Amgen (AMGN) Q2 FY26 earnings call: guidance and Q&A

Inquired about the protocol design for Olpasiran's Phase III studies, specifically regarding interim analyses and the impact of using a MACE-3 endpoint (excluding strokes) compared to MACE-4 on study duration.

Amgen's OCEAN(a) study for Olpasiran is a double-blind, randomized controlled trial with 7,297 patients. It requires Lp(a) elevations above 200 nanomoles per liter and uses a 3-point MACE endpoint. The exclusion of ischemic stroke from the endpoint was based on human genetics and population science indicating a less compelling association with Lp(a) elevation, and Amgen's modeling suggests it does not affect the event rate.

“We focused on 3-point MACE after extensive human genetics and population science analysis indicated to us that the association of ischemic stroke and Lp(a) elevation was not as compelling as other cardiac-specific cardiovascular endpoints. And this is, therefore, a potentially important distinction between this study and others.”

asked by Dina Elmonshed · answered by James Bradner

Asked about Amgen's current thinking on business development strategy, capital allocation, and whether the near-term BD strategy is dependent on clinical readouts from MariTide and Olpasiran.

Amgen's BD strategy remains consistent, focusing on therapeutic areas where they can add value (the four discussed areas) and advancing the best innovation, internal or external. They are seeing exciting early-stage progress in the industry and are primarily looking at smaller, earlier-stage assets. The BD strategy is not directly linked to the outcomes of late Phase III trials like MariTide and Olpasiran, though they are mindful of their full operational plate.

“I would just observe that we're seeing some exciting early-stage progress in our industry right now. So I suspect we're not the only ones that are interested in some of the emerging shoots that look intriguing. So we are looking, but primarily in smaller earlier-stage assets.”

asked by Salveen Richter · answered by Robert Bradway

Inquired about what Amgen will be looking for in competitor Lp(a) data (pelacarsen) and the potential read-through to Olpasiran if a 13-15% benefit is observed.

Amgen is following competitor data with interest but expects it to provide only directional insight, not decisional perspective. This is due to Olpasiran's superior properties, delivering 95% Lp(a) reduction compared to pelacarsen's ~70%, and differences in study design.

“What can we expect from the pelacarsen data? We're following it with interest. We can expect perhaps some directional insight, but not decisional perspective owing to the superior properties of our molecule that delivers 95% Lp(a) reduction compared to, say, 70% with that molecule and also some differences in the study design, which we just described.”

asked by Taylor Hanley · answered by James Bradner

Asked about confidence in MariTide's Phase III vomiting rates being mid-20s or better, and whether malignancies are being tracked on a blinded basis in the Dazodalibep trial.

Amgen is confident in MariTide's profile, with strong trial enrollment and disciplined data generation in Phase III. For Dazodalibep, a data safety monitoring committee is tracking all high and potentially associated adverse events, including malignancies, as appropriate for immunomodulatory medicines in Phase III. More will be learned in H2 this year.

“First, regarding the MariTide clinical development program, we are noses down delivering a very compelling Phase III data package right now. 2026 is a year of very disciplined data generation. Trial enrollment is strong. I think a clear sign of the remaining unmet need and also an interest in the MariTide profile. We're executing a broad therapeutic program very well, and we are very confident in the profile of this medicine.”

asked by Umer Raffat · answered by James Bradner

Asked about the portion of Repatha's growth from primary care adoption versus existing prescribers and how that might change. Also, inquired about the rationale for using two primary endpoints in the symptomatic Sjögren's trial for Dazodalibep and their concordance.

Repatha's growth is split roughly 50/50 between cardiologists broadening use and primary care physicians (PCPs) prescribing for high-risk primary prevention patients, especially those with diabetes, driven by VESALIUS data. For Dazodalibep, separate Phase III studies are conducted for systemic (using ESSDAI) and symptomatic (using ESSPRI and a patient-reported diary) Sjögren's populations. Two endpoints for symptomatic disease reflect regulatory and trialist guidance to capture both validated subjective and patient-reported experiences.

“And then the other half of our growth is coming from primary care physicians and expansion in the number of primary care physicians, in particular, who are prescribing Repatha for their high-risk primary prevention patients. And there, I would highlight one specific patient type, and that's -- those patients who have diabetes.”

asked by Susan Chor · answered by Murdo Gordon

Asked about Amgen's efforts to improve IMDELLTRA's monitoring requirements for earlier lines of therapy, whether reduced monitoring in Europe is a good sign, and if later-line monitoring requirements could be amended.

Amgen is actively working to expand IMDELLTRA's impact, including making administration easier and less burdensome. While the second-line Phase III used 16 hours of monitoring, real-world and ongoing clinical studies show monitoring can be reduced to 1-2 hours, particularly as ICANS (neurologic consequence) is infrequent and mainly observed at higher doses. This opens the door for sequential reductions in monitoring through prospective clinical investigation and engagement with global regulators.

“The second-line Phase III used 16 hours of monitoring at that time appropriate for that stage of development. We now have real-world experience and ongoing clinical study experience all the way down to 1 to 2 hours of monitoring, say, in the context of our limited stage.”

asked by Alexandria Hammond · answered by James Bradner

Inquired about the duration of effect for each mechanism (GLP-1 peptide and GIP antagonist antibody) in MariTide's construct and its implications for efficacy. Also asked if real-world patient-led dosing selection (1, 2, or 3 months) is expected.

MariTide is a unique antibody-peptide conjugate with an approximate 21-day half-life for the intact molecule, ensuring persistent GLP-1 agonism and GIP receptor antagonism. This design allows for monthly dosing and transitions to less frequent dosing (4-6 times per year) while maintaining efficacy and tolerability. While Amgen cannot predict real-world utilization, the observed activity at multiple doses and different maintenance schedules implies significant flexibility for prescribing physicians and patients.

“MariTide's appending peptides were designed and appended in order to maximize stability to tissue proteinases and to serum esterases and other xenobiotic-metabolizing enzymes in tissues and in circulation. And because of this, the duration of effect of the GIPR inhibitory variable chains of the antibody and the GLP-1 receptor agonizing peptides on MariTide is preserved through this long period of exposure.”

asked by David Risinger · answered by James Bradner