Eli Lilly and : Q4 2021 Lilly Press Release

February 3, 2022	Eli Lilly and Company
	Lilly Corporate Center
	Indianapolis, Indiana 46285
	U.S.A.
	+1.317.276.2000
	www.lilly.com

For Release: Immediately

Refer to: Jordan Bishop; [e-mail]; [phone] (Media) Kevin Hern; [e-mail]; [phone] (Investors)

Lilly Reports Solid Fourth-Quarter and Full-Year 2021 Financial Results,

Recent Late-Stage Pipeline Successes Set Up Next Wave of Innovative Medicines for Patients

• Revenue in the fourth quarter of 2021 increased 8 percent, driven by volume growth of 11 percent. Excluding COVID-19 antibodies, fourth-quarter 2021 revenue grew 6 percent.
• Full-year2021 revenue increased 15 percent, driven by volume growth of 16 percent. Excluding COVID-19 antibodies, full-year 2021 revenue grew 10 percent.
• Key growth products, consisting of Trulicity, Taltz, Verzenio, Jardiance, Olumiant, Emgality, Retevmo, Cyramza and Tyvyt, contributed 14 percentage points of revenue growth and represented 61 percent of total revenue in the fourth quarter of 2021, excluding revenue from COVID-19 antibodies.
• Notable recent pipeline events include positive Phase 3 readouts for lebrikizumab for moderate-to-severe atopic dermatitis and mirikizumab for moderately-to-severely active ulcerative colitis that support regulatory submissions in 2022.
• Fourth-quarter2021 earnings per share (EPS) decreased 18 percent to $1.90 on a reported basis and increased 8 percent to $2.49 on a non-GAAP basis. Full-year 2021 EPS decreased 10 percent to $6.12 on a reported basis and increased 20 percent to $8.16 on a non-GAAP basis.
• 2022 EPS guidance reaffirmed to be in the range of $8.00 to $8.15 on a reported basis and $8.50 to $8.65 on a non-GAAP basis.

Eli Lilly and Company (NYSE: LLY) announced financial results for the fourth quarter and full year of 2021 today.

"Lilly had a remarkable year of growth and pipeline success in 2021, despite the continued hardships from the pandemic," said David A. Ricks, Lilly's chair and CEO. "We have tremendous momentum moving into 2022 and beyond with strong revenue expectations, limited patent exposure, and an exciting pipeline of potential new medicines, which we hope will give us the opportunity to positively

impact millions more lives in meaningful ways. Lilly is committed to continuing to innovate as the

primary way to create value for patients and shareholders alike."

$ in millions, except	Fourth Quarter	%	Full Year	%
per share data
	2021		2020	Change	2021	2020	Change
Revenue	$ 7,999.9	$	7,440.0	8%	$ 28,318.4	$ 24,539.8	15%
Net Income - Reported	1,726.1		2,116.8	(18)%	5,581.7	6,193.7	(10)%
EPS - Reported	1.90		2.32	(18)%	6.12	6.79	(10)%
Net Income - Non-GAAP	2,267.8		2,107.7	8%	7,436.7	6,191.0	20%
EPS - Non-GAAP	2.49		2.31	8%	8.16	6.78	20%

Certain financial information for 2021 and 2020 is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the periods. Non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release. The company's 2022 financial guidance is being provided on both a reported and a non-GAAP basis. The non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business.

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Key Events Over the Last Three Months

Regulatory

• The U.S. Food and Drug Administration (FDA), Pharmaceuticals and Medical Devices Agency, and European Medicines Agency accepted Lilly's New Drug Application (NDA) in the U.S. and Japan, and Marketing Authorization Application in the European Union, respectively, for tirzepatide for the treatment of adults with type 2 diabetes. Lilly also submitted tirzepatide to six additional markets.
• The company initiated a rolling submission to the FDA for pirtobrutinib, seeking accelerated approval in mantle cell lymphoma, with expectations to complete the submission in 2022 and regulatory action anticipated in early 2023.
• The FDA accepted a supplemental NDA (sNDA) and granted priority review for Jardiance® for adults with heart failure independent of left ventricular ejection fraction.
• The company received Breakthrough Therapy designation from the FDA for an additional amyloid plaque lowering agent, N3pG 4.
• Lilly's bamlanivimab and etesevimab, administered together, were authorized by the FDA as the first and only neutralizing antibody therapy for emergency use in COVID-19 patients under the age of 12.
• The FDA has updated the Fact Sheet for bamlanivimab and etesevimab to include a new Limitation for Authorized Use: due to the high frequency of the Omicron variant, these antibody therapies are not currently authorized in any U.S. region. Authorization status will change as needed, depending on prevalence and trends of variants of concern.
• The company submitted a request for Emergency Use Authorization for bebtelovimab for the treatment of mild-to-moderateCOVID-19 in adults and pediatric patients 12 years of age and older. Authentic virus analysis of bebtelovimab confirm earlier pseudovirus findings, which demonstrate Lilly's investigational antibody neutralizes all known variants of concern, including Omicron.
• The FDA accepted an sNDA and granted priority review for baricitinib for the treatment of COVID-19.

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• Lilly is in ongoing discussion with the FDA regarding the status of the sNDA for Olumiant® for the treatment of adults with moderate-to-severe atopic dermatitis. At this point, the company does not have alignment with the FDA on the indicated population. Given the Agency's position, there is a possibility that this could lead to a Complete Response Letter.

Clinical

• Lilly's lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in its third Phase 3 study that supports regulatory submission in 2022.
• Lilly's mirikizumab demonstrated superiority over placebo in a Phase 3 maintenance study in ulcerative colitis that supports regulatory submissions in 2022.
• Based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II), the company has decided to discontinue the Phase 3 development program for Olumiant in adults with active systemic lupus erythematosus.

Business Development/Other Developments

• The U.S. Government signed a purchase agreement for 614,000 additional doses of Lilly's bamlanivimab and etesevimab for the treatment or post-exposure prevention of COVID-19 for a total of $1.29 billion. There were approximately 435,000 doses delivered in fourth-quarter 2021 with most of the remaining doses already shipped in January 2022.
• New guidelines released by the World Health Organization on treatments for COVID-19 strongly recommend the use of baricitinib in combination with corticosteroids for severely or critically ill hospitalized COVID-19 patients.
• Lilly announced new investments to increase the company's manufacturing capacity for current and future medicines. Lilly plans to invest more than 400 million euros in a new site in Limerick, Ireland to expand the company's manufacturing network for biologic active ingredients. Lilly plans to invest more than $1 billion in a new site in Concord, North Carolina to manufacture parenteral (injectable) products and devices.

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• Lilly and Foghorn Therapeutics Inc. announced a strategic collaboration for novel oncology targets using Foghorn's proprietary Gene Traffic Control® platform.
• The company and Entos Pharmaceuticals Inc. entered into a research and collaboration agreement to support the development of innovative therapies in multiple neurologic indications.
• Lilly and QILU Regor Therapeutics Inc. entered into a strategic collaboration to discover and develop novel therapies for metabolic disorders.
• The company announced a 15 percent dividend increase for shareholders beginning in the first quarter of 2022.
• Lilly and UNICEF announced a collaboration to help improve health outcomes for 10 million children and adolescents living with chronic, non-communicable diseases (NCD) through 2025. Lilly has committed $14.4 million in support of UNICEF's lifesaving work.

"Lilly closed 2021 with another solid quarter. Throughout the year we delivered strong top- and bottom-line growth, with volume-driven growth across key brands," said Anat Ashkenazi, Lilly's senior vice president and chief financial officer. "We continue to advance promising R&D opportunities and invest in potential launches that would bring needed therapies to patients worldwide. We expect to deliver top-tierrevenue growth throughout the decade."

Fourth-Quarter Reported Results

In the fourth quarter of 2021, worldwide revenue was $8.000 billion, an increase of 8 percent compared with the fourth quarter of 2020, driven by an 11 percent increase in volume, partially offset by a 3 percent decrease due to lower realized prices. Key growth products, consisting of Trulicity®, Taltz®, Verzenio®, Jardiance, Olumiant, Emgality®, Retevmo®, Cyramza® and Tyvyt®, contributed 14 percentage points of revenue growth and represented 61 percent of total revenue for the fourth quarter of 2021, excluding COVID-19 antibodies. The company recognized worldwide revenue of $1.063 billion from COVID-19 antibodies during the quarter compared with $871.2 million in the fourth quarter of 2020. Excluding revenue from COVID-19 antibodies, worldwide revenue increased

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