UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

Quarterly Report Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

For the quarterly period ended September 30, 2022

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 Class	Trading Symbols	Name of Each Exchange On Which Registered
Common Stock (no par value)	LLY	New York Stock Exchange
7 1/8% Notes due 2025	LLY25	New York Stock Exchange
1.625% Notes due 2026	LLY26	New York Stock Exchange
2.125% Notes due 2030	LLY30	New York Stock Exchange
0.625% Notes due 2031	LLY31	New York Stock Exchange
0.500% Notes due 2033	LLY33	New York Stock Exchange
6.77% Notes due 2036	LLY36	New York Stock Exchange
1.625% Notes due 2043	LLY43	New York Stock Exchange
1.700% Notes due 2049	LLY49A	New York Stock Exchange
1.125% Notes due 2051	LLY51	New York Stock Exchange
1.375% Notes due 2061	LLY61	New 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 Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☒	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No ☒

The number of shares of common stock outstanding as of October 28, 2022:

Class	Number of Shares Outstanding
Common	950,177,900

Eli Lilly and Company

Form 10-Q

For the Quarter Ended September 30, 2022

Table of Contents

		Page
PART I. Financial Information		5
Item 1.	Financial Statements	5
	Consolidated Condensed Statements of Operations	5
	Consolidated Condensed Statements of Comprehensive Income	6
	Consolidated Condensed Balance Sheets	7
	Consolidated Condensed Statements of Equity	8
	Consolidated Condensed Statements of Cash Flows	10
	Notes to Consolidated Condensed Financial Statements	11
Item 2.	Management's Discussion and Analysis of Results of Operations and Financial Condition	37
	Executive Overview	37
	Revenue	45
	Gross Margin, Costs, and Expenses	49
	Financial Condition and Liquidity	50
	Critical Accounting Estimates	51
	Available Information on our Website	51
Item 4.	Controls and Procedures	52
PART II. Other Information		53
Item 1.	Legal Proceedings	53
Item 1A.	Risk Factors	53
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	53
Item 6.	Exhibits	54
Signatures		54

2

Forward-Looking Statements

This Quarterly Report on Form 10-Q and 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 (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 be identified by the use of words such as "may," "believe," "will," "expect," "project," "estimate," "intend," "anticipate," "plan," "continue," or similar expressions or future or conditional verbs.

Forward-looking statements inherently involve many risks and uncertainties that could cause actual results to differ materially from those expressed in forward-looking statements. Where, in any forward-looking statement, we 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 or any future pandemic, epidemic, or similar public health threat and the global response thereto;

•uncertainties related to our efforts to develop, manufacture, and distribute 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 obtaining regulatory approvals;

•the impact and outcome of acquisitions and business development transactions and related integration costs;

•the expiration of intellectual property protection for certain of our products and competition from generic and/or biosimilar 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;

•market uptake of recently 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 information technology 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, disruptions, or shortages, including as a result of demand, labor shortages, third-party performance, or regulatory actions relating to our facilities;

•reliance on third-party relationships and outsourcing arrangements;

•regulatory changes or other 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;

•devaluations in foreign currency exchange rates, changes in interest rates, and inflation;

•changes in tax law, tax rates, or events that differ from our assumptions related to tax positions;

•asset impairments and restructuring charges;

•the impact of global macroeconomic conditions, trade disruptions, global disputes, unrest, war, or other costs, uncertainties and risks related to engaging in business in foreign jurisdictions;

•changes in accounting and reporting standards promulgated by the Financial Accounting Standards Board and the Securities and Exchange Commission (SEC); and

•regulatory compliance problems or government investigations.

3

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 our Annual Report on Form 10-K for the year ended December 31, 2021, particularly under the caption "Risk Factors." Investors should understand that it is not possible to predict or identify all such factors and should not consider the risks described above and under Part I, Item 1A, "Risk Factors" of our Annual Report on Form 10-K to be a complete statement of all potential risks and uncertainties.

All forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are expressly qualified in their entirety by the cautionary statements included in or incorporated by reference into this 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 Quarterly Report on Form 10-Q.

4

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,
	2022		2021		2022		2021
Revenue (Note 2)	$	6,941.6	$	6,772.8	$	21,239.6	$	20,318.5
Costs, expenses, and other:
Cost of sales	1,579.1		1,430.8		5,081.7		5,262.6
Research and development	1,802.9		1,705.3		5,194.9		5,032.4
Marketing, selling, and administrative	1,614.2		1,577.9		4,797.2		4,839.6
Acquired in-process research and development and development milestones (Note 3)	62.4		177.6		668.4		532.4
Asset impairment, restructuring, and other special charges (Note 5)	206.5		—		206.5		211.6
Other–net, (income) expense (Note 11)	111.0		635.9		580.9		124.3
	5,376.1		5,527.5		16,529.6		16,002.9
Income before income taxes	1,565.5		1,245.3		4,710.0		4,315.6
Income taxes (Note 7)	113.8		135.2		402.9		460.0
Net income	$	1,451.7	$	1,110.1	$	4,307.1	$	3,855.6
Earnings per share:
Basic	$	1.61	$	1.22	$	4.78	$	4.25
Diluted	$	1.61	$	1.22	$	4.76	$	4.23
Shares used in calculation of earnings per share:
Basic	900.7		906.7		901.8		907.7
Diluted	903.8		910.8		904.5		911.7

See notes to consolidated condensed financial statements.

5

Consolidated Condensed Statements of Comprehensive Income

(Unaudited)

ELI LILLY AND COMPANY AND SUBSIDIARIES

(Dollars in millions)

	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net income	$	1,451.7	$	1,110.1	$	4,307.1	$	3,855.6
Other comprehensive income (loss), net of tax (Note 10)	(8.1)		114.4		47.3		323.7
Comprehensive income	$	1,443.6	$	1,224.5	$	4,354.4	$	4,179.3

See notes to consolidated condensed financial statements.

6

Consolidated Condensed Balance Sheets

ELI LILLY AND COMPANY AND SUBSIDIARIES

(Dollars in millions)

	September 30, 2022		December 31, 2021
Assets	(Unaudited)
Current Assets
Cash and cash equivalents (Note 6)	$	2,617.4	$	3,818.5
Short-term investments (Note 6)	124.7		90.1
Accounts receivable, net of allowances of $17.7 (2022) and $22.5 (2021)	6,715.3		6,672.8
Other receivables	1,609.5		1,454.4
Inventories	3,831.1		3,886.0
Prepaid expenses and other	2,741.9		2,530.6
Total current assets	17,639.9		18,452.4
Investments (Note 6)	2,574.6		3,212.6
Goodwill	3,891.6		3,892.0
Other intangibles, net	7,124.1		7,691.9
Deferred tax assets	2,384.3		2,489.3
Property and equipment, net of accumulated depreciation of $10,074.0 (2022) and $9,976.7 (2021)	9,311.3		8,985.1
Other noncurrent assets	4,535.7		4,082.7
Total assets	$	47,461.5	$	48,806.0
Liabilities and Equity
Current Liabilities
Short-term borrowings and current maturities of long-term debt	$	1,744.6	$	1,538.3
Accounts payable	1,683.2		1,670.6
Employee compensation	984.1		958.1
Sales rebates and discounts	8,568.4		6,845.8
Dividends payable	—		885.5
Income taxes payable	685.6		126.9
Other current liabilities	1,986.9		3,027.5
Total current liabilities	15,652.8		15,052.7
Other Liabilities
Long-term debt	14,143.8		15,346.4
Accrued retirement benefits (Note 8)	1,832.5		1,954.1
Long-term income taxes payable	3,641.7		3,920.0
Deferred tax liabilities	171.9		1,733.7
Other noncurrent liabilities	1,852.9		1,644.3
Total other liabilities	21,642.8		24,598.5
Commitments and Contingencies (Note 9)
Eli Lilly and Company Shareholders' Equity
Common stock	594.1		596.3
Additional paid-in capital	6,829.0		6,833.4
Retained earnings	10,006.5		8,958.5
Employee benefit trust	(3,013.2)		(3,013.2)
Accumulated other comprehensive loss (Note 10)	(4,295.8)		(4,343.1)
Cost of common stock in treasury	(50.5)		(52.7)
Total Eli Lilly and Company shareholders' equity	10,070.1		8,979.2
Noncontrolling interests	95.8		175.6
Total equity	10,165.9		9,154.8
Total liabilities and equity	$	47,461.5	$	48,806.0

See notes to consolidated condensed financial statements.

7

Consolidated Condensed Statements of Equity

(Unaudited)

ELI LILLY AND COMPANY AND SUBSIDIARIES

	Equity of Eli Lilly and Company Shareholders
(Dollars in millions, except per-share data, and shares in thousands)	Common Stock			Additional Paid-in Capital		Retained Earnings		Employee Benefit Trust		Accumulated Other Comprehensive Loss		Common Stock in Treasury(1)			Noncontrolling Interests
	Shares	Amount										Shares	Amount
Balance at July 1, 2021	957,038	$	598.1	$	6,669.2	$	8,530.1	$	(3,013.2)	$	(6,287.1)	463	$	(52.7)	$	219.1
Net income (loss)						1,110.1									(22.6)
Other comprehensive income, net of tax										114.4
Issuance of stock under employee stock plans, net	14	0.1		(1.3)
Stock-based compensation				90.1
Other						(0.8)									0.6
Balance at September 30, 2021	957,052	$	598.2	$	6,758.0	$	9,639.4	$	(3,013.2)	$	(6,172.7)	463	$	(52.7)	$	197.1
Balance at July 1, 2022	950,619	$	594.1	$	6,746.0	$	8,556.0	$	(3,013.2)	$	(4,287.7)	450	$	(50.5)	$	114.5
Net income (loss)						1,451.7									(15.7)
Other comprehensive loss, net of tax										(8.1)
Issuance of stock under employee stock plans, net	8			(2.1)
Stock-based compensation				85.1
Other						(1.2)									(3.0)
Balance at September 30, 2022	950,627	$	594.1	$	6,829.0	$	10,006.5	$	(3,013.2)	$	(4,295.8)	450	$	(50.5)	$	95.8

(1) As of September 30, 2022, there was $3.25 billion remaining under our $5.00 billion share repurchase program authorized in 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 Stock			Additional Paid-in Capital		Retained Earnings		Employee Benefit Trust		Accumulated Other Comprehensive Loss		Common Stock in Treasury(1)			Noncontrolling Interests
	Shares	Amount										Shares	Amount
Balance at January 1, 2021	957,077	$	598.2	$	6,778.5	$	7,830.2	$	(3,013.2)	$	(6,496.4)	487	$	(55.7)	$	183.6
Net income						3,855.6									25.2
Other comprehensive income, net of tax										323.7
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 shares												2,467	(500.0)
Issuance of stock under employee stock plans, net	2,442	1.5		(287.1)								(24)	3.0
Stock-based compensation				267.5
Other				(0.9)		(5.0)									(11.7)
Balance at September 30, 2021	957,052	$	598.2	$	6,758.0	$	9,639.4	$	(3,013.2)	$	(6,172.7)	463	$	(52.7)	$	197.1
Balance at January 1, 2022	954,116	$	596.3	$	6,833.4	$	8,958.5	$	(3,013.2)	$	(4,343.1)	463	$	(52.7)	$	175.6
Net income (loss)						4,307.1									(63.7)
Other comprehensive income, net of tax										47.3
Cash dividends declared per share: $1.96						(1,765.9)
Retirement of treasury shares	(5,607)	(3.5)				(1,496.5)						(5,607)	1,500.0
Purchase of treasury shares												5,607	(1,500.0)
Issuance of stock under employee stock plans, net	2,118	1.3		(282.6)								(13)	2.2
Stock-based compensation				278.2
Other						3.3									(16.1)
Balance at September 30, 2022	950,627	$	594.1	$	6,829.0	$	10,006.5	$	(3,013.2)	$	(4,295.8)	450	$	(50.5)	$	95.8

(1) As of September 30, 2022, there was $3.25 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,
	2022		2021
Cash Flows from Operating Activities
Net income	$	4,307.1	$	3,855.6
Adjustments to Reconcile Net Income to Cash Flows from Operating Activities:
Depreciation and amortization	1,147.5		1,101.9
Change in deferred income taxes	(2,195.6)		(709.8)
Debt extinguishment loss (Note 6)	—		405.2
Stock-based compensation expense	278.2		267.5
Net investment (gains) losses	676.4		(271.1)
Acquired in-process research and development	252.0		498.3
Other changes in operating assets and liabilities, net of acquisitions and divestitures	821.5		(548.1)
Other non-cash operating activities, net	217.6		504.7
Net Cash Provided by Operating Activities	5,504.7		5,104.2
Cash Flows from Investing Activities
Net purchases of property and equipment	(1,353.6)		(1,018.4)
Proceeds from sales and maturities of short-term investments	83.1		46.6
Purchases of short-term investments	(65.0)		(27.9)
Proceeds from sales of noncurrent investments	251.6		537.2
Purchases of noncurrent investments	(474.1)		(710.1)
Cash paid for acquisitions, net of cash acquired (Note 3)	—		(747.4)
Purchases of in-process research and development	(574.8)		(460.6)
Other investing activities, net	(268.3)		(2.7)
Net Cash Used for Investing Activities	(2,401.1)		(2,383.3)
Cash Flows from Financing Activities
Dividends paid	(2,651.4)		(2,313.5)
Net change in short-term borrowings	1,741.3		(1.5)
Proceeds from issuance of long-term debt	—		2,410.8
Repayments of long-term debt	(1,560.0)		(1,905.3)
Purchases of common stock	(1,500.0)		(500.0)
Other financing activities, net	(295.2)		(295.3)
Net Cash Used for Financing Activities	(4,265.3)		(2,604.8)
Effect of exchange rate changes on cash and cash equivalents	(39.4)		15.0
Net decrease in cash and cash equivalents	(1,201.1)		131.1
Cash and cash equivalents at January 1	3,818.5		3,657.1
Cash and Cash Equivalents at September 30	$	2,617.4	$	3,788.2

See notes to consolidated condensed financial statements.

10

Notes to Consolidated Condensed Financial Statements

(Tables present dollars in millions, except per-share data)

Note 1: Basis of Presentation and Implementation of New Financial Accounting Standard

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, 2021. 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 this Quarterly Report on Form 10-Q.

Certain reclassifications have been made to prior periods in the consolidated condensed financial statements and accompanying notes to conform with the current presentation.

All per-share amounts, unless otherwise noted in the footnotes, are presented on a diluted basis; that is, based on the weighted-average number of 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.

Research and Development Expenses and Acquired In-Process Research and Development (IPR&D) and Development Milestones

Research and development costs are expensed as incurred. Research and development costs consist of expenses incurred in performing research and development activities, including but not limited to, compensation and benefits, facilities and overhead expense, clinical trial expense, and fees paid to contract research organizations.

Acquired IPR&D and development milestones include the initial costs of externally developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use. Additionally, milestone payment obligations related to these transactions that are incurred prior to regulatory approval of the compound are expensed when the event triggering an obligation to pay the milestone occurs.

Implementation of New Financial Accounting Standard

Accounting Standards Update 2021-01, Reference Rate Reform, provides for temporary optional expedients and exceptions in applying current GAAP to contracts, hedging relationships, and other transactions affected by the transition from the use of the London Interbank Offered Rate (LIBOR) to an alternative reference rate. The standard is currently applicable to contracts entered into before January 1, 2023. We adopted the standard in the first quarter of 2022. The adoption did not have a material impact on our consolidated condensed financial statements.

11

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,
	2022		2021		2022		2021
Net product revenue	$	6,119.2	$	6,189.0	$	19,123.0	$	18,579.5
Collaboration and other revenue(1)	822.4		583.8