Eli Lilly and : Q1 2022 Lilly Press Release

April 28, 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)

Solid First-Quarter Financial Results Reflect Lilly's Continued Momentum into 2022

• • Lilly's revenue growth in Q1 2022 increased 15%, driven by volume growth of 20%. Excluding revenue from COVID-19 antibodies and Alimta, Q1 2022 revenue grew 10%.

• • Outside of revenue from COVID-19 antibodies, which grew $660 million, revenue was driven by key growth products - consisting of Trulicity, Verzenio, Jardiance, Taltz, Olumiant, Emgality, Retevmo, Cyramza and Tyvyt - which contributed 13 percentage points of revenue growth and represented 61% of core revenue in Q1 2022.

• • The company advanced its pipeline with a positive Phase 3 readout for tirzepatide for obesity or overweight, an announcement that the Phase 3 trial of Jardiance for people with chronic kidney disease will stop early due to clear positive efficacy, and a U.S. regulatory submission for mirikizumab for moderately-to-severely active ulcerative colitis.

• • Q1 2022 EPS increased 41% to $2.10 on a reported basis and increased 63% to $2.62 on a non-GAAP basis. Q1 2022 reported and non-GAAP EPS are both inclusive of $0.15 of acquired IPR&D and development milestone charges.

• • 2022 EPS guidance updated to be in the range of $7.30 to $7.45 on a reported basis and $8.15 to $8.30 on a non-GAAP basis, both inclusive of $0.55 of acquired IPR&D and development milestone charges.

INDIANAPOLIS, April 28, 2022 - Eli Lilly and Company (NYSE: LLY) today announced its financial results for the first quarter of 2022.

"Lilly delivered another quarter of volume-driven revenue growth led by key products and anticipates 2022 to be an exciting year with several potential approvals and new pipeline events," said David A.

Ricks, Lilly's chair and CEO. "With the depth of our pipeline, and growth of our medicines in the market, we are well-positioned to help address health challenges in areas of significant unmet medical need, such as obesity, Alzheimer's disease and cancer."

Today, the company is sharing new notable announcements:

• • Tirzepatide delivered up to 22.5% weight loss in adults with obesity or overweight in the 72-week Phase 3 SURMOUNT-1 study. Participants taking tirzepatide lost up to 52 lb. and 63% of participants taking tirzepatide 15 mg achieved at least 20% body weight reduction as a key secondary endpoint.

• • Lilly submitted mirikizumab to the U.S. Food and Drug Administration (FDA) for the

  treatment of adults with moderately-to-severely active ulcerative colitis.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

• • The FDA approved Jardiance® to treat adults with heart failure regardless of left ventricular ejection fraction.

• • Bebtelovimab received Emergency Use Authorization (EUA) from the FDA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients.

• • The FDA issued a Complete Response Letter (CRL) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer.

• • As anticipated, Lilly received a CRL from the FDA for the Olumiant® atopic dermatitis indication as the company was not in alignment with the FDA on the indicated population.

• • Lebrikizumab combined with topical corticosteroids showed 70% of patients with moderate-to-severe atopic dermatitis experienced at least 75% reduction in disease severity at 16 weeks in the ADhere Phase 3 trial.

• • More than 50% of patients with moderate-to-severe atopic dermatitis experienced at least 75% reduction in disease severity at 16 weeks with lebrikizumab in Lilly's pivotal Phase 3 atopic dermatitis ADvocate studies.

• • Nearly 40% of adults with alopecia areata taking Olumiant 4-mg saw at least 80% scalp hair coverage at 52 weeks in Lilly's pivotal Phase 3 studies.

• • Nearly two-thirds of patients responded to mirikizumab treatment at 12 weeks in Lilly's first-

in-class ulcerative colitis Phase 3 LUCENT-1 study.

• • The company announced that the Jardiance Phase 3 EMPA-KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease.

• • Adults hospitalized for acute heart failure were 36% more likely to experience a clinical benefit over 90 days if initiated on Jardiance following stabilization and prior to discharge compared with placebo in the Phase 3 EMPULSE trial.

• • Lilly supplied 600,000 doses of bebtelovimab to the U.S. government in an ongoing effort to provide COVID-19 treatment options.

• • The company announced the launch of the Lilly Institute for Genetic Medicine and a $700 million investment to establish a new site in the Boston Seaport.

For additional information on these and other important public announcements, visit the news section of Lilly's website.

Financial Results

$ in millions, except

per share data	%
Change
Revenue	$7,810.0	$6,805.6	15%
Net Income - Reported	1,902.9	1,355.3	40%
EPS - Reported	2.10	1.49	41%
Net Income - Non-GAAP	2,372.8	1,465.5	62%
EPS - Non-GAAP	2.62	1.61	63%

First Quarter 2022 2021

A discussion of the non-GAAP financial measures is included under "Reconciliation of GAAP

Reported to Selected Non-GAAP Adjusted Information (Unaudited)." Beginning in 2022, presentations of non-GAAP financial measures will not include adjustments for upfront charges and development milestones related to acquired in-process research and development (IPR&D). Non-

GAAP financial measures for Q1 2021 have been adjusted to reflect this updated presentation.

First-Quarter Reported Results

In Q1 2022, worldwide revenue was $7.81 billion, an increase of 15% compared with Q1 2021, primarily driven by a 20% increase in volume, partially offset by a 3% decrease due to lower realized prices and a 2% decrease due to the unfavorable impact of foreign exchange rates. Key growth products, consisting of Trulicity®, Verzenio®, Jardiance, Taltz®, Olumiant, Emgality®, Retevmo®,

Cyramza® and Tyvyt®, contributed 13 percentage points of revenue growth and represented 61% of total revenue for Q1 2022, excluding revenue from COVID-19 antibodies. The company recognized worldwide revenue of $1.47 billion from COVID-19 antibodies during Q1 2022 compared with $810.1 million in Q1 2021. Excluding revenue from COVID-19 antibodies and Alimta®, which lost exclusivity in certain major markets, worldwide revenue increased 10% in Q1 2022.

Revenue in the U.S. increased 31%, to $5.17 billion, driven by a 32% increase in volume. The company recognized U.S. revenue from COVID-19 antibodies of $1.46 billion in Q1 2022 compared to $650.6 million in Q1 2021. Excluding revenue from COVID-19 antibodies and Alimta, revenue in the U.S. increased by 14% driven by key growth products.

Revenue outside the U.S. decreased 8%, to $2.64 billion, driven by a 7% decrease due to lower realized prices and a 5% decrease due to the unfavorable impact of foreign exchange rates, partially offset by a 4% increase in volume. The lower realized prices were primarily driven by the impact of the National

Reimbursement Drug List (NRDL) formulary for certain products in China, particularly Tyvyt. The increase in volume outside the U.S. was largely driven by key growth products and sales of the company's rights to Cialis® in Taiwan and Saudi Arabia, partially offset by decreased volume forAlimta, Cymbalta® and Forteo® resulting from the entry of generic competition, as well as decreased volume for COVID-19 antibodies. Excluding revenue from COVID-19 antibodies and Alimta, revenue outside the U.S. increased by 5%.

Gross margin increased 16%, to $5.74 billion, in Q1 2022 compared with Q1 2021. Gross margin as a percent of revenue was 73.5%, an increase of 1.1 percentage points compared with Q1 2021. The increase in gross margin percent was primarily driven by an unfavorable effect in Q1 2021 of foreign exchange rates on international inventories sold, partially offset by increased sales of COVID-19 antibodies and, to a lesser extent, lower realized prices.

In Q1 2022, research and development expenses decreased 4% to $1.61 billion, or 21% of revenue, largely driven by lower development expenses for COVID-19 antibodies, partially offset by higher development expenses for late-stage assets.

Marketing, selling and administrative expenses decreased 1% to $1.56 billion in Q1 2022.

In Q1 2022, the company recognized acquired IPR&D and development milestone charges of $165.6

million primarily related to a purchase of a Priority Review Voucher. In Q1 2021, the company recognized acquired IPR&D and development milestone charges of $312.0 million primarily related to business development transactions with Rigel Pharmaceuticals, Inc. and Precision BioSciences, Inc.

There were no asset impairment, restructuring and other special charges recognized in Q1 2022. In Q1 2021, the company recognized asset impairment, restructuring and other special charges of $211.6

million, largely related to an intangible asset impairment resulting from the decision to sell the rights to

Qbrexza®, as well as acquisition and integration costs associated with the acquisition of Prevail

Therapeutics Inc.