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Amgen, founded in 1980 as Applied Molecular Genetics, is a major biopharmaceutical company. Its top-selling drugs treat autoimmune diseases like rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis; anemia; osteoporosis; and osteoarthritis. It also makes a number of oncology treatments, including Neupogen and Neulasta, which reduce infection risks for cancer patients undergoing chemotherapy, and Imdelltra, a recent treatment for extensive-stage small-cell lung cancer. The company works with doctors, medical clinics, dialysis centers, hospitals, and pharmacies, as well as distributes treatments through direct-to-consumer channels.

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Q4 2024

Amgen (AMGN): Company Profile, Stock Price, News, Rankings

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Amgen

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My name is Julianne, and I will be your conference facilitator today for Amgen's fourth quarter and full year twenty twenty four 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 and A session. I would now like to introduce Justin Clays, Vice President of Investor Relations.

Thank you, Julianne. Good afternoon, everyone, and welcome to our fourth quarter twenty twenty four 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 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 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 changing 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 $1,000,000,000 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 Aventity continue to deliver attractive growth. Heart disease remains the leading cause of death globally and Repatha now a multi billion 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, twenty twenty five will be an exciting year. We look forward to regulatory approvals for TAPESA internationally and launches in new indications for Euplizna further strengthening the growth trajectory of our rare disease business. In inflammation, we continue to be inspired by the strong performance of TESSPIRE 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.

Imdelta showing impressive efficacy in hard to treat small cell lung cancer and zalyoritimig advancing into Phase III in advanced prostate cancer. Twenty twenty five 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 miratide 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 02/1930 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 nineteen percent and ten 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 $1,000,000,000 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 $2,200,000,000 in sales.

There are one hundred 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 focus 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 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. EVENITY sales increased 35% in 2024 reaching almost $1,600,000,000 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 two hundred and ten thousand patients in The U. S. Have been treated with EVENITY to date, while millions remain at risk. With over ninety percent 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, Aveniti continues to be the segment leader in the bone builder market. We drove a 14% quarter over quarter increase in new customers ordering Aveniti 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 Fieldforce towards EVENITY. I'll move to our rare disease portfolio which delivered over 4,500,000,000 in sales in 2024. TAPESA, our largest product in the rare disease portfolio generated sales of $1,900,000,000 in the year, representing 5% year on year growth. Since launch, TAPESZA has had a positive impact for thousands of patients living with thyroid eye disease. There are roughly one hundred thousand patients suffering from thyroid eye disease in The U.

S. Who could benefit from TAPESZA 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 TAPESA, which will drive additional growth. And we've successfully launched TAPESA in Japan, where it's the first and only medicine approved to treat active thyroid eye disease. In 2025, we expect to launch TAPESA in seven additional countries.

In inflammation, TESTBIR continues a strong trajectory with nearly $1,000,000,000 in sales in the year, a 71% year over year increase. We've driven increased adoption by pulmonologists supported by TESTBIR's unique profile to treat patients with multiple severe uncontrolled asthma triggers and drivers. Testfire has strong future growth potential given the need to treat the two point five million patients worldwide with severe uncontrolled asthma. Our innovative oncology portfolio including Blincyto, Lumacraz, Spectabix, Kyprolis, Enplate, XGEVA and Imdelta contributed almost $8,000,000,000 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 Blinccyto and Indaltra continues to address critical unmet needs in oncology, while providing significant opportunities for future growth. LENCHYTO sales grew 41% for the full year, reaching over $1,200,000,000 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 Imdelta 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 $115,000,000 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 IN DELTARA's transformational efficacy. INVELTRO has treated approximately two thousand patients since launch. Each year an estimated eight thousand to ten thousand patients progress to second line treatment for extensive stage small cell lung cancer.

Our medical and commercial teams are operating with urgency to bring in Delta to more patients living with this aggressive disease. Sales of our biosimilar products were $2,200,000,000 in 2024, an increase of 16% year over year. In the fourth quarter, our team readily executed the launch of PABLU, a biosimilar to EYLEA with nine weeks of sales totaling $31,000,000 Response from retina specialists to PABLO 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 PABLO at the end of twenty twenty four, we launched Wislana, a biosimilar to Solara.

And in the second quarter, we expect to launch Bekendi, a biosimilar to Soliris. With the Snyx 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 and 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 three studies and initiated three new Phase three trials while advancing the broad Meritide program. Let's begin with Meritide, a therapy with 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 fifty two 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. Meritide 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 twenty twenty five, 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 twenty twenty five, 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 Meritide, in general medicine, we look forward to data from the Repatha Vassalius 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 opaciran, our promising best in class small interfering RNA medicine targeting Lp, we are bringing a precision medicine to cardiovascular risk reduction for the many individuals with Lp elevation.

The fully enrolled OCEAN A Phase three cardiovascular outcomes trial of opaciran continues to progress and we expect to initiate an additional Phase three outcome study in patients with elevated Lp and at high risk for a first cardiovascular event late this year or in the first half of twenty twenty six. 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 Aplisna Phase three 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 04/03/2025. The FDA also granted orphan drug designation to Aplisna for the treatment of generalized myasthenia MYST 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 fifty two 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 Aplisna's expanding impact on the management of rare inflammatory diseases. In inflammation, we remain on track to initiate Phase three studies of TESBIRE in COPD targeting patients with moderate to very severe COPD with blood 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 TESBIRE could have in this setting.

Beyond COPD, regulatory submissions are underway in chronic rhinosinusitis with nasal polyps supported by positive Phase three data and we continue advancing a Phase three study in eosinophilic esophagitis. The rocatinolumab Phase three ROCKET program in atopic dermatitis is progressing with additional data expected throughout 2025. These studies will provide deeper insight into rocatinolumab's profile. Beyond atopic dermatitis, we continue to explore rocatenlimab in moderate to severe asthma and inferrigo nodularis, a chronic skin condition characterized by extreme itchiness. As previously indicated, we are pursuing B cell depletion in autoimmune disease with both blinatumumab and ineboluzumab.

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 three data readouts. I will start with our rapidly advancing BiTE portfolio. Last December, very exciting Blinn Cyto data were shared at ASH and published simultaneously in the New England Journal of Medicine. In a Phase three study conducted by the Children's Oncology Group, Blinccyto added to chemotherapy improved three year disease free survival to ninety six percent

to eighty eight percent with chemotherapy alone in the upfront treatment of pediatric B cell acute lymphoblastic leukemia. We are also advancing a subcutaneous formulation of blinatumumab with a potentially registration enabling study in adults and adolescents with relapsed refractory B ALL expected to begin in the second half of twenty twenty five. Based on our experience to date, subcutaneous blinatumumab has the potential to improve the patient experience, efficacy and tolerability. Our second approved BiTE therapy, ImDeltra, a first in class bispecific T cell engager targeting DLL3 for small cell lung cancer is rapidly advancing into earlier lines of therapy. Phase three studies are ongoing in both extensive stage and limited stage disease.

Data from Delphi304 are expected in the first half of twenty twenty five. This study compares ImdeltaRA with standard of care chemotherapy in second line extensive stage small cell lung cancer. Our first in class, STEEP-one, CV3 bispecific T cell engager, zelaridimig, has entered Phase III clinical development with a study in post taxane metastatic castrate resistant prostate cancer. We are also exploring Xeleridomega in combination therapy and in earlier lines of prostate cancer with multiple Phase 1b studies ongoing. We remain excited about the growth potential of our BiTE platform and the opportunity to reach additional cancer patients with Placido, Imdeltra and zalaridimin.

Beyond our T cell engagers, bamiratuzumab, 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 twenty twenty five from FORTITUDE-one hundred and one, a Phase three study of amerituzumab combined with M FOLFOX six chemotherapy versus chemotherapy alone. In the second half of twenty twenty five, we expect data from an analysis of FORTITUDE-one hundred and two, a Phase three study of bamrituzumab combined with chemotherapy and nivolumab. On biosimilars, we are rapidly advancing three Phase three programs evaluating our biosimilars to Opdivo, KEYTRUDA and Acrevus, 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 $33,400,000,000 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 and D spend increasing 25% year over year for the full year to a record $5,900,000,000 due to investments in the late stage pipeline, including Meritide, rocatinlimab, bemarituzumab and Dimdeltra as well as Horizon acquired programs.

Excluding Horizon, non GAAP R and D spending increased 15% year over year. The Horizon integration is progressing well and we expect to reach the previously announced $500,000,000 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 $1,100,000,000 year over year almost entirely due to increased interest expense from the Horizon acquisition. We continue to strengthen our balance sheet with $4,500,000,000 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 $10,400,000,000 in free cash flow for the full year and $4,400,000,000 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 $1,300,000,000 in line with the guidance provided with the cash outflow being $1,100,000,000 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 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 $34,300,000,000 to $35,700,000,000 and non GAAP earnings per share between $20 and $21.2 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, Aavenity, Tezfire, 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 twenty twenty five to have a relatively similar year over year growth rate. A reminder as you model the first quarter of twenty twenty five and consistent with our historical trends, we expect Otezla and Embro 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 AMGA Vida sales in The U. S. To be in line with Q3 twenty twenty four.

For the full year, we expect other revenue to be approximately $1,400,000,000 In 2025, we are driving R and D investments to support our promising late stage pipeline, including Meritide and Opasoram. 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 and D expense to grow year over year in the mid teens in 2025 with investments increasing to advance key pipeline assets, including Meritide and Opasoram.

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 and 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 OI and E to be approximately 2,400,000,000 in 2025.

We expect a non GAAP tax rate of 15% to 16%. Similar to 2024, we expect share repurchases not to exceed $500,000,000 in 2025 and we expect the share count in the first quarter of twenty twenty five to be flat to the fourth quarter of twenty twenty four. We expect capital expenditures of approximately $2,300,000,000 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 flows, strengthen our balance sheet and remain on track to return to our pre horizon capital structure by the end of twenty twenty five.

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 twenty twenty five will be impacted by strong 2024 year end collections timing. The shift in 2024 tax payments to the second quarter of twenty twenty five and also the final $1,800,000,000 repatriation tax payment in the second quarter of twenty twenty five. 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 and A session.

Okay. Just to recap before we go to the Q and 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 rates and 14 products annualizing at over $1,000,000,000 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.

Certainly. Thank you. Our first question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open.

Great. Thanks for taking my question. Maybe just a couple of things on five fourteen, the one that's on clinical hold for obesity. Can you comment with that in incretin or not in incretin mechanism? And then secondly, maybe just for Murdo, a few things looked really strong.

And Javedo was extremely strong at February. 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 five thirteen, I think it is.

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

And Yaron, it's Myrtle 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 ANGAVEDA.

Julien, we'll go to the next question. I will remind folks we

you can limit yourselves to one question, that'd be great.

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

Hi. Well, thanks for taking my question today. I wanted

about Rhopasa. 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?

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 successfully 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, 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 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

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 under appreciating growth and discuss how you factored in the Part D redesign to your projection? Thank you.

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

Yes, the Part D redesign at a total portfolio level for us is relatively neutral between

given that 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. Myrtle, 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 $1,000,000,000 or more and 21 that were records in 2024. So strong end market portfolio Salveen.

So when we're on to think about, Murdo talked about Repatha. So as he said 100,000,000 people around the world needing treatment. This value 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 ninety percent 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 two are very, very important.

But let me also share your test fire up seventy one percent in 2024 to almost $1,000,000,000 I think it was $972,000,000 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 disease, rare disease up to about $4,500,000,000 in 2024. And reminder, these are early low and when we think about those four, we see a lot of growth there and a lot of opportunities. Then we get to biosimilars.

We shared with you 16% growth up to about $2,200,000,000 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, Julien. Let's go to the next question please.

Salveen, our next question comes from David Amsellem 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. 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 TAPESA? Thanks.

If we include the Horizon performance from the prior period, KRYSTEXXA was up 23%, VUPLISNA up 40%, TAPNIO is up 111% and TIPEZIA up 5%. 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 Uplizna with our IGG IV data and additional gMG data coming on fifty two 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 TAPESSA 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.

Julien. 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 Maritide, 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 orals 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?

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

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 Meritide 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.

Amgen (AMGN) Q4 2024 Earnings Call Transcript

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