Q2 2025 Amgen Inc Earnings Call
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 1 question during the Q&A session,
To ask a question. Please press star. Then the number 1 on your telephone keypad. Withdraw, your question, please press star 1 again.
I would now like to introduce Justin clay vice president of investor relations Mr. Crazy 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 Griffith.
To 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. Uh, everyone and thank you for joining us today as you'll hear, mgen 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 biofarma manufacturing in the US. We believe the world needs more innovation, not less, and we're continuing to invest heavily in innovation to support long-term growth. We're, of course, doing that while building on a track record of success, including multiple Phase 3 readouts in the first half of 2025.
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 4 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 4 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
G were delivering therapies that are redefining standards of care and changing What patients can expect from treatment.
Our industry leading by a similar 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.
Sure, 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 it 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.
Improvement. Access is enabling more patients to benefit from repatha with an estimated 100 million people in need of effective ldlc, lowering the opportunity to expand our impact remains substantial in the US, 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
Divinity, sales, increased 32% year-over-year to 518 million. In the second quarter in the US of entity, grew 41% with increased prescription volume from both established and newly activated prescriber accounts.
In Japan. A vanity is positively impacting, many people with over 700,000 patients treated since launch.
Only therapy that both builds bone and slows bone loss. This entity is uniquely positioned to reduce fracture risk in women who are postmenopausal.
Approximately 250,000 patients in the US, have been treated with a vanity today.
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 Avanity.
Prolia sales declined, 4% year-over-year in the second quarter to 1.1 billion, dollars driven by lower net selling price in the US 3.
I'll move to a 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.
Topezat grew 5% in the quarter to $505 million in sales. Since launch, Topezat has had a positive impact for thousands of patients living with thyroid eye disease. We are 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 pezza in Japan in December, and we're happy with the progress to date.
Business sales increased 91% year-over-year to $176 million in the second quarter.
We placed that continues to be the number, 1, prescribed FDA approved treatment for nmosd.
The pleasant 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 foreign logist and key academic medical centers.
Additionally, launch preparations are underway for the anticipated approval of a plasma. For use in generalized, myasthenia gravis, a chronic autoimmune neuromuscular disorder,
We look forward to the potential to bring a prisoner to patients living with GMG who can benefit from a prisoner's differentiated profile, including its durable efficacy over time and convenient, dosing, and administration moving to inflammation, test fire delivered. Another strong quarter was sales up for 46% year-over-year to 342 million.
Adoption of biologic agents in severe. Asthma has accelerated meaningfully over the past 5 years, almost doubling as Physicians, increasingly recognize the value of these treatments.
% that remains substantial opportunity for continued growth.
Products based on those differentiated and broadly applicable profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma.
Our Innovative oncology portfolio, which includes blincyto M, Delta, lumac, kyprolis, end plate. And excha group 14% year-over-year generating, 2.2 billion dollars of sales in the quarter.
For of this growth is our industry-leading, by specific T-cell, engager, or bite platform, which led to the discovery of both in Delta 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 us launch of in Delta 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 him, Delta as a standard of care in second lines. Most all 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 in Delta, doses are now administered in the community setting indicating growing comfort with this important new cancer therapy, Bonito grew 45% year-over-year to 30084 million in sales, driven by broad prescribing across both academic and Community segments in the US recent updates to the nccn guidelines positioned on Saito as a preferred consolidation therapy in combination with continued multi-agent chemotherapy for both adults and pediatric patients with Philadelphia chromosome, negative B cell a
in the second quarter our bio similar portfolio sales grew 40% year-over-year to 661 million since the first launches in 2018 our biosimilars of delivered almost 12 billion dollars. In sales representing a significant contributor to Topline growth and generating meaningful cash flows.
Within this portfolio, our launch of Pablo, a biosimilar to IA, continues to gain momentum, reaching $130 million in the second quarter.
Specialists are responding very positively to Pablo, expressing appreciation. For this high-quality Amgen biosimilar, delivered in an easy to use pre-filled syringe
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 Moreau, and good afternoon everyone.
It's a period of strong momentum and execution across the R&D pipeline.
We deliver high-quality rapid progress advancing, multiple late stage programs.
Starting with Maritime, 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 maritime.
For the treatment of obesity and obesity related conditions.
Maritime is convenient the most advanced obesity treatment and development with monthly or less frequent dosing.
C is strong.
Approximately 20% weight loss at 52 weeks, without a plateau, and with a clinically meaningful Improvement in cardio, metabolic parameters, including hemoglobin A1c.
Maritime is safe.
Very well tolerated at target doses. We've significantly improved GI tolerability with dose escalation without compromising weight loss efficacy.
3 program is underway.
Well-informed by prior data and utilizing a refined 3-step dose escalation approach to optimize tolerability, enrollment momentum for chronic wave management is strong across multiple geographies.
Broad investigator, enthusiasm participant interest in these trials and significant remaining unmet need.
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 marit, represents a promising treatment. Advance for people living with obesity obesity, related conditions and type 2 diabetes.
3 studies underway and obstructive sleep. Apnea said to initiate this year. We are well, positioned to deliver a robust and comprehensive clinical knowledge base.
Beyond Maritime. In general medicine, we remain excited about data from the repatha velious, phase 3, primary prevention study expected later this year,
Turning to Old, pasaran our promising best-in-class. Small interfering RNA medicine. Targeting LP little a, the fully enrolled. Event-driven ocean a 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 a plasma. We look forward to the upcoming December 14th Padua date for, generalized, meiosis and 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 TZA for the treatment of adults with thyroid eye disease.
Additionally enrollment is complete in our phase 3, study examining subcutaneous administration of tapahtuma. Map representing another step forward towards improved patient convenience and treatment accessibility
And inflammation are 2, phase 3 studies of test, fire and 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 micrel.
Beyond COPD enrollment was recently completed and our phase 3, esynic esophagitis study and we look forward to the October 19th. Pedophile date for test buyer, in chronic rhinosinusitis with nasal polyps.
Moving to oncology in June interim results from the global phase 3 Deli, 304 trial of them deltra, the first and only FDA approved Delta Lagan 3 or dll3 targeting bite molecule. We're presented in simultaneously in the New England Journal of Medicine.
These compelling data showed that Delta significantly reduced the risk of death by 40% and significantly extended median overall survival by more than 5 months compared to standard of care chemotherapy in patients with small cell lung cancer who progressed on or after 1 line of platinum.
Therapy.
Additionally in Delta's, significantly improved patient, reported outcomes of DNA 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 delfi 301 data already reported as Myrtle. Highlighted in Delta has the potential to become the new standard of care for second line. Small cell, lung cancer.
We continue to investigate the delta in earlier lines of small cell lung cancer.
Currently 3 additional phase 3 studies are underway across limited stage and extensive stage disease.
Along with Phase 1 studies evaluating them Delta 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 cv19 directed bite medicine. Blind Saito in earlier treatment settings, while.
Also advancing a subcutaneous formulation.
In June Phase 1, B and 2, subcutaneous blinatumomab.
Demonstrating 89 to 92%. Remission rates and manageable safety in adults, with relaxed refractory cd19 positive Philadelphia chromosome, negative B, cell precursor acute. Lymphoblastic, leukemia,
Subcutaneous blend 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 Adolescence later this year.
Engager zero, egg is advancing in Phase 3 clinical development.
we are also exploring Delaware to make in combination therapy and in earlier stages of prostate cancer with multiple phase 1B studies ongoing
collectively in Delta blincyto and Valor to make exemplify the significant growth. Potential of our robust by specific T-cell engager platform and reinforce our commitment to Bringing groundbreaking treatments to cancer patients worldwide.
Beyond our T-cell. Engagers in June, we announced data from the phase 3, 4 to 2 101 study of first line of Emeritus and our first in class fiberblast growth factor receptor, 2B directed, monoclonal antibody.
So Meritus and AB Plus M full Fox 6 chemistry that its primary endpoint of overall.
At a pre-specified interim analysis, in patients with unresectable locally advanced or metastatic,
GFR to be positive, her to 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 a non-GAAP R&D growth of 18% year-over-year, reflecting continued investment in our late-stage pipeline, including Marital, Pasaran, Delta Zurich, 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 dollars 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 dollars 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 digitization, modernized workflows, 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 maritime.
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 twenty dollars and 2020 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.
Q3.
The Outlook continues to reflect our investments in advancing key late stage programs, including maritime.
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 million dollars. We now expect non-gaap R&D expense to grow over. 20% in 2025,
we now anticipate non-gaap to be approximately 2.2 billion in 2025.
For with Lana and MJ to be the 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.
Julian, could you now open the call for questions and just remind our callers of the procedure for submitting their questions to us? Thanks.
thank you, if you
If for any reason you would like to remove that question, please press star, followed by 1. To ask a question, press star 1.
Our first question comes from your own wber from TV Cowen. Please go ahead. Your line is open
A great thanks. Uh, maybe just um, the the first question on J for you on muride. Um, 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 on Q8 weeks and q12 weeks at that point? Thank you.
Thank you, Ron, as you, um, identify and gathered from our words moments ago. Um, the data readout from The Phase 2 type today, diabetes study in part 2 of The Chronic weight management. Studies are expected in Q4 of 2025 and we'll have more to share about, um, the uh, these data in due course.
Our next question comes from salvian Richter from Goldman Sachs. Please go ahead. Your line is open
Good afternoon. Thanks for taking my question. Um so the industry has been adopting a number of strategies here, which you spoke to um, 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 mfn. So curious here is to your thoughts on that cloud 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 uh 1 of your peers this morning. Thank you. Well so I think it may be a little premature to speak. Uh in detail about any 1 of
And we expect to to work with this Administration to try and find a path forward that helps to achieve uh their objectives. And I think uh the objectives of of many leaders uh in this industry. So uh, you know, still a little bit early days saline to talk in any detail about specific uh 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 uh to advance uh, on this front.
Hi, Julian. Take the next question, please.
Our next question comes from David Anselm. From Piper Sandler, please go ahead. Your line is open
Um, thanks. So you signed a strong performance in particular from the 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&A regarding rare diseases, and what is your appetite in general for continuing to build out that broad therapeutic vertical? Thank you.
And David. Your question seems to focus on the, on the word significant, um, 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, uh, portfolio of rare disease assets that we have both in the market now, and, and the pipeline of rare assets is very attractive. Um, we will continue to look for ways to, uh, to grow our rare disease business, both organically and, you know, to the extent that there are licensing or acquisition opportunities will look for those as well. I would point out on the, on the question of transactions, whether it's in rare disease or or elsewhere, that, you know, 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, um, but again, thanks for observing that the capital structure has followed the course that we told you to expect, um, and, um, we feel very good about the progress we've made and integrating, uh, Horizon.
And ensuring up the balance sheet.
Hi, I'm Jen team. Uh, thanks for taking my question today. Uh, the first 1 is just on on, on Maritime. Um, as we look at the 3-step dose escalation that you've incorporated into the phase 3 that have been announced. Um, this incorporates kind of a physician. If we think about the future clinical use having to select a maintenance dose, uh, kind of straight after the last titration, dose, rather than stepping through, uh, each of the potential maintenance doses, which is what we see in, 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 you 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, uh, up until that point.
Thank you very much Courtney. Why don't I try with an answer here? Um, as a monoclonal antibody dose escalation with marathon is naturally, very smooth uh very steady. Um as we've shared and as we firmly believe um Progressive benefits can be derived from a tolerability standpoint with both lower Doses. And also with multiple steps to Target. This is very consistent with the experience of the field and the 21 milligram starting dose selected for phase 3. Clinical investigation indeed has a very low rate
Risk of I'm serious, GI events and progressing um to highly efficacious Target dose and indeed we're studying several in the phase 3 study, I will deliver both the well, tolerated, patient experience and give us a greater understanding of dose in response.
And so the phase 3 design was very carefully conceived. In order to read out those those proportionate benefits the maritime and you also asked around maintenance and 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 to just very challenging with these weekly injectable peptides with very low persistence on medicine. And um, our studies together will guide the Oppo optimal use of Maritime Forum. Long-term maintenance therapy where patients and doctors will no doubt work together. Um, to sustain the benefits of Maritime on, um, Doses. And perhaps even different schedules Guided by these data.
Next question, please. Our next question comes from, Umar rafit, from evercore isi. Please go ahead. Your line is open
To taking my question. Um,
On the sale of cvot, your pcsk9, outcomes trial. I'm I'm curious how you're thinking about um, the event rate accumulation over time. Um, it looks like by the time it reads out by your end. This year it's basically right around that 4 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, uh, predefined events of 750, plus on the triple, and 1250 on the quadruple. Thank you, very much. Thank you so much for your question as you surely know. And basically, um, you're sophisticated question, vicilia CV for everyone is our primary prevention, um, study of, um, pcsk9 inhibition and cardiovascular risk reduction, anticipated, read out in the second half of this year. The readout is purely based on um, accumulated events or event rates.
Julian next question, please.
Our next question comes from Terrence Flynn from Morgan Stanley. Please go ahead. Your line is open.
Great. Uh, thanks so much for taking the question, uh, maybe another 1 for J. Um, I was just wondering if you could provide any more thoughts on how you're thinking about the design of a maritime cvot, study in type 2 diabetes, in light of Eli Lilly's, recent surpass, cvot data where they compared, uh, to appetite to trulicity.
Um and just how you're how that might influence, how you're thinking about control arm for your uh study. Thank you.
Yes. Thanks very much for the question. Uh we read the paper with real interest and if you can imagine follow the field quite closely. Um we indeed um have a 4, Maritime phase 3 studies underway, they're all enrolling. Well, the cbot presently open is with, um, atherosclerotic coronary vascular disease, um, with obesity and overweight and we'll have more to share around our, um, our plan for pivotal studies, um, in diabetes and in their cardiovascular outcomes, um, in the fullness of time,
Okay. Julian, take the next question, please.
Our next question comes from, Jay, Olsson from Oppenheimer, please go ahead. Your line is open.
Oh hey! Congrats on the quarter and it was nice to see the positive 42101 Topline results for bema. Can you provide some color on? Um, the timeline to file for approval, um, especially with regards to the results for from uh fortitude 102, do you?
Do you need those for filing? And also um, any color you can give us on when we should expect to see the detailed results from 42101. Thank you.
Thanks Jay. We're very excited about the um emerging picture around Bome. Uh the Double it was chemotherapy um was indeed positive for overall survival which quite matters for all cancers. Especially this 1, the fifth most common um with very little impact to date with targeted therapy and targeting fcfr to be um expression in this cancer combined with them. Full Fox 6, chemistry is a meaningful Advance um for these patients
We've not as yet disclosed our regulatory strategy. And as you point out, triplet study that importantly adds, um, a checkpoint therapy, um to this um, pairing of the Meritus mab and chemotherapy will read out in the second half of this year, or the first half of next year, um, where the adjusted date range based on our current best estimate and our regulatory strategy um integrates these data sets.
Hey Julian, let's take the next question, please.
Our next question comes from Chris Schott from JP Morgan. Please go ahead, your line is open.
Uh great, uh, thanks so much, just wanted to come back to repatha. Um, 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 need to see from that data to be clinically meaningful? And once you have that data on level on label, like how how big of a driver do you see this for that franchise, as a whole? Thanks so much.
Let me take this in 2 parts. Chris, maybe Jay you can kick off and then Moreau, once you have your thoughts.
You know, exhaustively in the secondary prevention. Um, realm the Mna. Yeah, thanks for the question. Uh, 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, uh, vascular event. And so, we're getting a lot of these high-risk patients right now. Um, what I think, uh, of aelius, uh, positive result could do is help reinforce the need for more aggressive LDL cholesterol or in guidelines.
Help reinforce the need to remove payer barriers which we have done successfully over over time. But still some, uh, uh, prior authorization criteria exists for some sub populations of patients. And of course we are. Uh, we are very interested in continuing to expand the penetration, uh, of pcsk9 both in secondary prevention and in primary prevention. So, I think this is uh, it's an important trial, um, 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 Phillips. From William Blair, please go ahead. Your line is open.
Estimate question. Uh notice AMG 732 listed on, the press release today, just curious how that program differentiates from tza and maybe what unmet need you're looking to address in thyroid eye disease. Thank you.
Thanks Matt. Yeah, no, thanks for, um, noticing. We're delighted to share, um, in these earnings materials for the first time, the development of AMG 732, which is a Next Generation, igf1r, targeting monicon, antibody. Um, this medicine's, um, uh, benefits from the target validation strongly, provided by tezza and will be presented to patients in a subcutaneous Administration. The Phase 2 study is enrolling patients with moderate, to severe and active Ted and progressing, very well. Thank you. I think the big, the big picture here. Matt is, at the time we acquired Verizon. 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 to the next question.
Our next question comes from Dave. Risinger from the rank Partners, please go ahead. Your line is open.
Congrats, Bob and team on.
Great financial momentum. So I I'm curious about um, the end of the press release highlighting the development of biosimilar, versions of opdivo K, truda and okra I know that that's not new news, but can you please discuss? How you see the potential for Ivy 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, murder. Do you want to take the first stab there and then invoke J? However, you like sure. Um, Dave, thanks for the question. Obviously, we're, um, excited about the growth that we're seeing in our bio similar portfolio overall and uh I'm Jen success here has been remarkable quite frankly since 2018 now accumulative, 12 billion dollars of revenue generated by this portfolio of products. Um we've had a 100% success
Rate and uh, regulatory, uh, both development and Regulatory milestones. And, of course, we continue to grow the business, uh, year-over-year this year with 40% growth. Um, with the most recent launches of power blue, uh, Bimi, um, this year. So we're we're very, uh, uh, pleased with the use of capital invested in this. Uh, we know the oncology space very well, we were, uh, 1 of the first companies to launch oncology biosimilar. So we feel that we understand the Dynamics for key truda and updo. Um we're watching the hyaluronidase uptake uh very closely and to see a 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 pd1 dosing lines up with the chemotherapy dosing um or other AD therapy and and and combination therapy. Um
But we're watching it closely. And, you know, if, if I'm Jen decided to to further develop other biosimilars, uh, we would and could
Okay. Yeah, I would just only have really medically is an oncologist. Um, you know, use of these breakthrough Amino oncology checkpoint medicines.
Into treatment plans, treatment practices, um, patterns of practice, really all across the world. And, um, bringing forward, um, these, um, these 2 medicines ABP, 206 and ABP, 234 is just really a seamless, um, a seamless move to, um, to bring biosimilar medicines into, you know, an area of oncology that has benefited from Innovation. And, and now will benefit even better from access.
Hey, Julian, take the next question, please.
Our next question comes from Evans sermon from beimo 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 in Delta. You noted impressive growth um 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, um, this ping 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.
On those patients, those small cell lung cancer patients, who 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 atasco were obviously compelling first time, real overall survival benefits been shown in uh that that particular setting or small cell lung cancer. Um, we're also seeing an improvement
In uh both academic and Community, setting ability to operationalize the monitoring required for him, Delta and I think um that that probably had a slightly uh dampening effect at the beginning of the launch and is now uh more or less being managed uh as appropriate. So we're seeing good volume growth uh very strong clinical conviction. As I said 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 uh how we see the the growth of this really important asset, as we see more data,
The only thing I, I might add there Evan, is that the, 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, uh, portfolio. And as you know, we're excited about that you already make. So, you know, the lessons we're learning here. No, doubt will be useful in that context. But again, all all all signs, so far are really positive.
Hey, Julian. Let's
Please.
Our next question comes from Alex Hammond. From Wolfe research, please go ahead. Your line is open.
Thanks for taking a question. So um, another 1 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 3 trials, be feasible. And how could these Dynamics, possibly modulate your long-term guidance of greater than 4 billion in sales by 2030?
We kicked this in 2 parts. J, there's some clinical regulatory questions in Murrow perspective on the market. Yes, thank you. Uh, we too have been very interested to see some possible. I mean, not as yet, from Pathways, but possible softening of some of the regulatory requirements for Bio similar medicines. And this really plays very favorably to our differentiated capacity to develop very high quality compositions that map to the established innovator medicine. Um, now this may or may not be true in all geographies around the world and so we have to consider this, a global regulatory. Um, go to market plan. Um, but from a drug development standpoint and an innovation about similar standpoint. Um, these changes, um, we, we believe accentuate our comparative and, and differentiated capacity by similar Myrtle.
The market is developing. Well, there’s an appropriate regulatory framework, and, you know, the assurance of safe, reliable supply is important here. But, you know, 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, Julian, go to the next question, please.
Our next question comes from Mohit benzol from Wells. Fargo, please go ahead. Your line is open.
Hi. Uh this is Saudi Armand on for mohead, thanks for taking our questions. Um can you talk about the uh content your confidence in the test? Prior COPD program in light of a competitors.
Phase 3 trial, missing, uh, despite good, Phase 2 Data, from from their module, and COPD. And how are you thinking about the, uh, patient profile? That's most likely to benefit from testfire particularly around EOC levels. Thanks.
Yes, thank you for the question. I mean, the short answer is, um, we feel great about the mechanism and confidence in it for COPD, um, and the profile especially, um, with an understanding of the responder population as likely, um, relating to a, um, the degree of
Th2 immunity is contribution as measured by the biomarker of bloodiest capil count. Um, as a possible biomarker of response, we feel very strong. I I assume here that you're speaking to the, to the recent roach data. And this is a molecule, we know. Well actually comes from Amgen, um, as to goam. Um, and uh, though that Phase 2 Data did not repeat in Phase 3. I would just remark that, um, the st2 pathway is distinct from the tslp pathway. And so, I wouldn't be quick not that you're doing this, um, to, um, to lump the 2, um, the st2 pathway, um, this suppressor of tumor, regenetic 2? Um, protein is quite distinct from the more allergic or eosinophil, driven t-s slip pathway. Um, SC2 is a non-allergic signaling pathway that relates more to epithelial damage.
And so, while disappointed for patients that the phase 3 and all comers didn't read through with that molecule, uh, we feel very confident, um, in the test by our mechanism of action, The Phase 2 data, and, you know, our conducting the experiments now together with our partners at a, 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 2 molecules in development here with Maritime and 513. However, I believe both molecules are injectables versus yellowy polish of some very encouraging data for or for glucan at Ada, which is obviously an oral small molecule.
What's the amen's appetite to augment? Your current offering in obesity by adding an oral small molecule via either, VD 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 color? They are much appreciated. Thanks so much. Yeah, may maybe we can add some color from a few different perspectives here, looka. So first I would say on BD obviously you know we're open, we're paying very close attention to all uh interesting innovation in the field of obesity and related conditions. Um so we we have and we will continue to look carefully at at things that might be uh, helpful to patients that are managing these diseases. J. Maybe you want to offer some thoughts on the clinical aspects and then Myrtle, why don't you talk about the, the market Dynamic? 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
Constituting a decent portion of the market, but I think our Flagship product Maritime is clear in its differentiation. And that is to treat, uh, people for their, uh, chronic weight management so that they can benefit, uh, in a cardio metabolic, uh, Way for their health. So that they have less, uh, ultimately uh, cardiovascular comorbidity or uh, mortality. And so, that's what we're doing. We're we're taking Maritime into the clinic for 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 uh, over the course of their lifespan so that they can benefit from that uh in important ways with outcomes. So uh, looking at the orals very closely, uh 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 Mitchum from City Bank. Please go ahead. Your line is open
Hi guys. Uh, thanks for taking the question, another 1 on Merit side for for J. You just post. Ada, were there any changes that you guys made to, to phase 3? Just thinking, you know, increase entry criteria, or maybe Pace the titration, just to optimize discontinuation. And then related, you know, from a strategy perspective,
Listen to the current study. So they constitute the majority of engines phase 3 investment in Maritime or or would you guys looking to expand more broadly into, you know, peripheral indications were, were waiting any place at all? Thank you.
Yeah. Thanks. Jeff. Um, the feedback, um, after the Ada was was quite strongly positive especially from Key opinion leaders investigators in the field. Um, and and, and that for us was was terrific to hear um, thought leaders present these data that we spent so much time with and get there on, varnished opinions was very positive and no there were no changes or edits to the phase 3 program as a result of those engagements at Ada. There was actually a really strong confidence that I think is well reflected by the very strong enrollment that we're seeing on this trial right on on these trials right now. Uh, we remain very interested in bringing Maritime to other obesity related conditions in the field is even suggesting some not overtly obesity related conditions to think about, um, and we'll have more to say on the, um, the broader Maritime safety program in due course and Jeff. It's Myrtle. I would just add that. We're also looking to inform clinical practice, um, as much as possible in chronic weight management,
So anything we can do to help uh those clinicians upon approval. Understand how to use Maritime in the real world setting. We we will continue to generate those data, right? Julian. I think we've got time for 1 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. Bob, Romero, I wanted to ask on the policy front. We've seen IP under attack across the industry on multiple fronts, 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 damage? Do you view compounding of the current wave of TLPs as a general concept and as a creeping direct or indirect threat?
The an expected to fade as a concern by the time Maritime launches. Any thoughts would be appreciated? Thank you know, obviously, Carter IP is a critical consideration in our industry and um you know, we're very respectful of of the importance of Ip is the basis on which Investments are made in this industry again, you know, the drill, right? We invest in a couple billion dollars, of, 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 of a direct, uh, issue for, for Amgen, uh, because our molecules in antibodies and it won't be compounded in the way that, um, peptides and, and small molecules have been and can be, uh, in light of the statutes that are available.
All right, let me just address 2 things quickly. Before we thank you for joining us on the call. Uh, 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, uh, geographies and our execution is also strong, uh, in operations, and, uh, 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 1 organization on announcement, which is that Justin Clays will be transitioning, his IR responsibilities, uh, to our treasure Adam ellenoff. Uh, Justin will be moving into a new role as the head of a 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 190 of investor relations. In addition to his
Uh, Treasury role. I'm confident that all of you will enjoy working with him, and that it will be a seamless transition. On behalf of Pete and the rest of the team, I want to thank Justin for the superb job that he's done in leading the investor relations effort. Thank you all for joining us, and we look forward to connecting with you at the next quarterly call.
This concludes our Amgen Q2 2025 earnings conference call. You may now disconnect