Lilly plans up to five 2023 launches, led by tirzepatide for obesity

Eli Lilly said on Tuesday it hopes to launch as many as five new treatments in 2023 and projected revenue of $30.3 billion to $30.8 billion for the year, with tirzepatide for obesity drawing the most investor attention of the group ^[1]. The forecast for adjusted profit came in below analysts' estimates, and the company's shares fell about 1% to $363.59 ^[1].

The revenue range was above the $30.12 billion Wall Street analysts expected, according to Refinitiv IBES data. Adjusted profit per share was forecast at $8.10 to $8.30, against the analysts' estimate of $9.15 ^[1]. Lilly's shares had risen about 31% during 2022 ^[1].

The company said it expects marketing and related expenses of $6.9 billion to $7.1 billion in 2023, about $500 million more than this year, and research and development spending of $8.2 billion to $8.4 billion ^[1].

Chief Executive David Ricks described two of the five planned launches as "generational opportunities": tirzepatide for obesity and donanemab for Alzheimer's disease. He called the other three "great opportunities in very competitive spaces" ^[1]. Those three are mirikizumab for a type of inflammatory bowel disease, lebrikizumab for atopic dermatitis and the cancer drug pirtobrutinib ^[1].

Tirzepatide was approved in the United States in 2022 for type 2 diabetes and is sold under the brand name Mounjaro ^[1]. Lilly said it was spending heavily on marketing and research as it prepares for data releases and potential approvals in 2023 for tirzepatide in obesity and for donanemab ^[1]. No date for a decision on the obesity use was disclosed ^[1].

Lilly also said it expects no sales from its COVID-19 antibody drugs in 2023, after the U.S. Food and Drug Administration pulled authorization for its therapy bebtelovimab in November 2022 ^[1].

Why it matters for patients

For anyone hoping to use tirzepatide for weight loss, the briefing was a business forecast rather than a medical one. It included no efficacy or safety results for the obesity use, and no information on what the drug would cost, whether insurers would cover it or how much supply would be available. None of those details had been disclosed ^[1].

At the time of the announcement, tirzepatide's only U.S. approval was for type 2 diabetes, under the Mounjaro brand ^[1]. An approval for obesity had not been granted, and the timing of any decision had not been reported ^[1].

Donanemab, the Alzheimer's drug, was also still in development, with Lilly preparing for a potential approval in 2023 ^[1]. No approval decision had been made ^[1].

What happens next

Lilly said it hopes to bring as many as five treatments to market in 2023 and is preparing for data releases and potential approvals for tirzepatide in obesity and donanemab during the year ^[1]. Specific dates for FDA decisions, or for the launches themselves, were not given ^[1].