Earnings Call Transcript - AMGN Q1 2025

Operator, Operator

My name is Julianne and I'll be your conference facilitator today for the Amgen Q1 FY 2025 Earnings 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. I would now like to introduce Justin Claeys, Vice President of Investor Relations. Mr. Claeys, you may now begin.

Justin Claeys, VP of Investor Relations

Good afternoon and welcome to our first quarter 2025 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.

Bob Bradway, CEO

Okay, good afternoon, everyone, and thank you for joining us today. We're off to a strong start in 2025 and this was an exciting quarter, one with strong volume growth across the enterprise, important new product launches, and positive Phase III data. Revenue grew 9% year-over-year. Volume grew 14% reflecting growing patient demand for our innovative medicines. 14 of our medicines delivered double-digit sales growth, spanning general medicine, rare disease, inflammation, and oncology. Our industry-leading biosimilars portfolio added to this performance, delivering more than $700 million in revenue this quarter, which was up 35% year-over-year. Beyond the strong financials, this quarter demonstrated the breadth and depth of our portfolio and the strength of our execution. We delivered multiple positive Phase III readouts, initiated four new Phase III studies, and launched three new products or indications. With that, let me turn to some of the key drivers of our momentum. Starting in general medicine, we're addressing large, underserved patient populations with multiple products which have significant room for growth. Heart disease remains the leading cause of death globally. Repatha, now a multi-billion dollar product, continues to grow as access improves for patients. We're also advancing the cardiovascular clinical program, which addresses an important residual risk factor in heart disease. It's currently being evaluated in a large Phase 3 cardiovascular outcomes trial. In bone health, Amgen is the global leader and we expect continued long-term growth in this area. EVENITY, which is the only bone builder which also slows bone loss, reduces fracture risk for millions of postmenopausal women. We're rapidly advancing MariTide, having initiated the first chronic weight management Phase 3 studies of our broad clinical program in obesity and obesity related conditions. Turning to rare disease. Our four key growth drivers: TEPEZZA, KRYSTEXXA, UPLIZNA and TAVNEOS, are all early in their life cycles and well positioned for long-term growth. UPLIZNA is a differentiated B-cell depleting therapy. It is the leading biologic for the treatment of NMOSD and recently launched as the first and only FDA-approved treatment for IgG4-related disease which is a serious and underserved autoimmune condition. We're encouraged by the positive reception from patients and physicians in the early stage of the launch. We've also filed Phase III data for UPLIZNA and generalized myasthenia gravis with the FDA and its potential across additional B-cell-mediated diseases. In inflammation, we remain focused on difficult-to-treat diseases where the need for innovation is the highest. Test Spire is a first-in-class therapy that targets TSLP, a differentiated mechanism with broad potential across a number of diseases. In severe asthma, it continues to build strong momentum with high prescriber confidence. We've also delivered compelling Phase III data in chronic rhinosinusitis with nasal polyps and most recently, initiated two pivotal Phase III studies in COPD, the world's third leading cause of death. In oncology, our leading bispecific T cell engager platform continues to develop new standards of care. BLINCYTO has moved into frontline treatment and continues to grow. The FDA has granted breakthrough therapy designation for blinatumomab for subcutaneous treatment of BALL, which Jay will speak to shortly. In Delta provided an overwhelming survival benefit at an interim analysis in a Phase III study in second-line small cell lung cancer, beating chemotherapy as a standard of care. These data represent a meaningful milestone for patients and will be presented at ASCO in June. Xaluritamig is enrolling well in our Phase III study in advanced prostate cancer patients. Next, our industry-leading biosimilars portfolio continues to contribute meaningfully to our long-term growth. We have a proven approach in this area, being in the first wave of launches and ensuring a safe and reliable supply. We're seeing that formula deliver again this quarter with our next wave of U.S. launches underway, including PAVBLU, WEZLANA and BEKEMV. I recognize there's a lot of uncertainty at the moment related to tariffs and taxes. Given the long life cycle of our business, clarity on these issues is important to us, and I'm sure it's important to all of you as well. While it's premature to speculate what the outcomes of tariffs and taxes might be for our business, I would remind you that we've proven our ability to adapt, and we've demonstrated the operating agility necessary to navigate change and deliver long-term growth. With respect to manufacturing, I want to point out that following the 2017 tax reform we invested nearly $5 billion in U.S. capital projects as measured through 2024. And in addition, we've recently announced nearly $2 billion in additional expansions in the states of Ohio and North Carolina. We're actively engaged on policy matters, and we remain focused on meeting the growing demand for our medicines. And to the extent that changes in taxes or tariffs require us to adapt, we'll do so accordingly. Let's go back to where I started. This was an exciting quarter, not just because of the financial results, but because of what those results signal about our future. In-line brands are delivering. We're advancing positive Phase III studies. We're launching new products, we're earning breakthrough designations, and we're initiating the next wave of late-stage programs. We're operating in a volatile environment, but what hasn't changed is the growing patient demand for our medicines and the unwavering focus of our people. Amgen is well-positioned to deliver innovation and growth, not just this year, but for the long term. And I want to thank our nearly 28,000 colleagues around the world for their dedication to our mission serving patients. With that, I'll turn it over to Murdo for a commercial update.

Murdo Gordon, Executive Vice President

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 U.S., 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 sales 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 U.S., 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 are 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 U.S. has never been stronger with many payers eliminating prior authorization requirements, making Repatha more accessible and affordable for patients. Outside the U.S., 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 U.S. 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 U.S., EVENITY delivered 36% sales growth in the first quarter. And we focused our U.S. 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 U.S. 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 U.S., 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 are encouraged by the feedback that we are 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 are 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 are 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 U.S. 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 as 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, TEZSPIRE delivered another strong quarter, up 65% year-over-year, adoption by pulmonologists is growing, driven by TEZSPIRE's unique profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma. We see significant growth opportunity for TEZSPIRE to treat the 2.5 million patients worldwide who suffer from this challenging disease.

James Bradner, President of R&D

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 III studies of rocatinlimab, UPLIZNA and IMDELLTRA, while initiating multiple Phase III trials of MariTide and TEZSPIRE. Let's begin with MariTide, our investigational therapy for obesity and obesity-related conditions that features a unique and differentiated profile. In March, we initiated two Phase III studies in chronic weight management as part of our comprehensive MARITIME Phase III 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 III studies later this year, evaluating MariTide in specific obesity-related conditions. Last November, we presented top-line results at 52 weeks from our Phase II 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 II study at 52 weeks will be presented. Clear from these data is the important finding that dose escalation, which was studied in two of the treatment arms, meaningfully improved tolerability, in particular, rates of nausea and vomiting as compared with fixed dose administration used in the other seven treatment arms. This finding is consistent with the clinical experience to date with GLP-1-based therapies and was further supported by our Phase I 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 two Phase III 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 II type 2 diabetes study, which has completed enrollment as well as end of treatment period data from Part II of the ongoing Phase II 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.

Peter Griffith, Chief Financial Officer

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 a 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 the retirement of debt, including $4.5 billion in 2024 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 the 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 order in the first quarter. And let me remind you of prior items that have not changed in 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 U.S. investment in manufacturing. Amgen has a robust manufacturing presence in the United States, including Puerto Rico. And of course, has invested for decades in U.S.-based research and development. To build on the manufacturing base in the U.S., 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.

Terence Flynn, Analyst

Hi, thanks for taking the question. 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 Phase II 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. Thank you.

James Bradner, President of R&D

Yes. Thanks, Terence, for the question. Really looking forward to the ADA. We've already shared the salient data from the Phase II 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 I 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 two 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 III. Oh, yes. And on the CVOT study, we won't share any details today regarding the CVOT study. But with our two Phase III chronic weight management programs now open and enrolling, enrolling well. We are working to initiate a broad Phase III 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.

Salveen Richter, Analyst

Good afternoon, thanks. 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? Thank you.

Murdo Gordon, Executive Vice President

Yes. Salveen, it's Murdo. Thanks for the question on UPLIZNA. We're obviously quite excited about the opportunity to be the first approved therapy for IgG4. It is 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 has 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 are hitting the ground running, so to speak, with the approval. The epidemiology here is roughly 20,000 patients in the U.S. and we are excited to have that impact. This is a horrible disease. People really do not fare well when this flares and UPLIZNA is 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.

James Bradner, President of R&D

Yes. I mean reflecting also on IgG4, we think a lot about how this will 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 III 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, acetylcholine receptor positive and must positive. This medicine provides a durable benefit to patients. It's given every 6 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 myasthenia gravis.

Michael Yee, Analyst

Thank you, good afternoon. Jay, I've been hearing two main discussions regarding the obesity program. One is about the high tolerability, and I know you've adjusted to a lower titration. I'm interested in your confidence that we will maintain strong tolerability and efficacy and that this narrative will continue. The second point involves a competitor's oral data, which seems poised to capture a significant market share, while we don't have an oral option. Could you address these points and explain how you plan to stay competitive in light of these developments? Thank you.

James Bradner, President of R&D

Yes, Mike. I'll begin with tolerability and then ask Murdo to comment on the development of oral medications and their significance. I'm very confident in the tolerability and efficacy we expect to see in the Phase III clinical study. This confidence is based on the strong results we observed in Phase II Part 1, particularly the 52-week data, which showed significant benefits for patients with measurable weight loss of up to 20% across various doses. We've learned, along with others in the field, that GLP-1-based mechanisms of action benefit from dose escalation and starting with lower doses. We confirmed these insights in a dedicated Phase I pharmacokinetic study and incorporated the findings from both trials into the design of Phase III. When we share this with you, you'll see that the design aims to provide competitive efficacy and tolerability for patients with and without type 2 diabetes.

Murdo Gordon, Executive Vice President

Yes. 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.

Trung Huynh, Analyst

Great. Thanks for the question. Just on Repatha, which has been doing well for a number of quarters now. In our recent doctor checks, some have pointed to an increasing preference for Novartis' Leqvio because of the buy-and-build program for that drug. Do you see increasing commercial competition from Leqvio 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? Thanks.

Murdo Gordon, Executive Vice President

Thank you for the question and for recognizing the growth of Repatha. In short, yes, there is competition in the market, and Leqvio is effectively treating patients in the U.S. and other regions. However, we still believe Repatha has the best profile in the PCSK9 category, particularly in its ability to significantly lower LDL cholesterol and reduce cardiovascular events. We are conducting additional clinical trials to enhance our understanding of how Repatha, when combined with standard therapy, can further lower cardiovascular risk in high-risk populations. The market remains underpenetrated, with millions of patients at risk, providing ample opportunity for competition. Our ongoing momentum, despite the rise of other products in the category, indicates our commitment to helping new patients access Repatha therapy. Additionally, Amgen has worked hard to improve access and affordability for patients, with 50% of commercially insured patients in the U.S. now not requiring prior authorization for therapy approval. The barriers to obtaining Repatha have mostly been removed, supporting our growth. We continue to promote Repatha to primary care and have invested in direct-to-consumer advertising, anticipating strong growth ahead.

Evan Seigerman, Analyst

Hi, guys. Thank you so much for taking my question. 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, Executive Vice President

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 are working on contracting with 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.

Chris Schott, Analyst

Hi, great. Thanks so much for the question. 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 in how you're thinking about these payer dynamics, potential new entrants in that space over time?

Murdo Gordon, Executive Vice President

Yes. 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.

Yaron Werber, Analyst

Great. Thanks so much. 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 II, including some of the less frequent dose in the Q2 and Q3 monthly dosing? And then secondly, would you consider separately from 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. Thank you.

James Bradner, President of R&D

Yes. 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 II study as well as additional data from the Phase I 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 they can 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 will be more to share on that in the future.

Umer Raffat, Analyst

Hi, guys. 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 maximum efficacy we see on FcRn. And we know FcRn 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 2 times for FcRn, 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 2 times the price? Could you aim for like a 40% to 50% market share in MG? Thank you.

James Bradner, President of R&D

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.

Murdo Gordon, Executive Vice President

Yes. In general, in categories like this, the medical policies from the payers will follow the indications in the label and/or the inclusion criteria that we are 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.

David Amsellem, Analyst

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, the 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 subcutaneous form to get the product really moving again? Thanks.

Murdo Gordon, Executive Vice President

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 progressive evolution given that the product started its journey in more serious higher cast patients treated by the oculoplastic surgeon 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.

Jay Olson, Analyst

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

Robert Bradway, CEO

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 III 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 bemarituzumab 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 II, 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.