Lilly Eli & Co - LLY STOCK NEWS

Eli Lilly has announced positive topline results from two phase 3 clinical trials, QWINT-1 and QWINT-3, evaluating once weekly insulin efsitora alfa in adults with type 2 diabetes. The trials showed that efsitora was non-inferior to daily basal insulins in reducing A1C levels.

QWINT-1 studied insulin-naïve patients, using a novel fixed-dose regimen with four doses administered via a single-use autoinjector. QWINT-3 focused on patients switching from daily basal insulin. Both trials met their primary endpoints, demonstrating similar A1C reductions to daily insulins glargine and degludec, respectively.

Efsitora showed a comparable safety profile to daily basal insulins, with QWINT-1 reporting approximately 40% lower rates of severe or clinically significant hypoglycemic events compared to insulin glargine.

Eli Lilly and Company (NYSE: LLY) has partnered with EVA Pharma to expand access to baricitinib in 49 low- to middle-income African countries. This collaboration aims to reach an estimated 20,000 people by 2030, aligning with Lilly's 30x30 initiative to improve healthcare access for 30 million people in resource- settings annually by 2030.

EVA Pharma will manufacture and supply baricitinib locally, with sales expected to begin by 2026. This agreement marks Lilly's first voluntary licensing agreement, providing manufacturing know-how to EVA Pharma. The collaboration builds on their existing partnership to expand access to affordable insulin in 56 countries, as announced in 2022.

Eli Lilly (NYSE: LLY) has announced the release of Zepbound® (tirzepatide) 2.5 mg and 5 mg single-dose vials for self-pay patients with obesity. This expansion aims to meet high demand and broaden access to the medication. The vials are priced at least 50% less than other incretin medicines for obesity. Available through LillyDirect®'s self-pay channel, the 2.5 mg four-week supply costs $399, while the 5 mg dose is $549.

Zepbound, which activates both GIP and GLP-1 hormone receptors, achieved an average of 15% weight loss over 72 weeks in clinical trials. The single-dose vials are intended for adults with obesity or overweight individuals with weight-related medical problems. Lilly emphasizes the importance of using Zepbound with a reduced-calorie diet and increased physical activity.

Eli Lilly and Company (NYSE: LLY) has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024. Jacob Van Naarden, executive vice president and president of Lilly Oncology, will engage in a fireside chat at 7:45 a.m. Eastern time.

Investors and interested parties can access a live audio webcast of the presentation through Lilly's Investor website. The webcast will be available in the 'Webcasts & Presentations' section at https://investor.lilly.com/webcasts-and-presentations. For those unable to attend live, a replay of the presentation will be accessible on the same website for approximately 90 days following the event.

Eli Lilly's tirzepatide showed remarkable results in a 176-week SURMOUNT-1 Phase 3 study for long-term weight management and diabetes prevention. The drug reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight. Participants on the 15 mg dose experienced an average 22.9% decrease in body weight compared to 2.1% for placebo.

The study involved 1,032 adults with pre-diabetes and obesity or overweight. Tirzepatide, a GIP and GLP-1 receptor agonist, demonstrated sustained weight loss and significant reduction in diabetes risk throughout the treatment period. The safety profile was consistent with previous studies, with gastrointestinal-related adverse events being most common.

Eli Lilly and Company (NYSE: LLY) has announced the retirement of Marschall S. Runge, M.D., Ph.D. from its Board of Directors, effective Aug. 31, 2024. Dr. Runge, who has served on Lilly's board since 2013, is also retiring from his roles as CEO of Michigan Medicine, executive vice president for medical affairs at the University of Michigan, and dean of the Medical School on June 30, 2025. He will remain on the Medical School faculty as a professor.

During his tenure, Dr. Runge served on the board's Science and Technology Committee and Ethics and Compliance Committee, bringing decades of experience as a physician, scientist, and expert in health care faculty systems, biomedical research, clinical trial design, and patient safety. His research-driven perspective has been particularly valuable in the areas of diabetes and obesity treatments.

Eli Lilly and Company (NYSE: LLY) has successfully completed its acquisition of Morphic Holding, Inc. (NASDAQ: MORF), a biopharmaceutical company developing oral integrin therapies for treating serious chronic diseases. The acquisition, valued at $57 per share, broadens Lilly's immunology pipeline, particularly in the field of inflammatory bowel disease (IBD).

Key highlights include:

• Acquisition of Morphic's oral integrin therapies, including MORF-057, a selective oral small molecule inhibitor of α4β7 integrin for IBD
• Reinforcement of Lilly's strategy to deliver first or best-in-class therapies in gastroenterology
• Potential for researching combination treatments to better serve patients
• Delisting of Morphic's common stock from The Nasdaq Global Market

Eli Lilly and Company (NYSE: LLY) has opened the Lilly Seaport Innovation Center (LSC) in the Boston Seaport, a state-of-the-art research and development facility focused on advancing RNA and DNA-based therapies. The 346,000 square foot, 12-story building will house approximately 500 Lilly scientists and researchers, plus 200 people from Lilly Gateway Labs' companies. LSC serves as the central hub for Lilly's genetic medicines efforts and includes the first East Coast Lilly Gateway Labs location.

The facility aims to discover new drug targets for creating life-changing medicines in areas such as diabetes, obesity, cardiovascular diseases, neurodegeneration, and chronic pain. This expansion reinforces Lilly's commitment to the Boston area and fosters collaboration with leading institutions to accelerate the development of novel medicines.

Eli Lilly (NYSE: LLY) reported Q2 2024 financial results with a 36% revenue increase to $11.30 billion, driven by strong sales of Mounjaro, Zepbound, and Verzenio. Excluding the previous year's $579 million Baqsimi sale, revenue rose by 46%. EPS surged 68% to $3.28 and 86% to $3.92 on a non-GAAP basis. The company raised its full-year revenue guidance by $3 billion and EPS guidance to $15.10-$15.60 reported and $16.10-$16.60 non-GAAP.

Pipeline progress included FDA approval of Kisunla for Alzheimer's and Jaypirca in Japan for relapsed mantle cell lymphoma, plus significant trial results for tirzepatide.

Gross margin increased by 40% to $9.13 billion, despite a 15% rise in R&D expenses. U.S. revenue grew 42%, led by Mounjaro and Zepbound, while international revenue rose 25%. Key products like Taltz and Jardiance also saw significant growth.

Financial guidance saw notable improvements, with revenue now expected between $45.4 billion and $46.6 billion. The company also announced a $5.3 billion manufacturing investment in Indiana to support pipeline medicines.