Amgen at Morgan Stanley Conference: Strategic Growth and Challenges

On Tuesday, 09 September 2025, Amgen (NASDAQ:AMGN) participated in the Morgan Stanley 23rd Annual Global Healthcare Conference. The company highlighted strong financial performance and strategic investments but also acknowledged challenges related to product exclusivity. Amgen’s focus remains on innovation and capital allocation, amidst ongoing healthcare reforms.

Key Takeaways

• Amgen reported a 9% revenue growth and a 21% increase in non-GAAP EPS in Q2.
• Significant investments are being made in U.S. manufacturing, with expansions in North Carolina and Ohio.
• The company is managing the loss of exclusivity for key products, expecting some erosion in the second half of the year.
• Amgen is advancing its pipeline with key trials for Rocatinlimab, Maridebart Cafraglutide, and Olpasiran.
• Engagement with U.S. healthcare reform remains a strategic priority.

Financial Results

• Second Quarter Performance:

- Revenue increased by 9% year-over-year.

- Volume rose 13%, with non-GAAP EPS up 21%.

- Fifteen products saw double-digit growth, and fourteen products are annualizing at $1 billion or more.

• Biosimilars:

- Sales grew 37% in the first half of the year, reaching nearly $1.4 billion.

- Cumulative sales since 2018 have hit $12 billion.

• Capital Expenditure:

- A $2.3 billion CapEx guide for the current year.

- Over $5 billion invested in U.S. capital expenditures since 2017.

Operational Updates

• Manufacturing Expansion:

- $1 billion expansion in North Carolina, total investment reaching $1.5 billion.

- $900 million expansion in Ohio, total investment over $1.4 billion.

- $600 million investment in the Center for Science and Innovation in California.

• Product Performance:

- Repatha and Evenity delivered over 30% growth in Q2.

- Tezspire and Blincyto grew 46% and 45% year-over-year, respectively.

- Tarlatamab sales increased by 65% quarter-over-quarter.

Future Outlook

• Growth Drivers:

- Continued growth expected for Repatha, Evenity, Tezspire, and the innovative oncology and biosimilars portfolios.

• Loss of Exclusivity:

- Anticipated erosion due to denosumab biosimilars in the latter half of the year.

• Capital Allocation:

- Focus remains on innovation, business investment, and returning capital to shareholders.

• Pipeline:

- Ongoing phase III trials for Maridebart Cafraglutide and Olpasiran.

- Continued investment in advancing the pipeline.

Q&A Highlights

• Policy Environment:

- Amgen supports reforms for affordability and access while preserving innovation.

- Advocates for 340B and rebate reforms.

• Capital Allocation:

- On track to achieve pre-Horizon acquisition capital structure by year-end.

- Open to business development opportunities with strong returns.

• Pipeline:

- Evaluation of Rocatinlimab data ongoing.

- Maridebart Cafraglutide trials aware of competitive dynamics.

- Olpasiran seen as a unique molecule.

For more detailed insights, readers are encouraged to refer to the full transcript provided below.

Full transcript - Morgan Stanley 23rd Annual Global Healthcare Conference:

Terence Flynn, Analyst, Morgan Stanley: Great. Good morning, everybody. I’m Terence Flynn, Morgan Stanley’s large-cap U.S. biopharma analyst. Very pleased to be hosting Amgen this morning. Joining us from the company, we have Peter Griffith, the company’s CFO, and Kaveh Niksefat, who is the company’s SVP of Global Marketing. Thank you both so much for being here today. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales rep. With that, I’m going to turn it over to Peter for some opening remarks, and then we’ll get into it.

Peter Griffith, CFO, Amgen: Thank you, Terence. We’re delighted to be here with you and the Morgan Stanley team today. We’re grateful for the relationship with Morgan Stanley. We’re investing in innovation and science that enable longer, healthier lives. We’re executing across our business with breadth and depth in four therapeutic areas, along with our leading biosimilars portfolio. We’re delivering strong results. Second quarter revenues grew 9%, and volume was up 13%. Non-GAAP EPS up 21% year over year. Fifteen products achieved double-digit or better growth in the second quarter, and fourteen products are annualizing at $1 billion or more based on the second quarter product sales. Let me start with an overview of the business, highlighting some of the key drivers across both the in-market portfolio and across the pipeline in each one of the therapeutic areas. Beginning with general medicine, Repatha and Evenity both delivered over 30% growth in the second quarter.

With these drugs, we’re reaching large underserved patient populations with single-digit penetration and significant room for growth. With over 100 million patients globally in need of effective LDL cholesterol-lowering, the opportunity to expand Repatha’s impact in cardiovascular care is substantial, and we expect growth through 2030. Despite Evenity’s strong growth, more than 90% of high-risk postmenopausal women remain untreated for osteoporosis. In our general medicine pipeline, maridebart cafraglutide continues to advance rapidly in obesity and related conditions. We now have four phase III studies underway, two in chronic weight management, one in cardiovascular disease, and one in heart failure, with obstructive sleep apnea expected to initiate later this year. Enrollment momentum is strong across these studies in maridebart cafraglutide, reflecting three items: broad investigator enthusiasm, participant interest in these trials, and the significant remaining unmet need. We look forward to additional phase II data in the fourth quarter.

Lastly, in the general medicine pipeline, our Lp(a) targeting molecule, olpasiran, for the reduction of cardiovascular risk, is progressing in phase III. Let’s turn to rare disease, the business that annualized over $5 billion in our second quarter sales. Based on second quarter sales, we have four key products in this therapeutic area, which are all early in their life cycle and well positioned for growth over the long haul. Ultomiris is the number one prescribed FDA-approved biologic for NMOSD, neuromyelitis optica spectrum disorder, and recently became the first FDA-approved therapy for IgG4-related disease, and the launch is progressing well. We’re preparing for Ultomiris’s December PDUFA date for generalized myasthenia gravis. We’re optimistic about Tepezza, which is the only FDA-approved therapy for thyroid eye disease. We’ve expanded our sales force to broaden our reach in the U.S., and the launch in Japan is progressing well.

Now let’s look at inflammation, where we’ve enjoyed decades of leadership. We’re excited about the progress we see in the difficult-to-treat diseases with high unmet medical need here. Tezspire continues to grow in severe uncontrolled asthma, growing 46% year over year in the second quarter and is advancing in additional indications, including chronic obstructive pulmonary disorder, with two phase III studies enrolling and an October PDUFA date in chronic rhinosinusitis with nasal polyps. Now let’s turn to our fourth area, oncology. We have a broad portfolio where we’ve been redefining outcomes across multiple cancers, led by our innovative bispecific T-cell engager platform, the BiTE platform. This journey began with Blincyto, which grew 45% year over year in the second quarter. We’re building on that foundation with tarlatamab, which is approved in second-line small cell lung cancer and is becoming the standard of care in this setting.

In the second quarter, tarlatamab grew 65% quarter over quarter and delivered $134 million of sales. Tarlatamab has a PDUFA date of December 18 in second-line small cell lung cancer based on the DELPHI-304 confirmatory study. We’re also progressing tarlatamab into earlier lines of small cell lung cancer, and multiple phase III studies are underway. Before we get to Q&A, I’ll have Kaveh give a—actually, why don’t you give it now, Kaveh? Why don’t you give us an update on tarlatamab? We’ve got news yesterday from WCLC.

Kaveh Niksefat, SVP of Global Marketing, Amgen: Yes, thanks, Peter. Last night at WCLC, we presented phase 1b data from our DELFI-303 program, which is studying Imdelltra in the first-line maintenance setting for small cell lung cancer in combination with PD-L1 therapy. This data was presented at WCLC with a simultaneous publication in Lancet Oncology. To date, this study has a median overall survival of 25.3 months, with data continuing to mature in the durvalumab arm. That’s roughly twice current standard of care when compared outside of the trial to what’s known in the field. There were no new or unexpected safety signals from the study, and we feel that this study strongly supports our rapid movement into earlier lines of therapy in small cell lung cancer with three ongoing phase 3 trials in that upfront setting.

Peter Griffith, CFO, Amgen: Thank you, Kaveh. That’s really great news for patients with small cell lung cancer. In oncology, beyond Blincyto and our T-cell engager platform, we continue to expand with Valiuritamib, which is in phase III for patients with advanced prostate cancer. It’s also important to note that our industry-leading biosimilars portfolio continues to contribute meaningful growth, delivering a cumulative $12 billion in sales since our first launches in 2018. In the first half of this year, biosimilars sales grew 37% year over year to reach nearly $1.4 billion, driven by the addition of our second wave of biosimilar products. We’ve proven to be a leading competitor in this field, and we’re advancing our third wave of products, which is comprised of biosimilars to Opdivo, Keytruda, and Ocrevus.

I’d also like to highlight our approach to capital allocation as we continue to invest in science and innovation that improve the lives of patients and positions Amgen for long-term growth. Our priorities are clear. Number one, innovation is number one, and we invest in it either internal or external, the very best innovation. Number two, we invest in our business, and right now, particularly in our manufacturing network and capacity and also in artificial intelligence and technology. Number three, we return capital to shareholders through a growing dividend, opportunistic share repurchases, while we also strengthen the balance sheet. To sum up, I know there’s a lot of focus on the macro and policy environment. We’ve always engaged with Washington and the administrations, and we certainly do with this one. We share their goals of expanding U.S.

manufacturing and improving patient access and affordability, while advocating for a policy environment that fosters innovation. We know we need more innovation, not less, and we’ll stay focused on investing in innovation and science that enable longer, healthier lives. In summary, the breadth and depth of the portfolio, the focus on execution and innovation, and our disciplined capital allocation approach position us to deliver innovation and growth not just this year, but over the long term. With that, Terence, back to you.

Terence Flynn, Analyst, Morgan Stanley: Great. Thank you so much, Peter, Kaveh. Really appreciate the remarks. I think we’ll dig into probably a lot of these areas. The first, obviously, front and center is still the policy side. I know you guys have had a lot of interaction with the administration, as you highlighted, Peter. Maybe you could just provide the latest perspective on kind of MFN and tariffs, where we stand. Are we getting closer to a resolution or an outcome here? What are you most focused on?

Peter Griffith, CFO, Amgen: Great. Thank you, Terence. We’re always, as I mentioned, we’re always engaged with the administration and with the officials on the Hill. We continue to talk to them. I think right now is a great time to have Kaveh share with us his view. He is very active in Washington, D.C., and I believe we’re sending him off there after this conference. It’s very important to us. We share the same objectives as the administration: access, affordability, and innovation. Kaveh?

Kaveh Niksefat, SVP of Global Marketing, Amgen: Yeah, no, Peter, I think you’ve summed it up well. At Amgen, we’ve agreed that reform in the U.S. health care system is needed, and we’ve long supported and touted reforms that improve the affordability and access to medicine, while preserving the innovation environment of which the U.S. is the world leader in biopharmaceutical innovation. We’ve engaged with this administration in this term, and we’ve engaged with the president’s administration in the prior term on these exact points. When we look at reforms overall, we think there are at least three areas where reform can really help change and support those goals jointly. First, Peter brought this up earlier, I believe, 340B reform. 340B is a now massive structural subsidy that’s being transferred from patients, employers, and federal taxpayers to private hospitals. The total program is estimated to be well in excess of $50 billion a year.

That is multiples above what we see, for instance, patients having to pay out of pocket in Medicare. We think structural reform of 340B in a way that enabled those discount dollars to benefit patients in their out-of-pocket and improve access to medicine would be a right place for the government to look to reduce the structural costs that are built into the health care system today. Second, we’ve long advocated, back to my time in 2019, speaking to Congress around the need for rebate reform in the country. Nearly $0.50 of every dollar that is sold for pharmaceuticals within the U.S. is captured by middlemen. Unfortunately, those discount dollars do not show up when a patient goes to the pharmacy counter to pick up their medicine. We would advocate that that price should reflect those discounts that are being extracted in the system so patients directly benefit from them.

That would include support for direct-to-consumer-like programs where, where appropriate, where needed to help with the system. Finally, we welcome the government’s focus on how foreign governments can better support the innovation environment. We look forward to working with the administration as they look to see how innovation can be more fairly valued outside of the U.S. in support of reducing the structural burden that is currently carried by the U.S. As Peter said, as I said, we continue to engage with the administration. We know that the world needs more innovation, not less. It’s up to us to work with them to find solutions to meet their goals and our goals around improving affordability and access to health care.

Terence Flynn, Analyst, Morgan Stanley: Do you think we’re getting closer to resolving a lot of these outstanding questions, or are we still kind of going to be in this steady state, you know, a month away, if you had to use your crystal ball?

Kaveh Niksefat, SVP of Global Marketing, Amgen: Look, I think it’s premature to opine on any time frame. Obviously, we’ve and 16 other manufacturers received a letter from the President about a month ago. There’s about a month left on his ask for engagement, and we continue to engage over that month to learn more and to see where solutions can be found.

Terence Flynn, Analyst, Morgan Stanley: Yep. One other area, obviously, which you guys have leaned into is, you know, the U.S. manufacturing announcements. You made some investments in North Carolina, Ohio. Maybe, Peter, you could just talk to us about kind of the importance of those in addressing one of the administration’s priorities, but also how does that impact your forward CapEx outlook for the company?

Peter Griffith, CFO, Amgen: This year, I’ll jump right into that. This year, we’ve got a CapEx guide of $2.3 billion, and we’re excited about that. That’s really focused in the United States. Amgen has a longstanding commitment, as I think all of you know, to the United States and innovation. We’ve spent more than $40 billion in manufacturing and research and development since the 2017 Tax Cut and Jobs Act, the TCJA, the first one, and including over $5 billion in direct United States capital expenditures. We’ve recently announced a more than $600 million investment. I’m sure you saw this, Terence, since we were talking about Thousand Oaks a little bit earlier. The new state-of-the-art Center for Science and Innovation in our global headquarters in Thousand Oaks, California. This facility is going to bring together both scientists and engineers.

We’re very excited about it across the disciplines, and it’s going to feature advanced automation and digital capabilities. We’ve announced major expansions of the U.S. manufacturing footprint. North Carolina, a $1 billion expansion announced in December 2024, bringing our investment there to about $1.5 billion. In Ohio, a $900 million expansion announced in April 2025, bringing our total investment in central Ohio to over $1.4 billion. These facilities are state-of-the-art biologics plants designed to support both in-market products and our late-stage pipeline, which, of course, with 13% growth in the second quarter and a robust late-stage pipeline, we’re thinking ahead, and we’re going to be ready to produce for every patient every time throughout our manufacturing system. Our 2025 CapEx guidance I mentioned is $2.3 billion. We don’t go beyond that.

We don’t give long-term guidance on CapEx, but certainly, you would expect there are multi-year investments here, and it’s going to be reasonable to expect some increased CapEx versus historical run rates as we complete these projects, which we’re very encouraged to do. Overall, these investments are central to our strategy. Every patient, every time. We’re a company that’s really focused on the science of manufacturing. We have a world-leading process development group, a world-leading manufacturing group. We’re very proud of our supply chain, and we’re focused on every patient, every time. Terence, we’ve really responded beginning in 2017 to put our capital here and really push hard. That’s what we’re going to do. We’re going to honor those volume commitments as best as we possibly can to get the medicine to the patients.

Terence Flynn, Analyst, Morgan Stanley: Okay, great. One other area, Kaveh, you mentioned was just, you know, foreign governments bearing more of their share of development costs on the innovation side. Lilly announced that they were raising the price of Mounjaro in the U.K. I know there are differences across companies’ portfolios, but is that something you guys are thinking about, or as you think about maybe upcoming new launch products on the ex-U.S. side, how are you guys approaching that from a strategic perspective?

Kaveh Niksefat, SVP of Global Marketing, Amgen: Yeah, obviously, we’re monitoring the entire ecosystem. We’re familiar with Lilly’s announcement recently. Probably premature at this point to opine on what we would do for existing products. With any product coming to market, we have really kind of taken in the various value and access levers that exist across the world and are developing in a way to make sure that we can get fair value for our products within those marketplaces. We’re obviously cognizant of the overall environment and making sure that we are negotiating with the President’s goals in mind across the rest of the world.

Terence Flynn, Analyst, Morgan Stanley: Do you think that foreign governments have been receptive to that message at this point?

Kaveh Niksefat, SVP of Global Marketing, Amgen: At this point, I would say our observation is that they are learning as quickly as we are around the President’s goals here, not dissimilar to the tariff situation, and we would expect adjustments to take some time.

Terence Flynn, Analyst, Morgan Stanley: Okay, understood. Maybe just pivoting over to capital allocation, we talked about CapEx already, Peter. You mentioned your priority is pretty clear, no major changes there, innovation, CapEx, cash to shareholders. Maybe just give us an update in terms of kind of where you are in delevering from the Horizon deal and then how you think about, you know, potential either therapeutic area, size of any future deals. Obviously, Horizon was probably at the higher end of kind of the size you guys typically contemplate. On the delevering process, where would that put you as you think about future deals?

Peter Griffith, CFO, Amgen: Thank you, Terence. On Horizon, as I mentioned, in rare disease, we’re annualizing at over $5 billion based on the second quarter. We’re very, very pleased with being in rare disease. We’re much more happier today for patients, staff, and shareholders than we were when we announced the deal. We just think it’s working out really well. Our leverage is exactly where we thought we were going to get it to by the end of this year, which is our pre-acquisition, we call it our pre-Horizon acquisition capital structure. We’ll be back to those ratios by the end of the year, and that’s worked out really, really well. The deal, as we also indicated at the time, was going to be accretive, which it certainly has been shortly after the deal. We also indicated pre-tax cost synergies of about $500 million, which have been well achieved.

We’re very excited about how that’s worked out. Turning over to capital allocation, as I mentioned in my capital allocation discussion, business development is a key part of finding the best innovation, and we feel confident by way of example with the Horizon situation, we were able to do that in the rare disease area. We really always have our aperture open on business development. It’s really, really important that we do that. As you can imagine, in terms of what we’re looking at, we want to be the best buyer. When we model it up, we want to do something with the opportunity that other companies can’t do. We pay attention to that. We look for cash-on-cash returns above our hurdle rate. We look for areas where we have some research, and particularly discovery research. We think that adds to the potential success of the transactions.

Finally, we look for opportunities where we can collaborate, where the licensing of the product makes a lot of sense, where we can merge it in quickly, post-merge integration. We think that increases returns quickly. That’s what we’ll stay focused on, those four criteria. Aperture is open. We’re excited to continue to look what’s out there. We mentioned in the third quarter, on our second quarter call, we mentioned in the third quarter we’ve got a couple of business development opportunities, about $200 million that we’re acting on. We’ll continue to be active. We think it’s really important. We know we’ve got excellent internal innovation, and we know there’s some excellent external innovation. Aperture is open, and we’ll continue to look for it.

Terence Flynn, Analyst, Morgan Stanley: Does the policy environment make it, is it making it tougher to get deals done, do you think, or is it making it easier as you think about it on the forward from a transaction standpoint?

Peter Griffith, CFO, Amgen: We haven’t had too much trouble getting deals done other than during Horizon. We had a little bit of discussion with the FTC for a while, as we all know, but we worked our way through that, and it certainly has worked out well, and we’re delighted that our persistence paid off to get that closed. I think, Terence, we look at the environment and we say, you know, we’re here for the patients, and we’ll stick with it. If we need to get something done, we’ll work to get it done. Certainly, the policy environment, we’re thoughtful about what we’re thinking about and what we’re going to do, but we’ve always been that way. Amgen’s, you know, always been a very rigorous company when it comes to business development.

Terence Flynn, Analyst, Morgan Stanley: Okay, great. Maybe one more before we turn to the business is just, you know, occasionally we get some questions on the Puerto Rico tax litigation, which is ongoing. Maybe just level set us in terms of where that stands and when we might get another update on that front.

Peter Griffith, CFO, Amgen: Sure. With respect to litigation, trial began in November, stopped in January of this year. It began in November 2024. There have been closing arguments and discussions in June and July. There will be one more round of those replying to each other, I think it’s in September or October. We do not expect a decision before the second half of 2026 at the very earliest. We continue to believe that we have a very strong position. We think the trial really went that way. We were able to get the facts across as to the importance and the complexity of our biological manufacturing and the science of manufacturing in Puerto Rico. We are confident in that. As we’ve said all along, Terence, we think we’ve got appropriate reserves put up on this.

Terence Flynn, Analyst, Morgan Stanley: Okay, great. Maybe turn over to the outlook. You know, you walked through some of the key growth drivers. I think your new guidance for 2025 implies, I think, somewhat of a stepdown in growth, second half versus first half, so 6% versus 10%. I know there’s a lot of puts and takes in kind of that revenue dynamic because you have these new products ramping, but you have some pressure on some legacy products. You’ve got biosimilars. Maybe just as you think about that second half dynamic, what are the other pieces that we should consider as we think about the new guidance that you guys provided on the second quarter call?

Peter Griffith, CFO, Amgen: In a moment, I’ll ask Kaveh to jump in too, because he’s on top of this all the time, 24/7. I would just add our six growth drivers we mentioned in the fourth quarter call, we mentioned again off the first quarter call and the second quarter call. Repatha, Evenity, Tezspire, our innovative oncology portfolio, our rare disease portfolio, and our biosimilars portfolio continue to perform well. I think, as everybody knows, we have the LOEs on denosumab, which is Prolia and XGEVA. We have those in the second half of the year. We’re delighted by the strength of the launch in IgG4-related disease for Efgartigimod, so that’s exciting. We’re excited about the strength in Problimab and how that’s working out too. There are some puts and takes. Kaveh, you may have some good thoughts to add for our colleagues.

Kaveh Niksefat, SVP of Global Marketing, Amgen: Yeah, Peter, I think that’s fair. I think for the six growth drivers, we expect them to continue to grow and accelerate growth in the back half of this year and into next year. Obviously, with denosumab, we expect some erosion during the second half of this year. We’ve had three biosimilars of denosumab launch to date in the U.S., early days, but thus far, the situation’s playing out exactly as we expected. Those expectations were built based off our 10-year history of both defending against biosimilars, but also launching them on our own. As a reminder, we do expect XGEVA and Prolia dynamics to be slightly different, given that the oncology market, there’s greater consolidation and greater familiarity with biosimilars.

In the bone market, we continue to promote one of our growth drivers in Evenity, a bone builder that’s highly complementary to the bone resorption business that we have with Prolia. The growth drivers continue to grow. We’re managing the biosimilar to denosumab. There are a few puts and takes on ordering patterns on biosimilars and some ex-U.S. that change overall, but very strong growth story that we continue to execute against.

Terence Flynn, Analyst, Morgan Stanley: Okay, great. Maybe one more. I know, Peter, we talk about margins a lot. You guys have very robust margins. You obviously managed those through multiple different cycles. Maybe just remind us where you stand for this year. I know you’re not going to obviously guide to next year, but again, you guys do have a pretty robust pipeline. Help us think about some of the, again, puts and takes as we think about some of the spend levers that you might be considering as we look at our models for 2026.

Peter Griffith, CFO, Amgen: As you know, Terence, thank you for this question on margins. We pay a lot of attention to margins at Amgen. Rigorous financial discipline throughout the company. We know that what we want to do is try to reallocate as much capital as possible back into innovation. With that in mind, we’ve always signaled that when we flex that margin down, which we are this year, I think we’ve guided to a 45% margin, that we know our shareholders expect us to return at some point with returns well above the cash-on-cash return on that above the hurdle rate. We communicate that beforehand. This year, we took the 46% original guide down to 45%, primarily due to that business development activity in the third quarter.

What I would say on margins is we’re living up to where we’re at in the sense that we’ve raised our guide on our research and development costs to over a 20% increase year over year. What that represents is the probability in the pipeline, the middle-aged pipeline continues to increase and improve for patients. With that, that certainly gives us an opportunity to invest and get those medicines to the patients as quickly as possible. I think that really covers it. I think that those are the most important salient points on the margin. We will continue to focus for patients, staff, and shareholders on disciplined financial allocation. We understand how important it is. We live executional excellence.

Like all our colleagues in the industry, we are interrogating and implementing where it makes sense, artificial intelligence, technology, and so forth to make sure that we’re just staying at the edge in everything we can do across the company, by the way, all the way from discovery research through to our commercial activities. We put pressure on ourselves, but we know at the end of the day on that margin, when we do that and we’re able to produce another dollar for innovation that it benefits patients.

Terence Flynn, Analyst, Morgan Stanley: Yes. Should we expect on the pipeline again that you’re going to continue to invest here into next year? I know Maritide is one of those programs, but it seems like you have still a pretty rich set of pipeline here that you guys want to advance.

Peter Griffith, CFO, Amgen: Yeah, we don’t guide long term, but I think it’s fair to assume we are going to make sure we explore everything we need to explore in that clinic. We have four phase IIIs. We talked about getting into obstructive sleep apnea this year, initiating that with maridebart cafraglutide. We’ve got olpasiran also progressing in phase III. We’re excited about that. We’re going to make sure, and our shareholders, we know they want us to get those medicines interrogated, look at the data, and get them to patients as quickly as possible, of course, depending on the data and regulatory approval.

Terence Flynn, Analyst, Morgan Stanley: Okay, great. Maybe I want to pivot over to the pipeline here just in the interest of time and really wanted to touch on three programs in the last several minutes here: Rocatinlimab, Maridebart Cafraglutide, and Olpasiran. Rocatinlimab, I know you and your partner at Kyowa Kirin, Kieran, had some updated data yesterday on the SEN data, looking at Q4 weekly and Q8 weekly in atopic derm. Maybe just, Kaveh, you could give us kind of the quick hits of that data. On the competitive profile, I know Sanofi had some of their first phase III data recently as well. Cross-trial comparisons are challenging, but just give us your take on kind of how your profile stacks up there.

Kaveh Niksefat, SVP of Global Marketing, Amgen: Yeah, happy to, Terence. Maybe I’ll start with Ascend. For those of you that didn’t see, we released data with our partner Kyowa Kirin late last night, right before the Japanese market open from this particular phase III study. Ascend is a descriptive study. It’s a long-term extension study whose primary objective was safety, and secondary objective was efficacy. That was testing this extension for Rocatinlimab in Q4 week and Q8 week, once a month and once every other month-based dosing. The press release does include quite a bit of information. I’ll point you back to that for the details. This is an interim read. There are portions of the study that are still ongoing, which is also why we’ve released limited data to date. The data that we showed last night or we announced last night really adds to our understanding of the OX40 mechanism within atopic dermatitis.

It also starts to complete the Rocatinlimab program. It’s the seventh of eight studies that we said we would require to file at a certain point. We’re now evaluating the totality of that data in total to understand what’s the potential position for Rocatinlimab in this market that has a number of competitive dynamics, including a competitor coming from Sanofi. Beyond that, to your point, that cross-trial comparison with the Sanofi data is rather challenging. It’s also rather early. We’ve only seen a portion of their first phase III study.

Terence Flynn, Analyst, Morgan Stanley: Is this, just to remind us, the last piece for the filing, or are there other studies that you guys need?

Kaveh Niksefat, SVP of Global Marketing, Amgen: This study first must complete before we make any determination, along with one additional study we are still waiting for. We’ll take the totality of the evidence at that point, evaluate positioning, competitive dynamics, and determine the best path forward.

Terence Flynn, Analyst, Morgan Stanley: Okay, great. Maybe moving over to Maritide, I think Peter highlighted you have a broad phase III program underway, including an OSA trial that’s going to start as well. Maybe just remind us, I know there’s some upcoming phase II data coming in the fourth quarter. What are you going to be most focused on or what should we all be focused on when we see that data coming up?

Kaveh Niksefat, SVP of Global Marketing, Amgen: Peter, maybe I’ll ask you to take Maritide.

Peter Griffith, CFO, Amgen: Sure. On Maritide, Terence, at the end of the day, that data is coming in the fourth quarter. We’re excited about where Maritide sits. As I said, we’ve got the four phase III trials in obstructive sleep apnea coming up. We’ve used the data that we understand from phase II to inform ourselves on that in very thoughtful ways, as you can imagine. We look forward to seeing that data, and we’ll be back here with that.

Terence Flynn, Analyst, Morgan Stanley: Okay. One question we get is about the CVOT trial that you guys are planning here in type 2 diabetes. I think there’s been some new data out from Lilly about a month ago on their head-to-head Trulicity versus Tirzepatide. As you guys think about your Maritide type 2 diabetes CVOT trial, any updates you can share there in terms of how you’re thinking about that design? I know that’s a pretty important study as well.

Kaveh Niksefat, SVP of Global Marketing, Amgen: I’d just add that we’re aware of the different competitive dynamics out there, Terence. We think we have a highly differentiated molecule with an antibody backbone that gives us obviously very convenient monthly dosing. We’re taking in all of the information as part of trial design, and we’ll be able to update in due course.

Terence Flynn, Analyst, Morgan Stanley: Okay. Maybe we’ll pivot over to olpasiran, your Lp(a) here. Just remind us about, you know, why you guys are excited about this target. I think you’re one of the leading companies here, neck and neck with Novartis in terms of a phase III program. What is it about the target? As we look to this Novartis data, which I think is coming next year, what’s the read across to your program?

Kaveh Niksefat, SVP of Global Marketing, Amgen: Yeah, so, you know, thinking about Lp(a), going back to 2009 and the seminal paper originally written on this subject, this appears to be one of the additional cardiovascular risk factors that’s out there that is genetic in nature. Approximately 20% of people have elevated Lp(a). The literature is well documented at this point that high Lp(a) is directly correlated with higher risk of CV events. The open question that Novartis, ourselves, and others are trying to ask is whether lowering Lp(a) also results in a reduction in CV events. The studies that we have ongoing look to prove that. The thing on Lp(a) that makes it different than LDL is it can’t be modified by diet or exercise, nor is it modified by any other therapy today, meaning that it’s a completely uncontrolled risk factor. We think we have an incredible molecule in Opasitamab that reduces Lp(a) by 95%.

That’s differentiated by the other molecules that are out there in terms of size of effect and frequency of treatment, given that Opasitamab’s given once a quarter. We’re looking forward to learning from Novartis, but we do fundamentally feel that our molecule is different and our study is different. At the end of the day, we’ll add it to the body of evidence on Lp(a), but probably won’t determine based off what we see from Novartis.

Terence Flynn, Analyst, Morgan Stanley: Great. Anything else in the pipeline that you guys want to just flag in the last 30 seconds here?

Kaveh Niksefat, SVP of Global Marketing, Amgen: I think we’ve continued to highlight Blincyto, continued to highlight Tepezza, continued to highlight Eculizumab and the upcoming approval we have in GMG as three programs that are near term in addition to Maritide, Valiuritamib, Dazodilabop, and Opassiram that we’re very excited about from a pipeline perspective.

Peter Griffith, CFO, Amgen: I think I’d throw in Tepezza too with the chronic obstructive pulmonary disease and the chronic rhinosinusitis with nasal polyps. We’re excited about all those. When we think about Eculizumab and Tepezza, I mean, we really kind of feel like we see, you know, pipeline in a couple of products. It’s just, it’s fantastic.

Terence Flynn, Analyst, Morgan Stanley: Yeah.

Peter Griffith, CFO, Amgen: All good for patients, Terence.

Terence Flynn, Analyst, Morgan Stanley: Great. Thank you so much, Peter, Kaveh. Really appreciate the time today.

Peter Griffith, CFO, Amgen: Nice to see you. Thank you, Morgan Stanley.

Kaveh Niksefat, SVP of Global Marketing, Amgen: Thank you, Morgan Stanley. Thank you, Terence.

Terence Flynn, Analyst, Morgan Stanley: Thank you.

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