Lilly Reports First-Quarter 2023 Financial Results, Highlights Continued Core

• Revenue in Q1 2023 decreased 11% driven by a $1.47 billion decline in revenue from COVID-19 antibodies. Excluding COVID-19 antibodies, revenue in Q1 2023 increased 10%, driven by volume growth from Mounjaro, Trulicity, Verzenio and Jardiance.
• Pipeline progress included positive results in the tirzepatide Phase 3 SURMOUNT-2 study; FDA approval of an expanded indication for Verzenio; approval of mirikizumab in Japan; and regulatory submissions of tirzepatide for obesity in the EU and lebrikizumab for atopic dermatitis in Japan.
• New Products⁽ⁱ⁾ contributed $573.6 million to revenue in Q1 2023, led by Mounjaro. Growth Products⁽ⁱⁱ⁾ revenue increased 18% to $4.56 billion in Q1 2023, led by Verzenio, Trulicity, Jardiance and Taltz.
• Driven by the decline in COVID-19 antibodies revenue, Q1 2023 EPS decreased 29% to $1.49 on a reported basis and decreased 38% to $1.62 on a non-GAAP basis, both inclusive of $0.10 of acquired IPR&D.
• 2023 reported EPS guidance raised $0.28 to be in the range of $8.18 to $8.38 and non-GAAP EPS guidance raised $0.30 to be in the range of $8.65 to $8.85.

INDIANAPOLIS, April 27, 2023 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced its financial results for the first quarter of 2023.

“Core business growth drove solid first-quarter financial results and a strong start for Lilly in 2023, which includes pipeline progress led by positive SURMOUNT-2 data for tirzepatide in obesity,” said David A. Ricks, Lilly’s chair and CEO. “We also announced important price reductions to make insulin more affordable and accessible for people with diabetes, as well as a significant investment in manufacturing facilities. It is an exciting year for Lilly and we look forward to delivering more medicines for unmet health needs to more people around the world.”

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

• 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