Amgen Inc.

My name is Julianne and I will be your conference facilitator today for Amgen's fourth quarter and full year 2024 financial results conference call. All lines have been placed on mute to prevent any background noise. There will be a question and answer session at the conclusion of the last speaker's prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. To ask a question, please press star, then the number one on your telephone keypad. To withdraw your question, please press star one again. I would now like to introduce Justin Clays, Vice President of Investor Relations. Mr. Clays, you may now begin.

Thank you, Julianne. Good afternoon, everyone, and welcome to our fourth quarter 2024 earnings call. Bob Bradway will lead the call and be followed by a broader review of our performance by Myrtle Gordon, Jay Bradner, and Peter Griffiths. Through the course of our discussion today, we will use non-GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompany this call. We will also make some forward-looking statements, which are qualified by our Safe Harbor Statement, and please note that actual results can vary materially. Over to you, Bob.

Good afternoon, everyone, and thank you for joining us today. 2024 capped another year of strong execution at Amgen. Our operations teams supplied every patient every time. Our clinical teams reliably delivered quality results across the portfolio, and our commercial teams grew the business across our four therapeutic areas and in each of our geographic regions. The operating rhythm that we've established in our business will serve us well for 2025 and the longer term. Looking ahead, our objective is to deliver long-term growth while navigating regulatory and political change, declining net prices, and losses of exclusivity. We have a track record of doing just that. If you consider the past decade, we grew revenues above a mid-single-digit percent level and EPS at approximately 9% per year over the period, despite facing biosimilar and generic competition across products that accounted for about 50% of our revenues. As we look to the next decade, our novel medicines are well-positioned to address patient demographics in a rapidly aging world, And we expect that our operating discipline to enable us to scale to meet the needs of patients while continuing to deliver for our shareholders. Reflecting on our marketed products in 2024, we exited the fourth quarter with 14 medicines, each annualizing at over a billion dollars. And notably, several of these will be key drivers of growth through the decade. Let me highlight a few. Starting in general medicine, Repatha and Avenity continue to deliver attractive growth. Heart disease remains the leading cause of death globally, and Repatha, now a multibillion-dollar product, continues to expand as access improves worldwide. We are the leader worldwide in bone health, addressing the huge need for fracture prevention in those living with osteoporosis. The clinical performance of Avenity since its launch demonstrates the leading role it can play in reducing fracture risk for millions of postmenopausal women. In rare diseases, 2025 will be an exciting year. We look forward to regulatory approvals for Tepeza internationally and launches in new indications for Uplizna, further strengthening the growth trajectory of our rare disease business. In inflammation, we continue to be inspired by the strong performance of Tezspire and the progress we're making advancing into new indications, including COPD, which is the third leading cause of death, where we intend to initiate Phase III studies. And, of course, in chronic rhinocytosis, which runs in parallel with other respiratory diseases. In oncology, our leading bispecific T-cell engager platform, provides further opportunities for growth, with Blinsido moving into frontline treatment and demonstrating compelling survival benefit in BALL. Mdeltra, showing impressive efficacy in hard-to-treat small cell lung cancer, and Zaluridamig advancing into Phase III in advanced prostate cancer. 2025 promises to be another milestone year for our rapidly advancing pipeline. with important Phase III data readouts for programs including across our general medicine, rare disease, inflammation, and oncology portfolios. Beyond these readouts, we'll be initiating several new Phase III trials of Meritide in obesity and related conditions. This is an exciting time for innovation in our laboratories, in our factories with the science of manufacturing, and in leveraging technology across the company. When it comes to artificial intelligence, we're finding new opportunities across our business, and AI is helping us deliver innovative medicines to more patients even faster. To wrap up, 2024 demonstrated the strength of our business, the depth and breadth of our portfolio, and the power of our pipeline. As we step into 2025, we're poised to deliver continued growth and innovation in the near term through 2030 and beyond. And I want to thank our global team for their exceptional contributions and dedication to our mission. With that, I'll turn it over to Murdo for an update on our commercial organization. Thanks, Bob.

In the fourth quarter, product sales grew 11% year over year, capping off a year of growth fueled by strong execution across the business. For the full year, product sales grew 19%. and 10 products grew by double digits or better, creating strong momentum for growth in 2025 and beyond. Two products on a strong growth trajectory are Repatha and Avenity, which together grew 35% year-over-year, driven by 39% volume growth and accounting for nearly $1 billion in sales growth in the year. Both of these important brands serve large patient populations that are mostly untreated, despite the availability of highly impactful therapies, indicating robust growth potential. Repatha sales increased 36% in 2024, reaching over $2.2 billion in sales. There are 100 million patients globally in need of effective treatment for lowering their LDL-C. And we see strong potential for growth of Repatha around the world as physicians, patients, and payers recognize the importance of therapies like Repatha for patients at risk of major cardiovascular events. In the United States, Repatha sales grew 44% in 2024 with volume growth of 54%. The majority of patients with elevated LDL-C are in the primary care setting. And in 2024, our increased investment focused on primary care physicians improved the number of Repatha prescribers by 50%, supporting future growth strategy. Our direct patient education efforts doubled the number of patients who asked their doctor for Repatha. Volume growth was further supported by Repatha's broad access and reimbursement, and we see more payers seeking to ease or even remove prior authorization barriers, making Repatha more accessible and affordable for patients. Cardiologists and primary care physicians reported in a recent survey that Repatha access has improved significantly versus two years ago. Outside the U.S., Repatha continues to grow across major markets despite increased competition in the segment. Over the past several years, the price of Repatha has been impacted by an expansion of coverage in the U.S. and the growth of new markets around the world. Moving forward, we expect less price erosion for Repatha, with 2025 net price expected to decline by mid-single digits or less. Avenity sales increased 35% in 2024, reaching almost $1.6 billion in sales. Avenity is the only therapeutic that both builds bone and slows resorption, which can play a critical role in reducing fracture risk for millions of women who are postmenopausal. Despite this significant need, only 210,000 patients in the U.S. have been treated with Avenity to date, while millions remain at risk. With over 90% of very high-risk patients not currently receiving appropriate treatment, we see a significant opportunity to grow Avenity in 2025 and beyond. In the U.S., Avenity continues to be the segment leader in the bone builder market. We drove a 14% quarter-over-quarter increase in new customers ordering Avenity and saw an increase in prescription volume from both established and new Avenity prescribers. We've increased our investment in identity and have fully shifted the focus of our U.S. bone field force towards identity. I'll move to our rare disease portfolio, which delivered over $4.5 billion in sales in 2024. Tepeza, our largest product in the rare disease portfolio, generated sales of $1.9 billion in the year, representing 5% year-on-year growth. Since launch, Tepeza has had a positive impact for thousands of patients living with thyroid eye disease. There are roughly 100,000 patients suffering from thyroid eye disease in the U.S. who could benefit from Tepeza, and to reach them, we've intensified our efforts to engage a broad prescriber base of oculoplastic surgeons, ophthalmologists, and endocrinologists. We're moving quickly in international markets to secure regulatory approval for Tepeza, which will drive additional growth And we've successfully launched APEZA in Japan, where it's the first and only medicine approved to treat active thyroid eye disease. In 2025, we expect to launch APEZA in seven additional countries. In inflammation, TESPIRE continues a strong trajectory with nearly $1 billion in sales in the year, a 71% year-over-year increase. We've driven increased adoption by pulmonologists supported by TESPIRE's unique profile to treat patients with multiple severe uncontrolled asthma triggers and drivers. TESPIRE has strong future growth potential given the need to treat the 2.5 million patients worldwide with severe uncontrolled asthma. Our innovative oncology portfolio, including Bonsaito, Lumicraz, Vectabix, Kyprolis, Endplate, Xgeva, and Indeltra, contributed almost $8 billion in sales for the full year. Year-over-year sales grew 11%, driven by volume growth and higher net selling price. Our leading bispecific T-cell engager platform, which developed Blincyto and Indeltra, continues to address critical unmet needs in oncology while providing significant opportunities for future growth. Blincyto sales grew 41% for the full year, reaching over $1.2 billion in sales. We expect continued strong growth in 2025, driven by broad prescribing across academic and community segments. Physician prescribing is growing, and compelling new clinical data is redefining BlinCyto as the standard of care for both adult and pediatric patients with Philadelphia chromosome-negative B-cell ALL. Our U.S. launch of IMDeltra for the treatment of patients with extensive stage small cell lung cancer who are progressing on or after chemotherapy is off to a strong start. generating $115 million in sales in seven months since launch. We see increasing breadth of adoption in both academic and community settings driven by strong clinical conviction for Indeltra's transformational efficacy. Indeltra has treated approximately 2,000 patients since launch. Each year, an estimated 8,000 to 10,000 patients progress to second-line treatment for extensive stage small cell lung cancer. Our medical and commercial teams are operating with urgency to bring Indeltra to more patients living with this aggressive disease. Sales of our biosimilar products were $2.2 billion in 2024, an increase of 16% year-over-year. In the fourth quarter, our team readily executed the launch of Pablu, a biosimilar to ILEA, with nine weeks of sales totaling $31 million. Response from retina specialists to PABLU has been very positive, with strong intent to purchase and administer this high-quality antigen biosimilar, delivered in an easy-to-use pre-filled syringe. The next wave of biosimilar launches continues in 2025. In January, building on the strong introduction of PABLU at the end of 2024, we launched Wislana, a biosimilar to Stelara. And in the second quarter, we expect to launch Bekembe, a biosimilar to Solaris. With this next wave of launches, we anticipate robust growth and attractive returns from our biosimilar portfolio. 2024 was a strong year of execution across Amgen. We view execution as a team effort. The tightly coordinated integration between research and development, manufacturing operations, and our commercial teams enables us to serve record numbers of patients across the portfolio and around the world. This relentless cross-enterprise focus will accelerate our ability to reach even more patients with Amgen Medicines in 2025. And with that, I'll hand it over to Jay.

Thank you, Murdo, and good afternoon, everyone. At this time last year, we planned a very ambitious R&D agenda, and I'm very proud to say we delivered, meeting or exceeding almost all enrollment targets and generating impact and value across the portfolio. Specifically, in 2024, we received two important U.S. regulatory approvals in oncology, completed five positive Phase III studies, and initiated three new Phase III trials while advancing the broad Meritide program. Let's begin with Meritide, a therapy with a unique, differentiated, and highly competitive profile. Since our Phase II data disclosure last November, we have engaged extensively with key opinion leaders and have received strong enthusiasm and support. This excitement stems from Meritide's ability to deliver consistent, predictable, and sustained weight loss through 52 weeks without hitting a weight loss plateau and convenient monthly or less frequent dosing, a clear advantage over current weekly therapies. Additionally, key opinion leaders conveyed their excitement for robust and clinically meaningful improvements in cardiometabolic parameters, including hemoglobin A1c, demonstrated by Meritide treatment. With a further optimized simple dose escalation schedule and significantly fewer injections per year, we expect to improve persistence and long-term health outcomes. Maritime represents a promising treatment advance for people living with obesity and related conditions, and we are committed to fully realizing its potential. In the first half of 2025, we expect to initiate the first studies in our broad Phase III Maritime program, and expect to present the full Maritide Phase II data set at a major medical congress. In the second half of 2025, we expect key data readouts from both the ongoing Phase II Type II Diabetes Study and Part II of the ongoing Phase II Chronic Weight Management Study. Beyond Maritide, in general medicine, we look forward to data from the Repassa-Vesalius Phase III Primary Prevention Study in the second half of this year. Having demonstrated profound and sustained benefit of RPASA in the secondary prevention setting, we're excited about these data and the opportunity to reach additional patients at high risk of a first cardiovascular event. Turning to Olpaceran, our promising best-in-class small interfering RNA medicine targeting LP little a, we are bringing a precision medicine to cardiovascular risk reduction for the many individuals with LP little a elevation. The fully enrolled OceanA phase III cardiovascular outcomes trial of Olpaceran continues to progress, and we expect to initiate an additional phase III outcome study in patients with elevated LP little a and at high risk for a first cardiovascular event late this year or in the first half of 2026. Shifting to rare disease, we are very excited about APLISNA's potential to serve even more patients facing rare inflammatory illnesses. In 2024, we generated compelling data from the Aplizna Phase III Mitigate Study in patients with IgG4-related disease, a serious inflammatory condition with no approved therapies. These data are now under FDA priority review with a PDUFA date of April 3, 2025. The FDA also granted orphan drug designation to Aplizna for the treatment of generalized myasthenia gravis based upon 26-week data from the Phase III Mint Study. This study showed Aplizna to be highly effective on multiple clinical outcomes, also reducing the need for steroids with patient-centered, convenient dosing. We eagerly anticipate the 52-week data later this year, which will provide further insight into response and long-term durability. With two anticipated approvals on the horizon in IgG4-related disease and generalized myasthenia gravis, We are more confident than ever about Aplizna's expanding impact on the management of rare inflammatory diseases. In inflammation, we remain on track to initiate Phase III studies of TESPIRE and COPD, targeting patients with moderate to very severe COPD with bloody acinophil counts greater than or equal to 150 cells per microliter. COPD is the world's third leading cause of death, and we're excited about the impact TESPIRE could have in this setting. Beyond COPD, regulatory submissions are underway in chronic rhinosinusitis with nasal polyps supported by positive Phase III data, and we continue advancing a Phase III study in eosinophilic esophagitis. The rocatinlamab Phase III rocket program in atopic dermatitis is progressing, with additional data expected throughout 2025. These studies will provide deeper insight into rocatinlamab's profile. Beyond atopic dermatitis, we continue to explore rocatinlamab in moderates of severe asthma and in prurigo nodularis, a chronic skin condition characterized by extreme itchiness. As previously indicated, we are pursuing B-cell depletion in autoimmune disease with both blinitumumab and inebuluzumab. Our initial focus is on systemic lupus erythematosus with plans to expand into additional indications. 2025 will be an important year in oncology, where we expect three key Phase III data readouts. I will start with our rapidly advancing BITE portfolio. Last December, very exciting BlinCyto data were shared at ASH and published simultaneously in the New England Journal of Medicine. In a Phase III study conducted by the Children's Oncology Group, BlinCyto added to chemotherapy improved three-year disease-free survival to 96%, compared to 88% with chemotherapy alone in the upfront treatment of pediatric B-cell acute lymphoblastic leukemia. We are also advancing a subcutaneous formulation of Blinitumumab with a potentially registration-enabling study in adults and adolescents with relapsed refractory BALL expected to begin in the second half of 2025. Based on our experience to date, subcutaneous Blinitumumab has the potential to improve the patient experience efficacy, and tolerability. Our second approved bite therapy, Mdeltra, a first-in-class bispecific T-cell engager targeting DLL3 for small cell lung cancer, is rapidly advancing into earlier lines of therapy. Phase III studies are ongoing in both extensive-stage and limited-stage disease. Data from Delphi 304 are expected in the first half of 2025. This study compares Mdeltro with standard-of-care chemotherapy in second-line extensive-stage small-cell lung cancer. Our first-in-class STEEP1-CV3 bispecific T-cell engager, Zaluridamig, has entered Phase III clinical development with a study in post-taxane metastatic castrate-resistant prostate cancer. We are also exploring Zaluridamig in combination therapy and in earlier lines of prostate cancer with multiple Phase Ib studies ongoing. We remain excited about the growth potential of our BITE platform and the opportunity to reach additional cancer patients. We put Cyto, Infeltra, and Xaloritamate. Beyond our T-cell engagers, Bomerituzumab, our first-in-class fibroblast growth factor receptor 2B-directed monoclonal antibody, is advancing to frontline gastric cancer therapy. We expect data in the first half of 2025 from Fortitude 101, a Phase III study of vomerituzumab combined with M-Folfox-6 chemotherapy versus chemotherapy alone. In the second half of 2025, we expect data from an analysis of Fortitude 102, a Phase III study of vomerituzumab combined with chemotherapy and nivolumab. On biosimilars, we are rapidly advancing three Phase III programs, evaluating our biosimilars to Opdivo, Keytruda, and Acrevis, the next wave of Amgen biosimilar products. In closing, I want to thank my Amgen colleagues for their unwavering commitment to patients facing grievous illnesses and for their focus and collaboration throughout a highly productive 2024. We look forward to an exciting year ahead and continued pipeline momentum. I'll now turn it over to Peter. Thank you, Jay.

We're pleased with our execution excellence in the fourth quarter and for the full year 2024, and we remain on track with our long-term objectives. The financial results are shown on slides 28 to 30 of this slide deck. Full year total revenues of $33.4 billion grew 19% year-over-year, driven by 21 products with record sales. Product sales increased 19% year-over-year, driven by 23% volume growth. Excluding products acquired from Horizon, product sales for the full year increased 7% year-over-year, driven by 11% volume growth. For the full year, we delivered a non-GAAP operating margin of 47%. We continue to invest in advancing our pipeline, with non-GAAP R&D spend increasing 25% year-over-year for the full year to a record $5.9 billion. Due to investments in the late-stage pipeline, including Meritide, Roca-Tinlamab, Bima-Rituzumab, and Dymdeltra, as well as Horizon-acquired programs. Excluding Horizon, non-GAAP R&D spending increased 15% year-over-year. The Horizon integration is progressing well, and we expect to reach the previously announced $500 million in pre-tax cost synergies by year three post-acquisition. The acquisition was accretive to non-GAAP EPS for the full year 2024. Full year non-GAAP other income and expense was up $1.1 billion year over year, almost entirely due to increased interest expense from the Horizon acquisition. We continue to strengthen our balance sheet with $4.5 billion of debt retired in 2024. Our non-GAAP tax rate decreased two percentage points year-over-year to 14.5% for the full year, primarily due to the change in earnings mix, including the addition of the Horizon business and net favorable items. The company generated $10.4 billion in free cash flow for the full year and $4.4 billion in free cash flow in the fourth quarter. These results reflect strong momentum in the business. and favorable timing of collections at year-end. We executed capital expenditures in 2024 of $1.3 billion in line with the guidance provided, with the cash outflow being $1.1 billion and the remainder to be paid in 2025. Our commitment to innovation is also evident as we deploy artificial intelligence across the value chains. including informing molecule design and discovery research, enabling faster trial enrollment and streamlining regulatory filings in clinical development, and enhancing our responsiveness to customers in commercial operations. In addition, we returned capital to shareholders as we paid competitive dividends of $2.25 per share in the fourth quarter. This represented a 6% increase compared to 2023. we expect that we will continue to increase our dividend. Let's turn to the outlook for the business for 2025 on slide 31. We expect our 2025 total revenues in the range of $34.3 billion to $35.7 billion, and non-GAAP earnings per share between $20 and $21.20. Our revenue range reflects our strong growth outlook driven by numerous opportunities across each of our therapeutic areas. We expect continued growth across a number of products led by our near-term growth drivers, Repatha, Avenity, Tesfire, our innovative oncology portfolio, our rare disease portfolio, and biosimilars. This growth will more than offset declines due to the upcoming Denosumab patent expiration, as well as continued price declines across our portfolio in 2025. For total company revenues, we expect each quarter of 2025 to have a relatively similar year-over-year growth rate. A reminder as you model the first quarter of 2025, and consistent with our historical trends, We expect Otesla and Dembril to follow their typical pattern of lower sales in the first quarter relative to subsequent quarters. Also note that biosimilar sales in the U.S. can significantly vary quarter to quarter depending on customer ordering patterns. For example, we expect Q1 Amgevita sales in the U.S. to be in line with Q3 2024. For the full year, we expect other revenue to be approximately $1.4 billion. In 2025, we are driving R&D investments to support our promising late-stage pipeline, including Meritide and Opaceran. As a result, we project the full-year non-GAAP operating margin as a percentage of product sales to be roughly 46%. We project non-GAAP cost of sales to be in the range of 18% to 19% as a percentage of product sales for 2025. This projection reflects the ongoing impact of sales mix, including profit share and royalties. We expect non-GAAP R&D expense to grow year-over-year in the mid-teens in 2025, with investments increasing to advance key pipeline assets, including Meritide and Opacerant. We see significant potential in our innovative pipeline, and it is important that we strategically invest now to fully unlock these opportunities. And for the non-GAAP SG&A spend, we expect the 2025 full-year amount as a percentage of product sales to decline by approximately one to two percentage points year over year, as we continue to drive efficiencies and prioritize resources, including leveraging both automation and our newly established innovation and technology hub in India. Overall, the operating margin of roughly 46% indicates our commitment to investing in the best innovation, while also driving execution excellence, efficiency, and prioritization across the organization. Consistent with prior years and in line with typical lower product sales in Q1, We expect Q1 non-GAAP operating margin to be the lowest of the year at roughly 42%, and then accelerate in each of the quarters following the first quarter. We anticipate non-GAAP OINE to be approximately $2.4 billion in 2025. We expect a non-GAAP tax rate of 15% to 16%. Similar to 2024, we expect share repurchases not to exceed $500 million in 2025, and we expect the share count in the first quarter of 2025 to be flat to the fourth quarter of 2024. We expect capital expenditures of approximately $2.3 billion in 2025. This is consistent with our capital allocation priority to invest in our business and scale capacity for growth and marketed products and the pipeline. We expect to maintain strong investment-grade credit ratings as we continue to generate strong free cash flows, strengthen our balance sheet, and remain on track to return to our pre-horizon capital structure by the end of 2025. In 2025, we expect free cash flow performance to be similar to 2023. This decline is primarily driven by 2024 working capital favorability and incremental capital expenditures. Free cash flow in the first half of 2025 will be impacted by strong 2024 year-end collections timing. The shift in 2024 tax payments to the second quarter of 2025 and also the final $1.8 billion repatriation tax payment in the second quarter of 2025. Our long-term outlook remains strong, and I'm grateful to our colleagues worldwide for their dedication to serving patients. This concludes our financial update. I'll now hand it back to Bob for our Q&A session.

Okay, just to recap before we go to the Q&A session. As you can see, our results highlight the breadth and depth of opportunities across our business. And we exited the fourth quarter with 10 products growing at double-digit sales rate and 14 products annualizing at over a billion dollars. And for the year, to repeat, we had 21 products delivering record sales. So this momentum supports our outlook for 2025 and through the long term. And with that, we'd be happy to take questions.

Julianne, if you could please remind our of the procedures here.

Certainly. Thank you. If you would like to ask a question, please press star followed by 1 on your telephone keypad. If for any reason you would like to remove that question, please press star followed by 1. Again, to ask a question, press star 1. Our first question comes from Yaron Werber from TD Cowan. Please go ahead. Your line is open.

Great. Thanks for taking my question. Maybe just a couple of things. On 514, the one that's on clinical hold for obesity, can you comment, was that an incretin or not an incretin mechanism? And then secondly, maybe just for Myrto, a few things looked really strong. Mgivita was extremely strong at 294. Is that sustainable from now on? What drove that? Thank you.

All right, we'll take it in two parts. Jay, you want to address the 513, I think it is.

Thanks, Jeroen. AMG 513 is a novel investigational medicine for patients with obesity. It's currently in phase one investigation. We have not disclosed the mechanism of action. This remains a competitive space, as you know.

And Jeroen, it's Myrtle here. We're pleased with overall biosimilars performance in our biosimilar portfolio, as I mentioned. last year grew about 16%, and we're confident we can continue to grow that portfolio going forward, one of which those growth contributors will be Angevita.

Great. Julian, we'll go to the next question. I will remind folks we have quite a full queue today, so if you can limit yourselves to one question, that'd be great.

Thank you, Jeroen. Our next question comes from Courtney Breen from Bernstein. Please go ahead. Your line is open.

Hi, all. Thanks for taking my question today. I wanted to ask a little bit about Rapasa. Obviously, we're seeing kind of strong growth there and there's new indications coming, particularly in the primary prevention space. Can you just talk a little bit about kind of how you anticipate this market evolving as we think about the oral PCSK9s and Merck's coral reef lipids trial that is also scheduled to read out later this year. There seem to be suggestions that that could perform as well as an injectable in terms of the efficacy. So just wanting to understand how you would position. Thank you.

Yeah, thanks, Courtney. We're obviously very pleased with the performance of Repatha in 2024. putting up some very strong growth, both in volume and in revenues, both in the US and outside of the United States. And we expect to see that continue. We expect to be able to treat the many patients who have not had their LDL cholesterol optimized. And there's millions upon millions of these patients. We're barely scratching the surface when it comes to treating them. we think that Repatha offers a really ideal solution for patients to receive it and for prescribers to prescribe it. What we're really pleased about is the perception amongst prescribers now that Repatha is an easy to access medicine and an affordable medicine. And that's thanks to the efforts of our access teams around the world making sure that Repatha is appropriately reimbursed and positioned on formularies with PBMs and you know, we've been successful in removing those barriers. So we really are an inflection point in Repatha's performance and feel very, very good about the trajectory and momentum we established in 2024. With respect to new competition, you know, obviously there's more than just LDL cholesterol lowering evidence that needs to be introduced here. Repatha has clearly demonstrated benefit in secondary prevention of heart attacks, strokes, and other cardiovascular sequelae. And the goal, of course, as you mentioned, is that with the salience, which reads out later this year, that we'll be able to show that you can actually lower the risk of a first heart attack or stroke or other cardiovascular event. So we're kind of, we're in the mode of helping treat heart endpoints now in this market and not just lowering LDL. So we'll see what the evidence is and how it accumulates with not just the orals, but other competitors that are trying to come into this market. But again, obviously, Repatha is a very important growth driver for us now and into the future. All right, Julianne, take the next question, please.

Thank you, Courtney. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead. Your line is open.

Good afternoon. Thanks for taking my question. In the context of your 2025 sales guidance, can you speak to where you feel the street is underappreciating growth, and discuss how you factored in the Part D redesign to your projections. Thank you.

Let me take it in two pieces. Murdo, why don't you first start on the Part D redesign, and then Pete, why don't you jump in? Sure.

Yeah, the Part D redesign, at a total portfolio level for us, is relatively neutral. Between some chronic care cardiovascular products at an affordable price like Repatha tend to do well when patients out of pocket is capped and smoothed. And that's what we believe will happen for products like Repatha going forward. Peter?

Great. Murdo, thank you. Salveen, thank you for the question. I would just remind you what we've said, which is let's start from 10 products with a double-digit growth in 2024 over 2023, 14 products annualizing or at blockbuster status of a billion or more, and 21 that were records in 2024. So strong in-market portfolio, Salveen. So when we look at 2025, I'd really like to start with two and then add four more. So as he said, 100 million people around the world needing treatment. Visalia is coming later this year. And less price erosion, maybe mid-single digit or less this year on that. He talked about the strong access globally. So, you know, we expect Repatha to continue to be a strong medicine going forward. And the second on Avenity, you know, it's got low single-digit penetration. You know, greater than 90% of the high-risk patients in the U.S., you know, haven't been treated. And, you know, there's a significant unmet need there with Avenity. So... We think those two are very, very important. But let me also share, you know, Tespire, up 71% in 2024 to almost a billion dollars. I think it was $972 million of product sales. Innovative Oncology, up 11%, the seven innovative oncology products we have in 2024. We think that's a very strong portfolio to help patients with oncology and hematology issues. disease, a rare disease, up to about $4.5 billion in 2024. So they've got a ways to go. And when we think about those four, we see a lot of growth there and a lot of opportunity. But then we get to biosimilars. We shared with you 16% growth up to about $2.2 billion in 2024. We've got some launches coming this year. And so we continue to see a lot of growth in that. So We think there's a lot of opportunity to continue to grow this business in a strong way in 2025 and going forward. And as I shared in my opening remarks, we see that driving us right past the expiry on denosumab. So I'll leave it there. But we're very pleased with the business. And most importantly, we expect more medicine to more patients in 2025 around the world.

All right, Julian, let's go to the next question, please.

Salveen, our next question comes from David Amselem from Piper Sandler. Please go ahead. Your line is open.

Thanks. So I wanted to switch gears and get your thoughts on some of the Horizon products. Cristexa, how are you thinking about the growth runway there and the potential for a biosimilar down the road? And then also how you're thinking about about the competitive landscape for Tepeza. Thanks.

Sure.

Murdo, you want to jump in? Yeah, thank you, David. If we include the Horizon performance from the prior period, Cristexa was up 23 percent, Duplizna up 40 percent, Tavneos up 111 percent, and Tepeza up 5 percent. So this is, as Peter mentioned, overall it's a portfolio of products very early on in their lifecycle. with more data to flow, as is the case, of course, with Uclizna with our IGG4 data and additional GMG data coming on 52 weeks. So we have a number of catalysts that will grow our business in the U.S. And then we have catalysts for growth outside the U.S. with, of course, international launches and expansion, which is well underway with the recent approval of Tepeza in Japan. With respect to Cristexa overall, again, Even though Cristexa is part of our rare disease portfolio, severe uncontrolled gout is not a rare disease. It's not a rare condition. There are lots of patients out there who suffer continuously. And with the immunomodulation data, we are now able to help many of those patients. And so we see continued robust opportunity for growth there. And we're also looking to develop additional pipeline assets. And so Jay and his team are looking at those opportunities.

All right, Julian, we'll go to the next question, please.

Thank you, David. Our next question comes from Michael Yee from Jefferies. Please go ahead. Your line is open.

Hey, guys. Thanks for the question. Other than Meritide, you know, you've had one or two obesity assets have some slip-ups. Can you maybe comment about your strategic view about where you'd like to be in a couple of years if you are so confident on Meritide, given that everyone's chasing a multiple asset portfolio, including Oral's? and you seem to be pretty early stage outside of Meritide. So maybe just comment about your appetite there and whether you can add to the portfolio. Thank you.

Sure. Mike, I'm not sure we'd accept the premise, but anyway, let's talk about the portfolio of obesity programs. Go ahead, Jay.

Yeah, thanks, Mike. Akin to what Bob said, I wouldn't call these slip-ups at all. Early phase clinical investigation here at Amgen has a really high bar for what medicines go forward, and The next medicine up after Maritide did not meet that bar. Our obesity efforts fit very well with our strengths in cardiovascular disease, nephrology, and more generally, the emerging presence in primary care. And so we're very confident that we have all the talent, capabilities, ideas, and rising medicines to be a major player in obesity for the fullness of time, which we've studied for more than a decade. The research and early development pipeline has ideas targeting integrins, also non-integrins. We have medicines that will be given orally, others by subcutaneous administration. We're also interested to open partnerships through external innovation. And so we're very confident and merit-tied and very confident in the pipeline behind it.

Sorry, Jay, just to clarify one thing, the 513 is still, we still expect to have that development. We don't believe the issue that we referenced is related to the drug, but we'll go through the usual steps with the regulators on that. But Jay was referring to another product that we're no longer advancing that was previously in the clinic. So when he said it didn't pass the hurdle. But, again, we're excited about the program and the molecules that are coming forward to the clinic out of the obesity portfolio.

All right, Julian, let's go to the next question, please.

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

Oh, hey, congrats for this update. Since you've been here, Hey, Jay.

Jay, we can't hear you. Jay, sorry, we can't hear you. I want to take another start.

Can you hear me better now?

Yes, go ahead.

Oh, okay. Could you describe the key lessons you expect to learn from the Repatha Vesalia CV outcome study results, how you can leverage those lessons across your portfolio, including OPASRN and Meritide, and any synergies you plan to capture across these programs? Thank you.

Sure. Jay? Sure. Why don't I start, and then Myrtle will invite you to speak to synergies and the like. We've learned a lot from Repatha already. We have a leading capability in population genetics and epidemiology, and now the broad use of herpaphla and secondary prevention is a fantastic setup for vaselius CV. As you know, this is a Phase III large cardiovascular outcome study of more than 12,000 patients, placebo-controlled patients at high cardiovascular risk without prior MI or stroke. This is ongoing. We have an event-driven readout expected in the second half of this year. This will be a large and valuable data set for us to mine to understand the further improvement of cardiovascular outcomes for patients as relates to LDL-C, but also for other parameters. We have already harvested so many insights from RAPASA and carried that into the design and execution of the El Pasaran Phase III program, which, as you heard, is a It has an event-driven outcome, expected a readout in the second half of next year. So, a very valuable data set that will, no doubt, prompt significant further insights.

Thanks, Jay. And the synergies here are significant and substantial, given the leadership presence we have in LDL lowering and being able to apply that to LP little a lowering with Elpacerin, obviously, is successful in the readout of our phase three trial. I do think there's going to be some differences, though, given that Lp cannot be modified by lifestyle, diet, and exercise. There are no other generically available or branded available products that can lower Lp . We do think that the intentionality and the speed to move to a pharmacotherapeutic for Lp lowering will be different than it has been for LDL, but nonetheless, We're clearly engaged with all of the different stakeholders in the lipid-lowering and atherosclerotic market, and we're engaging them as appropriate to make sure that they understand the profile of opacerin and the design of the trial that Jay mentioned, and ultimately when we have results to share. All right, Julianne, let's go to the next question, please.

Thank you, Jay. Our next question comes from Alex Hammond from Wolf Research. Please go ahead. Your line is open.

Thanks for taking the question. So with more and more companies looking to China for innovation, what is Amgen's stance on looking overseas for clinical stage assets? And I guess more broadly, what is your appetite for M&A now post the Horizon acquisition? Thank you.

Our position on business development remains pretty consistent, Alex. We're focused on molecules that we think we can add value to irrespective of where they come from. We have had and maintain a very active search for interesting opportunities for licensing and acquisition all around the globe. And, yeah, we're open for business, looking for those opportunities.

All right, Julian, let's go to the next question, please.

Thank you, Alex. Our next question comes from Terrence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Hi, thanks so much for the question. Also just wanted to say my thoughts are with all those Amgen employees and everyone in the LA area who's been impacted by the devastating wildfires. I had a two-parter on Maritide. You know, I know you're doing part two of the phase two to explore quarterly dosing. Just wondering if there's an interim look there so you can incorporate that schedule into the phase three program if you decide to. And then was wondering if you can tell us if ADA is a fair assumption for presentation of the full Maritide phase two obesity data. Thank you.

Sure. Yeah, thanks, Terrence, for your question and really appreciate the call out for the associates here and the area residents facing these fires. We have, as you know, an ongoing part two of our phase two study in chronic weight management. That is a 52-week study, and we expect a data readout late this year. I can confirm that we look forward to presenting the Phase 2 Part 1 data at the ADA meeting in June this year in Chicago, and look forward to seeing you there.

All right, Julia, next question, please.

Thank you, Terrence. Our next question comes from Dave Reisinger from LeRank Partners. Please go ahead. Your line is open.

Yes, thanks very much. So I have sort of a simple question. Clearly, you've provided a lot of helpful pipeline updates on the call. So thank you for that. So my question, Jay, is could you just explain why you're announcing today the plans to initiate a new old passer and phase three trial and high risk patients when it's not going to be initiated until late 25 or early 26? what is pending, you know, initiating that trial. Thank you.

Again, Dave, maybe I just clarify. I mentioned this in January at JPM in the context, this is Bob speaking, Dave, in the context of what to expect for the year. But, Jay, go ahead and address the specific question if you'd like.

Yeah, no, nothing more to add. We have already announced our intention to initiate a Phase III clinical investigation of old-past-random primary prevention. This is a strong hypothesis for protecting patients with elevations of Lp and we hope to initiate this study, intend to initiate this study in the second half this year or in the first half next year. We just have a total commitment to the benefit of patients facing, in this case, genetically defined risk of cardiovascular disease.

All right, Julian, let's go to the next question, please.

Thank you, Dave. Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open.

Great. Thanks so much. Just wanted to talk through Tepeza and just how we should be thinking about growth in both the U.S. and internationally here. I guess specifically, can you talk about ex-U.S., the Japan opportunity and some of these new markets? And can we think about the rapid ramp that we saw in the U.S. kind of repeating itself in those markets or were these more gradual ramps as these roll out? Thank you.

Yeah. Hi, Chris. It's Murdo here. Thanks for the question on Tepeza. In Japan, the epidemiology is quite significant here. Roughly 25,000 patients is what we're talking about. The care model in Japan does reduce the friction that prescribers and patients experience in terms of finding access to the right physician and then access to a site of care. So we do expect there to be a pretty good uptake in this market. Not sure about the bolus dynamic that we saw in the United States. That did have some impact because it was a launch during the COVID period. So I'm not sure I would compare curves there. But I would expect steady penetration of the Japanese patient population. We know there have been over 550 patients already identified by prescribers. I was there for the launch at the end of last year. The weekly data are showing some pretty good steady momentum. And so Japan will be a very good source of growth for Tepeza internationally. As I mentioned, we've got seven other markets that we'll be launching in hopefully this year pending regulatory approvals. And we do see that international catalyst, that international growth as a catalyst for the overall brand. And it's obviously one of the things that drove the acquisition and the ability for Amgen's global footprint to bring these medicines to more patients. In the U.S., we continue to focus on broadening the prescriber base for TPEZA, so helping general ophthalmology and endocrinology diagnose not just the Graves' disease but also the thyroid eye disease and then find a site of care for patients to receive TPEZA treatment. Just one overarching comment I'll make on TPEZA. It does follow the pattern we see in some other products in our portfolio where that first quarter this year will be a little bit lower than the other three quarters, mostly a function of people having their insurance re-verified and or purchasing patterns in the market. So just something to watch out for. But long-term, Tepeza growth is looking very good given the international approvals and the momentum that we plan to generate in the U.S. All right, Julian, let's go to the next question, please.

Thank you, Chris. Our next question comes from James Shin from Deutsche Bank. Please go ahead. Your line is open.

Hey, guys. Thank you for taking my question. Any color on the indication for the maritime child that will start in first half 25? And can you say anything on whether or not maritime will have head-to-head against incumbents such as terzapatide or SEMA at this point? Thank you.

Yeah, thank you, James. The maritime phase three program has a focus on chronic weight management. on cardiovascular disease, kidney disease, type 2 diabetes, sleep apnea, heart failure, and possibly additional indications. As our discussions are at a rather mature state with the federal regulators, it would be premature to talk through any design principles around these trials at this time, but we look very much forward to initiating the Maritime Phase III program.

All right, Julian, let's go to the next question, please.

Thank you, James. Our next question comes from Tim Anderson from Bank of America. Please go ahead. Your line is open.

Thank you. I know Amgen commonly says it doesn't get enough credit by the street for its biosimilar business, so I'd like to ask about that and just one product in particular, Pavlu, the ILEA biosimilar. Why can't that be a very significant product for you guys as the only seller into that large market? probably for the next few years. It seems like it could, you know, get to a billion-dollar-plus type sales level. And can you give us some idea of what's in your 2025 guide for this? Thank you.

Okay, Tim, we couldn't hear very clearly the beginning of your question, but it seems that you're asking about biosimilars. Perhaps you suggested we don't get enough credit for what we do in biosimilars. If that's what you said, we're grateful. We are world leaders, you know, in biosimilars and Our focus has been to reliably supply biosimilars when we're appropriately able to enter the market, and our objective is to be amongst the first wave of biosimilar entrants, and that's what we've achieved with PAVBlue. But as to the specifics, Murdo, do you want to address Tim's question?

Yeah, Tim, as you know, we don't give product-specific guidance, but given your comments, I would say we're very pleased with how the launch is going. We, as Bob mentioned, always try to target being in the first wave. We find ourselves being the only biosimilar available in the market right now. And of course, that represents an opportunity that we will capitalize on. The current feedback from retina specialists that we've been talking to is very enthusiastic, very positive. They are pleased that Amgen is bringing yet another high quality biosimilar in a very easy to use prefilled syringe. Given the number of administrations these retina specialists do each and every day, that device is quite important. And thanks to our legal colleagues and our manufacturing operations and process development teams, they've done a very, very nice job of making sure that we have a path to helping many more patients with another Amgen biosimilar.

Maybe to add on just a little bit, Murdo and Bob, I would suggest, Tim, we build what we think obviously is an industry-leading biosimilar franchise. We operate very efficiently. We leverage the broader Amgen footprint, including manufacturing and operations. We believe we're earning attractive returns for our shareholders in this. When we pursue an opportunity, we deliver to date. Remind you that we have 100% success rate of FDA approval once we enter the clinic. And with $10 billion in cumulative biosimilar sales through 24, we're on track to double 2021 sales to over $4 billion by the end of the decade. I think this reinforces our leadership and ability to deliver attractive returns. So it's a really important question. We're delighted, and we think this is a good use of shareholder capital.

All right, Julianne, let's go to the next question, please.

Thank you, Tim. Our next question comes from Evan Siegerman from BMO Capital Markets. Please go ahead. Your line is open.

Hi there. This is Connor McKay on for Evan. Thanks for our question and congrats on the quarter. We just had one question on the Phase 3 rocket program with several readouts coming over the balance of the year. You know, what are you looking to see from those readouts to get comfortable with your competitive positioning in the atopic dermatitis market and sort of any updated thoughts on how you're thinking about that? Thank you.

Yeah, thanks for the question. Rokatinlumab, our T-cell rebalancing monoclonal antibody, targets the OX40 receptor. As you note, we are reading out this year a number of studies of this rocket program. This eight-study, more than 3,300-patient program really gives a lot of granularity, to answer your question, around the target product profile, the safety and tolerability of Rokatinlumab, and its full efficacy in patients with atopic dermatitis. In the shuttle study, we study rocatinlamab combination with topical steroids or calcineurins in adults with moderate to severe AD, day to first half of this year. In the IGNITE study, we study monotherapy in adults with moderate to severe, day to first half of this year. And then in the back half of the year, we have two studies, ASCEND and ASTRO. ASCEND will help us understand maintenance in adults and adolescents. And then ASTRO is an adolescent study with moderate to severe AD. And so, As you can tell, we're going to generate a lot of information about the potential to contribute to better therapy for this very common, in many cases, morbid disease, as well as the tolerability profile.

Great. Julian, I think we've got time for two more.

Certainly. Thank you, Evan. Our next question will come from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open.

Hi. Good afternoon, and thanks for taking my question, Bob and Tim. Bob, as you and the team talk about the global footprint and leveraging and penetrating new markets, I'm just wondering if you could comment a bit about the opportunity in China, and namely just about the commercial opportunity for those oncology medicines and how that's being achieved through your partnership with Beijing, and maybe just longer term, how is that in Beijing or V1 arrangement just factoring into those longer term goals? Thank you very much.

Maybe we'll take it in two parts. Let me just, at the high altitude perspective, reiterate what I said at the beginning, Gregory, which is that the business is growing globally. All three of our geographic regions are growing. Our Japan, Asia Pacific business is the most rapidly growing of our regions right now. So we're really pleased with the performance in Japan and China and elsewhere in the region. And the collaboration with Beijing continues to go well. And Murdo, feel free to jump in and address any specifics about the portfolio there and the plans.

Yeah, both elements of our business in China are performing well. The Amgen affiliate business is growing nicely. That's essentially Repatha and Prolia, both products doing well, both products listed on the national reimbursement drug list and growing rapidly, as Bob described. And with B1, formerly Beijing, our partnership, I think, has exceeded our expectations in China. The team execute extremely well across Caprolis, and we continue to enjoy that partnership and feel good about it. And obviously, we continue to work closely with them on the other R&D projects that we've partnered on. So overall, pleased with that.

All right, Julianne, we'll have time for one more question.

Thank you, Gregory. Our last question will come from Mohit Vanzal from Wells Fargo. Please go ahead. Your line is open.

Great. Thank you very much for taking my question. I have a question regarding dinosumab and mostly in the sense of how should we think about the cadence of biosimilar erosion, the biosimilars coming? I'm assuming it is more back half-loaded, but would love to get any color how you are thinking about that.

Sure. Murdo, do you want to address that for Mohit?

Yeah. Thanks, Mohit. Well, we have a bit of a clearer understanding on the timing of when biosimilars will enter given the settlements that we've reached. So, I would agree that the slope of the biosimilar erosion is going to be by definition of the timing more towards the back end. I would just encourage everybody to remember the cadence of biosimilar erosion in general. and the fact that we've got two slightly different situations here with HGIVA largely used in the oncology setting and probably are used in postmenopausal osteoporosis so that the slopes there could be different. But overall, we are in a good position given our participation in the biosimilar market. It teaches us lessons on how to defend successfully on the innovator side. We have a fairly large team of account executives that have been calling on our Xtiva and Polia accounts for many years now, and we are the bone market leader. And so there's a certain incumbency that we have that we think positions us well to defend against other biosimilar competition as the end of the market.

Okay. Well, thank you all for your interest, and I appreciate you joining the call. We'll look forward to catching up. after the next quarter. Thank you.

This concludes our 2024 Q4 and full year earnings call. You may now disconnect.