Amgen Inc.

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 Clay, Vice President of Investor Relations. Mr. Clay, you may now begin.

Good afternoon, everyone, and welcome to our second quarter 2025 earnings call. Bob Bradway will lead the call and be followed by a broader review of our performance by Myrtle Gordon, Jay Bradner, and Peter Griffiths. 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.

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, 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 III 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. We've proven to be a leading competitor in this field, and it remains an attractive 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. And 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 Murdo for an update on the commercial progress in the quarter.

Thanks, Bob. 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 billion 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. Avenity sales increased 32% year-over-year to $518 million in the second quarter. In the U.S., Avenity grew 41% with increased prescription volume from both established and newly activated prescriber accounts. In Japan, Avenity 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, Avenity is uniquely positioned to reduce fracture risk in women who are postmenopausal. Approximately 250,000 patients in the U.S. have been treated with Avenity 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 Avenity. Prolius sales 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. Tepeza grew 5% in the quarter to $505 million in sales. Since launch, Tepeza 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, and we're 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 PEZA 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 Iplizna for use in generalized myasthenia gravis, a chronic autoimmune neuromuscular disorder. We look forward to the potential to bring Iplizna to patients living with GMG who can benefit from Iplizna's differentiated profile, including its durable efficacy over time and convenient dosing and administration. Moving to inflammation, Tespire 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. Testbuyer 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 Blinsito, Imdeltra, Lumicraz, Vectabix, Caprolis, Endplate, 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 Indeltra 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 IMDOTRA 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 IMDOTRA as a standard of care in second-line small cell lung cancer. Mdeltra is being administered broadly across sites of care, including academic cancer centers, regional cancer hospitals, and community oncology clinics. Over half of all Mdeltra 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 PapBlue, a biosimilar to ILEO, continues to gain momentum, reaching $130 million in the second quarter. Retina specialists are responding very positively to PapBlue, expressing appreciation for this high-quality Amgen biosimilar delivered in an easy-to-use pre-filled 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. And now I'd like to hand it over to Jay.

Thank you, Murdo, 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 for Maritide for the treatment of obesity and obesity-related conditions. Maritide is convenient, the most advanced obesity treatment and 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. Meritide is safe, very well tolerated at target doses. We've significantly improved GI tolerability with dose escalation without compromising weight loss efficacy. The phase three 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 three studies. The first, Maritime CV, evaluates cardiovascular outcomes in adults living with atherosclerotic cardiovascular disease and obesity or overweight. The second, Maritime 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, Meritide represents a promising treatment advance for people living with obesity, obesity-related conditions, and type C diabetes. With four Phase III 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 Meritide, in general medicine, we remain excited about data from the repath of the Salius Phase III primary prevention study expected later this year. turning to Olpaceran, our promising best-in-class small interfering RNA medicine targeting LP little a, the fully enrolled event-driven OceanA phase 3 cardiovascular outcome study continues to mature. This medicine and study reflect our precision medicine approach to cardiovascular risk reduction in patients with elevated LP little a levels. Moving on to our rare disease portfolio and APLISNA, we look forward to the upcoming December 14th PDUFA date for generalized myasthenia gravis, recognizing ever more 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 TPEZA for the treatment of adults with thyroid eye disease. Additionally, enrollment is complete in our phase three study examining subcutaneous administration of tepritumumab, representing another step forward towards improved patient convenience and treatment accessibility. In inflammation, Our two phase three studies of TESPIRE 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 three eosinophilic esophagitis study, and we look forward to the October 19th pedophilate for TESPIRE in chronic rhinosinusitis with nasal polyps. Moving to oncology, in June, interim results from the Global Phase III DELPHI-304 trial of MDELTRA, the first and only FDA-approved delta-like Ligand-3, or DLL-3, targeting bite molecule, were presented and simultaneously published in the New England Journal of Medicine. These compelling data showed Indeltra 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 Murdo highlighted, IMDELTRA has the potential to become the new standard of care for second-line small-cell lung cancer. We continue to investigate MDELTRA in earlier lines of small cell lung cancer. Currently, three additional phase three studies are underway across limited stage and extensive stage disease, along with phase one studies evaluating MDELTRA 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 bike medicine Blin-Cyto in earlier treatment settings while also advancing a subcutaneous formulation. In June, Phase 1b and 2 subcutaneous Blinitumumab beta 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 blinitumumab 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 STEEP1 CD3 bispecific T-cell engager, Zaluridamig, is advancing in Phase III clinical development. We are also exploring Zalaritamig in combination therapy and in earlier stages of prostate cancer with multiple phase 1B studies ongoing. Collectively, Indeltra, Blinsito, and Zalaritamig 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 III Fortitude 101 study of first-line bimerituzumab, our first-in-class fibroblast growth factor receptor 2B directed monoclonal antibody. Bimerituzumab plus M-FOLFOX6 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.

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, a vanity test buyer in our innovative oncology, rare disease, and biosimilar portfolios. Our non-GAAP operating expenses rose 8%, led by non-GAAP R&D growth of 18% year-over-year, reflecting continued investment in our late-stage pipeline, including Meritide, Opaciran, Indeltra, Zyridimig, and Rare Disease. Our non-GAAP OINE 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 percentage points 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% year-over-year, 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 GNA. 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 MeritSide. In addition, we return capital to shareholders through competitive dividend payments of $2.38 per share, representing a 6% increase compared to the second quarter of 2024. Turning to the outlook for the business 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 Meritide, Opasaran, and Indeltra. and leveraging technological investments, 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 OINE to be approximately $2.2 billion in 2025. For Weslana and Amgabeta sales in the United States, we continue to expect quarterly sales to fluctuate and do not expect any sales in the third quarter. And 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 United States. 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.

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

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 a question, press star one. Our first question comes from Yaron Werber from TD Cowan. Please go ahead. Your line is open.

Great. Thanks so much. Maybe just the first question, and, Jake, for you on Meritide. In Q4, when we have the second-year data, how much granularity are we going to be able to glean from the patients who are going on maintenance? And are you going to give us data on Q8 weeks and Q12 weeks at that point? Thank you.

Thank you, Rowan. As you identified and gathered from our words moments ago, the data readout from the Phase II Tachydiabetes Study and Part II of the Chronic Weight Management Studies are expected in Q4 of 2025, and we'll have more to share about these data in due course.

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 has been adopting a number of strategies here, which you spoke to, with regard to helping the administration achieve their goals to reduce drug pricing. But that goalpost is still shifting around you with the latest angle being Medicaid, MSN. So 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 peers this morning. Thank you.

Well, Savya, 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 needs 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 medicines. So 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. and 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. So, you know, still a little bit early days, Salveen, 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.

julian let's take the next question please our next question comes from david ansellum from piper sandler please go ahead your line is open um thanks so you you signed a strong performance in particular from a rare disease business and uh you're getting back to a capital structure that looks more like it was prior to the horizon transaction so 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.

David, your question seems to focus on the word significant, and 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 And we have a lot of activity right now in particular in our portfolio, a lot of late-stage activity, and so we'll be very mindful about wanting to continue to execute flawlessly across those programs. But, 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. All right, Julian, take the next question, please.

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

Hi, I'm . 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 a physician, if we think about the future clinical use, having to select a maintenance dose 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?

Thank you very much, Courtney. Why don't I try with an answer here? As a monoclonal antibody, dose escalation with Meritide 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 III clinical investigation indeed has a very low risk of serious GI events. to a highly efficacious target dose, and indeed we're studying several in the Phase 3 study, will deliver both a well-tolerated patient experience and give us a graded understanding of dose and response. And so the Phase 3 design was very carefully conceived in order to read out dose proportion and benefit to Maritide. And you also asked around maintenance, and I appreciate you bringing this up. It's just true that these are chronic diseases that run with obesity, as is obesity and overweight themselves. And long-term treatment of these diseases has proven just very challenging with these weakly injectable peptides with very low persistence on medicine. And our studies together will guide the optimal use of Meritide for long-term maintenance therapy, where patients and doctors will no doubt work together to sustain the benefits of Meritide on doses and perhaps even different schedules guided by these data.

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

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

Hi, guys. Thanks for taking my question. On the LES-CVOT, your PCSK9 outcomes trial, I'm curious how you're thinking about the event rate accumulation over time. It looks like by the time it reads out by your end this year, 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 hitting those predefined events of 750-plus on the triple and 1250 on the quadruple? Thank you very much.

Thanks, Noor, for your question. As you surely know, and based on your sophisticated question, vaselius 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 rates.

Okay. Julianne, next question, please.

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

Great. Thanks so much for taking the question. Maybe another one for Jay. I was just wondering if you could provide any more thoughts on how you're thinking about the design of a Maritide CVOT study in type 2 diabetes in light of Eli Lilly's recent or past CVOT data, where they compared terzapatide to trulicity, and just how that might influence how you're 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 III studies underway. They're all enrolling well. The CBOT presently open is with atherosclerotic coronary vascular disease with obesity and overweight, and 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, Julianne, take the next question, please.

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

Oh, hey, congrats on the quarter, and it was nice to see the positive Fortitude 101 top line results for BEMA. 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? And 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 around blumerituzumab. 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. And 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, and as you point out, triplet study that importantly adds a checkpoint therapy to this pairing of omaracuzumab and chemotherapy. We'll read out in the second half of this year or the first half of next year. We've adjusted the date range based on our current best estimate, and our regulatory strategy integrates these datasets.

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

Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open.

Great. Thanks so much. Just wanted to come back to Repatha. Just as we're thinking about that primary prevention study, can you just talk a little bit about the bar that you see here in terms of what we see from that data to be clinically meaningful? And 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.

Let me take this in two parts, Chris. Maybe, Jay, you can kick off, and then Myrtle, why don't you add your thoughts?

Thanks for the question. You know, there's no level of LDL-C that confers a better outcome for patients with coronary vascular disease. And so really suppressing LDL-C with rapacin, these high-risk patients who have not yet had an MI or Re-vascularization is, we think, a great opportunity for benefit. I'd be loathe 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?

Yeah, thanks for the question, Chris. And I would just say that we're already doing very well in the quote-unquote primary prevention population of patients. Roughly 40% of our Repatha new-to-brand prescriptions are from patients who have yet to suffer a first dose. a vascular event, and so we're getting a lot of these high-risk patients right now. What I think a Vaselius 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, but still some prior authorization criteria exist for some subpopulations of patients. And, of course, we are very interested in continuing to expand the penetration of PCSK9s, both in secondary prevention and in primary prevention. So I think this is an important trial, but it continues to drive the tailwind that we're already experiencing that we've been able to create for Repatha growth in the market. All right, Julian, let's go to the next question, please.

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

Thanks for my question. I noticed AMG-732 listed on the press release today. Just curious how that program differentiates from Tefeza and maybe what unmet need you're looking to address in thyroid eye disease. Thank you.

Thanks, Matt. Yeah, no, thanks for noticing. We're delighted to share in these earnings materials for the first time the development of AMG-732, which is a next-generation IGF-1R targeting monoclonal antibody. This medicine benefits from the target validation strongly provided by TPEZA and will be presented to patients in a subcutaneous administration. The Phase II study is enrolling patients with moderate to severe and active TED and progressing very well. Thank you.

i think the big the big picture here matt is that the time we acquired horizon we said we felt there would be lots of opportunities given uh the the large molecule uh nature of the portfolio lots of opportunities for us to introduce innovation over time and this would be an example of that all right julian let's move on the next question our next question comes from dave risinger from the rink partners please go ahead your line is open

Yes, thanks very much, and congrats, Bob and team, on some great financial momentum. So I'm curious about the end of the press release highlighting the development of biosimilar versions of Opdivo, Keytruda, and Okravas. I know that 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.

Yeah, Murdo, do you want to take the first stab there and then... Invoke Jay, however you'd like. Sure.

Dave, thanks for the question. Obviously, we're excited about the growth that we're seeing in our biosimilar portfolio overall. And Amgen's success here has been remarkable, quite frankly, since 2018, now a cumulative $12 billion of revenue generated by this portfolio of products. We've had 100% success rate in regulatory, both development and regulatory milestones. And, of course, we continue to grow the business year over year this year with 40% growth with the most recent launches of PavBlue, Bekemvi. this year. So we're very pleased with the use of capital invested in this. We know the oncology space very well. We were one of the first companies to launch oncology biosimilars, so we feel that we understand the dynamics for Keytruda and Opdivo. We're watching the hyaluronidase uptake very closely to see if SubQ 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 PD-1 dosing lines up with the chemotherapy dosing or other adjuvant therapy and combination therapy. But we're watching it closely, and if Amgen decided to further develop other biosimilars, we would and could. Okay.

Yeah, I would just only add really medically as an oncologist, you know, 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. And bringing forward these two medicines, ABP-206 and ABP-234, is just really a seamless process. 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, Julia, take the next question, please.

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

Hi, guys. Thank you so much for taking my question. I actually wanted to touch on Indultra. You noted impressive growth this quarter, and I'm really trying to understand kind of what's driving the volume. Is it, you know, increased penetration into that refractory population? And how do you see this 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.

yeah thanks evan the the growth in indeltra is uh definitely an uptake on those patients those small cell lung cancer patients are progressing on or after chemotherapy um so we're we're seeing uh 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 benefits been shown in uh that 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 MDELTRA. And I think that that probably had a slightly dampening effect at the beginning of the launch and is now more or less being managed as appropriate. So we're seeing good volume growth there. 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. And, you know, I'm looking forward to, you know, more data as it progresses. And, you know, we'll have more to say about how we see the growth of this really important asset as we see more data.

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. And as you know, we're excited about xyluridamig. So, you know, lessons we're learning here, no doubt, will be useful in that context. But again, all signs so far are really positive.

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

Our next question comes from Alex Hammond from Wolf Research. Please go ahead. Your line is open.

Thanks for taking the question. So another one on the biosimilar front. So we've seen this regulatory landscape evolving. So I guess looking forward, what changes could we see from regulatory standards to establish comparability? Could we see PK comparability versus randomized phase three trials be feasible? And how could these dynamics possibly modulate your long-term guidance of greater than $4 billion in sales by 2030?

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

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

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 in 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, and 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.

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. I think from our perspective, the market is developing well. There's an appropriate regulatory framework, and the assurance of safe, reliable supply is important here. But, again, 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. Okay, Jillian, go to the next question, please.

Our next question comes from Mohit Vanzal from Wells Fargo. Please go ahead. Your line is open.

Hi, this is Sadia Rahman. I'm from 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 III trial missing despite good Phase II data from their molecule in COPD? And how are you thinking about the patient profile that's most likely to benefit from test fire, particularly around eosinophil levels? Thanks.

Yes, thank you for the question. I mean, the short answer is we feel great about the mechanism and confidence 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, we feel very strong. I assume here that you're speaking to the recent Roche data. This molecule we know well actually comes from Amgen, Astegolamab, 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 so I wouldn't be quick, not that you're doing this, to lump the two. The ST2 pathway, this suppressor of tumorogenicity 2 protein is quite distinct from the more allergic or eosinophil-driven T-slip pathway. ST2 is a non-allergic signaling pathway that relates more to epithelial damage. And so, while disappointed for patients that the Phase III and all comers didn't read through with that molecule, we feel very confident in the test fire mechanism of action, the Phase II data, and, you know, are conducting the experiments now together with our partners at AD to get an answer.

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

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

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 Meritide and 513. However, I believe both molecules are injectables versus Elioli, which is some very encouraging data for glupron and 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 percentage of the obesity market do you think would ultimately be oral versus injectable? Any call there, much appreciated. Thanks so much.

Maybe we can add some color from a few different perspectives here, Luca. So first, I say on BD, obviously, we're open. We're paying very close attention to all interesting innovation in the field of obesity and related conditions. So 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 Myrtle, why don't you talk about the market to have? Well, 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 a calendar year and, of course, aren't cured by these medicines. And so there's a big opportunity for distinctive medicines, new mechanisms. 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. And so, please, more to follow from Amgen Research. Myrna, would you want to comment about the market and how it's shaping up for orals and for Maritide?

Yeah, Luca, 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. But 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. And so that's what we're doing. We're taking Maritide into the clinic for a full breadth of indications And 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. So looking at the orals very closely, but excited about our flagship product that we're developing.

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

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

Hi, guys. Thanks for taking the question. Another one on Merit's side for Jay. You just posted ADA. 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 see, do the current studies, do they constitute the majority of Amgen's Phase III investment in Maritide, or would you guys looking to expand more broadly into, you know, peripheral indications where weight gaining 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. And 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. And no, there were no changes or edits to the Phase III 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 these trials right now. we remain very interested in bringing Maritide to other obesity-related conditions. And the field is even suggesting some not overtly obesity-related conditions to think about. And we'll have more to say on the broader Maritide Phase 3 program in due course.

And, Jeff, it's Myrtle. I would just add that we're also looking to inform clinical practice as much as possible in chronic weight management. So 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.

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

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

All right, great. Good afternoon. Thanks for taking the question for Bob. I wanted to ask on the policy front, we've seen IP under attack across the industry on multiple fronts, though 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? Or 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 yourself? Or does Amgen expect it to fade as a concern by the time Meritide launches? Any thoughts would be appreciated.

Thank you. 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. But, you know, 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. But in general, I think we're pretty clear that compounding is not good for the industry, probably not good for patients, and we would be mindful of the importance of the kind of quality framework that we have in place that the regulators have routinely assess us on, and that's what gives us comfort that we're providing safe, reliable supply of medicines to our patients. Murdo, feel free to jump in if you want to add anything. No, I would concur.

I think it's important to underscore that there isn't a compounding pathway for a biologic such as Maritide, and it's concerning that compounders continue to be product available despite the supply situation having been resolved by other manufacturers.

All right, let me just address two things quickly before we thank you for joining us on the call. So 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. And our execution is also strong in operations and research and development. And, of course, that's setting the stage for what we expect to be attractive long-term growth for the company. So, again, excited about the performance, looking forward to the second half of the year. But before we conclude today, I just want to share one organizational announcement, which is that Justin Clays will be transitioning his IR responsibilities to our treasurer, Adam Elanoff. 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. So 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. So I'm confident that all of you will enjoy working with him and that it will be a seamless transition. And 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. So thank you all for joining us, and we'll look forward to connecting with you at the next quarterly call.

This concludes our Amgen Q2 2025 Earnings Conference call. You may now disconnect.