Q1 2025 Amgen Inc Earnings Call

And welcome to our first quarter 2025 earnings call, Bob Bradway will lead the call 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 Okay. Good afternoon, everyone.

Speaker Change: Thank you for joining us today.

Bob: 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.

Bob: Revenue grew 9% year over year volume grew 14%, reflecting growing patient demand for our innovative medicines.

Bob: 14 of our medicines delivered double digit sales growth.

Bob: 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.

Bob: Beyond the strong financials this quarter demonstrated the breadth and depth of our portfolio and the strength of our execution we.

Bob: We delivered multiple positive phase III Readouts initiated four new phase III studies, and launched three new products or indications.

Bob: With that let me turn to some of the key drivers of our momentum starting in general medicine.

Bob: We're addressing large underserved patient populations with multiple products, which have significant room for growth.

Bob: Heart disease remains the leading cause of death globally.

We're paso now a multibillion dollar product continues to grow as access improves for patients.

Bob: We're also advancing the <unk> clinical program, which addresses an important residual risk factor in heart disease.

Bob: It is currently being evaluated in a large phase III cardiovascular outcomes trial.

Bob: In bone health Amgen is the global leader and we expect continued long term growth in this area.

Unknown Executive: Good afternoon, and welcome to our first quarter 2025 earnings call.

Bob: As entity, which is the only one builder, which also slows bone loss reduces fracture risk for millions of post menopausal women.

Bob Bradley: Bob Bradley will lead the call and be followed by a broader review of our performance by Murdo Gordon, Jay Bradner, and Peter Griffith.

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.

Bob: We're rapidly advancing maritime having initiated the first chronic weight management phase III studies of our broad clinical program in obesity and obesity related conditions.

Unknown Executive: With 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.

Unknown Executive: 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.

Bob: Turning to rare disease, our four key growth drivers to pezza, KRYSTEXXA prisoner and tab nios.

Bob Bradley: Over to you, Bob. Okay.

Bob Bradley: 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 three data. Revenue grew 9% year over year. Volume grew 14%, reflecting growing patient demand for our innovative 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.

Are all early in their life cycles, and well positioned for long term growth.

We're also advancing the <unk> clinical program, which addresses an important residual risk factor in heart disease.

Bob: <unk> is a differentiated b cell depleting therapy.

It is currently being evaluated in a large phase III cardiovascular outcomes trial.

Bob: It's the leading biologic for the treatment of Nm OSD and recently launched as the first and only FDA approved treatment for Iga G. Four related disease, which is a serious and underserved autoimmune condition.

In bone health Amgen is the global leader and we expect continued long term growth in this area.

As entity, which is the only one builder, which also slows bone loss reduces fracture risk for millions of post menopausal women.

Bob: We're encouraged by the positive reception from patients and physicians in the early stage of the launch.

We're rapidly advancing maritime having initiated the first chronic weight management phase III studies of our broad clinical program in obesity and obesity related conditions.

Bob: We have also filed phase III data for <unk> in generalized myasthenia gravis.

Bob: With the FDA and we're exploring its potential across additional b cell mediated diseases.

Turning to rare disease, our four key growth drivers to pezza, KRYSTEXXA <unk> and <unk>.

Bob: But in inflammation, we remain focused on difficult to treat diseases, where the need for innovation is the highest.

Are all early in their life cycles, and well positioned for long term growth.

Bob: Tests buyer is a first in class therapy that targets T cell P. A differentiated mechanism with broad potential across a number of diseases.

Bob Bradley: We delivered multiple positive Phase 3 readouts, initiated four new Phase 3 studies, and launched three new products or indications.

<unk> is a differentiated b cell depleting therapy is.

The leading biologic for the treatment of Nm OSD and recently launched as the first and only FDA approved treatment for IGT for related disease, which is a serious and underserved autoimmune condition.

Bob: In severe asthma. It continues to build strong momentum with high prescriber confidence.

Bob Bradley: 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 El Paso Rand 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.

Bob: 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 worlds third leading cause of death.

We're encouraged by the positive reception from patients and physicians in the early stage of the launch.

Bob: In oncology, our leading bi specific T cell engaging platform continues to develop new standards of care.

We've also filed phase III data for <unk> in generalized myasthenia gravis with.

With the FDA and we're exploring its potential across additional b cell mediated diseases.

Bob: <unk> has moved into frontline treatment and continues to grow.

In inflammation, we remained focused on difficult to treat diseases, where the need for innovation is the highest.

Bob: The FDA has granted breakthrough therapy designation for Blinatumomab for subcutaneous treatment of B, a L L, which Jay will speak to shortly.

Tests buyer is a first in class therapy that targets, TFS LP and differentiated mechanism with broad potential across a number of diseases.

Bob: And Delta provided an overwhelming survival benefit at an interim analysis in our phase III study in second line small cell lung cancer, beating chemotherapy as a standard of care.

Bob Bradley: Eventide, which is the only bone builder which also slows bone loss, reduces fracture risk for millions of postmenopausal 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. According to Rare Disease, our four key growth drivers, tepeza, cristexa, uplizna, and tabneos are all early in their life cycles and well positioned for long term growth. Uplizna 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.

In severe asthma and 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 worlds third leading cause of death.

Bob: These data represent a meaningful milestone for patients and will be presented at <unk> in June.

Bob: Dale you rid of Mega is enrolling well and our phase III study in advanced prostate cancer patients.

Bob: Next our industry, leading biosimilar portfolio continues to contribute meaningfully to our long term growth.

In oncology, our leading bi specific T cell engage your platform continues to develop new standards of care.

Bob: We have a proven approach in this area.

<unk> has moved into frontline treatment and continues to grow.

Bob: B in the first wave of launches and ensure a safe and reliable supply.

Bob: We're seeing that formula deliver again this quarter with our next wave of U S launches underway, including <unk> blue, whereas Lana and Mackenzie.

Speaker Change: The FDA has granted breakthrough therapy designation for <unk> for subcutaneous treatment of B, a L L, which Jay will speak to shortly.

Speaker Change: I recognize there's a lot of uncertainty at the moment related to tariffs and taxes.

Speaker Change: In Delta provided an overwhelming survival benefit at an interim analysis in our phase III study in second line small cell lung cancer, beating chemotherapy as a standard of care.

Speaker Change: 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.

Bob Bradley: were encouraged by the positive reception from patients and physicians in the early stage of the launch. We've also filed phase three data for Oplizna and generalized Myasthenia gravis. With the FDA and we're exploring its potential across additional B cell mediated diseases.

Speaker Change: While it is 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.

These data.

Speaker Change: <unk> represent a meaningful milestone for patients and will be presented at <unk> in June.

Speaker Change: <unk> is enrolling well and our phase III study in advanced prostate cancer patients.

Bob Bradley: 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 TSLT, 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 three data in rhinosinusitis with nasal polyps, and most recently initiated two pivotal phase three studies in COPD, the world's third leading cause of death.

Speaker Change: Next our industry, leading biosimilar portfolio continues to contribute meaningfully to our long term growth.

Speaker Change: 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.

Speaker Change: We have a proven approach in this area.

Speaker Change: In the first wave of launches and ensure a safe and reliable supply.

Speaker Change: We're seeing that formula deliver again this quarter with our next wave of U S launches underway, including <unk> Blue was Lana and Mackenzie.

Speaker Change: 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 will do so accordingly.

Speaker Change: I recognize there's a lot of uncertainty at the moment related to tariffs and taxes.

Speaker Change: Given the long lifecycle of our business clarity on these issues is important to us and I'm sure. It's important to all of you as well.

Speaker Change: 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.

Bob Bradley: In oncology, our leading bi-specific T cell engager platform continues to develop new standards of care. Blansado has moved into frontline treatment and continues to grow. The FDA has granted breakthrough therapy designation for Blenitumumab for subcutaneous treatment of BALL, which Jay will speak to shortly. Imdeltra provided an overwhelming survival benefit at an interim analysis in a phase 3 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. Zaluritamig is enrolling well in our Phase 3 study in advanced prostate cancer patients.

Speaker Change: While it is 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.

Speaker Change: In line brands are delivering we're advancing positive phase III studies, we're launching new products, we're earning breakthrough designations.

Were initiating the next wave of late stage programs.

Speaker Change: 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 and additional expansions in the states of Ohio, and North Carolina.

Speaker Change: We're operating in a volatile environment, but what hasnt changed is the growing patient demand for our medicines and the unwavering focus of our people.

Speaker Change: Amgen is well positioned to deliver innovation and growth not just this year, but for the long term.

Speaker Change: Want to thank our nearly 28000 colleagues around the world for their dedication to our mission serving patients.

Speaker Change: 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 will do so accordingly.

Murdo: With that I'll turn it over to Murdo for a commercial update.

Murdo: Thanks, Bob we've entered 2025 with strong momentum driven by strategic focus disciplined execution and an unwavering commitment to the patients we serve and.

Speaker Change: 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.

Bob Bradley: 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 launchers and ensure a safe and reliable supply. We're seeing that formula deliver again this quarter, with our next wave of U.S. launches underway, including PavBlue, Weslana, and BKEMVI.

Murdo: In the first quarter global product sales grew 11% year over year in the U S. Our largest region product sales grew 14%.

Speaker Change: In line brands are delivering we're advancing positive phase III studies for <unk>.

Speaker Change: <unk> new products, we're earning breakthrough designations and were initiating the next wave of late stage programs.

Murdo: Globally, 14 products delivered double digit or better growth underscoring, the breadth and depth of our portfolio and ability to deliver consistently and that scale.

Speaker Change: We're operating in a volatile environment, but what hasnt changed is the growing patient demand for our medicines and the unwavering focus of our people.

Murdo: Turning to general Medicine, <unk> sales increased 27% year over year, delivering $656 million in sales in the first quarter.

Bob Bradley: 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. With respect to manufacturing, I want to point out that following the 2017 tax reform, we invested nearly $5 billion in US capital projects as measured through 2024.

Speaker Change: 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 28000 colleagues around the world for their dedication to our mission serving patients.

Murdo: It is a brand built on deep clinical conviction we're.

Murdo: We're making meaningful improvements in access helping more patients benefit from it.

Murdo: With a 100 million patients globally in need of the factors LDL cholesterol lowering.

Murdo: With that I'll turn it over to Murdo for a commercial update.

Murdo: Thanks, Bob we've entered 2025 with strong momentum driven by strategic focus disciplined execution and an unwavering commitment to the patients we serve and the first quarter global product sales grew 11% year over year in the U S. Our largest region product sales grew 14%.

Murdo: We see significant opportunity ahead to further broaden our impact.

Murdo: And deliver long term growth.

Murdo: In the U S. <unk> sales grew 26% in the first quarter with volume up 42%.

Murdo: This growth reflects steady expansion in the base of primary care prescribers and enhanced depth of prescribing amongst cardiologists.

Bob Bradley: 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.

Murdo: Globally, 14 products delivered double digit or better growth underscoring, the breadth and depth of our portfolio and ability to deliver consistently and that scale.

Murdo: Driving increased patient activation through direct to consumer efforts, leading more patients living with cardiovascular disease to ask their physicians.

Murdo: Turning to general Medicine, <unk> sales increased 27% year over year, delivering $656 million in sales in the first quarter.

Murdo: <unk>.

Murdo: Access in the U S has never been stronger with many payers, eliminating prior authorization requirements, making where path more accessible and affordable for patients.

Murdo: As a brand built on deep clinical conviction we're.

Bob Bradley: 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. 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. is well positioned to deliver innovation and growth, not just this year, but for the long term.

Murdo: We're making meaningful improvements in access helping more patients benefit from the Panther.

Murdo: Outside the U Astro path of continues to deliver strong growth across major markets.

Murdo: With a 100 million patients globally in need of effective LDL cholesterol lowering.

Murdo: Administrative sustained leadership amidst rising competition in this segment.

Murdo: <unk> sales increased 29% year over year to $442 million in the first quarter.

Murdo: We see significant opportunity ahead to further broaden our impact and deliver long term growth.

Murdo: In the U S. <unk> sales grew 26% in the first quarter with volume up 42%.

Murdo: <unk> 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.

Murdo: This growth reflects steady expansion in the base of primary care prescribers and enhanced depth of prescribing amongst cardiologists.

Murdo: Despite this clear clinical value fewer than 250000 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 thats a significant gap in a meaningful opportunity to drive growth by ensuring more patients.

Murdo: Driving increased patient activation through direct to consumer efforts, leading more patients living with cardiovascular disease to ask their physicians.

Bob Bradley: And I want to thank our nearly 28,000 colleagues around the world for their dedication to our mission, serving patients.

Murdo: <unk>.

Murdo Gordon: With that, I'll turn it over to Murdo for a commercial update. 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, Repata sales increased 27% year over year, delivering $656 million in sales in the first quarter. Repata is a brand built on deep clinical conviction.

Murdo: Access in the U S has never been stronger with many payers, eliminating prior authorization requirements, making where path more accessible and affordable for patients.

Murdo: Steve the protection they deserve from those entities.

Murdo: In the U S entity delivered 36% sales growth in the first quarter and.

Murdo: Outside the U Astro path that continues to deliver strong growth across major markets demonstrating sustained leadership amidst rising competition in this segment.

Murdo: And we focus our U S bone field force on identity and increased investment in brand awareness. These efforts are driving meaningful growth in prescription volume across established and newly activated prescriber accounts.

Murdo: <unk> sales increased 29% year over year to $442 million in the first quarter.

<unk> 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.

Murdo: Prolia sales grew 10% year over year in the first quarter with 13% volume growth, reaching almost $1 $1 billion in sales.

Murdo: 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 of sales of the <unk> 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: Despite this clear clinical value fewer than 250000 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 in a meaningful opportunity to drive growth by ensuring more patients.

Murdo Gordon: We're making meaningful improvements in access, helping more patients benefit from Repata. 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'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.S. has never been stronger, with many payers eliminating prior authorization requirements, making Repatha more accessible and affordable for patients.

Murdo: Since launched as has had a positive impact for thousands of patients living with <unk> disease in the U S. There are roughly 100000 patients suffering from TD, who could benefit from <unk> and to reach them. We've intensified our efforts to engage a broad prescriber base of ocular plastic surgeons ophthalmologists.

Murdo: Received the protection they deserve from a vanity.

Murdo: In the U S of entity delivered 36% sales growth in the first quarter and we focus our U S bone field force on <unk> and increased investment in brand awareness. These efforts are driving meaningful growth in prescription volume across established and newly activated prescriber accounts.

Murdo: And endocrinologists.

Murdo: We are 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: Prolia sales grew 10% year over year in the first quarter with 13% volume growth, reaching almost $1 $1 billion in sales.

Murdo: Access is also improved for patients with more than 85% of medical plans.

Murdo: I'll move to our rare disease portfolio, which grew 3% year over year delivering $1 billion in sales in the quarter.

Murdo: Removing clinical activity score requirements.

Murdo: I would note that within this portfolio of sales of the <unk> and KRYSTEXXA were adversely impacted in the quarter by changes to U S wholesaler inventory levels we.

Murdo: We're advancing our international expansion of <unk> in Japan to Peds is now the first and only approved therapy for active thyroid eye disease.

Murdo Gordon: Outside the U, Astropathic continues to deliver strong growth across major markets, demonstrating sustained leadership amidst rising competition in the segment. The Venity sales increased 29% year over year to $442 million in the first quarter. Divinity 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 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 a vanity.

Murdo: We do not expect similar reductions in inventory levels for the remainder of the year.

Murdo: And in the first full quarter since launch, we're seeing strong uptake and positive physician engagement.

Murdo: Since launched as has had a positive impact.

Murdo: In the European Union, we are preparing to launch following the recent positive opinion issued by the committee for medicinal products for human use.

Murdo: Tens of patients living with thyroid eye disease in the U S. There are roughly 100000 patients suffering from TD, who could benefit from <unk> and to reach them. We've intensified our efforts to engage a broad prescriber base of ocular plastic surgeons ophthalmologists and endocrinologists.

Murdo: On the approval of <unk> for the treatment of moderate to severe thyroid eye disease in adults. This marks a significant step forward for patients living with TD, who currently have no approved disease modifying therapies available to them in Europe.

Murdo: We are 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: <unk> sales increased 14% year over year to $91 million in the first quarter driven by continued growth in treating patients with neuro myelitis kick us spectrum disorder.

Murdo: Access is also improved for patients with more than 85% of medical plans, removing clinical activity score requirements.

Murdo: In April the <unk> is the first approved breakthrough therapy in the U S for the treatment of adults with immuno globulin <unk> related disease or IGT for.

Murdo: We're advancing our international expansion of <unk> in Japan to <unk> now to the first and only approved therapy for active thyroid eye disease.

Murdo Gordon: In the U.S., Avenity delivered 36% sales growth in the first quarter, and we focused our U.S. bone and field force on Avenity 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 Dipeza and Christexa were adversely impacted in the quarter by changes to U.S.

Murdo: A chronic and debilitating immune mediated inflammatory condition that can affect multiple organs launches underway and the first patient with IGT for disease, which treated shortly after approval.

Murdo: And in the first full quarter since launch we've seen strong uptake and positive physician engagement.

Murdo: 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 <unk> for the treatment of moderate to severe thyroid eye disease in adults. This marks a significant step forward for patients living with TD, who currently have no approved disease modifying.

Murdo: Amgen has many years of experience with Rheumatologists have been helpful in establishing Arjun seat to diagnose and treat patients suffering from IGT for related disease with in place now.

Murdo: In inflammation test fire delivered another strong quarter up 65% year over year adoption. Among pulmonologists is growing driven by test fire's unique profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma we.

Murdo: Therapies available to them in Europe.

Murdo: <unk> sales increased 14% year over year to $91 million in the first quarter driven by continued growth in treating patients with neuro myelitis optica spectrum disorder and.

Murdo Gordon: wholesaler inventory levels. We do not expect similar reductions in inventory levels for the remainder of the year. Since launch, Tepeza 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 T.E.D. who could benefit from Tepeza, and to reach them, we've intensified our efforts to engage a broad prescriber base of oculoplastic surgeons, ophthalmologists and endocrinologists. We're encouraged by the feedback that we're receiving from the medical community, including an increase in intent to prescribe reported by endocrinologists during the first quarter. Access is also improved for patients with more than 85% of medical plans removing clinical activity score requirements.

Murdo: We see significant growth opportunity for test fire to treat the $2 5 million patients worldwide, who suffer from this challenging disease.

Murdo: In April the plasma was the first approved breakthrough therapy in the U S for the treatment of adults with immuno globulin <unk> related disease or <unk> for.

Murdo: Our innovative oncology portfolio, including <unk> and Delta <unk>, Vectibix, Kyprolis, and <unk> and <unk> grew 10% year over year generating over $2 billion in sales in the quarter.

Murdo: A chronic and debilitating immune mediated inflammatory condition that can affect multiple organs the launches underway and the first patient with IGT for disease was treated shortly after approval.

Murdo: At the core of this growth is our industry, leading bi specific T cell engaging platform, which developed both been insightful and delta.

Murdo: Amgen has many years of experience with Rheumatologists have been helpful in establishing Arjun seat to diagnose and treat patients suffering from IGT for related disease with in place now.

Murdo: With these products, we're not only addressing critical unmet needs in oncology, we are helping to redefine the standard of care in difficult to treat cancers, creating meaningful opportunities to reach more patients and drive long term growth.

Murdo: In inflammation test fire delivered another strong quarter up 65% year over year adoption. Among pulmonologists is growing driven by test buyers unique profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma we.

Murdo Gordon: We're advancing our international expansion of TAPEZA in Japan. TAPEZA is now the first and only approved therapy for active thyroid eye disease. And in the first four quarters 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 Tepeza for the treatment of moderate to severe thyroid eye disease in adults. This marks a significant step forward for patients living with T.E.D. who currently have no approved disease-modifying therapies available to them in Europe.

Murdo: <unk> sales were $317 million in the quarter with year over year growth of 52% driven by broad prescribing across both academic and community segments.

Murdo: We see significant growth opportunity for test fire to treat the $2 5 million patients worldwide, who suffer from this challenging disease.

Murdo: We see strong conviction in <unk> as a standard of care for both adults and pediatric patients with Philadelphia chromosome negative b cell.

Murdo: Our innovative oncology portfolio, including <unk> and Delta <unk>, Vectibix, Kyprolis, and <unk> and <unk> grew 10% year over year generating over $2 billion in sales in the quarter.

Murdo: Al.

Murdo: Our U S launch of <unk> Delta for the treatment of patients with extensive stage small cell lung cancer, who are progressing on or after chemotherapy continues its strong momentum generating $81 million in sales in the first quarter to date and Delta has been administered in patients and academic cancer centers regional.

Murdo: At the core of this growth is our industry, leading bi specific T cell engaging platform, which developed both blood insightful and delta.

Murdo Gordon: The Plisna sales increased 14% year-over-year to $91 million in the first quarter, driven by continued growth in treating patients with neuromyelitis or kick-off spectrum disorder. In April, the Plisna 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, and 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 iplisna.

Murdo: 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.

Murdo: Cancer hospitals, and community oncology clinics, indicating broad adoption and comfort with this important new cancer therapy and.

Murdo: In April we expanded our global reach with the launch of <unk> Delta in Japan, marking an important step forward in our commitment to bringing innovative oncology therapies to patients around the world.

Murdo: <unk> sales were $317 million in the quarter with year over year growth of 52% driven by broad prescribing across both academic and community segments.

Murdo: The momentum behind them Delta is being reinforced by compelling new data, we recently announced new clinical data demonstrating that <unk> met the primary endpoint of superior overall survival in small cell lung cancer compared to standard of care chemotherapy.

Murdo: We see strong conviction in <unk> as a standard of care for both adults and pediatric patients with Philadelphia chromosome negative b cell.

Murdo: Al.

Murdo: Our U S launch of <unk> Delta for the treatment of patients with extensive stage small cell lung cancer, who are progressing on our after chemotherapy continues its strong momentum generating $81 million in sales in the first quarter to date and Delta has been administered in patients and academic cancer centers regional.

Murdo Gordon: In inflammation, Tespire delivered another strong quarter, up 65% year-over-year. Adoption among pulmonologists is growing, driven by Tespire's unique profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma. We see significant growth opportunity for Tespire to treat the 2.5 million patients worldwide who suffer from this challenging disease. Our innovative oncology portfolio, including BlinCytl, Mdeltra, Lumicrast, Vectabix, Kyprolis, Endplate, and Xgeva grew 10% year-over-year, generating over $2 billion in sales in the quarter. At the core of this growth is our industry-leading bispecific T-cell engager platform, which developed both BlinCytl and Mdeltra. 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.

Murdo: This is a meaningful confirmation of the delta is 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 million in the first quarter, representing an increase of 35% year over year.

Murdo: Cancer hospitals, and community oncology clinics, indicating broad adoption and comfort with this important new cancer therapy and.

Murdo: Sales of pad blue the Biosimilar to Eylea reached $99 million in the first quarter retina.

Murdo: In April we expanded our global reach with the launch of <unk> Delta in Japan, marking an important step forward in our commitment to bringing innovative oncology therapies to patients around the world.

Our retina specialists are responding very positively to Pat blue expressing appreciation for this high quality Amgen Biosimilar delivered in an easy to use pre filled syringe.

Murdo: The momentum behind them Delta is being reinforced by compelling new data, we recently announced new clinical data demonstrating that in Delta met the primary endpoint of superior overall survival in small cell lung cancer compared to standard of care chemotherapy. This as a meaningful confirmation of the delta is efficacy for patients.

Murdo: <unk> on April one.

Murdo: <unk> received its permanent reimbursement Q code, which will facilitate easier access for patients.

Murdo: We're also pleased with the successful U S launches are with lineup a biosimilar to soliris and that can be a biosimilar to soliris.

Murdo: <unk> 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.

Murdo: 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.

Murdo Gordon: Blood Cytocells were $370 million in the quarter, with year-over-year growth of 52%, driven by broad prescribing across both academic and community segments. We see strong conviction in Blood Cyto as a standard of care for both adults and pediatric patients with Philadelphia chromosome negative B cell ALL. Our U.S. launch of MDELTRA for the treatment of patients with extensive-stage small-cell lung cancer who are progressing on or after chemotherapy continues its strong momentum, generating $81 million in sales in the first quarter. To date, MDELTRA 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.

Murdo: Biosimilar portfolio sales were $735 million in the first quarter, representing an increase of 35% year over year sales.

Murdo: 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.

Murdo: Sales of pad blue the Biosimilar to Eylea reached $99 million in the first quarter retina.

James: High performing team and above all a clear and unwavering commitment to the patients we serve I'll now hand, it over to James.

Murdo: The retina specialists are responding very positively to <unk> blue expressing appreciation for this high quality Amgen Biosimilar delivered in an easy to use pre filled syringe.

James: Thank you Murdo and good afternoon, everyone.

James: 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.

Murdo: <unk> on April <unk> <unk> received its permanent reimbursement Q code, which will facilitate easier access for patients.

James: Most notably we received FDA approval for <unk> in <unk> related disease, the second approval and a series of B cell mediated diseases, we're studying with this medicine.

Murdo: We're also pleased with the successful U S launches of with lineup a biosimilar to soliris and they can be a biosimilar to soliris and <unk>.

Murdo: <unk> 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.

James: We also announced positive data from phase III studies of <unk>, <unk> and Telstra, while initiating multiple phase III trials of maritime intensifier.

Murdo Gordon: In April, we expanded our global reach with the launch of Imdelta in Japan, marking an important step forward in our commitment to bringing innovative oncology therapies to patients around the world. The momentum behind MDELTRA is being reinforced by compelling new data. We recently announced new clinical data demonstrating that MDELTRA 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 MDELTRA'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.

Murdo: 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.

James: Let's begin with maritime our investigational therapy for obesity in obesity related conditions that features a unique and differentiated profile in.

James: In March we initiated two phase III studies in chronic weight management as part of our comprehensive maritime Phase III program.

Jay: High performing team and above all a clear and unwavering commitment to the patients we serve I'll now hand, it over to Jay.

James: These trials will evaluate mirror tightened two distinct populations.

Jay: Thank you Murdo and good afternoon, everyone.

James: <unk> living with obesity or overweight without type two diabetes in adults with obesity are overweight with type two diabetes.

Jay: 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.

James: Both studies will assess the safety efficacy and Tolerability of three target dose levels of maritime preceded by an optimized dose escalation regimen to improve the patient experience.

Jay: Most notably we received FDA approval for <unk> in <unk> related disease, the second approval and a series of B cell mediated diseases, we're studying with this medicine.

Murdo Gordon: Biosimilar portfolio sales were $735 million in the first quarter, representing an increase of 35% year-over-year. Sales of PAB Blue, the biosimilar to ILEA, reached $99 million in the first quarter. Retina specialists are responding very positively to PAB Blue, expressing appreciation for this high-quality Amgen biosimilar delivered in an easy-to-use pre-filled syringe. Importantly, on April 1st, PAB Blue received its permanent reimbursement Q code, which will facilitate easier access for patients. We're also pleased with the successful U.S. launches of Wislana, a biosimilar to Stelara, and Bikambi, a biosimilar to Solaris. Both launches have been received well by our patient and prescriber communities.

James: The primary endpoint for each study is the change from baseline body weight at 72 weeks.

Jay: We also announced positive data from phase III studies of broker <unk>, <unk> and Telstra, while initiating multiple phase III trials of maritime intensifier.

James: Beyond these first two studies, we anticipate initiating additional maritime phase III studies later this year evaluating maritime specific obesity related conditions.

Jay: Let's begin with maritime our investigational therapy for obesity in obesity related conditions that features a unique and differentiated profile in.

James: Last November we presented topline results of 52 weeks from our phase II chronic weight management study, which highlighted maritime monthly or less frequent dosing consistent predictable and sustained weight loss across all doses without a weight loss plateau through 52 weeks.

Jay: In March we initiated two phase III studies in chronic weight management as part of our comprehensive maritime Phase III program.

Jay: These trials will evaluate mirror tightened two distinct populations.

Jay: <unk> living with obesity are overweight without type two diabetes in adults with obesity are overweight with type two diabetes.

James: <unk> maritime clinically meaningful impact on cardio metabolic parameters, including hemoglobin <unk>.

Murdo Gordon: 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.

Jay: Both studies will assess the safety efficacy and Tolerability of three target dose levels of maritime preceded by an optimized dose escalation regimen to improve the patient experience.

James: At the American Diabetes Association or <unk> annual meeting. This June the underlying details from this phase III study at 52 weeks will be presented.

James: 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, which was used in the other seven treatment arms.

Murdo Gordon: Looking ahead, we see significant growth potential powered by discipline and execution, a high-performing team, and above all, a clear and unwavering commitment to the patients we serve.

Jay: The primary endpoint for each study is the change from baseline body weight at 72 weeks.

Jay: Beyond these first two studies, we anticipate initiating additional maritime phase III studies later this year evaluating maritime specific obesity related conditions.

Jay Bradner: I'll now hand it over to Jay. 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 achievement. Most notably, we received FDA approval for Eplizna, an IgG4-related disease, the second approval in a series of B-cell-mediated diseases we are studying with this medicine. We also announced positive data from phase 3 studies of rocatinlamab, oplizna, and imdeltra, while initiating multiple phase 3 trials of maritide and tedspire.

James: This finding is consistent with the clinical experience to date with <unk> based therapies and was further supported by our phase one pharmacokinetic study that tested even lower starting doses of maritime.

Jay: Last November we presented top line results of 52 weeks from our phase II chronic weight management study, which highlighted maritime monthly or less frequent dosing consistent predictable and sustained weight loss across all doses without a weight loss plateau through 52 weeks.

James: Details from this study will also be discussed at Ada.

James: These learnings have informed the design of our two phase III studies of maritime for chronic weight management, which are open and enrolling robustly.

Jay: And <unk> clinically meaningful impact on cardio metabolic parameters, including hemoglobin <unk> C.

James: Looking ahead to the second half of 2025, we expect key data for maritime, including both the ongoing phase III type two diabetes study, which has completed enrollment as well as end of treatment period data from part two of the ongoing phase II chronic weight management study.

Jay: At the American Diabetes Association or <unk> annual meeting. This June the underlying details from this phase II study at 52 weeks will be presented.

Jay Bradner: Let's begin with Meritide, 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 Meritime 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.

Jay: 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, which was used in the other seven treatment arms.

James: Maritime represents a promising treatment advantage 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 cardio metabolic parameters, we are committed to fully realizing its therapeutic potential.

Jay: This finding is consistent with the clinical experience to date with <unk> based therapies and was further supported by our phase one pharmacokinetic study that tested even lower starting doses of maritime.

James: Beyond Maritime and General Medicine, we look forward to data from the <unk> of the affiliates phase III primary prevention study in the second half of this year.

Jay: Details from this study will also be discussed at Ada.

Jay: These learnings have informed the design of our two phase III studies of maritime for chronic weight management, which are open and enrolling robustly.

James: Given the profound and sustained benefit of our path 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.

Jay: Looking ahead to the second half of 2025, we expect key data for maritime, including both the ongoing phase III type two diabetes study, which has completed enrollment as well as end of treatment period data from part two of the ongoing phase II chronic weight management study.

Jay Bradner: Beyond these first two studies, we anticipate initiating additional Maritime Phase III studies later this year, evaluating maritime and specific obesity-related conditions. Last November, we presented top-line results at 52 weeks from our Phase 2 Chronic Weight Management Study, which highlighted Meritide's monthly or less frequent dosing, consistent, predictable, and sustained weight loss across all doses without a weight loss plateau through 52 weeks, and Meritide's clinically meaningful impact on cardiometabolic parameters, including hemoglobin A1c.

James: Turning to our pass ran our promising best in class small interfering RNA medicines targeting LP little a we're bringing a precision medicine approach to cardiovascular risk reduction for the many patients with LP little a elevation.

Jay: Maritime represents a promising treatment advances for people living with obesity and related conditions.

The fully enrolled ocean, a phase III cardiovascular outcomes trial level <unk> continues to progress.

Jay: Especially given its monthly or less frequent dosing predictable and sustained weight loss and clinically meaningful impact on cardio metabolic parameters, we are committed to fully realizing its therapeutic potential.

James: Moving on to our rare disease portfolio. We are very excited about <unk> expanding potential to improve the lives of those facing rare inflammatory conditions in.

Jay Bradner: For more information, visit www.FEMA.gov At the American Diabetes Association, or ADA, annual meeting this June, the underlying details from this Phase 2 study at 52 weeks will be presented. Clear from these data is the important finding that dose escalation, which was studied in 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 GLT-1-based therapies and was further supported by our Phase I pharmacokinetic study that tested even lower starting doses of maritide.

Jay: Beyond Maritime and General Medicine, and we look forward to data from the <unk> of the affiliates phase III primary prevention study in the second half of this year.

James: In April the FDA approved the prisoner as the first and only treatment for adults living with immunoglobulin G. Four related disease, delivering durable disease control. In this recently described chronic and debilitating immune mediated inflammatory condition that often affects multiple organ systems.

Jay: Given the profound and sustained benefit of our pathway 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: <unk> is an innovative biologic that targets CD 19 positive b cells and addresses a core driver of <unk> related disease significantly reducing disease flares and dependence on harmful long term steroid treatment.

Jay: Turning to our pass ran our promising best in class small interfering RNA medicines targeting LP little a we're bringing a precision medicine approach to cardiovascular risk reduction for the many patients with LP little a elevation.

James: Additionally, we recently presented compelling 52 week data from our pivotal phase III <unk> study evaluating <unk> in patients with generalized myasthenia gravis. These.

Jay: The fully enrolled ocean, a phase III cardiovascular outcomes trial level passerine continues to progress.

Jay Bradner: 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 from Maritime, including both the ongoing Phase 2 Type 2 diabetes study, which has completed enrollment, as well as end of treatment period data from Part 2 of the ongoing Phase 2 chronic weight management study. 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.

Jay: Moving on to our rare disease portfolio. We are very excited about <unk> expanding potential to improve the lives of those facing rare inflammatory conditions.

James: These results demonstrated durable and sustained efficacy of <unk> in patients with acetylcholine receptor autoantibody positive generalized myasthenia gravis with only two doses a year following an initial loading dose.

Jay: In April the FDA approved the prisoner is the first and only treatment for adults living with immunoglobulin G. Four related disease, delivering durable disease control. In this recently described chronic and debilitating immune mediated inflammatory condition that often affects multiple organ systems.

James: The 52 week results highlight a pleasant promise as a new standard of care in generalized myasthenia gravis.

James: Offering durable and sustained symptom relief with a simplified treatment regimen, while minimizing steroid use.

Jay: <unk> is an innovative biologic that targets CD 19 positive b cells and addresses a core driver of <unk> related disease significantly reducing disease flares and dependence on harmful long term steroid treatment.

James: Since the publication of these data we have met with numerous opinion leaders who are also enthusiastic about our pleasantness profile highlighting the unique mechanism of action patient centered every six month dosing schedule and durable sustained efficacy.

Jay: Additionally, we recently presented compelling 52 week data from our pivotal phase III <unk> study evaluating <unk> in patients with generalized myasthenia gravis.

Jay Bradner: Beyond Maritime, in General Medicine, we look forward to data from the Rapatha Vesalius Phase III 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: We are also pleased to announce that the FDA has accepted the regulatory submission of the <unk> phase III generalized myasthenia gravis data with a <unk> date of December 14th 2025.

Jay: These results demonstrated durable and sustained efficacy of <unk> in patients with acetylcholine receptor autoantibody positive generalized myasthenia gravis with only two doses a year following an initial loading dose.

James: The recent FDA approval in <unk> related disease, and the strong clinical evidence in myasthenia gravis underscore amgen's ongoing leadership in developing innovative treatments targeting CD 19 positive b cells in cancer inflammation and in rare disease more generally we're only 5%.

Jay Bradner: Turning to Opassaran, our promising best-in-class, small-interfering RNA medicine targeting Lp a, we are bringing a precision medicine approach to cardiovascular risk reduction for the many patients with Lp a elevation. The fully enrolled OCEAN-A Phase III Cardiovascular Outcomes Trial of olfactory end continues to progress.

Jay: The 52 week 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.

James: The estimated 10000 rare diseases have available treatments.

Jay: Since the publication of these data we have met with numerous opinion leaders who are also enthusiastic about our <unk> profile highlighting the unique mechanism of action patient centered every six month dosing schedule and durable sustained efficacy.

James: In inflammation, we and our partner Astrazeneca have initiated two phase III studies of <unk> in chronic obstructive pulmonary disease targeting patients with moderate to very severe COPD with blood eosinophil counts greater than or equal to 150 cells per microliter.

Jay Bradner: Moving on to our rare disease portfolio, we are very excited about Eplisna's expanding potential to improve the lives of those facing rare inflammatory conditions. In April, the FDA approved Eplizuna 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 Aplizna is an innovative biologic that targets CD19-positive B-cells and addresses a core driver of IgG4-related disease, significantly reducing disease flares and dependence on harmful long-term steroid treatment. Additionally, we recently presented compelling 52-week data from our pivotal Phase III MINT study evaluating aplisna in patients with generalized myasthemia gravis.

Jay: We are also pleased to announce that the FDA has accepted the regulatory submission of the <unk> phase III generalized myasthenia gravis data with a <unk> date of December 14th 2025.

James: COPD is the worlds third leading cause of death and we're excited about the impact has buyer can have in this setting.

James: Beyond COPD, we completed the regulatory submission of <unk> phase III data for chronic rhinosinusitis with nasal polyps and look forward to a <unk> date of October 19 2025.

Jay: The recent FDA approval in <unk> related disease, and the strong clinical evidence in myasthenia gravis underscore amgen's ongoing leadership in developing innovative treatments targeting CD 19 positive b cells in cancer inflammation and in rare disease more generally we're only 5% of.

James: In March we announced data from three additional phase III studies from the <unk> rocket program in atopic dermatitis, notably ignite, which met its primary and key secondary endpoints. We look forward to additional data from the rocket program in the second half of 2025 and oncology, we recently announced compelling.

Jay: The estimated 10000 rare diseases have available treatments.

Jay: In inflammation, we and our partner Astrazeneca have initiated two phase III studies of test buyer in chronic obstructive pulmonary disease.

James: For the <unk> trial from our Delphi, three or four phase III trial, where at a planned interim analysis. The study met its primary endpoint, demonstrating a significant and clinically meaningful overall survival benefit.

Jay Bradner: These results demonstrated durable and sustained efficacy of Oplizna in patients with acetylcholine receptor autoantibody positive generalized myasthenia gravis with only two doses a year following an initial loading dose. The 52-week MINT results highlight Eplizuna's promise as a new standard of care in generalized myasthenia gravis, offering durable and sustained symptom relief with a simplified treatment regimen while minimizing steroid use. Since the publication of these data, we have met with numerous opinion leaders who are also enthusiastic about Eplizuna's 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 Eplisna Mint Phase 3 Generalized Myasthenia Gravis data with a PDUFA date of December 14, 2025.

Jay: <unk> patients with moderate to very severe COPD with blood eosinophil counts greater than or equal to 150 cells per microliter.

Jay: COPD is the worlds third leading cause of death and we're excited about the impact has buyer can have in this setting.

James: <unk> three or four evaluated <unk> in patients with small cell lung cancer, who progressed on or after initial platinum based chemotherapy versus chemotherapy alone.

Jay: Beyond COPD, we completed the regulatory submission of <unk> phase III data for chronic rhinosinusitis with nasal polyps and look forward to a <unk> date of October 19 2025.

James: These randomized data are the first to show a substantial survival improvement head to head against standard of care chemotherapy.

Jay: In March we announced data from three additional phase III studies from the <unk> rocket program in atopic dermatitis, notably ignite, which met its primary and key secondary endpoints. We look forward to additional data from the rocket program in the second half of 2025 and oncology, we recently announced compelling result.

James: Offering new hope for patients with this difficult disease.

James: Together with the remarkable Delphi 301 data already reported and Delta has the potential to become the new standard of care for second line small cell lung cancer.

James: An oncologist I'm really encouraged by and Delta as a new and highly efficacious therapy for an aggressive and common solid tumor for which there has been very little progress.

Jay: For Delta from our del <unk>, three or four phase III trial, where at a planned interim analysis. The study met its primary endpoint, demonstrating a significant and clinically meaningful overall survival benefit.

James: We look forward to sharing more detailed results at the upcoming <unk> meeting in early June.

Jay Bradner: 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 5% of the estimated 10,000 rare diseases have available treatment.

James: In addition to Delphi three or four we continue to investigate and delta in earlier lines of small cell lung cancer.

Jay: <unk> three or four evaluated <unk> in patients with small cell lung cancer, who progressed on or after initial platinum based chemotherapy versus chemotherapy alone.

James: Currently two phase III studies are underway and we are pleased to announce plans to initiate Delphi <unk> two.

James: A phase III trial evaluating <unk> as induction and maintenance therapy in first line treatment of extensive stage small cell lung cancer here in combination with Carboplatin and Etoposide and development.

Jay: These randomized data are the first to show a substantial survival improvement head to head against standard of care chemotherapy.

Jay Bradner: In inflammation, we and our partner AstraZeneca have initiated two phase three studies of Tez-Spire in chronic obstructive pulmonary disease, targeting patients with moderate to very severe COPD, with bloody acinophil counts greater than or equal to 150 cells per microliter. COPD is the world's third leading cause of death, and we're excited about the impact Tespire could have in this setting. Beyond CLPD, we completed the regulatory submission of TESFIRE's Phase 3 data for chronic rhinosinusitis with nasal polyps and look forward to a PDUFA date of October 19, 2025.

Jay: Offering new hope for patients with this difficult disease.

Jay: Together with the remarkable Delphi 301 data already reported and Delta has the potential to become the new standard of care for second line small cell lung cancer.

James: We also continue to investigate our CD 19, directed bite medicine, <unk> and earlier treatment setting while also advancing a subcutaneous formulation of <unk> tumor map.

Jay: An oncologist I'm really encouraged by <unk> as a new and highly efficacious therapy for an aggressive and Tom in solid tumor for which there has been very little progress.

James: In April the FDA granted breakthrough therapy designation for subcutaneous <unk> in the treatment of adults with relapsed refractory CD 19 positive b cell precursor acute lymphoblastic leukemia.

Jay: We look forward to sharing more detailed results at the upcoming <unk> meeting in early June.

James: Based on our experience to date subcutaneous split of tumor map has the potential to improve both the patient experience and efficacy.

Jay: In addition to Delphi three or four we continue to investigate and delta in earlier lines of small cell lung cancer.

Jay Bradner: In March, we announced data from three additional Phase III studies from the Roka-Tinlamab rocket program in atopic dermatitis, notably IGNITE, which met its primary and key secondary endpoints. We look forward to additional data from the rocket program in the second half of 2025.

James: Sure.

Jay: Currently two phase III studies are underway and we are pleased to announce plans to initiate Delphi <unk> two a phase III trial evaluating <unk> as induction and maintenance therapy in first line treatment of extensive stage small cell lung cancer here in combination with Carboplatin and Etoposide and development.

James: Our first in class steep one CD three bi specific T cell engagement <unk> is advancing in phase III clinical development, where we are rapidly enrolling patients with metastatic castrate resistant prostate cancer, who have progressed following taxane based therapy.

Jay Bradner: In oncology, we recently announced compelling results from DELTRA, from our DEL5304 Phase III trial, where at a planned intramural analysis, the study met its primary endpoint, demonstrating a significant and clinically meaningful overall survival benefit. Delphi 304 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 301 data already reported, Imdeltra has the potential to become the new standard of care for second-line small cell lung cancer.

James: We are also exploring celebrated making combination therapy and in earlier stages of prostate cancer with multiple phase <unk> studies ongoing.

Jay: We also continue to investigate our CD 19, directed bite medicine, <unk> and earlier treatment setting while also advancing a subcutaneous formulation of <unk> tumor map.

James: Collectively and Telstra when <unk> celebrated make exemplify the significant growth potential of our robust bi specific T cell engagement platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide.

Jay: In April the FDA granted breakthrough therapy designation for subcutaneous <unk> in the treatment of adults with relapsed refractory <unk> 19 positive b cell precursor acute lymphoblastic leukemia based.

James: Beyond our T cell engagements are first in class fibroblast growth factor receptor two be directed monoclonal antibody, but merit to the mab is advancing to frontline gastric cancer therapy.

Jay: Based on our experience to date subcutaneous <unk> has the potential to improve both the patient experience and efficacy.

James: We expect data this quarter from 4% to 101 phase III study of <unk> combined with <unk> six chemotherapy versus chemotherapy alone.

Jay: Our first in class steep one CD three bi specific T cell engagement <unk> is advancing in phase III clinical development, where we are rapidly enrolling patients with metastatic castrate resistant prostate cancer, who have progressed following taxane based therapy.

James: In the second half of 2025, we expect data from 42 to 102 a.

Jay Bradner: As an oncologist, I'm really encouraged by Imdeltra as a new and highly efficacious therapy for an aggressive and common solid tumor for which there has been very little progress.

James: Our phase III study of <unk>, combined with chemotherapy and Nolan that verse.

Jay: We are also exploring celebrated making combination therapy and in earlier stages of prostate cancer with multiple phase <unk> studies ongoing.

James: Chemotherapy nimble on that alone.

James: On Biosimilars, we are rapidly advancing three phase III programs evaluating our biosimilars to Opdivo Keytruda and <unk> as the next wave of Amgen Biosimilar products.

Jay Bradner: We look forward to sharing more detailed results at the upcoming ASCO meeting in early June. In addition to Delphi 304, we continue to investigate in Delta and earlier lines of small cell lung cancer. Currently, two Phase III studies are underway, and we are pleased to announce plans to initiate Delphi 3.1.2, a Phase III trial evaluating amdeltra as induction and maintenance therapy in first-line treatment of extensive-stage small-cell lung cancer, here in combination with carboplatin, atoposide, and dervalamin.

Jay: Collectively and Telstra <unk> exemplify the significant growth potential of our robust bi specific T cell engagement platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide.

James: 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.

Jay: Beyond our T cell engagements are first in class fibroblast growth factor receptor <unk> directed monoclonal antibody, but merit to the mab is advancing to frontline gastric cancer therapy.

Peter: Now I'll turn it over to Peter.

Peter: 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.

Jay: We expect data this quarter from 4% to 101 phase III study of <unk> combined with <unk> full Fox six chemotherapy versus chemotherapy alone.

Peter: Actual results are shown on slides, 29% to 30 of the slide deck and.

Jay Bradner: We also continue to investigate our CD19-directed bite medicine Blincito in earlier treatment settings, while also advancing a subcutaneous formulation of Blinitumumab. In April, the FDA granted breakthrough therapy designation for subcutaneous blinitumumab in the treatment of adults with relapsed refractory CV19 positive B-cell precursor acute lymphoblastic leukemia. Based on our experience to date, subcutaneous blinitumumab has the potential to improve both the patient experience and efficacy.

Peter: In the first quarter, we delivered revenues of $8 1 billion and 9% increase year over year. This reflects double digit sales growth of 11% driven by 14% volume growth from key brands, including <unk> buyer and the entity, partially offset by 6% lower net selling price.

Jay: In the second half of 2025, we expect data from 42 to 102, a phase III study of <unk> combined with chemotherapy and <unk> map versus chemotherapy Nivola Mab alone.

Jay: On Biosimilars, we are rapidly advancing three phase III programs evaluating our biosimilars to Opdivo Keytruda and <unk> as the next wave of Amgen Biosimilar products.

Peter: Yeah.

Peter: Our non-GAAP operating expenses rose, 4% led by non-GAAP R&D growth of 12% year over year, reflecting continued investment in our late stage pipeline, including maritime paths are in and rare disease.

Peter: 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 I'll now turn it over to Peter.

Jay Bradner: Our first-in-class STEEP1 CD3 bispecific T-cell engager, Xeloritamig, is advancing in Phase 3 clinical development, where we are rapidly enrolling patients with metastatic, castrate-resistant prostate cancer who progress following taxane-based therapy. We are also exploring Zeller-Rittemegen combination therapy and in earlier stages of prostate cancer with multiple Phase 1b studies ongoing. Collectively, Indeltra, Blincito, and Valiretamig exemplify the significant growth potential of our robust, bi-specific T-cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide.

Peter: Our Q1 non-GAAP operating margin was 45, 7%. This is above the outlook. We gave on our 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.

Peter: 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 with an actual results are shown on slides, 29% to 30 of the slide deck.

Speaker Change: In the first quarter, we delivered revenues of $8 1 billion and 9% increase year over year. This reflects double digit sales growth of 11% driven by 14% volume growth from key brands, including <unk> prior end of entity, partially offset by 6% lower net selling price.

Peter: 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.

Peter: Our non-GAAP <unk> was down $53 million year.

Jay Bradner: Beyond our T-cell engagers, our first-in-class fibroblast growth factor receptor 2B-directed monoclonal antibody, bumerituzumab, is advancing to frontline gastric cancer therapy. We expect data this quarter from Fortitude 101, a Phase 3 study of Bemerituzumab combined with M-Full Fox-6 chemotherapy versus chemotherapy alone. In the second half of 2025, we expect data from Fortitude 102, a phase three study of bimerituzumab combined with chemotherapy and nivolumab versus chemotherapy and nivolumab alone.

Peter: Year over year, driven by lower interest expense through retirement of debt, including $4 5 billion in 2024, and $2 9 billion in the first quarter of 2025.

Peter: Yes.

Peter: Our non-GAAP operating expenses rose, 4% led by non-GAAP R&D growth of 12% year over year, reflecting continued investment in our late stage pipeline, including maritime paths are in and rare disease.

Peter: In addition, we repaid $1 billion today as we continue to progress the strengthening of our balance sheet.

Peter: Our Q1 non-GAAP operating margin was 45, 7%. This is above the outlook. We gave on our 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.

Peter: Since the announcement of the Horizon acquisition, we have now retired $10 $8 billion of debt.

Peter: Our non-GAAP tax rate decreased <unk> eight percentage points year over year to 14, 6% primarily due to the change in earnings mix.

Jay Bradner: On biosimilars, we are rapidly advancing three phase three programs, evaluating our biosimilars to Opdivo, Keytruda, and Acrevis 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.

Peter: 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.

The company generated 1.0 billion and free cash flow in the first quarter, reflecting continued investment in growth and operational momentum across the business.

Peter: Our non-GAAP <unk> was down $53 million year.

Peter: 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.

Peter: Year over year, driven by lower interest expense through retirement of debt, including $4 5 billion in 2024, and $2 9 billion in the first quarter of 2025.

Peter Griffith: I'll now turn it over to Peter. 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.

Peter: For 2025, we expect no change in our capital expenditures outlook of $2 3 billion.

Peter Griffith: 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 and a 9% increase year over year. This reflects double-digit sales growth of 11%, driven by 14% volume growth from key brands, including Repasible, Insight, Otespire, and Divinity, partially offset by 6% lower net selling price. Our non-GAAP operating expenses rose 4%, led by non-GAAP R&D growth of 12% year-over-year, reflecting continued investment in our late-stage pipeline, including Maritide, Opaciran, 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.

Peter: In addition, we repaid $1 billion today as we continue to progress the strengthening of our balance sheet.

Peter: Which will support our products across the portfolio and our innovative pipeline, including maritime.

Peter: Since the announcement of the Horizon acquisition, we have now retired $10 $8 billion of debt.

Peter: Our commitment to innovation is also evident as we deploy artificial intelligence across the value chain informing molecule design and discovery research innate.

Peter: Our non-GAAP tax rate decreased <unk> eight percentage points year over year to 14, 6% primarily due to the change in earnings mix.

Peter: Enabling faster trial enrollment and streamlining regulatory filings in clinical development.

Peter: The company generated 1.0 billion and free cash flow in the first quarter, reflecting continued investment in growth and operational momentum across the business.

Peter: And enhancing our responsiveness to customers and commercial operations.

Peter: 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.

Peter: 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.

Peter: Let's turn to the outlook for the business for 2025 on slide 31.

Peter: For 2025, we expect no change in our capital expenditures outlook of $2 3 billion.

Peter: 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.

Peter: Which will support our products across the portfolio and our innovative pipeline, including maritime.

Peter Griffith: The Horizon integration has progressed well, and we expect to reach the previously announced $500 million in pre-tax cost synergies by the end of this year. Our non-GAAP OI&E was down $53 million year-over-year, driven by lower interest expense through retirement of debt, including $4.5 billion in 2024 and $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 Verizon acquisition, we have now retired $10.8 billion of debt. Our non-gap tax rate decreased 0.8 percentage points year over year to 14.6%, primarily due to the change in earnings mix.

Peter: Our commitment to innovation is also evident as we deploy artificial intelligence across the value chain and forming molecule design and discovery research.

Peter: And $21 20.

Peter: 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.

Peter: Enabling faster trial enrollment and streamlining regulatory filings in clinical development and.

Peter: And enhancing our responsiveness to customers and commercial operations.

Peter: 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.

Peter: 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.

Peter: Let's turn to the outlook for the business for 2025 on slide 31.

Peter: Including maritime and <unk>.

Peter: 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.

Peter: We now anticipate non-GAAP Hawaiian E to be approximately $2 3 billion in 2025, we now expect our non-GAAP tax rate of 14, 5% to 16%.

Peter Griffith: 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 Meritize. 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 in clinical development, and enhancing our responsiveness to customers in commercial operations.

Peter: And for <unk> 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.

Peter: 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.

Peter: And let me remind you of prior items that have not changed to our outlook for the remainder of the year for the full year. We continue to expect other revenue to be approximately $1 4 billion. We continue to project that full year non-GAAP operating margin as a percentage of product sales to be roughly 40.

Peter: 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.

Peter: 6%.

Peter: 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 2020 for working capital.

Peter: Including maritime and <unk>.

Peter: We now anticipate non-GAAP <unk> to be approximately $2 3 billion in 2025, we now expect our non-GAAP tax rate of 14, 5% to 16%.

Peter: And for <unk> 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.

Peter: <unk> ability and incremental capital expenditures free.

Peter Griffith: 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.

Peter: Free cash flow in the second quarter will be impacted by the shift in 2020 for tax payments to Q2, 25, and the final $1 8 billion.

Peter: And let me remind you of prior items that have not changed to our outlook for the remainder of the year for the full year. We continue to expect other revenue to be approximately $1 4 billion. We continue to project that full year non-GAAP operating margin as a percentage of product sales to be roughly <unk> <unk>.

Peter Griffith: 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.

Peter: Repatriation tax payment.

Peter: I know theres, a lot of interest and taxes and tariffs we understand the impetus for increasing U S investment in manufacturing Amgen.

Peter: <unk> 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.

Peter: 36%.

Peter: 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.

Peter: With 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 cut and jobs Act.

Peter: As mentioned on our fourth quarter earnings call. This decline is primarily driven by 2024, working capital favorability and incremental capital expenditures free.

Peter Griffith: 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 Meritide and Opasaran. 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 Wes Lana 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.

Peter: 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.

Peter: Free cash flow in the second quarter will be impacted by the shift in 2020 for tax payments to Q2, 25, and the final $1 8 billion.

Peter: Repatriation tax payment.

Peter: I know theres, a lot of interest and 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 the United States based research and development to build on the manufacturing.

Peter: 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.

Peter: Driving innovation in areas of high unmet medical need and maintaining rigorous financial discipline.

Peter: <unk> base in the U S. We agree with our peers that.

Peter: We continue to focus on execution excellence across the enterprise and remain well positioned for sustained growth through the long term.

Peter: With 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.

Peter Griffith: And let me remind you of prior items that have not changed to our outlook for the remainder of the year. For the full year, we continue to expect other revenue to be approximately $1.4 billion. We continue to project that full year non-GAAP operating margin as a percentage of product sales to be roughly 46 percent. 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 incremental capital expenditures.

Peter: I am grateful to work with all of our colleagues worldwide and serving patients.

Peter: This concludes our financial update I'll hand, it back to Bob for our Q&A session.

Peter: 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.

Peter: Okay.

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

Thank you if you would like to ask a question. Please press star followed by one on your telephone keypad.

Peter: 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.

Peter: Any reason you would like to turn that question. Please press star followed by one.

Peter: To ask a question press star one.

Speaker Change: Our first question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Peter: Driving innovation in areas of high unmet medical need and maintaining rigorous financial discipline.

Terence Flynn: Thanks for taking the question congrats on all the progress.

Speaker Change: I was just wondering Jay if you could help frame for us what we should be looking for.

Peter Griffith: Free cash flow in the second quarter will be impacted by the shift in 2024 tax payments to Q2 2025 and the final $1.8 billion repatriation tax payment.

Peter: We continue to focus on execution excellence across the enterprise and remain well positioned for sustained growth through the long term.

Speaker Change: With respect to maritime I know this is going to be the first detailed presentation of the phase II data, but what do you think kind of a key message and key learnings coming out from that will be and then kind of related question is I know theres a lot of focus on the <unk>.

Peter: I am grateful to work with all of our colleagues worldwide and serving patients.

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

Peter Griffith: 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 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. 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.

Speaker Change: Central Cbot trial that you guys are like we plan to conduct with maritime and the design. So just wondering if you could comment at all on the potential control arm there. Thank you.

Peter: Yeah.

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

Speaker Change: Thank you if you would like to ask a question. Please press star followed by one on your telephone keypad.

Speaker Change: Okay.

Speaker Change: Yeah. Thanks, Terence for the question.

Speaker Change: Really looking forward to the AA, we've already shared the salient data from the phase II Chronically management study.

Speaker Change: Any reason you would like to turn that question. Please press star followed by one.

Speaker Change: To ask a question press star one.

Speaker Change: <unk> loss.

Speaker Change: Excellent Tolerability at 52 weeks in what we call part one on that trial as well as data from a dedicated phase one pharmacokinetic study in the.

Speaker Change: Our first question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Terence Flynn: Hi, Thanks for taking the question congrats on all the progress.

Speaker Change: The key insights remain unchanged strong efficacy no plateau to 52 weeks a.

Speaker Change: I was just wondering Jay if you could help frame for us what we should be looking for.

Speaker Change: Monthly maritime is very well tolerated at the target dose.

Speaker Change: With respect to maritime I know this is going to be the first detailed presentation of the phase II data, but what do you think kind of a key message and key learnings coming out from that will be and then kind of related question is I know theres a lot of focus on the.

Speaker Change: The dose escalation works.

Speaker Change: It comes without any compromise to weight loss also strong activity on cardio metabolic parameters.

Speaker Change: Including <unk>. So the 88 will focus on these insights as.

Peter Griffith: 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.

Speaker Change: Cbot trial that you guys are like we plan to conduct with maritime and the design. So just wondering if you could comment at all on the potential control arm there. Thank you.

Speaker Change: As well as some underlying details of the two trials.

Speaker Change: It will feature some new mechanistic data, including some recently published data in nature metabolism that <unk>.

Speaker Change: Okay.

Speaker Change: Serves to really validate the mechanism of action the dual mechanism of action of maritime.

Speaker Change: Yeah. Thanks, Terence for the question.

Speaker Change: I'm really looking forward to the Ada we've already shared the salient data from the phase II Chronically management study.

Speaker Change: We're looking forward to sharing these details at Ada hearing from the presenters who are true leaders in the field.

Speaker Change: <unk> loss.

Speaker Change: Following session, we intend to have an IR call them out.

Speaker Change: Excellent Tolerability at 52 weeks in what we call part one on that trial as well as data from a dedicated phase one pharmacokinetic study in the key insights remain unchanged strong efficacy no plateau to 52 weeks.

Speaker Change: After the event to take questions reflect on the results through 52 weeks, but here at Amgen, we're on to phase III.

Peter Griffith: This concludes our financial update.

Speaker Change: Okay, and then on the <unk>.

Bob Bradley: I'll hand it back to Bob for our Q&A session.

Speaker Change: And on the Cbot study, we won't share any details today regarding the cbot study, but with our two phase III chronic weight management programs now open and enrolling enrolling well.

Speaker Change: Monthly maritime is very well tolerated at the target dose that the dose escalation works.

Unknown Executive: To remind our callers, please, of the procedure for asking questions. Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by one. Again, to ask a question, press star one.

And Tom's without any compromise to weight loss also strong activity on cardio metabolic parameters.

Speaker Change: We are working to initiate a broad phase III program that includes an <unk> 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.

Speaker Change: Including <unk>. So the 88 will focus on these insights.

Speaker Change: As well as some underlying details of the two trials.

Speaker Change: It will feature some new mechanistic data, including some recently published data in each of metabolism that <unk>.

Terence Flynn: Our first question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open. Hi, thanks for taking the question. Congrats on all the progress.

Speaker Change: Serves to really validate the mechanism of action that dual mechanism of action in maritime.

Speaker Change: Okay. Thanks, Julianne, let's go to the next caller.

Speaker Change: Thank you Terrence our next question comes from Saudi and Rector from Goldman Sachs. Please go ahead. Your line is open.

Speaker Change: We're looking forward to sharing these details at Ada hearing from the presenters who are true leaders in the field then.

Jay Bradner: You know, 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 to be the first detailed presentation of the phase two 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 likely plan to conduct with Meritide and the design. So just wondering if you'd comment at all on the potential control arm there.

Speaker Change: Good afternoon. Thanks for taking my question with regard to cleanse that in.

Speaker Change: Following this session, we intend to have an IR call.

Speaker Change: After the event to take questions reflect on the results through 52 weeks, but here at Amgen, we're on to phase III.

Speaker Change: And IGT for us given the recent approval as well as myasthenia gravis could you just help us understand that.

Speaker Change: Okay, and then on the Oh, yes, and on the Cbot study, we won't share any details today regarding the cbot study, but with our two phase III chronic weight management programs now open and enrolling enrolling well.

Speaker Change: Marshall strategy, including developing prescribers and patient identification efforts for the former okay.

Speaker Change: Yes, <unk>. Thanks for the question on <unk>.

Jay Bradner: Thank you. Monthly Meritide is very well tolerated. It's a target dose. The dose escalation works. It 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'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 Maritide.

Speaker Change: We're obviously quite quite excited about the opportunity to be the first approved therapy for agg for it's a condition that is primarily diagnosed.

Speaker Change: We are working to initiate a broad phase III program that includes of CVD 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.

Speaker Change: I should say recently.

Speaker Change: There's been a the evolution of the diagnostic code, which really will only was introduced in October of 2023. So it's been a relatively recent phenomenon to actually have formal diagnostic criteria not code for this disease.

Speaker Change: Okay. Thanks, Julianne, let's go to the next caller.

Speaker Change: Thank you Karen our next question comes from Savi <unk> Richter from Goldman Sachs. Please go ahead. Your line is open.

Speaker Change: But primarily <unk>.

Savi Richter: Good afternoon. Thanks for taking my question with regard to cleanser.

Speaker Change: <unk> managed by Rheumatologists, you do see on occasion, Gastroenterologists, sometimes neurologists, just given the way in which the disease might manifest in the Oregon involvement.

Speaker Change: And IGT for us given the recent approval as well as myasthenia gravis could you just help us understand that.

Speaker Change: Obviously because of Amgen has very long history in dealing with inflammation and autoimmune diseases. We've got very good very good presence.

Speaker Change: Marshall strategy, including the relevant prescribers and patient identification efforts for the former thank you.

Speaker Change: Yes, <unk>. Thanks for the question on <unk>.

Speaker Change: Here with the key customer types in key prescribers, we have had a field force deployed for several months now profiling and engaging with the relevant.

Speaker Change: We're obviously quite quite excited about the opportunity to be the first approved therapy for agg for it's a condition that is primarily diagnosed and I should say recently.

Jay Bradner: 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.

Speaker Change: Physician community. So we're hitting the ground running so to speak with the approval.

Speaker Change: There's been a the evolution of the diagnostic code, which really will only was introduced in October of 2023. So it's been a relative recent phenomenon to actually have formal diagnostic criteria and a code for this disease.

Speaker Change: The epidemiology here is roughly 20000 patients in the U S and we're we're excited to have that impact. This is a horrible disease.

Jay Bradner: But here at Amgen, we're on to Facebook. Oh yes, and on the CVOT study, 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, and we'll have more to share in the fullness of time about the details of these trials.

Speaker Change: People really do not fare well when this flares and it.

Speaker Change: But primarily <unk>.

Speaker Change: Plus as a highly effective.

Speaker Change: 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 Oregon involvement.

Product as part of the clinical data generated thus far and then on Gmg, we're really thrilled with.

Speaker Change: The opportunity to go into a competitive category with a very different mechanism.

Speaker Change: Obviously because of Amgen has very long history in dealing with inflammation and autoimmune diseases. We've got very very very good presence.

Speaker Change: Then the drugs that are available today.

Dan: Dan This is.

Speaker Change: 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 Jamie do you want to add anything on gmg.

Speaker Change: Here with the key customer types in key prescribers, we have had a field force deployed for several months now profiling and engaging with the relevant.

Unknown Executive: Okay, thanks, Julianne.

Unknown Executive: Let's go to the next caller. Thank you, Terence.

Salveen Richter: Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead. Your line is open. Good afternoon. Thanks for taking my question.

Speaker Change: It reflects the also on <unk>, we think a lot about how will that fit into the standards of care in both diseases in IGT for related disease has no standard of care. These are patients with chronic inflammatory.

Speaker Change: Physician community. So we're hitting the ground running so to speak with the approval.

Speaker Change: The epidemiology here is roughly 20000 patients in the U S and we're we're excited to have that impact. This is a horrible disease.

Murdo Gordon: With regard to Uplenza in IGG4, given the recent approval, as well as my senior Gravis, could you just help us understand the commercial strategy, including the relevant prescribers and patient identification efforts for the former? Thank you.

Painful protean symptoms recurrent flares and we saw an 87% reduction in disease specific.

Speaker Change: People really do not fare well when this flares and.

Speaker Change: <unk> is a highly effective.

Speaker Change: Specific flair 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 that 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 <unk> trial, and we put up just.

Speaker Change: 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.

Murdo Gordon: Yeah, Salveen, it's Murdo. Thanks for the question on Eplizva. 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 a the evolution of a diagnostic code, which really only was introduced in October 2023. So it's been a relative recent phenomenon to actually have formal diagnostic criteria 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 and the organ involvement.

Speaker Change: 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 will be thrilled I don't know Jamie do you want to add anything on gmg.

Speaker Change: 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.

Speaker Change: Reflecting also on <unk>, we think a lot about how will this fit into the standards of care in both diseases in <unk> related disease has no standard of care. These are patients with chronic inflammatory.

Speaker Change: This medicine is provides a durable benefit to patients. It's given every six months I think what's really suits. The lifestyle of people, who will then feel hopefully very healthy.

Speaker Change: And it's quite convenient for them to receive but most importantly, it targets the core biology.

Speaker Change: Painful protean symptoms recurrent flares.

Speaker Change: 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 and we had a chance to share back in April and it was also simultaneously published in New England Journal.

Speaker Change: The disease caused by pathologic auto antibodies and here, we are targeting to sell that elaborate that those antibodies. So.

Speaker Change: With your very hopeful that <unk> will be an important new standard of care in generalized myasthenia gravis.

Julian: Alright, Julian answer the next question please.

Speaker Change: Thank you. Our next question comes from Michael Yee from Jefferies. Please go ahead. Your line is open.

Speaker Change: The really strong data from the phase III <unk> trial, and we put up just outstanding efficacy data against the myasthenia gravis activities of daily living score we showed activity in both important subpopulations of patients acetylcholine receptor positive and must positive in.

Speaker Change: Thanks, Greg Good afternoon, maybe.

Speaker Change: Maybe for Jay I, often hear about two narratives on the obesity program. One is the Tolerability remains high and I know you cant go lower titration show I'm curious about your confidence that we will see very competitive tolerability and very strong efficacy in that that narrative will hold up and secondly that.

Speaker Change: <unk> Medicine is provides a durable benefit to patients. It's given every six months I think what's really suits the lifestyle of people, who will then fill hopefully very healthy.

Jay Bradner: And then on GMG, you know, 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.

Speaker Change: There's a competitor out there who has now put up oral data, which apparently is going to have a huge market share and show you don't have an oral maybe you could respond to either of those and how youre going to be competitive against these developments that have played out. Thank you.

Speaker Change: And it's quite convenient for them to receive but most importantly, it targets the core biology.

Speaker Change: The disease caused by pathologic auto antibodies and here, we are targeting the cell that elaborate that those antibodies. So.

Speaker Change: Yes, Mike Thanks, why don't I start on Tolerability, and then Murdo ask you if you wouldn't mind to weigh in on that.

Speaker Change: We are very hopeful that <unk> will be an important new standard of care in generalized myasthenia gravis.

Speaker Change: The development of oral medicines.

Jay Bradner: I don't know, Jay, would you want to add anything on GMG? Yeah. I mean, reflecting also on IgG4, you know, we think a lot about how will this fit into the standards of care in both diseases and IgG4-related disease has no standard of care. These are patients with chronic, inflammatory, painful, protean symptoms, recurrent flares and, you know, 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 stacked up really well to what physicians and patients have access to today. And we had a chance to share, you know, back in April, and it was also simultaneously published in the New England Journal, the really strong data from the Phase III MIM trial.

Speaker Change: Their importance.

Speaker Change: Alright, Julian answer the next question please.

Speaker Change: Mike we feel very confident I feel very confident about the tolerability.

Speaker Change: Thank you <unk>. Our next question comes from Michael Yee from Jefferies. Please go ahead. Your line is open.

Speaker Change: And efficacy that we stand to observe in the phase III clinical study. It is very well informed by the strong efficacy that we saw in phase II part, one and 52 week data where we.

Greg: Alright, Thanks, Greg Good afternoon, maybe.

Speaker Change: Maybe for Jay I, often hear about two narratives on the obesity program. One is the Tolerability remains high and I know you've talked about lower titration show I'm curious about your confidence that we will see very competitive tolerability and very strong efficacy in that that narrative will hold up and secondly that.

Speaker Change: Observed across the range of doses significant benefit to patients with measurable weight loss as high as 20%.

Speaker Change: The Tolerability, we learned as have others in the field that <unk> based mechanisms of action.

Speaker Change: There is a competitor out there who has now put up oral data, which apparently is going to have a huge market share and so you don't have an oral maybe you could respond to either of those and how youre going to be competitive against these developments that have played out. Thank you.

Speaker Change: Benefit from dose escalation benefit from lower starting doses, we confirmed these insights.

Speaker Change: Dedicated phase one pharmacokinetic study and we've taken the directionality of those two trials into the design of phase III, which when we can share this with you.

Speaker Change: Yes, Mike Thanks, why don't I start on Tolerability, and then Murdo ask you if you wouldn't mind to weigh in on that.

Jay Bradner: 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 provides a durable benefit to patients. It's given every six months, I think, which really suits the lifestyle of people who will then feel hopefully very healthy. And it's quite convenient for them to receive. But most importantly, it targets the core biology. This is a disease caused by pathologic autoantibodies. And here we are targeting the cells that elaborate those antibodies.

Speaker Change: The development of oral medicines.

Speaker Change: Well, we will surely underscore that the design is constructed to deliver.

Speaker Change: Their importance.

Speaker Change: Mike we feel very confident I feel very confident about the tolerability.

Speaker Change: Competitive.

Speaker Change: And efficacy that we stand to observe in the phase III clinical study. It is very well informed by the strong efficacy that we saw in phase II part 152 week data, where we observed across the range of doses on significant benefit to patients with measurable weight loss as high as <unk>.

Speaker Change: <unk> efficacy and tolerability in patients with and without type two diabetes murdo about oil.

Mike: Yes, Thanks, Mike we have obviously accounted for.

Speaker Change: Segment of the market to be an oral market.

Speaker Change: We do anticipate given the size of the obesity category our.

Speaker Change: A relevant.

Speaker Change: Opportunity for oral so come in thus far of course, we haven't seen necessarily the same degree of weight loss being achievable with oral <unk> as we've seen with maritime and of course maritime it really given it's monthly or even less frequent dosing, we think will be less vulnerable to oral switch are.

Speaker Change: Percent.

Jay Bradner: So we're very hopeful that Eplizno will be an important new standard of care in generalized myasthenia gravis.

Speaker Change: The Tolerability, we learned as have others in the field that <unk> based mechanisms of action.

Speaker Change: Benefit from dose escalation benefit from lower starting doses. We confirmed these insights in our dedicated phase one pharmacokinetic study and we've taken the directionality of those two trials into the design of phase III, which when we can share this with you.

Unknown Executive: All right, Julianne, let's go to the next question, please. Thank you, Salveen.

Michael Yee: Our next question comes from Michael Yee from Jeffries. Please go ahead. Your line is open. Thanks, great, good afternoon.

Speaker Change: Certainly going to come in.

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

Speaker Change: Displace some of the weekly <unk> ones that are incumbent in the market today.

Speaker Change: <unk>.

Speaker Change: <unk> will surely underscore that the design is constructed to deliver.

Speaker Change: I'd also just say that we are pursuing other.

Speaker Change: Competitive.

Speaker Change: <unk> in our early pipeline that are both large molecule small molecule oral and self administered <unk>.

Speaker Change: <unk> efficacy and tolerability in patients with and without type two diabetes murdo about oil.

Speaker Change: <unk> and non <unk>. So we really are looking at oral and non oral mechanisms ourselves right.

Mike: Yes, Thanks, Mike we have obviously accounted for.

Speaker Change: Segment of the market to be an oral market, we do anticipate given the size of the obesity category our.

Julian: Alright, Julian is go to the next question. Please.

Speaker Change: Thank you Michael our next question comes from Trung Nguyen from UBS. Please go ahead. Your line is open.

Speaker Change: A relevant.

Jay Bradner: Thank you. Yeah, Mike, thanks.

Speaker Change: Opportunity for oral so come in thus far of course, we haven't seen necessarily the same degree of weight loss being achievable with oral <unk> as we've seen with maritime and of course maritime it really given it's monthly or even less frequent dosing, we think will be less vulnerable to oral switch are.

Murdo Gordon: 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. It is very well informed by the strong efficacy that we saw in phase two, part one, the 52-week data, where we observed across the range of doses, some significant benefit to patients with measurable weight loss as high as 20%. The tolerability, we learned, as have others in the field, that GLP-1 based mechanisms of action benefit from dose escalation, benefit from lower starting doses.

Speaker Change: Great. Thanks for the question just on <unk>, which has been doing well for a number of quarters now.

Speaker Change: Our recent Doc checks some have pointed to an increasing preference for novartis is <unk> because of the volume build program for that drug.

Speaker Change: Do you see increasing commercial competition from back.

Speaker Change: Certainly going to come in.

Speaker Change: In general and going forward, there is going to be some late stage data oral Pcs canines this year.

Speaker Change: Display some of the weekly <unk> ones that are incumbent in the market today.

Speaker Change: I'd also just say that we are pursuing other.

Speaker Change: What's your thoughts about the <unk> products.

Speaker Change: <unk> in our early pipeline that are both large molecule small molecule oral and self administered <unk>.

Speaker Change: Yes, thanks for the question and thanks for noticing the growth in Repositrak.

Speaker Change: <unk> and non <unk>. So we really are looking at oral and non oral mechanisms ourselves okay.

Speaker Change: The trajectory that we're on.

Speaker Change: The short answer to your question is yes, there is competition in the market and yes <unk> is.

Julian: Alright, Alright, Julian is go to the next question. Please.

Jay Bradner: 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 surely underscore that the design is constructed to deliver competitive, both efficacy and tolerability in patients with and without type 2 diabetes.

Speaker Change: Definitely treating patients both in the U S and in some other markets around the world.

Speaker Change: Thank you Michael our next question comes from Trung Nguyen from UBS. Please go ahead. Your line is open.

Speaker Change: I would say, though that we still believe we have the.

Speaker Change: Great. Thanks for the question just on <unk>, which has been doing well for a number of quarters now.

Speaker Change: The best profile in the <unk> canine category, given the ability to put finally lower LDL cholesterol. The fact that we've generated cardiome.

Speaker Change: Our recent Doc checks some have pointed to an increasing preference for novartis as <unk> because of the volume build program for that drug.

Speaker Change: Cardiovascular event reduction.

Speaker Change: We have ongoing additional clinical trials to further expand the understanding of how <unk>.

Speaker Change: Do you see increasing commercial competition from back.

Murdo Gordon: Murdo, about oral? 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.

Speaker Change: In general and going forward, there is going to be some late stage data oral PCF canines this year.

Speaker Change: Papa with added to conventional therapy can actually further reduce cardiovascular risk in a primary prevention high risk population.

Speaker Change: What's your thoughts about the entry of those products. Thanks.

Speaker Change: So we do think that there is the <unk>.

Speaker Change: Yes, thanks for the question and thanks for noticing the growth in <unk> and the.

Speaker Change: <unk> 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.

Speaker Change: The trajectory that we're on.

Speaker Change: The short answer to your question is yes, there is competition in the market and yes, <unk> is definitely treating patients both in the U S and in some other markets around the world.

Speaker Change: The growth of some of the other products in that category should tell you that we continue to find ways to help new patients received the <unk> therapy that they should the last piece of this of course as we have done a lot of work as Amgen. So.

Speaker Change: I would say, though that we still believe we have the.

Speaker Change: The best profile in the <unk> canine category, given the ability to put finally lower LDL cholesterol. The fact that we have generated a cardiovascular event reduction.

Speaker Change: Open up access and affordability for patients and so we now have.

Speaker Change: We have ongoing additional clinical trials to further expand the understanding of how <unk> when added to conventional therapy can actually further reduce cardiovascular risk in a primary prevention high risk population.

Speaker Change: The commercial.

Speaker Change: Insured patients in the U S, 50% of which have no prior authorization requirement to receive approval for their therapy. So they're really the barriers that once we're there in obtaining a passage.

Unknown Executive: All right, Julianne, let's go to the next question, please. Thank you, Michael.

Speaker Change: So we do think that there is 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.

Speaker Change: Have largely dissipated so where we're growing nicely and we continue to promote to primary care. We have invested in direct to consumer advertising now and we expect a strong growth trajectory to come.

Trung Huynh: Our next question comes from Trung Huynh from UBS. Please go ahead. Your line is open. 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' Lecvaeo because of the buy and build program for that drug. Do you see increasing commercial competition from Lecvaeo in general? And going forward, there is going to be some late stage data or oral PCSK9s this year. What's your thoughts about the entry of those products?

Speaker Change: Hi, Julien, let's take the next question please.

Speaker Change: Thank you Tom Our next question comes from Evan <unk> from BMO Capital markets. Please go ahead. Your line is open.

Speaker Change: We continue to find ways to help new patients received <unk> therapy that they should the last piece of this of course as we have done a lot of work as Amgen. So.

Speaker Change: 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 tableau in the field and are you seeing any pronounced shift to the biosimilar. Following the defunding of the patient assistance charities.

Speaker Change: Open up access and affordability for patients and so we know.

Speaker Change: Thanks for the question Evan.

Speaker Change: The commercial.

Murdo Gordon: 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, Lecreo is definitely treating patients both in the U.S. and in some other markets around the world. I would say though that we still believe we have the best profile in the PCSK9 category given the ability to profoundly lower LDL cholesterol, the fact that we've generated cardiovascular event reduction. We have ongoing additional clinical trials to further expand the understanding of how Repatha when added to conventional therapy can actually further reduce cardiovascular risk in a primary prevention high-risk population.

Speaker Change: We're obviously pleased with our Biosimilar portfolio in general we had a strong quarter there.

Speaker Change: Insured patients in the U S, 50% of which have no prior authorization requirement to receive approval for their therapy. So they're really the barriers that once we're there in obtaining a path up.

Speaker Change: Pi Blue has been well received by the retinal specialist community. They like the high quality Biosimilar, they really like our Prefilled syringe device that we launched.

Speaker Change: Have largely dissipated so where we're growing nicely and we continue to promote the primary care we've invested in direct to consumer advertising now and we expect a strong growth trajectory to come.

Speaker Change: And.

Speaker Change: We expect to continue to be able to help many patients to serve many patients with this product we're working on contracting with a larger a retina specialist groups and we will have more to say as the year progresses.

Julien: Hi, Julien, let's take the next question please.

Julien: Thank you Tom Our next question comes from Evan <unk> from BMO Capital markets. Please go ahead. Your line is open.

Speaker Change: And then.

Speaker Change: Jen.

Speaker Change: As happy to support.

Speaker Change: 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 Pablo in the field and are you seeing any pronounced shift to the biosimilar following that the funding of the patient assistance charities.

Speaker Change: Patients through the charitable donations that we make to various agencies.

Speaker Change: Alright, let's go to the next question please Julien.

Speaker Change: Thank you Evan our next question comes from Chris Schott from Jpmorgan. Please go ahead. Your line is open.

Murdo Gordon: So we do think that the class here is so under-penetrated 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.S., 50% of which have no prior authorization requirement to receive approval for their therapy.

Speaker Change: Thanks for the question Evan.

Speaker Change: We're obviously pleased with our Biosimilar portfolio in general we had a strong quarter there.

Chris Schott: Great. Thanks, so much for the question just a question on the curtain payer environment I think we've seen some concern in the market today about more aggressive payer behavior with the CBS will go via announcement I'm just interested in how youre thinking about these payer dynamics or potential new entrants in that space over time. Thank you.

Speaker Change: Pi Blue has been well received by the retina specialists community. They like the high quality biosimilar, they really like our pre filled syringe device that we launched.

Speaker Change: And.

Speaker Change: We expect to continue to be able to help many patients to serve many patients with this product. We are working on contracting with a larger retina specialist groups and we will have more to say as the year progresses.

Chris Schott: Yes. Thanks for the question, Chris look our focus in.

Chris Schott: Any payer environment and it will be with obesity categories to help.

Chris Schott: Make our products as available as possible to a large segment of the population I think we're still understanding what happened with the recent decision.

Speaker Change: And then I am.

Speaker Change: Jen.

Speaker Change: As happy to support.

Speaker Change: Patients through the charitable donations that we make to various agencies.

Chris Schott: I believe youll be referring to the Cvs change that was announced I do think overall.

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

Murdo Gordon: 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, we've invested in direct-to-consumer advertising now and we expect a strong growth trajectory to come.

On Pbms and manufacturers alike are trying to make sure that more patients have access to reimbursement for <unk>.

Speaker Change: Thank you Evan our next question comes from Chris Schott from J P. Morgan. Please go ahead. Your line is open.

Chris Schott: Obesity medicines, and we look forward to being able to do that when we enter the market.

Chris Schott: Great. Thanks, so much for the question just a question on the curtain 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 youre thinking about these payer dynamics or potential new entrants in that space over time. Thank you.

Speaker Change: Okay Julian will go to the next question. Please.

Speaker Change: Thank you Chris Our next question comes from year round Barbara from TD Cowen. Please go ahead. Your line is open.

Unknown Executive: Alright Julian, let's take the next question please. Thank you, Trung.

Barbara: Thanks, so much.

Evan Seigerman: Our next question comes from Evan Seigerman from BMO Capital Markets. Please go ahead. Your line is open. 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 Pablo in the field? And are you seeing any pronounced shift to the biosimilar following the defunding of the patient's assistance charities?

Barbara: Interrelated questions about maritime, but maybe just the first one.

Chris Schott: Yes, thanks for the question Chris.

Barbara: Is there a chance to get maybe even the 76 week data.

Chris Schott: Look our focus.

Chris Schott: Any payer environment and it will be with obesity categories to help.

Barbara: The obesity study from the phase two include.

Barbara: Including some of the less frequent dosing into Q2 and Q3 monthly dosing and then secondly would you consider separately from doing a would you consider doing a switch study where patients switch from prior <unk> right into maritime and doing less frequent dosing as an additional strategy to ultimately firewood. Thank you Jay.

Chris Schott: 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.

Murdo Gordon: Thanks for the question, Evan. We're obviously pleased with our biosimilar portfolio in general. We had a strong quarter there. Pablu 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, 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 the larger retina specialist groups, and we'll have more to say as the year progresses. And then, you know, Amgen is happy to support patients through the charitable donations that we make to various agencies.

Chris Schott: I believe youll be referring to the Cvs change that was announced I do think overall.

Chris Schott: On Pbms and manufacturers alike are trying to make sure that more patients have access to reimbursement for <unk>.

Speaker Change: Got it okay. Yeah. Thanks your own first answer is no.

Chris Schott: Obesity medicines, and we look forward to being able to do that when we enter the market.

Speaker Change: 80, <unk> presentation will.

Speaker Change: Focus on some mechanistic study.

Julian: Okay Julian will go to the next question. Please.

Speaker Change: Some of the underlying details of part one the first 52 weeks of the phase III study as well as additional data from the phase one pharmacokinetic study and reflection from these external key opinion leaders that we can't wait to herself.

Speaker Change: Thank you Chris Our next question comes from year round Barbara from TD Cowen. Please go ahead. Your line is open.

Speaker Change: Great. Thanks, so much.

Speaker Change: Interrelated questions about maritime, but maybe just the first one in <unk>.

They're a chance to get maybe even the 76 week data from the obesity study from the phase two.

Speaker Change: 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.

Unknown Executive: All right, let's go to the next question, please, Julian.

Speaker Change: Some of the less frequent dosing into Q2 and Q3 monthly dosing and then secondly would you consider separately from doing a would you consider doing a switch study where patients switch from prior <unk> right into maritime and doing less frequent dosing as an additional strategy to ultimately firewood.

Speaker Change: Your second question I'll welcome to the Maritime development team, it's great to have you thinking about next trials.

Unknown Executive: Thank you, Evan.

Chris Schott: Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open. Great. Thanks so much for the question.

Speaker Change: And I take from your question that debt.

Murdo Gordon: Just a question on the the Inkerton pair environment. I think we've seen some concern in the market today about more aggressive pair behavior with the CVS Mugovia announcement. I'm just interested in how you're thinking about these pair dynamics, the potential new entrant in that space over time. Thank you. Yes, thanks for the question, Chris. Look, our focus in any pair 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.

Speaker Change: We agree actually the patients and physicians will want to know how can they.

Speaker Change: <unk> maritime if they're on another weight loss medicine.

Speaker Change: Got it okay. Yeah. Thanks your own first answer is no.

Speaker Change: And maybe is working but as inconvenient or maybe isn't working well enough.

Speaker Change: Presentation will.

Speaker Change: We do intend to generate data to support such a consideration there'll be more to share on that in the future.

Speaker Change: Focus on the mechanistic study.

Speaker Change: Some of the underlying details of part one the first 52 weeks of the phase III study as well as additional data from the phase one pharmacokinetic study and reflections from these external key opinion leaders that while we can't wait to herself.

Speaker Change: Perfect. Let's go to the next question. Thanks.

Speaker Change: Thank you your own our next question comes from Omar <unk> from Evercore ISI. Please go ahead. Your line is open.

Omar: Hi, guys. The question I've been thinking about for a while on the myasthenia gravis market dynamic specifically.

Speaker Change: 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.

Omar: A lot of times when some of the cross trial comparisons have been made for a plasma.

Murdo Gordon: 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.

Omar: They're often versus the Max efficacy, we see on CRM and we now have CRM 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 two X for CRM, if you're truly dose them through without them dosing holiday, which is apparently what a lot of clinicians are doing. So my question is are.

Speaker Change: Your second question I'll welcome to the Maritime development team, it's great to have you thinking about next trials.

Speaker Change: Take from your question that.

Speaker Change: We agree actually that patients and physicians will want to know how can they start on maritime if they're on another weight loss medicine.

Unknown Executive: Okay, Julianne, we'll go to the next question, please. Thank you, Chris.

Yaron Werber: Our next question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open. Great. Thanks so much.

Omar: Aware of this dynamic and what do you see as the realistic market share aspiration, knowing that your competitor might potentially be two extra price could you aim for like a $40 to 50% market share in Mg. Thank you.

Speaker Change: And maybe is working but as inconvenient or maybe isn't working well enough.

Jay Bradner: I have two interrelated questions about Meritide. Maybe just the first one. At ADA, is there a chance to get maybe even the 76-week data from the obesity study from the Phase 2, including some of the less frequent dosing, the Q2 and Q3 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 Meritide and doing less frequent dosing as an additional strategy to ultimately follow with? Thank you.

Speaker Change: We do intend to generate data to support such a consideration there'll be more to share on that in the future.

Speaker Change: Perfect. Let's go to the next question. Thanks.

Speaker Change: Let's try and take this in two pieces Uber I think on the clinical piece Jay if you want to add any perspective around the market. Obviously murdo you you can share our perspectives on the payer environment and so forth, yes. Thanks Bob.

Speaker Change: Thank you your own our next question comes from Omar <unk> from Evercore ISI. Please go ahead. Your line is open.

Speaker Change: 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 pleasant.

Speaker Change: Thanks for the question.

Speaker Change: Gmg space will surely be shaped by the efficacy and the target product profile of the medicine available to treat the patients primarily in and here. We think a pleasant. It has some really favorable consideration, it's very hard to do trial by trial comparisons.

Speaker Change: They are often versus the Max efficacy, we see on <unk> and we now have CRM 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 two X for CRM, if you're truly dose them through without them dosing holiday, which is apparently what a lot of clinicians are doing. So my question is are.

Jay Bradner: Jay, go ahead, Jay. Yeah, thanks, Yaron. First answer is no. The ADA presentation will focus on some mechanistic studies, some of the underlying details of Part 1, the first 52 weeks of the Phase 2 study, as well as additional data from the Phase 1 pharmacokinetic study and reflections from these external key opinion leaders that we can't wait to hear ourselves. So no, I would not expect to see interim data from Part 2, which is ongoing, and we intend to share these data when we have them at the end of the year. Your second question, welcome to the Meritide development team, it's great to have you thinking about next trials, and I take from your question that we agree actually that patients and physicians will want to know how can they start on 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.

Speaker Change: But suffice it to say that this significant observed efficacy by Mg ADL that we saw all the way out to week 52, and the durability of living in a.

Speaker Change: Aware of this dynamic and what do you see as a realistic market share aspiration, knowing that your competitor might potentially be two extra price could you aim for like a 40% 50% market share in Mg. Thank you.

Speaker Change: Randomized control trial environment through week 52 is indeed, very strong targeting the core biology, one might expect higher efficacy.

Speaker Change: <unk> 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.

Speaker Change: Let's try and take this in two pieces I think on the clinical piece Jay if you want to add any perspective around the market. Obviously murdo you you can share our perspectives on the payer environment. So forth, yes. Thanks, Bob.

Speaker Change: Are quite attractive, we believe and we're receiving that feedback.

Speaker Change: Thanks for the question.

Speaker Change: From prescribing physicians, who weighed in on on these data in the program.

Speaker Change: Gmg space will surely be shaped by the efficacy and the target product profile of the medicines available to treat the patients primarily in and here. We think <unk> has some really favorable consideration, it's very hard to do trial by trial comparisons.

Murdo: Murdo do you have any comments about the pricing dynamics, yes.

Murdo: Yes in general in categories in diseases like this the medical policies from the payers will follow.

Murdo: The indications in the label and or the inclusion criteria that were.

Speaker Change: But suffice it to say that this significant observed efficacy by Mg ADL that we saw all the way out to week 52, and the durability of living in a.

Murdo: Provided for for the clinical trial. So the there is likely to be fairly broad access to these products now with.

Unknown Executive: For more information visit www.meritide.com Perfect. Let's go to the next question. Thanks. Thank you, Yaron.

Umer Raffat: Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open. Hi, guys. The 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 plisna, they're often versus the max efficacy we see on FCRNs. And we know FCRNs have this waxing waning because as per label, you have to get off the drug. So my point being, the true commercial price would actually be 2x for FCRNs if you truly dose them through without the dosing holiday, which is apparently what a lot of clinicians are doing.

Speaker Change: Randomized controlled trial environment through week 52 is indeed, very strong targeting the core biology, one might expect higher efficacy than <unk>.

Murdo: 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.

Speaker Change: <unk> 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.

Murdo: Our cost advantage to trading with a pleasant versus other agents could be borne out.

Chris Schott: Okay. Julian it's go to the next question.

David: Thank you Omar our next question comes from David <unk> from Piper Sandler. Please go ahead. Your line is open.

Speaker Change: Are quite attractive, we believe and we're receiving that feedback from prescribing physicians, who weighed in on on these data in the program.

David: Quick question on <unk> I feel like over the past.

Speaker Change: Murdo do you have any comments about the pricing dynamics.

David: Couple of years, even talking.

Speaker Change: Yes in general in categories in diseases like this the medical policies from the payers will follow.

Bob Bradley: 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?

David: Expansively about a wider physician audience getting in front of more prescribers raising awareness product hasnt been growing so I guess, what's it going to take to see an inflection here.

Speaker Change: The indications in the label and or the inclusion criteria that were.

Speaker Change: Provided for for the clinical trial. So the there is 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.

Murdo Gordon: Thank you.

Murdo Gordon: Let's try to think 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. Yeah, thanks, Bob. Um, you know, Umer, thanks for the question. The GMG space will surely be shaped by the efficacy and the target product profiles, the medicines available to treat the patients primarily. And here we think a plisna has some really favorable considerations. It's very hard to do trial by trial comparisons. Um, 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 control trial environment through week 52 is indeed very strong.

David: Or maybe put put differently do you think there has to be.

David: Some externality like the availability of a sub Q form.

David: To get the product really moving again.

David: Thanks for the question David.

Speaker Change: Our cost advantage to trading with a pleasant versus other agents could be borne out.

David: I think we're actually making.

David: Good progress in broadening the prescribing base for <unk>.

Julian: Okay, Julian it's going to the next question.

Speaker Change: Thank you Omar our next question comes from David <unk> from Piper Sandler. Please go ahead. Your line is open.

David: <unk> is as you mentioned it is a progress a progressive.

David: Evolution given that the product started it.

Julian: Yeah.

David: Quick question on <unk> I feel like over the past.

David: Its journey and more serious higher caste 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.

David: A couple of years even talking.

David: Expansively about a wider physician audience getting in front of more prescribers raising awareness product hasnt been growing so I guess, what's it going to take to see an inflection here.

Murdo Gordon: 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 quite attractive, we believe, and we're receiving that feedback from prescribing physicians who've weighed in on these data in the program.

David: Really two challenges that we're working on with them one getting them to actually take the time, not just to diagnose craves, 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.

David: Or maybe put put differently do you think there has to be.

David: Some externality like the availability of a sub Q form.

To get the product really moving again.

David: Thanks for the question David.

David: I think we are.

Murdo Gordon: Um, Murdo, do you have any comments about the pricing dynamics? 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 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 the plisna versus other agents could be borne out.

David: Making.

David: This increase in intent to prescribe.

David: Quite good progress in broadening the prescribing base for <unk>.

David: Some 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 in that prescription is written to when we can get that patient started on their first infusion.

David: <unk> is as you mentioned it is a progress progressive.

David: Evolution given that the products started it.

David: Its journey and more serious higher caste 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.

David: Navigating the payer process finding a site of care does take some time as well so it's not going to be a rapid.

David: Change in the trajectory of the product, but it will be a progressive one and then last but not least a.

David: Definitely a subcutaneous.

David: 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 and some progress but as I mentioned in prepared remarks, we're seeing a nice.

David: Administration will help here because it simplifies the site of care selection and affords more.

Unknown Executive: Okay, Julianne, let's go to the next question.

David: Opportunities for patients to be initiated with their treatment.

David Amsellem: Thank you, Umer.

Murdo Gordon: Our next question comes from David Amsellem from Piper Sandbar. Please go ahead. Your line is open. I have a question on tepeza. 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 going to 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? Thanks. Thanks for the question, David.

David: But I would anticipate both being able to grow prior to the availability of the subcutaneous form and then being able to accelerate that thereafter and Murdo, maybe you want to touch on the international progress Yeah. Thanks, Justin we've made making great progress with <unk> internationally.

David: This increase in intent to prescribe.

David: Some 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 in that prescription is written to when we can get that patient started on their first infusion.

David: With the recent approval in Japan, we've been approved in.

David: Saudi Arabia, Brazil, we have a positive opinion in the <unk> in Europe, we anticipate launching there in the back half of the year.

David: Navigating the payer process finding a site of care does take some time as well so it's not going to be a rapid.

David: So the international expansion is progressing very well and I would say ahead of schedule.

David: There to what we thought we'd be able to do when we made the acquisition.

Change in the trajectory of the product, but it will be a progressive one and then last but not least definitely a subcutaneous.

David: 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.

David: Administration will help here because it simplifies the site of care selection and affords more.

Murdo Gordon: I think we're actually making quite good progress in broadening the prescribing base for Tepeza. 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. One, getting them to actually take the time, not just to diagnose craves, but to diagnose thyroid eye disease, and two, to initiate treatment with an infused biologic, and then find the site of care.

David: Diseases that these drugs treat.

David: Opportunities for patients to be initiated with their treatment.

David: And whether it's a pleasant.

David: Nah KRYSTEXXA or <unk>. These are going to be key growth driving products for us over the long haul both in the U S and internationally speaking of use David its Peter here. Just a reminder, that the transaction closed on October 23, So you've mentioned a couple of years, it's been about a year and a half.

David: 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 and Murdo, maybe you want to touch on the international progress, yes. Thanks, Justin we've made making great progress with <unk> internationally.

David: With the recent approval in Japan, we've been approved in.

David: Although so much has happened in the world it might feel like more than that.

Murdo: Saudi Arabia, Brazil, we have a positive opinion in the <unk> in Europe, we anticipate launching there in the back half of the year.

David: We're delighted with the progress so far as I mentioned in my remarks, we're right on target with pre tax 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 right Julien Let's go to next question.

Murdo: So the international expansion is progressing very well and I would say ahead of schedule.

Murdo: There to what we thought we would be able to do when we made the acquisition.

Murdo: 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 a.

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

Murdo Gordon: 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. 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 pair process, finding a site 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.

Oh, Hey, congrats on all the progress and thank you for providing this update can you help us understand what to expect on that.

Speaker Change: The merritts who's in that Phase III study readouts coming up here in the second quarter and how are you thinking about the market opportunity for Burma. Thank you.

Murdo: Pleasant KRYSTEXXA or <unk>. These are going to be key growth driving products for us over the long haul both in the U S and internationally.

Speaker Change: Yes, Thanks, Jay for the kind words <unk> is our first in class fibroblast growth factor receptor <unk> directed monoclonal antibody. This is a protein that appears on the surface of malignant gastric cancer cells.

Murdo: King of youth David its Peter here, just a reminder, that the transaction closed in October 23, So you've mentioned a couple of years, it's been about a year and a half although so much has happened in the world it might feel like more than that.

Murdo Gordon: 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. 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 Topeza, Uplizna, Cristexa, or Tavneos, these are going to be key growth-driving products for us over the long haul, both in the U.S.

Murdo: So we're delighted with the progress so far as I mentioned in my remarks, we're right on target with pre tax 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 right Julien Let's go to the next question.

Speaker Change: 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 improved overall survival in this patient population.

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

Speaker Change: We've.

Jay Olson: Oh, Hey, congrats on all the progress and thank you for providing this update can you help us understand what to expect on the.

Speaker Change: Designed it outstanding study that's.

Speaker Change: Fully enrolled and we hope to have data to share in the next quarter.

Speaker Change: 4% to 102 is the triplet study this is where we combine bema with chemotherapy.

Jay Olson: But merritts who's in that phase III study readouts coming up here in the second quarter and how are you thinking about the market opportunity for Burma. Thank you.

Speaker Change: And checkpoint therapy Nivola map both of these are frontline gastric cancer studies.

Speaker Change: More patients today receive a should receive chemotherapy with <unk> in the frontline of this disease, we're very hopeful that <unk> can work on top of that with a data readout in the second half of this year.

Speaker Change: Yes, Thanks, Jay for the kind words <unk> is our first in class fibroblast growth factor receptor <unk> directed monoclonal antibody. This is a protein that appears on the surface of malignant gastric cancer cells.

Speaker Change: <unk> showed pretty strong data in phase two especially in the target population that we selected and so we're hopeful that this will become a component of frontline standard of care for this disease I guess more to follow on next quarter.

Speaker Change: With some frequency and as you point out we're conducting two prospective phase III clinical trials, one that we call. The doublet study of <unk> 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 improved overall survival in this patient population.

Speaker Change: Yes.

Speaker Change: Addressable population here is quite large this is the fifth most common cancer worldwide over 1 million New cases globally 25000 cases in the U S. The addressable initial addressable patient population of about 7000 in the U S.

Speaker Change: We've.

Speaker Change: Designed it outstanding study, that's fully enrolled and we hope to have data to share the next quarter.

Peter Griffith: and internationally.

Peter Griffith: Speaking of youth, David, it's Peter here. Just a reminder that the transaction closed on October 23, so you mentioned a couple of years. It's been about a year and a half. Although so much has happened in the world, it might feel like more than that. So we're delighted with the progress so far, as I mentioned in my remarks. We're right on target with pre-tax 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.

Speaker Change: 42, <unk> hundred two is the triplet study this is where we combine bema with chemotherapy.

Much larger worldwide.

Speaker Change: A real.

Speaker Change: <unk> in Japan, and Southeast Asia.

Speaker Change: And checkpoint therapy Nivola Mab both of these are frontline gastric cancer studies and as more patients today receive our should receive chemotherapy with <unk> in the frontline of this disease. We're very hopeful that <unk> can work on top of that with a data readout in the second half of this year.

Speaker Change: Just in terms of the epidemiology of gastric cancer, and I think what really helps us as Jay outlined the combinability of the Merritts who's a mab with other available agents to treat this.

Speaker Change: Very difficult cancer.

Unknown Executive: All right, Julian, let's go to the next question.

Speaker Change: <unk> 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 I guess more to follow on next quarter.

Speaker Change: Hey, Julien It's go to next question. Please.

Jay Olson: Thank you, David. Our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open. Oh, hey, congrats on all the progress. And thank you for providing this update.

Speaker Change: Thank you J. Our next question comes from Alexandria, Hammond from Wolfe Research. Please go ahead. Your line is open.

Speaker Change: My apologies. Our next question will come from Gregory <unk> from RBC capital markets. Please go ahead. Your line is open.

Jay Bradner: Can you help us understand what to expect on the Merituzumab Phase 3 study readouts coming up here in the second quarter? And how are you thinking about the market opportunity for BEMA? Thank you. Yeah, thanks, Jay, for the kind words. Bamarituzumab is our first-in-class fibroblast growth factor receptor 2B-directed monoclonal antibody. This is a protein that appears on the surface of malignant gastric cancer cells with some frequency. And as you point out, we're conducting two prospective phase 3 clinical trials, one that we call the doublet study or Fortitude 101. We expect this to read out in the second quarter of this year, as I shared in the opening remarks.

Speaker Change: Yes.

Speaker Change: Addressable population here is quite large this is the fifth most common cancer worldwide over 1 million New cases globally 25000 cases in the U S. The addressable initial addressable patient population of about 7000 in the U S.

Speaker Change: Great. Thanks, Good afternoon, guys and congrats congrats on the quarter. Thanks. Thanks for the question, maybe just keeping with the oncology portfolio and and maybe moving earlier earlier down the pipeline a little bit and as you build on the alumina kras experience.

Speaker Change: Much larger worldwide and there are real.

Speaker Change: Want to ask that you elaborate a bit on the K Ras franchise strategy, just particular with the AMG 410 asset which was recently highlighted at the ACR.

Jay Olson: Opportunity in Japan, and Southeast Asia, just in terms of the epidemiology of gastric cancer and I think what really helps us as Jay outlined the combinability of <unk> with other available agents to treat this.

Speaker Change: We have a world with that competitive landscape for care restaurants, just curious if you could just elaborate how confident you are on the potential for <unk> or even better in class.

Speaker Change: Very difficult cancer.

Jay Bradner: What to expect here? We're very hopeful that this will meaningfully contribute to improved 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.

Julian Scott: Okay Julian Scott next question please.

Speaker Change: About this molecule. Thanks, so much.

Speaker Change: Thank you J. Our next question comes from Alexandra Hammond from Wolfe Research. Please go ahead. Your line is open.

Speaker Change: Alright, great. Thank you so much for picking up on the AMG 410 presentation at the ACR This week.

Speaker Change: My apologies.

Speaker Change: Our next question will come from Gregory <unk> from RBC capital markets. Please go ahead. Your line is open.

Jay Bradner: Fortitude 102 is the triplet study. This is where we combine BEMA with chemotherapy and checkpoint therapy, nivolumab. Both of these are frontline gastric cancer studies, and as more patients today receive or should receive chemotherapy with nivolumab in the frontline of this disease, we're very hopeful that pomerituzumab can work on top of that with the data readout in the second half of this year. Pomerituzumab showed pretty strong data in phase two, 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.

Speaker Change: This is a very interesting molecule and I think you've covered of two key attributes which is the properties of the molecule itself to make it exciting and then the moment at which it reaches human clinical investigation.

Speaker Change: Great. Thanks, Good afternoon, guys and congrats congrats on the quarter. Thanks. Thanks for the question, maybe just keeping with the oncology portfolio and and maybe moving earlier earlier down the pipeline a little bit and as you build on the alumina Kras experience just wanted to ask that you elaborate a bit on the <unk> franchise strategy.

Speaker Change: For others on the call that don't know the medicine. This is a low molecular weight orally bio available.

Speaker Change: Structured is closed.

Speaker Change: Small molecule inhibitor of K Ras Alrighty, we were first to develop K Ras therapy as a reality with lunar crash targeting the GE 12 C allele selectively through 16, covalent chemistry, but to get the other allele that trick doesn't work there is no <unk> handle and so we worked to.

Speaker Change: With the AMG 410 asset, which was recently highlighted at the ACR, we have our world what that competitive landscape for care restaurants. Just curious if you could just elaborate how confident you are on the potential for <unk> or even better in classes as you learn more about this molecule. Thanks so much.

Murdo Gordon: I guess more to follow next quarter. Murdo? Yeah, the addressable population here is quite large. This is the fifth most common cancer worldwide, over a million new cases globally, 25,000 cases in the U.S. The initial addressable patient population is about 7,000 in the U.S., much larger worldwide, and a real opportunity in Japan and Southeast Asia just in terms of the epidemiology of gastric cancer. I think what really helps is, as Jay outlined, the combinability of pomerituzumab with other available agents that treat this very difficult cancer.

Speaker Change: <unk>, a reversible pan K Ras inhibitor that hits Wild type <unk> D. G 12 B G.

Speaker Change: Alright, great. Thank you so much for picking up on the AMG 410 presentation at the ACR This week.

Speaker Change: <unk> actually as well in <unk> <unk>.

Speaker Change: It binds an allosteric pocket that is shared by other clinical stage <unk> inhibitors. This one is what's called a dual off and dual on state inhibitor. It has outstanding selectivity for <unk> over <unk> of more than 100 fold, which should confer excellent tolerability of strong <unk>.

Speaker Change: This is a very interesting molecule and I think you've covered of two key attributes which is the properties of the molecule itself to make it exciting and then the moment at which it reaches human clinical investigation for.

Speaker Change: For others on the call that don't know the medicine. This is a low molecular weight orally bio available.

Speaker Change: <unk> disclosed.

Speaker Change: Pudic index.

Speaker Change: The small molecule inhibitor of K Ras alrighty.

Speaker Change: And so we are developing this medicine in an expedited way.

Unknown Executive: Okay Julianne, let's go to the next question please.

Speaker Change: First to develop K Ras therapy, as a reality with Luna <unk> targeting the <unk> selectively through 16, covalent chemistry, but to get the other allele that trick doesn't work. There is no <unk> handle and so we work to develop a reversible pan K Ras inhibitor that hit.

Speaker Change: <unk> target solid tumors, both alone and in combination in a combined phase one two design.

Unknown Executive: Thank you, Jay.

Unknown Executive: Our next question comes from Alexandria Hammond from Wolf Research. Please go ahead. Your line is open. My apologies.

Speaker Change: So it's a very it's a stunning molecule.

Speaker Change: Now, it's a competitive space and this is great for patients.

Gregory Renza: Our next question will come from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open. Great, thanks. Good afternoon, guys. And congrats. Congrats on the quarter. Thanks. Thanks for the question.

We entered this space with AMG 410, being the leader in <unk> Therapeutics and so our eyes are wide open to some of the competitive programs that are more advanced in clinical study.

Speaker Change: Wild type <unk>.

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

Speaker Change: <unk> actually as well in <unk> <unk>.

Speaker Change: It binds an allosteric pocket that is shared by other clinical stage <unk> inhibitors. This one is what's called a dual off and dual on state inhibitor. It has outstanding selectivity for <unk> over <unk> of more than 100 fold, which should confer excellent tolerability of <unk>.

Speaker Change: I was very pleased to hear the reception from the leaders in the K Ras community at ACR.

Speaker Change: Social media and in private conversations, we're really bullish about the properties of <unk> and the need.

Speaker Change: Some of the K Ras inhibitors have shown a more narrow therapeutic index and then why might have hoped for so a competitive space, but an excellent offering and we hope to learn a lot and expedited phase one and two clinical development.

Speaker Change: <unk> therapeutic index.

Speaker Change: And so we are developing this medicine in an expedited way.

Julian: Julian I think we've got time for two more questions.

Speaker Change: A number of target solid tumors, both alone and in combination in a combined phase one two design.

Speaker Change: Thank you. Thank you Gregory our next question comes from Matt Phipps from William Blair. Please go ahead. Your line is open.

Jay Bradner: All right, Greg, thank you so much for picking up on the AMG 410 presentation at the AACR this week. This is a very interesting molecule. And I think you've covered two key attributes, which is the properties of the molecule itself 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 K-Ras. Already, we were first to develop K-Ras therapy as a reality with LumaCraft targeting the G12 C allele selectively through cysteine covalent chemistry.

So it's a very it's a stunning molecule.

Speaker Change: Now, it's a competitive space and this is great for patients.

Hi, Thanks for taking my question I actually wanted to ask about the market opportunity for test fire in cirrhosis nasal polyps on 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.

Speaker Change: We entered this space with AMG 410, being the leader in <unk> Therapeutics and so our eyes are wide open to some of the competitive programs that are more advanced in clinical study.

Speaker Change: I was very pleased to hear the reception from the leaders in the K Ras community at ACR.

Speaker Change: Yes, Thanks, Matt for the question there are there is indeed.

Speaker Change: A real opportunity here with chronic rhinosinusitis chronic rhinosinusitis with nasal polyps.

Speaker Change: Social media and in private conversations, we're really bullish about the properties of <unk> and the need.

Speaker Change: Where we're looking at roughly one to 2 million patients in the U S that suffer from this it is a significantly overlapping with us.

Speaker Change: Some of the <unk> inhibitors have shown a more narrow therapeutic index and then one might have hoped for so a competitive space, but an excellent offering and we hope to learn a lot and expedited phase one and two clinical development Alright, Julian I think we've got time for two more questions.

Jay Bradner: But to get the other allele, that trick doesn't work. There's no cysteine handle. And so we worked to develop a reversible pan-K-Ras inhibitor that hits wild-type G12D, G12V, G12C actually as well, and G13D. It binds an allosteric pocket that is shared by other clinical stage K-Ras G12C inhibitors. This one is what's called a dual-off and dual-on state inhibitor. It has outstanding selectivity for K-Ras over H-Ras and N-Ras of more than 100-fold, which should confer excellent tolerability, a strong therapeutic index. So we're developing this medicine in an expedited way, in a number of target solid tumors, both alone and in combination, in a combined phase one, two design.

Speaker Change: Severe asthma.

Speaker Change: Roughly 40% of asthma patients will present with some nasal polyp.

Speaker Change: Thank you. Thank you Gregory our next question comes from Matt Phipps from William Blair. Please go ahead. Your line is open.

Speaker Change: Sorry, some chronic rhinosinusitis 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 trial show that we can reduce almost entirely the need for surgery and so there is an opportunity I believe for us with tests.

Matt Phipps: Hi, Thanks for taking my question I actually wanted to ask about the market opportunity for test buyer and Crs with nasal polyps on 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 time.

Speaker Change: Fire, which has performed exceptionally well in severe uncontrolled asthma to go in and help these patients with this.

Speaker Change: Yes, Thanks, Matt for the question there is indeed.

Speaker Change: A real opportunity here with chronic rhinosinusitis chronic rhinosinusitis with nasal polyps.

Speaker Change: Frankly, a miserable condition.

Speaker Change: And help help their overall quality of life as we demonstrated in our clinical trial alright.

Speaker Change: Where we're looking at roughly one to 2 million patients in the U S that suffer from this it is significantly overlapping with severe.

Speaker Change: Alright, let's go to our last question.

Jay Bradner: So it's a stunning molecule.

Speaker Change: Thank you Matt our last question will come from Alexandria Hammond from Wolfe Research. Please go ahead. Your line is open.

Jay Bradner: Now, it's a competitive space, and this is great for patients. We enter this space with AMG 410 being the leader in KRAS therapeutics. And so our eyes are wide open to some of the competitor programs that are more advanced in clinical study. I was very pleased to hear the reception from the leaders in the KRAS community at AACR, who on social media and in private conversations were really bullish about the properties of 410 and the need. Some of the KRAS inhibitors have shown a more narrow therapeutic index than one might have hoped for. So a competitive space, but an excellent offering, and we hope to learn a lot in expedited phase one and two clinical development.

Speaker Change: Severe asthma.

Alexandria Hammond: Thanks for taking the question so whats your expectation for future market split between <unk> and tenancy as competitor Ox 40 are you thinking of 50 50 split in let's say, the atopic dermatitis market or how you're kind of thinking about that shaking out. Thank you.

Speaker Change: Roughly 40% of asthma patients will present with some.

Speaker Change: Nasal polyp.

Speaker Change: Sorry, some chronic rhinosinusitis 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 trial show that we can reduce almost entirely the need for surgery and so there is an opportunity I believe for us with tests.

Sure Murdo firewood.

Murdo: As we said in the past, where we're really looking carefully at the roka till I Mab opportunity atopic dermatitis is clearly a condition that has opportunity for continued improvement.

Speaker Change: Fire, which has performed exceptionally well in severe uncontrolled asthma to go in and help these patients with this.

Murdo: In terms of the number of treatments that are available there is 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 split is going to be versus agents that are still in clinical development, but.

Speaker Change: Frankly, a miserable condition.

Unknown Executive: All right, Julianne, I think we've got time for two more questions. Thank you.

Speaker Change: And help help their overall quality of life as we demonstrated in the clinical trial alright.

Unknown Executive: Thank you, Gregory.

Matt Phipps: Our next question comes from Matt Phipps from William Blair. Please go ahead. Your line is open. Hi, thanks for my question.

Speaker Change: Alright, let's go to our last question.

Speaker Change: Thank you Matt our last question will come from Alexandra Hammond from Wolfe Research. Please go ahead. Your line is open.

Murdo: We're quite confident that there's a very nice opportunity in the market for rockets that law.

Murdo Gordon: I actually wanted to ask about the market opportunity for Tespire and CRS with nasal polyps on inundation 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. Yeah, thanks, Matt, for the question. There, there is indeed a real opportunity here with chronic rhinosinus, chronic rhinosinusitis with nasal polyps. We're, we're looking at roughly one to two million patients in the US that suffer from this. It is significantly overlapping with severe asthma. Roughly 40% of asthma patients will present with some nasal polyp, sorry, some chronic rhinosinusitis involvement, and some of them with nasal polyps.

Alexandra Hammond: Thanks for taking the question so whats your expectation for future market split between <unk> and tenancy as competitor Ox 40 are you thinking of 50 50 split in let's say, the atopic dermatitis market or how you're kind of thinking about that shaking out. Thank you.

Speaker Change: Alright, 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.

Murdo: And as you can tell we're excited about the momentum of the business excited about.

Murdo: Our current performance as well as what we see coming down the Pike.

Murdo: Sure Murdo answers borrower.

Speaker Change: As we said in the past, where we're really looking carefully at the <unk> opportunity atopic dermatitis is clearly a condition that has opportunity for continued improvement.

Murdo: Okay.

Murdo: Okay.

Speaker Change: In terms of the number of treatments that are available there is 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 split is going to be versus agents that are still in clinical development, but.

Speaker Change: We're quite confident that there is a very nice opportunity in the market for rockets in Lima.

Murdo Gordon: And indeed, these patients undergo some very difficult treatments, inclusive of surgery, and we were able to, in our clinical trial, show that we can reduce almost entirely the need for surgery. And so, there is an opportunity, I believe, for us with Tespire, which has performed exceptionally well in severe uncontrolled asthma, to go in and help these patients with this, you know, quite frankly, a miserable condition, and help, help their overall quality of life as we demonstrated in the clinical trial.

Speaker Change: Alright, 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.

Speaker Change: And as you can tell we're excited about the momentum of the business excited about food.

Speaker Change: Our current performance as well as what we see coming down the pipe. So look forward to seeing later in the year. Thank you.

Speaker Change: Yeah.

Speaker Change: This concludes our Amgen Q1, FY 2025 earnings call.

Unknown Executive: All right, let's go to our last question. Thank you, Matt.

Alexandria Hammond: Our last question will come from Alexandria Hammond from Wolf Research. Please go ahead. Your line is open. Thanks for taking the question. So what's your expectation for a future market split between Broccola-Tilamap and Sanofi's competitor OX40? Are you thinking of 50-50 split in let's say the atopic dermatitis market or how are you kind of thinking about that shaking out? Thank you. Sure. Murdo, why don't you fire away. As we've said in the past, we're really looking carefully at the rocotillumab 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 split is 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 rocotillumab.

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