Lilly Reports First-Quarter 2023 Financial Results, Highlights Continued Core Business Growth and Pipeline Momentum

• The announcement that tirzepatide achieved superior weight loss and met both co-primary objectives and all key secondary objectives compared to placebo at 72 weeks in the Phase 3 SURMOUNT-2 study;
• The U.S. Food and Drug Administration's (FDA) approval of an expanded indication for Verzenio^®, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence;
• Price reductions of 70% for the company's most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month;
• The FDA's issuance of a complete response letter for mirikizumab in ulcerative colitis, citing issues related to the proposed manufacturing of mirikizumab with no concerns about the clinical data package, safety or label;
• The FDA's acceptance of the supplemental New Drug Application for Jardiance^® for children 10 years and older with type 2 diabetes;
• The announcement that the company will invest an additional $1.6 billion at its two new manufacturing sites in Indiana, bringing the company's total commitment to $3.7 billion and up to 700 new jobs;
• The agreement to sell the rights of the olanzapine portfolio, including Zyprexa^®, to Cheplapharm Arzneimittel GmbH for $1.05 billion in cash upon regulatory approval and successful closing of the transaction, with an additional $305 million in cash upon the one year anniversary of closing and milestone payments of up to $50 million.
• The agreement to sell the rights of Baqsimi^® to Amphastar Pharmaceuticals, Inc. for $500 million in cash upon regulatory approval and successful closing of the transaction, with an additional $125 million in cash upon the one year anniversary of closing and milestone payments of up to $450 million.
• The collaboration with International Agencies Ltd. to increase patient access and improve affordability for high-quality insulin for nearly one million people living with diabetes in Bangladesh by 2030.

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

Financial Results

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

First-Quarter Reported Results

In Q1 2023, worldwide revenue was $6.96 billion, a decrease of 11% compared with Q1 2022, driven by a 5% decrease due to lower realized prices, a 4% decrease due to lower volume, and a 2% decrease from the unfavorable impact of foreign exchange rates. The decline in volume was driven by $1.47 billion in revenue from COVID-19 antibodies in Q1 2022. Excluding COVID-19 antibodies, revenue in Q1 2023 increased 10% and total worldwide volume increased 18%. New Products contributed $573.6 million to revenue in Q1 2023. Growth Products revenue increased 18% to $4.56 billion in Q1 2023.

Revenue in the U.S. decreased 14% to $4.44 billion, driven by a 10% decrease in volume and a 5% decrease due to lower realized prices. The decline in volume was driven by $1.46 billion in revenue from COVID-19 antibodies in Q1 2022. Excluding revenue from COVID-19 antibodies, revenue in the U.S. increased 19%, primarily driven by volume from Mounjaro^®, Trulicity^® and Verzenio, partially offset by decreased volume from Alimta^® due to the loss of patent exclusivity. The lower realized prices in the U.S. were primarily driven by Humalog^® and Trulicity.

Revenue outside the U.S. decreased 4% to $2.52 billion, driven by a 6% decrease from the unfavorable impact of foreign exchange rates and a 5% decrease due to lower realized prices, partially offset by a 7% increase in volume. The lower realized prices were primarily driven by the impact of government pricing in China from the volume-based procurement (VBP) for Humalog. The increase in volume outside the U.S. was largely driven by Verzenio and Jardiance and, to a lesser extent, Taltz^®, Trulicity and Mounjaro, partially offset by a decrease in Cialis^® volume due to the Q1 2022 sales of the company's rights to Cialis in Taiwan and Saudi Arabia.

Gross margin decreased 7% to $5.33 billion in Q1 2023. Gross margin as a percent of revenue was 76.6%, an increase of 3.1 percentage points. The increase in gross margin percent was primarily driven by sales of COVID-19 antibodies in Q1 2022, partially offset by lower realized prices.

In Q1 2023, research and development expenses increased 23% to $1.99 billion, or 29% of revenue, primarily driven by higher development expenses for late-stage assets.

Marketing, selling and administrative expenses increased 12% to $1.75 billion in Q1 2023, primarily driven by costs associated with launches of new products and indications.

In Q1 2023, the company recognized acquired in-process research and development (IPR&D) charges of $105.0 million. In Q1 2022, the company recognized acquired IPR&D charges of $165.6 million, primarily related to a purchase of a Priority Review Voucher.

Other income (expense) was income of $35.7 million in Q1 2023 compared with expense of $350.7 million in Q1 2022. The increase in other income (expense) was primarily driven by net losses on investments in equity securities in Q1 2022.

The effective tax rate was 12.1% in Q1 2023 compared with 7.3% in Q1 2022. The effective tax rate in Q1 2023 reflects the tax impact of the new Puerto Rico tax regime, partially offset by a net discrete tax benefit. The effective tax rate in Q1 2022 reflected the favorable tax impact of net investment losses on equity securities.

In Q1 2023, net income and earnings per share (EPS) were $1.34 billion and $1.49, respectively, compared with $1.90 billion and $2.10 in Q1 2022. EPS in Q1 2023 was inclusive of $0.10 of acquired IPR&D, compared with $0.15 in Q1 2022.

First-Quarter Non-GAAP Measures

On a non-GAAP basis, Q1 2023 gross margin decreased 8% to $5.46 billion. Gross margin as a percent of revenue was 78.4%, an increase of 2.3 percentage points. The increase in gross margin percent was primarily driven by sales of COVID-19 antibodies in Q1 2022, partially offset by lower realized prices.

The effective tax rate on a non-GAAP basis was 12.8% in Q1 2023 compared with 10.3% in Q1 2022. The effective tax rate for Q1 2023 reflects the tax impact of the new Puerto Rico tax regime, partially offset by a net discrete tax benefit.

On a non-GAAP basis, Q1 2023 net income and EPS were $1.46 billion and $1.62, respectively, compared with $2.37 billion and $2.62 in Q1 2022. Non-GAAP EPS in Q1 2023 was inclusive of $0.10 of acquired IPR&D, compared with $0.15 in Q1 2022.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Selected Revenue Highlights

(Dollars in millions)	First Quarter
Selected Products	2023		2022		% Change
Trulicity	$          1,977.1		$          1,741.3		14 %
Verzenio	750.9		469.4		60 %
Jardiance(a)	577.5		419.4		38 %
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