Lilly Eli & Co Stock Price, News & Analysis

Eli Lilly (LLY) reported strong Q4 2024 financial results with revenue increasing 45% to $13.53 billion, primarily driven by Mounjaro and Zepbound sales. Q4 EPS grew 102% to $4.88 on a reported basis and 114% to $5.32 on a non-GAAP basis.

The company received FDA approval for Zepbound for moderate-to-severe obstructive sleep apnea in adults with obesity and Omvoh for Crohn's disease. Notable developments include a pending acquisition of Scorpion Therapeutics' PI3Kα inhibitor program and a $15 billion share repurchase program.

For 2025, Lilly provided guidance with revenue expected between $58.0-61.0 billion, representing approximately 32% growth compared to 2024. EPS guidance for 2025 is set at $22.05-23.55 on a reported basis and $22.50-24.00 on a non-GAAP basis.

Eli Lilly (NYSE: LLY) has scheduled the announcement of its fourth-quarter 2024 financial results and 2025 financial guidance for February 6, 2025. The company will host a conference call at 10 a.m. Eastern time on the same day to discuss the results with investors, media, and the general public.

A live webcast of the conference call will be accessible through Lilly's investor relations website, with a replay available afterward for those unable to attend the live event.

Eli Lilly (NYSE: LLY) has received FDA approval for Omvoh® (mirikizumab-mrkz) to treat moderately to severely active Crohn's disease in adults. This approval follows its October 2023 authorization for ulcerative colitis treatment. The drug targets interleukin-23p19 protein to reduce gastrointestinal inflammation.

In the Phase 3 VIVID-1 trial, 53% of Omvoh-treated patients achieved clinical remission at one year versus 36% on placebo, and 46% showed intestinal lining healing compared to 23% on placebo. Among patients achieving clinical remission and endoscopic response at one year, nearly 90% maintained clinical remission after two years of continuous treatment.

The drug's safety profile aligns with its known characteristics in ulcerative colitis patients. Common side effects include upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.

Eli Lilly (LLY) has updated its revenue guidance for 2024 and announced expectations for 2025. The company projects 2024 full-year revenue of approximately $45.0 billion, representing 32% growth from the previous year, though Q4 2024 revenue is expected to be $13.5 billion, about $400 million below recent guidance.

For 2025, Lilly anticipates revenue between $58.0-61.0 billion, a 32% growth at midpoint compared to 2024. Q4 2024 performance includes approximately $3.5 billion from Mounjaro® and $1.9 billion from Zepbound®, with non-incretin revenue growing 20% compared to Q4 2023.

The company attributes the Q4 2024 guidance miss to slower-than-expected incretin market growth and lower channel inventory. Lilly expects continued momentum in 2025, planning to increase incretin production by at least 60% in the first half of 2025 compared to the same period in 2024.

Eli Lilly (NYSE: LLY) has announced a definitive agreement to acquire Scorpion Therapeutics' PI3Kα inhibitor program STX-478, a precision oncology treatment currently in Phase 1/2 clinical trials. The deal, valued at up to $2.5 billion, includes upfront payment and milestone-based subsequent payments.

STX-478 is a once-daily oral, mutant-selective PI3Kα inhibitor being evaluated for breast cancer and other advanced solid tumors. The treatment could potentially benefit 30-40% of people with hormone-positive breast cancer by selectively targeting cancerous cells while sparing healthy ones, potentially offering better disease control and improved tolerability compared to current treatments.

As part of the transaction, Scorpion will spin out a new independent entity to retain its employees and non-PI3Kα pipeline assets, with Lilly maintaining a minority equity stake. The new company will be led by Dr. Friedman and the current Scorpion management team.

Eli Lilly (NYSE: LLY) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference, scheduled for January 13-16, 2025. The company's chair and CEO, David A. Ricks, will engage in a fireside chat on Tuesday, January 14 at 5:15 p.m. Eastern time.

The event will be accessible through a live audio webcast on Lilly's Investor website under the 'Webcasts & Presentations' section. Investors and interested parties can access the replay of the presentation on the same platform for approximately 30 days following the event.

Eli Lilly's Zepbound (tirzepatide) has received FDA approval as the first prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. In clinical trials, patients taking Zepbound experienced 25 fewer breathing interruptions per hour and achieved up to 20% weight loss. The approval was based on the SURMOUNT-OSA phase 3 trials, where 42-50% of adults on Zepbound experienced remission or mild, non-symptomatic OSA after one year, compared to 14-16% on placebo. Patients lost an average of 45-50 pounds, significantly outperforming the placebo group's 4-6 pounds. This marks Zepbound's second FDA indication following its November 2023 approval for obesity treatment.

Gan & Lee Pharmaceuticals announced FDA clearance of their IND application for GZR18 Injection, a bi-weekly GLP-1 receptor agonist, to conduct a Phase 2 clinical trial. The trial will be a head-to-head comparison with Eli Lilly's Tirzepatide for chronic weight management in obese or overweight patients, with or without T2DM.

According to the World Obesity Federation's 2024 report, approximately 2.2 billion adults worldwide were overweight in 2020, with projections reaching 3.3 billion by 2035. GZR18, as the first bi-weekly GLP-1 mono-agonist formulation, works by delaying gastric emptying and suppressing appetite. Current clinical data suggests weight loss effects comparable to or better than multi-target once-weekly GLP-1 formulations.

Eli Lilly's Kisunla™ (donanemab-azbt) has received approval from China's National Medical Products Administration for treating early symptomatic Alzheimer's disease. This marks China as the fourth major market to approve Kisunla, following approvals in the US, Japan, and Great Britain in 2024. The treatment targets adults with mild cognitive impairment and mild dementia stage of Alzheimer's with confirmed amyloid pathology.

In clinical trials, Kisunla demonstrated significant results, showing a 35% slowing of decline in less advanced patients and 22% in the overall population. The drug reduced amyloid plaques by 61% at 6 months, 80% at 12 months, and 84% at 18 months. Notably, 66% of patients achieved plaque clearance at one year, allowing them to complete treatment.