Amgen (AMGN) Q4 FY25 earnings call: guidance and Q&A

How does Amgen view the overall obesity portfolio, especially with MariTide, given competitors' focus on combinations and monthly dosing?

Jay Bradner highlighted MariTide's broad development across multiple indications and mentioned an internal clinical-stage asset, AMG 513, with an undisclosed mechanism, as well as preclinical programs. Robert Bradway emphasized Amgen's intent to compete broadly in the obesity field.

“Internally, we have another clinical stage asset, called AMG 513. We have yet to disclose the mechanism of that medicine, it is progressing in Phase I clinical investigation.”

asked by Michael Yee · answered by James Bradner

With both Phase III studies for dazodalibep fully enrolled and completion expected in H2 2026, when can we expect data, and what is the confidence in translating Phase II reliability to Phase III?

Jay Bradner explained dazodalibep's CD40 ligand-targeting mechanism and the two Phase III populations. He noted Sjogren's has been challenging for drug development but expressed confidence due to Phase II performance against the ESSDAI score. He stated that the company would inform later about plans to communicate the information.

“The second study has already completed enrollment of patients. This is the moderate-to-high symptom burden group with low systemic disease activity, and we expect completion of the trials later this year, and we'll inform later about our plans to communicate this information.”

asked by Yaron Werber · answered by James Bradner

Can you discuss the size of the IgG4-related disease population compared to literature estimates and the opportunity? Also, how is UPLIZNA being used in gMG, and what is its role in a crowded market?

Jay Bradner noted that the availability of targeted therapy can increase disease awareness, making precise epidemiology a 'moving object.' Murdo Gordon estimated the diagnosed IgG4 population in the U.S. at ~35,000, with potential for growth. For gMG, initial uptake is strong, with roughly half of patients being bio-naive and the other half switching from other therapies, driven by UPLIZNA's mechanism and convenience.

“Right now, we estimate the diagnosed population to be in the neighborhood of 35,000 and that could grow.”

asked by David Amsellem · answered by Murdo Gordon

What gives Amgen confidence in moving forward with a Phase III study for UPLIZNA in CIDP, and how is the company thinking about the potential impact of Merck's oral PCSK9 on Repatha's commercial strategy?

Jay Bradner explained UPLIZNA's CD19 B-cell depletion mechanism targets autoantibody-mediated conditions, making it suitable for CIDP, which is a steroid-intensive condition. Murdo Gordon reiterated Repatha's focus on promoting its landmark VESALIUS data for primary and secondary prevention, highlighting its established data package and broad access, while acknowledging market room for other therapies.

“In some cases, there are signals from CD20 that we intend to follow up with a broader, more active and hopefully, much more convenient UPLIZNA.”

asked by Salveen Richter · answered by James Bradner

What percentage of Repatha prescriptions currently come from primary care, and how is this segment expected to evolve with the VESALIUS data?

Murdo Gordon stated that roughly 40% of Repatha prescriptions were coming from primary prevention patients before the VESALIUS data promotion began, and he expects this percentage to increase over time. He noted equal interest from cardiologists and primary care physicians in the VESALIUS data.

“I put a number out before the VESALIUS data promotion started where roughly 40% of our prescriptions were coming from patients who were considered primary prevention patients who have not yet had an event, where physicians were looking to lower those patients' LDL-cholesterol. I would imagine that, that will increase and grow over time.”

asked by Mohit Bansal · answered by Murdo Gordon

What are Amgen's thoughts on a potential competitor for TEPEZZA, and what is the status of AMG 732 for Thyroid Eye Disease (TED)?

Jay Bradner highlighted TEPEZZA's strong evidence base and the ongoing subcutaneous Phase III clinical study in moderate-to-severe active TED, which is fully enrolled with completion expected in H2 2026. He also mentioned AMG 732, an IGF-1R targeting monoclonal antibody, is in a Phase II study for moderate-to-severe active TED. Murdo Gordon added that TEPEZZA is expanding its treatment to lower clinical activity score patients and growing its international presence.

“We have an ongoing subcutaneous Phase III clinical study in moderate-to-severe active TED fully enrolled, as we had shared, and we expect to complete this study in the second half of this year.”

asked by Louise Chen · answered by James Bradner

Can you provide an update on the design of the MariTide Phase III type 2 diabetes CVOT trial, specifically regarding the control arm?

Jay Bradner expressed excitement for MariTide in type 2 diabetes, highlighting its potential for monthly or less frequent dosing. He noted that the ongoing Phase II type 2 diabetes study has provided insights into low-BMI patients and A1c across the dose range. Specific Phase III design details, including the control arm, will be shared in a future engagement.

“The specific design of these studies, control arms and the patients recruited, will be a subject for a future engagement.”

asked by Terence Flynn · answered by James Bradner

For MariTide's less frequent than monthly dosing, what profile is needed for market relevance, are there minimum efficacy bars, and what is the confidence in achieving this beyond monthly?

Murdo Gordon noted dissatisfaction with weekly GLP-1s and sees MariTide's potential for monthly, every 8-week, or quarterly dosing for weight maintenance as a compelling offering. Jay Bradner challenged the premise that less frequent dosing would necessarily trade off efficacy, suggesting that schedule-ranging effects on weight loss could be individualized for patients and that weight regain avoidance indicates body weight reset.

“This idea of less frequent dosing being an absolute trade-off for efficacy. We're not certain that we will see that.”

asked by Christopher Schott · answered by James Bradner

What prompted the FDA's request to pull the ChemoCentryx drug (TAVNEOS), and specifically, which endpoint was involved in the re-adjudication for the 9 patients?

Jay Bradner explained that the FDA requested a voluntary withdrawal of TAVNEOS on January 16, 2026, due to concerns over the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients in the ADVOCATE study. Amgen is currently in discussions with the FDA.

“As we shared, the FDA requested a voluntary withdrawal on January 16. We were surprised by this, there were concerns raised by the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients.”

asked by Umer Raffat · answered by James Bradner

How does Amgen envision MariTide's role in maintenance, specifically for less frequent dosing? Is it only post-MariTide weight loss, or is there a switching opportunity from other therapies?

Murdo Gordon stated that MariTide is seen as a paradigm-changing therapy for weight loss, diabetes, ASCVD, and heart failure management. He believes it's effective for both initiating patients to reach weight goals and for long-term maintenance with convenient, well-tolerated, and efficacious monthly, every 8-week, or quarterly regimens. He also sees an opportunity for patients on other therapies to switch to MariTide.

“And then, of course, as you hinted that, there may be patients out there on other therapies that want to switch to something as convenient and as well tolerated as MariTide. So the answer is all of the above.”

asked by Courtney Breen · answered by Murdo Gordon