“Results are expected later this year.”

In context

“James Bradner (President, Research and Development): Thank you, Murdo, and good afternoon, everyone. In the second quarter, we enjoyed continued progress advancing our late-stage pipeline and expanding the impact of our in-line medicines. Starting with cardiovascular disease, where Amgen is a global leader in developing medicines that target remaining often genetically defined cardiometabolic risk factors for heart disease. Repatha anchors our cardiovascular efforts as the only PCSK9 targeting therapy with outcomes data in both primary and secondary prevention, supported by 51 clinical trials involving more than 57,000 patients and over 100,000 patient years of exposure. We continue to generate additional insights from VESALIUS-CV, the landmark study of Repatha in pre-event cardiovascular disease. We recently reported that for patients with high-risk diabetes with and without atherosclerosis, Repatha reduced 3-point major adverse cardiovascular events by 29% and produced a nominal 21% reduction in the risk of all-cause death. Also based on the positive VESALIUS-CV study, we recently received a positive CHMP opinion supporting a broader label for Repatha in the EU. Our cardiovascular leadership further extends to Olpasiran, targeting lipoprotein(a) or Lp(a). Elevated Lp(a) is an independent genetically defined risk factor for cardiovascular disease affecting approximately 1 in 5 people. Having demonstrated greater than 95% reduction in Lp(a) level in Phase II, Olpasiran advanced into 2 ongoing Phase III outcome studies in both primary and secondary prevention. Deep Lp(a) suppression and quarterly dosing position Olpasiran for a potentially best-in-class profile. A third widely prevalent and modifiable risk factor for cardiovascular disease is, of course, obesity. Our lead obesity asset, MariTide, is fundamentally different from other GLP-1 therapies as MariTide is uniquely designed for monthly therapy with the potential for as few as 4 or 6 doses per year. Clinical development of MariTide continues to progress rapidly with 9 ongoing and 3 additional planned Phase III studies across obesity and related serious chronic diseases. Beyond establishing efficacy, these studies will guide how to start and stay on MariTide and how to switch from other GLP-1-based therapies and stay on MariTide. One, start and stay on MariTide. MariTide Phase III dosing features a simple 3-step dose escalation, allowing patients to start MariTide to reach their target dose in only 2 months, followed by monthly dosing thereafter. MariTide's unique monoclonal antibody backbone with appended GLP-1 peptides is designed for extended dosing. Our Phase III maintenance extension studies will evaluate how patients stay on MariTide to maintain weight loss while transitioning from monthly dosing to as few as 4 or 6 doses per year. Two, switch and stay on MariTide. The next chapter in obesity treatment is not simply greater weight loss, but achieving long-term persistent benefit. We are, therefore, evaluating switching from weekly GLP-1 therapies to MariTide in a dedicated Phase III study with the goal of enabling patients to move from weekly injections to a maintenance schedule with again as few as 4 or 6 doses per year. Through this comprehensive program, we aim to establish MariTide as the first monthly or less frequent obesity therapy and make long-term treatment easier for patients to sustain weight loss and enjoy durable health benefits. Closing out our cardiometabolic pipeline, we have decided to stop development of AMG 513, a Phase I asset. As I've said before, the bar is high at Amgen for obesity medicines. Our next generation of differentiated preclinical programs continues to progress, featuring both incretin and non-incretin mechanisms of action. Let me now turn to rare disease, where we are focused on challenging and rare autoimmune diseases with UPLIZNA, dazodalibep and blinatumomab. UPLIZNA has established the benefit of CD19-directed B-cell depletion in severe autoimmune diseases, including NMOSD, myasthenia gravis and IgG4-related disease with strong efficacy, durable benefit and twice yearly maintenance dosing. In IgG4-related disease, we recently completed a 1-year open-label extension of the Phase III MITIGATE study. Building on the remarkable 87% reduction in flare risk versus placebo in year 1 of UPLIZNA therapy, 100% of patients who continued UPLIZNA treatment remained flare-free at year 2 and 71.4% achieved complete remission without glucocorticoids. Based on the emerging profound clinical impact of UPLIZNA in autoantibody-mediated disease, we have initiated the registrational MERCURY study in autoimmune hepatitis, a disease affecting as many as 150,000 patients in the U.S. We are also planning a Phase III study in chronic inflammatory demyelinating polyneuropathy, a rare and debilitating autoimmune condition that attacks the myelin sheath on peripheral nerves affecting about 35,000 patients in the U.S. For patients suffering from Sjögren's disease, we are developing dazodalibep. Dazodalibep targets CD40 ligand mediated signaling between activated T cells and B cells and has been artfully designed to avoid the platelet-related adverse events observed with first-generation CD40 ligand targeting agents. We are conducting 2 dedicated Phase III studies in symptomatic and in systemic disease. Results are expected later this year. Turning to inflammation. TEZSPIRE has validated targeting TSLP and the alarmin pathway in severe asthma and chronic rhinosinusitis with nasal polyps. We are now extending its potential to other diseases where epithelial-driven inflammation plays a key role. Our Phase III study in eosinophilic esophagitis or EoE, is expected to complete in the second half of the year. EoE is a chronic progressive inflammatory disorder characterized by epithelial-driven inflammation, remodeling and dysfunction of the esophagus, affecting over 400,000 patients in the U.S. Building on the impact of TEZSPIRE, we are developing sunakiment, previously AMG 104 as an inhaled anti-TSLP fragment antigen-binding protein or Fab. In the Phase II LEVANTE dose-ranging study of sunakiment, we observed numerical reductions in composite asthma exacerbation events or CompEx as the primary endpoint at 12 weeks. Although the primary endpoint was not statistically significant, we are encouraged by the overall profile and are planning a Phase III program with AstraZeneca. In oncology, we continue to expand our bispecific T cell engager or BiTE platform across tumor types and earlier lines of treatment. IMDELLTRA or tarlatamab is becoming a standard of care after first-line treatment for small cell lung cancer, supported by a strong survival benefit. We are actively advancing IMDELLTRA into earlier treatment lines, where we hope to further impact survival with 3 Phase III studies well underway. Success in these early-stage settings would allow IMDELLTRA to reach as many as 28,000 addressable patients in the U.S. We are also pursuing more convenient administration. DeLLphi-309 is informing our strategy for extended interval dosing, while the new Phase III DeLLphi-315 study is evaluating subcutaneous tarlatamab. Building on the success of our BiTE platform in solid tumors, Xaluritamig is advancing in two Phase III studies of metastatic castration-resistant prostate cancer, while we also evaluate opportunities in earlier stages of this disease. Shifting gears before closing, I'll briefly comment on artificial intelligence. Amgen has a differentiated foundation in proprietary human data, high-performance computing and deep scientific expertise. We are applying AI strategically across discovery, development, manufacturing and access to medicines to improve insight, speed and decision quality. The impact and insight from these investments are already proving valuable. For example, in Amgen research, we recently established a frontier AI laboratory that combines advanced models with proprietary data and scientific capabilities unique to Amgen. Bringing agentic workflows to discovery research powerfully augments the insights and ideas of our brilliant research scientists. We look forward to sharing more over time. In closing, I'd like to thank my colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases. I'll now turn it over to Peter for the financial update.”