Amgen at Jefferies Conference: Strategic Growth and Innovation

On Wednesday, June 4, 2025, Amgen Inc. (NASDAQ:AMGN) presented at the Jefferies Global Healthcare Conference 2025, highlighting its robust financial growth and strategic innovations. The company reported a strong first quarter, with both opportunities and challenges in its commercial and R&D efforts. While Amgen’s revenue and earnings showed impressive growth, the company also addressed competitive pressures in the biosimilars market.

Key Takeaways

• Amgen reported a 9% increase in Q1 2024 revenues and a 24% rise in non-GAAP earnings per share.
• Key products, Repatha and Evenity, together generated over $1 billion in revenue, marking a 28% year-over-year increase.
• The company is actively managing biosimilar competition, particularly for denosumab, with a focus on volume growth.
• Amgen is advancing its pipeline with promising developments in Meritide for chronic weight management and other therapies.
• The company emphasized its commitment to innovation and shareholder value through disciplined capital allocation.

Financial Results

• Q1 2024 revenues rose by 9% year-over-year.
• Non-GAAP earnings per share increased by 24% in the same period.
• 14 products achieved double-digit growth in Q1 2024.
• Biosimilars contributed $735 million in revenue, up 35% from the previous year.
• Amgen targets an operating margin of approximately 46% for the year.

Operational Updates

• Repatha experienced over 40% growth in the U.S. during Q1 2024, with improved market access.
• The launch of a denosumab biosimilar includes a 10-14% discount on WAC pricing, with manageable sales impact expected.
• New product Euplisna was launched for IgG4-related disease, and TESPIRE continues to grow in severe asthma treatment.

Pipeline and R&D

• Meritide’s Phase 3 studies for chronic weight management are underway, with data to be presented at the ADA meeting.
• Opasiran’s Phase 3 cardiovascular outcomes trial is fully enrolled.
• Euplisna is on track for a December 14 PDUFA date for generalized myasthenia gravis.
• Amgen is advancing biosimilars to major therapies like Opdivo and Keytruda, now in Phase 3 trials.

Future Outlook

• Meritide’s Phase 2 trial data will be available by year-end, with potential for less frequent dosing.
• Amgen focuses on technological advancements and AI to enhance efficiency.
• The company plans to expand Meritide’s indications to include ASCVD, CKD, and chronic sleep apnea.

Q&A Highlights

• Amgen addressed biosimilar competition, emphasizing its unique position in osteoporosis care.
• The company highlighted Meritide’s potential for monthly or quarterly dosing and its differentiated profile.
• Amgen remains committed to innovation and patient access, engaging with policymakers to support sustainable R&D efforts.

For a more detailed understanding, readers are encouraged to refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Michael Yee, Senior Biotechnology Analyst, Jefferies: Good morning, everyone. I’m Michael Yee, a senior biotechnology analyst here at Jefferies, and very excited to continue on with our next fireside discussion here at the Jefferies Healthcare Conference. I am quite pleased to have members of the Amgen team up here with us. That includes, the CFO, Peter Griffith, Executive Vice President, Myrto Gordon, and of course, one of the best IR, leaders out there, Justin Clays, who we all know. I would love to give, maybe Peter or Murdo an opportunity just to make some opening comments.

Obviously, the company, has a lot going on, commercially, been executing quite well and and crushing numbers on some of the legacy stuff. But obviously, some of the R and D pipeline is a big focus, and I’m sure everyone will be at ADA in a couple weeks. So maybe Peter or Murdo, you’d love to give some opening comments about the state of Amgen, then we’ll go into some, some key questions.

Peter Griffith, CFO, Amgen: Mike, thank you. And and, Murdo, Justin, we’ve got Adam, our treasurer here with us today. We’re really glad to be here. We really appreciate it, Mike. But I Mike, I can’t let it go, the video this weekend.

Right? Can’t let the video go. I had to my four year old grandson Cameron walked in. He looked at the video, he said, is that Mikey? Planning for planning for the

Unidentified speaker: next He said he said that’s

Peter Griffith, CFO, Amgen: not okay. He said that’s not okay. But in all seriousness, we’re glad to be here.

Michael Yee, Senior Biotechnology Analyst, Jefferies: You a shout out in the video too.

Peter Griffith, CFO, Amgen: And thank you. And so look, we are really excited about the business. We’re excited to be here. So with that, we’re seeing strong momentum in the breadth and the depth of what we’re doing. We’re seeing innovation at speed and scale at Amgen.

First quarter revenues increased 9%, and earnings non GAAP earnings per share were up 24% year over year. The strength was broad based, as you saw, with 14 products delivering double digit growth. Many of the near term growth drivers were very strong in the quarter. We have an exciting pipeline advances across the therapeutic areas. So let’s start with general medicine.

Repatha and Evenity together delivered over $1,000,000,000 in revenue in the first quarter, up 28 year over year. Significant opportunity ahead for both brands, and I’m sure you’ll hear a lot from Murdo on that. With one hundred million patients globally in need of further LDL cholesterol lowering and ninety percent of very high risk patients for postmenopausal osteoporosis not receiving appropriate therapy. In obesity, our two phase three studies for meritide in chronic weight management are initiated and enrolling. At the ADA meeting in June, we look forward to sharing further details of the fifty two week Meritide data from Part I of our Phase II trial, along with additional data from our previously discussed Phase I pharmacokinetic study testing lower starting doses of meratide.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Mhmm.

Peter Griffith, CFO, Amgen: And for our LP little a therapy, opasiran, our secondary prevention phase three Yep. Cardiovascular outcomes trial is fully enrolled. Now let’s go over to rare disease. Euplisna recently launched as the first FDA approved therapy for I g g four related disease, and we’re now on track for December 14 PDUFA date and generalized myasthenia gravis for Euplisna. Mike, I know you’re interested in TEPEZZA Yeah, yeah, yeah.

And which addresses a complex patient journey. Many patients with low clinical activity scores, or CAS, scores are undiagnosed or not referred for appropriate treatment. So educating physicians across specialties, particularly endocrinologists and general ophthalmologists, is essential. We’ve expanded our field force and are executing our commercial strategy to better reach these prescribers. Now let’s go over to inflammation.

TESPIRE continues to grow in severe uncontrolled asthma. We have an October 19 PDUFA date for chronic rhinosinusitis with nasal polyps, and we’re enrolling patients in phase three studies in both COPD and eosinophilic esophagitis. Now let’s go to oncology with ASCO last weekend. Our industry leading bispecific T cell engager platform is progressing very well, and we’re excited about the potential patient benefits from BLINCYTO and b cell acute lymphoblastic leukemia, Emdeltra in small cell lung cancer

Michael Yee, Senior Biotechnology Analyst, Jefferies: Yep.

Peter Griffith, CFO, Amgen: And zaluritamab in advanced prostate cancer. We’re also looking forward to two phase three readouts this year for bema rituximab in first line gastric cancer. Biosimilars generated seven hundred and thirty five million dollars in revenue in the first quarter, up 35% year over year, driven by our latest United States launches of Pavlue and Wezlana. We’re also advancing BaKemvi, a biosimilar to Soliris, in The United States on April 2, and are advancing our next wave of biosimilar candidates, including biosimilars to Opdivo, Keytruda, and Ocrevus, all of which are now in phase three. With respect to the second quarter ’twenty five and specifically the outlook for operating expenses, let me remind our audience and you of our comments from the first quarter earnings call that we had certain research and development expenses previously expected in the first quarter that we now expect in the second quarter, including milestone payments and other investments.

And with that said, we expect the second quarter at 25% year over year non GAAP total OpEx growth in the low teens. And finally, let me acknowledge the interest in the macro and policy environment, including the tariffs, taxes, and pricing. It’s a fluid situation. We’re not speculating on any specific policy proposals or implementation mechanisms at this stage. With that said, we firmly believe that society needs more innovation, not less.

And we remain actively engaged with policymakers on policies that improve patient access while supporting sustainable and important innovation in research and development and in manufacturing. And with that, Mike, back to you.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Well, a lot to unpack there. Let me start with the fact that one of the big surprises is that the commercial business, certainly for the last few quarters, it seems quite evident that people who are not even looking at some of these things because there’s so much focus on Meritide, has been doing quite strong. Evenity, Repatha, some of these numbers are up significant double digits, and nobody thought that was going to be the case a couple of years ago, and these are crossing multibillion now. So maybe for Murdo or Peter, do you expect that that type of significant growth can continue, and that’s why you feel confident about the numbers this year, even in the face of a biosimilar of denosumab, which was a thing that people were quite concerned about like a year ago. Here we are now.

I think one just launched like yesterday, I saw an announcement. So where are you with the risks of the biosimilar offset by the fact that you’ve got strong growth of your products that are going to offset that? So you’re going to grow through a biosimilar against your biggest drug. Can you comment on that dynamic?

Myrto Gordon, Executive Vice President, Amgen: Yeah. Thanks, Mike. We’re really pleased, obviously, with the execution of our commercial and medical and all our customer facing teams around the world. But if you look at our portfolio, and Peter went through it pretty rapidly, if you look at the major growth drivers that are already approved and in market and in line, you’ve got Repatha, you’ve got Avenida, you’ve got Taspire, they’re the very large market products with a lot of untapped growth potential. Then you go into innovative oncology, think BLINCYTO, think IMDELTRA, which we just put TARLATINAP,

Michael Yee, Senior Biotechnology Analyst, Jefferies: which is a big thing at ASCO.

Myrto Gordon, Executive Vice President, Amgen: Yeah, big data at ASCO showing for the first time ever, you know, a forty percent improvement in overall survival in second line small cell lung cancer. Then you go into the rare disease portfolio with four key products growth driving there and expanding international. And then you look at our biosimilars portfolio which is also growing nicely through the time period that you mentioned the last few quarters. So we have a portfolio that isn’t just one big product or two big products, it’s a very broad portfolio of growth drivers. So very, very pleased with that.

You mentioned Repatha specifically, yes, it’s been a long journey. I can attest to that. But we are very pleased now with the way we’ve opened up access in The U. S. And the way Repatha is also growing around the world.

In The U. S, we’re seeing over 40% growth through the first quarter. That will continue in terms of being able to expand the volume of patients that we treat. We’ve substantially improved access now with over fifty percent of commercial lives having no prior authorization. You can prescribe Repatha with no attestation, no prior authorization at retail.

It’s a very easy product now for patients to And then we’ve got a catalyst for Repatha in the back half of the year with the Vesalius trial that’s in a primary prevention, high risk patient population. So we’re trying to prevent that first heart attack or stroke by adding Repatha for aggressive LDL management in that patient population. You know, there are a number of really good catalysts. The other thing with Repatha this year is we will see less year on year price erosion. So for the last few years, erosion has taken some of that volume growth out when it comes to net sales evolution.

This year, we’ll see more of that top line volume growth come all the way through. EVENITY, untapped patient population, very low penetration so far. We have the responsibility of selling that product and booking sales in The US and Japan. The Japan market’s way ahead of The US in terms of patient penetration. If we just catch up to that, that will be an

Michael Yee, Senior Biotechnology Analyst, Jefferies: impressive So the net of those is that you are very confident about the strength of some of these volume growth businesses that you just mentioned. They are definitely have been beating numbers. And I think people are concerned that this year, certainly for the next six months and going into ’26, that there’s a biosimilar denosumab that is launched, I think two. So what are you seeing out there? Things within your expectations?

I don’t know if prices of these things have been announced yet. But what should we expect? What should we expect to hear? And what should we expect to happen? Because denosumab biosimilar is available.

Myrto Gordon, Executive Vice President, Amgen: Think you You know, I think, I’m not sure what all the competitors will do, but so far we’ve seen nominal differences in WAC pricing. So slightly lower than the innovator WAC.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Is that the first one I think is out there from Sandoz. Sandoz,

Myrto Gordon, Executive Vice President, Amgen: yeah. Sandoz launched yesterday. I think, you know, 10 to 14% Okay. Depending on whether Some large. Yeah.

They have two brands out, one to XGEVA and one to Prolia.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay.

Myrto Gordon, Executive Vice President, Amgen: But we, you know, again, is something that we’ve been seeing all along. We understand the biosimilars business. We’re a biosimilar competitor. We understand the dynamics of it competitively. We understand provider preference, particularly in the buy and bill space, which is where we are here with denosumab.

Obviously, our roots in oncology have helped us understand the XGEVA picture, and then we are unique in that we are the only company with the footprint that we have in osteoporosis for Prolia. So I think we’re in a

Michael Yee, Senior Biotechnology Analyst, Jefferies: So in the osteoporosis standpoint, as part of the what like, Wall Street sees somewhere there’s a biosimilar pricing collapse, and, you know, maybe it falls by 50%, but you think that there is a particular advantage because in osteoporosis, which is I think 65 or 70% of the sales of denosumab. That’s unique because these are buy and bill centers treating elderly women with this injection, and so it’s not just like a cancer biosimilar where everyone just swaps over. Is that an advantage?

Myrto Gordon, Executive Vice President, Amgen: I think it’s different mostly in how the product flows through the supply chain.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Right.

Myrto Gordon, Executive Vice President, Amgen: In oncology, you’ve got a concentration of GPOs Yeah. And networks in the community Yeah. That are relatively easy for a biosimilar competitor to cover Yeah. With a field force, with a contracting team. Got it.

In osteoporosis, it’s a little bit different in that there are a lot of individual clinics that are buying small amounts that add up to a large amount.

Michael Yee, Senior Biotechnology Analyst, Jefferies: So there’s not going be a salesperson coming over to them from

Myrto Gordon, Executive Vice President, Amgen: San Diego? Well, will be some, but the footprint that we have is a little more competitive than what we think the biosimilars will be able to deploy.

Michael Yee, Senior Biotechnology Analyst, Jefferies: So when you take strong growth on your branded products that we’ve mentioned, some offset on denosumab this year. We’re going look for the second and the third quarters coming up. You said 10% to 14% discount, that’s at least the gross price. There could be some rebating. And expenses, Peter, what was in the expectation at the beginning of the year?

And I don’t recall exactly what you did to guidance, but I don’t think there was much raising of guidance in the first quarter post EPS. But, you know, as you get more visibility, you’re gonna look at your guidance this year, and based on what you guys are saying, which seemed bullish, that you’ll you’ll come back to the guidance?

Peter Griffith, CFO, Amgen: Mike, we always look at guidance.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Yeah.

Peter Griffith, CFO, Amgen: We’re very thoughtful, and we’ve got a very strong, well controlled process on that at Amgen. But when we look at our operating margin as a percentage of product sales, that’s something we’re very focused on. Yeah. We’ve been thinking about that for many, many years, all the way back to when Justin Clays was in corporate FP and A, twelve or fifteen years ago.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Yeah.

Peter Griffith, CFO, Amgen: And that’s important to us because our investors expect us to be very efficient with the capital we deploy. Having said that, and having had a guiding principle of about 50% of product sales for our operating income percentage for any number of years now, this year we guided about 46%. Okay? And we said we need to earn that flex, that flex down. We’ve got a pipeline that’s really important to patients.

And Murdo covered some of that. I covered some of that in my opening remarks, whether it’s Opasiran phase three, absolutely Meritide, whether it’s our oncology medicines. And then so we think about that. That’s the number one allocation is innovation. In this case, we’re grateful for patients, for staff, and for shareholders how strong that pipeline is to allocate that capital into that.

As we go along here in the next few years, look, we’re gonna have you know, we’ve got an opportunity to do a great launch on I g g four related disease in Euclid. We got a great opportunity to get him delta out, what Murdo said, this important medicine. So we’ll stay focused on that. And we’re also, at the same time, while it’s not OpEx, Mike, it’s CapEx, we’re deploying capital to build capacity. 14% volume growth in the first quarter.

So we’re continuing to deploy capital there. So we’re we wanna be very predictable and disciplined on our capital allocation. Innovation, investing in the business, returning capital to shareholders and to our debt holders. We’re on track Yeah. To get back to our pre horizon capital structure by the end of the year.

So all in all, we are very disciplined. You’d probably ask me the next question would be, what are you doing to be as efficient as possible? And I would just make one note that as most companies our size, regardless of industry, we’re pushing ourselves very, very hard on technology and AI. We’re not gonna work beyond the speed of accuracy and controls, but we’re gonna push ourselves on that. And we’ve been doing that for a long time.

We moved our head of r and d, as you know, Dave Reese over in as our chief technology officer. We have high expectations of ourselves, and we know our investors do also on this. So we’re going to stay focused on

Michael Yee, Senior Biotechnology Analyst, Jefferies: that one. So your branded drugs are growing. The impact of denosumab, you think, is manageable, and that you should be able to grow through that. And we will see that, I think, when you look at this year’s numbers. The guidance was for growth.

I believe in the exact numbers. And therefore, you’ll take a look at the guidance this year after we get past denosumab and we’ll see what the numbers look like. Okay. So then therefore, one of the, other developments, if the numbers are strong, are going to be based on what also the opportunity is for Maritime. So, in just a few weeks, we’ll be at ADA.

You guys are going to be presenting, I think, a one hour session. It’s all sort of split up. But there’s a one hour session on Maritime. What should the takeaways be for people going to ADA? And what should, what is the messaging from Amgen about how Meritide is going to compete against tirzepatide and some of these other big programs?

Because I think people are still trying to scratch their head. How is Meritide going to compete? Lilly’s a formidable competitor, right, Murdo? I don’t know. What’s the takeaway coming away from ADA?

Myrto Gordon, Executive Vice President, Amgen: Well, we we respect all of the incumbents in the market, but our product is highly differentiated from what’s available.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Tell us about

Myrto Gordon, Executive Vice President, Amgen: that. So it starts with that. I mean, as a as a marketer, if you don’t have a differentiated offering, it is hard to compete, but we have a differentiated offering, the only peptide antibody conjugate in the category. We’ve obviously given the top line, Jay’s been very clear with what we’ve presented so far on the phase two trial that we’ll read out on the fifty two week data in its entirety at ADA. A couple of things just to keep in mind that are very clear.

Weight loss up to 20%, very clear that dose escalation is important for the tolerability of the product. And we had a number of cohorts in this trial where we didn’t dose escalate, you’ll see those And then you’ll see in the same presentation a phase one PK study, which we’ve alluded to publicly already. You’ll see that dose escalation actually significantly improves tolerability of the product, and we will take those learnings and apply them into phase three. This is the tricky part. We’re going to show fifty two week data from a phase two trial that was intended to cover the range of possible ways of treating patients with maretide, many of which we have not taken into phase three, many of which we have taken into phase three.

So the real challenge will be for people to look at what we present at ADA and then look at our phase three program, and from that deduce what the profile of Myratig would

Michael Yee, Senior Biotechnology Analyst, Jefferies: So to be clear, you’ve started phase three,

Myrto Gordon, Executive Vice President, Amgen: two

Michael Yee, Senior Biotechnology Analyst, Jefferies: big but you haven’t disclosed the doses or the titration.

Myrto Gordon, Executive Vice President, Amgen: That’s correct.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. So when we go to ADA, people are going to see the original phase two design, was designed to cover a whole range of different doses, including a titration. Yes. But to be fair, Wall Street initially saw some of that data and the, it’s been verbally said on that conference call what the GI and nausea rates were. But Wall Street was a bit sour on those numbers, and the stock went down.

And then you have disclosed that you have a further titration enhancement in Phase I that you think significantly lowers those numbers. To be fair, I think those numbers have also been disclosed. But the weight loss has not been disclosed. So people think like, well, Murdov, you’re going to lower dosing. Lower dosing.

Maybe that improves tolerability, but how are you going to get more weight loss? And you guys are saying you will see good weight loss with that.

Myrto Gordon, Executive Vice President, Amgen: Yeah, I think what going to see, just to remind everybody, you’re going to see some cohorts in the phase two with no dose escalation. Right. And then you’re going to see a phase one trial where we did a two step dose escalation. And what we’ve learned from that will allow us then to optimally design the dose escalation in the phase three. We are still confident though that our dose escalation, given the profile of maritide, will be a good patient experience and will not compromise maximal weight loss effects.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Will we have some weight loss follow-up numbers on that new titration that was initially disclosed back in November?

Myrto Gordon, Executive Vice President, Amgen: Well, was a phase one trial, so we really looking for efficacy.

Michael Yee, Senior Biotechnology Analyst, Jefferies: So how do we know that you can get good weight loss with a lower step titration? How do we know that?

Myrto Gordon, Executive Vice President, Amgen: Well you can see in the kinetics of the efficacy of the product. And you can model from that.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. So I think one of the parts too is that in the phase two there was initial titration, and that weight loss is similar to no titration. So that’s part of the messaging.

Myrto Gordon, Executive Vice President, Amgen: Think the curves for us look very good, and that’s why we made the choice that we’ve made for phase three.

Michael Yee, Senior Biotechnology Analyst, Jefferies: And you guys have not disclosed too much on the actual injection, but in the phase three are you using a pen injection or that comes later? Or what is the administration in the phase three?

Myrto Gordon, Executive Vice President, Amgen: We’ll be talking about that at the ADA. Okay.

Peter Griffith, CFO, Amgen: And Mike, on that, we’ve been

Michael Yee, Senior Biotechnology Analyst, Jefferies: really So people were, this is like, yeah, is this a simple injection?

Peter Griffith, CFO, Amgen: We’ve been really clear on that. You know, this device can be very patient friendly and incorporates in Amgen’s long experience on use of devices. We have a fantastic process development group. We think it’s as good as there is worldwide. You know, best protein engineers, best at viscosity, best at excipients, good on patient friendly devices all the way from, you know, the device we use for our EYLEA biosimilar to what we do when Repatha gets delivered to well over a million patients.

So we understand what needs to be done on that, and we’ll talk about it at the right time. But we’re very confident in terms of how that’s going get delivered.

Myrto Gordon, Executive Vice President, Amgen: And the most important part of this device is that the patient will only have to use it once a month or potentially even less frequently. So I think they’ll

Michael Yee, Senior Biotechnology Analyst, Jefferies: enjoy the you said pen and simple and these things, so people are skeptical, but you say you have it. By the way, Lilly just announced a collaboration to do a long acting, I think, yesterday, so they’re trying. But you have that, and you’re going forward in phase three with it. So a lot of investors, particularly generalists, just seem to believe that if you’re given this dose once a month, it’s either a lot of drug, or that there’s tolerability issues. What are the things that will come out later this year, because there’s two year data, guys, that we’re going to get more information on Meritide that’s going to say, hey, look, see what, how this is more differentiated?

Or what would we get later this year that could be scenarios that help people understand how good this product could be?

Myrto Gordon, Executive Vice President, Amgen: Well, think you’re referring to what we call part two.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Part two?

Myrto Gordon, Executive Vice President, Amgen: Okay. The phase two, where we follow patients out beyond fifty two weeks for an additional year. So just a couple of things to keep in mind on that trial. The way that works is anybody who lost at least 15% weight loss or more is re randomized into a prospective trial. And so the the data from that part, that second part of that trial will be available by the end of the year, and we’ll make sure that we we characterize the design of that trial, because it’s a little different than what people are used to.

It’s not just taking the existing part one and following everybody for another year.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Right. They do get randomized. They get them least stay on a monthly. In some cases, one arm comes off. That’s cool.

You see what goes on. In some cases, they just stay on from monthly. They could have more weight loss.

Myrto Gordon, Executive Vice President, Amgen: Yeah, because we didn’t see a plateau in the first fifty two weeks. So we’re curious to see. The challenge will be not having continuity of cohorts through that period.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Right, because they were re randomizing There

Myrto Gordon, Executive Vice President, Amgen: you go. But we will see at least what different dosing intervals and or different doses, including placebo, will do to that weight loss maintenance over time.

Michael Yee, Senior Biotechnology Analyst, Jefferies: One of the arms is quarterly? Yes. Is that a totally plausible viable scenario?

Myrto Gordon, Executive Vice President, Amgen: We’ll see, but given the kinetics of maritide, and given that we’re maintaining weight loss, it’s possible that quarterly is a suitable dose for many patients.

Unidentified speaker: And Mike, I would just add one point that in terms of the part one to part two, over ninety percent of the patients who were given the choice to continue did continue. So, in terms of the patient experience, we think that’s a good vote

Michael Yee, Senior Biotechnology Analyst, Jefferies: of Right. Well first of all, the discontinuation rate, which a lot of people say, that was very small to begin with, and then you’re saying people continued on.

Unidentified speaker: That’s right, it was eight percent discontinuation rate in the dose escalation arms due to GI, 11% due to any

Michael Yee, Senior Biotechnology Analyst, Jefferies: other I mean Murdo, that’s a commercial question, or for Peter, like people say, well the numbers, they look at the incidence table and they see this and they stack it at tirzepatide. But you guys have tried to emphasize that you think that the onset or the time course of that adverse event, if we have the plot, is all like in the first dose, and you don’t really see it in the second dose. Is that true? Is that a fair way to characterize it?

Myrto Gordon, Executive Vice President, Amgen: Well, it’s what we’ve seen. Yeah. We see the tolerability of the product in the dose escalation cohorts. All of the, not all, but the vast majority of the nausea and vomiting was peri first dose, and on subsequent doses was very, very low. And that’s another good reason for the persistency of this product to potentially be better, and for the patient experience to be better.

Right.

Unidentified speaker: But

Myrto Gordon, Executive Vice President, Amgen: let let’s level up here. We’ve got a product that we know we can dose escalate to improve that tolerability even on that first dose because we haven’t optimized that yet. Right. We don’t think the phase two is the best we can do.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Right. You’ve started a lower dose.

Myrto Gordon, Executive Vice President, Amgen: We we think we can do it even better. So first dose experience, improve it. Weight loss up to 20%. Maintenance options of every other month, potentially quarterly. But we’re already improving at the monthly option.

And then we’re covering the waterfront with a phase three program that will bring in ASCVD indication, CKD, chronic sleep apnea, and on and on. We’re going into this market with a full package of clinical trials, a highly differentiated product, and an offering that quite frankly, by the time we launch, patients will be interested in. Because taking a weekly injection, and in some cases, feeling nauseous on the day of your dose, on a weekly injection will be an incentive for patients to look for something else.

Michael Yee, Senior Biotechnology Analyst, Jefferies: It’s kind of interesting, Murdo, because in many cases, sure, new patients, but there could be a significant amount is swapping. And so if they’ve already been on a GLP-one and they swap versus a de novo, maybe the side effects are even less. It’s sort of interesting, you planning to start a safety or some sort of design study where people are already on a drug and then they come onto this

Peter Griffith, CFO, Amgen: Yeah.

Myrto Gordon, Executive Vice President, Amgen: Look, there are a lot of questions to answer with the promise that Maritide offers for patients. We have a group of thought leaders advising us on ideas like that, and we’re taking those ideas seriously.

Peter Griffith, CFO, Amgen: Mike Mike, maybe if if I could jump in for a moment. Please. Yeah. I doctor Bradner, j Bradner, would say, you brought the question up of generalists, you know, we’d

Unidentified speaker: have to give

Peter Griffith, CFO, Amgen: them a big slug of drug or this or that.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Right? Yeah. What they say.

Peter Griffith, CFO, Amgen: Yeah. But he constantly reminds people that this is a monoclonal antibody. This is different. And so with a couple of peptides conjugated to it. That’s right.

And so he would really make the point that the pharmacokinetics of that are much more stable for us, he believes, than these other medicines which I think these are my words and he may use them, but are a little bit sawtoothed that may go up and down in their What it that

Michael Yee, Senior Biotechnology Analyst, Jefferies: the people who are looking at the doses, like Met Serra is an example, for those who are familiar with Met Serra, but also the tirzepatide dosing, that is a peptide, that is not an antibody with an Fc. And and So you cannot compare four hundred twenty mg to a peptide.

Peter Griffith, CFO, Amgen: That’s right. And mono Amgen is monoclonal antibody. Right. I mean, that’s who we are. 80 plus of our approved medicines, 40 approved medicines are monoclonal antibodies.

And that’s who we are. And I think we’re

Michael Yee, Senior Biotechnology Analyst, Jefferies: We’ll show the data. They get around to it. We’ve to put up the data.

Peter Griffith, CFO, Amgen: Let’s see

Michael Yee, Senior Biotechnology Analyst, Jefferies: what it says. Let’s see the data and through this year. So lastly, want to hit on in the last minute is another important blockbuster, because it’s right around the corner. So LP, you guys are a cardiovascular powerhouse. You’re selling billions of dollars of Repatha.

So Novartis is going to read out a phase three LP. People think it could be positive. You have a product that’s also in phase three. You already completed enrollment. You think it could be better.

It could be. What do you see out of LP in the last minute? And, you know, we should pay attention to this, because Novartis reads out.

Myrto Gordon, Executive Vice President, Amgen: Yeah, we definitely think we have an opportunity with opacillin for a best in class profile. We’ve got a very large ongoing secondary prevention clinical trial. We’re looking obviously very closely at what the competitors might put out between now and when our trial reads out. You know, I’ll just say, you know, thirty odd years ago, I was sitting in citywide endocrinology rounds in Toronto, and I heard about this independent atherogenic lipoprotein particle called Lp. So this is it’s not new science in understanding the correlation between elevated levels of Lp and elevated incidence of cardiovascular events.

And so there’s a volume of evidence that shows the correlation. Yes. The question is, when you have a drug like opacillin that lowers Lp by over 95%, can you knock down events? Right. And our hope is that the answer to that is yes, because we are still obviously working very hard to aggressively lower LDL.

You can’t do much about your Lp diet, exercise, lifestyle modification won’t bring it down, it’s genetically determined, You’ve got to have a drug. And I do think that the adoption behavior will be different, because you won’t have that, Doc, I’ll eat better, I’ll exercise, don’t put me on Right, that’s independent of diet and these other Yeah, I think there’ll be more urgency to treat. And we’re starting in secondary prevention. If you think about the history of LDL, it usually starts in primary, or it starts with just LDL modification. Here we’re starting about hard endpoints.

So I think the promise of opacerin is significant, and it’s 100% overlap with what we’re already doing with Repatha.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Guys, thank you so much. Look forward to the progress this year and more data, and we look forward to all of the developments. So thank you guys very much.

Peter Griffith, CFO, Amgen: Appreciate Thank you, Mike.

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