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Amgen, founded in 1980 as Applied Molecular Genetics, is a major biopharmaceutical company. Its top-selling drugs treat autoimmune diseases like rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis; anemia; osteoporosis; and osteoarthritis. It also makes a number of oncology treatments, including Neupogen and Neulasta, which reduce infection risks for cancer patients undergoing chemotherapy, and Imdelltra, a recent treatment for extensive-stage small-cell lung cancer. The company works with doctors, medical clinics, dialysis centers, hospitals, and pharmacies, as well as distributes treatments through direct-to-consumer channels.

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Amgen (AMGN): Company Profile, Stock Price, News, Rankings

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My name is Julianne, and I will be your conference facilitator today for the Amgen Q2 FY twenty twenty five Earnings Conference Call. All lines have been placed on mute to prevent any background noise. There will be a question and answer session at the conclusion of the last speaker's prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q and A session. Would now like to introduce Justin Clade, Vice President of Investor Relations. Mr. Clade, you may now begin.

Good afternoon, everyone and welcome to our second quarter twenty twenty five earnings call. Bob Bradway will lead the call and be followed by a broader review of our performance by Myrto Gordon, Jay Bradner and Peter Griffith. Through the course of our discussion today, we will use non GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompany this call. We will also make some forward looking statements which are qualified by our Safe Harbor statement and please note that actual results can vary materially. Over to you, Bob.

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%.

15 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 are 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 three readouts in the 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 lifecycles 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 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. In line 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, clear demonstration of the strength of our portfolio and quality of our execution. Turning to General Medicine, Repatha delivered $696,000,000 in the second quarter, up 31% year over year. Improved access is enabling more patients to benefit from Repatha with an estimated 100,000,000 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 $518,000,000 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 seven hundred thousand 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 two and fifty thousand patients in The U.

S. Have been treated with EVENITY today. However, many remain at high risk of fracture with about ninety percent of the roughly two 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. Prolia sales declined 4% year over year in the second quarter to $1,100,000,000 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 $1,400,000,000 in sales in the quarter and now annualizing at over $5,000,000,000 TEPEZZA grew 5% in the quarter to $5.00 $5,000,000 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 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 TEPEZZA in Japan in December and we're happy with the progress to date. EPLISSA sales increased 91% year over year to $176,000,000 in the second quarter. VUPLAZMA continues to be the number one prescribed FDA approved treatment for NMOSD. VUPLAZMA 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 Vaplisna for use in generalized myasthenia gravis, a chronic autoimmune neuromuscular disorder. We look forward to the potential to bring EPLISA to patients living with gMG who can benefit from EPLISA's differentiated profile, including its durable efficacy over time and convenient dosing and administration. Moving to inflammation, TestBio delivered another strong quarter with sales up 46% year over year to $342,000,000 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. TestBiR has not only helped expand the category, but continues to grow faster than the market gaining share from legacy products based on as 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, Lumacraz, VECTOBIX, Kyprolis, Endplate and XGEVA grew 14% year over year generating $2,200,000,000 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 Vimdeltra for the treatment of patients with extensive stage small cell lung cancer who are progressing on or after chemotherapy continues to build momentum generating $134,000,000 in sales in the second quarter. We see strong conviction in IMDAULTRA as a standard of care in second line small cell lung cancer. And Delta is being administered broadly across sites of care including academic cancer centers, regional cancer hospitals and community oncology clinics. Over half of all And Delta doses are now administered in the community setting indicating growing comfort with this important new cancer therapy.

BLINCYTO grew 45% year over year to $384,000,000 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 $661,000,000 Since the first launches in 2018, our biosimilars have delivered almost $12,000,000,000 in sales representing a significant contributor to top line growth and generating meaningful cash flows.

Within this portfolio, our launch of PABLUE, a biosimilar to EYLEA continues to gain momentum reaching $130,000,000 in the second quarter. Retina specialists are responding very positively to PABLUE 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. 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 and D pipeline. We delivered high quality rapid progress advancing multiple late stage programs. Starting with Meritide, our investigational therapy for obesity and obesity related conditions, in June data were presented at the ADA and simultaneously published in New England Journal of Medicine. Let me highlight some of the key points that define the differentiated profile for Meritide for the treatment of obesity and obesity related conditions.

Meritide 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 fifty two weeks without a plateau and with a clinically meaningful improvement in cardiometabolic parameters including hemoglobin A1c. Miratide 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 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, Miratide represents a promising treatment advance for people living with obesity, obesity related conditions and Type two diabetes. With four Phase three 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 Repatha Vesalius Phase three primary prevention study expected later this year. Turning to opaciran, our promising best in class small interfering RNA medicine targeting Lp, the fully enrolled event driven Oceana Phase three cardiovascular outcome study continues to mature. This medicine and study reflects our precision medicine approach to cardiovascular risk reduction in patients with elevated Lp levels. Moving on to our rare disease portfolio in APLISNA, we look forward to the upcoming December 14 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 TEPEZZA for the treatment of adults with thyroid eye disease.

Additionally, enrollment is complete in our Phase three study examining subcutaneous administration of teprotumumab representing another step forward towards improved patient convenience and treatment accessibility. In inflammation, our two Phase three studies of TESSPIRE 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 19 PDUFA date for TESSPIRE in chronic rhinosinusitis with nasal polyps. Moving to oncology, in June interim results from the global Phase three DELPHY-three zero four trial of Vimdeltra, the first and only FDA approved delta like ligand three or DLL3 targeting BiTE molecule were presented and simultaneously published in the New England Journal of Medicine. These compelling data showed Andeltra significantly reduced the risk of death by forty percent 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, INVELTRA 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 DEL PHY-three zero one data already reported as Myrtle highlighted, INVELTRA has the potential to become the new standard of care for second line small cell lung cancer. We continue to investigate INVELTRA 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 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 two subcutaneous blinatumomab data were presented and simultaneously published in The Lancet Hematology, demonstrating eighty nine percent to ninety two percent remission rates and manageable safety in adults with relapsedrefractory 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 STEEP-one CD3 bispecific T cell engager zalaritamab is advancing in Phase three clinical development.

We are also exploring zalaritamab in combination therapy and in earlier stages of prostate cancer with multiple Phase 1b studies ongoing. Collectively, EMDELTRA, BLINCYTO and zalaritamab 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 three FORTITUDE-one 101 study of first line our first in class fibroblast growth factor receptor 2b directed monoclonal antibody. Bimetuzumab 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 will now turn it over to Peter.

Thank you, Jay. We are pleased with our strong second quarter performance and remain on track with our twenty twenty five full year goals and long term objectives. The financial results are shown on Slides thirty one and thirty two of the slide deck. In the second quarter, we delivered revenues of $9,200,000,000 reflecting our key growth drivers highlighted on our Q4 earnings call Repatha, AVENITY, TESSPIRE and our innovative oncology, rare disease and biosimilar portfolios.

Our non GAAP operating expenses rose 8% led by non GAAP R and D growth of 18% year over year reflecting continued investment in our late stage pipeline including Meritide, Opasiran, Emdeltra, Ziuritimig and rare disease. Our non GAAP OI and E was favorable $213,000,000 year over year driven by gains from early retirement of debt and lower interest expense. Recall, we retired $4,500,000,000 of debt in 2024 and have retired $4,300,000,000 in the 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 $1,900,000,000 in free cash flow in the second quarter reflecting operational momentum across the business while continuing to invest in innovation.

We invested $1,700,000,000 in non GAAP R and 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 G and 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 $2,300,000,000 to expand network capacity for our products across the portfolio and our innovative pipeline including Meritide. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share representing a 6% increase compared to the 2024.

Turning to the outlook for the business for 2025 on Slide 33, we expect our 2025 total revenues in the range of $35,000,000,000 to $36,000,000,000 and non GAAP earnings per share between $20.2 and $21.3 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 $200,000,000 of incremental R and D expense expected in Q3.

The outlook continues to reflect our investments in advancing key late stage programs including Meritide, Opasiran 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 $200,000,000 we now expect non GAAP R and D expense to grow over 20% in 2025. We now anticipate non GAAP OI and E to be approximately $2,200,000,000 in 2025. For WESLANNA and AMGEVITA 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 1,400,000,000 We expect a non GAAP tax rate of 14.5% to 16%. We expect share repurchases not to exceed $500,000,000 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 and 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 Our first question you. Comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open.

Great. Thanks so much for taking my questions. Maybe just the the first question on on, Jake, for you on Meritide. In in q four, 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 on q eight weeks and q twelve 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 two type two diabetes study in part two, the chronic weight management studies are expected in 2025, and we'll have more to share about the 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. Since 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, Savi, I think it's maybe 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 US healthcare system. And 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. So at Amgen, obviously, also believe that this country and the world needs more innovation, not less. And so the 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.

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, 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.

Hi, Julian. Let's take the next question please.

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

Thanks. So you you cited strong performance in particular from rare disease business, and 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 and 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, 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've 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. So, 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 ensuring up the balance sheet.

Hi, Julien. Take the next question please.

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 Miratide. As we look at the three step dose escalation that you've incorporated into the Phase three 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 meratide 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 twenty one milligram starting dose selected for phase three clinical investigation indeed has a very low risk of serious GI events.

And progressing to a highly efficacious target dose, and indeed we're studying several in the phase three study, will deliver both a well tolerated patient experience and give us a graded understanding of dose and response. And so the phase three design was very carefully conceived in order to read out dose proportionate benefit to Meritide. 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 weekly injectable peptides with very low persistence on medicine.

And, our studies together will guide the optimal use of meratide for, long term maintenance therapy where patients and doctors will no doubt work together, to sustain the benefits of Miratide on, doses and perhaps even different schedules guided by these data.

Alright, Julian. Let's go to next question, please.

Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.

Hi, guys. Thanks for taking my question. On the CELIA CVOT or 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 year end this year, it's basically right around that four point five year follow-up, which you were anticipating. I guess my confusion is, is that timeline driven by the four point five year follow-up?

Or is it rather because you're hitting those predefined events of seven fifty plus on the triple and twelve fifty on the quadruple? Thank you very much.

Thanks, Umer, for your question. As you surely know and based on your just get a question. Vasilius CV for everyone is our primary prevention study of PCSK nine inhibition in cardiovascular risk reduction. Anticipate a readout in the second half of this year. The readout is purely based on accumulated events or event rate.

Our next question comes from Terence 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 Meritide CVOT study in Type two diabetes in light of Eli Lilly's recent surpassed CVOT data where they compared tirzepatide to Trulicity? And just how you're 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 meridhide phase three 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 our plan for pivotal studies in diabetes and in their cardiovascular outcomes in the fullness of time.

Okay. Julian, take the next question please.

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

Hey, congrats on the quarter and it was nice to see the positive FORTITUDE-one 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 bimetuzumab. 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 M. FOLFOX6 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, checkpoint therapy, to this, pairing of bimertuzumab and chemotherapy will read out in the second half of this year or the first half of next year.

We're adjusted date range based on our current best estimate and our regulatory strategy, integrates these datasets.

Hey, Joanne. Let's take the next question, please.

Our next question comes from Chris Schott from JPMorgan. 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 would you see from that data to be clinically meaningful? And once you have that data on label, like 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 Murdo, why you add your thoughts?

Thanks for the question. 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 Ripassan, these high risk patients who've not as yet had an MI or a revascularization is in a, 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. Murna?

Yeah. Thanks for the question, Chris. And I would just say that we're already doing very well in the primary prevention population of patients, roughly forty percent of our Repatha new to brand prescriptions are from patients who have yet to suffer a first vascular event. And so 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 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 it's 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.

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

Thanks for taking my question. Noticed AMG seven thirty two listed on the press release today. Just curious how that program differentiates from TEPEZZA and maybe what unmet need you're looking to address in thyroid eye disease? Thank you.

Thanks, Matt. Yes. No, thanks for noticing. We're delighted to share in these earnings materials for the first time the development of AMG seven thirty two which is a next generation IGF-1R targeting monoclonal antibody. This medicines benefits from the target validation strongly provided by TEPEZZA and will be presented to patients in a subcutaneous administration.

The phase two study is enrolling patients with moderate to severe and active TED and progressing very well. Thank you.

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 and this would be an example of that.

Alright, Julian. Let's move on to the next question.

Our next question comes from Dave Risinger from Leerink 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 Ocrevus. 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 success here has been remarkable quite frankly since 2018 now accumulative $12,000,000,000 of revenue generated by this portfolio of products. We've had a 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 Pav Blue, Bekemvy 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 and to see if subcu 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-one 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. Jay?

Yeah, I was 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 and bringing forward these these two medicines, a b p two zero six and a b p two three four is just really a a seamless a seamless move to to bring biosimilar medicines into an area of oncology that has benefited from innovation and now will benefit even better from access.

Hey, Julien. Take the next question, please.

Our next question comes from Evan Seigerman 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 INVELTRA. 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.

Amgen (AMGN) Q2 2025 Earnings Call Transcript

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