Amgen Inc. (AMGN) Q4 2025 Earnings Call Transcript

Amgen Inc. (NASDAQ: AMGN) Q4 2025 Earnings Call dated Feb. 03, 2026

Corporate Participants:

Casey Capparelli — Vice President, Investor Relations

Robert A. Bradway — Chairman and Chief Executive Officer

Murdo Gordon — Executive Vice President, Global Commercial Operations

James Bradner, M.D. — Executive Vice President, Research & Development

Peter H. Griffith — Executive Vice President & Chief Financial Officer

Analysts:

Michael Yee — Analyst

Yaron Werber — Analyst

David Amsellem — Analyst

Salveen Richter — Analyst

Mohit Bansal — Analyst

Louise Chen — Analyst

Terence Flynn — Analyst

Chris Schott — Analyst

Umer Raffat — Analyst

Alexandria Hammond — Analyst

Courtney Breen — Analyst

Presentation:

operator

My name is Julianne and I will be your conference facilitator today for the Amgen Q4 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. There will be a question and answer session at the conclusion of the last speaker’s prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q and A session. To ask a question, please press star and the number one on your telephone keypad. To withdraw your question, please press star one again.

I would now like to introduce Casey Caporelli, Vice President of Investor Relations. Mr. Caparelli, you may now begin.

Casey Capparelli — Vice President, Investor Relations

Thank you, Gillian. 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.

Robert A. Bradway — Chairman and Chief Executive Officer

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, Repatha, Evenity and Test Buyer, 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 multi billion dollar global franchise, 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 life cycle 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. UPLSNA 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 mdeltra, 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 two and Phase three 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 Maritide, we remain excited about Opaziran and what it might represent for patients with elevated lp, 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 Maritide 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 There’s 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 over to Jay for an update in R. And D.

James Bradner, M.D. — Executive Vice President, Research & Development

Thank you Bob and good afternoon everyone. Fourth quarter capped off a year of strong, disciplined execution across R and 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 Maritime, which continues to develop in meaningful and very encouraging ways. The Maritime Phase 3 program is rapidly advancing with strong enthusiasm from investigators and participants. Both of our Phase three 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 maritide across obesity related conditions as we begin enrollment of our two phase 3 sleep apnea studies in adults with and without positive airway pressure therapy. Altogether, we now have six global Phase three studies underway with maritide collectively designed to deliver a comprehensive evidence base. In addition, as we shared last month, We’ve completed part two of the Meritide Phase 2 chronic weight management study. We also completed the first 24 weeks of the phase two type 2 diabetes study that enrolled participants with and without obesity. Results from these two studies further increase our confidence that maritide can represent a new paradigm in obesity, type 2 diabetes and other obesity related conditions.

We believe maritide has the potential to expand what’s possible for patients availing an opportunity for monthly or less frequent dosing. Maritide’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 RPATHA. In November, full results from the Phase 3 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 repatha for LDL C lowering when added to optimized lipid therapy, namely statins, with a median follow up of approximately 4.5 years.

In Visalia CV, Repatha 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 rupatha can meaningfully reduce the risk of a first cardiovascular event reinforcing its role across the full continuum of cardiovascular risk. Turning to elpasaran, our potentially best in class small interfering RNA medicine targeting lp, 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 the study matures, we will update on the date for primary analysis as appropriate. Our conviction in opaciran 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 a plisma. In November the European Commission approved the plisma for the treatment of adults with active IgG4 related disease and in December the FDA approved the PLSNA for the treatment of generalized myasthenia gravis in adults who are anti acetylcholine receptor or anti musk antibody positive.

These approvals built on strong phase 3 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 cibp, a disabling immune mediated neuropathy that damages peripheral nerve myelin, resulting in worsening strength, worsening sensation and for many patients, substantial impairment in daily activity with aplisma.

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 a plisma 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 Dazodalibep, our CD40 ligand targeting biotherapeutic. With both phase three 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 2 data with daxdilumab A, first in class Plasma cytoid dendritic cell depleting monoclonal antibody targeting ILT7 or the immunoglobulin like Transcript7 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 Daxtylimab to the next phase of development in this setting. An inflammation. The test by our 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 rokatinlumab development and commercialization collaboration with Kioa Kirin with significant breadth and depth across all four therapeutic areas.

We took a portfolio decision to focus resources on other late stage programs. Roqatinlumab will return to our partners at Kiwa Kirin who will assume full ownership of the program. Turning to Oncology In November the FDA granted full approval to IMDELTRA 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 EMDELTRA with an ongoing Phase 3 study of limited stage small cell lung cancer. It’s a joy to see mdeltra like Lyncyto becoming a standard of care in the management of advanced cancer. Our first in class steep 1 directed bispecific T cell engager zaleiridomig continues to advance through phase 3 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 1 expression and patients in an urgent need for targeted therapy. Across indeltra, blendsyto and Zaloridamag, 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 rocatidinlimab, 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 Tavnios, 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 Myrto for the commercial update.

Murdo Gordon — Executive Vice President, Global Commercial Operations

Thanks very much Jay. In 2025 we delivered 10% sales growth with 13 products achieving double digit or better performance. 14 products exceeded $1 billion in annual sales and 18 products achieved record sales. These results underscore the strength and growth potential of our portfolio and and demonstrate the disciplined execution of our teams serving patients globally. Starting with general Medicine. Repatha sales grew 36% year over year in 2025, surpassing $3 billion. This performance was driven by growing urgency to treat patients in both secondary and primary prevention. Today, more than 100 million people around the world still need effective LDL cholesterol lowering and Repatha remains the first and only PCSK9 inhibitor with outcomes data for patients in both high risk primary and secondary prevention.

As Jay mentioned, the landmark Vesalia CB trial showed a reduction in the risk of first major cardiovascular events by 25% in high risk patients. These data strengthen Repatha’s position as the most evidence backed therapy in the PCSK9 class and support this critical role in earlier and more intensive LDL cholesterol management. Given these results and our leadership in this category, we believe there’s now a clear opportunity to update clinical guidelines and quality measures. We expect these changes will encourage cardiologists and primary care physicians to manage LDL cholesterol more proactively alongside lifestyle modification and reduced cardiovascular risk in both primary and secondary prevention.

In the US we continue to improve patient access to Repatha with broad formulary coverage and the launch of Amgen now, our new direct to Patient program. Amgen now offers a simplified, lower cost cash pay option for patients to access repatha. Following a successful launch, we’ve announced plans to expand this program to additional medicines and we’re excited to make our therapies available through Trumprx, helping improve affordability for Americans. Evenity sales increased 34% in 2025, reaching $2.1 billion in sales. Even remains the only treatment that simultaneously builds new bone and reduces bone resorption, a dual mechanism that is proven to rapidly reduce fracture risk in the postmenopausal women.

In the US even sales grew 41%, driven by higher volumes from both established and new prescribers. Evenity leads the bone builder Segment with over 60% market share and is now growing faster than the category overall. To date, approximately 300,000 U.S. patients have been treated with Avenity, with a 33% increase of new patients in just one year. Increased investment has helped accelerate this growth, which we expect to continue. Despite strong progress, nearly 90% of the 2 million women at very high risk of fracture remain untreated, presenting a clear opportunity for eventy to drive growth and impact.

Prolia delivered $4.4 billion in sales in 2025, an increase of 1% year over year. In 2026, we expect accelerated sales erosion driven by increased compet as multiple biosimilars have launched globally. Our rare disease portfolio grew 14% year over year to nearly $5.2 billion and 19% in the quarter, with strong performance across the portfolio. The plsna sales increased 73% year over year to $655 million, reflecting growing patient demand across all three approved indications. In December, a PLISNA received FDA approval for the treatment of generalized myasthenia gravis, marking an important mil milestone for patients with this chronic debilitating disease.

Early physician response has been strong across both bionaive and switch patients. Prescribers have noted the benefits of Aplizna’s upstream B cell mechanism targeting the root cause of the disease and also its demonstrated safety profile and the convenience of its twice yearly dosing. Uptake of BPLISMA for use in IgG4 related disease continues to grow. Since the launch in the US nearly 500 specialists, including rheumatologists, gastroenterologists, among others have prescribed BPLISMA. In addition to the more recent launches. The Plizna continues to lead in NMOSD and remains the most prescribed FDA approved therapy in the US for this condition, supported by consistent new patient growth and strong adherence across treatment cycles.

Topaza grew 3% to $1.9 billion in 2025 driven by higher net selling price. Over 25,000 patients have received treatment since launch in the US with growing interest from both new and returning prescribers. We continue to see increased prescribing by endocrinologists and a broadening base of specialists. In Japan, approximately 1,200 patients have been treated since launch, reflecting growing awareness of the burden of thyroid eye disease among both patients and prescribers. We plan to launch Topeza in additional markets in 2026, expanding access to this important therapy. Globally, Tapnios sales were $459 million in 2025, an increase of 62% year over year driven by strong volume growth.

More than 7,000 patients with ANCA associated vasculitis have now been treated with Tapnios, with over 4,000 healthcare professionals prescribing the therapy since its launch in 2021. ANCA Associated Vasculitis is a serious, potentially life threatening disease that can cause if not well controlled and has limited therapeutic options. We remain confident that Tavnios is an important and effective medicine based on clinical data, real world evidence and its favorable benefit risk profile in inflammation. Testbire sales grew 52% year over year to nearly $1.5 billion for the full year. Testbire is well positioned to reach more patients in the United States due to its differentiated TSLP mechanism that targets multip inflammatory pathways driving severe uncontrolled asthma, including in those with coexisting chronic rhinositis with innate rhinosinusitis with nasal polyps.

Testbire substantially reduced the need for surgery in this population, reinforcing its value in eosinophilic disease. Testbire is now the leading therapy for new to brand patients amongst allergists in severe uncontrolled asthma fueled by strong prescriber confidence and continued expansion across respiratory specialties. OTASLA sales increased 7% year over year to nearly $2.3 billion for 2026. We expect sales erosion driven by unfavorable pricing in the US and generic launches, particularly in the eu. Our innovative oncology portfolio which includes Blincito, Imdeltra, Lumicras, Vectibix, Kyprolis, Nplate and Xgeva grew 11% year over year generating $8.7 billion in full year sales Imdeltra delivered $627 million in full year sales fueled by strong clinical conviction and rapid adoption across care settings.

Over 1,600 U.S. sites now administer Mdeltra, with the majority of doses provided in the community setting. Imdeltra was granted full FDA approval in the fourth quarter supported by compelling data from the Phase 3 Delphi 304 trial. NCCN guidelines also recognize Mdeltra as the highest recommended therapy and it has become the standard of care in the second line setting, reinforcing its leadership position in small cell lung cancer. Lyncyto grew 28% year over year to over $1.5 billion in full year sales driven by broad prescribing across both academic and community segments. Blincito is widely recognized as a standard of care in combination with multi agent chemotherapy for patients with Philadelphia chromosome negative B cell.

All our biosimilar portfolio delivered another strong year with sales increasing 37% to $3 billion. Our expanding biosimilar portfolio provides meaningful top line growth, durable cash flow and broad patient access to high quality cost saving biologic medicines. PAV Blue A Bio similar to Eylea continues to gain momentum reaching $700 million in sales in 2025. Adoption continues to build among retina specialists who value the product’s ready to use pre filled syringe format and the reliability of Amgen’s manufacturing and supply chain. We deliver strong results in 2025 with continued momentum across our priority growth brands and we look forward to serving even more patients with amgen products in 2026.

Now I’d like to hand it over to Peter.

Peter H. Griffith — Executive Vice President & Chief Financial Officer

Thank you Mirto. We’re pleased with our execution and performance in the fourth quarter and for the full year 2025 and we remain on track with our long term objectives. The financial results are shown on slides 34 to 36 of the slide deck. Myrto’s covered our strong revenue growth across the portfolio for the full year. We delivered a non GAAP operating margin of 46%. We continued to invest in advancing our pipeline with non GAAP. R&D spending increased 22% year over year for the full year to a record $7.2 billion. This reflects increased spending on an unprecedented number of opportunities in our late stage pipeline including continued investments in maritide, opacarenza, urhydemic and rare disease.

In addition, we closed several business development transactions in the third and fourth quarters resulting in roughly $300 million in incremental R and D spending full year non GAAP other income and expense was $2.1 billion. We continued to strengthen our balance sheet with $6 billion of debt retired in 2025. Our non GAAP tax rate increased 1.4 percentage points year over year to 15.9% for the full year, primarily due to changes in earnings mix. We generated $8.1 billion in free cash flow for the full year, reflecting operational momentum across the business and rigorous management of working capital, all while continuing to invest in innovation.

We’re leveraging AI across the value chain to accelerate therapeutic discovery and late stage development, optimize manufacturing and improve customer engagement, allowing us to drive productivity at speed and scale. We executed capital expenditures of $2.2 billion in 2025. Our capital expenditures reflect significant investments across the United States, including Ohio, North Carolina, Puerto Rico, Rhode island and California to support continued volume growth in our commercial brands and to prepare for pipeline product launches including maritime. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024.

Let’s turn to the 2026 outlook on Slide 37. We expect our 2026 total revenues in the range of 37.0 billion to 38.4 billion and non GAAP earnings per share between $21.60 to $23. Our revenue range reflects continuing strong performance from our six key growth Repatha, Avenity Test Buyer, our Rare Disease, Innovative Oncology and biosimilars portfolios, positioning 2026 as a springboard year for future growth. We expect this growth in 2026 to more than offset anticipated declines from increased denosumab biosimilar competition, price declines for certain other products in 2026, and continued increases in 340B. Program utilization as you model the first quarter of 2026 consistent with historical trends tied to the annual United States health insurance cycle, we expect a seasonal headwind to sales driven by benefit plan changes, insurance reverifications and higher patient co pay obligations.

We also expect Otezla and Enbrel to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters and expect additional impact from denosumab biosimilar competition in Q1. Additionally, note that we saw roughly $250 million of inventory build in the fourth quarter of 2025 that could potentially impact first quarter sales. For total company revenues, we expect lower mid single digit year over year growth in the first quarter. For the full year, we expect other revenue in the range of 1.6 to $1.8 billion. Reflecting our commitment to investing in the best innovation while also driving execution, excellence, efficiency and prioritization across the organization.

We project the full year non GAAP operating margin as a percentage of product sales to be roughly 45 to 46%. This guidance does not include any potential business development transactions that may occur throughout the year. We expect non GAAP R and D expense to grow low single digits excluding the roughly $300 million of business development transactions in 2025. We continue to execute six global Phase 3 clinical trials for Maritide, advance additional late stage assets and invest in the best innovation while maintaining disciplined resource allocation in line with lower product sales in the first quarter. We expect Q1 non GAAP operating margin to be the lowest of the year and roughly the same as Q4 of 2025.

We anticipate non GAAP other income and expense to be about 2.3 to $2.4 billion in 2026. We expect a non GAAP tax rate of 16% to 17.5%. We expect share repurchases not to exceed $3 billion in 2026. We expect capital expenditures of about $2.6 billion in 2026. This is consistent with our capital allocation priority to invest in our business and scale manufacturing capacity for volume growth, including preparing for Maritide’s launch. We remain focused on delivering sustained long term growth and creating value for patients and shareholders by doing what we said we would do, advancing innovation in areas of high unmet medical need and maintaining rigorous financial discipline.

I’m grateful to work with all of our colleagues worldwide in serving patients. This concludes the financial update and now I’ll hand it back to Bob for Q and A.

Robert A. Bradway — Chairman and Chief Executive Officer

Okay, thank you Peter. And as I hope you all appreciate Now I think we ended 25 with our track record intact for having delivered against the objectives that we set for you at the beginning of the year. And we’re determined to do the same now in 2026. So we’re entering the year with momentum. Excited about what we see ahead. Let’s open up the call to questions. Julianne, we’d be happy to entertain any of our callers now.

Questions and Answers:

operator

Thank you. If you would like to ask a question, please press STAR followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by 1. Again, to ask a question, press star 1. Our first question comes from Michael Yee from UBS Financial. Please go ahead. Your line is open.

Michael Yee

Hey guys, good afternoon and thanks for all the color and looks like guidance is growth for the year despite the biosimilars. Obviously obesity is top of mind for everybody. And you’ve disclosed some information on maritide recently. I was wondering and curious to ask your view of the portfolio overall in obesity given that folks like today are disclosing combinations with monthly or monthly and then combinations and how you see this playing out given you’re focused on maritide but not so sure about the rest of the portfolio there. Thank you.

Robert A. Bradway

Okay, thank you, Michael. We’ll take a stab at answering your question. Connection wasn’t great, but I think we got most of what you were trying to ask. Jay, you want to kick off?

James Bradner, M.D.

Yeah, I’d be happy to. Thanks, Michael. Amsin is really made for this moment developing maritide across so many different indications. A leading cardiovascular company, also a leading respiratory disease company and there’s so many opportunities there for maritide. We’ve been in obesity, as you know, a long while, all the way back to the leptin days and enjoyed stable discoveries recovery leadership team since that time. Internally, we have another clinical stage asset called AMG513. We have yet to disclose the mechanism of that medicine and is progressing in phase one clinical investigation. And preclinically we have a rather exciting set of rising programs that are both incretin based as well as non incretin based, both injectable as well as oral medicines.

And the aperture is always open for innovation on the outside.

Robert A. Bradway

I think you should expect us to be competing broadly in the field, Michael. Okay, let’s move on. Next question.

operator

Thank you, Michael. Our next question comes from Jeroen Werber from TD Cowan. Please. Go ahead. Your line is open.

Yaron Werber

Great. Thanks so much. I have a question actually about dazodalibap for primary Sjogren’s syndrome. It looks like both studies are now fully enrolled and you’re saying completion in the second half. You’re the only company with both a systemic and a symptomatic study in phase 3. Based on the phase 2s, should we expect the data this year? And do you want to give us any color on the reliability of the phase two into the phase three just given. It’s a tough condition. Thank you.

James Bradner, M.D.

Thanks, Jeroen. And thanks for noticing about vasodali Buff. This is a very exciting medicine in the portfolio. This is a CD40 ligand targeting biotherapeutic and the CD40 pathway has long been postulated to be driving the inflammatory cascade in Sjogren’s syndrome. The challenge is only that the biology is somewhat ambiguous and so we take a really nice and incisive approach with DASOV in this disease. As you noted, the two phase 3s that we have open in Sjogren’s syndrome will be in moderate to severe symptomatic activity. That’s our population one, as well as in patients with a very high symptom burden.

That’s population two. Sjogren’s has been very challenging for drug development, but we find this hypothesis quite compelling. 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 will inform later about our plan to communicate these information. As for reading through the reliability of phase two into phase three, there have been historic challenges here, but the performance against this SDI score, which is the clinically utilized as well as regulatory paradigm for approval, you know, was one of the first medicines ever to improve an SDI score in that disease space.

So we’re confident going into phase three and can’t wait to look at the results.

operator

Thank you, Jerome. Our next question, our next question comes from David Ansellem from Piper Sandler. Please go ahead. Your line is open.

David Amsellem

Hey, thanks. So I had a couple of Uplizna related questions. Can you talk about the extent to which the underlying IgG4 related disease population is larger than what literature has suggested historically and what that means for the underlying opportunity? And then secondly, I know it’s early. In gmg, but can just, can you. Talk about how the product’s being used to date and what kind of role do you think it’s going to have in the. In an admittedly more crowded treatment Armamentarium. Thanks.

Robert A. Bradway

Yeah, let’s. Why don’t we tackle this in two parts, Jay, if you take the first part and then maybe Myrto, you can jump in on the second. Go ahead.

James Bradner, M.D.

You know, there is in medicine an experience where the availability of a targeted therapy, a really effective therapy, can actually increase the incidence of a disease through awareness of the disease. Why take a diagnosis unless you have reason to intervene effectively? And that may, in the fullness of time, be the case here, limiting a precise description of the epidemiology even over the last five to 10 years is the lack of really coherent registry data as well as appropriate coding that would allow such an analysis from electronic medical record data. And so I think it’s a good question.

I think it’s a moving object and we’ll have better precision on that in a few years to come. Myrtle, what are your Instincts.

Murdo Gordon

I think that’s a very clear description, Jay. I think the availability of the ICD10 coding as you alluded to, is really about a three year presence in the market right now. We estimate the diagnosed population to be in the neighbourhood of 35,000 and that could grow. As you outlined, there are mentions in the literature of higher numbers. However, we’re obviously focused on those that are already diagnosed, already in care and we’re trying to build that awareness that you spoke of. Jane, so far so good. PLISNA is doing extremely well in its uptake in IgG4 related diseases.

We see a nice breadth of prescribing across a number of different specialties that see these patients because of the end organ involvement in the inflammatory condition. And we’ll continue to make sure that we do our part to improve that aware, improve that diagnosis. These patients undergo a very complicated patient journey in that this disease can masquerade as many other things. But so far so good and we’re happy to be able to help these patients finally get a treatment, the only one FDA approved, that can help with their symptoms and obviously the long term health outcomes, particularly for their target organs, just on the pliza and gmg.

We’re very pleased with the initial uptake as you said, David. It’s very early in the launch, but what we’re pleased about, and I mentioned this in my opening remarks, is that roughly half of the patients who are being treated are bio naive patients and the other half coming from switches from other therapies. As we said before, this is a large but still quite dissatisfied category where the current treatments have limitations, whether that be dosing inconvenience, whether that be duration of efficacy and perhaps some waning efficacy in this category. And so far what we’ve seen is a very strong interest in Biplizna for its mechanism as well as for the convenience that it represents for patients.

So, so far so good. Excited about BPLSNA overall in the broader rare disease portfolio.

Robert A. Bradway

Okay, thanks. Let’s go to the next question.

operator

Thank you, David. Our next question comes from Salvine Richter from Goldman Sachs. Please go ahead. Your line is open.

Salveen Richter

Good afternoon. Thanks for taking my question. Just a follow up here on Applensa. Walk us through what’s given you confidence here in moving forward with a phase 3 study in CIDP and the opportunity in that indication. And if you could also just separately touch on Repatha and how you’re thinking about potential impact from the launch of Merck’s oral PCSK9 and how you’re adapting Your commercial strategy there. Thank you.

Robert A. Bradway

Two ends of a spectrum there, from the very rare to the very common. So let’s do. Jay, you do the first question and then Myrto, you can take second.

James Bradner, M.D.

Okay, thanks Alvin. We are, as Myrto shared, very bullish about a plsna specifically this unique mechanism of action that targets and depletes the CD19 pathologic B cell. These as you surely know, CD19, the B cell compartment is evident on mature B cells like CD20 targeted by rituximab and other medicines of that type. But also the pre B cell, the more naive B cell, the cell that expands and elaborates many of these autoantibodies. And so now seeing efficacy of a PLSNA in so many immunoglobulin related disorders like IgG4 related disease like myasthenia gravis, the chance to bring it to additional autoantibody mediated immune conditions is just a great chance to help patients with these severe diseases.

In some cases there are signals from CD20s that we intend to follow up with a broader, more active and hopefully much more convenient a plizna. Autoimmune hepatitis which I mentioned earlier, is associ with autoantibodies. You see ana, you see anti smooth muscle, you see anti actin, you see anti LC1 and the same is true though to a lower proportion with CIDP as Well, where maybe 5 to 10% of patients will have autoantibodies to what are called paranodal proteins NF155C and TN1. I could go on for a long time. And so this biology being driven by the compartment that a plisma targets, makes for a really great chance to extend the benefits of targeting B cells in both of these conditions.

Myrtle?

Murdo Gordon

Yeah, just the size of the opportunity here is interesting. Roughly the prevalent pool in the US is estimated to be about 35,000 patients, maybe 7 to 10,000 incident new diagnosed cases per year in the US so hopefully we can develop this drug and offer some benefit for these patients which is yet another steroid intensive condition. And we believe that we can do better than that. So let’s hope for that best outcome in those clinical trials on Repatha. I alluded to what our strategy is in my opening remarks. We are excited by the landmark data that were revealed at the American Heart association last year in November, where we can now clearly promote REPATHA for the prevention of first heart attack or first stroke in a high risk patient population and or a high risk primary prevention population.

And so that is Our focus right now, and we are the only PCSK9 that has both secondary and primary prevention data in our label. The Vesalius data are being met very positively by both cardiologists and primary care physicians, in particular for the primary care physician for the diabetes patients that were enrolled in the trial who did very well. So we are focused on making sure there’s high awareness of these data. Repatha enjoys great access, broadly preferred on national template formularies by PBMs and health plans around the country and around the world. And of course, we know that there’s an immense amount of trust now in the profile by prescribers and, and for the millions of patients that have received treatment and are taking Repatha, there’s strong acceptance that a every two week injection to lower cholesterol to the 45mg per deciliter target dose that was achieved in the Repatha arm in Vesalius so that patients can reduce their cardiovascular risk.

So we’ve got a lot to talk about. We’ve maintained all along that there is a lot of room in this market for other therapies to come in, but they will not have the data package and profile that Repatha has established. And we’ll continue to remind prescribers and others about that. Thank you.

Robert A. Bradway

Okay, let’s go to the next question.

operator

Thank you, Salvine. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Mohit Bansal

Great. Thank you very much for taking my question and congrats on all the group progress here. Like just again, the question on PCSK9. And Ritanta at this point. So, Mardo, can you please remind us what percentage of your prescriptions are coming from primary care at this point? And with the Vasilius data, how do you see the primary care segment of. The market evolving over time? Thank you.

Murdo Gordon

Yeah, thanks, Mohe. I put a number out before the Vesali’s 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. What we’re seeing is equal interest, quite frankly, from cardiologists who are excited by the Vesalius data and the consistency of both the primary endpoint, the secondary endpoint, the MI subgroup. Quite frankly, the overall incidence of death in the trial was also something that attracted attention from specialists.

So the cardiology group has seen this as an AFFIRMATION of what they were already doing in being aggressive in treating LDL cholesterol. And primary care physicians, as I mentioned, are much more intent and aligned to adding rupatha to the optimized statin therapy that most patients are on. As for how much, we don’t give product specific guidance, but hopefully you can tell I am extremely excited about the momentum that we have on Repatha right now. I’m really pleased with the execution of our teams around the world. We’ve made incremental investments in advance of the opportunity of promoting the Vesalius data and I expect that momentum to continue.

Robert A. Bradway

Okay, thank you. Let’s go to the next question.

operator

Thank you, Mohit. Our next question comes from Louise Chen from Scotiabank. Please go ahead. Your line is open.

Louise Chen

Hi. Thanks for taking my question. I wanted to ask you about Topeza and your thoughts on another potential competitor coming to market and then also where you stand with AMG732 for Ted. Thank you.

Robert A. Bradway

Okay, great. Maybe again we could do this in two chunks. Jay, you want to talk about the clinical piece and then myrto talk about the commercial piece.

James Bradner, M.D.

Thanks, Louise. Topeza is proving to be just a very important medicine for the management of thyroid eye disease. We have established a very strong evidence base in both the high clinical activity score and lower clinical activity score patient populations and are quite proud of this data generation and also the apparent impact that it’s having on patients being treated. Today we have an ongoing subcutaneous phase 3 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. So we have a really terrific medicine that’s increasingly a standard of care that’s helping a lot of patients and a strong data set that it sits on top of before handing off to Myrtle.

I’ll just quickly comment on AMG732. Thank you for noticing. This is an IGF1R targeting monoclonal antibody also achieves subcutaneous administration phase 2 studies enrolling initially studied in moderate to severe and active ted and we’ll have more to say on that in the future. Berto.

Murdo Gordon

Yeah, thanks Jay. As Jay mentioned, we’re expanding our treatment for patients with thyroid eye disease into the lower clinical activity score patient population who tend to be maximum managed by different specialists than the higher clinical activity score patients. We have historically been able to drive very strong penetration with oculoplastic surgeons and general ophthalmologists. We’re expanding our prescribing base to include Endocrinologists. We made investments the beginning of last year and those investments are starting to return now by an increased base of endocrinologists prescribing. So that’s in the US and we expect that we’ll continue to broaden our treatment of the low clinical activity score patients while maintaining our share of the higher clinical activity score patients.

But also our international launches, our launch in Japan has gone extremely well. We’re seeing nice uptake there. We’re seeing a very well received product for higher clinical activity score patients. And we’re in the process of launching in multiple markets around the world as we speak. So overall, Topaza will be a good growth driver for us this year.

Robert A. Bradway

Thank you. Let’s go to the next question.

operator

Thank you, Louise. Our next question comes from Terrence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Terence Flynn

Hi, thanks for taking the question. I had one on the Maritide Phase 3 program. Appreciate all the details today, but just was wondering if you have any update in terms of how to think about the design of the type 2 diabetes CVOT trial, particularly the control arm, as I know that’s something that you guys were debating here. Post the, you know, seeing some of data from some of the competitors, but just wondering how you’re thinking about control arm in that setting. Thank you.

Robert A. Bradway

Sure. Jay, you want to.

James Bradner, M.D.

Sure. I’m happy to share. Terrence. We’re just thrilled by the opportunity to develop Maritide for patients with type 2 diabetes. And this is really where we see a potential paradigm shift in the management of that disease. In my medical training, we practice with insulin and insufficient orals and titrating dosing. And here we have a medicine that can be dosed monthly. We’ve seen efficacy in chronic weight management bimonthly. We’ve recently described maintenance approach using quarterly dosing. This is just a new paradigm in management of diabetes. We’ve shared the major insights at JP Morgan from the Phase 2 type 2 diabetes study, which is ongoing.

There are additional parts to this trial. It’s importantly given us an experience with low BMI patients and also seeing a across the dose range. And so the robust findings of this trial position us very well to start to pursue phase three clinical investigation. The specific design of these studies, control arms and the patients recruited will be a subject for a future engagement.

Robert A. Bradway

Okay, thank you. Let’s go to the next question.

operator

Thank you, Terrence. Our next question comes from Chris Schott from JP Morgan. Please go ahead. Your line is open.

Chris Schott

Great. Thanks so much. Just another Maritide Question. And just on the topic of less frequent than monthly dosing, it certainly seems like there could be a trade off here where even more infrequent dosing would obviously be a huge benefit, even if it was associated with a bit less weight loss. I guess as you’re thinking about just pushing the program beyond monthly, what profile do you think you’d need to see for that to have a role in the market? Are there minimum efficacy bars you’re looking at? And just in general, what is your confidence about the ability to push this beyond monthly? Thanks so much.

Robert A. Bradway

Okay, that’s an interesting question, Murdo. Do you want to take a shot at what we think we see in the marketplace and why we believe maritime has the potential to address what is emerging as a very large unmet need in the field?

Murdo Gordon

Yeah, I’ll make a few comments here. Bob, thanks for the opportunity. I think it’s pretty clear as we look at the market as it exists today that there’s dissatisfaction with the weekly GLP1s. And I think you can actually see that in a fairly dramatic way with the advent of oral SEMA and how rapidly it’s been taken up in the market. That tells you that clearly patients and prescribers are looking for other opportunities. Now what I like is the opportunity that we have to deliver what has been mentioned a couple of times in this call as a paradigm changing therapy.

And that’s, you know, the ability to come into a weekly market, bring a monthly therapy that can achieve similar weight loss in a very well tolerated regimen and then for those patients who achieve their weight goal, for them to convert to every 8 week or every 12 week dosing regimen to maintain that weight and or the metabolic benefits of their therapy. And I think that’s a pretty compelling offering. I think that we’re targeting that kind of profile and we’ll have multiple ways of generating data to that effect.

Robert A. Bradway

Chris, maybe we’ll have Jay just address a piece as well. Go ahead.

James Bradner, M.D.

Yeah. Chris, thanks for the question. If you don’t mind, I’m going to reject part of the premise of your question. This idea of less frequent dosing being an absolute trade off for efficacy. We’re not certain that we will see that having observed the large majority of patients maintaining weight on low dose and on quarterly dosing. In the field of obesity, they call this the defended fat mass and the capacity to avoid weight regain is a sign that the reset of body weight has been achieved. We have seen with all medicines to date dose ranging effects on weight loss.

And here we might expect to see schedule ranging effects on weight loss that would be individualized for patients. And so I wouldn’t necessarily assume that we’ll see a big trade off with less frequent dosing of maritide.

Robert A. Bradway

Okay, thank you. Let’s go to the next question.

operator

Thank you, Chris. Our next question comes from Umar Raffit from Evercore isi, please go ahead. Your line is open.

Umer Raffat

Hi guys. Thanks for taking my question. I’m really, really lost today. I’m trying to figure out what happened all of a sudden. Why did FDA decide to ask you to pull the chemo centrics drug? Was there some litigation or some correspondence, like what prompted it in the first place? And then if I dig in a little more specifically, they’re saying that nine patients need to be re adjudicated. Is that referring to the primary endpoint on week 26 remission or the week 52 sustained remission? I asked because the week 26 endpoint was not inferior anyway. So even if you readjudicate those, it’s still not inferior.

So I’m just really lost today.

Robert A. Bradway

Okay, well, Jay asked. Jay, you addressed a question. You may want to just start at the high altitude, remind people what Tavnios is, say a few words about the disease that it addresses. It’s obviously a very small product and our portfolio relative to the other things we have going on, but it may be a medicine that’s less familiar to most of our callers.

James Bradner, M.D.

Yes, sure. Thanks Umer. And just by way of background then, ANCA associated vasculitis is a group of very serious, rare and destructive inflammatory illnesses that targets blood vessels and can therefore damage vital organs like kidneys, lungs, skin, nerves, even heart. The prior treatment paradigm before Tavnios was quite toxic. Cyclophosphamide chemotherapy with azathioprine and rituximab accompanied by long term steroid use and chronic use of steroids proved very common but also very challenging. Hyperglycemia, lipid dystrophy, bone health, mood disorders, immune suppression, and then enter Tavniose or Avacopan. This is an oral complement factor 5A receptor blocker and so it blocks complement mediated destruction.

We acquired Tavniose from Chemocentrix in 2022 after it had been on the market for a year based on approval for the Advocate Phase 3 study that you referenced as published in the New England Journal. This established the efficacy of Tavnios over prednisone steroid tapering for sustained remission out to 52 weeks when it was added to induction therapy. Which with at that time standard of care. Rituximab and cyclophosphamide. As we shared, the FDA requested a voluntary withdrawal on January 16th. We were surprised by this. There were concerns raised about a process followed by chemocentrics to re adjudicate primary endpoint results for nine of the 331 patients.

And we’re in discussions with FDA and we’ll answer questions as we talk with them.

Robert A. Bradway

Okay, let’s go on to the next question.

operator

Thank you, Umer. Our next question comes from Alex Hammond from Wolff Research. Please go ahead. Your line is open.

Alexandria Hammond

Hey guys, thanks for taking the question. So you had another strong quarter with Pavlou, I guess. How do you kind of expect to maintain this leadership position when other manufacturers launch their biosimilars in the second half of the year? I guess, essentially. Can you kind of help level site growth expectations for this year?

Robert A. Bradway

Well, obviously we’re not giving guidance on an individual product, Alexander, but Myrtle, go ahead and talk a little bit about the strong performance that we’ve observed so far.

Murdo Gordon

Yes, I think what we’ve been able to do thus far is establish good inroads with the largest national retina specialist networks. And. I think what I would say is they tend to want to pick a product that they know allows them to manage their patients effectively. We think we’ve got a great device that helps them do that. We obviously are competing effectively against the innovator. And given that we have a lot of biosimilar experience, we’ll compete effectively when others enter the market, whenever that may be.

Robert A. Bradway

Okay, we’ll take one last question as we’re right up against the bottom of the 30 minute mark here the hour. So why don’t we take one last question and then as always, Casey and his team will be around to answer questions. If we didn’t get to you on this call, call Julianne.

operator

Last question. Thank you, Alex. Our last question will come from Courtney Breen from Bernstein. Please go ahead. Your line is open.

Robert A. Bradway

Okay, Courtney, bring us home.

Courtney Breen

Fantastic. Thanks so much for squeezing this in. I am going to bounce you back to Maritide. And just as we think about maintenance and that kind of less frequent dosing opportunity, can you describe how you might think about the role of this product in the market? Is it only post maritime weight loss or how should we be thinking about kind of that switching opportunity and the type of data that you might demonstrate for that positioning over time? Thanks so much.

Robert A. Bradway

Yeah, I can imagine there’s probably a lot of interest in that. Myrtle, do you want to share any thoughts at this point?

Murdo Gordon

Well, thanks, Courtney. Obviously we think we’ve got, as has been said now many times, and I’ll repeat it again, a product that changes the paradigm of which weight loss, diabetes, ascvd, heart failure management, and we see it as both an effective product to start patients on to get to weight goal and also for patients who to receive the medical benefit of their treatment need to be on these therapies for multiple years. This opportunity for Maritized profile to deliver a convenient, well tolerated, efficacious regimen that could be monthly, could be every eight weeks and could be quarterly.

We think that’s really exciting. And then of course, as you hinted at, 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.

Robert A. Bradway

Okay. So again, thank you all for your interest. We appreciate your joining our call. Well, I’ll just reiterate if we didn’t get to you, please reach out directly to Casey and his team. In the meanwhile, I hope we’ve left you confident about the momentum that we’re carrying into 2026. And again, I would just reiterate that we’re excited about the year that we have in prospect here. A year which, as Peter has described, we view as a springboard to the future growth here at Amgen. So excited about the hand that we have and look forward to sharing it with you during the course of the year.

Thanks. Thank you.

operator

This concludes our Amgen Q4 2025 earnings conference call. You may now disconnect.