Eli Lilly & Co. - LLY STOCK NEWS

Lilly reported Q3 2022 revenue of $6.94 billion, up 2% year-over-year, with strong volume growth offset by lower prices and decreased Alimta revenue due to generics. Key growth products saw a 19% increase, contributing 70% of total revenue. Mounjaro launched successfully, generating $97.3 million in U.S. sales. Q3 EPS rose 32% to $1.61. The company updated its 2022 EPS guidance to $6.50-$6.65 (reported) and $7.70-$7.85 (non-GAAP), citing unfavorable foreign exchange impacts and asset impairment charges. Overall, Lilly continues to advance its pipeline with multiple regulatory approvals.

Eli Lilly and Company has committed $92.5 million to Purdue University to establish a pharmaceutical manufacturing scholarship program and extend research collaboration. This initiative includes $42.5 million for scholarships aimed at underrepresented students, offering up to 100 annual scholarships with guaranteed internships at Lilly. The renewed five-year collaboration will focus on advancements in drug delivery and genetic medicine, supported by an additional $50 million. This partnership aims to enhance Indiana's pharmaceutical ecosystem and training for future professionals.

Eli Lilly and Company (NYSE: LLY) will announce its third-quarter 2022 financial results on November 1, 2022. The announcement will be followed by a conference call at 9 a.m. Eastern time to discuss the financial performance in detail. Investors and the public can access a live webcast via the company's investor relations website. Lilly continues to innovate in healthcare, enhancing diabetes care, obesity treatments, Alzheimer's, and immune system disorders, benefiting over 47 million people globally.

Eli Lilly has announced a definitive agreement to acquire Akouos, valued at $487 million with potential additional payouts of up to $610 million. This acquisition aims to enhance Lilly's gene therapy capabilities for treating hearing loss. Akouos specializes in developing innovative adeno-associated viral gene therapies for inner ear conditions, including its lead candidate AK-OTOF for otoferlin gene mutations. The deal, approved by both companies' boards, secures Lilly a premium of 121% over Akouos's stock price before the announcement, with expectations to close in Q4 2022.

Eli Lilly and Company (NYSE: LLY) declared a dividend of $0.98 per share for Q4 2022, payable on Dec. 9, 2022, to shareholders of record on Nov. 15, 2022. This reflects Lilly’s commitment to returning value to investors. The company emphasizes its dedication to delivering innovative medicines and advancing biotechnology to tackle health challenges. Forward-looking statements are included, covering potential risks and uncertainties in pharmaceutical development that may affect future results.

Eli Lilly (NYSE: LLY) announced that the FDA has granted Fast Track designation for tirzepatide, aimed at treating adults with obesity or overweight related comorbidities. This designation accelerates the drug’s path for FDA submission, with a rolling NDA submission planned based on results from two Phase 3 trials: SURMOUNT-1 and SURMOUNT-2. Positive outcomes from these trials could expedite the approval process. Lilly emphasizes its commitment to addressing obesity, a significant health challenge in the U.S., affecting nearly 100 million adults.

Eli Lilly announced the FDA approval of Retevmo® (selpercatinib) for adult patients with locally advanced or metastatic solid tumors exhibiting a RET gene fusion, after previous treatments or lacking alternatives.

The approval is based on tumor-agnostic data from the LIBRETTO-001 trial, showing a 44% overall response rate across various cancers. The FDA also granted traditional approval for Retevmo in adult patients with non-small cell lung cancer (NSCLC) with RET fusion.

Warnings for Retevmo include hepatotoxicity and interstitial lung disease.

Eli Lilly announced positive results from its Phase 3 trials for lebrikizumab, an IL-13 inhibitor for atopic dermatitis (AD). Responders at Week 16 maintained skin clearance and itch relief after a year of treatment, with similar efficacy between every four weeks and every two weeks dosing. Regulatory submissions to the U.S. FDA and EU EMA are planned for this year. Notably, the trials showed a stable safety profile, with most adverse events being mild to moderate.

Eli Lilly and Company (NYSE: LLY) announced its participation in the 2022 European Society for Medical Oncology (ESMO) Congress, scheduled for September 9-13, 2022. The company will present key data on its drugs Verzenio® (abemaciclib) and Retevmo® (selpercatinib). Highlights include interim overall survival results from the Phase 3 MONARCH 3 study for Verzenio in advanced breast cancer, and long-term follow-up data for Retevmo in medullary thyroid cancer and non-small cell lung cancer. These presentations aim to advance understanding and treatment options in oncology.