Amgen Q1 2025 Earnings Report

Amgen EPS Results

• Actual EPS: $4.90
• Consensus EPS: $4.18
• Beat/Miss: Beat by +$0.72
• One Year Ago EPS: $3.96

Amgen Revenue Results

• Actual Revenue: $8.15 billion
• Expected Revenue: $8.05 billion
• Beat/Miss: Beat by +$95.74 million
• YoY Revenue Growth: +9.40%

Amgen Announcement Details

• Quarter: Q1 2025
• Date: 5/1/2025
• Time: After Market Closes
• Conference Call Date: Thursday, May 1, 2025
• Conference Call Time: 4:30PM ET

Amgen (NASDAQ:AMGN) is a multinational biopharmaceutical company headquartered in Thousand Oaks, California. Established in 1980 by William Bowes from Cetus Corporation and Winston Salser from UCLA, Amgen is now one of the world's largest independent biotechnology companies, with over 24,000 employees worldwide. The company's primary focus is on molecular biology and biochemistry, intending to provide healthcare solutions based on recombinant DNA technology.

Neulasta, one of Amgen's most prominent selling product lines, is used to prevent infections in patients undergoing cancer chemotherapy. Enbrel is another famous selling product line for Amgen, used in the treatment of rheumatoid arthritis and other autoimmune diseases. The company's other products have various applications in treating cancer, anemia, osteoporosis and other conditions.

Amgen has a rich history of strong leadership, with the appointment of several successful CEOs since its inception. Robert A. Bradway is the current CEO and was brought to Amgen in May 2012 following his predecessor's retirement. Bradway has led the company to new heights with strategic acquisitions and partnerships.

Amgen has made at least five major corporate acquisitions. In 2019, the company announced it would acquire Nuevolution AB and the Otezla drug program from Celgene and a 20.5% stake in the Beijing-based BeiGene for $2.7 billion. These acquisitions have strengthened Amgen's drug pipeline and provided new revenue streams for the company. In March 2021, Amgen announced its plans to acquire Five Prime Therapeutics and its lead research drug candidate, bemarituzumab, for $1.9 billion. It also agreed to acquire Rodeo Therapeutics for up to $720 million. These acquisitions are part of the company's ongoing efforts to expand its drug pipeline and bring new treatments to patients.

In 2012, Amgen faced legal issues when it pleaded guilty and agreed to pay $150 million in criminal penalties and $612 million in damages to resolve 11 related whistleblower complaints. Amgen has also faced criticism for lobbying for a two-year extension on sales of drugs, including Sensipar, without government controls, which will cost taxpayers an estimated $500 million. However, the company remains committed to providing innovative and effective healthcare solutions for patients.

Amgen's success can be attributed to its commitment to innovation, strategic acquisitions, strong partnerships and top-end leadership. The company's impressive portfolio of products and its commitment to the community has solidified Amgen's position as a leader in biopharmaceuticals.

Amgen Q1 2025 Earnings Call Transcript

Presentation

[Operator]

My name is Julianne, and I will be your conference facilitator today for the Amgen Q1 FY twenty twenty five 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. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q and A session. I would now like to introduce Justin Clays, Vice President of Investor Relations.

[Operator]

Mr. Clays, you may now begin.

[Justin Claeys, VP of IR at Amgen]

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

[Robert Bradway, Chairman, CEO & President at Amgen]

Okay. Good afternoon, everyone, and thank you for joining us today. We're off to a strong start in 2025, this was an exciting quarter, one with strong volume growth across the enterprise, important new product launches and positive Phase three 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.

[Robert Bradway, Chairman, CEO & President at Amgen]

Our industry leading biosimilars portfolio added to this performance delivering more than $700,000,000 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 three readouts, initiated four new Phase three 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.

[Robert Bradway, Chairman, CEO & President at Amgen]

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 opaziran clinical program, which addresses an important residual risk factor in heart disease. It's currently being evaluated in a large Phase three cardiovascular outcomes trial. In bone health, Amgen is the global leader and we expect continued long term growth in this area.

[Robert Bradway, Chairman, CEO & President at Amgen]

EVENITY, which is the only bone builder, which also slows bone loss reduces fracture risk for millions of post menopausal women. We're rapidly advancing Meritide having initiated the first chronic weight management phase three studies of our broad clinical program in obesity and obesity related conditions. Turning to rare disease, our four key growth drivers TEPEZZA, KRYSTEXXA, OUPLAZMA and TABNIOZ are all early in their life cycles and well positioned for long term growth. Plasma is a differentiated B cell depleting therapy. It's 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.

[Robert Bradway, Chairman, CEO & President at Amgen]

We're encouraged by the positive reception from patients and physicians in the early stage of the launch. We've also filed phase three data for Oplisna in generalized myasthenia gravis with the FDA and we're exploring 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. TESSPIRE is a first in class therapy that targets TSLP and differentiated mechanism with broad potential across a number of diseases. In severe asthma, it continues to build strong momentum with high prescriber confidence.

[Robert Bradway, Chairman, CEO & President at Amgen]

We've also delivered compelling phase three data in chronic rhinosinusitis with nasal polyps and most recently initiated two pivotal phase three 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.

[Robert Bradway, Chairman, CEO & President at Amgen]

The FDA has granted breakthrough therapy designation for blinatumomab for subcutaneous treatment of B ALL, which Jay will speak to shortly. IMDELTRA provided an overwhelming survival benefit at an interim analysis in a phase three study in second line small cell lung cancer, beating chemotherapy as a standard of care.

[Robert Bradway, Chairman, CEO & President at Amgen]

These data represent a meaningful milestone for patients and will be presented at ASCO in June. Now, Uridamig is enrolling well in our Phase three 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, be in the first wave of launches and ensure a safe and reliable supply. We're seeing that formula deliver again this quarter with our next wave of U.

[Robert Bradway, Chairman, CEO & President at Amgen]

S. Launches underway including Pavblue, Weslana and BaKemvi. 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 tariff 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.

[Robert Bradway, Chairman, CEO & President at Amgen]

With respect to manufacturing, I want to point out that following the 2017 tax reform, we invested nearly $5,000,000,000 in U. S. Capital projects as measured through 2024. And in addition, we've recently announced nearly $2,000,000,000 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.

[Robert Bradway, Chairman, CEO & President at Amgen]

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. Inline brands are delivering. We're advancing positive Phase three studies. We're launching new products.

[Robert Bradway, Chairman, CEO & President at Amgen]

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 VP of Global Commercial Operations at Amgen]

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%.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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 $656,000,000 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 one hundred million patients globally in need of effective LDL cholesterol lowering, we see significant opportunity ahead to further broaden our impact and deliver long term growth.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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'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 U.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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. Sales increased 29% year over year to $442,000,000 in the first quarter.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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 post menopausal. Despite this clear clinical value, fewer than two hundred and fifty thousand patients in The U. S. Have been treated to date, while millions remain at risk. Today, than ninety percent 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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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 1,100,000,000 in sales. I'll

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

move

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

to our rare disease portfolio, which grew 3% year over year delivering $1,000,000,000 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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Since launch TEPEZZA has had a positive impact for thousands of patients living with thyroid eye disease. In The U. S. There are roughly one hundred thousand 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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Access has also improved for patients with more than eighty five percent 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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

This marks a significant step forward for patients living with TED who currently have no approved disease modifying therapies available to them in Europe. VUPLAZMA sales increased 14% year over year to $91,000,000 in the first quarter, driven by continued growth in treating patients with neuromyelitis optica spectrum disorder. In April, VUPLISMA 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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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 the Eplisna. In inflammation, TestBio delivered another strong quarter, up sixty five percent year over year. Adoption among pulmonologists is growing, driven by TestBio's unique profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma. We see significant growth opportunity for TestBio to treat the two point five million patients worldwide who suffer from this challenging disease.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Our innovative oncology portfolio including BLINCYTO, Andeltra, Lumacras, VECTOVIX, Kyprolis, Endplate and XGEVA grew 10% year over year generating over $2,000,000,000 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 UDELTRA. 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 Cytos sales were $370,000,000 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 a standard of care for both adults and pediatric patients with Philadelphia chromosome negative B cell ALL.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Our U. S. Launch of IMDELTRA for the treatment of patients with extensive stage small cell lung cancer who are progressing on or after chemotherapy continues its strong momentum generating $81,000,000 in sales in the first quarter. To date, IMDELTA 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 Emdeltra in Japan, marking an important step forward in our commitment to bringing innovative oncology therapies to patients around the world.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

The momentum behind Andeltra is being reinforced by compelling new data. We recently announced new clinical data demonstrating that Andeltra 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 Emdeltra's efficacy for patients facing one of the most aggressive and difficult to treat cancers. And our field teams are acting with urgency in their educational efforts with the medical community. Biosimilar portfolio sales were $735,000,000 in the first quarter, an increase of 35% year over year.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Sales of PABLUE, the biosimilar to EYLEA reached $99,000,000 in the first quarter. Retina specialists are responding very positively to PABLUE expressing appreciation for this high quality Amgen biosimilar delivered in an easy to use prefilled syringe. Importantly, on April 1, Tableau received its permanent reimbursement Q code, which will facilitate easier access for patients. We're also pleased with the successful U. S.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Launches of WIZLANA, a biosimilar to Stellara and Bikanvi, a biosimilar to Solaris. 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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

I'll now hand it over to Jay.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Thank you, Murdo and good afternoon everyone. The first quarter has been exceptionally productive for R and 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 APLISNA 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 three studies of rocotinlimab, APLISNA and INVELTRA while initiating multiple Phase three trials of Meritide and TEDSPIRE. Let's begin with MERITADE, our investigational therapy for obesity and obesity related conditions that features a unique and differentiated profile.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

In March, we initiated two Phase three studies in chronic weight management as part of our comprehensive maritime phase three program. These trials will evaluate maritime two distinct populations, adults living with obesity or overweight without type two diabetes, and adults with obesity or overweight with type two diabetes. Both studies will assess the safety, efficacy and tolerability of three target dose levels of meratide, proceeded 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 seventy two weeks. Beyond these first two studies, we anticipate initiating additional maritime phase three studies later this year, evaluating Maritime specific obesity related conditions.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Last November, we presented top line results at fifty two weeks from our Phase two chronic weight management study, which highlighted Maritime's monthly or less frequent dosing, consistent, predictable, and sustained weight loss across all doses without a weight loss plateau through fifty two weeks, and Meritide'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 two study at fifty two 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 improves tolerability, in particular, rates of nausea and vomiting, as compared with fixed dose administration, which was used in the other seven treatment arms. This finding is consistent with the clinical experience to date with GLP-one based therapies and was further supported by our phase one pharmacokinetic study that tested even lower starting doses of meratide. Details from this study will also be discussed at ADA.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

These learnings have informed the design of our two Phase three studies of Miratide for chronic weight management, which are open and enrolling robustly. Looking ahead to the second half of twenty twenty five, we expect key data from Meritide, including both the ongoing phase two type two diabetes study, which has completed enrollment, as well as end of treatment period data from part two of the ongoing phase two chronic weight management study. Meritide 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 Meritide, in general medicine, we look forward to data from the Repatha Vesalius Phase three 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.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Turning to opasiran, our promising best in class small interfering RNA medicine targeting Lp, we are bringing a precision medicine approach to cardiovascular risk reduction for the many patients with LP elevation. The fully enrolled OCEAN Phase III cardiovascular outcomes trial of opasiran continues to progress. Moving on to our rare disease portfolio, we are very excited about Aplisna's expanding potential to improve the lives of those facing rare inflammatory conditions. In April, the FDA approved Aplisna 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. Aplisna is an innovative biologic that targets CD 19 positive B cells and addresses a core driver of IgG4 related disease, significantly reducing disease flares and dependence on harmful long term steroid treatment.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Additionally, we recently presented compelling fifty two week data from our pivotal Phase three MINT study evaluating Aplisna in patients with generalized myasthenia gravis. These results demonstrated durable and sustained efficacy of Aplisna in patients with acetylcholine receptor autoantibody positive generalized myasthenia gravis with only two doses a year following an initial loading dose. The fifty two week mint results highlight a pleasant 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 aplizness 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 APLISNA MINT Phase III generalized myasthenia gravis data with a PDUFA date of 12/14/2025.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

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 CV19 positive B cells in cancer, inflammation and in rare disease more generally, where only five percent of the estimated ten thousand rare diseases have available treatments. In inflammation, we and our partner AstraZeneca have initiated two Phase three studies of TESSPIRE in chronic obstructive pulmonary disease, targeting patients with moderate to very severe COPD with bloody eosinophil counts greater than or equal to a 50 cells per microliter. COPD is the world's third leading cause of death, and we're excited about the impact TESFYRE could have in this setting. Beyond COPD, we completed the regulatory submission of TESFYRE's phase three data for chronic rhinosinusitis with nasal polyps and look forward to a PDUFA date of 10/19/2025. In March, we announced data from three additional phase three studies from the rocotinlimab ROCCAT program in atopic dermatitis, notably IGNITE, which met its primary and key secondary endpoints.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

We look forward to additional data from the ROCCAT program in the second half of twenty twenty five. In oncology, we recently announced compelling results for IMBELTRA from our DEL-five 304 Phase three trial, where at a planned interim analysis, the study met its primary endpoint, demonstrating a significant and clinically meaningful overall survival benefit. CEL5-three zero four evaluated in DELTRA 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 DELPHI three zero one data already reported, Indaltra has the potential to become the new standard of care for second line small cell lung cancer.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

As an oncologist, I'm really encouraged by Indaltra 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-three zero four, we continue to investigate Emdeltra in earlier lines of small cell lung cancer. Currently, two Phase three studies are underway and we are pleased to announce plans to initiate DELPHI-three twelve, a Phase three trial evaluating Imdeltra 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 CD 19 directed BiTE medicine Blincyto in earlier treatment settings while also advancing a subcutaneous formulation of blinatumomab.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

In April, the FDA granted breakthrough therapy designation for subcutaneous blinatumomab in the treatment of adults with relapsedrefractory CD19 positive B cell precursor acute lymphoblastic leukemia. Based on our experience to date, subcutaneous blinatumomab has the potential to improve both the patient experience and efficacy. Our first in class STEAP1 CD3 bispecific T cell engagers zalaritamab is advancing in Phase three clinical development, where we are rapidly enrolling patients with metastatic castrate resistant prostate cancer who progressed following taxane based therapy. We are also exploring zalaritamab in combination therapy and in earlier stages of prostate cancer with multiple Phase 1b studies ongoing. Collectively, Indaltra, BLINCYTO and Zalaritimig exemplify the significant growth potential of our robust bispecific T cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Beyond our T cell engagers, first in class fibroblast growth factor receptor 2b directed monoclonal antibody, bimirtuzumab is advancing to frontline gastric cancer therapy. We expect data this quarter from FORTITUDE-one hundred one, a Phase three study of bimirtuzumab combined with mFULFOX6 chemotherapy versus chemotherapy alone. In the second half of twenty twenty five, we expect data from FORTITUDE one zero two, a phase three study of bimertuzumab combined with chemotherapy and nivolumab versus chemotherapy and nivolumab alone. On biosimilars, we are rapidly advancing three phase three programs, evaluating our biosimilars to Opdivo, Keytruda, and Accrevis as the next wave of Amgen biosimilar products. In closing, I want to thank my Amgen colleagues for delivering on a number of important milestones so far this year and for their relentless focus on the patients we serve.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

I'll now turn it over to Peter.

[Peter Griffith, Executive VP & CFO at Amgen]

Thank you, Jay. We're pleased with our strong first quarter performance and are on track with our twenty twenty five 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 $8,100,000,000 a 9% increase year over year. This reflects double digit sales growth of 11% driven by 14% volume growth from key brands including Repatha, Blincyte, OTESPIRE and DIVENITY, partially offset by 6% lower net selling price.

[Peter Griffith, Executive VP & CFO at Amgen]

Our non GAAP operating expenses rose 4% led by non GAAP R and D growth of 12% year over year reflecting continued investment in our late stage pipeline including Meritide, Opasiran 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 and 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 $500,000,000 in pretax cost synergies by the end of this year. Our non GAAP OI and E was down $53,000,000 year over year driven by lower interest expense through retirement of debt including $4,500,000,000 in 2024 and $2,900,000,000 in the first quarter of twenty twenty five.

[Peter Griffith, Executive VP & CFO at Amgen]

In addition, we repaid $1,000,000,000 today as we continue to progress the strengthening of our balance sheet. Since the announcement of the Horizon acquisition, we have now retired $10,800,000,000 of debt. Our non GAAP tax rate decreased 0.8 percentage points year over year to 14.6% primarily due to the change in earnings mix. The company generated $1,000,000,000 in free cash flow in the first quarter reflecting continued investment in growth and operational momentum across the business. We spent 400,000,000 in the first quarter on capital expenditures driven by investments across our manufacturing sites including Ohio, North Carolina and Puerto Rico.

[Peter Griffith, Executive VP & CFO at Amgen]

For 2025, we expect no change in our capital expenditures outlook of $2,300,000,000 which will support our products across the portfolio and our innovative pipeline including Meritide. 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 twenty twenty four.

[Peter Griffith, Executive VP & CFO at Amgen]

Let's turn to the outlook for the

[Peter Griffith, Executive VP & CFO at Amgen]

business for 2025 on Slide 31. We are reaffirming our 2025 total revenue guidance in the range of $34,300,000,000 to $35,700,000,000 and also reaffirming our non GAAP earnings per share guidance between $20 and $21.2 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 and D expense to grow approximately 20% in 2025 versus growing mid teens previously, reflecting increased investments to advance key late stage pipeline assets including Meritide and Opasiran. We now anticipate non GAAP OI and E to be approximately $2,300,000,000 in 2025.

[Peter Griffith, Executive VP & CFO at Amgen]

We now expect a non GAAP tax rate of 14.5% to 16%. And for Weslana 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 to our outlook for the remainder of the year. For the full year, we continue to expect other revenue to be approximately $1,400,000,000 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 $500,000,000 in 2025.

[Peter Griffith, Executive VP & CFO at Amgen]

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 incremental capital expenditures. Free cash flow in the second quarter will be impacted by the shift in 2024 tax payments to Q2 twenty twenty five and the final $1,800,000,000 repatriation tax payment. I know there's a lot of interest in taxes and tariffs. We understand the impetus for increasing U.

[Peter Griffith, Executive VP & CFO at Amgen]

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 The United States based research and development. To build on the manufacturing base in The U. S, we agree with our peers that the most effective answer is not tariffs but tax policy.

[Peter Griffith, Executive VP & CFO at Amgen]

In fact, for Amgen and others, investment in manufacturing has significantly increased since President Trump's twenty seventeen 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.

[Peter Griffith, Executive VP & CFO at Amgen]

This concludes our financial update. I'll hand it back to Bob for our Q and A session.

[Robert Bradway, Chairman, CEO & President at Amgen]

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

[Operator]

Thank you. Our first question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

Question. I was just wondering, Jay, if you could help frame for us what we should be looking for at ADA with respect to Meritide. I know this is going be the first detailed presentation of the Phase II data. But what do you think kind of the key message and key learnings coming 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 are likely plan to conduct with Meritide and the design.

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

So just wondering if you comment at all on the potential control arm there. Thank you.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Yes. Thanks, Terrence, for the question. Really looking forward to the ADA. You know, we've already shared the salient data from the phase two chronic weight management study, weight loss and excellent tolerability of fifty two weeks, what we call part one on that trial, as well as data from a dedicated phase one pharmacokinetic study. And the key insights remain unchanged.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Strong efficacy, no plateau to fifty two weeks, Monthly meritides, 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 a one c. So the ADA will focus on these insights as well as some underlying details of the two trials. It'll 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 maritime. We're looking forward to sharing these details at ADA, hearing from the presenters who are true leaders in the field.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

And and and following the session, we intend to have an IR call, after the event to take questions, reflect on the results through fifty two weeks. But here at Amgen, we're we're on to phase three. And then on the CVOT Oh, yes. And on the CVOT study, we we won't share any details today regarding the CVOT study, but with our two phase three chronic weight management programs now open and enrolling enrolling well, we are working to initiate a broad phase three program that includes ASCVD, heart failure studies, chronic kidney disease, obstructive sleep apnea, and other indications of interest. We'll have more to share in the fullness of time about the details of these trials.

[Robert Bradway, Chairman, CEO & President at Amgen]

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

[Operator]

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

[Salveen Richter, Biotechnolgy Equity Research at Goldman Sachs]

Good afternoon.

[Salveen Richter, Biotechnolgy Equity Research at Goldman Sachs]

Thanks for taking my question. With regard to Uplenza 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 VP of Global Commercial Operations at Amgen]

Yep. Salveen, it's Murdoch. Thanks for the question on atlasma. We're obviously quite quite excited about the opportunity to be the first approved therapy for IgG4. 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 of twenty twenty three.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

So it's been a relative recent phenomenon to actually have formal diagnostic criteria and 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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

So we're hitting the ground running so to speak with the approval. The epidemiology here is roughly twenty thousand patients in The U. S. And we're excited to have an impact. This is a horrible disease.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

People really do not fare well when this flares and Oplisner 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. 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 wanna add anything on on g m g?

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Yeah. And I mean, reflecting also on IgG four, you know, we think a

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

lot about how will this fit into the standards of care in both diseases. And IgG four related disease has no standard of care. These are patients with chronic inflammatory, painful protein symptoms, recurrent flares, and, you know, we saw an eighty seven percent reduction in in in disease specific flare activity. And so this hopefully becomes a a powerful new standard of care. And then in gMG, this medicine stacked up really well to what physicians and patients have access to today.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

And we had a chance to share, you know, back in April and it was also simultaneously published in New England Journal, the really strong data from the phase three MIN trial. And we put up just outstanding efficacy data against the myasthenia gravis activity of daily living score. We showed activity in, you know, both important subpopulations of patients, acetylcholine receptor positive and MUSK positive. And, you know, 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.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

But most importantly, it targets the core biology. This is disease caused by pathologic autoantibodies, and here we are targeting the cells that elaborate those antibodies. So we feel very hopeful that aplisno will be an important, new standard of care in in generalized myasthenia gravis.

[Robert Bradway, Chairman, CEO & President at Amgen]

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

[Operator]

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

[Mike Yee, Managing Director at Jefferies Financial Group]

Thanks. Great. Good afternoon. 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.

[Mike Yee, Managing Director at Jefferies Financial Group]

And secondly, that there's a competitor out there who's now put up oral data, which apparently is gonna have a huge market share and so you don't have an oral. Maybe you could respond to to either of those and how you're gonna be competitive against these developments that have played out. Thank you.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Yeah, Mike. Thanks. 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 three clinical study.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

It is very well informed by the strong efficacy that we saw in phase two part one, the fifty two week data where we observed across the range of doses some significant benefits of patients with measurable weight loss as high as twenty percent. The tolerability, we learned, as have others in the field, that GLP one based mechanisms of action benefit from dose escalation, benefit from lower starting doses. We confirmed these insights in a dedicated phase one pharmacokinetic study, and we've taken the directionality of those two trials into the design of phase three, which when we can share this with you, will will will surely underscore, that the design is is is constructed to deliver competitive, both efficacy and tolerability in patients with and without type two diabetes. Murdo, about oral?

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Yes. Thanks, Mike. We 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 Maratide.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

And of course Maratide 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 incretin. So we really are looking at oral and non oral mechanisms ourselves.

[Robert Bradway, Chairman, CEO & President at Amgen]

Alright, Julian. Let's go to the next question, please.

[Operator]

Thank you, Michael. Our next question comes from Trung Kwan from UBS. Please go ahead. Your line is open.

[Trung Huynh, Analyst at UBS Group]

Great. Thanks for the question. 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' Lecveo because of the buy and bill program for that drug. Do you see increasing commercial competition from Lecveo in general?

[Trung Huynh, Analyst at UBS Group]

And going forward, there is going to be some late stage data for oral PCSK9s this year. What's your thoughts about the entry of those products? Thanks.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Yes. 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, Lecvio is 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 the best, profile in the PCSK9 category given the ability to profoundly lower LDL cholesterol.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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 receive 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 commercial insured patients in The U.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

S. Fifty Percent of which have no prior authorization requirement to receive approval for their therapy. So they're really the barriers that once were there in obtaining Repatha have largely dissipated. So we're growing nicely. We continue to promote the primary care.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

We've invested in direct to consumer advertising now and we expect a strong growth trajectory to come.

[Robert Bradway, Chairman, CEO & President at Amgen]

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

[Operator]

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

[Evan Seigerman, MD & Senior Research Analyst at BMO Capital Markets]

Hi, guys. Thank you so much for taking my question. So with the Q code in place, can

[Evan Seigerman, MD & Senior Research Analyst at BMO Capital Markets]

you help us think about

[Evan Seigerman, MD & Senior Research Analyst at BMO Capital Markets]

the near term uptake of Tableau in the field? And are you seeing any pronounced shift to the biosimilar following the defunding of the patient's assistance charities?

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Thanks for the question, Evan. We're obviously pleased with our biosimilar portfolio in general. We had a strong quarter there. PABLUE has been well received by the retina specialist community. They like the high quality biosimilar.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

They really like our prefilled syringe device that we launched. And, you know, 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, you know, Amgen, is is happy to support, patients through the, charitable donations that we make to to various agencies.

[Robert Bradway, Chairman, CEO & President at Amgen]

Alright. Let's go to the next question, please, Julian.

[Operator]

Thank you, Evan. Our next question comes from Chris Schott from JPMorgan. Please go ahead. Your line is open.

[Chris Schott, Managing Director at JP Morgan]

Great. Thanks so much for the question. Just a question on the Inkriton payer environment. I think we've seen some concern in the market today about more aggressive payer behavior with the CVS, Wegovy announcement. I'm just interested in how you're thinking about these payer dynamics, potential new entrant in that space over time?

[Chris Schott, Managing Director at JP Morgan]

Thank you.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Yes. Thanks for the question, Chris. Look, our focus in any payer environment and it will be with 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 CVS change that was announced.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

I do think overall PBMs and manufacturers alike are trying to make sure that more patients have access to reimbursement for obesity medicines. We look forward to being able to do that when we enter the market.

[Robert Bradway, Chairman, CEO & President at Amgen]

Okay, Julian. We'll go to the next question, please.

[Operator]

Thank you, Chris. Our next question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open.

[Yaron Werber, Managing Director, Senior Biotechnology Analyst at Cowen and Company]

Great. Thanks so much. I have two interrelated questions about Meritide. Maybe just the first one, at ADA, is there a chance to get maybe even the seventy six week data from the obesity study from the phase two, including some of the the less frequent dosing, the q two and q three, monthly dosing? And then secondly, would you consider separately from doing a would you consider doing a switch study where patients switch from prior GLPs right into meridide and doing less frequent dosing is an additional strategy to ultimately file with?

[Yaron Werber, Managing Director, Senior Biotechnology Analyst at Cowen and Company]

Thank you.

[Robert Bradway, Chairman, CEO & President at Amgen]

Jake, go ahead, Jake.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Yeah. Thanks, Yaron. First answer is no. The ADA presentation will, focus on, some mechanistic studies, some of the underlying details of part one, the first fifty two weeks of the phase two study, as well as additional data from the phase one 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 two, which is ongoing, and we intend to share these data when we have them at the end of the year.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Your second question, welcome to the Ameritide development team. It's great to have you thinking about, next trials. And I take from your question that that we agree actually that patients and physicians will will want to know how can they, start on Meritide 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.

[Robert Bradway, Chairman, CEO & President at Amgen]

Perfect. Let's go to the next question. Thanks.

[Operator]

Thank you, Yaron. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.

[Umer Raffat, Senior Managing Director at Evercore ISI]

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 a plasma, they're often versus the max 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 x for FcRn if you truly dose them through without the dosing holiday, which is apparently what a lot of clinicians are doing.

[Umer Raffat, Senior Managing Director at Evercore ISI]

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? Thank you.

[Robert Bradway, Chairman, CEO & President at Amgen]

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

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Yeah. Thanks, Bob. You know, 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 aplizumab has some really favorable considerations.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

It's very hard to do trial by trial comparisons, you know, 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, you know, 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 onto a single medicine, at which point the durability and the convenience with every six month dosing after a loading dose, are are are quite attractive, we believe, and we're receiving that feedback, from prescribing physicians who've weighed in on on these data in the program. Murdo, do you

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

have any comments about the pricing dynamics?

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Yes. In general, in categories and diseases like this, the medical policies from the payers will follow the indications in the label and or the inclusion criteria that were provided for for the clinical trial. So the there there's likely to be fairly broad access to these products. Now with 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 a plasma versus other agents could be borne out.

[Robert Bradway, Chairman, CEO & President at Amgen]

Okay. Julian, let's go to the next question.

[Operator]

Thank you, Umer. Our next question comes from David Amsellem from Piper Sandler. Please go ahead. Your line is open.

[David Amsellem, Sr. Research Analyst at Piper Sandler Companies]

Have a question on TEPEZZA. I feel like over the past, couple of years, you've been 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 gonna take to see an inflection here? Or maybe put put differently, do you think there has to be some externality like the availability of a sub q form to get the product really moving again?

[David Amsellem, Sr. Research Analyst at Piper Sandler Companies]

Thanks.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Thanks for the question, David. I 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 really two challenges that we're working on with them.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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 and 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.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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 a side 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.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

And Murdo, maybe you wanna touch on the international progress?

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Yeah. Thanks 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 in CHMP in Europe.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

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, Uplisna, 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, Executive VP & CFO at Amgen]

Speaking of use, 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 a year and

[Peter Griffith, Executive VP & CFO at Amgen]

a half. Although so much has happened in the world, it might feel like more than that. So we're 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.

[Robert Bradway, Chairman, CEO & President at Amgen]

Great, Julian. Let's go to the next question.

[Operator]

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

[Jay Olson, Research Analyst at Oppenheimer & Co. Inc.]

Oh, hey. Congrats on all the progress and thank you for providing this update. Can you help us understand what to expect on the bimirtuzumab phase three study readouts coming up here in the second quarter? And how are you thinking about the market opportunity for bema?

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Thank you.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Yes. Thanks, Jay, for the kind words. Bimirtuzumab is our first in class fibroblast growth factor receptor two b 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 three clinical trials.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

One that we call the doublet study or FORTITUDE one zero one. 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.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

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. As more patients today receive or should receive chemotherapy with nivolumab in the frontline of this disease, we're very hopeful that bimirtuzumab can work on top of that with the data readout in the second half of this year. Omerituzumab showed pretty strong data in phase two, especially in the target population that we selected.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

And so we're hopeful that this will become a component of frontline standard of care for this disease.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

I guess more to follow, next quarter. Murdo?

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Yeah. The addressable population here is quite large. This is the fifth most common cancer worldwide.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Over a million new cases globally, twenty five thousand cases in The US. The addressable initial addressable patient population is about seven thousand 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 the marituzumab with other available agents that treat this very difficult cancer.

[Robert Bradway, Chairman, CEO & President at Amgen]

Okay, Julian. Let's go to the next question, please.

[Operator]

Thank you, Jay. Our next question comes from Alexandra Hammond from Wolfe Research. Please go ahead. Your line is open. My apologies.

[Operator]

Our next question will come from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open.

[Gregory Renza, Senior Biotechnology Analyst at RBC Capital Markets]

Great. Thanks. Good afternoon, guys, and congrats on the quarter. Thanks for the question. Maybe just keeping with the oncology portfolio and maybe moving earlier down the pipeline a little bit, and as you build on the Lumicraft experience, just wanted to ask that you elaborate a bit on the KRAS franchise strategy, just particularly with the AMG four ten asset, which was recently highlighted at AACR.

[Gregory Renza, Senior Biotechnology Analyst at RBC Capital Markets]

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 four one zero to be best or even better in class as you learn more about this molecule. Thanks so much.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Alright. Greg, thank you so much for picking up on the AMG four one zero 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 that 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 lumacraft targeting the g 12 c allele selectively through cysteine covalent chemistry.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

But to get the other alleles, that that trick doesn't work. There's no cysteine handle. And so we worked to develop a reversible pan KRAS inhibitor that hits wild type g 12 d, g 12 v, g 12 c actually as well, and g 13 d. It binds an allosteric pocket that is shared by, other clinical stage KRAS g twelve c inhibitors. This one is what's called a dual off and dual on state inhibitor.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

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 a number of target solid tumors, both alone and in combination in a combined phase one two design. So it's a very it's a stunning molecule. Now it's, a competitive space, and this is great for patients. We, enter this space with AMG four ten being the leader in KRAS therapeutics.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

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 were really bullish about the properties of four ten and the need. Some of the KRAS inhibitors have shown a more narrow therapeutic index and, than than one might have hoped for. So competitive space, but an excellent offering, and we hope to learn a lot in expedited phase one and two clinical development. Right.

[James Bradner, Executive VP of Research & Development and Chief Scientific Officer at Amgen]

Julianne, I think we've got time for two more questions.

[Operator]

Thank you. Thank you, Gregory. Our next question comes from Matt Phipps from William Blair. Please go ahead. Your line is open.

[Matt Phipps, Group Head - Biotechnology at William Blair]

Hi. Thanks for taking my question. I actually wanted to ask about the market opportunity for TESSPIRE and CRS nasal polyps on an indication 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, Executive VP of Global Commercial Operations at Amgen]

Yes. Thanks Matt for the question. There is indeed a real opportunity here with chronic rhinosinusitis with nasal polyps. We're looking at roughly one to two million patients in The US that suffer from this. It is significantly overlapping with severe asthma.

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

Roughly forty percent 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 TESSPIRE, 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, Chairman, CEO & President at Amgen]

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

[Operator]

Thank you, Matt. Our last question will come from Alexandria Hammond from Wolfe Research. Please go ahead. Your line is open.

[Alexandria Hammond, Director, Head of Therapeutics at Wolfe Research LLC]

Thanks for taking the question. So what's your expectation for future market split between brocotilimab and Sanofi's competitor OX40? Are you thinking of fifty-fifty split in let's say the atopic dermatitis market or how are kind of thinking about that shaking out? Thank you.

[Robert Bradway, Chairman, CEO & President at Amgen]

Sure. Myrtle, why you fire away?

[Murdo Gordon, Executive VP of Global Commercial Operations at Amgen]

We're as we said in the past, we're really looking carefully at the rocotilimab 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 rocotinlimab.

[Robert Bradway, Chairman, CEO & President at Amgen]

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 pipe.

[Robert Bradway, Chairman, CEO & President at Amgen]

So look forward to seeing you later in the year. Thank you.

[Operator]

This concludes our Amgen Q1 FY twenty twenty five earnings call.

Participants

Executives

• Justin Claeys, VP of IR
• Robert Bradway, Chairman, CEO & President
• Murdo Gordon, Executive VP of Global Commercial Operations
• James Bradner, Executive VP of Research & Development and Chief Scientific Officer
• Peter Griffith, Executive VP & CFO

Analysts

• Terence Flynn, Equity Research Analyst at Morgan Stanley
• Salveen Richter, Biotechnolgy Equity Research at Goldman Sachs
• Mike Yee, Managing Director at Jefferies Financial Group
• Trung Huynh, Analyst at UBS Group
• Evan Seigerman, MD & Senior Research Analyst at BMO Capital Markets
• Chris Schott, Managing Director at JP Morgan
• Yaron Werber, Managing Director, Senior Biotechnology Analyst at Cowen and Company
• Umer Raffat, Senior Managing Director at Evercore ISI
• David Amsellem, Sr. Research Analyst at Piper Sandler Companies
• Jay Olson, Research Analyst at Oppenheimer & Co. Inc.
• Gregory Renza, Senior Biotechnology Analyst at RBC Capital Markets
• Matt Phipps, Group Head - Biotechnology at William Blair
• Alexandria Hammond, Director, Head of Therapeutics at Wolfe Research LLC