ELI LILLY & Q1 FY26 earnings call LLY

Eli Lilly's new oral GLP-1, Foundayo (orforgopron), received U.S. FDA approval for weight management and has just begun its launch. The company is focused on broad digital and traditional distribution, high consumer awareness, educating healthcare professionals, and building broad access across commercial, Medicare (via the bridge program), and Medicaid. Foundayo is a new molecule and modality, representing the first incretin medicine launched with obesity as its primary indication. Regulatory reviews are ongoing in over 40 countries, and a U.S. submission for type 2 diabetes is planned for late Q2 2026.

The incretin analog market continues robust growth, with total U.S. obesity prescriptions up over 80% in Q1. Lilly is strategically segmenting the market with its diverse GLP-1 portfolio, including Mounjaro, Zepbound, the newly launched Foundayo, and pipeline assets like Retatrutide and Eloralintide. Management believes different patients will require tailored medicines, with Retatrutide potentially offering greater weight loss and Eloralintide providing a non-GLP-1 mechanism or an add-on therapy. The company is investing in common manufacturing platforms to support these diverse offerings.

Lilly achieved several key pipeline milestones, including positive Phase III data for Foundayo in cardiovascular safety for type 2 diabetes, positive Phase III data for Adbry in pediatric atopic dermatitis, and positive Phase III data for Taltz plus Zepbound in psoriasis and obesity. Retatrutide showed profound A1c improvements and significant weight loss in its first Phase III trial for type 2 diabetes. The company also initiated new Phase III programs for Eloralintide in OA pain, obstructive sleep apnea, and as an add-on therapy, and for Berenepatide in major depressive disorder.

Consistent with its capital allocation strategy, Lilly announced multiple business development transactions to complement its internal portfolio. These include the acquisitions of Orna Therapeutics (in vivo CAR T for autoimmune diseases), Syntessa Pharmaceuticals (sleep-wake medicines), Colonia Therapeutics (in vivo CAR T for multiple myeloma), and Ajax Therapeutics (JAK inhibitors for blood cancers). The acquisition of Ventix Biosciences (NLRP3 inhibitors) was completed, and a licensing agreement with CSL for clazakizumab was announced, demonstrating an active approach to pipeline expansion.

CMS announced the extension of the Medicare GLP-1 bridge program, providing access to obesity medicines for Medicare beneficiaries with a $50 per month out-of-pocket cap, starting no later than July 1, 2026, and running through December 2027. Additionally, Lilly launched Employer Connect, a platform for employers to offer obesity management medicines to employees with transparent pricing and flexible design. These initiatives aim to expand access and improve affordability for obesity care, with gradual impact expected through 2027.

Mounjaro continues its strong international performance, with revenue more than doubling in constant currency in the Rest of the World segment, driven by rapid share gains in Latin America and Asia. The total international incretin analog market increased by 77% year-over-year. Despite the entry of generic semaglutide in some markets, Mounjaro has maintained its market share, suggesting that dual agonists are outperforming single agonists and that generics are stimulating overall market growth. Lilly expects continued strong year-on-year growth internationally.