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Murdo Gordon

Thanks, Bob. We've entered 2025 with strong momentum driven by strategic focus, disciplined execution and an unwavering commitment to the patients we serve. In the first quarter, Global Product sales grew 11% year over year. In the US, our largest region, product sales grew 14%. Globally, 14 products delivered double-digit or better growth, underscoring the breadth and depth of our portfolio and ability to deliver consistently and at scale.
Turning to General Medicine. Repatha sale increased 27% year over year, delivering $656 million in sales in the first quarter. Repatha is a brand built on deep clinical conviction. We're making meaningful improvements in access, helping more patients benefit from Repatha. With 100 million patients globally in need of effective LDL and cholesterol lowering, we see significant opportunity ahead to further broaden our impact and deliver long-term growth.
In the US, Repatha sales grew 26% in the first quarter with volume up 42%. This growth reflects steady expansion in the base of primary care prescribers and enhanced depth of prescribing amongst cardiologists. We're driving increased patient activation through direct-to-consumer efforts, leading more patients living with cardiovascular disease to ask their physicians about Repatha. Access in the US has never been stronger with many payers eliminating prior authorization requirements making Repatha more accessible and affordable for patients.
Outside the US, Repatha continues to deliver strong growth across major markets demonstrating sustained leadership amidst rising competition in the segment. Evenity sales increased 29% year over year to $442 million in the first quarter. Evenity is the only therapy that builds new bone and slows bone loss, uniquely positioning it to help reduce fracture risk in women who are postmenopausal. Despite this clear clinical value, fewer than 250,000 patients in the US have been treated to date, while millions remain at risk.
Today, more than 90% of very high-risk patients are not receiving appropriate therapy and that's a significant gap and a meaningful opportunity to drive growth by ensuring more patients receive the protection they deserve from Evenity. In the US, Evenity delivered 36% sales growth in the first quarter. And we focused our US bone field force on Evenity and increased investment in brand awareness. These efforts are driving meaningful growth in prescription volume across established and newly activated prescriber accounts. Prolia sales grew 10% year over year in the first quarter, with 13% volume growth, reaching almost $1.1 billion in sales.
I'll move to our rare disease portfolio, which grew 3% year over year, delivering $1 billion in sales in the quarter. I would note that within this portfolio, sales of TEPEZZA and KRYSTEXXA were adversely impacted in the quarter by changes to US wholesaler inventory levels. We do not expect similar reductions in inventory levels for the remainder of the year. Since launch, TEPEZZA has had a positive impact for thousands of patients living with thyroid eye disease.
In the US, there are roughly 100,000 patients suffering from TED 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 encouraged by the feedback that we're receiving from the medical community, including an increase in intent to prescribe reported by endocrinologists during the first quarter. Access has also improved for patients with more than 85% of medical plans, removing clinical activity score requirements. We're advancing our international expansion of TEPEZZA in Japan, TEPEZZA is now the first and only approved therapy for active thyroid eye disease. And in the first full quarter since launch, we've seen strong uptake and positive physician engagement.
In the European Union, we're preparing to launch following the recent positive opinion issued by the committee for medicinal products for human use on the approval of TEPEZZA for the treatment of moderate to severe thyroid eye disease in adults. This marks a significant step forward for patients living with TED who currently have no approved disease-modifying therapies available to them in Europe.
UPLIZNA sales increased 14% year over year to $91 million in the first quarter, driven by continued growth in treating patients with neuromyelitis optica spectrum disorder. In April, UPLIZNA was the first approved breakthrough therapy in the US for the treatment of adults with immunoglobulin G4 related disease or IgG4 a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The launch is underway in the first patient with IgG4 disease was treated shortly after approval.
Amgen's many years of experience with rheumatologists have been helpful in establishing urgency to diagnose and treat patients suffering from IgG4-related disease with UPLIZNA. In inflammation, Test fire delivered another strong quarter, up 65% year over year adoption among pulmonologists is growing, driven by test buyer's unique profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma.
We see significant growth opportunity for Test fire to treat the 2.5 million patients worldwide who suffer from this challenging disease. Our innovative oncology portfolio, including BLINCYTO, IMDELLTRA, LUMAKRAS, Vectibix, KYPROLIS, Nplate and XGEVA grew 10% year over year generating over $2 billion in sales in the quarter. At the core of this growth is our industry-leading bispecific T cell engager platform, which developed both BLINCYTO and IMDELLTRA.
With these products, we're not only addressing critical unmet needs in oncology. We're helping to redefine the standard of care in difficult-to-treat cancers, creating meaningful opportunities to reach more patients and drive long-term growth. Blood cycle sales were $370 million in the quarter with year over year growth of 52%, driven by broad prescribing across both academic and community segments. We see strong conviction in BLINCYTO as the standard of care for both adults and pediatric patients with Philadelphia chromosome-negative B-cell ALL.
Our US launch of IMDELTRA for the treatment of patients with extensive stage small cell lung cancer who are progressing on or after chemotherapy continues its strong momentum, generating $81 million in sales in the first quarter. To date, IMDELTRA has been administered in patients in academic cancer centers, regional cancer hospitals and community oncology clinics, indicating broad adoption and comfort with this important new cancer therapy.
In April, we expanded our global reach with the launch of IMDELLTRA in Japan, marking an important step forward in our commitment to bringing innovative oncology therapies to patients around the world. Momentum behind IMDELTRA is being reinforced by compelling new data. We recently announced new clinical data demonstrating that IMDELLTRA met the primary endpoint of superior overall survival in small cell lung cancer compared to standard of care chemotherapy. This is a meaningful confirmation of IMDELTRA's efficacy for patients facing one of the most aggressive and difficult-to-treat cancers. And our field teams are acting with urgency and their educational efforts with the medical community.
Biosimilar portfolio sales were $735 million in the first quarter, representing an increase of 35% year over year. Sales of PAVBLU, the biosimilar to EYLEA reached $99 million in the first quarter. Retina Specialists are responding very positively to PAVBLU, expressing appreciation for this high-quality Amgen biosimilar delivered in an easy-to-use prefilled syringe.
Importantly, on April 1, PAVBLU received its permanent reimbursement Q code, which will facilitate easier access for patients. We're also pleased with the successful US launches of WEZLANA, a biosimilar to STELARA and BEKEMV, a biosimilar to Soliris. Both launches have been received well by our patient and prescriber communities. We expect these recent launches will further enhance the robust growth and attractive returns from our biosimilar portfolio.
2025 is off to a strong start with double-digit growth across our broad and deep portfolio. Looking ahead, we see significant growth potential powered by disciplined execution, a high-performing team and above all, a clear and unwavering commitment to the patients we serve.
I'll now hand it over to Jay.

James Bradner

Thank you, Murdo, and good afternoon, everyone. The first quarter has been exceptionally productive for R&D, extending our track record of high-quality on-time execution and highlighted by significant clinical and regulatory achievements. Most notably, we received FDA approval for UPLIZNA in IgG4-related disease, the second approval in a series of B cell-mediated diseases we are studying with this medicine. We also announced positive data from Phase 3 studies of rocatinlumab, UPLIZNA and IMDELLTRA, while initiating multiple Phase 3 trials of Mirati and TEZSPIRE.
Let's begin with Mirati, our investigational therapy for obesity and obesity-related conditions that features a unique and differentiated profile. In March, we initiated 2 Phase 3 studies in chronic wave management as part of our comprehensive MARITIME Phase 3 program. These trials will evaluate MariTide in two distinct populations, adults living with obesity or overweight without type 2 diabetes and adults with obesity or overweight with type 2 diabetes. Both studies will assess the safety, efficacy and tolerability of three target dose levels of MariTide preceded by an optimized dose escalation regimen to improve the patient experience. The primary endpoint for each study is the change from baseline body weight at 72 weeks.
Beyond these first two studies, we anticipate initiating additional MariTide Phase 3 studies later this year, evaluating MariTide in specific obesity-related conditions. Last November, we presented top line results at 52 weeks from our Phase 2 chronic weight management study, which highlighted MariTide's monthly or less frequent dosing, consistent, predictable and sustained weight loss across all doses without a weight loss plateau through 52 weeks and MariTide's clinically meaningful impact on cardiometabolic parameters, including hemoglobin A1c.
At the American Diabetes Association or ADA Annual Meeting this June, the underlying details from this Phase 2 study at 52 weeks will be presented. Clear from these data is the important finding that dose escalation which was studied in 2 of the treatment arms, meaningfully improved tolerability, in particular, rates of nausea and vomiting as compared with fixed dose administration, which was used in the other 7 treatment arms.
This finding is consistent with the clinical experience to date with GLP-1-based therapies and was further supported by our Phase 1 pharmacokinetic study that tested even lower starting doses of MariTide. Details from this study will also be discussed at ADA. These learnings have informed the design of our 2 Phase 3 studies of MariTide for chronic weight management, which are open and enrolling robustly.
Looking ahead to the second half of 2025, we expect key data for MariTide, including both the ongoing Phase 2 type 2 diabetes study, which has completed enrollment as well as end of treatment period data from Part 2 of the ongoing Phase 2 chronic weight management study. MariTide represents a promising treatment advance for people living with obesity and related conditions, especially given its monthly or less frequent dosing, predictable and sustained weight loss and clinically meaningful impact on cardiometabolic parameters, we are committed to fully realizing its therapeutic potential.
Beyond MariTide, in General Medicine, we look forward to data from the Repatha Vesalius Phase 3 primary prevention study in the second half of this year. Given the profound and sustained benefit of Repatha in the secondary prevention setting, we're optimistic about these data and the potential 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 approach to cardiovascular risk reduction for the many patients with Lp(a) elevation. The fully enrolled OCEAN A Phase 3 cardiovascular outcomes trial of Olpasiran continues to progress.
Moving on to our rare disease portfolio. We are very excited about UPLIZNA's expanding potential to improve the lives of those facing rare inflammatory conditions. In April, the FDA approved UPLIZNA as the first and only treatment for adults living with immunoglobulin G4-related disease, delivering durable disease control in this recently described chronic and debilitating immune-mediated inflammatory condition that often affects multiple organ systems.
UPLIZNA is an innovative biologic that targets CD19 positive B cells and addresses a core driver of IgG4-related disease, significantly reducing disease flares and dependence on harmful long-term steroid treatment. Additionally, we recently presented compelling 52-week data from our pivotal Phase 3 MINT study, evaluating UPLIZNA in patients with generalized myasthenia gravis. These results demonstrated durable and sustained efficacy of UPLIZNA in patients with acetylcholine receptor autoantibody positive generalized myasthenia gravis with only two doses a year following an initial loading dose.
The 52-week MINT results highlight UPLIZNA's promise as a new standard of care in generalized myasthenia gravis, offering durable and sustained symptom relief with a simplified treatment regimen while minimizing steroid use.
Since the publication of these data, we have met with numerous opinion leaders who are also enthusiastic about UPLIZNA profile, highlighting the unique mechanism of action, patient-centered every six month dosing schedule and durable sustained efficacy. We are also pleased to announce that the FDA has accepted the regulatory submission of the UPLIZNA MINT Phase 3 generalized myasthenia gravis data with a PDUFA date of December 14, 2025.
The recent FDA approval in IgG4-related disease and the strong clinical evidence in myasthenia gravis, underscore Amgen's ongoing leadership in developing innovative treatments targeting CD19 positive B cells in cancer, inflammation and in rare disease more generally, where only 5% of the estimated 10,000 rare diseases have available treatments.
In inflammation, we and our partner, AstraZeneca, have initiated 2 Phase 3 studies of TEZSPIRE in chronic obstructive pulmonary disease, 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 TEZSPIRE could have in this setting. Beyond COPD, we completed the regulatory submission of TEZSPIRE's Phase 3 data for chronic rhinosinusitis with nasal polyps and look forward to a PDUFA date of October 19, 2025.
In March, we announced data from three additional Phase 3 studies from the rocatinlumab ROCCAT program in atopic dermatitis, notably IGNITE, which met its primary and key secondary end points. We look forward to additional data from the ROCCAT program in the second half of 2025.
In oncology, we recently announced compelling results for IMDELLTRA from our DeL5304 Phase 3 trial, where at a planned interim analysis, the study met its primary endpoint, demonstrating a significant and clinically meaningful overall survival benefit. CellF304 evaluated IMDELLTRA in patients with small cell lung cancer who progressed on or after initial platinum-based chemotherapy versus chemotherapy alone.
These randomized data are the first to show a substantial survival improvement head-to-head against standard of care chemotherapy, offering new hope for patients with this difficult disease. Together with the remarkable Del 5301 data already reported, IMDELLTRA has the potential to become the new standard of care for second-line small cell lung cancer. As an oncologist, I'm really encouraged by IMDELLTRA as a new and highly efficacious therapy for an aggressive and common solid tumor for which there has been very little progress.
We look forward to sharing more detailed results at the upcoming ASCO meeting in early June. In addition to Delphi 304, we continue to investigate IMDELLTRA in earlier lines of small cell lung cancer. Currently, 2 Phase 3 studies are underway, and we are pleased to announce plans to initiate Delphi 312, a Phase 3 trial evaluating IMDELLTRA as induction and maintenance therapy in first-line treatment of extensive stage small cell lung cancer, here in combination with carboplatin, etoposide and durvalumab. We also continue to investigate our CD19 directed BiTE medicine BLINCYTO in earlier treatment settings, while also advancing a subcutaneous formulation of blinatumomab.
In April, the FDA granted Breakthrough Therapy designation for subcutaneous blinatumumab in the treatment of adults with relapsed/refractory CD19-positive B-cell precursor acute lymphoblastic leukemia. Based on our experience to date, subcutaneous blinatumumab has the potential to improve both the patient experience and efficacy. Our first-in-class STEAP1 CD3 bispecific T cell engager Xaluritamig, is advancing in Phase 3 clinical development, where we are rapidly enrolling patients with metastatic castrate-resistant prostate cancer who will progress following taxane-based therapy. We are also exploring Xaluritamig in combination therapy and in earlier stages of prostate cancer with multiple Phase Ib studies ongoing.
Collectively, IMDELLTRA, BLINCYTO and Xaluritamig exemplified the significant growth potential of our robust bispecific T cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide. Beyond our T cell engagers, our first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody bemarituzumab is advancing the frontline gastric cancer therapy.
We expect data this quarter from FORTITUDE 101, a Phase 3 study of omerituzumab combined with MFFOX6 chemotherapy versus chemotherapy alone. In the second half of 2025, we expect data from FORTITUDE-102, the Phase 3 study of omirituzumab combined with chemotherapy and nivolumab versus chemotherapy nivolumab alone. On biosimilars, we are rapidly advancing 3 Phase 3 programs, evaluating our biosimilars to Opdivo, KEYTRUDA and OCREVUS as the next wave of Amgen biosimilar products.
In closing, I want to take Amgen colleagues for delivering on a number of important milestones so far this year and for their relentless focus on the patients we serve.
I'll now turn it over to Peter.

Peter Griffith

Thank you, Jay. We're pleased with our strong first quarter performance and are on track with our 2025 full year goals and long-term objectives. The financial results are shown on slides 29 to 30 of the slide deck. In the first quarter, we delivered revenues of $8.1 billion, a 9% increase year over year. This reflects double-digit sales growth of 11%, driven by 14% volume growth from key brands, including Repatha, BLINCYTO, TEZSPIRE and EVENITY, partially offset by 6% lower net selling price. Our non-GAAP operating expenses rose 4% and led by non-GAAP R&D growth of 12% year over year, reflecting continued investment in our late-stage pipeline, including MariTide, olpasiran and rare disease.
Our Q1 non-GAAP operating margin was 45.7%. This is above the outlook we gave on the fourth quarter earnings call, in part due to the timing of R&D spend now expected primarily in the second quarter, including milestone payments and other investments.
The Horizon integration has progressed well, and we expect to reach the previously announced $500 million in pretax cost synergies by the end of this year. Our non-GAAP OI&E was down $53 million year over year, driven by lower interest expense through retirement of debt, including $4.5 billion in 2024 and and $2.9 billion in the first quarter of 2025. In addition, we repaid $1 billion today as we continue to progress the strengthening of our balance sheet.
Since the announcement of the Horizon acquisition, we have now retired $10.8 billion of debt. Our non-GAAP tax rate decreased 0.8 percentage-points year over year to 14.6% and primarily due to the change in earnings mix. The company generated $1.0 billion in free cash flow in the first quarter, reflecting continued investment in growth and operational momentum across the business. We spent $400 million in the first quarter on capital expenditures, driven by investments across our manufacturing sites, including Ohio, North Carolina and Puerto Rico.
For 2025, we expect no change in our capital expenditures outlook of $2.3 billion, which will support our products across the portfolio and our innovative pipeline, including MariTide. Our commitment to innovation is also evident as we deploy artificial intelligence across the value chain, informing molecule design and discovery research, enabling faster trial enrollment and streamlining regulatory filings and clinical development and enhancing our responsiveness to customers in commercial operations. In addition, we returned capital to shareholders as we paid competitive dividends of $2.38 per share, representing a 6% increase compared to the first quarter of 2024.
Let's turn to the outlook for the business for 2025 on slide 31. We are reaffirming our 2025 total revenue guidance in the range of $34.3 billion to $35.7 billion and also reaffirming our non-GAAP earnings per share guidance between $20 and $21.20. This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future including potential sector-specific tariffs.
In addition, let me highlight a few updates to our outlook for the remainder of the year. We now expect non-GAAP R&D expense to grow approximately 20% in 2025 versus growing mid-teens previously, reflecting increased investments to advance key late-stage pipeline assets, including MariTide and olpasiran. We now anticipate non-GAAP OI&E to be approximately $2.3 billion in 2025. We now expect a non-GAAP tax rate of 14.5% to 16%. And for WEZLANA in the United States, we now expect quarterly sales to fluctuate and do not expect any sales in the second quarter following a large sales ordered in the first quarter.
And let me remind you of prior items that have not changed to our outlook for the remainder of the year. For the full year, we continue to expect other revenue to be approximately $1.4 billion. We continue to project that full year non-GAAP operating margin as a percentage of product sales to be roughly 46%. We expect share repurchases not to exceed $500 million in 2025. We continue to expect 2025 free cash flow performance to be roughly comparable to 2023.
As mentioned on our fourth quarter earnings call, this decline is primarily driven by 2024 working capital favorability and the incremental capital expenditures. Free cash flow in the second quarter will be impacted by the shift in 2024 tax payments to Q2 '25 and the final $1.8 billion repatriation tax payment. I know there's a lot of interest in taxes and tariffs. We understand the impetus for increasing US investment in manufacturing.
Amgen has a robust manufacturing presence in the United States, including Puerto Rico. And of course, has invested for decades in the United States-based research and development. To build on the manufacturing base in the US, we agree with our peers, but the most effective answer is not tariffs but tax policy. In fact, for Amgen and others, investment in manufacturing has significantly increased since President Trump's 2017 Tax Cuts and Jobs Act.
In part, based on the expectation of continued pro-growth tax policy, we recently announced among other investments in the United States that we are more than doubling down on our investments in manufacturing capacity in North Carolina and Ohio. We are focused on delivering sustained long-term value for patients and shareholders by doing what we said we would do growing leadership in the United States and internationally, driving innovation in areas of high unmet medical need and maintaining rigorous financial discipline. We continue to focus on execution excellence across the enterprise and remain well positioned for sustained growth through the long term.
I'm grateful to work with all of our colleagues worldwide in serving patients. This concludes our financial update. I'll hand it back to Bob for our Q&A session.

Robert Bradway

You remind our callers please of the procedure for asking questions.

Question and Answer Session

Operator

(Operator Instructions)
Terence Flynn, Morgan Stanley.

Terence Flynn

Congrats on all the progress. I was just wondering, Jay, if you could help frame for us what we should be looking for at ADA with respect to MariTide. I know it's going to be the first detailed the Phase 2 data. But what do you think kind of the key message and key learnings coming out from that will be? And then the kind of related question is I know there's a lot of focus on the potential CVOT trial that you guys are like we plan to conduct with MariTide in the design. So just wondering if you could comment at all on the potential control arm there.

James Bradner

Yeah. Thanks, Terence, for the question. Really looking forward to the ADA. We've already shared the salient data from the Phase 2 chronic weight management study, weight loss and excellent tolerability at 52 weeks. So what we call Part 1 on that trial as well as data from a dedicated Phase 1 pharmacokinetic study. And the key insights remain unchanged, strong efficacy, no plateau to 52 weeks, monthly MariTide, very well tolerated at the target dose that the dose escalation works and comes without any compromise to weight loss, also strong activity on cardiometabolic parameters, including A1c.
So the ADA will focus on these insights as well as some underlying details of the 2 trials. It will feature some new mechanistic data, including some recently published data in Nature metabolism that serves to really validate the mechanism of action, the dual mechanism of action of MariTide. We're looking forward to sharing these details at ADA, hearing from the presenters who are true leaders in the field. And following the session, we intend to have an IR call after the event to take questions reflect on the results through 52 weeks.
But here at Amgen, we're on to Phase 3. Oh, yes. And on the CVOT study, we won't share any details today regarding the CVOT study. But with our 2 Phase 3 chronic weight management programs now open and enrolling, enrolling well. We are working to initiate a broad Phase 3 program that includes ASCVD, heart failure studies, chronic kidney disease, obstructive sleep apnea and other indications of interest, and we'll have more to share in the fullness of time about the details of these trials.

Robert Bradway

Okay. Thanks, Julien. Let's go to the next caller.

Operator

Salveen Richter, Goldman Sachs.

Salveen Richter

With regard to UPLIZNA in IgG4 as given the recent approval as well as myasthenia gravis, could you just help us understand the commercial strategy, including the relevant prescribers and patient identification efforts for the former?

Murdo Gordon

Yeah. Salveen, it's Murdo. Thanks for the question on is UPLIZNA. We're obviously quite excited about the opportunity to be the first approved therapy for IgG 4. It's a condition that is primarily diagnosed and I should say recently, there's been the evolution of a diagnostic code, which really only was introduced in October 2023. So it's been a relative recent phenomenon to actually have formal diagnostic criteria in a code for this disease.
But primarily diagnosed and managed by rheumatologists, You do see on occasion gastroenterologists, sometimes neurologists, just given the way in which the disease might manifest in the organ involvement. Obviously, because of Amgen's very long history in dealing with inflammation and autoimmune diseases, we've got very good presence here with the key customer types and key prescribers.
We have had a field force deployed for several months now profiling and engaging with the relevant physician community. So we're hitting the ground running, so to speak, with the approval. The epidemiology here is roughly 20,000 patients in the US and we're excited to have that impact. This is a horrible disease. People really do not fare well when this flares and UPLIZNA a highly effective product as part of the clinical data generated thus far.
And then on GMG, we're really thrilled with the opportunity to go into a competitive category with a very different mechanism than the drugs that are available today. Again, this is a therapeutic area where we have an installed presence with the key prescribing community. So optimistic that when we secure approval for this indication that we'll be thrilled. I don't know, Jay, would you want to add anything on GMG?

James Bradner

Yeah. I mean reflecting also on IgG4, we think a lot about how will this fit into the standard of care in both diseases. And IgG4-related disease has no standard of care. These are patients with chronic inflammatory painful protein symptoms, recurrent flares and we saw an 87% reduction in disease-specific flare activity. And so this hopefully becomes a powerful new standard of care.
And then in GMG, this medicine stacks up really well to what physicians and patients have access to today. We had a chance to share back in April, and it was also simultaneously published in New England Journal, the really strong data from the Phase 3 MINT trial. And we put up just outstanding efficacy data against the myasthenia gravis activity of daily living score we showed activity in both important subpopulations of patients, acetycholine receptor positive and must positive. And -- this medicine is -- provides a durable benefit to patients.
It's given every six months. I think which really suits the lifestyle of people who will then feel hopefully very healthy. and it's quite convenient for them to receive. But most importantly, it targets the core biology. This is a disease caused by pathologic auto antibodies. And here, we are targeting the cell that elaborate those antibodies. So we feel very hopeful that UPLIZNA will be an important new standard of care in generalized by myasthenia gravis.

Operator

Michael Yee, Jefferies.

Michael Yee

Maybe for Jay, I often hear about two narratives on the obesity program. One is the tolerability remains high. And I know you've gone to a lower titration. So I'm curious about your confidence that we will see very competitive tolerability and very strong efficacy and that, that narrative will hold up? And secondly, that there's a competitor out there -- oral data, which apparently is going to have a huge market share. And so you don't have an oral. Maybe you could respond to either of those and how you're going to be competitive against these developments that have played out.

Robert Bradway

Yeah, Mike. Why don't I start on tolerability and then Murdo ask you if you wouldn't mind to weigh in on the development of oral medicines and their importance. Mike, we feel very confident -- I feel very confident about the tolerability and efficacy that we stand to observe in the Phase 3 clinical study, it is very well informed. By the strong efficacy that we saw in Phase 2 Part 1, the 52-week data, where we observed across the range of doses, significant benefit to patients with measurable weight loss as high as 20%.
The tolerability we learned, as have others in the field that GLP-1-based mechanisms of action benefit from dose escalation, benefit from lower starting doses, we confirmed these insights in a dedicated Phase 1 pharmacokinetic study, and we've taken the directionality of those 2 trials into the design of Phase 3, which when we can share this with you, will surely underscore that the design is constructed to deliver competitive, both efficacy and tolerability in patients with and without type 2 diabetes. Murdo about oral?

Murdo Gordon

Yeah. Thanks, Mike. We have obviously accounted for a segment of the market to be an oral market. We do anticipate, given the size of the obesity category, a relevant opportunity for orals to come in. Thus far, of course, we haven't seen necessarily the same degree of weight loss being achievable with orals as we've seen with MariTide.
And of course, MariTide really, given its monthly or even less frequent dosing, we think will be less vulnerable to orals, which are certainly going to come in and display some of the weekly GLP-1s that are incumbent in the market today. I would also just say that we are pursuing other products in our early pipeline that are both large molecule, small molecule, oral and self-administered incretin and non-incretins. So we really are looking at oral and non-oral mechanisms ourselves.

Operator

Trung Huynh, UBS.

Trung Huynh

Great. Just on Repatha, which has been doing well for a number of quarters now. In our recent doc checks, some have pointed to an increasing preference for Novartis' (inaudible) because of the buy-and-build program for that drug. Do you see increasing commercial competition from like they are in general? And going forward, there is going to be some late-stage data oral PCSK9 this year. What's your thoughts about the entry of those products?

Murdo Gordon

Yeah. Thanks for the question, and thanks for noticing the growth in Repatha and the trajectory that we're on. The short answer to your question is yes, there's competition in the market. And yes, Leqvio definitely treating patients both in the US and in some other markets around the world. I would say though that we still believe we have the best profile in the PCSK9 category given the ability to profoundly lower LDL cholesterol, the fact that we've generated cardiovascular event reduction. We have ongoing additional clinical trials to further expand the understanding of how Repatha when added to conventional therapy, can actually further reduce cardiovascular risk in a primary prevention, high-risk population.
So we do think that there's -- the class here is so underpenetrated in terms of the millions -- tens of millions, quite frankly, of patients who are at risk that really, there is room for competition and the fact that we have the momentum that we have, despite the growth of some of the other products in the category, should tell you that we continue to find ways to help new patients received the Repatha therapy that they should.
The last piece of this, of course, is we have done a lot of work as Amgen to open up access and affordability for patients. And so we now have the commercial insured patients in the US, 50% which have no prior authorization requirement to receive approval for their therapy. So they're really the barriers that once we're there in obtaining Repatha have largely dissipated. So we're growing nicely. We continue to promote the primary care. We've invested in direct-to-consumer advertising now, and we expect a strong growth trajectory to come.

Operator

Evan Seigerman, BMO Capital Markets.

Evan Seigerman

So with the Q code in place, can you help us think about the near-term uptake of PAVBLU in the field? And are you seeing any pronounced shift to the biosimilar following the defunding at the patient's assistance charities?

Murdo Gordon

Thanks for the question, Evan. We're obviously pleased with our biosimilar portfolio in general. We had a strong quarter there. PAVBLU has been well received by the retina specialist community. They like the high-quality biosimilar. They really like our prefilled syringe device that we launched. And we expect to continue to be able to help many patients and serve many patients with this product. We're working on contracting with a larger retina specialist groups and we'll have more to say as the year progresses. And then Amgen is happy to support patients through the charitable donations that we make to various agencies.

Operator

Chris Schott, JPMorgan.

Chris Schott

Just a question on the incretin payer environment. I think we've seen some concern in the market today about more aggressive payer behavior with the CVS -- announcement. I'm just interested and how you're thinking about these payer dynamics, potential new entrants in that space over time?

Murdo Gordon

Yeah. Thanks for the question, Chris. Look, our focus in any payer environment, and it will be with the obesity categories to help make our products as available as possible to a large segment of the population. I think we're still all understanding what happened with the recent decision I believe you'll be referring to the CBS change that was announced. I do think, overall, PBMs and manufacturers alike are trying to make sure that more patients have access to reimbursement for obesity medicines. And we look forward to being able to do that when we enter the market.

Operator

Yaron Werber, TD Cowen.

Yaron Werber

Great. I have two interrelated questions about MariTide. Maybe just the first one, at ADA, is there a chance to get maybe even the 76-week data, from the obesity study from the Phase 2, including some of the less frequent dose in the Q2 and Q3 monthly dosing?
And then secondly, would you consider separately from doing a -- would you consider doing a switch study or patients switched from prior GLPs right into MariTide and doing less frequent dosing is an additional strategy to ultimately follow with?

Robert Bradway

Go ahead, Jay.

James Bradner

Yeah. Thanks, Yaron. First answer is no. The ADA presentation will focus on some mechanistic studies, some of the underlying details of Part 1, the first 52 weeks of the Phase 2 study as well as additional data from the Phase 1 pharmacokinetic study and reflections from these external key opinion leaders that we can't wait to hear ourselves. So no, I would not expect to see interim data from Part 2 which is ongoing, and we intend to share these data when we have them at the end of the year.
Your second question, welcome to the MariTide development team. It's great to have you thinking about next trials. And I take from your question that we agree actually that patients and physicians will want to know how can they start on MariTide if they're on another weight loss medicine that maybe is working, but is inconvenient or maybe isn't working well enough. And we do intend to generate data to support such a consideration. There'll be more to share on that in the future.

Operator

Umer Raffat, Evercore ISI.

Umer Raffat

It's a question I've been thinking about for a while on the myasthenia gravis market dynamic. Specifically, a lot of times when some of the cross-trial comparisons have been made for UPLIZNA. They're often versus the MAX efficacy we see on FcRn. And we know FcRns have this waxing waning because as per label, you have to get off the drug.
So my point being, the true commercial price would actually be 2x for FcRns if you truly dose them through without the dosing holiday, which is apparently what a lot of clinicians are doing. So my question is, are payers aware of this dynamic? And what do you see as a realistic market share aspiration knowing that your competitor might potentially be 2x the price? Could you aim for like a 40% to 50% market share in MG?

Robert Bradway

Let's try and take this in two pieces, Umer. I think on the clinical piece, Jay, if you want to add any perspective. But on the market, obviously, Murdo, you can share our perspectives on the payer environment and so forth.

James Bradner

Yeah. Thanks, Bob. Umer, thanks for the question. The GMG space will surely be shaped by the efficacy and the target product profile of the medicines available to treat the patients primarily. And -- and here, we think UPLIZNA has some really favorable considerations. It's very hard to do trial-by-trial comparisons, but suffice it to say that the significant observed efficacy by MG-ADL that we saw all the way out to week 52 and the durability of living in a randomized controlled trial environment through week 52 is indeed very strong, targeting the core biology, one might expect higher efficacy.
The steroid sparing that was built into our study will be an advantage to get people on to a single medicine at which point the durability and the convenience with every 6-month dosing after a loading dose are quite attractive, we believe, and we're receiving that feedback from prescribing physicians who waited in on these data in the program. Murdo, would you have any comments about the pricing dynamics?

Murdo Gordon

Yeah. In general, in categories, is like this, the medical policies from the payers will follow the indications in the label and/or the inclusion criteria that we're provided for the clinical trial. So there's likely to be fairly broad access to these products now with real-world experience and our ability to generate real-world evidence in this category. I would think that the hypothesis that there might be a cost advantage to treating with UPLIZNA versus other agents could be borne out.

Operator

David Amsellem, Piper Sandler.

David Amsellem

Question on TEPEZZA. I feel like over the past couple of years, even talking expansively about a wider physician audience getting in front of more prescribers, raising awareness, product hasn't been growing. So I guess, what's it going to take to see an inflection here? Or maybe put differently, do you think there has to be some externality like the availability of a subcu form to get the product really moving again?

Murdo Gordon

Thanks for the question, David. I think we're actually making quite good progress in broadening the prescribing base for TEPEZZA. It is, as you mentioned, it is a progress -- progressive evolution given that the product started its journey in more serious higher cast patients treated by the oculoplastic surgeon -- surgical community. And that's really what drove the initial uptake of the product. Going beyond that means that we have to activate general ophthalmologists and endocrinologists who are the really two challenges that we're working on with them.
One, getting them to actually take the time not just to diagnose graves but to diagnose thyroid eye disease. And two, to initiate treatment with an infused biologic and then find a site of care. So all of that does take some time in some progress. But as I mentioned in prepared remarks, we're seeing a nice increase in intent to prescribe from endocrinologists and that's the earliest leading indicator.
We hope to follow that with an actual increase in prescribing. And then it will take time between when that intent and that prescription is written to when we can get that patient started on their first infusion. Navigating the payer process, finding inside of care does take some time as well. So it's not going to be a rapid change in the trajectory of the product, but it will be a progressive one.
And then last but not least, definitely a subcutaneous administration will help here because it simplifies the site of care selection and affords more opportunities for patients to be initiated with their treatment. But I would anticipate both being able to grow prior to the availability of a subcutaneous form and then being able to accelerate that thereafter.

Robert Bradway

And Murdo, maybe you want to touch on the international progress.

Murdo Gordon

Yeah. Thanks, Justin. We've been making great progress with TEPEZZA internationally. With the recent approval in Japan, we've been approved in Saudi Arabia, Brazil, we have a positive opinion CHMP in Europe. We anticipate launching there in the back half of the year. So the international expansion is progressing very well, and I would say, ahead of schedule compared to what we thought we'd be able to do when we made the acquisition.
Overall, the rare disease portfolio of products, it's a very young portfolio of products where we're really just beginning to address the severe diseases that these drugs treat -- and whether it's TEPEZZA, UPLIZNA, KRYSTEXXA or TAVNeOS, these are going to be key growth driving products for us over the long haul, both in the US and internationally.

Peter Griffith

Speaking of youth, David, it's Peter here. Just a reminder that the transaction closed in October '23. So you mentioned a couple of years, it's been about 1.5 years, although so much has happened in the world that might feel like more than that. So we're delighted with the progress so far. As I mentioned in my remarks, we're right on target with pretax cost synergies, and we're right on target with getting back to our pre-Horizon capital structure by the end of this year. So thanks for the question.

Operator

Jay Olson, Oppenheimer.

Jay Olson

Congrats on all the progress, and thank you for providing this update. Can you help us understand what to expect on the meratuzumab Phase 3 study readout coming up here in the second quarter? And how are you thinking about the market opportunity for Bema.

Justin Claeys

Yeah. Thanks, Jay, for the kind words. Bemarituzumab is our first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody. This is a protein that appears on the surface of malignant gastric cancer cells with some frequency. And as you point out, we're conducting two prospective Phase 3 clinical trials, one that we call the doublet study or FORTITUDE 101.
We expect this to read out in the second quarter of this year, as I shared in the opening remarks. What to expect here, we're very hopeful that this will meaningfully contribute to improve the overall survival in this patient population. We've designed an outstanding study that's fully enrolled, and we hope to have data to share in the next quarter. FORTITUDE-102 is the triplet study.
This is where we combine bema with chemotherapy and checkpoint therapy nivolumab, both of these are frontline gastric cancer studies. And as more patients today receive or should receive chemotherapy with nivolumab in the frontline of this disease, we're very hopeful that bemarituzumab can work on top of that. with the data readout in the second half of this year. Omerituzumab showed pretty strong data in Phase 2, especially in the target population that we selected. And so we're hopeful that this will become a component of frontline standard of care for this disease. I guess more to follow next quarter. Murdo?

Murdo Gordon

Yeah. The addressable population here is quite large. This is the fifth most common cancer worldwide, over 1 million new cases globally, 25,000 cases in the US, the addressable -- initial addressable patient population of about 7,000 in the US much larger worldwide and a real opportunity in Japan and Southeast Asia, just in terms of the epidemiology of gastric cancer. And I think what really helps is as Jay outlined, the combinability of bemarituzumab with other available agents that treat this very difficult cancer.

Operator

Alexandra Hammond, Wolfe Research.
My apologies. Our next question will come from Gregory Renza, RBC Capital Markets.

Gregory Renza

Congrats on the quarter. Maybe just keeping with the oncology portfolio and maybe moving earlier down the pipeline a little bit. And as you build on the Lumicrast experience, just wanted to ask that you elaborate a bit on the KRAS franchise strategy, just particularly with the AMG 410 asset, which was recently highlighted at AACR. We have a world with a competitive landscape for KRAS drugs. Just curious if you could just elaborate how confident you are on the potential for 410 to be best or even better in class as you learn more about this molecule.

Murdo Gordon

All right. Greg, thank you so much for picking up on the AMG 410 presentation at the AACR this week. This is a very interesting molecule. And I think you've covered two key attributes, which is the properties of the molecule itself to make it exciting and then the moment at which it reaches human clinical investigation. For others on the call that don't know the medicine, this is a low molecular weight orally bioavailable structure disclosed a small molecule inhibitor of KRAS. Already, we were first to develop KRAS therapy as a reality with Lumicrast targeting the G12C allele selectively through cystine covalent chemistry.
But to get the other alleles that trick doesn't work. There's no cystine handle. And so we work to develop a reversible pan-KRAS inhibitor that hits wild-type G12D, G12V, G12C actually as well in G13D. It finds an allosteric pocket that is shared by other clinical-stage KRAS G12C inhibitor. This one is what's called a dual off and dual on-state inhibitor. It has outstanding selectivity for KRAS over HRAS and NRAS of more than 100 fold, which should confer excellent tolerability, a strong therapeutic index.
And so we're developing this medicine in an expedited way in a number of target solid tumors, both alone and in combination in a combined Phase 1/2 design. So it's very -- it's a stunning molecule. Now it's a competitive space, and this is great for patients. We entered this space with AMG 410 being the leader in KRAS therapeutics. And so our eyes are wide open to some of the competitor programs that are more advanced in clinical study.
I was very pleased to hear the reception from the leaders in the KRAS community at AACR, who on social media and in private conversations, we're really bullish about the properties of 410 and the need. Some of the KRAS inhibitors have shown a more narrow therapeutic index than one might have hoped for. So competitive space, but an excellent offering, and we hope to learn a lot in expedited Phase 1 and 2 clinical development.

Operator

Matt Phipps, William Blair.

Matt Phipps

I actually wanted to ask about the market opportunity for TEZSPIRE and CRS nasal polyps in a mitigation that gets talked a lot about. But particularly how much overlap there is with asthma patients and maybe your thoughts on the ability for biologics to move ahead of surgery longer term?

Murdo Gordon

Yeah. Thanks, Matt, for the question. There is indeed a real opportunity here with chronic rhinosinusitis with nasal polyps. We're looking at roughly 1 million to 2 million patients in the US that suffer from this. It is significantly overlapping with severe asthma, roughly 40% of asthma patients will present with some nasal polyp -- sorry, some chronic sinusitis involvement and some of them with nasal polyps. And indeed, these patients undergo some very difficult treatments inclusive of surgery, and we were able to in our clinical trials show that we can reduce almost entirely the need for surgery.
And so there is an opportunity, I believe, for us with TEZSPIRE, which has performed exceptionally well in severe uncontrolled asthma to go in and help these patients with this quite frankly, a miserable condition and help their overall quality of life as we demonstrated in the clinical trial.

Robert Bradway

All right. Let's go to our last question.

Operator

Alexandria Hammond, Wolfe Research.

Alex Hammond

So what's your expectation for future market split between broclatilumab and (inaudible). Are you thinking a 50-50 split in, let's say, the atopic dermatitis market? Or how are you kind of thinking about that shaking out?

Robert Bradway

Sure. Murdo, why don't you fire away.

Murdo Gordon

As we've said in the past, we're really looking carefully at the rocutilimab opportunity. Atopic dermatitis is clearly a condition that has opportunity for continued improvement in terms of the number of treatments that are available, there's a large refractory patient population out there with respect to what they currently have available to them and how they respond. It's hard for me to speculate on what our market splits going to be versus agents that are still in clinical development. But we're quite confident that there's a very nice opportunity in the market for rocatinlimab.

Robert Bradway

All right. Well, thank you all for joining our call. We appreciate your interest. Justin and his team will be around for the balance of the day. If you have any questions that you didn't get a chance to ask. And as you can tell, we're excited about the momentum of the business, excited about the current performance as well as what we see coming down the pike. So look forward to seeing you later in the year. Thank you.

Operator

This concludes our Amgen Q1 FY 2025 earnings call.