Amgen Inc.

Thank you, Jillian. Good afternoon, everyone, and welcome to our fourth quarter 2025 earnings call. Bob Bradway will lead the call today and be followed by a broader review of our performance by Jay Bradner, Myrto Gordon, and Peter Griffith. Through the course of our discussion today, we will use non-GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompany this call. We will also make some forward-looking statements which are qualified by our safe harbor statement, and please note that actual results can vary materially. Over to you, Bob.

Okay. Thank you, Casey, and good afternoon, everyone. Thank you for joining us today. Today we'll cover full-year results for 2025 and provide a preview of what to expect from us in 2026. Amgen delivered strong operational performance across the board in 2025, and you can see that in the breadth of our business. Note that 14 of our products achieved blockbuster status with sales of a billion dollars or more, 13 products delivered double-digit sales growth, and 18 products achieved record results for us. The strength of that broad portfolio enabled us to post double-digit growth in revenues and earnings per share for 2025. Looking to 2026, I would highlight six areas of momentum. Three of these were PASA, Avenity and Tespire all grew by more than 30% year-over-year in 2025. These medicines have a few important things in common. First, they're highly effective, innovative therapies that address important public health needs. Second, they're leading products in their fields. And third, while each of these products represents a multibillion-dollar global franchise already, they address areas of large unmet medical need where there are millions of patients yet to be treated. In this sense, they represent growth drivers not just for 2026, but for the rest of the decade. In rare disease, our portfolio generated more than $5 billion in sales in 2025. Here, too, many of our medicines are early in their lifecycle and positioned as leaders in their respective categories. Growth has been fueled by reaching new patients, expanding into additional geographies, and launching new indications. We see further opportunity ahead as we scale these therapies. Uplizna exemplifies this growth opportunity with approvals in IgG4-related disease and generalized myasthenia gravis in 2025. Our innovative oncology portfolio grew at 11% year-over-year in 2025, driven by our bite or bispecific T-cell engager medicines. We're particularly excited about Imdeltra, which has rapidly become the standard of care in patients with second line or later small cell lung cancer, supported by unprecedented survival benefits. We're an industry leader in biosimilars. Our biosimilars portfolio has contributed more than $13 billion in sales since the launch of our first medicine there in 2018. With $3 billion in 2025 sales, this business is an important contributor to our organization. and poised for growth with the next wave of biosimilar launches. You can appreciate the depth of our business through the lens of our research and development activities. 2026 will be a year of disciplined data generation from a number of exciting Phase II and Phase III programs that will pave the way for long-term growth at Amgen. Our confidence continues to build in Maritide as a differentiated treatment for obesity, type 2 diabetes, and obesity-related conditions. In a field featuring dozens of potential daily oral and weekly injectable medicines, Maritide stands alone as the only therapy in late-stage development to offer the paradigm-changing prospect of strong efficacy and favorable tolerability at monthly, every other month, or even quarterly dosing. In addition to Meritide, we remain excited about Opaziran and what it might represent for patients with elevated LP little a, a heritable risk factor for cardiovascular disease. We see Opaziran as an opportunity to build on our leading positions in cardiometabolic disease. It shouldn't be lost on any of us that Repatha, Opaziran, and Meritide together would represent a very compelling set of cardiometabolic medicines to expand our leadership in the treatment of serious chronic diseases well into the next decade. Beyond the pipeline is a great deal of enthusiasm about the convergence of technology and life science. And based on what we're seeing at Amgen, we believe that enthusiasm for convergent innovation is well placed and will have significant impact on how we discover, develop, and commercialize medicines. As always, I thank my Amgen colleagues around the world for supporting our mission to serve patients. And with that, let me turn it over to Jay for an update in R&D.

Thank you, Bob, and good afternoon, everyone. Fourth quarter capped off a year of strong, disciplined execution across R&D. Throughout 2025, we advanced multiple late-stage programs, delivered five key regulatory approvals, and strengthened the evidence base supporting our marketed medicines. Taken together, these contributions demonstrate real scientific rigor and illustrate the breadth of opportunity ahead. Let me begin with Meritide, which continues to develop in meaningful and very encouraging ways. The Maritime Phase III program is rapidly advancing, with strong enthusiasm from investigators and participants. Both of our Phase III chronic weight management studies are fully enrolled, and our ASCVD and heart failure outcome studies are progressing well. In parallel, we continue to expand the clinical landscape of Maritime across obesity-related conditions as we begin enrollment of our two Phase III sleep apnea studies. in adults with and without positive airway pressure therapy. Altogether, we now have six global Phase 3 studies underway with Meritide, collectively designed to deliver a comprehensive evidence base. In addition, as we shared last month, we've completed Part 2 of the Meritide Phase 2 Chronic Weight Management Study. We also completed the first 24 weeks of the Phase 2 Type 2 Diabetes Study that enrolled participants with and without obesity. Results from these two studies further increase our confidence that Meritide can represent a new paradigm in obesity, type 2 diabetes, and other obesity-related conditions. We believe Meritide has the potential to expand what's possible for patients, availing an opportunity for monthly or less frequent dosing. Meritide's strong efficacy, infrequent dosing, and excellent tolerability at target dose have the potential to further enhance the patient experience, and therefore, treatment persistence, a major unmet need in the field. Beyond obesity and general medicine, the fourth quarter brought a landmark contribution to cardiovascular health from RPASA. In November, full results from the Phase III Visalia CV trial were presented at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine. This study enrolled more than 12,000 patients without a prior heart attack or stroke testing the impact of RPASA for LDL-C lowering when added to optimize lipid therapy, namely statins, with a median follow-up of approximately 4.5 years. In Vesalius CV, RPASA demonstrated a 25% relative risk reduction in the composite of coronary heart disease death, heart attack, or ischemic stroke, and delivered a 36% reduction in heart attack, with no new safety signals observed. These data clearly demonstrate that intensive LDL-C lowering with Repatha can meaningfully reduce the risk of a first cardiovascular event, reinforcing its role across the full continuum of cardiovascular risk. Turning to Olpaceran, our potentially best-in-class small interfering RNA medicine targeting LP little a, the fully enrolled OCEAN-A outcome study continues to progress. As previously discussed, this is an event-driven study and the aggregate endpoint accrual rate remains lower than initial predictions. As this study matures, we will update on the date for primary analysis as appropriate. Our conviction in Olpaceran to reduce cardiovascular risk conferred by elevated Lp remains strong, grounded in compelling genetic and epidemiologic evidence that establish elevated Lp as an independent risk factor for heart disease. Moving to rare disease, The fourth quarter was highlighted by important regulatory momentum for aplizna. In November, the European Commission approved aplizna for the treatment of adults with active IgG4-related disease. And in December, the FDA approved aplizna for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-MUSC antibody positive. These approvals built on strong Phase III data demonstrating durable efficacy, a steroid-sparing benefit with every six-month dosing. This research further extends the impact of CD19-directed B-cell depletion across serious autoimmune diseases. More broadly in B-cell depletion, where we have a number of proof-of-concept studies underway, we expect to initiate two pivotal studies this year. The first is for patients with autoimmune hepatitis, a serious disease. characterized by persistent liver inflammation that can lead to progressive scarring, loss of liver function, and ultimately liver failure. The second studies chronic inflammatory demyelinating polyneuropathy, or CIDP, a disabling immune-mediated neuropathy that damages peripheral nerve myelin, resulting in worsening strength, worsening sensation, and for many patients, substantial impairment in daily activities. With Aplizna, we are targeting these diseases at their root cause by depleting pathologic B cells that drive disease through secreted autoantibodies. Given the strong efficacy of Aplizna in other settings, we're excited about the potential to bring a meaningful new option to patients with these two devastating conditions. We are also advancing Dezodolibep, our CD40 ligand-targeting biotherapeutic, with both Phase III studies in Sjogren's disease now fully enrolled and study completion expected in the second half of 2026. We're pleased today to announce positive Phase II data with daxidilumab, a first-in-class plasmacytoid dendritic cell-depleting monoclonal antibody targeting ILT7 for the immunoglobulin-like transcript 7 protein. This study in patients with primary discoid lupus erythematosus met both primary and key secondary endpoints with an attractive safety profile. Encouraged by these data, we are working to advance dextilumab to the next phase of development in this setting. In inflammation, the test-buyer phase three program continues to advance with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, where we expect study completion in the second half of this year. We recently announced the decision to terminate the rocatinlamab development and commercialization collaboration with Keoa Kiran. With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs. Rocatinlamab will return to our partners at Keoa Kiran, who will assume full ownership of the program. Turning to oncology, in November, the FDA granted full approval to Indeltra, for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. This approval represents a meaningful advancement for patients facing a disease that has seen very little innovation for decades. To extend the impact of Indeltra, we are presently advancing this medicine as combination therapy in frontline extensive stage small cell where we observed unprecedented survival in early phase clinical trials. Further, we are also advancing MDELTRA with an ongoing Phase III study of limited-stage small-cell lung cancer. It's a joy to see MDELTRA, like BlinCyto, becoming a standard of care in the management of advanced cancer. Our first-in-class STEEP1-directed bispecific T-cell engager, Zaluridamig, continues to advance through Phase III development in prostate cancer. Beyond prostate cancer, we have recently initiated a phase 1B study in relapsed or refractory Ewing sarcoma, a rare malignancy with high steep one expression and patients in an urgent need for targeted therapy. Across Indeltra, Blinsito, and Zaluritimib, we continue to see meaningful long-term impact from our bispecific T-cell engager platform. We remain committed to bringing transformative and innovative therapies like these to patients with cancer. To close out oncology, given the previously announced results from Fortitude 101 and Fortitude 102, we have decided not to pursue regulatory approval for bimerituzumab, our FGFR2B-targeting monoclonal antibody in first-line gastric cancer. Though overall efficacy did not meet our expectations, we observed an emerging signal of putative survival benefit in a subset of biomarker-defined patients. We expect to share these findings with the scientific community in the future. As with rocatinlamab, we took a portfolio decision to focus resources on our other late-stage programs. Across biosimilars, both ABP206 and ABP234 biosimilar candidates to Opdivo and Keytruda, respectively, have completed enrollment in each of their comparative clinical studies, supporting continued progress of the next wave of our biosimilar portfolio. Before closing, as described in our press release, We are engaged in an ongoing dialogue with the FDA regarding TABNEOS, our medicine for the treatment of a rare and severe disease, ANCA-associated vasculitis. We will update you on those discussions as necessary. Now let me finish by saying that 2025 was a year of consistent execution, real scientific progress, and disciplined decision-making. We expect 2026 to bring another year of strong execution, disciplined data generation, and new scientific advances as we continue to progress our robust pipeline. I want to thank our colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases. With a broad and deep pipeline, we are well positioned to deliver sustained long-term growth. I'll now turn it over to Murdo for the commercial update.