Amgen at TD Cowen Conference: Strategic Growth and Future Prospects

On Wednesday, 05 March 2025, Amgen Inc. (NASDAQ: AMGN) presented at the TD Cowen 45th Annual Healthcare Conference, showcasing its robust performance in 2024 and outlining strategic plans for 2025. The discussion highlighted both successes and challenges, with a focus on new clinical trials and manufacturing expansions.

Key Takeaways

• Amgen announced Phase III trials for Meritide, targeting obesity and type 2 diabetes.
• The company reported double-digit sales growth for 10 products in 2024.
• Manufacturing expansions are underway in North Carolina and Ohio.
• Biosimilar sales surged by 60% year-over-year, with a target to exceed $4 billion by 2030.
• A positive outlook was shared for the upcoming year, focusing on product pipeline advancements.

Financial Results

• 2024 saw 10 products with double-digit sales growth.
• 14 products reached over $1 billion in annual sales in Q4 2024.
• Repatha and EVENITY sales increased by 36% and 35% year-over-year, respectively.
• The rare disease portfolio grew by 17%, totaling $4.5 billion in sales.
• Biosimilar sales hit $2.2 billion, marking a 60% increase from the previous year.
• Non-GAAP operating margins are expected to be around 42% in Q1 2025, with a full-year average of 46%.

Operational Updates

• Phase III trials for Meritide have begun, targeting obesity and type 2 diabetes.
• TAPESLA continues to expand with international approvals.
• Oplizna is anticipating approvals for IgG4-related disease and generalized myasthenia gravis.
• TESPIRE sales rose by 71% in 2024, with new indications being explored.
• New product launches include PAVLU, Weslana, and Bekhemvy in the US market.
• Manufacturing efforts in Ohio and North Carolina aim to meet future demand.

Future Outlook

• Consistent revenue growth is expected throughout 2025.
• Focus remains on advancing the product pipeline and biosimilars.
• Further development of Meritide for obesity-related conditions is planned.
• Rocotilumab data for atopic diseases is anticipated by year-end.
• Aplizna filings for generalized myasthenia gravis are expected this year.

Q&A Highlights

• Meritide trials involve over 4,000 patients, focusing on weight change over 72 weeks.
• The dosing strategy for Meritide includes three levels, with further details to follow.
• Rocotilumab is being explored for dosing intervals of four and eight weeks.
• The North Carolina plant is set to open in 2026, supporting future biologics production.

In conclusion, Amgen’s presentation at the TD Cowen conference highlighted its strategic initiatives and financial achievements. Readers are encouraged to consult the full transcript for more detailed insights.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Yaron Warburg, Moderator, DidiKauin: good morning, everybody, and thanks once again for joining us at the forty fifth Annual DidiKauin Healthcare Conference. I’m Yaron Warburg from the Biotech team, and it’s a great pleasure to moderate the next fireside chat with Amgen. To my left is Jay Bradner, Executive Vice President and Head of R and D. I think this is officially our first fireside chat together. Yes, it is.

And to his left is Justin Clay that needs an introduction, VP of IR. Justin, this is not our first fireside chat together. It is. So let me turn it over to Justin and then Jay to make some opening remarks, and we’ll go into Q and A.

Justin Clay, VP of IR, Amgen: Great. Good morning, Yaron. Thank you for hosting us, and thank you, everyone, for joining us. It’s an exciting time for Amgen, and we’re glad to discuss the opportunities ahead. We exited 2024 with strong momentum, including 10 products growing at double digit sales rate, 14 products annualizing at over $1,000,000,000 in the fourth quarter and 21 products delivering record sales for the year.

This momentum supports our growth outlook for 2025 and through the long term. The breadth and depth of our portfolio spans our four therapeutic areas. Let me highlight a few key drivers in each. Starting with general medicine, Repatha is now a multi billion dollar product with 36% year over year sales growth in 2024. Cardiovascular disease remains the leading cause of mortality worldwide, and we see continued robust growth for Bepatha, especially with strong access in place and price stabilizing in 2025.

This opportunity could be further augmented with a second half readout of our Phase III primary prevention trial, VASALIUS. Our bone builder, EVENITY, also delivered in 2024 with sales increasing 35% year over year. Despite its strong growth trajectory, the large majority of patients at high risk for fracture from postmenopausal osteoporosis remain untreated, highlighting the continued opportunity for expansion. Turning to the general medicine pipeline, we are excited about Meritide and look forward to sharing more detailed results from the first fifty two weeks of our Phase two study at the upcoming ADA meeting in June. We also look forward to sharing results from the second fifty two weeks of this Phase two study later in the year.

And of course, in cardiovascular, our Phase three outcome study of opaciran in individuals with elevated Lp is fully enrolled and continues to progress. Turning to rare disease, this portfolio has four products early in their lifecycle with significant growth ahead, building on $4,500,000,000 of sales with 17% year over year growth in 2024. Starting with TAPESLA, we continue to execute on the low clinical activity score opportunity in The U. S, while launching and gaining new approvals internationally. It’s a landmark year for Oplizna with two anticipated approvals on the horizon, namely in IgG4 related disease with an April 3 PDUFA date and in generalized myasthenia gravis where Aplisma has been granted orphan drug designation.

In inflammation, TESPIRE continues its strong ramp in severe asthma with sales up 71% year over year in 2024. We are advancing TESTBIRE in additional indications highlighted by COPD, the world’s third leading cause of death, where we plan to initiate Phase three studies in the first half of twenty twenty five. We also recently shared compelling Phase three data in chronic rhinosinusitis with nasal polyps, which was also published in the New England Journal of Medicine. Our innovative oncology portfolio is well positioned for continued growth, including our bispecific T cell engager platform. Blincyto is moving into earlier treatment lines, demonstrating compelling survival benefits in B ALL.

Imdelta is showing impressive potential in small cell lung cancer. And Xyluretimig is advancing in prostate cancer, adding another promising program to our late stage innovative oncology pipeline. And in precision oncology, we look forward to two Phase three readouts for bemabrotuzumab in 2025. Our biosimilars continue to be an important contributor to our business with sales up 60% year over year to $2,200,000,000 in 2024. We launched PAVLU at the end of last year and Weslana in The U.

S. In January, and we expect to launch Bekhemvy in The U. S. In the second quarter. Given our strong biosimilar performance in the market and our pipeline of new biosimilars, we remain on track to more than double sales from 2021 levels to over $4,000,000,000 by 02/1930.

Given that we’re already in March, let me remind everyone of a few points from our fourth quarter earnings call on the outlook for the first quarter. First, we provided guidance that we expect first quarter non GAAP operating margin as a percentage of product sales to be around 42% and to accelerate in subsequent quarters for a full year average of 46%. This includes a typical pattern of lower sales in the first quarter for certain products including TUPEZA, Embryl and Otezla. Also, we provided guidance that we expect relatively consistent revenue growth for each quarter of twenty twenty five. In other words, whatever growth rate you are assuming for the full year would be roughly the same across each of the four quarters.

Peter provided commentary on additional items for the first quarter and the full year, and I’d encourage you to reference the Q4 transcript for those. In summary, we have momentum across the business and are focused on strong execution for our end market products, our rapidly advancing pipeline and biosimilars. Jay, let me turn it over to you now for a few comments.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Yes. Thanks, Justin. And Jerome, it’s great to be here with you and thanks for the invitation. We have some exciting news to show this morning that our progression of the Meritide obesity medicine is progressing quite well. And this year, we intend to initiate a number of Phase III clinical trials across both obesity and chronic weight management as well as a number of obesity related conditions.

Pleased to share with you all this morning for very much the first time that we’ve now initiated both of the Phase III studies. Soon to post to clinicaltrials.gov are some of the high level descriptors for this trial, and I’m happy to share some insights into that here this morning. There are two Phase III clinical trials, both initiated. One will be in patients with obesity is with patients with obesity or overweight without type two diabetes, we anticipate enrolling three thousand five hundred patients on that trial. The second is for patients with obesity or overweight who have type two diabetes.

We intend to initiate nine ninety nine patients on that trial. The primary endpoint will be a change from baseline body weight at seventy two weeks. And our approach to dosing will have a chance to describe in the fullness of time. But for today, you can think of it as three doses high, medium and low, and you could think of a titration scheme as starting lower. But we’re delighted to share that these trials have now been initiated and really the progression of the maritime Phase three program is going very,

Yaron Warburg, Moderator, DidiKauin: very well. Wow. Okay. That’s big news. So I was gonna leave maritime

Unidentified speaker: for a little later, but I think we’re gonna move it.

Yaron Warburg, Moderator, DidiKauin: Let’s move it up. So this is gonna be the data so far has been really interesting and the date and you’ve shared a little bit of the Phase one Health and Volunteer data that I think you’re probably referring to starting low. Although just to remind the audience, in the Phase two, you also had a starting lower in the Phase one Health and Wealthyours, you really started low, right? And you escalated up. And you either escalated up over a month or over three months.

Can you give us maybe a little bit of a hint? Is it one of those schemes, either one month or three months titration?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Well, today I won’t prescribe provide discrete insights into the dosing approach for Phase three. Meritide has proven itself highly efficacious, also very well tolerated with antecedent low dose escalation. This can come as no surprise because the entire class of GLP-one targeting medicines requires lower dose dose escalation. As you kindly referred, our Phase two study, which had 11 arms, featured only two arms, sampling dose escalation and so we undertook to perform concurrently a phase one pharmacokinetic study that could provide really discrete information around drug exposure as well as give us experience with two additional dose escalation schemes. From these two sets of data that we’ve largely presented in our last engagement and teleconference, but we hope to and expect to present even more data at the ADA meeting mid year.

We have all the guidance needed to, we believe, to undertake Phase three clinical investigation across a number of indications with a dose escalation approach that will provide a terrific patient experience. I would remind that, with dose escalation, we observed a very low discontinuation rate overall of eleven percent, eight percent or lower due to GI effects. We had outstanding persistence across the study and in fact, as you probably remember, this phase two study was designed to feature a second calendar year that patients were invited to continue participating in this study so that we could understand maintenance dosing and lower doses. Indeed ninety percent of patients eligible chose to take another year of Meritide. We take all of this as a strong vote of confidence that emerging from phase three will have a very competitive tolerability profile and what’s more important, a great onboarding patient experience so the patients can take this medicine and benefit from it for a long, long time.

Yaron Warburg, Moderator, DidiKauin: In the the phase one healthy volunteer, that was a forty three day dosing scheme. Right? Maybe just correct us. Just remind us, how do you dose escalated and how long did you follow for efficacy?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: What we presented was, the interim analysis from a three arm phase one pharmacokinetics study where we sampled one of the dosing schemes that we had prior experience with from the Phase two. This is to help with almost an apples to apples comparison. There are major differences in how one undertakes a Phase one study with sample collection and intensive clinician interaction over a very short period of time versus a study like a Phase two that’s more like how one might be managed on the Serengeti of medical practice. And so we wanted to have emulate discretely one of the dose escalation experiences from phase two. That proved to be very helpful.

The other two dose escalation schemes had lower index starting doses of twenty one or thirty five milligrams. This gave us a very good experience, with that first dose of Meritide and what associated symptoms we might observe. In the interim analysis, we did not as yet have the full data from either the pharmacokinetics or a longer term follow-up. Longer term follow-up isn’t even the right term for a Phase one study, but we did have a snapshot of the data an informative snapshot of the data and FELCOME that it was adequate to present our experience. With lower dose escalation, we were able to, just in that study with two additional dose escalation schemes, achieve an onboarding of Meritide that had an increasingly competitive profile with approximately twenty percent or lower incident emesis.

Yaron Warburg, Moderator, DidiKauin: The the so it was less than twenty percent. So I think it was it was dramatically lower than it was previously.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Yes. It depends how you define drama, but it was meaningfully lower.

Yaron Warburg, Moderator, DidiKauin: Dramatically. Yes. Dramatically. Yes. Yeah.

Yeah.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: It was a step in the right direction. From phase one to phase two, we learned a lot, and we saw a very meaningful decrease in incident nausea and vomiting. And from phase two to phase one with this PK study, we cut that number almost in half. And so the trajectory of an informative data gives a very strong learning going into phase three. I also want to point out that we talk about these absolute numbers and their incident numbers and it’s very important, very important.

I would also point out that these symptoms were very mild. They were very transient and as we shared in that Manhattan plot at our more detailed teleconference, they’re quite limited to just the early experience with Meritide. Across the whole of the ensuing fifty two weeks, patients receive this medicine monthly on that trial, with without incident.

Yaron Warburg, Moderator, DidiKauin: And in this, in the seventy two week study, are they getting monthly doses after the titration throughout the seventy two weeks? Or is there a chance to switch at fifty two weeks from monthly to less frequent?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Are we talking about the Phase three studies that we’ve just initiated? Yes.

Yaron Warburg, Moderator, DidiKauin: We’ll

Jay Bradner, Executive Vice President and Head of R and D, Amgen: have more to share about the design of those trials and the fullness of time, but they’ve strongly benefited from our experience today with the medicine.

Yaron Warburg, Moderator, DidiKauin: And do both studies have the same three doses?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Both studies will feature the same three doses.

Yaron Warburg, Moderator, DidiKauin: Randomized one to one to one against placebo?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: It is a randomized controlled trial of low, medium, and high dose Meritide.

Yaron Warburg, Moderator, DidiKauin: Is the titration the same at at least day zero, 14, 20 eight? And then or

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Both studies employ the same dosing scheme.

Yaron Warburg, Moderator, DidiKauin: Okay. So with TBD, exactly how you dose escalating? Correct.

Justin Clay, VP of IR, Amgen: Yes.

Yaron Warburg, Moderator, DidiKauin: And you’re just waiting to put that in clinicaltrials.gov?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Clinicaltrials Gov should go live really at any time now that we’ve initiated this study. We really want it up online to encourage patients to enroll and participate.

Yaron Warburg, Moderator, DidiKauin: And what formulation are you using? Is this the commercial formulation? Is this an auto injector?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: We haven’t gone into those details publicly. It is very important that one studies the material and ultimately the format with which you go to market and we’ll have more details on that in the fullness of time.

Yaron Warburg, Moderator, DidiKauin: Okay. But there could be three doses in that study but those are the doses after the escalation. So I imagine you have an escalation and then you have three different doses.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: We will escalate to target doses of low, medium, and high. And I hate to be so opaque. It’s just it’s a competitive space and we’re very excited about these studies and, actually can’t wait to share more details, but at the right time.

Yaron Warburg, Moderator, DidiKauin: Yeah. What maybe just give us a little bit of a sense that the choice to use a seventy two week endpoint in this study? There’s been endpoints at different time points for different

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Yeah. Happy to give some insight there. First of all, it’s quite standard among these trials. And secondly, as we were excited to share when we reported, the early returns from part one of our phase two study, that one of the remarkable findings of that trial was that we observed, you know, 20% weight loss approximately 20% weight loss in patients with obesity or overweight without type two diabetes and seventeen percent approximate weight loss in patients with obesity or overweight with type two diabetes, and these are strong numbers. And we observe the data, which we shared in graphical form, you could view it yourselves, the absolute magnitude of contribution had yet to achieve a plateau.

And so seeing these data not as yet level out made us very motivated to characterize a longer term experience, to really understand the capacity for real benefit for patients with obesity and overweight. It is just true that incremental weight loss, even over twenty percent, can confer significant medical benefit. And so we designed our Phase III trials in this way.

Yaron Warburg, Moderator, DidiKauin: Yeah. And then the data at ADA, what can we Is it going to be the obesity data and some data from the diabetes study? And how much follow-up would there be?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Well, I would expect at the ADA I mean, we’ve already presented a lot of data. That teleconference that we held has more data than most podium presentations, but we wanted to give the community a clear sense of the characterization of the medicine to date. And I would expect the ADA presentation to go to even more detail around that Phase two dataset, which is so rich. I mean, 11 arms of data.

Yaron Warburg, Moderator, DidiKauin: Yeah. If anybody has any questions, feel free to raise your hand. We just need to get a mic. Why don’t you go ahead and we’ll repeat the question here.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Oh, I see the schedule, the dose schedule. No, not at this time. We have a clinical experience now with monthly dosing, with every other month dosing, and in part two of the Phase two study, with every three month dosing. And this is the advantage of working with a medicine that has an immunoglobulin core backbone, is that patients can experience very steady, very stable and predictable pharmacokinetic exposure as opposed to the jigsaw of weekly subcutaneous injectables. And so we’ve been very motivated to characterize that pharmacology at each of those three dose schedules and we’ll have a chance to share our Phase III designs later.

Unidentified speaker: Yes, Jay, congrats on Meritide.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Thank you.

Unidentified speaker: When you started on this journey, demand was probably less well known, but pricing was probably near better.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Justin, I’d love to get your insights here.

Justin Clay, VP of IR, Amgen: Yeah. I think it’s probably a bit early for us to comment on pricing and where it’s going. I think what we would highlight is that this is a huge unmet need, that the demand is tremendous. We there’s different figures around the epidemiology, but you hear upwards of a billion people worldwide are afflicted with this. We also think that there’s going to be it’s a heterogeneous situation.

There’s going to be different medicines and treatments required for different patients. So we feel like there’s going to be plenty of room for Meritide and it will be a good opportunity.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: The unmet need is just not met and which is crazy, right? Because there are these incredible paradigm changing medicines out there yet real world data as published by others, you know, one calendar year, sixty five percent of people are no longer taking weekly subcutaneous injectable obesity medicines. And so, you know, given the massive, burden of this disease and its prevalence, especially in this country, and the apparent feedback from patients, prescribers, in real clinical practice, we think there’s still a remaining huge unmet need. These are all chronic conditions that we’re studying, that we’re all studying. Obesity and overweight with all of its comorbidities and then discretely heart failure, atherosclerotic cardiovascular disease, chronic kidney disease, obstructive sleep apnea, MASH, and and and.

Those diseases are not optimally treated with a medicine or an approach that only thirty five percent of people can stay on a drug

Unidentified speaker: for a year off a clinical trial.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: And so we think that there’s a significant residual unmet need and and that prescribers, patients and payers will recognize this.

Yaron Warburg, Moderator, DidiKauin: So I’m going to maybe ask a quick question on manufacturing. But before that, I’m going to shamelessly put in a plug in that we published last Thursday. And you can actually see it. And we apologize if many of you are seeing it over and over again. A video with Amgen and Generate Biomedicine, focusing on how Amgen and Generate also in their partnership.

And Amgen extensively is using AI, anything from drug discovery, to their packaging plant. And you can actually see the new Albany, Ohio plant in that video that is currently already doing Rippasana. I think some probably is already getting packaged there. And I think that plant, you’ve said publicly, will eventually handle all future biologics too. There’s a lot of expansion capacity in that site, but that’s a packaging plant.

North Carolina is your new biologics plant that I think is supposed to open next year. Is that correct? Maybe say whatever you can about that. And then secondly, have you broken ground on the extension yet?

Justin Clay, VP of IR, Amgen: Sure. Yes. So thanks for the opportunity to comment on it. Maybe just stepping back one click, I’ve had the pleasure to be with the company for a number of years and I think what’s probably not totally appreciated from the outside is, how the deep expertise and commitment to manufacturing excellence that the company has. There’s a mantra within Amgen, every patient, every time.

There’s really a badge of honor that the team works so hard to make sure that all of our medicines reach the patients who need them. So it runs deep throughout the company and I think the investments we’re making in Ohio and North Carolina really exemplify that. In terms of North Carolina, what we’ve shared is that we it’s a high yield drug substance facility. The first portion of that investment was announced and that’s expected to be approved by the FDA in 2026. So you write your own, that’ll be next year.

We subsequently announced an additional $1,000,000,000 of investment in the site. And as you know, the site will support a number of products. Obviously, Meritide is a driver, but actually it’s certainly not just Meritide. We have volume growth going across the business. So in total, our investment in that site is over $1,500,000,000 In terms of the second leg of the investments, we had a rim coming cutting earlier this year.

We’re looking forward to breaking ground and they’re rapidly advancing that one, so full steam ahead there.

Yaron Warburg, Moderator, DidiKauin: So that’s going to be a second facility?

Justin Clay, VP of IR, Amgen: Or second maybe a second portion of the site. Okay.

Yaron Warburg, Moderator, DidiKauin: Let’s, I’m going to move on. There’s so much to talk about. I think that I’m going to maybe shift the order a little bit here. So maybe we’ll focus on the rocotilumab next cause we’re expecting two additional sets of data. Maybe just a broad question.

The horizon study, I think we’re going to see the full study at some point. We you tested lower and mid doses relative to what you tested previously. Just remind us there’s a loading dose in that study too. Your dosing is and that was a Q4 weeks and a well in the Phase 2B you tested Q4 and Q2 weeks. So I guess my question is what can you share with us on dosing for Horizon versus what we’re going to see from the upcoming studies, which I believe the shuttle and the Voyager studies are coming soon.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: And IGNITE. So rocotintlimab is a OX40 targeting monoclonal antibody. We’re developing this medicine in atopic diseases and extensively in atopic dermatitis. Atopic dermatitis, we’ve undertaken a program called ROCKET that is eight phase three clinical trials building on very exciting phase two clinical trial data. This is a first in class, first in mechanism medicine that rebalances the t cell compartment.

AUX40 is a signaling pathway that drives inflammation in this and other diseases like, prorogon angillaris et al. But, importantly, by targeting the receptor of AUX40 with a depleting strategy, we don’t only impair signaling of AUX40 to these inflammatory tissues, we remove AUX40 positive autoreactive T cells without impairing the healthy T cell compartment, which is very important from a tolerability standpoint. And there’s in that way no medicine like it in development for atopic dermatitis today. Building on the very strong Phase two data, we undertook these eight Phase three clinical trials that will importantly characterize rocetinumab in a half year dosing exposure as well as a longer term extension in adult patients and in adolescent patients with and without the allowed use of corticosteroids applied topically and with a maintenance dosing schedule. We have experience with Q2, Q4 and also within the larger program Q8 week dosing.

And with the aggregate data reading out by the end of this year, we have three studies still to read out this calendar year. We’ll have a good sense of the target product profile as well as the intended approach for treating patients in the marketplace.

Yaron Warburg, Moderator, DidiKauin: So how do you you know when we do a lot of these panels and physicians consistently like the Sanofi approach better so far at least that’s the K O the view out there a little bit. And I think it’s been a function of maybe their previous data. There’s an appreciation or thought that it offers more potency, slightly better safety, but also they’re testing Q12 week doses. Your data looked fairly durable just like they did in the Phase 2b. So why only do Q8 weeks?

And then thoughts about kind of where do you fit in the paradigm?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: It would be reasonable in the fullness of time to explore longer duration longer interval dosing, especially in the maintenance paradigm. The depleting strategy for T cells could have scientifically a much more durable impact. I mean, look at the experience of depleting B cells and the durability afforded with medicines like aplisma in autoimmune or inflammatory diseases. This, you know, guided by the pharmacology as well as the Phase two efficacy data, we feel great about a Q4 week dosing schedule and are interested to, at the right time share when we have the full data, the Q8 experience. Regarding the comparisons, it’s very hard, especially with medicines that have yet to read out their full Phase III datasets.

But I would highlight again that mechanistically, though these both build off OX40 pathway modulation, it’s quite a different thing to the immune system to take out just a single ligand and block its signaling versus to deplete autoreactive T cells?

Yaron Warburg, Moderator, DidiKauin: You would think that depleting the auto re the the autoreactive T cells will give you a more durable effect.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: I mean, you know, we approach these studies with echo poise. We’re surely hoping, that both the proportion of meaningful responses and their durability could be better. But these will be limited by the inability of comparing between clinical trials.

Yaron Warburg, Moderator, DidiKauin: Does it make sense to push the dose maybe higher?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: We have a very strong dose ranging experience with roketinumab and I’ve not as yet seen any data to suggest that we need to approach doses higher than those that we are, including as the high doses in our Phase three ROCKET program.

Yaron Warburg, Moderator, DidiKauin: So I want to maybe move to a specifically in gMG. The Phase three data, the MINT study was presented, MGFA, that was the twenty six weeks. That study is still blinded reading out the fifty two week, I think, presumably this year. Do you need that fifty two week data to file, or can you file with the twenty six week data?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: We should not need that fifty two week data to file. There’s no limitation on our capacity to file, from the data we already have and are approaching a registration strategy, full force. The the Aplisma data in generalized Miocene gravis is quite strong. And at the time that we read out the twenty six week data, the numbers were continuing to improve. And so Justin are very excited to see and to then share the fifty two week, MG data with Aplisma.

Yaron Warburg, Moderator, DidiKauin: I mean, I think you’re talking about filing in the first half and you had for GMG or Yeah.

Justin Clay, VP of IR, Amgen: We haven’t specified yet.

Yaron Warburg, Moderator, DidiKauin: You just said filing in this year.

Justin Clay, VP of IR, Amgen: Yeah. Exactly.

Yaron Warburg, Moderator, DidiKauin: Filing this year. So you had the data for MGFA. Presumably, you probably even had the data a little bit earlier than that. So ’26 another twenty six weeks is probably going to reach out soon. So theoretically, you could actually ultimately have that fifty two week data at the time in which you file.

The Wall Street always loves to look at the MGADL differences and immediately do math and we totally get it. When you talk to physicians, they actually think this profile is super compelling, zero, fifteen days and then essentially Q6 months. It was very well tolerated. MGADL, as you said, continues to the curves are diverging. So that fifty two week durability is going to be critical.

I actually think this mechanism could be used a lot more broadly. I think Wall Street right now is thinking it’s going to go more niche. Thoughts about what I just said?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: I mean, it really resonates with me, to be honest with you. Just objectively, you know, moving the MG ADL, clinical score, which is also used clinically to follow patients in the real world, by 4.2 points compared to placebo of 2.2 is really quite meaningful. And to do this with a medicine that has a loading dose and then from there on can be given on a Q six month schedule, is wonderful for patients, especially those that are responding that don’t want to feel like a patient taking a medicine every couple of weeks or worrying that they’re going to miss their medicine and it flares right back up. And so here the durability of CD19 B cell depletion, which is not just the mature B cells, but also some of the more the more immature cells that can really drop these auto antibodies and has dropped these auto antibodies meaningfully, we think is a very strong offering.

Justin Clay, VP of IR, Amgen: And I’m sorry, you run, I’m going to correct myself. We did say we were going to file in the first half. We haven’t specified the approval date. So just wanted to It was showing that at JPMorgan. Yes, that’s right.

The

Yaron Warburg, Moderator, DidiKauin: onset with Aplizna is shorter than, let’s say, C5 or an FCRN. But as you said, you also showed the ability to taper steroids at the same time. What’s an ideal patient that can go on aplizona as opposed to going on an FCR and let’s say RC5?

Jay Bradner, Executive Vice President and Head of R and D, Amgen: What’s the profile of the patient?

Yaron Warburg, Moderator, DidiKauin: Or ideally, what do you think this ultimately gets used kind of the first year and three years? If it

Jay Bradner, Executive Vice President and Head of R and D, Amgen: gets used people sick with generalized myasthenia gravis who don’t want to be taking steroids and, seek to have a highly efficacious durable medicine that they can take every six months and not worry about their disease. FCRN medicines are are quite active, across a broad number of autoimmune conditions. They have different issues with some advantages, such as the immediate onset of action, some limitations, such as the high target mediated drug disposition and the very rapid turnover of the pharmacologic agent that requires constant dosing. And so I think it will be different horses for different courses for the patients, but those that seek a strong and durable benefit with every six month dosing will be right for aplizna.

Yaron Warburg, Moderator, DidiKauin: And I know we’re time, but Justin maybe one quick question for you. Any PathBlue’s launch?

Justin Clay, VP of IR, Amgen: Just to reiterate what we said on the earnings call, we’re pleased with the launch so far. We disclosed that we recorded $31,000,000 of sales in the first nine weeks. The team is fully deployed, talking to customers, and we’re getting good feedback on the presentation, both the prefilled syringe and the vial. So I think so far so good.

Yaron Warburg, Moderator, DidiKauin: Okay. Well, terrific. Jay and Justin, thanks so much for joining us. We appreciate it.

Jay Bradner, Executive Vice President and Head of R and D, Amgen: Thank you. Congratulations.

Yaron Warburg, Moderator, DidiKauin: Thank you.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.