Q4 2024 Earnings Call Transcript

My name is Julienne, and I will be your conference facilitator today for Amgen's Fourth Quarter and Full Year 2024 Financial Results Conference Call. [Operator Instructions] I would now like to introduce Justin Claeys, Vice President of Investor Relations. Mr. Claeys, you may now begin.

Thank you, Julienne. 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 Murdo Gordon, Jay Bradner and Peter Griffith. 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 4 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 $1 billion. 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 EVENITY continued 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 EVENITY 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 TEPEZZA 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 rhinosinusitis, which runs in parallel with other respiratory diseases.

In oncology, our leading bispecific T-cell engager platform provides further opportunities for growth with BLINCYTO moving into frontline treatment and demonstrating compelling survival benefit in B-ALL. IMDELLTRA showing impressive efficacy in hard-to-treat small cell lung cancer and xaluritamig 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 MariTide in obesity and related conditions.

This is an exciting time for innovation in our laboratories, in our factories with the science and 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 EVENITY, 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-to-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 2 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. EVENITY sales increased 35% in 2024, reaching almost $1.6 billion in sales. EVENITY 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 the significant need, only 210,000 patients in the U.S. have been treated with EVENITY 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 EVENITY in 2025 and beyond. In the U.S., EVENITY continues to be the segment leader in the bone-builder market. We drove a 14% quarter-over-quarter increase in new customers ordering EVENITY and saw an increase in prescription volume from both established and new EVENITY prescribers. We've increased our investment in EVENITY and have fully shifted the focus of our U.S. bone field force towards EVENITY.

I'll move to our rare disease portfolio, which delivered over $4.5 billion in sales in 2024. TEPEZZA, 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, TEPEZZA 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 TEPEZZA 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 TEPEZZA, which will drive additional growth. And we've successfully launched TEPEZZA in Japan, where it's the first and only medicine approved to treat active thyroid eye disease. In 2025, we expect to launch TEPEZZA in 7 additional countries. In inflammation, TEZSPIRE continues its strong trajectory of nearly $1 billion in sales in the year, a 71% year-over-year increase.

We've driven increased adoption by pulmonologists supported by TEZSPIRE's unique profile to treat patients with multiple severe uncontrolled asthma triggers and drivers. TEZSPIRE 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 BLINCYTO, LUMAKRAS, Vectibix, KYPROLIS, Nplate, XGEVA and IMDELLTRA 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 IMDELLTRA, 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 IMDELLTRA 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 7 months since launch. We see increasing breadth of adoption in both academic and community settings driven by strong clinical conviction for IMDELLTRA's transformational efficacy. IMDELLTRA 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 IMDELLTRA 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 PAVBLU, a biosimilar to EYLEA, with 9 weeks of sales totaling $31 million. Response from retina specialists to PAVBLU has been very positive with strong intent to purchase and administer this high-quality Amgen biosimilar delivered in an easy-to-use prefilled syringe.

The next wave of biosimilar launches continues in 2025. In January, building on the strong introduction of PAVBLU at the end of 2024, we launched WEZLANA, a biosimilar to STELARA. And in the second quarter, we expect to launch BEKEMV, a biosimilar to SOLIRIS. 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 that 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 2 important U.S. regulatory approvals in oncology, completed 5 positive Phase III studies and initiated 3 new Phase III trials while advancing the broad MariTide program. Let's begin with MariTide, 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 MariTide'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 MariTide treatment.

With a further optimized simple dose-escalation schedule and significantly fewer injections per year, we expect to improve persistent and long-term health outcomes. MariTide 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 2 diabetes study and part 2 of the ongoing Phase II chronic weight management study.

Beyond MariTide, in general medicine, we look forward to data from the Repatha VESALIUS Phase III primary prevention study in the second half of this year. Having demonstrated profound and sustained benefit of Repatha 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 olpasiran, our promising best-in-class, small interfering RNA medicine targeting Lp(a), we are bringing a precision medicine to cardiovascular risk reduction for the many individuals with Lp(a) elevation. The fully enrolled OCEAN(a) Phase III cardiovascular outcomes trial of olpasiran continues to progress, and we expect to initiate an additional Phase III outcome study in patients with elevated Lp(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 UPLIZNA's potential to serve even more patients facing rare inflammatory illnesses. In 2024, we generated compelling data from the UPLIZNA 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 UPLIZNA for the treatment of generalized Myasthenia Gravis based upon 26-week data from the Phase III MINT study. This study showed UPLIZNA 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 2 anticipated approvals on the horizon in IgG4-related disease and generalized Myasthenia Gravis, we are more confident than ever about UPLIZNA's expanding impact on the management of rare inflammatory diseases. In inflammation, we remain on track to initiate Phase III studies of TEZSPIRE in COPD, targeting patients with moderate to very severe COPD with bloody eosinophil 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 TEZSPIRE 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 rocatinlimab Phase III ROCKET program in atopic dermatitis is progressing with additional data expected throughout 2025. These studies will provide deeper insight into rocatinlimab's profile. Beyond atopic dermatitis, we continue to explore rocatinlimab in moderate-to-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 blinatumomab and inebilizumab. 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 3 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 3-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 blinatumomab with a potentially registration-enabling study in adults and adolescents with relapsed/refractory B-ALL expected to begin in the second half of 2025. Based on our experience to date, subcutaneous blinatumomab has the potential to improve the patient experience, efficacy and tolerability.

Our second approved BiTE therapy, IMDELLTRA, 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 DeLLphi-304 are expected in the first half of 2025. This study compares IMDELLTRA with standard-of-care chemotherapy in second-line extensive-stage small cell lung cancer. Our first-in-class STEAP1 CD3 bispecific T-cell engager, xaluritamig, has entered Phase III clinical development with a study in post-taxane, metastatic castrate-resistant prostate cancer.

We are also exploring xaluritamig 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 with BLINCYTO, IMDELLTRA and xaluritamig. Beyond our T-cell engagers, bemarituzumab, our first-in-class fibroblast growth factor receptor IIb-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 bemarituzumab combined with mFOLFOX6 chemotherapy versus chemotherapy alone.

In the second half of 2025, we expect data from an analysis of FORTITUDE-102, a Phase III study of bemarituzumab combined with chemotherapy and nivolumab. On biosimilars, we are rapidly advancing 3 Phase III programs evaluating our biosimilars to OPDIVO, KEYTRUDA and OCREVUS, 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 the 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 MariTide, rocatinlimab, bemarituzumab and IMDELLTRA 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 pretax cost synergies by year 3 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 2 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 chain, 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 dividend 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, EVENITY, TEZSPIRE; 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 Otezla and Enbrel 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 MariTide and olpasiran. 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 MariTide and olpasiran. 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 1 to 2 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 OI&E 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 in marketed products and the pipeline.

We expect to maintain strong investment-grade credit ratings as we continue to generate strong free cash flow, 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 $1 billion. 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.

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

[Operator Instructions] Our first question comes from Yaron Werber from TD Cowen.

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 non-incretin mechanism? And then secondly, maybe just for Murdo. A few things looked really strong. AMGEVITA was extremely strong at 294. Is that sustainable from now on? What drove that?

All right. We'll take it in 2 parts. Jay, do you want to address the 513, I think it is.

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

And Yaron, this is Murdo here. We're pleased with overall biosimilars performance. And 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 -- of those growth contributors will be AMGEVITA.

Great. Julienne, we'll go to the next question. I will remind folks we have quite a full queue today. So if you can limit yourself to one question, that would be great.

Our next question comes from Courtney Breen from Bernstein.

I wanted to ask a little bit about Repatha. Obviously, we've seen 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 CORALreef 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.

Yes. 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 U.S. 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 are barely scratching the surface when it comes to treating them. And 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 we've been successful in removing those barriers. So we really are at 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, 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 sequel. And the goal, of course, as you mentioned, is that with VESALIUS, 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 hard 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.

Our next question comes from Salveen Richter from Goldman Sachs.

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?

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 here?

Sure.

Yes. The Part D redesign at a total portfolio level for us is relatively neutral between some [Technical Difficulty] chronic care cardiovascular products at an affordable price like Repatha tend to do well when patients' out of pocket is capped and smooth. 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 double-digit growth in 2024 over 2023, 14 products annualizing or at blockbuster status of $1 billion or more and 21 that were records in 2024, so strong end-market portfolio, Salveen.

So when we look at 2025, I'd really like to start with 2 and then add 4 more on to think about, Murdo talked about Repatha. 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 we expect Repatha to continue to be a strong medicine going forward.

And the second on EVENITY, it's got low single-digit penetration. Greater than 90% of the high-risk patients in the U.S. haven't been treated. And there's a significant unmet need there with EVENITY. So we think those 2 are very, very important.

But let me also share TEZSPIRE, up 71% in 2024 to almost $1 billion. I think it was $972 million of product sales. Innovative oncology, up 11%, the 7 innovative oncology products we have in 2024. We think that's a very strong portfolio to help patients with oncology and hematology disease. Rare disease, up to about $4.5 billion in 2024. And reminder, these are early life cycle products, and so they've got a ways to go.

And when we think about those 4, we see a lot of growth there and a lot of opportunities. But then we get to biosimilars. We shared with you a 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 -- 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.

Our next question comes from David Amsellem from Piper Sandler.

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

Sure. Murdo, do you want to...

Yes. Thank you, David. KRYSTEXXA, KRYSTEXXA had a very strong year in growth year-over-year. When we look at the performance from the prior period, KRYSTEXXA was up 23%; UPLIZNA up 40%; TAVNEOS up 111%; and TEPEZZA up 5%.

So this is -- as Peter mentioned, overall, it's a portfolio of products very early on in their life cycle with more data to flow as is the case, of course, with UPLIZNA 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 TEPEZZA in Japan. With respect to KRYSTEXXA overall, again, even though KRYSTEXXA 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.

Our next question comes from Michael Yee from Jefferies.

Other than MariTide, you've had 1 or 2 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 MariTide, given that everyone's chasing a multiple asset portfolio, including orals, and you seem to be pretty early stage outside of MariTide. So maybe just comment about your appetite there and whether you can add to the portfolio?

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.

Yes. 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 strength 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 in MariTide 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.

Our next question comes from Jay Olson from Oppenheimer.

Congrats [Technical Difficulty]...

Jay, sorry, we can't hear you. Take another start.

Can you hear me better now?

Yes. Go ahead.

Okay. Could you describe the key lessons you expect to learn from the Repatha VESALIUS-CV outcome study results, how you can leverage those lessons across your portfolio, including olpasiran and MariTide? And any synergies you plan to capture across these programs?

Sure. Jay?

Sure. Why don't I start and then Murdo, I 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 Repatha in secondary prevention is a fantastic setup for VESALIUS-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 it relates to LDL-C, but also for other parameters. We have already harvested so many insights from Repatha and carried that into the design and execution of the olpasiran Phase III program, which as you heard is -- it has an event-driven outcome, expected a readout in the second half of next year. So very valuable data set that will, no doubt, prompt significant further insights.

Thanks, Jay. The synergies here are significant and substantial given the leadership presence we have in LDL lowering and being able to apply that to Lp(a) lowering with olpasiran obviously is successful in the readout of our Phase III trial. I do think there's going to be some differences, though, given that Lp(a) cannot be modified by lifestyle, diet and exercise. There are no other generically available or branded available products that can lower Lp(a).

We do think that the intentionality and the speed to move to a pharmacotherapeutic for Lp(a) 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 olpasiran and the design of the trial that Jay mentioned and ultimately when we have results to share.

Our next question comes from Alex Hammond from Wolfe Research.

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?

We're -- 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. So we have had and maintained a very active search for interesting opportunities for licensing and acquisitions all around the globe. And yes, we're open for business, looking for those opportunities.

Our next question comes from Terence Flynn from Morgan Stanley.

Just wanted to say my thoughts are with all those Amgen employees and everyone in the L.A. area who's been impacted by the devastating wildfires. I had a 2-parter on MariTide. I know you're doing part 2 of the Phase II to explore quarterly dosing. Just wondering if there's an interim look there so you can incorporate that schedule into the Phase III program if you decide to?

And then I was wondering if you can tell us if ADA is a fair assumption for presentation of the full MariTide Phase II obesity data?

Sure. Jay?

Yes. Thanks, Terence, 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 2 of our Phase II study in chronic weight management. That is a 52-week study, and we expect data readout late this year.

I can confirm that we look forward to presenting the Phase II Part 1 data at the ADA meeting in June this year in Chicago and look forward to seeing you there.

Our next question comes from Dave Risinger from Leerink Partners.

So I have sort of a simple question. Clearly, you've provided a lot of helpful pipeline updates on the call. So my question, Jay, is could you just explain why you're announcing today the plans to initiate a new olpasiran Phase III trial in high-risk patients when it's not going to be initiated until late '25 or early '26? What is pending initiating that trial?

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

Yes. No, nothing more to add. We have already announced our intention to initiate a Phase III clinical investigation of olpasiran in primary prevention. This is a strong hypothesis for protecting patients with elevations of Lp(a).

We hope to initiate this study -- intend to initiate this study in the second half of this year or in the first half of next year. We just have a total commitment to the benefit of patients facing in this case, genetically defined risk of cardiovascular disease.

Our next question comes from Chris Schott from JPMorgan.

Just wanted to talk through TEPEZZA 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 are these more gradual ramps as these roll out?

Yes. Chris, it's Murdo here. Thanks for the question on TEPEZZA. In Japan, the epidemiology is quite significant here, roughly 25,000 patients, 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 TEPEZZA internationally. As I mentioned, we've got 7 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, 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 TEPEZZA. So helping general ophthalmology and endocrinology diagnose, not just the Gravis disease but also the thyroid eye disease and then find a site of care for patients to receive as a treatment. Just one overarching comment I'll make on TEPEZZA, 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 3 quarters, mostly a function of people having their insurance reverified and/or purchasing patterns in the market. So just something to watch out for.

But long term, TEPEZZA growth is looking very good given the international approvals and the momentum that we plan to generate in the U.S.

Our next question comes from James Shin from Deutsche Bank.

Any color on the indication for the MARITIME trials that will start in the first half '25? And can you say anything on whether or not MARITIME will have head-to-head against incumbents such as tirzepatide or sema at this point?

Yes. Thank you, James. The MARITIME Phase III 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.

Our next question comes from Tim Anderson from Bank of America Merrill Lynch.

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, PAVBLU, the EYLEA biosimilar, why can't that be a very significant product for you guys as the only seller into that large market, right, for the next few years? It seems like it could get to a $1 billion-plus-type sales level. And can you give us some idea of what's in your 2025 guide for this?

Okay. Tim, we couldn't hear the -- very clearly at 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 a world leader, as 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 PAVBLU. But as to the specifics, Murdo, do you want to address Tim's question?

Yes. 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 delivered to date. I would remind you that we have a 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.

Our next question comes from Evan Seigerman from BMO Capital Markets.

This is Conor MacKay on for Evan. Congrats on the quarter. We just had one question on the Phase III ROCKET program. With several readouts coming over the balance of the year, 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?

Thanks for the question. Rocatinlimab, our T-cell rebalancing monoclonal antibody targets the OX40 receptor. As you note, is -- we are reading out this year a number of studies of this ROCKET program. This eighth 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 rocatinlimab and its full efficacy in patients with atopic dermatitis in the SHUTTLE study.

We study rocatinlimab combination with topical steroids or calcineurin in adults with moderate-to-severe AD, data first half of this year. In the IGNITE study, we study monotherapy in adults with moderate-to-severe data first half of this year. And then in the back half of the year, we have 2 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 a better therapy for this very common in many cases, morbid disease as well as the tolerability profile.

Our next question will come from Gregory Renza from RBC Capital Markets.

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 BeiGene. And maybe just longer term, how is that BeiGene or BeOne arrangement just factoring into those longer-term goals?

Maybe we'll take it in 2 parts. Let me just at the high altitude reiterate what I said at the beginning, Gregory, which is that the business is growing globally. All 3 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 BeiGene continues to go well. And Murdo, feel free to jump in and address any specifics about the portfolio there and plans.

Yes. 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 BeOne, formerly BeiGene, our partnership, I think, has exceeded our expectations in China. The team executed extremely well across KYPROLIS, BLINCYTO and XGEVA. 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.

Our last question will come from Mohit Bansal from Wells Fargo.

I have a question regarding denosumab and mostly just a franchise, mostly in the sense of how should we think about the cadence of a biosimilar erosion with 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, want to address that for Mohit?

Yes. Thanks, Mohit. Well, we have a bit of a clearer understanding on the timing of when biosimilars will enter given the settlements 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 2 slightly different situations here with XGEVA largely used in the oncology setting and Prolia used in postmenopausal osteoporosis. So 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. And so we have a fairly large team of account executives that have been calling on our XGEVA and Prolia 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 they enter the market.

Okay. Well, thank you all for your interest, and I appreciate you joining the call. We 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.