SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

Quarterly Report Under Section 13 or 15(d) of the

Securities Exchange Act of 1934

FOR THE QUARTER ENDED JUNE 30, 2019

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 of principal executive offices)

Registrant’s telephone number, including area code (317) 276-2000

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 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 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 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 July 29, 2019:

Class	Number of Shares Outstanding
Common	965,432,952

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of Each Class	Trading Symbol	Name of Each Exchange On Which Registered
Common Stock (no par value)	LLY	New York Stock Exchange
1.000% Notes Due June 2, 2022	LLY22	New York Stock Exchange
7 1/8% Notes Due June 1, 2025	LLY25	New York Stock Exchange
1.625% Notes Due June 2, 2026	LLY26	New York Stock Exchange
2.125% Notes Due June 3, 2030	LLY30	New York Stock Exchange
6.77% Notes Due January 1, 2036	LLY36	New York Stock Exchange

Eli Lilly and Company

Form 10-Q

For the Quarter Ended June 30, 2019

Table of Contents

		Page
PART I. Financial Information		4
Item 1.	Financial Statements	4
	Consolidated Condensed Statements of Operations	4
	Consolidated Condensed Statements of Comprehensive Income (Loss)	5
	Consolidated Condensed Balance Sheets	6
	Consolidated Condensed Statements of Equity	7
	Consolidated Condensed Statements of Cash Flows	9
	Notes to Consolidated Condensed Financial Statements	10
Item 2.	Management's Discussion and Analysis of Results of Operations and Financial Condition	36
	Executive Overview	36
	Revenue	43
	Gross Margin, Costs, and Expenses	47
	Financial Condition	48
	Financial Expectations	48
	Available Information on our Website	49
Item 4.	Controls and Procedures	49
PART II. Other Information		50
Item 1.	Legal Proceedings	50
Item 1A.	Risk Factors	51
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	52
Item 6.	Exhibits	52
Index to Exhibits		53
Signatures		53

2

Forward-Looking Statements

This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can generally be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,” “intend,” “anticipate,” “plan,” “continue,” or similar expressions.

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 projected in these 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. The following include some but not all of the factors that could cause actual results or events to differ materially from those anticipated:

• uncertainties in the pharmaceutical research and development process, including with respect to the timing of anticipated regulatory approvals and launches of new products;

• market uptake of recently launched products;

• competitive developments affecting current products and our pipeline;

• the expiration of intellectual property protection for certain of our products;

• our ability to protect and enforce patents and other intellectual property;

• the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and access to pharmaceuticals;

• regulatory compliance problems 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 involving past, current, or future products as we are largely self-insured;

• unauthorized disclosure, misappropriation, or compromise of trade secrets or other confidential data stored in our information systems, networks, and facilities, or those of third parties with whom we share our data;

• changes in tax law, including the impact of United States tax reform legislation enacted in December 2017 and related guidance;

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

• asset impairments and restructuring charges;

• changes in accounting 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;

• reliance on third-party relationships and outsourcing arrangements; and

• the impact of global macroeconomic conditions.

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 our Annual Report on Form 10-K for the year ended December 31, 2018, particularly under the caption “Risk Factors”, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019.

All forward-looking statements herein speak only as of the date of this report and are expressly qualified in their entirety by the cautionary statements included in or incorporated by reference into this report. 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.

3

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 June 30,					Six Months Ended June 30,
	2019		2018			2019			2018
Revenue (Note 2)	$	5,636.7	$	5,585.0		$	10,728.9		$	10,548.8
Costs, expenses, and other:
Cost of sales	1,124.9		1,234.3			2,263.6			2,398.9
Research and development	1,402.2		1,271.0			2,632.7			2,378.5
Marketing, selling, and administrative	1,586.3		1,485.6			3,103.4			2,824.3
Acquired in-process research and development (Note 3)	25.0		1,624.5			161.9			1,624.5
Asset impairment, restructuring, and other special charges (Note 6)	—		(25.5		)	423.9			31.3
Other–net, (income) expense (Note 13)	32.4		(46.6		)	(53.6		)	(116.1		)
	4,170.8		5,543.3			8,531.9			9,141.4
Income before income taxes	1,465.9		41.7			2,197.0			1,407.4
Income taxes (Note 9)	138.7		273.3			308.7			471.8
Net income (loss) from continuing operations	1,327.2		(231.6		)	1,888.3			935.6
Net income (loss) from discontinued operations (Note 5)	—		(28.3		)	3,680.5			21.9
Net income (loss)	$	1,327.2	$	(259.9	)	$	5,568.8		$	957.5
Earnings (loss) per share:
Earnings (loss) from continuing operations - basic	$	1.44	$	(0.22	)	$	1.99		$	0.90
Earnings (loss) from discontinued operations - basic	—		(0.03		)	3.87			0.02
Earnings (loss) per share - basic	$	1.44	$	(0.25	)	$	5.86		$	0.92
Earnings (loss) from continuing operations - diluted	$	1.44	$	(0.22	)	$	1.98		$	0.90
Earnings (loss) from discontinued operations - diluted	—		(0.03		)	3.86			0.02
Earnings (loss) per share - diluted	$	1.44	$	(0.25	)	$	5.84		$	0.92
Shares used in calculation of earnings (loss) per share:
Basic	920.8		1,030.2			950.4			1,039.6
Diluted	924.6		1,030.2			954.2			1,041.6

See notes to consolidated condensed financial statements.

4

Consolidated Condensed Statements of Comprehensive Income (Loss)

(Unaudited)

ELI LILLY AND COMPANY AND SUBSIDIARIES

(Dollars in millions)

	Three Months Ended June 30,					Six Months Ended June 30,
	2019		2018			2019		2018
Net income (loss)	$	1,327.2	$	(259.9	)	$	5,568.8	$	957.5
Other comprehensive income (loss) from continuing operations, net of tax (Note 12)	87.0		(511.0		)	82.9		(215.4		)
Other comprehensive income (loss) from discontinued operations, net of tax (Note 12) (1)	—		(160.2		)	56.8		(69.5		)
Other comprehensive income (loss), net of tax (Note 12)	87.0		(671.2		)	139.7		(284.9		)
Comprehensive income (loss)	$	1,414.2	$	(931.1	)	$	5,708.5	$	672.6

⁽¹⁾ For the six months ended June 30, 2019, other comprehensive income related to discontinued operations consisted of $45.8 million of accumulated other comprehensive income attributable to controlling interest and $11.0 million of accumulated other comprehensive income attributable to noncontrolling interest.

See notes to consolidated condensed financial statements.

5

Consolidated Condensed Balance Sheets

ELI LILLY AND COMPANY AND SUBSIDIARIES

(Dollars in millions)

	June 30, 2019			December 31, 2018
Assets	(Unaudited)
Current Assets
Cash and cash equivalents (Note 7)	$	2,290.2		$	7,320.7
Short-term investments (Note 7)	77.7			88.2
Accounts receivable, net of allowances of $23.7 (2019) and $24.1 (2018)	4,612.5			4,593.9
Other receivables	977.5			1,182.9
Inventories	3,181.1			3,098.1
Prepaid expenses and other	2,315.5			2,036.7
Current assets of discontinued operations (Note 5)	—			2,229.1
Total current assets	13,454.5			20,549.6
Investments (Note 7)	1,852.7			2,005.4
Goodwill	3,820.1			1,366.6
Other intangibles, net	6,586.6			1,068.0
Deferred tax assets	2,507.4			2,613.7
Sundry	2,052.1			1,824.9
Property and equipment, net of accumulated depreciation of $8,956.3 (2019) and $8,666.9 (2018)	7,847.5			7,996.1
Operating lease assets (Note 8)	545.5			—
Noncurrent assets of discontinued operations (Note 5)	—			6,484.1
Total assets	$	38,666.4		$	43,908.4
Liabilities and Equity
Current Liabilities
Short-term borrowings and current maturities of long-term debt	$	2,068.6		$	1,102.2
Accounts payable	1,198.9			1,207.1
Employee compensation	588.2			955.6
Sales rebates and discounts	4,993.7			4,849.5
Dividends payable	593.9			650.8
Income taxes payable	222.9			393.4
Other current liabilities	2,189.2			2,036.7
Current liabilities of discontinued operations (Note 5)	—			692.8
Total current liabilities	11,855.4			11,888.1
Other Liabilities
Long-term debt	13,717.6			9,196.4
Noncurrent operating lease liabilities (Note 8)	503.3			—
Accrued retirement benefits (Note 10)	2,723.4			2,802.2
Long-term income taxes payable	3,485.7			3,700.0
Deferred tax liabilities	2,380.9			1,312.7
Other noncurrent liabilities	1,142.8			1,357.6
Noncurrent liabilities of discontinued operations (Note 5)	—			2,742.3
Total other liabilities	23,953.7			21,111.2
Commitments and Contingencies (Note 11)
Eli Lilly and Company Shareholders’ Equity
Common stock	603.7			661.0
Additional paid-in capital	6,534.5			6,583.6
Retained earnings	4,318.1			11,395.9
Employee benefit trust	(3,013.2		)	(3,013.2		)
Accumulated other comprehensive loss (Note 12)	(5,600.5		)	(5,729.2		)
Cost of common stock in treasury	(62.1		)	(69.4		)
Total Eli Lilly and Company shareholders’ equity	2,780.5			9,828.7
Noncontrolling interests	76.8			1,080.4
Total equity	2,857.3			10,909.1
Total liabilities and equity	$	38,666.4		$	43,908.4

See notes to consolidated condensed financial statements.

6

Consolidated Condensed Statements of Equity

(Unaudited)

ELI LILLY AND COMPANY AND SUBSIDIARIES

	Equity of Eli Lilly and Company Shareholders
ELI LILLY AND COMPANY AND SUBSIDIARIES (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					Noncontrolling Interest
	Shares		Amount															Shares		Amount
Balance at April 1, 2018	1,089,234		$	680.8		$	5,758.0		$	16,608.2		$	(3,013.2	)	$	(5,437.5	)	604		$	(69.3	)	$	60.8
Net income (loss)									(259.9		)												4.2
Other comprehensive loss, net of tax															(671.2		)
Cash dividends declared per share: $1.13									(1,148.6		)
Retirement of treasury shares	(11,735	)	(7.3		)				(943.3		)							(11,735	)	950.7
Purchase of treasury shares																		11,735		(950.7		)
Issuance of stock under employee stock plans, net	49		—			(2.5		)										—		(0.1		)
Stock-based compensation						70.2
Other									(9.1		)												0.6
Balance at June 30, 2018	1,077,548		$	673.5		$	5,825.7		$	14,247.3		$	(3,013.2	)	$	(6,108.7	)	604		$	(69.4	)	$	65.6
Balance at April 1, 2019	971,363		$	607.1		$	5,756.6		$	4,879.4		$	(3,013.2	)	$	(5,687.5	)	541		$	(62.1	)	$	84.7
Net income (loss)									1,327.2														(1.1		)
Other comprehensive income, net of tax															87.0
Cash dividends declared per share: $1.29									(1,178.1		)
Retirement of treasury shares	(5,430	)	(3.4		)				(696.6		)							(5,430	)	700.0
Purchase of treasury shares (1)						700.0												5,430		(700.0		)
Issuance of stock under employee stock plans, net	24		—			(1.6		)
Stock-based compensation						79.5
Other									(13.8		)												(6.8		)
Balance at June 30, 2019	965,957		$	603.7		$	6,534.5		$	4,318.1		$	(3,013.2	)	$	(5,600.5	)	541		$	(