Lilly Eli & Co Stock Price, News & Analysis

Eli Lilly and Company (NYSE: LLY) will participate in the SVB Securities Global Biopharma Conference on February 16, 2023. Ilya Yuffa, Executive Vice President and President of Lilly International, will take part in a virtual fireside chat at 12 p.m. Eastern time. A live audio webcast will be available on Lilly's Investor website, with a replay accessible for approximately 90 days thereafter. Lilly has been a leader in creating innovative treatments, helping over 47 million people globally. Their research focuses on serious health challenges, including diabetes, obesity, Alzheimer's, and certain cancers.

Eli Lilly and Company (NYSE: LLY) will participate in the Guggenheim Oncology Conference on February 9, 2023. Key executives, including Jacob Van Naarden, CEO of Loxo@Lilly, and Dr. David Hyman, Chief Medical Officer, will engage in a fireside chat at 10:10 a.m. Eastern Time.

A live audio webcast of the event can be accessed through the 'Webcasts & Presentations' section on Lilly's Investor website. A replay will be available for 30 days after the event. Lilly has been at the forefront of medical innovations for nearly 150 years, focusing on life-changing therapies and ensuring accessibility for millions globally.

For Q4 2022, Eli Lilly (NYSE: LLY) reported a 9% decline in revenue to $7.30 billion, influenced by a 4% negative foreign exchange impact.EPS increased 13% to $2.14, while non-GAAP EPS fell 4% to $2.09. Excluding COVID-19 antibodies, revenue rose 5%, driven by a 21% growth in key products, which accounted for 70% of total revenue. The company updated its 2023 EPS guidance to $7.90 to $8.10 reported and $8.35 to $8.55 non-GAAP. Pipeline advancements include FDA approvals for Jaypirca and Jardiance. Lilly aims for mid-teen revenue growth for its core business in 2023.

Jaypirca™ (pirtobrutinib), developed by Eli Lilly (NYSE: LLY), has been approved by the FDA for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two systemic therapies, including a BTK inhibitor. This landmark approval marks Jaypirca as the first FDA-approved non-covalent reversible BTK inhibitor. In clinical trials, a 50% overall response rate was reported in patients pre-treated with other BTK inhibitors. While the approval is significant, it comes with a note that continued approval depends on confirming clinical benefits in future trials. Jaypirca's safety profile includes risks of serious infections and hemorrhage.

Eli Lilly (NYSE: LLY) announced a $1.15M contribution to support Direct Relief's initiative to enhance cold chain capacity in 17 low- and middle-income countries. This funding will help purchase and install 150 medical-grade refrigeration units at 25 partner facilities across Africa, Latin America, the Caribbean, and Southeast Asia. Effective cold chain systems are crucial for transporting temperature-sensitive medications, especially insulin. Lilly's initiative is part of its larger goal to improve access to healthcare for 30 million people by 2030, building on its previous contributions to diabetes care.

Eli Lilly and Company (NYSE: LLY) has partnered with Be Nimble Foundation to enhance career opportunities for historically underrepresented communities through the Skills First @ Lilly program. Launched in January 2023, this collaboration aims to recruit individuals without four-year degrees, focusing on roles in information technology and other areas. Over 70 individuals have already been trained since 2020. The initiative reflects Lilly's commitment to diversity, equity, and inclusion, with goals to recruit at least 50 professionals in the first year and provide them access to high-paying, two-year apprenticeships.

Eli Lilly (NYSE: LLY) announced a $450 million investment to expand its manufacturing facility in Research Triangle Park, North Carolina, creating 100 new jobs. This expansion aims to increase production capacity for incretin products that treat diabetes, addressing rising demand. Since 2020, Lilly has invested approximately $4 billion in North Carolina, with plans for initial production to start this year. The company has introduced 18 new medicines since 2014 and anticipates further growth with new treatments for diabetes, obesity, and more. The expansion is crucial for ensuring future patient access to essential medications.

The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets, which aims to reduce kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD). The application is based on data from the EMPA-KIDNEY phase III trial, which demonstrated a 28% reduction in the risk of kidney disease progression or cardiovascular death compared to placebo. Nearly 37 million U.S. adults are affected by CKD. Jardiance could potentially fill a significant gap in treatment options for CKD, which is associated with high hospitalization rates and healthcare costs.

Eli Lilly and Company (NYSE: LLY) has received a complete response letter from the FDA regarding the accelerated approval submission for donanemab, intended for treating early symptomatic Alzheimer's disease. The FDA’s concerns centered on the insufficient number of patients—less than 100 with at least 12 months of drug exposure—provided in the application. No additional deficiencies were noted. The ongoing Phase 3 TRAILBLAZER-ALZ trial, which is expected to yield topline data in Q2 2023, will support future traditional approval. Lilly confirmed that this regulatory setback does not alter its 2023 financial guidance.