                                                                                                                            Revenue
The following table summarizes our revenue activity by region:
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
20202019Percent Change20202019Percent Change20212020Percent Change20212020Percent Change
U.S. (1)
U.S. (1)
$3,161.4 $3,060.2 3$9,631.4 $9,203.5 5
U.S. (1)
$3,989.6 $3,161.4 26$11,635.1 $9,631.4 21
Outside U.S.Outside U.S.2,579.3 2,416.4 77,468.5 7,002.1 7Outside U.S.2,783.3 2,579.3 88,683.4 7,468.5 16
RevenueRevenue$5,740.6 $5,476.6 5$17,099.8 $16,205.5 6Revenue$6,772.8 $5,740.6 18$20,318.5 $17,099.8 19
Numbers may not add due to rounding.
(1) U.S. revenue includes revenue in Puerto Rico.
The following are components of the change in revenue compared with the prior year:
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
2020 vs. 20192020 vs. 20192021 vs. 20202021 vs. 2020
U.S.Outside U.S.ConsolidatedU.S.Outside U.S.ConsolidatedU.S.Outside U.S.ConsolidatedU.S.Outside U.S.Consolidated
VolumeVolume%12 %%10 %15 %12 %Volume22 %11 %17 %22 %15 %19 %
PricePrice(4)(7)(5)(5)(7)(6)Price(4)— (1)(3)(2)
Foreign exchange ratesForeign exchange rates— — (1)— Foreign exchange rates— — 
Percent changePercent change3 %7%5 %%%6 %Percent change26 %%18 %21 %16 %19 %
Numbers may not add due to rounding.
In the U.S. for the three and nine months ended September 30, 2020,2021, the increase in volume was primarily driven by COVID-19 therapies, Trulicity®, Taltz®, Humalog, Emgality, and Verzenio®, partially offset by lower volume for Cialis®, Forteo, and TrajentaTaltz®. In the U.S. for the three months ended September 30, 2020,2021, the decreaseincrease in realized prices was primarily driven by lower utilization in the 340B program, unfavorable changes to estimates for rebates and discounts most notably impactingfor Trulicity as well asin the three months ended September 30, 2020, and modest list prices increases, partially offset by increased rebates to gain and maintain broad commercial access for products across the portfolio, partially offset by modest listbusiness. U.S. price increases. In the U.S. forperformance was not a major driver during the nine months ended September 30, 2020,2021, as increased utilization in more highly-rebated segments was largely offset by lower utilization in the decrease in realized prices was340B program, primarily driven by changes to estimates for rebates and discounts and changes to segment mix.the diabetes portfolio.
Outside the U.S. for the three and nine months ended September 30, 2020,2021, the increase in volume was primarily driven by Tyvyt®,COVID-19 therapies, Trulicity, Alimta, Olumiant®, Verzenio, Taltz, and Jardiance®, partially offset by decreased volume for Forteo and Trajenta®. The increase in volume for Tyvyt and Alimta was driven primarily by their inclusion in government reimbursement programs in China.Taltz. Outside the U.S. for the three and nine months ended September 30, 2020,2021, the decreaseincrease in realized pricesvolume was also driven primarily by the inclusionsale of Tyvyt and Alimtaour rights to Cialis® in government reimbursement programs in China and bi-annual government mandated price decreases in Japan.

China.










4449



The following table summarizes our revenue activity by product for the three months ended September 30, 20202021 and 2019:2020:
Three Months Ended September 30,Three Months Ended September 30,
2020201920212020
ProductProduct
U.S. (1)
Outside U.S.TotalTotalPercent ChangeProductU.S.Outside U.S.TotalTotalPercent Change
TrulicityTrulicity$791.2 $315.4 $1,106.6 $1,011.5 9Trulicity$1,201.4 $398.8 $1,600.1 $1,106.6 45
Humalog (2)(1)
Humalog (2)(1)
390.1 266.9 656.9 648.9 1
Humalog (2)(1)
347.3 279.4 626.7 656.9 (5)
TaltzTaltz422.2 170.9 593.1 454.5 30
AlimtaAlimta291.9 286.1 578.0 508.2 14Alimta297.2 159.8 457.0 578.0 (21)
Taltz326.2 128.3 454.5 340.0 34
Olumiant (2)
Olumiant (2)
194.0 212.9 406.9 162.0 NM
Jardiance (3)
Jardiance (3)
163.3 147.5 310.8 240.7 29
Jardiance (3)
221.2 169.2 390.4 310.8 26
VerzenioVerzenio199.6 135.9 335.5 234.4 43
Humulin®
Humulin®
214.0 91.9 305.9 321.8 (5)
Humulin®
193.4 93.4 286.7 305.9 (6)
Cyramza®
Cyramza®
84.8 168.6 253.4 252.7 
COVID-19 antibodies (4)
COVID-19 antibodies (4)
215.5 1.6 217.1 — NM
ForteoForteo144.6 122.3 266.9 370.7 (28)Forteo109.6 91.3 200.9 266.9 (25)
Cyramza®
94.5 158.2 252.7 240.0 5
Basaglar®
Basaglar®
178.5 69.7 248.2 263.2 (6)
Basaglar®
114.7 78.1 192.8 248.2 (22)
Verzenio158.9 75.5 234.4 157.2 49
Emgality®
Emgality®
99.9 40.1 140.0 91.5 53
Erbitux®
Erbitux®
114.0 20.3 134.3 136.4 (2)
CymbaltaCymbalta11.1 175.5 186.6 178.6 5Cymbalta7.0 125.1 132.0 186.6 (29)
CialisCialis15.1 147.3 162.5 184.3 (12)Cialis(6.5)137.4 130.9 162.5 (19)
Olumiant14.5 147.5 162.0 114.6 41
Erbitux®
122.5 14.0 136.4 128.6 6
Tyvyt®
Tyvyt®
 125.6 125.6 84.4 49
Zyprexa®
Zyprexa®
21.2 91.5 112.7 105.4 7
Zyprexa®
13.0 88.7 101.7 112.7 (10)
Trajenta (4)
19.4 72.3 91.7 155.5 (41)
Emgality81.4 10.1 91.5 47.7 92
Other productsOther products123.1 259.3 382.2 459.7 (17)Other products161.5 286.3 447.7 389.6 15
RevenueRevenue$3,161.4 $2,579.3 $5,740.6 $5,476.6 5Revenue$3,989.6 $2,783.3 $6,772.8 $5,740.6 18
Numbers may not add due to rounding.
NM - not meaningful
(1) U.S. revenue includes revenue in Puerto Rico.
(2) Humalog revenue includes insulin lispro.
(2) Olumiant revenue includes sales for baricitinib, for treatment in hospitalized COVID-19 patients, that were made pursuant to EUA.
(3) Jardiance revenue includes Glyxambi®, Synjardy®, and Trijardy® XR.
(4) Trajenta revenue includes Jentadueto®.COVID-19 antibodies include sales for bamlanivimab administered alone as well as sales for bamlanivimab and etesevimab administered together and were made pursuant to EUAs.
4550



The following table summarizes our revenue activity by product for the nine months ended September 30, 20202021 and 2019:2020:
Nine Months Ended September 30,Nine Months Ended September 30,
2020201920212020
ProductProduct
U.S. (1)
Outside U.S.TotalTotalPercent ChangeProduct
U.S. (1)
Outside U.S.TotalTotalPercent Change
TrulicityTrulicity$2,673.2 $892.5 $3,565.7 $2,919.7 22Trulicity$3,465.7 $1,122.5 $4,588.2 $3,565.7 29
Humalog (2)(1)
Humalog (2)(1)
1,070.4 837.4 1,907.8 2,057.3 (7)
Humalog (2)(1)
1,009.0 842.3 1,851.3 1,907.8 (3)
AlimtaAlimta933.4 743.8 1,677.2 1,585.1 6Alimta911.9 714.7 1,626.6 1,677.2 (3)
TaltzTaltz942.9 350.3 1,293.2 946.3 37Taltz1,071.6 493.8 1,565.4 1,293.2 21
COVID-19 antibodies (2)
COVID-19 antibodies (2)
949.5 226.7 1,176.2 — NM
Jardiance (3)
Jardiance (3)
566.8 492.1 1,058.9 840.3 26
VerzenioVerzenio582.1 363.7 945.8 631.1 50
HumulinHumulin642.5 292.7 935.2 942.1 (1)Humulin633.5 290.3 923.8 935.2 (1)
Olumiant (4)
Olumiant (4)
236.5 572.6 809.1 446.7 81
CyramzaCyramza266.3 496.3 762.5 748.4 2
BasaglarBasaglar638.7 203.7 842.3 805.4 5Basaglar423.3 226.8 650.1 842.3 (23)
Jardiance (3)
453.0 387.3 840.3 676.2 24
ForteoForteo386.7 405.2 791.9 1,044.4 (24)Forteo330.1 287.7 617.8 791.9 (22)
Cyramza277.6 470.8 748.4 680.1 10
Verzenio430.0 201.1 631.1 400.6 58
CialisCialis(3.1)541.8 538.7 486.2 11
CymbaltaCymbalta30.5 546.5 576.9 529.9 9Cymbalta30.3 454.0 484.3 576.9 (16)
Cialis64.6 421.6 486.2 692.7 (30)
Olumiant39.0 407.7 446.7 299.1 49
EmgalityEmgality313.5 102.2 415.7 252.9 64
ErbituxErbitux356.1 40.6 396.7 406.4 (2)Erbitux357.7 45.9 403.7 396.7 2
TyvytTyvyt 340.2 340.2 205.9 65
ZyprexaZyprexa41.5 266.2 307.7 317.0 (3)Zyprexa28.3 264.5 292.8 307.7 (5)
Trajenta (4)
64.5 197.2 261.7 441.4 (41)
Emgality229.3 23.6 252.9 96.3 NM
Other productsOther products357.5 780.4 1,137.9 1,365.6 (17)Other products462.1 805.1 1,267.3 1,193.7 6
RevenueRevenue$9,631.4 $7,468.5 $17,099.8 $16,205.5 6Revenue$11,635.1 $8,683.4 $20,318.5 $17,099.8 19
Numbers may not add due to rounding.
NM - not meaningful
(1) U.S. revenue includes revenue in Puerto Rico.
(2) Humalog revenue includes insulin lispro.
(2) COVID-19 antibodies include sales for bamlanivimab administered alone as well as sales for bamlanivimab and etesevimab administered together and were made pursuant to EUAs.
(3) Jardiance revenue includes Glyxambi, Synjardy, and Trijardy XR.
(4) TrajentaOlumiant revenue includes Jentadueto.sales for baricitinib, for treatment in hospitalized COVID-19 patients, that were made pursuant to EUA.

Revenue of Trulicity, a treatment for type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adult patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors, increased 552 percent and 2130 percent in the U.S. during the three and nine months ended September 30, 2020,2021, respectively, driven by increased demand and, to a lesser extent, higher realized prices due to segment mix, including lower utilization in the 340B program, and modest list price increases, partially offset by lower realized prices.increased rebates to maintain access. Trulicity's lowerhigher realized prices in the U.S. during the three months ended September 30, 20202021 were primarilyalso due to unfavorable changes to estimates for rebates and discounts higher contracted rebates and changes to segment mix, partially offset by modest list price increases. Trulicity's lower realized prices in the U.S. during the ninethree months ended September 30, 2020 were primarily due to changes to segment mix and higher contracted rebates, partially offset by modest list price increases.2020. Revenue outside the U.S. increased 23 percent and 26 percent during the three and nine months ended September 30, 2020, respectively,2021, driven primarily by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates, partially offset by lower realized prices.
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Revenue of Humalog, an injectable human insulin analog for the treatment of diabetes, increased 10decreased 11 percent and 6 percent in the U.S. during the three months ended September 30, 2020, driven primarily by higher demand. Revenue decreased 11 percent in the U.S. during theand nine months ended September 30, 2020,2021, respectively, driven by lower realized prices, due to changes in estimates for rebates and discounts, reflecting both a favorable adjustment in the Medicaid segment in the second quarter of 2019 and an unfavorable adjustment in the commercial segment in the second quarter of 2020, partially offset by an increase inincreased demand. Revenue outside the U.S. decreased 9increased 5 percent during the three months ended September 30, 2020, primarily2021, driven by decreased volume.the favorable impact of foreign exchange rates and increased volume, partially offset by lower realized prices. Revenue outside the U.S. decreased 2increased 1 percent during the nine months ended September 30, 2020,2021, primarily driven primarily by the unfavorablefavorable impact of foreign exchange rates. Included in the revenue of Humalog in the U.S. are our own insulin lispro authorized generics, which began launching in the second quarter of 2019 in order to lower out-of-pocket costs for patients.rates, largely offset by decreased volume. While it is difficult to estimate the severity of the impact of similar insulin lispro products entering the market, we do not expect and have not experienced a rapid and severe decline in revenue. DueHowever, due to the impact of competition and due to pricing pressure in the U.S. and some international markets, we expect some price decline and loss of market share to continue over time.
Revenue of Alimta, a treatment for various cancers, increased 32 percent in the U.S. during the three months ended September 30, 2020,2021, primarily driven by increased volume and, to a lesser extent, higher realized prices.prices, partially offset by decreased demand and customer buying patterns. Revenue increased 3decreased 2 percent in the U.S. during the nine months ended September 30, 2020,2021, primarily driven by decreased demand, partially offset by higher realized prices. Revenue outside the U.S. increased 27 percent and 9decreased 44 percent during the three months ended September 30, 2021, primarily driven by decreased volume due to entry of generic competition and, to a lesser extent, lower realized prices. Revenue outside the U.S. decreased 4 percent during the nine months ended September 30, 2020, respectively, primarily2021, driven by increasedlower realized prices and decreased volume, in Germany and China, partially offset by lower realized prices.the favorable impact of foreign exchange rates. We have faced and remain exposed to generic entrycompetition following the loss of exclusivity in multiplemajor European countries and Japan in June 2021, which has eroded revenue and is likely to continue to rapidly and severely erode revenue in those countries from current levels. We expect the limited entry of generic competition in the U.S. starting February 2022 and subsequent unlimited entry starting April 2022. We expect that the entry of generic competition following the loss of exclusivity in the U.S. will cause a rapid and severe decline in revenue. See "Executive Overview - Other Matters- Patent Matters" for more information.
Revenue of Taltz, a treatment for moderate-to-severe plaque psoriasis, active psoriatic arthritis, ankylosing spondylitis, and active non-radiographic axial spondyloarthritis, increased 3029 percent and 3514 percent in the U.S. during the three and nine months ended September 30, 2020,2021, respectively, primarily driven by increased demand, and, to a lesser extent, higher realized prices. Revenue outside the U.S. increased 44 percent during the three months ended September 30, 2020, primarily driven by increased volume. Revenue outside the U.S. increased 42 percent during the nine months ended September 30, 2020, driven primarily by increased volume, partially offset by lower realized prices.
Revenue of Humulin, an injectable human insulin for the treatment of diabetes, decreased 2 percentprices due to increased rebates to gain commercial access. Taltz's lower realized prices in the U.S. during the three months ended September 30, 2020,2021 were also driven by lower realized prices and lower volume. Revenue remained essentially flat in the U.S. during the nine months ended September 30, 2020, as increased volume was largely offset by lower realized prices. Revenue outside the U.S. decreased 11 percent driven primarily by decreased volume,unfavorable segment mix, partially offset by higher realized prices. Revenue outside the U.S. decreased 3 percent during the nine months ended September 30, 2020, duechanges to the unfavorable impact of foreign exchange ratesestimates for rebates and decreased volume, partially offset by higher realized prices.
Revenue of Basaglar, a long-acting human insulin analog for the treatment of diabetes, decreased 12 percent in the U.S. during the three months ended September 30, 2020, driven by lower realized prices and, to a lesser extent, decreased demand caused by competitive pressures. Revenue in the U.S. increased 1 percent during nine months ended September 30, 2020, primarily driven by increased demand, partially offset by lower realized prices.discounts. Revenue outside the U.S. increased 1533 percent and 1841 percent during the three and nine months ended September 30, 2020,2021, respectively, driven by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates, partially offset by lower realized prices. See Note 4
Revenue of COVID-19 antibodies, treatments that were authorized pursuant to EUAs for mild to moderate COVID-19 for higher-risk patients and for post-exposure prophylaxis in certain individuals for the consolidated condensed financial statementsprevention of SARS-CoV-2 infection, was $215.5 million and $949.5 million in the U.S. during the three and nine months ended September 30, 2021, respectively. Revenue outside the U.S. was $1.6 million and $226.7 million during the three and nine months ended September 30, 2021, respectively. The availability of superior or competitive therapies, including therapies that can be administered more easily, or preventative measures, such as vaccines, coupled with the transient nature of pandemics, have and could further negatively impact or eliminate demand for information regardingthese COVID-19 antibodies. In addition, mutations or the spread of other variants of the coronavirus have in some cases impacted the effectiveness of our collaboration with Boehringer Ingelheim involving Basaglar.COVID-19 antibodies, and may further render our antibodies more or less effective or ineffective.
Revenue of Jardiance, a treatment for type 2 diabetes, and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and established cardiovascular disease, and to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction, increased 1635 percent and 1125 percent in the U.S. during the three and nine months ended September 30, 2020,2021, respectively, primarily driven by increased demand. Revenue outside the U.S. increased 47 percent and 4515 percent during the three andmonths ended September 30, 2021, driven by increased volume, partially offset by the unfavorable impact of foreign exchange rates. Revenue outside the U.S. increased 27 percent during the nine months ended September 30, 2020, respectively,2021, driven by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates. See Note 4 to the consolidated condensed financial statements for information regarding our collaboration with Boehringer Ingelheim involving Jardiance.
4752


Revenue of Forteo, an injectableVerzenio, a treatment for osteoporosis in postmenopausal womenHR+, HER2- metastatic breast cancer and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women, decreased 17early breast cancer, increased 26 percent in the U.S. during the three months ended September 30, 2020,2021, driven by lowerincreased demand, partially offset by higherlower realized prices. Revenue in the U.S. decreased 18of Verzenio increased 35 percent in the U.S. during the nine months ended September 30, 2020,2021, primarily driven primarily by lowerincreased demand. Revenue outside the U.S. decreased 37increased 80 percent and 2981 percent during the three and nine months ended September 30, 2020,2021, respectively, primarily driven by decreased volume and lower realized prices. We expect further volume decline as a result of the anticipated entry of generic and biosimilar competition following the loss of patent exclusivity in the third quarter of 2019 in the U.S., Japan, and major European markets. See "Executive Overview - Other Matters - Patent Matters" for more information.increased volume.
Revenue of Cyramza, aHumulin, an injectable human insulin for the treatment for various cancers, increased 14of diabetes, decreased 10 percent and 121 percent in the U.S. during the three and nine months ended September 30, 2020,2021, respectively, driven by increased demandlower realized prices and higher realized prices.decreased demand. Revenue outside the U.S. was relatively flat forincreased 2 percent during the three months ended September 30, 2020.2021, driven by higher realized prices and, to a lesser extent, the favorable impact of foreign exchange rates, largely offset by decreased volume. Revenue outside the U.S. fordecreased 1 percent during the nine months ended September 30, 20202021, driven by decreased volume, largely offset by the favorable impact of foreign exchange rates and higher realized prices.
Revenue of Olumiant, a treatment for adults with moderately-to-severely active rheumatoid arthritis, and of baricitinib, a treatment authorized pursuant to EUA, with or without remdesivir, of hospitalized patients with COVID-19, increased 9$179.5 million and $197.5 million in the U.S. during the three and nine months ended September 30, 2021, respectively, driven by utilization for the treatment of hospitalized patients with COVID-19 during the third quarter of 2021. Revenue outside the U.S. increased 44 percent and 40 percent during the three and nine months ended September 30, 2021, respectively, driven by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates, partially offset by lower realized prices.
Revenue of Verzenio,Cyramza, a treatment for a certain type of metastatic breast cancer, increased 27various cancers, decreased 10 percent and 334 percent in the U.S. during the three and nine months ended September 30, 2020,2021, respectively, primarily driven by increaseddecreased demand, and, to a lesser extent,partially offset by higher realized prices. Revenue outside the U.S. increased $43.1 million7 percent and $124.0 million during5 percent for the three and nine months ended September 30, 2020,2021, respectively, primarily driven by increased volume. In addition, the increase in revenue outside the U.S. for the three months ended September 30, 2021 was partially offset by lower realized prices and the unfavorable impact of foreign exchange rates.

4853


Gross Margin, Costs, and Expenses

Gross margin as a percent of revenue decreased 1.6increased 2.0 percentage points to 76.978.9 percent and 0.8decreased 3.9 percentage points to 78.074.1 percent for the three and nine months ended September 30 2020,2021, respectively. The decreaseincrease in gross margin percent for the three months ended September 30, 20202021 was primarily due to the unfavorablefavorable product mix and favorable effect of foreign exchange rates on international inventories sold, higher intangibles amortization expense related to the launch of Retevmosold. The decrease in the second quarter of 2020, and lower realized prices on revenue, partially offset by greater manufacturing efficiencies and favorable product mix. The decreasegross margin percent for the nine months ended September 30, 20202021 was primarily driven by lower gross margin on COVID-19 therapies, including the impact of $435.1 million of a net inventory impairment charge related to our COVID-19 antibodies. As part of our response to the COVID-19 pandemic, and at the request of the U.S. and international governments, we invested in large-scale manufacturing of COVID-19 antibodies at risk, in order to ensure rapid access to patients around the world. As the COVID-19 pandemic has continued to evolve during 2021, we incurred a net inventory impairment charge primarily due to lower realized prices on revenue, the unfavorable effectcombination of foreign exchange rates onchanges to current and forecasted demand from U.S. and international inventories sold, and higher intangibles amortization expense related to Retevmo, partially offset by favorable product mix, the charges in 2019 resulting from the withdrawal of Lartruvo®governments, including changes to our agreement with the U.S. government, and greater manufacturing efficiencies.near-term expiry dates of COVID-19 antibodies.
Research and development expenses increased 617 percent to $1.471.71 billion and 19 percent to $4.25$5.07 billion for the three and nine months ended September 30, 2020,2021, respectively. The increase in research and development expenses for the three and nine months ended September 30, 2020 was2021 was primarily driven primarily by approximately $125 million of higher development expenses for COVID-19 antibody therapies and baricitinib in the third quarter of 2020. In addition, thelate-stage assets. The increase in research and development expenses for the threenine months ended September 30, 20202021 was partially offsetalso driven by lowerhigher research and development expenses for late-stage assets.COVID-19 therapies.
Marketing, selling, and administrative expenses increased 111 percent to $1.57$1.58 billion and 16 percent to $4.57 $4.84 billion for the three and nine months ended September 30, 2020,2021, respectively. The increase in marketing, selling, and administrative expenses for the nine months ended September 30, 2021 was primarily driven by lower marketing expenses for the nine months ended September 30, 2020 due to pandemic-related spending reductions.
We recognized $174.0 million and $498.3 million of acquired IPR&D charges for the three and nine months ended September 30, 2021, respectively. The charges for the three months ended September 30, 2020, was primarily due2021 were related to higher marketing expense, reflecting increased promotionbusiness development transactions with Protomer, Kumquat, Lycia, and ProQR. The charges for the nine months ended September 30, 2021 also included charges related to physiciansbusiness development transactions with Rigel, Precision, Merus, MiNA, and consumers in connection with increases in healthcare utilization around the world.
Asahi. We recognized $294.1 million of acquired IPR&D charges for the nine months ended September 30, 2020. The2020, related to the acquisition of Petra, as well as business development transactions with Sitryx, AbCellera, Evox, and Junshi Biosciences.
We recognized asset impairment, restructuring, and other special charges of $211.6 million for the nine months ended September 30, 2020 were2021, primarily related to an intangible asset impairment resulting from the sale of the rights to Qbrexza, as well as acquisition and integration costs associated with the acquisition of a pre-clinical stage company as well as collaborations with Sitryx, AbCellera, Evox Therapeutics Ltd and Junshi Biosciences. We recognized $77.7 million and $239.6 million of acquired IPR&D charges for the three and nine months ended September 30, 2019, respectively. The charge for the three months ended September 30, 2019 related to the collaborations with Centrexion and AC Immune. The nine months ended September 30, 2019 also included charges related to the collaborations with ImmuNext and Avidity. See Note 3 to the consolidated condensed financial statements for additional information.
Prevail. We recognized asset impairment, restructuring, and other special charges of $101.4 million and $161.3 million for the three and nine months ended September 30, 2020, respectively. The charges for the three months ended September 30, 2020 respectively, primarily related to severance costs incurred as a result of actions taken worldwide to reduce our cost structure. The chargesstructure.
Other–net, (income) expense was expense of $635.9 million and $124.3 million for the three and nine months ended September 30, 2020 also included acquisition and integration costs as part of the closing of the acquisition of Dermira. We recognized asset impairment, restructuring, and other special charges of $423.9 million during the nine months ended September 30, 2019, which included $400.7 million related to the acquisition of Loxo, substantially all of which was associated2021, respectively, compared with the accelerated vesting of Loxo employee equity awards.
Other–net, (income) expense was income of $158.9 million and $694.9 million for the three and nine months ended September 30, 2020, respectively, compared withrespectively. The decrease in other-net, (income) expense of $24.9 million and income of $28.7 million for the three months ended September 30, 2021 was driven primarily by a debt extinguishment loss of $405.2 million related to the repurchase of debt and unfavorable mark-to-market adjustments on investments in equity securities during the three months ended September 30, 2021 compared to favorable mark-to-market adjustments on investments in equity securities during the three months ended September 30, 2020. The decrease in other-net, (income) expense for the nine months ended September 30, 2019, respectively. The increase in other income2021 was driven by higher net gainslower favorable mark-to-market adjustments on investment securities.investments in equity securities and a debt extinguishment loss of $405.2 million related to the repurchase of debt, partially offset by income from patent settlements in Europe for Alimta.
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The effective tax rate was 10.9 percent for the three months ended September 30, 2021, compared with 15.9 percent for the three months ended September 30, 2020, compared with 10.82020. The effective tax rate was 10.7 percent for the threenine months ended September 30, 2019. The effective tax rate was2021, compared with 14.4 percent for the nine months ended September 30, 2020, compared with 12.8 percent2020. The lower effective tax rate for the ninethree months ended September 30, 2019. The higher effective2021 was primarily due to the income tax rates for the threeimpact of a debt extinguishment loss and nine months ended September 30, 2020 were driven primarilyunfavorable mark-to-market adjustments on investments in equity securities, partially offset by a mix of earnings in higher tax jurisdictions and a lower net discrete tax benefit compared to the same periodthree months ended September 30, 2020. The lower effective tax rate for the nine months ended September 30, 2021 was primarily due to the income tax impacts of a net inventory impairment charge related to our COVID-19 antibodies and a debt extinguishment loss, as well as higher acquired IPR&D charges and lower favorable mark-to-market adjustments on investments in 2019.equity securities compared to the nine months ended September 30, 2020, partially offset by a lower net discrete tax benefit compared to the nine months ended September 30, 2020.

4955


Financial Condition and Liquidity    
We believe our available cash and cash equivalents, together with our ability to generate operating cash flow and our access to short-term and long-term borrowings, are sufficient to fund our existing and planned capital requirements. For a discussion of our capital requirements, see “Management's Discussion and Analysis of Results of Operations and Financial Condition” in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2020.
Cash and cash equivalents increased to $3.60$3.79 billion as of September 30, 2020,2021, compared with $2.34$3.66 billion as of December 31, 2019. Net cash provided by operating activities for the nine months ended September 30, 2019 included approximately $360 million of cash paid to settle the accelerated vesting of Loxo employee equity awards (see Note 6 to the consolidated condensed financial statements).2020. Refer to the consolidated condensed statements of cash flows for additional information on the significant sources and uses of cash for the nine months ended September 30, 20202021 and 2019.2020.
In addition to our cash and cash equivalents, we held total investments of $2.51$3.39 billion and $2.06$2.99 billion as of September 30, 20202021 and December 31, 2019,2020, respectively. See Note 76 to the consolidated condensed financial statements for additional information.
Total debt increasedIn January 2021, we acquired all shares of Prevail for a purchase price that included $22.50 per share in cash (or an aggregate of $747.4 million, net of cash acquired) plus one non-tradable CVR per share. The CVR entitles Prevail stockholders up to $16.92 billion as of September 30, 2020, compared with $15.32 billion as of December 31, 2019. The increase primarily related to the net proceeds from the issuance of $1.00 billion of 2.25 percent fixed-rate notes in May 2020, as well as the net proceeds from the issuance of an additional $250.0 million$4.00 per share in cash (or an aggregate of 2.25 percent fixed-rate notesapproximately $160 million) payable, subject to certain terms and the issuance of $850.0 million of 2.50 percent fixed-rate notes in August 2020. We used the net proceeds from the sale of these notes for general corporate purposes, which included the repayment of outstanding commercial paper used to fund a portion of the purchase price for ourconditions. The acquisition of Dermira.was funded primarily through cash on hand. See Note 73 to the consolidated condensed financial statements for additional information.
As of September 30, 2020,2021, total debt was $17.09 billion, an increase of $490.1 million compared with $16.60 billion as of December 31, 2020. In September 2021, we issued euro-denominated notes consisting of €500.0 million of 1.125 percent fixed-rate notes due in September 2051 and €700.0 million of 1.375 percent fixed-rate notes due in September 2061, with interest to be paid annually, and British pound-denominated notes consisting of £250.0 million of 1.625 percent fixed-rate notes due in September 2043, with interest to be paid annually. We paid $1.91 billion of the net cash proceeds from the offering to purchase and redeem certain higher interest rate U.S. dollar-denominated notes with an aggregate principal amount of $1.50 billion. We used the remaining net proceeds from the offering to prefund certain 2022 debt maturities and for general corporate purposes In addition, in September 2021, we issued euro-denominated notes consisting of €600.0 million of 0.50 percent fixed-rate notes due in September 2033, with interest to be paid annually. The net proceeds from the offering will be used to fund, in whole or in part, eligible projects designed to advance one or more of our environmental, social, and governance objectives. See Note 6 to the consolidated condensed financial statements for additional information.
As of September 30, 2021, we had a total of $5.21$5.24 billion of unused committed bank credit facilities, $5.00 billion of which is available to support our commercial paper program. We believe that amounts accessible through existing commercial paper markets should be adequate to fund short-term borrowing needs.
During the nine months ended September 30, 2020,2021, we repurchased $500.0 million of shares under our $8.00 billion share repurchase program authorized in June 2018. As of September 30, 2020,2021, we had $1.00 billion$500.0 million remaining under this program.
We believe that cash generated from operations, along with available cash and cash equivalents, will be sufficient to fund our normal operating needs, including installment payments of the one-time repatriation transition tax In May 2021 we authorized an additional $5.00 billion share repurchase program. There were no shares repurchased under the U.S. Tax Cuts and Jobs Act of 2017 (also known as the Toll Tax), dividends paid to shareholders, share repurchases under our$5.00 billion share repurchase program and capital expenditures.during the nine months ended September 30, 2021.
During the nine months ended September 30, 2021, we paid dividends of approximately $2.31 billion, or $2.55 per share, to our shareholders. In October 2021, we declared a dividend for the fourth quarter of 2021 of $0.85 per share on outstanding common stock. The dividend of approximately $770 million is payable on December 10, 2021 to shareholders of record at the close of business on November 15, 2021.
See "Executive Overview - Other Matters - Patent Matters" for information regarding recent and upcoming losses of patent protection.
Both domestically and abroad, we continue to monitor the potential impacts of the economic environment; the creditworthiness of our wholesalers and other customers, including foreign government-backed agencies and suppliers; the uncertain impact of health care legislation; various international government funding levels; and changesfluctuations in interest rates, foreign currency exchange rates (see "Executive Overview - Other Matters - Foreign Currency Exchange Rates")., and fair values of equity securities.

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Financial Expectations
We have updated certain elements of our 20202021 financial guidance to reflect management's current expectations for underlying business performance.on a reported basis.
Earnings per share for 20202021 are now expected to be in the range of $6.20$6.38 to $6.40.$6.48.
Key management assumptions related to the COVID-19 pandemic that support our 2020 guidance include:
Healthcare activity will continue the positive trends seen in the third quarter of 2020, returning to historical levels as health care providers utilize telehealth or in-person visits to see patients despite additional COVID-19 outbreaks;
New patient prescriptions will continue to improve in the U.S.;
Pricing headwinds from increased utilization of patient affordability programs and changes in segment mix due to increased U.S. unemployment will continueWe now anticipate 2021 revenue to be modest; and
Promotional spend will constitute a mix of in-person customer interactions, direct-to-consumer advertising and investments in digital promotion.
We still expect 2020 revenue between $23.7$27.2 billion and $24.2$27.6 billion. Achieving the higher end of the range would likely require the inclusion of moderateThis increase reflects additional revenue from potential COVID-19 treatments, whichantibodies and the underlying core business. Estimated revenue from COVID-19 antibodies is possible but not certain at this point. Revenue growth is stillnow expected to be driven by volume from Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant, Emgality, Baqsimi, Tyvyt, and Retevmo. Revenue growth is expected to be partially offset by lower revenue for products that have lost patent exclusivity. Revenue growth is also expected to be partially offset by a mid-single digit net price decline in the U.S. (driven primarily by rebates and legislated increases to Medicare Part D cost sharing, and patient affordability programs), as well as net price declines in China, Japan and Europe.$1.3 billion.
Gross margin as a percent of revenue for 2021 is stillunchanged and expected to be approximately 7875 percent. Research and development expenses for 2021 are unchanged and remain in the range of $6.9 billion to $7.1 billion. Marketing, selling, and administrative expenses for 2021 are now expected to beunchanged and remain in the range of $6.0$6.2 billion to $6.1 billion, reflecting additional savings from reduced travel, meetings, and promotional activities. Research and development expenses are now expected to be in the range of $5.8 billion to $5.9 billion, with current expectations trending towards the higher end of the range, reflecting additional COVID-19 investments. We anticipate our full-year 2020 COVID-19 research and development expenses to be approximately $400 million. Other—net, (income) expense$6.4 billion.
Acquired IPR&D is now expected to be $498.3 million reflecting charges related to business development transactions with Lycia Therapeutics, Inc. and ProQR Therapeutics N.V. recognized during the three months ended September 30, 2021.
Other—net, (income) expense for 2021 is now expected to be expense in the range of $450$150 million to $600$250 million, reflecting the impact of income, reflecting additional gainsa debt extinguishment loss related to the repurchase of debt and unfavorable mark-to-market adjustments on investmentinvestments in equity securities induring the third quarter of 2020.three months ended September 30, 2021.
The 2020 effective tax rate for 2021 is stillnow expected to be approximately 14 percent.11 percent, reflecting primarily the tax impact of the charges associated with a debt extinguishment loss related to the repurchase of debt and acquired IPR&D, as well as unfavorable mark-to-market adjustments on investments in equity securities during the three months ended September 30, 2021.

Available Information on our Website
We make available through our company website, free of charge, our company filings with the Securities and Exchange Commission (SEC) as soon as reasonably practicable after we electronically file them with, or furnish them to, the SEC. The reports we make available include annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements, registration statements, and any amendments to those documents.
The website link to our SEC filings is http://investor.lilly.com/sec.cfmfinancial-information/sec-filings. The information contained in, or that can be accessed through, our website is not a part of, or incorporated by reference in, this quarterly report.Quarterly Report.
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Item 4. Controls and Procedures
(a)Evaluation of Disclosure Controls and Procedures. Under applicable SEC regulations, management of a reporting company, with the participation of the principal executive officer and principal financial officer, must periodically evaluate the company’s “disclosure controls and procedures,” which are defined generally as controls and other procedures of a reporting company designed to ensure that information required to be disclosed by the reporting company in its periodic reports filed with the SEC (such as this Quarterly Report on Form 10-Q) is recorded, processed, summarized, and reported on a timely basis.
Our management, with the participation of David A. Ricks, chairman, president and chief executive officer, and Joshua L. Smiley,Anat Ashkenazi, senior vice president and chief financial officer, evaluated our disclosure controls and procedures (as such terms are defined in our Annual Report on Form 10-K for the year ended December 31, 2020) as of September 30, 2020,2021, and concluded that they were effective.
(b)Changes in Internal Controls. During the third quarter of 2020,2021, there were no changes in our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. Other Information
Item 1. Legal Proceedings
We are a party to various currently pending legal actions, government investigations, and environmental proceedings. See Note 109 to the consolidated condensed financial statements for information on various legal proceedings, including but not limited to:
The patent litigation and administrative proceedings involving Alimta, Jardiance, Taltz, and Emgality;
The litigation related to the Cosmopolis facility in Brazil; and
Pricing litigation, investigations, and inquiries.
That information is incorporated into this Item by reference.proceedings.
This Item should be read in conjunction with the Legal Proceedings disclosures"Legal Proceedings" in Part I, Item 3 of our Annual Report on Form 10-K for the year ended December 31, 2019 (Part I, Item 3) and our Quarterly Reports on Form 10-Q for the quarters ended 2020.March 31, 2020 and June 30, 2020 (Part II, Item 1).
Other Matters
We and Boehringer Ingelheim Pharmaceuticals, Inc., a subsidiary of Boehringer Ingelheim (BI), are named as a defendant in approximately 90 product liability lawsuits in the U.S., mostly in Stamford Superior Court in Connecticut, alleging that Jardiance caused or contributed to plaintiffs’ Fournier’s gangrene. We believe these lawsuits are without merit and are defending against them vigorously. Our agreement with BI calls for BI to defend and indemnify us against any damages, costs, expenses, and certain other losses with respect to product liability claims in accordance with the terms of the agreement.

We are also a defendant in other litigation and investigations, including relating to product liability, patent, employment, and premises liability matters, of a character we regard as normal to our business.

Item 1A. Risk Factors
Our material risk factors are disclosed in "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019. The following represents a change in our2020. There have been no material changes from the risk factors from those listedpreviously disclosed in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019.2020.
The novel coronavirus (COVID-19) pandemic and efforts to reduce its spread has impacted, and may in future periods negatively impact, our business and operations.
The COVID-19 pandemic has substantially burdened healthcare systems worldwide. Progression of clinical trials and required inspections and reviews by regulatory agencies may be delayed due to the focus of resources on COVID-19 as well as travel and other restrictions. Significant delays in the timing of our clinical trials and in regulatory reviews could adversely affect our ability to commercialize some assets in our product pipeline. Lack of normal access by patients to the healthcare system, along with concern about the continued supply of medications, also resulted in changes in buying patterns throughout the supply chain, including by patients, which could increase or decrease demand for our products. Similarly, where COVID-19 outbreaks continue, we temporarily halt in-person interactions by our employees with healthcare providers and resume such activity when it is safe to do so. This may decrease demand for our products. COVID-19 could also have an adverse impact on our manufacturing operations, supply chain and distribution systems, which could impact our ability to produce and distribute our products and the ability of third parties on which we rely to fulfill their obligations to us, and could increase our expenses. Therapeutics that we may develop to address COVID-19 will be subject to risks in addition to those normally associated with pharmaceutical research, development, and commercialization, such as higher risk of technical failure; lower and transient opportunities for revenue; higher manufacturing costs, including take or pay contracts with contract manufacturing organizations; product safety or efficacy risks related to an expedited research and development timeline; and novel liability theories. These risks may affect our ability to commercialize these therapeutics for COVID-19 or any other current or future indication. In addition, the conditions created by the pandemic may intensify other risks inherent in our business, including, among other things, risks related to drug pricing and access, intellectual property protection, product safety and efficacy concerns, product liability and other litigation, and the impact of adverse global and local economic conditions.
As a result, while the financial impact on us has not been material to date, given the rapid and evolving nature of the virus, the COVID-19 pandemic could negatively affect our results of operations, financial condition, liquidity and cash flows in future periods, perhaps materially. The degree to which the COVID-19 pandemic affects us will depend on developments that are highly uncertain and beyond our knowledge or control, including, but not limited
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to, the duration and severity of the pandemic, the actions taken to reduce its transmission, and the speed with which, and extent to which, more stable economic and operating conditions resume. Should the COVID-19 pandemic and any associated recession or depression continue for a prolonged period, our results of operations, financial condition, liquidity, and cash flows could be materially impacted by lower revenues and profitability and a lower likelihood of effectively and efficiently developing and launching new medicines.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Information relating to the principal market for our common stock and related shareholder matters is described in "Management's Discussion and Analysis of Results of Operations and Financial Condition" in Part II, Item 7 and in "Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters" in Part III, Item 12 of our Annual Report on Form 10-K for the year ended December 31, 2020.
The following table summarizes the activity related to repurchases of our equity securities during the three months ended September 30, 2020:2021:
PeriodTotal Number of
Shares Purchased
(in thousands)
Average Price Paid 
per Share
Total Number of Shares
Purchased as Part of
Publicly Announced
Plans or Programs
(in thousands)
Approximate Dollar Value
of Shares that May Yet Be
Purchased Under the
Plans or Programs
(in millions)
July 20202021— $— — $1,000.05,500.0 
August 20202021— — — 1,000.05,500.0 
Sept 2020September 2021— — — 1,000.05,500.0 
Total— — — 
During the three months ended September 30, 2020,2021, we did not repurchase any shares under our $8.00 billion or $5.00 billion share repurchase programprograms authorized in June 2018.2018 and May 2021, respectively.
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Item 6. Exhibits
The following documents are filed as exhibits to this Report:
EXHIBIT 3.1Amended Articles of Incorporation
EXHIBIT 3.2Bylaws, as amended
EXHIBIT 18.1Preferability Letter from Independent Registered Public Accounting Firm Regarding Change in Accounting Principle
EXHIBIT 31.1Rule 13a-14(a) Certification of David A. Ricks, Chairman, President, and Chief Executive Officer
EXHIBIT 31.2Rule 13a-14(a) Certification of Joshua L. Smiley, Senior Vice President and Chief Financial Officer
EXHIBIT 32.Section 1350 Certification
EXHIBIT 101.Interactive Data Files
EXHIBIT 104.Cover Page Interactive Data File
(i) Long-term debt instruments under which the total amount of securities authorized does not exceed 10% of our consolidated assets are not filed as exhibits to this report. We will furnish a copy of these agreements to the SEC upon request.
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Index to Exhibits
The following documents are filed as a part of this Quarterly Report:
Exhibit  Description
EXHIBIT 3.1
EXHIBIT 3.2
EXHIBIT 18.1
EXHIBIT 31.1  
EXHIBIT 31.2  
EXHIBIT 32.  
EXHIBIT 101.  Interactive Data Files (embedded within the Inline XBRL document)
EXHIBIT 104.Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
(i) Long-term debt instruments under which the total amount of securities authorized does not exceed 10% of our consolidated assets are not filed as exhibits to this Quarterly Report. We will furnish a copy of these agreements to the SEC upon request.

Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
ELI LILLY AND COMPANY
(Registrant)
Date:October 28, 202027, 2021/s/Joshua L. SmileyAnat Ashkenazi
Joshua L. SmileyAnat Ashkenazi
Senior Vice President and Chief Financial Officer
Date:October 28, 202027, 2021/s/Donald A. Zakrowski
Donald A. Zakrowski
Vice President, Finance, and Chief Accounting Officer
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