Amgen - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 was a clean beat: revenue $9.18B (+9% YoY) and non-GAAP EPS $6.02 (+21% YoY), both materially above S&P Global consensus; GAAP EPS rose to $2.65 (+92% YoY) on stronger operating performance. Versus consensus: revenue $8.92B* and EPS $5.28* were expected; actuals were $9.18B and $6.02, respectively, constituting broad beats*.
• Guidance was raised on revenue and nudged up on non‑GAAP EPS, but management lowered GAAP EPS and cut full‑year non‑GAAP operating margin to “~45%” (from ~46%) to fund late‑stage R&D and BD transactions; OI&E trimmed to ~$2.2B.
• Product breadth drove momentum: 15 products hit double‑digit growth; standouts included Repatha (+31% YoY), EVENITY (+32%), TEZSPIRE (+46%), BLINCYTO (+45%), and rare disease drivers UPLIZNA (+91%) and TAVNEOS (+55%). New oncology entrant IMDELLTRA grew 65% QoQ to $134M.
• Key watch items: expected H2 biosimilar erosion for Prolia/XGEVA, Enbrel pressure from 340B mix and Medicare Part D redesign, and inventory timing impacts in parts of rare disease portfolio.
• Near‑term catalysts: raised FY revenue guide, visible pipeline milestones (MariTide Phase 3 enrollment; TEZSPIRE CRSwNP PDUFA Oct 19, 2025; UPLIZNA gMG PDUFA Dec 14, 2025) that can sustain narrative momentum.

What Went Well and What Went Wrong

What Went Well

• Broad-based growth: total revenue +9% to $9.18B; product sales +9% on +13% volume with only −3% price pressure.
• Oncology and inflammation outperformed: BLINCYTO +45% YoY to $384M; TEZSPIRE +46% YoY to $342M; IMDELLTRA $134M with +65% QoQ adoption momentum.
• Management confidence and investment posture: “We’re delivering strong performance…” (CEO Bradway) and stepped-up AI, late-stage R&D, and manufacturing capex to scale for growth.

What Went Wrong

• Enbrel and denosumab headwinds: Enbrel −34% YoY (price and 340B/Part D mix), with continued pressure expected; XGEVA −5% YoY and Prolia −4% YoY, with H2 biosimilar erosion flagged.
• Free cash flow down YoY to $1.9B on deferred 2024 tax payments and higher capex; non-GAAP cost of sales ticked up (17.7% of product sales, +0.2 pts) on profit share/sales mix.
• Margin outlook eased: non‑GAAP operating margin guide lowered to ~45% as R&D and launch investments rise; GAAP EPS outlook reduced versus Q1 guide.

Transcript

Speaker 3

My name is Julianne and I will be your conference facilitator today for the Amgen Q2 FY 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&A session. To ask a question, please press Star, then the number one on your telephone keypad. To withdraw your question, please press Star one again. I would now like to introduce Justin Claeys, Vice President of Investor Relations. Mr. Claeys, you may now begin.

Speaker 5

Good afternoon, everyone, and welcome to our.

Speaker 0

Second quarter 2025 earnings call.

Speaker 5

Bob Bradway will lead the call.

Speaker 0

Be followed by a broader review of.

Speaker 5

Our performance by Myrto Gordon, Jay Bradner, and Peter Griffith.

Speaker 0

Through the course of our discussion today, we will use non-GAAP financial measures.

Speaker 5

To describe our performance and have provided.

Speaker 0

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.

Speaker 5

Materially.

Speaker 0

Over to you, Bob.

Speaker 2

Good afternoon everyone and thank you for joining us today. As you'll hear, Amgen delivered another strong quarter driven by growing demand for our medicines across the board. With net selling prices for medicines declining across the industry, borrowing volume growth is a key differentiator and once again this quarter that's what we delivered. We did this, of course, while also advancing a world-class pipeline. In the quarter, revenues grew by 9% year over year and volume increased at an impressive 13%. Fifteen of our products delivered at least double-digit sales growth, demonstrating the breadth and depth of our portfolio. As you're all aware, there's a focus on pricing and tariffs in our industry and I would just say that we are actively engaged in discussions with our government officials and share the objectives of improving patient access, affordability, and expanding biopharma manufacturing in the U.S.

We believe the world needs more innovation, not less, and we're continuing to invest heavily in innovation to support long-term growth. We're, of course, doing that while building on a track record of success, including multiple Phase 3 readouts in the first half of 2025. We also believe that AI will be additive to the innovative capacity of our industry and we feel we remain well positioned to accelerate progress through the convergence of biotech and technology, including the application of AI across the company. Let me turn to a few key drivers behind this quarter's momentum. I'll remind you that we're focused in four areas and each are performing well. In general medicine, we're reaching large underserved patient populations with multiple products that have significant room for growth, for example in cardiovascular disease and bone health. In addition, our obesity pipeline programs are advancing broadly.

In rare disease, we have four key growth drivers which are all early in their life cycles and well positioned for robust long-term growth with attractive pipeline molecules following closely behind. In inflammation, where we've enjoyed decades of leadership, we're excited about the progress we're seeing in difficult-to-treat diseases where innovation is most needed. In oncology, we're delivering therapies that are redefining standards of care and changing what patients can expect from treatment. Our industry-leading biosimilars portfolio continues to contribute meaningful growth as well and we've proven to be a leading competitor in this field and it remains an effective area for us to close. This was an exciting quarter, not just because of the financial results, but because of what it signals about Amgen's future. Inline brands are delivering, we're launching new products and we're advancing the next wave of late-stage programs.

Amgen is well positioned to deliver innovation and growth not just this year, but for the long term. I want to thank our colleagues around the world for their dedication to our mission to serve patients. With that, let me turn over to Myrto for an update on the commercial progress in the quarter.

Speaker 0

Thanks, Bob.

Speaker 1

In the second quarter, sales increased 9% year over year, driven by 13% volume growth. As you heard from Bob, 15 products delivered double-digit or better growth, a clear demonstration of the strength of our portfolio and quality of our execution. Turning to general medicine, Repatha delivered $696 million in the second quarter, up 31% year over year. Improved access is enabling more patients to benefit from Repatha. With an estimated 100 million people in need of effective LDL-C lowering, the opportunity to expand our impact remains substantial. In the U.S., we saw continued demand growth across both cardiology and primary care, supported by an expanding prescriber base and deepening engagement across key customer segments. Our direct-to-consumer campaign continues to make a positive impact, with more patients actively asking their doctors about Repatha. On pricing, we expect less net price erosion than we've experienced historically.

Evenity sales increased 32% year over year to $518 million in the second quarter. In the U.S., Evenity grew 41% with increased prescription volume from both established and newly activated prescriber accounts. In Japan, Evenity is positively impacting many people, with over 700,000 patients treated since launch. As the only therapy that both builds bone and slows bone loss, Evenity is uniquely positioned to reduce fracture risk in women who are postmenopausal. Approximately 250,000 patients in the U.S. have been treated with Evenity to date. However, many remain at high risk of fracture, with about 90% of the roughly 2 million very high-risk patients still not receiving appropriate therapy. This represents a meaningful opportunity to drive growth by ensuring more patients receive the protection they need from Evenity.

Speaker 0

Prolius sales.

Speaker 1

Declined 4% year over year in the second quarter to $1.1 billion, driven by lower net selling price in the U.S. Three biosimilars have now launched, and while it remains early, initial market dynamics are unfolding in line with our expectations. I'll move to our rare disease portfolio, which grew 19% year over year, delivering nearly $1.4 billion in sales in the quarter and now annualizing at over $5 billion. Tepezza grew 5% in the quarter to $505 million in sales since launch. Tepezza has had a positive impact for thousands of patients living with thyroid eye disease. We're continuing our efforts to engage a broad prescriber base of oculoplastic surgeons, ophthalmologists, and endocrinologists, encouraged by the feedback we're receiving from the medical community, including an increase in intent to prescribe reported by endocrinologists during the second quarter.

We launched Tepezza in Japan in December, and we're happy with the progress to date. Uplizna sales increased 91% year over year to $176 million in the second quarter. Uplizna continues to be the number one prescribed FDA approved treatment for NMOSD. Uplizna growth is also bolstered by the FDA approval in April for use in IgG4-related disease. Our launch in IgG4-related disease is going well with strong uptake amongst rheumatologists and key academic medical centers. Additionally, launch preparations are underway for the anticipated approval of Uplizna for use in generalized myasthenia gravis, a chronic autoimmune neuromuscular disorder. We look forward to the potential to bring Uplizna to patients living with GMG who can benefit from Uplizna's differentiated profile, including its durable efficacy over time and convenient dosing and administration. Moving to inflammation, Tezspire delivered another strong quarter with sales up 46% year over year to $342 million.

Adoption of biologic agents in severe asthma has accelerated meaningfully over the past five years, almost doubling as physicians increasingly recognize the value of these treatments. Yet with U.S. biologic penetration still under 25%, there remains substantial opportunity for continued growth. Tezspire has not only helped expand the category but continues to grow faster than the market, gaining share from legacy products based on a differentiated and broadly applicable profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma. Our innovative oncology portfolio, which includes Blincyto, Imdeltra, Lumakras, Vectibix, Kyprolis, Nplate, and XGEVA, grew 14% year over year, generating $2.2 billion of sales in the quarter. At the core of this growth is our industry-leading Bispecific T Cell Engager, or BiTE, platform, which led to the discovery of both Imdeltra and Blincyto.

With these products, we're helping to redefine the standard of care and improve overall survival rates in difficult-to-treat cancers, creating meaningful opportunities to reach more patients and drive long-term growth. Our U.S. launch of Imdeltra for the treatment of patients with extensive-stage small cell lung cancer who are progressing on or after chemotherapy continues to build momentum, generating $134 million in sales in the second quarter. We see strong conviction in Imdeltra as a standard of care in second-line small cell lung cancer. Imdeltra is being administered broadly across sites of care, including academic cancer centers, regional cancer hospitals, and community oncology clinics. Over half of all Imdeltra doses are now administered in the community setting, indicating growing comfort with this important new cancer therapy. Blincyto grew 45% year over year to $384 million in sales, driven by broad prescribing across both academic and community segments in the U.S.

Recent updates to the NCCN guidelines position Blincyto as a preferred consolidation therapy in combination with continued multi-agent chemotherapy for both adults and pediatric patients with Philadelphia chromosome-negative B cell ALL in the second quarter. Biosimilar portfolio sales grew 40% year over year to $661 million. Since the first launches in 2018, our biosimilars have delivered almost $12 billion in sales, representing a significant contributor to top-line growth and generating meaningful cash flows within this portfolio. Our launch of Pablu, a biosimilar to Eylea, continues to gain momentum, reaching $130 million in the second quarter. Retina specialists are responding very positively to Pablu, expressing appreciation for this high-quality Amgen biosimilar delivered in an easy-to-use prefilled syringe. I'm very pleased with our performance in the second quarter, powered by life-changing medicines, disciplined execution, and a clear and enduring commitment to the patients we serve.

Now I'd like to hand it over to Jay.

Speaker 0

Thank you, Myrto, and good afternoon, everyone. The second quarter marked a period of strong momentum and execution across the R&D pipeline. We delivered high-quality, rapid progress advancing multiple late-stage programs, starting with maritide, our investigational therapy for obesity and obesity-related conditions. In June, data were presented at the ADA and simultaneously published in the New England Journal of Medicine. Let me highlight some of the key points that define the differentiated profile of maritide for the treatment of obesity and obesity-related conditions. Maritide is convenient, the most advanced obesity treatment in development with monthly or less frequent dosing. Efficacy is strong, with up to approximately 20% weight loss at 52 weeks without a plateau and with a clinically meaningful improvement in cardiometabolic parameters, including hemoglobin A1C.

Speaker 5

Maritide is safe, very well tolerated at target doses.

Speaker 0

We've significantly improved GI tolerability with dose escalation without compromising weight loss efficacy. The Phase 3 program is underway, well informed by prior data and utilizing a refined three-step dose escalation approach to optimize tolerability. Enrollment momentum for chronic weight management is strong across multiple geographies, reflecting broad investigator enthusiasm, participant interest in these trials, and significant remaining unmet need. Since June, we initiated two additional Phase 3 studies. The first, maritide CV, evaluates cardiovascular outcomes in adults living with atherosclerotic cardiovascular disease and obesity or overweight. The second, maritide HF, evaluates reduction of heart failure events and cardiovascular risk in adults living with heart failure with a preserved or mildly reduced ejection fraction and obesity. In summary, maritide represents a promising treatment advance for people living with obesity, obesity-related conditions, and type 2 diabetes.

With four Phase 3 studies underway and obstructive sleep apnea set to initiate this year, we are well positioned to deliver a robust and comprehensive clinical knowledge base beyond maritide in general medicine. We remain excited about data from the Repatha Vesalius Phase 3 primary prevention study expected later this year. Turning to Opathiran, our promising best-in-class small interfering RNA medicine targeting LP(a), the fully enrolled event-driven OCEAN(a) Phase 3 cardiovascular outcomes study continues to mature. This medicine and study reflect our precision medicine approach to cardiovascular risk reduction in patients with elevated LP(a) levels. Moving on to our rare disease portfolio, in Uplizna, we look forward to the upcoming December 14 PDUFA date for generalized myasthenia gravis, recognizing evermore the significant unmet need for durable, convenient therapies consistently highlighted to us by treating physicians.

We are pleased by the European Commission's approval of Tepezza for the treatment of adults with thyroid eye disease. Additionally, enrollment is complete in our Phase 3 study examining subcutaneous administration of teprotumumab, representing another step forward towards improved patient convenience and treatment accessibility in inflammation. Our two Phase 3 studies of Tezspire in chronic obstructive pulmonary disease continue to enroll patients with moderate to very severe COPD with blood eosinophil counts greater or equal to 150 cells per microliter. Beyond COPD, enrollment was recently completed in our Phase 3 eosinophilic esophagitis study, and we look forward to the October 19 PDUFA date for Tezspire in chronic rhinosinusitis with nasal polyps.

Moving to oncology, in June, interim results from the global Phase 3 DELPHI-304 trial of Imdeltra, the first and only FDA-approved delta-like ligand 3, or DLL3, targeting BiTE molecule, were presented and simultaneously published in the New England Journal of Medicine. These compelling data showed Imdeltra significantly reduced the risk of death by 40% and significantly extended median overall survival by more than five months compared to standard of care chemotherapy in patients with small cell lung cancer who progressed on or after one line of platinum-based therapy. Additionally, Imdeltra significantly improved patient-reported outcomes of dyspnea and cough and was numerically better tolerated on numerous parameters when compared to standard of care chemotherapy. Regulatory filings are underway together with the remarkable DELPHI-301 data already reported. As Myrto Gordon highlighted, Imdeltra has the potential to become the new standard of care for second-line small cell lung cancer.

We continue to investigate Imdeltra in earlier lines of small cell lung cancer. Currently, three additional Phase 3 studies are underway across limited-stage and extensive-stage disease, along with Phase 1 studies evaluating Imdeltra in combination with novel agents to potentially further improve patient outcomes. We are also focused on enhancing patient convenience by evaluating less frequent dosing and subcutaneous delivery. We continue to investigate our CD19-directed BiTE medicine Blincyto in earlier treatment settings while also advancing a subcutaneous formulation. In June, Phase 1b and 2 subcutaneous blinatumomab data were presented and simultaneously published in The Lancet Hematology, demonstrating 89% to 92% remission rates and manageable safety in adults with relapsed refractory CD19-positive, Philadelphia chromosome-negative B cell precursor acute lymphoblastic leukemia.

Subcutaneous blinatumomab has the potential to improve both the patient experience and efficacy, and we remain on track to initiate a potentially registration-enabling study in both adults and adolescents later this year. Our first-in-class STEAP1 CD3 bispecific T cell engager, zaliridamig, is advancing in Phase 3 clinical development. We are also exploring zaliridamig in combination therapy and in earlier stages of prostate cancer, with multiple Phase 1b studies ongoing. Collectively, Imdeltra, blinatumomab, and zaliridamig exemplify the significant growth potential of our robust bispecific T cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide. Beyond our T cell engagers, in June we announced data from the Phase 3 FORTITUDE-101 study of first-line bimekizumab.

Our first-in-class fibroblast growth factor receptor 2b-directed monoclonal antibody, bimekizumab plus mFOLFOX6 chemotherapy, met its primary endpoint of overall survival at a pre-specified interim analysis in patients with unresectable, locally advanced, or metastatic FGFR2b-positive, HER2-negative gastric or gastroesophageal junction cancer. In closing, I want to extend my gratitude to our colleagues for their dedication to achieving these critical milestones and their unwavering focus on improving outcomes for patients facing serious diseases. I'll now turn it over to Peter.

Speaker 5

Thank you, Jay. We're pleased with our strong second quarter performance and remain on track with our 2025 full year goals and long term objectives. The financial results are shown on slides 31 and 32 of the slide deck. In the second quarter, we delivered revenues of $9.2 billion, reflecting our key growth drivers highlighted on our Q4 earnings call. Repatha, Evenity, Tepezza, and Uplizna in our innovative oncology, rare disease, and biosimilar portfolios. Our non-GAAP operating expenses rose 8%, led by a non-GAAP R&D growth of 18% year over year, reflecting continued investment in our late stage pipeline including maritide, Opathiran, Imdeltra, Zairidomic, and rare disease. Our non-GAAP OI&E was favorable $213 million year over year, driven by gains from early retirement of debt and lower interest expense. Recall, we retired $4.5 billion of debt in 2024 and have retired $4.3 billion in the first half of 2025.

Our non-GAAP tax rate decreased 0.7% year over year to 14.2%, primarily due to the change in earnings mix. The company generated $1.9 billion in free cash flow in the second quarter, reflecting operational momentum across the business while continuing to invest in innovation. We invested $1.7 billion in non-GAAP R&D spend, an increase of 18%, and expect to build on this momentum in the second half of the year. With increased investment in our innovative late stage pipeline, we are accelerating innovation and productivity through AI investments across the value chain from discovery to development to commercial execution and in G&A. This is enabled by digitized workflows, modernized data infrastructure, and global access to advanced generative AI tools. For 2025, we continue to expect capital expenditures of $2.3 billion to expand network capacity for our products across the portfolio and our innovative pipeline including maritide.

In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share, representing a 6% increase compared to the second quarter of 2024.

Speaker 0

Turning to the outlook for the business.

Speaker 5

For 2025 on Slide 33, we expect our 2025 total revenues in the range of $35.0 billion to $36.0 billion and non-GAAP earnings per share between $20.20 and $21.30. This guidance includes the estimated impact of implemented tariffs. It does not account for tariffs or pricing actions announced or described but not implemented. In addition, let me highlight a few updates to our outlook for the remainder of the year. We now expect full year non-GAAP operating margin as a percentage of product sales to be roughly 45%. Our outlook now includes several business development transactions resulting in roughly $200 million of incremental R&D expense expected in Q3. The outlook continues to reflect our investments in advancing key late-stage programs including maritide, Opathiran, and Imdeltra, and leveraging technological advancements including artificial intelligence. Our operating margin outlook also includes incremental launch and commercial investments starting in the third quarter.

In line with these priorities and reflecting the business development transactions of roughly $200 million, we now expect non-GAAP R&D expense to grow over 20% in 2025. We now anticipate non-GAAP O, I and E to be approximately $2.2 billion in 2025. For Wetlana and Amjevita sales in the U.S., we continue to expect quarterly sales to fluctuate and do not expect any sales in the third quarter. Let me remind you of prior items that have not changed for the full year. We continue to expect other revenue to be approximately $1.4 billion. We expect a non-GAAP tax rate of 14.5% to 16.0%. We expect share repurchases not to exceed $500 million in 2025. We are focused on delivering sustained long-term value for patients and shareholders by doing what we said we would do, growing leadership in the U.S.

and internationally, driving innovation in areas of high unmet medical need and maintaining rigorous financial discipline. We continue to focus on execution excellence across the enterprise and remain well positioned for sustained growth through the long term. I'm grateful to work with all of our colleagues worldwide in serving patients. This concludes our financial update. I'll now hand it back to Bob for our Q&A session.

Speaker 2

Julianne, could you now open the call for questions and just remind our callers of the procedure for submitting their question to us? Thanks.

Speaker 3

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 one again. To ask the question, press STAR one. Our first question comes from Jeroen Werber from TD Cowen. Please go ahead. Your line is open.

Speaker 2

Great. Thanks so much for maybe just the first question on Jay for you. On maritide in Q4 when we have.

Speaker 0

The second year data, how much granularity are we going to be able to glean from the patients who are going on maintenance?

Speaker 2

Are you going to give U.S.?

Speaker 0

Data on Q8 weeks and Q12 weeks at that point? Thank you. Thank you. Roan, as you identify and gathered from our words moments ago, the data readout from the Phase 2 type 2 diabetes study and part 2, the chronic weight management studies are expected in Q4 of 2025, and we'll have more to share about these data in due course.

Speaker 3

Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead. Your line is open.

Good afternoon. Thanks for taking my question. The industry's been adopting a number of strategies here, which you spoke to with regard to helping the administration achieve their goals to reduce drug pricing. That goal post is still shifting around you with the latest angle being Medicaid MSN. I'm curious here as to your thoughts on that clause specifically, but additionally how you are thinking about DTC efforts, which seem to be a growing theme across the industry and was called out by one of your thank you.

Speaker 2

Savion, I think it may be a little premature to speak in detail about any one of the particular proposals, but what I would say at a higher altitude is that we agree that reform is needed in the U.S. healthcare system. We would like for our medicines and all the medicines in this country to be more affordable and for those medicines to be more widely available. At Amgen, obviously we also believe that this country and the world need more innovation, not less. The onus is on us to help find ways to reform, to bring the price of medicines down, to make them more widely accessible, while preserving the innovative ecosystem that has enabled this country to be the world leader in biopharmaceutical medicine.

We welcome the government's focus on the role that foreign countries can play in trying to preserve that innovative ecosystem by rewarding innovation fairly. We expect to work with this administration to try and find a path forward that helps to achieve their objectives and I think the objectives of many leaders in this industry. It is still a little bit early days, Savion, to talk in any detail about specific initiatives or specific proposals, but we've enjoyed a good working relationship with the administration and we expect that we'll continue to have the opportunity to work with them to advance on this front.

Speaker 0

All right, Julian, let's take the next question, please.

Speaker 3

Our next question comes from David Ansellem from Piper Sandler. Please go ahead. Your line is open.

Speaker 2

Thanks.

Speaker 0

You cited strong performance in particular from rare disease business, and you're getting.

Speaker 2

Back to a capital structure that looks.

Speaker 0

More like it was prior to the Horizon transaction. I guess my question here is what is your appetite for significant, consequential M&A regarding rare diseases, and what is your appetite in general for continuing to build out that broad therapeutic vertical? Thank you.

Speaker 2

David, your question seems to focus on the word significant. I don't know what your definition of significant is, but what I would say, I would reiterate that we remain very interested in rare disease. We think the portfolio of rare disease assets that we have both in the market now and the pipeline of rare assets is very attractive. We will continue to look for ways to grow our rare disease business both organically and to the extent that there are licensing or acquisition opportunities, we'll look for those as well. I would point out on the question of transactions, whether it's in rare disease or elsewhere, that we have a lot of activity right now, in particular in our portfolio, a lot of late-stage activity. We will be very mindful about wanting to continue to execute flawlessly across those programs.

Again, thanks for observing that the capital structure has followed the course that we told you to expect and we feel very good about the progress we've made in integrating Horizon and insuring up the balance sheet.

Speaker 0

All right, Julianne, take the next question, please.

Speaker 3

Our next question comes from Courtney Breen from Bernstein. Please go ahead. Your line is open.

Hi Amgen team, thanks for taking my question today. The first one is just on maritide. As we look at the three-step dose escalation that you've incorporated into the Phase 3s that have been announced, this incorporates kind of a physician, if we think about the future clinical use, having to select a maintenance dose kind of straight after the last titration dose, rather than stepping through each of the potential maintenance doses, which is what we see in practice in the market today. Can you explain kind of why you think this is a better paradigm to be using or how you expect kind of physicians to select that right dose for the patient that they have in front of them, given they will have only had the titration information or feedback for that particular patient up until that point.

Speaker 1

Thank you very much, Courtney.

Speaker 0

Why don't I try out an answer here? As a monoclonal antibody dose, escalation with maritide is naturally very smooth, very steady. As we've shared and as we firmly believe, progressive benefit can be derived from a tolerability standpoint with both lower doses and also with multiple steps to target. This is very consistent with the experience of the field, and the 21 milligram starting dose selected for Phase 3 clinical investigation indeed has the very low risk of serious GI events and progressing to a highly efficacious target dose. We're studying several in the Phase 3 study, which will deliver both a well-tolerated patient experience and give us a graded understanding of dose and response. The Phase 3 design was very carefully conceived in order to read out dose proportionate benefit to maritide.

You also asked around maintenance, and appreciate you bringing this up, but it's just true that these are chronic diseases that run with obesity, as is obesity and overweight themselves. Long-term treatment of these diseases has proven just very challenging with these weekly injectable peptides with very low persistence on medicine. Our studies together will guide the optimal use of maritide for long-term maintenance therapy, where patients and doctors will no doubt work together to sustain the benefits of maritide on doses and perhaps even different schedules guided by these data. All right, Julianne, let's go to the next question please.

Speaker 3

Our next question comes from Umar Rafat from Evercore ISI. Please go ahead. Your line is open.

Speaker 1

Hi, thanks for taking my question.

Speaker 0

On Vesalius CVOT or PCSK9 outcomes trial, I'm curious how you're thinking about the event rate accumulation over time.

Speaker 1

It looks like by the time it reads out by year end this year.

Speaker 0

It's basically right around that four and a half year follow-up which you were anticipating. I guess my confusion is, is that timeline driven by the 4.5 year follow-up or is it rather because you're...

Speaker 1

Hitting those predefined events of 750 plus on the triple and 1,250 on the quadruple?

Speaker 0

Thank you very much. Thanks, Numer, for your question. As you surely know and based on your sophisticated question, Vesalius CV for everyone is our primary prevention study of PCSK9 inhibition and cardiovascular risk reduction. We anticipate a readout in the second half of this year. The readout is purely based on accumulated events or event rate. Julia, next question please.

Speaker 3

Our next question comes from Terrance Flynn from Morgan Stanley. Please go ahead. Your line is open.

Speaker 0

Great.

Speaker 2

Thanks so much for taking the question.

Speaker 0

Maybe another one for Jay.

Speaker 2

I was just wondering if you could.

Speaker 0

Provide any more thoughts on how you're thinking about the design of a maritide study in type 2 diabetes in light of Eli Lilly's recent surpassed CVOT data where they compared tirzepatide to Trulicity.

Speaker 2

Just how that might influence how you're.

Speaker 0

Thinking about control arm for your study. Thank you. Yeah, thanks very much for the question. We read the paper with real interest, and as you can imagine, follow the field quite closely. We indeed have four maritide Phase 3 studies underway. They're all enrolling well. The CVOT presently open is with atherosclerotic coronary vascular disease with obesity and overweight. We'll have more to share around our plan for pivotal studies in diabetes and in their cardiovascular outcomes in the fullness of time. Okay, Julian, take the next question please.

Speaker 3

Our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Speaker 2

Oh, hey, congrats on the quarter.

Speaker 0

It was nice to see the.

Speaker 2

Positive FORTITUDE-101 top-line results for bemarituzumab.

Speaker 0

Can you provide some color on the timeline to file for approval, especially with regards to the results from Fortitude 102? Do you need those for filing? Also, any color you can give us on when we should expect to see the detailed results from Fortitude 101? Thank you. Thanks, Jay. We're very excited about the emerging picture. Rhombomerituzumab, the doublet with chemotherapy, was indeed positive for overall survival, which quite matters for all cancers, especially this one, the fifth most common with very little impact to date with targeted therapy. Targeting FGFR2B expression in this cancer combined with mFOLFOX6 chemotherapy is a meaningful advance for these patients. We've not as yet disclosed our regulatory strategy.

As you point out, the triplet study that importantly adds checkpoint therapy to this pairing of omeratuzumab and chemotherapy will read out in the second half of this year or the first half of next year, adjusted the date range based on our current best estimate, and our regulatory strategy integrates these data sets. Julianne, let's take the next question, please.

Speaker 3

Our next question comes from Chris Schott from JPMorgan. Please go ahead. Your line is open.

Speaker 0

Great, thanks so much. Just wanted to come back to Repatha just as we were thinking about that primary prevention study. Can you talk a little bit about the bar that you see here in terms of what we see from that data to be clinically meaningful? Once you have that data on label, how big of a driver do you see this for that franchise as a whole? Thanks so much.

Speaker 2

We take this in two parts. Chris, maybe Jay, you can kick off, and then Myrto, why don't you add your thoughts.

Speaker 0

Thanks for the question. You know, there's no level of LDL C that confers a better outcome for patients with coronary vascular disease. Really suppressing LDL C with Repatha in these high risk patients who've not as yet had an MI or revascularization is, we think, a great opportunity for benefit. I'd be loath to peg a specific overall risk reduction here today, but the field is quite calibrated to what a meaningful outcome would look like for these patients as we've studied this medicine exhaustively in the secondary prevention realm. Myrna?

Speaker 1

Yeah, thanks for the question, Chris. I would just say that we're already doing very well in the "primary prevention" population of patients. Roughly 40% of our Repatha new to brand prescriptions are from patients who have yet to suffer a first vascular event, and we're getting a lot of these high risk patients right now. What I think a Vesalius positive result could do is help reinforce the need for more aggressive LDL cholesterol lowering guidelines, help reinforce the need to remove payer barriers, which we have done successfully over time. Still, some prior authorization criteria exist for some soft populations of patients. Of course, we are very interested in continuing to expand the penetration of PCSK9s both in secondary prevention and in primary prevention.

I think this is an important trial, and it continues to drive the tailwind that we're already experiencing, that we've been able to create for Repatha growth in the market.

Speaker 0

All right, Julianne, let's go to the next question, please.

Speaker 3

Our next question comes from Matthew Phipps from William Blair. Please go ahead. Your line is open.

Speaker 0

Thanks, Jimmy. Question, noticed AMG 732 listed on the press release today. Just curious how that program differentiates from Tepezza and maybe what unmet need you're.

Speaker 1

Looking to address in thyroid eye disease.

Speaker 0

Thank you.

Speaker 2

Thanks, Pat.

Speaker 1

Yeah, no, thanks for noticing.

Speaker 0

We're delighted to share in these earnings materials for the first time the development of AMG 732, which is a next-generation IGF1R targeting monoclonal antibody. This medicine benefits from the target validation strongly provided by Tepezza and will be presented to patients in a subcutaneous administration. The Phase 2 study is enrolling patients with moderate to severe and active TED and progressing very well. Thank you.

Speaker 2

I think the big picture here, Matt, is at the time we acquired Horizon, we said we felt there would be lots of opportunities given the large molecule nature of the portfolio. Lots of opportunities for us to introduce innovation over time. This would be an example of that. All right, Julianne, let's move on to the next question.

Speaker 3

Our next question comes from Dave Reese from B. Riley Partners. Please go ahead. Your line is open.

Speaker 0

Yes, thanks very much and congrats, Bob and team, on some great financial momentum. I'm curious about the end of the press release highlighting the development of biosimilar versions of Opdivo, Keytruda, and Ocrevus. I know that's not new news, but can you please discuss how you see the potential for IV biosimilars to compete with hyaluronidase subcutaneous versions, which are set to experience significant uptake ahead of the opportunity to launch IV biosimilars. Thanks so much.

Speaker 2

Yeah. Myrto, do you want to take the first stab there and then invoke Jay however you'd like?

Speaker 1

Sure, Dave, thanks for the question. Obviously, we're excited about the growth that we're seeing in our biosimilar portfolio overall. Amgen success here has been remarkable, quite frankly, since 2018. Now, cumulative $12 billion of revenue generated by this portfolio of products, we've had 100% success rate in regulatory, both development and regulatory milestones. Of course, we continue to grow the business year over year. This year with 40% growth, with the most recent launches of biosimilars this year.

Speaker 0

We are very pleased with the use.

Speaker 1

Of capital invested in this. We know the oncology space very well. We were one of the first companies to launch oncology biosimilars. We feel that we understand the dynamics for Keytruda and Opdivo. We're watching the hyaluronidase uptake very closely to see if Subcute has a role to play in the treatment of cancers. I think what we're particularly interested in seeing is whether or not the cadence of the PD1 dosing lines up with the chemotherapy dosing or other adjuvant therapy and combination therapy. We're watching it closely, and if Amgen decided to further develop other biosimilars, we would and could.

Speaker 0

Yeah, I would just only really medically, as an oncologist. Use of these breakthrough immuno-oncology checkpoint medicines is pretty firmly mapped into treatment plans, treatment practices, patterns of practice, really all across the world. Bringing forward these two medicines, ABP 206 and ABP 234, is just really a seamless move to bring biosimilar medicines into an area of oncology that has benefited from innovation and now will benefit even better from access. Hey, Julian, take the next question, please.

Speaker 3

Our next question comes from Evan Segerman from BMO Capital Markets. Please go ahead. Your line is open.

Speaker 2

Hi guys.

Speaker 0

Thank you so much for taking my question. I actually wanted to touch on Imdeltra. You noted impressive growth this quarter. I'm really trying to understand what's driving the volume. Is it increased penetration into that refractory population, and how do you see it panning out over the course of the year? I'm just trying to get a sense as to where this could go. Thank you very much.

Speaker 1

Yeah, thanks, Evan. The growth in Imdeltra is definitely an uptake on those patients, those small cell lung cancer patients who are progressing on or after chemotherapy. We're seeing utilization consistent with the data that we've generated so far. I think the data that we presented in June at ASCO were obviously compelling. First time real overall survival benefit has been shown in that particular setting of small cell lung cancer. We're also seeing an improvement in both academic and community setting ability to operationalize the monitoring required for Imdeltra. I think that probably had a slightly dampening effect at the beginning of the launch and is now more or less being managed as appropriate. We're seeing good volume growth, very strong clinical conviction. As I said, it's the first time we've seen such compelling data in this setting in small cell lung cancer.

I'm looking forward to more data as it progresses. We'll have more to say about how we see the growth of this really important asset as we see more data.

Speaker 2

The only thing I might add there, Evan, is that the strength of the launch and the breadth of uptake that we've seen in particular from the clinics encourages us for the future of the BITE portfolio. As you know, we're excited about Zeyluridamig. Lessons we're learning here no doubt will be useful in that context. Again, all signs so far are really positive.

Speaker 0

Okay, Julianne, let's go to the next question, please.

Speaker 3

Our next question comes from Alex Hammond from Wolf Research. Please go ahead, your line is open. Thanks for taking the question.

We've seen this regulatory landscape evolving. I guess looking forward, what changes could we see from regulatory standards to establish comparability? Could we see PK comparability versus randomized Phase 3 trials be feasible? How could these dynamics possibly modulate your long-term guidance of greater than $4 billion in sales by 2030?

Speaker 2

Why don't we take this in two parts, Jay? There's some clinical regulatory questions and Myrto, your perspective on the market.

Speaker 0

Yeah, thanks Alex. We too have been very interested to see some possible, I mean not as yet, but possible softening of some of the regulatory requirements for biosimilar medicines. This really plays very favorably to our differentiated capacity to develop very high quality compositions that map to the established innovator medicines. This may or may not be true in all geographies around the world. We have to consider this a global regulatory go to market plan. From a drug development standpoint and an innovation of biosimilar standpoint, these changes we believe accentuate our comparative and differentiated capacity in biosimilars. Merrill?

Speaker 1

Yeah, thanks Jay. The only thing I would add is this is still a technically difficult area and requires significant expertise in designing molecules that will meet the parameters, even the new parameters that the FDA are requiring for comparability of a biosimilar to an originator. There might be less clinical trial effort required for data generation, but it's still technically difficult to do what we do. We're fortunate we have a very strong process development organization here at Amgen, who are often very adept at finding unique ways to develop biosimilars that do not infringe on the intellectual property of others.

Speaker 2

Alex, this topic of biosimilars and the adoption of them in the U.S. is often a subject in policy and other circles in Washington, D.C., and I think from our perspective the market's developing well. There's an appropriate regulatory framework, and the assurance of safe, reliable supply is important here. I think this is a market that's developing well and pretty much playing out as we expected it would when we committed capital to developing products in the area.

Speaker 0

Okay, Julia, go to the next question, please.

Speaker 3

Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open. Hi, this is Sadiahman on for Mohit. Thanks for taking our question. Can you talk about your confidence in the test prior COPD program in light of a competitor's Phase 3 trial missing despite good Phase 2 data from their molecule in COPD? How are you thinking about the.

Patient profile that's most likely to benefit.

From testfire, particularly around eosinophil levels? Thanks.

Speaker 0

Yes, thank you for the question. The short answer is we feel great about the mechanism and confident in it for COPD and the profile, especially with an understanding of the responder population as likely relating to the degree of TH2 immunity's contribution as measured by the biomarker of blood eosinophil count as a possible biomarker of response.

Speaker 1

We feel very strong.

Speaker 0

I assume here that you're speaking to the recent Roche data and this is a molecule we know well, actually comes from Amgen, Astegolimab, and though that phase 2 data did not repeat in phase 3, I would just remark that the ST2 pathway is distinct from the TSLP pathway, and I wouldn't be quick, not that you're doing this, to lump the two. The ST2 pathway, this suppressor of tumorigenicity 2 protein, is quite distinct from the more allergic or eosinophil-driven TSLP pathway. ST2 is a non-allergic signaling pathway that relates more to epithelial damage. While disappointed for patients that the phase 3 in all comers didn't read through with that molecule, we feel very confident in the test-fire mechanism of action, the phase 2 data, and are conducting the experiments now together with our partners at AG to get an answer.

Hey Julianne, let's take the next question, please.

Speaker 3

Our next question comes from Luca Issy from RBC Capital. Please go ahead. Your line is open.

Speaker 0

Oh great. Thanks so much for taking my question. Maybe if I can circle back on obesity, you obviously have two molecules in development here with maritide and 513. However, I believe both molecules are injectables versus oral.

Speaker 5

Lily.

Speaker 0

Cool, just some very encouraging data for glucagon at ADA, which is obviously an oral small molecule. What's Amgen's appetite to augment your current offering in obesity by adding an oral small molecule via either BD or organic discovery? I guess the other way to ask that question is, what % of the obesity market do you think would ultimately be oral versus injectable? Any call there, much appreciated. Thanks so much.

Speaker 2

Yeah, maybe we can add some color from a few different perspectives here, Luca. First, I would say on BD, obviously, you know, we're open, we're paying very close attention to all interesting innovation in the field of obesity and related conditions. We have, and we'll continue to look carefully at things that might be helpful to patients that are managing these diseases. Jay, maybe you want to offer some thoughts on the clinical aspects and then, Myrto, why don't you talk about the market?

Speaker 0

You're right. There remains a massive unmet need. Maybe 2% of patients with obesity are currently addressed by current medicines, which are quite hard to take for even longer than the calendar year, and of course aren't cured by these medicines. There is a big opportunity for distinctive medicines, new mechanisms, systems, differentiated properties, and potentially different routes of administration as well. Just exactly as Bob said, you know, we didn't just wander into obesity because it became hot. We've been studying these pathways for more than a decade. Our research and development pipeline, earlier than the two medicines you cited, targets incretin pathway, also non-incretin pathway medicines rising up in our pipeline. Some of these medicines may indeed be given orally. Please, more to follow from Amgen Research. Myrto, would you want to comment about the market and how it's shaping up for orals and for maritide.

Speaker 1

Yeah, thanks for the interest in this. Obviously, an important question as we try to project the market going forward. As Bob said, we are interested in looking at orals, and that comes from us seeing orals constituting a decent portion of the market. I think our flagship product, maritide, is clear in its differentiation, and that is to treat people for their chronic weight management so that they can benefit in a cardiometabolic way for their health, so that they have less ultimately cardiovascular comorbidity or mortality. That's what we're doing. We're taking maritide into the clinic for full breadth of indications. As Jay also mentioned, we believe we have a differentiated product that makes it much easier for patients to persist with their chronic weight management treatment over the course of their lifespan so that they can benefit from that in important ways with outcomes.

Looking at the orals very closely, but excited about our flagship product that we're developing.

Speaker 0

All right, Julian, let's go to the next question, please.

Speaker 3

Our next question comes from Jeff Meacham from Citibank. Please go ahead. Your line is open.

Speaker 0

Hi guys, thanks for taking the question. Another one on maritide for Jay.

Speaker 2

You just post, Adam.

Speaker 0

Were there any changes that you guys made to Phase 3? Just thinking, you know, increased entry criteria or maybe pace of titration just to optimize discontinuations and then related, you know, from a strategy perspective, let's say to the current study, do they constitute the majority of Amgen's Phase 3 investment in maritide or would you guys looking to expand more broadly into peripheral indications where WAVY plays a role? Thank you. Yeah, thanks, Jeff. The feedback after the ADA was quite strongly positive, especially from key opinion leaders, investigators in the field. That for us was terrific to hear thought leaders present these data that we spent so much time with and get their unvarnished opinions was very positive. No, there were no changes or edits to the Phase 3 program as a result of those engagements at ADA.

There was actually really strong confidence that I think is well reflected by the very strong enrollment that we're seeing on this trial on these trials right now. We remain very interested in bringing maritide to other obesity related conditions. The field is even suggesting some not overtly obesity related conditions to think about. We'll have more to say on the broader maritide Phase 3 program in due course.

Speaker 1

Jeff, it's Myrto. I would just add that we're also looking to inform clinical practice as much as possible in chronic weight management. Anything we can do to help those clinicians upon approval understand how to use maritide in the real world setting, we will continue to generate those data.

Speaker 0

All right, Jillian, I think we've got time for one more question, and then Bob will wrap up the call.

Speaker 3

Our last question today will come from Carter Gold from Cantor Fitzgerald. Please go ahead. Your line is open.

Speaker 0

Great. Good afternoon. Thanks for taking the question for Bob or Myrto. I wanted to ask, on the policy front, we've seen intellectual property under attack across the industry on multiple fronts, but most notably in the obesity space. Are you taking actions or advocating either on your own or in conjunction with peers to address persistent unlawful compounding? Does Amgen not view compounding of the current wave of GLP-1s, or as a general concept, as a creeping direct or indirect threat to nuclear? Does Amgen expect it to fade as a concern by the time maritide launches? Any thoughts would be appreciated. Thank you.

Speaker 2

Obviously, Carter, IP is a critical consideration in our industry and you know, we're very respectful of the importance of IP as the basis on which investments are made in this industry. Again, you know the drill, right? We invest a couple billion dollars of research and development over 10 or 15 years, and we need to have confidence in the IP that protects those investments. Compounding is less a direct issue for Amgen because our molecule is an antibody, and it won't be compounded in the way that peptides and small molecules have been and can be in light of the statutes that are available to permit it. In general, I think, you know, we're pretty clear that compounding is not good for the industry, probably not good for patients.

You know, we would be mindful of the importance of the kind of quality framework that we have in place that the regulators routinely assess us on. That's what gives us comfort that we're providing safe, reliable supply of medicines to our patients. Myrto, feel free to jump in if you want to add anything.

Speaker 1

No, I would concur. I think it's important to underscore that there isn't a compounding pathway for a biologic such as maritide. It's concerning that compounders continue to make products available despite the supply situation having been resolved by other manufacturers.

Speaker 2

All right, let me just address two things quickly before we thank you for joining us on the call. First, just to highlight again, I hope you got a clear sense from us that the business is performing well and that's true across therapeutic categories and geographies. Our execution is also strong in operations and Research and Development. Of course, that's setting the stage for what we expect to be attractive long term growth for the company. Again, excited about the performance, looking forward to the second half of the year. Before we conclude today, I just want to share one organizational announcement, which is that Justin Claeys will be transitioning his Investor Relations responsibilities to our Treasurer, Adam Eleanoroff.

Justin will be moving into a new role as the Head of Financial Planning and Analysis at Amgen, and that's an area where he has spent much of his 20 year career with us. We're looking forward to having him back in that leadership role and thrilled that Adam, who's been with the company for nearly 19 years, will take on the responsibility of Investor Relations in addition to his Treasury role. I'm confident that all of you will enjoy working with him and that it will be a seamless transition. On behalf of Pete and the rest of the team, I want to thank Justin for the superb job that he's done in leading the Investor Relations effort. Thank you all for joining us, and we'll look forward to connecting with you at the next quarterly call.

Speaker 3

This concludes our Amgen Q2 2025 earnings conference call. You may now disconnect.