“We look forward to working with regulators as they evaluate this important new medicine and plan to submit in the U.S. in Q1 2027 under the BLA pathway.”

In context

“Daniel Skovronsky (Chief Scientific and Product Officer): Thanks, Lucas. Since our last earnings call, we've made significant progress across R&D, with advances in each major therapeutic area. I'll begin with Cardiometabolic Health. Starting with retatrutide, we announced positive results from three Phase 3 trials: TRIUMPH-1 in people with obesity or overweight; TRIUMPH-2 in people with type 2 diabetes and obesity or overweight; and TRIUMPH-3 in people with severe obesity and established cardiovascular disease with or without type 2 diabetes. Across the TRIUMPH program, we've seen profound levels of weight loss and improvements in A1C, cardiovascular risk factors, osteoarthritis pain, and sleep apnea. With the recent completion of TRIUMPH-2 and TRIUMPH-3 trials, we now have the clinical data package to support global registrations in obesity, obstructive sleep apnea, and knee osteoarthritis pain. Slide 15 shows impressive and consistent weight loss across the TRIUMPH registrational program. In TRIUMPH-1, we saw weight loss approaching bariatric surgery levels at the highest doses, and clinically meaningful efficacy at low doses with only one titration step. In patients with diabetes and obesity who typically struggle to lose weight, retatrutide delivered a magnitude of weight loss not previously seen with incretin therapy. We look forward to working with regulators as they evaluate this important new medicine and plan to submit in the U.S. in Q1 2027 under the BLA pathway. Turning to orforglipron, we completed our U.S. submission in type 2 diabetes, supported by the ACHIEVE Phase 3 program. In June, we presented detailed results from three of those trials: ACHIEVE-2, ACHIEVE-3, and ACHIEVE-5 at the American Diabetes Association Scientific Sessions. ACHIEVE-3 was the first head-to-head comparison of two oral GLP-1s, and orforglipron delivered superior glycemic control and weight reduction against 7 mg and 14 mg oral semaglutide in patients with type 2 diabetes. For the many people with type 2 diabetes who prefer an oral option and have difficulty reaching their glycemic targets, we believe orforglipron has the potential to be a foundational daily oral treatment. Also in Cardiometabolic Health, the CHMP adopted a positive opinion recommending EU approval of insulin efsitora alfa for patients with type 2 diabetes. The opinion was based on the Phase 3 program, where once-weekly insulin efsitora alfa achieved reductions in A1C comparable to those of once-daily basal insulin. For people with type 2 diabetes who require insulin, a single weekly injection can simplify treatment and ease the burden of daily dosing. We look forward to European approval in the coming months. We also shared clinical results from VERVE-102, our gene-editing program in cardiovascular disease, designed to inactivate the PCSK9 gene, resulting in lowered LDL cholesterol. In the Phase 1b study, a single infusion reduced PCSK9 by 88% and LDL cholesterol by 62% at the highest dose. These early data are encouraging and suggest that we may be able to have a medicine delivered once, lasting cardiovascular benefit. Moving to Neuroscience, we announced an agreement to acquire AtaiBeckley, which is advancing a pipeline of rapid-acting neuroplastogens for treatment-resistant depression and other mental health conditions. The lead asset, BPL-003, has shown encouraging Phase 2b results. This remains one of the most significant unmet needs in psychiatry, and we're encouraged by the potential of a rapid-acting therapy designed to deliver durable relief. We look forward to welcoming the AtaiBeckley team to Lilly. With the Centessa acquisition now complete, we added cleminorexton to the pipeline in Phase 2. Cleminorexton is a potential best-in-class orexin receptor 2 agonist being studied in a Phase 2/3 trial in central hypersomnias. Orexin biology plays an important role in regulating the sleep-wake cycle, and sleep disorders are associated with many neurological, neurodegenerative, and neuropsychiatric conditions. We believe with the Centessa pipeline, we may have the potential to treat a broad range of diseases. Turning to Oncology, we recently presented detailed Phase 3 results from BRUIN CLL-322 at the 2026 EHA meeting, which added pirtobrutinib to a time-limited venetoclax and rituximab regimen in previously treated CLL. As shown on Slide 16, in the overall study population, adding pirtobrutinib reduced the risk of disease progression or death by 45% compared to the fixed-duration regimen. Additionally, in patients whose disease progressed after treatment with one prior covalent BTK inhibitor, adding pirtobrutinib to the fixed-duration regimen led to a 68% reduction in the risk of progression or death. These results are the first to outperform a venetoclax-containing control arm in a CLL Phase 3 trial. We believe this study has the potential to establish a new standard of care in this population, and we've submitted these data to global regulatory authorities. Also in Oncology, we shared impressive new data from the LIBRETTO-432 Phase 3 trial of selpercatinib in adjuvant RET fusion-positive non-small cell lung cancer. These results were presented during the Plenary Session at the 2026 ASCO meeting, and showed that selpercatinib reduced the risk of disease recurrence or death by 83% versus placebo. This striking effect size highlights the efficacy that can be achieved by targeted therapies and underscores the importance of comprehensive biomarker testing across all stages of disease. We were also excited by the encouraging data presented at medical meetings from two recently acquired hematology programs: AJ1-11095, a type II JAK inhibitor from Ajax Therapeutics, and KLN-1010, an in vivo CAR-T therapy from Kelonia Therapeutics. Both programs demonstrated compelling early efficacy and safety, and we look forward to progressing both through clinical development alongside the teams from Ajax and Kelonia. Moving to Immunology, the FDA approved a new maintenance dosing option for lebrikizumab, giving patients with atopic dermatitis the option to manage their condition with as few as six maintenance injections per year. The potential to deliver sustained disease control with greater convenience has been well received by physicians and patients, reinforcing the strong and durable effect of lebrikizumab. With our partner, Almirall, we're exploring even less frequent dosing, once every 12 weeks. These data are expected in 2027. We're also working to bring lebrikizumab to more patients. Based on the positive Phase 3 results in children six months to 18 years old in the ADorable trial program, we submitted for a pediatric atopic dermatitis indication in the U.S., and plan to submit to other global regulators later this year. We also continue to expand our study of incretin biology into new settings and initiated two Phase 2 trials of brenipatide, our GIP/GLP-1 dual agonist, in irritable bowel syndrome. Irritable bowel syndrome is a disorder of gut-brain interaction defined by heightened visceral pain sensitivity and disorders of intestinal motility. Incretin pathway signaling has been shown to reduce visceral pain sensitivity, modulate gut motility, and help restore the intestinal barrier. We also began a Phase 2 trial of our FXR agonist in combination with mirikizumab in Crohn's disease, and a Phase 2 trial of our XCL1/2 antibody in vitiligo. Finally, we announced initiatives to address global morbidity. New medicines could be important to prevent acute disease and the downstream long-term consequences. We believe that combining these companies' platforms and teams with Lilly's global scale could position Lilly to address significant population-level health problems. The acquisitions include Curevo, adding amezosvatein, a potential next-generation varicella zoster virus vaccine for the prevention of shingles. In a Phase 2 head-to-head study against the current standard of care, amezosvatein showed a comparable immune response with meaningfully improved tolerability. With growing evidence linking shingles to elevated stroke risk, and shingles vaccination to reduced dementia risk, a better-tolerated vaccine could extend the reach of shingles prevention and reduce long-term risks of dementia and stroke. Next, LimmaTech Biologics is developing vaccines to prevent serious bacterial infections. Its platform focuses on bacteria by targeting the toxins and superantigens that drive disease. The most advanced program is in Phase 1 for the prevention of the leading bacterial cause of surgical site infections, where no vaccine exists today. Vaccines to prevent bacterial infection could play an important role as antimicrobial resistance grows globally. And finally, Vaccine Company, which has a lead program against Epstein-Barr virus, an infection with no vaccine today. Beyond acute mononucleosis, Epstein-Barr is linked to chronic oncological and neurological sequelae, including multiple sclerosis. A vaccine could prevent not just the infection, but the serious diseases that follow it. As highlighted by all the new molecules we added to our pipeline through acquisitions, business development is an important component of our R&D strategy. In the first half of 2026, we made strong progress and announced deals to acquire potential new medicines across established and emerging areas at Lilly. We have been increasingly active in business development over the last several years. The pace and average deal size have also continued to increase, reflecting our strategy to grow within our core therapeutic areas and create new opportunities through emerging science. Lilly is uniquely positioned to pursue diseases where there is significant unmet need, exciting early science, and the need for Lilly's development, regulatory, and manufacturing scale to create value. We expect to remain active in business development, while maintaining discipline to create value. Finally, Slides 18 and 19 show the pipeline movement since our last earnings call and the full list of potential key events expected in 2026. It was another productive quarter in Lilly R&D, and we have an ambitious agenda for the second half of the year. I'll now turn the call back to Dave for closing.”