Eli Lilly and : Q2 2021 Lilly Press Release

August 3, 2021	Eli Lilly and Company
	Lilly Corporate Center
	Indianapolis, Indiana 46285
	U.S.A.
	+1.317.276.2000
	www.lilly.com

For Release: Final

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

Lilly Delivers Strong Second-Quarter 2021 Financial Results,

Updates 2021 Financial Guidance

• Revenue in the second quarter of 2021 increased 23 percent, driven by volume growth of 22 percent. Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development.
• Year-to-daterevenue grew 11 percent - excluding revenue from COVID-19 antibodies - with strong sequential growth from first quarter to second quarter 2021, suggesting continued recovery from the COVID-19 pandemic in line with company expectations.
• Revenue from all key products grew in the quarter and 2021 year-to-date. These key growth products, consisting of Trulicity, Taltz, Verzenio, Jardiance, Emgality, Olumiant, Tyvyt, Retevmo, and Cyramza, contributed 17 percentage points of revenue growth and represented approximately 54 percent of total revenue in the second quarter of 2021, excluding revenue from COVID-19 antibodies.
• Notable pipeline events included positive data readouts for tirzepatide for type 2 diabetes and Jardiance for adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). The company announced plans to submit donanemab for Alzheimer's disease and tirzepatide for type 2 diabetes to regulatory authorities by the end of 2021.
• Second-quarter2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020.
• Second-quarter2021 earnings per share (EPS) decreased to $1.53 on a reported basis and increased to $1.87 on a non-GAAP basis.
• 2021 EPS guidance updated to be in the range of $6.73 to $6.93 on a reported basis and remains in the range of $7.80 to $8.00 on a non-GAAP basis.

Eli Lilly and Company (NYSE: LLY) today announced financial results for the second quarter of

2021.

"We delivered strong performance this quarter, with volume-driven growth across our core business and most major geographies. We accelerated use of our newest medicines around the world with solid sequential growth versus first-quarter 2021," said David A. Ricks, Lilly's chairman and CEO. "We had another robust period of pipeline milestones, as we announced plans to submit tirzepatide in type 2 diabetes and donanemab in Alzheimer's disease to regulatory authorities later this year, as well as positive results for Jardiance in patients with heart failure with preserved ejection fraction. We continue to increase investment in our future and look forward to several additional pipeline events in the second half of the year, along with the continued strengthening of our business."

$ in millions, except	Second Quarter	%
per share data
	2021		2020	Change
Revenue	$ 6,740.1	$	5,499.4	23%
Net Income - Reported	1,390.2		1,412.0	(2)%
EPS - Reported	1.53		1.55	(1)%
Net Income - Non-GAAP	1,703.3		1,323.0	29%
EPS - Non-GAAP	1.87		1.45	29%

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. Beginning in 2021, non-GAAP measures exclude gains and losses on investments in equity securities and 2020 amounts have been reclassified for comparability. The company's 2021 financial guidance is being provided on both a

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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 FDA has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir. The EUA now provides for the use of baricitinib for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
• The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer's disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ.
• The company confirmed the tirzepatide SURPASS program has met global regulatory submission requirements for evaluating cardiovascular risk and its intention to submit the registration package to regulatory authorities by the end of 2021.
• The European Commission granted marketing authorization for Jardiance® as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure).
• The company and Incyte announced the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action date for the supplemental new drug application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis. The delay is related to the FDA's ongoing assessment of JAK inhibitors.
• In June 2021, the Office of the Assistant Secretary for Preparedness and Response halted shipment of bamlanivimab and etesevimab administered together in the U.S. This was due to the prevalence of the Gamma and Beta variants in the U.S. at that time and the fact that bamlanivimab and etesevimab administered together do not retain neutralization effects against those variants. The COVID-19 pandemic has involved, and may continue to involve, the spread of variants, including the Delta variant which is currently estimated to be the most dominant variant in the U.S. Preclinical data demonstrate that bamlanivimab and etesevimab

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administered together retain neutralization activity against the variants currently in circulation in many countries, including Delta and Alpha.

Clinical

• The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. Additionally, results from previously announced SURPASS trials were presented at the American Diabetes Association Scientific Sessions.
• The company and Boehringer Ingelheim announced positive top-line data from the EMPEROR-Preserved Phase 3 trial in which Jardiance significantly reduced the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF).
• The company and Pfizer Inc. announced top-line results of a Phase 3 study evaluating subcutaneous administration of tanezumab in adults with moderate to severe cancer pain due to bone metastases or multiple myeloma. Study A4091061 (NCT02609828) met its primary endpoint of demonstrating a statistically significant improvement in daily average pain intensity at eight weeks for tanezumab compared to placebo in patients receiving background opioid therapy. Preliminary safety data showed that during the 24-week treatment period, the adverse event profile of tanezumab 20 mg was generally consistent with the adverse events expected in patients with cancer pain due to bone metastasis and the known safety profile of tanezumab. There were two adjudicated composite joint safety outcomes, both pathological fractures, which occurred near the site of the bone metastases in tanezumab-treated patients.

Business Development/Other Developments

• The company and MiNA Therapeutics Limited announced a global research collaboration to develop novel drug candidates using MiNA's proprietary small activating RNA (saRNA) technology platform.

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