Amgen Q4 2025 Amgen Inc Earnings Call | AllMind AI Earnings | AllMind AI
Q4 2025 Amgen Inc Earnings Call
Casey Capparelli: and be followed by a broader review of our performance by Jay Bradner, Murdo Gordon, 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.
Casey Capparelli: and be followed by a broader review of our performance by Jay Bradner, Murdo Gordon, 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.
Speaker #1: Followed by a broader review of our performance. By Jay Bradner, Murdo Gordon, 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.
Speaker #1: 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
Speaker #1: you, Bob. Okay.
Robert Bradway: Okay, thank you, Casey, and good afternoon, everyone. Thank you for joining us today. Today, we'll cover full year results for 2025 and provide a preview of what to expect from us in 2026. Amgen delivered strong operational performance across the board in 2025, and you can see that in the breadth of our business. Note that 14 of our products achieved blockbuster status with sales of $1 billion or more, 13 products delivered double-digit sales growth, and 18 products achieved record results for us. The strength of that broad portfolio enabled us to post double-digit growth in revenues and earnings per share for 2025. Looking to 2026, I would highlight 6 areas of momentum. Three of these, Repatha, Evenity, and Tezspire, all grew by more than 30% year-over-year in 2025. These medicines have a few important things in common.
Robert Bradway: Okay, thank you, Casey, and good afternoon, everyone. Thank you for joining us today. Today, we'll cover full year results for 2025 and provide a preview of what to expect from us in 2026. Amgen delivered strong operational performance across the board in 2025, and you can see that in the breadth of our business. Note that 14 of our products achieved blockbuster status with sales of $1 billion or more, 13 products delivered double-digit sales growth, and 18 products achieved record results for us. The strength of that broad portfolio enabled us to post double-digit growth in revenues and earnings per share for 2025. Looking to 2026, I would highlight 6 areas of momentum. Three of these, Repatha, Evenity, and Tezspire, all grew by more than 30% year-over-year in 2025. These medicines have a few important things in common.
Speaker #2: Thank you, Casey, and good afternoon, everyone. Thank you for joining us today. Today, we'll cover full-year results for 2025 and provide a preview of what to expect from us in 2026.
Speaker #2: AMGEN delivered strong operational performance across the board in 2025, and you can see that in the breadth of our business. Note that 14 of our products achieved blockbuster status with sales of a billion dollars or more.
Speaker #2: 13 products delivered double-digit sales growth, and 18 products achieved record results for us. The strength of that broad portfolio enabled us to post double-digit growth in revenues and earnings per share for 2025.
Speaker #2: Looking to 2026, I would highlight six areas of momentum. Three of these were PATHA, EVENITY, and TESPIRE, all grew by more than 30% year-over-year in 2025.
Speaker #2: These medicines have a few important things in common. First, they're highly effective innovative therapies that address important public health needs. Second, they're leading products in their fields, and third, while each of these products represents a multibillion-dollar global franchise already, they address areas of large unmet medical need where there are millions of patients yet to be treated.
Robert Bradway: First, they're highly effective, innovative therapies that address important public health needs. Second, they're leading products in their fields. And third, while each of these products represents a multi-billion dollar global franchise already, they address areas of large unmet medical need where there are millions of patients yet to be treated. In this sense, they represent growth drivers, not just for 2026, but for the rest of the decade. In rare disease, our portfolio generated more than $5 billion in sales in 2025. Here, too, many of our medicines are early in their life cycle and positioned as leaders in their respective categories. Growth has been fueled by reaching new patients, expanding into additional geographies, and launching new indications. We see further opportunity ahead as we scale these therapies. Uplizna exemplifies this growth opportunity with approvals in IgG4-related disease and generalized myasthenia gravis in 2025.
Robert Bradway: First, they're highly effective, innovative therapies that address important public health needs. Second, they're leading products in their fields. And third, while each of these products represents a multi-billion dollar global franchise already, they address areas of large unmet medical need where there are millions of patients yet to be treated. In this sense, they represent growth drivers, not just for 2026, but for the rest of the decade. In rare disease, our portfolio generated more than $5 billion in sales in 2025. Here, too, many of our medicines are early in their life cycle and positioned as leaders in their respective categories. Growth has been fueled by reaching new patients, expanding into additional geographies, and launching new indications. We see further opportunity ahead as we scale these therapies. Uplizna exemplifies this growth opportunity with approvals in IgG4-related disease and generalized myasthenia gravis in 2025.
Speaker #2: In this sense, they represent growth drivers not just for 2026, but for the rest of the decade. In rare disease, our portfolio generated more than $5 billion in sales in 2025.
Speaker #2: Here, too, many of our medicines are early in their life cycle and positioned as leaders in their respective categories. Growth has been fueled by reaching new patients, expanding into additional geographies, and launching new indications.
Speaker #2: We see further opportunity ahead as we scale these therapies. Uprizna exemplifies this growth opportunity with approvals in IGG-4-related disease and generalized myasthenia gravis in 2025.
Robert Bradway: Our innovative oncology portfolio grew at 11% year-over-year in 2025, driven by our BiTE or bispecific T-cell engager medicines. We're particularly excited about Imdelltra, which has rapidly become the standard of care in patients with second-line or later small cell lung cancer, supported by unprecedented survival benefits. We're an industry leader in biosimilars. Our biosimilars portfolio has contributed more than $13 billion in sales since the launch of our first medicine there in 2018. With $3 billion in 2025 sales, this business is an important contributor to our organization and poised for growth with the next wave of biosimilar launches. You can appreciate the depth of our business through the lens of our research and development activities.
Robert Bradway: Our innovative oncology portfolio grew at 11% year-over-year in 2025, driven by our BiTE or bispecific T-cell engager medicines. We're particularly excited about Imdelltra, which has rapidly become the standard of care in patients with second-line or later small cell lung cancer, supported by unprecedented survival benefits. We're an industry leader in biosimilars. Our biosimilars portfolio has contributed more than $13 billion in sales since the launch of our first medicine there in 2018. With $3 billion in 2025 sales, this business is an important contributor to our organization and poised for growth with the next wave of biosimilar launches. You can appreciate the depth of our business through the lens of our research and development activities.
Speaker #2: Our innovative oncology portfolio grew at 11% year-over-year in 2025, driven by our BITE or bispecific T-cell engager medicines. We're particularly excited about Imdeltra, which has rapidly become the standard of care in patients with second-line or later small cell lung cancer.
Speaker #2: Supported by unprecedented survival benefits. We're an industry leader in biosimilars. Our biosimilars portfolio has contributed more than $13 billion in sales since the launch of our first medicine there in 2018.
Speaker #2: With $3 billion in 2025 sales, this business is an important contributor to our organization and poised for growth with the next wave of biosimilar launches.
Speaker #2: You can appreciate the depth of our business through the lens of our research and development activities. 2026 will be a year of disciplined data generation, from and phase three programs that will pave the way for long-term growth at AMGEN.
Robert Bradway: 2026 will be a year of disciplined data generation from a number of exciting phase 2 and phase 3 programs that will pave the way for long-term growth at Amgen. Our confidence continues to build in MariTide as a differentiated treatment for obesity, type 2 diabetes, and obesity-related conditions. In a field featuring dozens of potential daily, oral, and weekly injectable medicines, MariTide stands alone as the only therapy in late-stage development to offer the paradigm-changing prospect of strong efficacy and favorable tolerability at monthly, every other month, or even quarterly dosing. In addition to MariTide, we remain excited about Olpasiran and what it might represent for patients with elevated Lp(a), a heritable risk factor for cardiovascular disease. We see Olpasiran as an opportunity to build on our leading positions in cardiometabolic disease.
Robert Bradway: 2026 will be a year of disciplined data generation from a number of exciting phase 2 and phase 3 programs that will pave the way for long-term growth at Amgen. Our confidence continues to build in MariTide as a differentiated treatment for obesity, type 2 diabetes, and obesity-related conditions. In a field featuring dozens of potential daily, oral, and weekly injectable medicines, MariTide stands alone as the only therapy in late-stage development to offer the paradigm-changing prospect of strong efficacy and favorable tolerability at monthly, every other month, or even quarterly dosing. In addition to MariTide, we remain excited about Olpasiran and what it might represent for patients with elevated Lp(a), a heritable risk factor for cardiovascular disease. We see Olpasiran as an opportunity to build on our leading positions in cardiometabolic disease.
Speaker #2: Our confidence continues to build in Maritide as a differentiated treatment for obesity, type 2 diabetes, and obesity-related conditions. In a field featuring dozens of potential daily oral and weekly injectable medicines, Maritide stands alone as the only therapy in late-stage development to offer the paradigm-changing prospect of strong efficacy and favorable tolerability at monthly, every other month, or even quarterly dosing.
Speaker #2: Maritide, we remain excited about In addition to Olpazolam and what it might represent for patients with elevated Lp(a), a heritable risk factor for cardiovascular disease.
Speaker #2: We see Olpazolam as an opportunity to build on our leading positions in cardiometabolic disease. It shouldn't be lost on any of us that Repatha, Olpazolam, and Maritide together would represent a very compelling set of cardiometabolic medicines to expand our leadership in the treatment of serious chronic diseases well into the next decade.
Robert Bradway: It shouldn't be lost on any of us that Repatha, Olpasiran, and MariTide together would represent a very compelling set of cardiometabolic medicines to expand our leadership in the treatment of serious chronic diseases well into the next decade. Beyond the pipeline, there's a great deal of enthusiasm about the convergence of technology and life science, and based on what we're seeing at Amgen, we believe that enthusiasm for convergent innovation is well placed and will have significant impact on how we discover, develop, and commercialize medicines. As always, I thank my Amgen colleagues around the world for supporting our mission to serve patients. And with that, let me turn over to Jay for an update in R&D.
Robert Bradway: It shouldn't be lost on any of us that Repatha, Olpasiran, and MariTide together would represent a very compelling set of cardiometabolic medicines to expand our leadership in the treatment of serious chronic diseases well into the next decade. Beyond the pipeline, there's a great deal of enthusiasm about the convergence of technology and life science, and based on what we're seeing at Amgen, we believe that enthusiasm for convergent innovation is well placed and will have significant impact on how we discover, develop, and commercialize medicines. As always, I thank my Amgen colleagues around the world for supporting our mission to serve patients. And with that, let me turn over to Jay for an update in R&D.
Speaker #2: Beyond the pipeline, there's a great deal of enthusiasm about the convergence of technology and life science. And based on what we're seeing at AMGEN, we believe that enthusiasm for convergent innovation is well placed, and we'll have significant impact on how we discover, develop, and commercialize medicines.
Speaker #2: As always, I thank my AMGEN colleagues around the world for supporting our mission to serve patients. And with that, let me turn over to Jay for an update in
Speaker #2: R&D. Thank you, Bob, and good
James Bradner: Thank you, Bob, and good afternoon, everyone. Q4 capped off a year of strong, disciplined execution across R&D. Throughout 2025, we advanced multiple late-stage programs, delivered five key regulatory approvals, and strengthened the evidence base supporting our marketed medicines. Taken together, these contributions demonstrate real scientific rigor and illustrate the breadth of opportunity ahead. Let me begin with MariTide, which continues to develop in meaningful and very encouraging ways. The MariTide phase 3 program is rapidly advancing, with strong enthusiasm from investigators and participants. Both of our phase 3 chronic weight management studies are fully enrolled, and our ASCVD and heart failure outcome studies are progressing well. In parallel, we continue to expand the clinical landscape of MariTide across obesity-related conditions as we begin enrollment of our two phase 3 sleep apnea studies in adults with and without positive airway pressure therapy....
James Bradner: Thank you, Bob, and good afternoon, everyone. Q4 capped off a year of strong, disciplined execution across R&D. Throughout 2025, we advanced multiple late-stage programs, delivered five key regulatory approvals, and strengthened the evidence base supporting our marketed medicines. Taken together, these contributions demonstrate real scientific rigor and illustrate the breadth of opportunity ahead. Let me begin with MariTide, which continues to develop in meaningful and very encouraging ways. The MariTide phase 3 program is rapidly advancing, with strong enthusiasm from investigators and participants. Both of our phase 3 chronic weight management studies are fully enrolled, and our ASCVD and heart failure outcome studies are progressing well. In parallel, we continue to expand the clinical landscape of MariTide across obesity-related conditions as we begin enrollment of our two phase 3 sleep apnea studies in adults with and without positive airway pressure therapy....
Speaker #3: afternoon, everyone. Fourth quarter capped off a year of strong disciplined execution across R&D. Throughout 2025, we advanced delivered five key regulatory approvals, and strengthened the evidence base supporting our marketed medicines.
Speaker #3: Taken together, these contributions demonstrate real scientific rigor and illustrate the breadth of opportunity ahead. Let me begin with Maritide, which continues to develop in meaningful and very encouraging ways.
Speaker #3: The Maritime Phase 3 program is rapidly advancing, with strong enthusiasm from investigators and participants. Both of our Phase 3 chronic weight management studies are fully enrolled, and our ASCVD and heart failure outcome studies are progressing well.
Speaker #3: In parallel, we continue to expand the clinical landscape of Maritide across obesity-related conditions, as we begin enrollment of our two Phase 3 sleep apnea studies.
Speaker #3: In adults with and without positive airway pressure therapy. Altogether, we now have six global Phase 3 studies underway with Maritide, collectively designed to deliver a comprehensive evidence base.
James Bradner: Altogether, we now have six global phase 3 studies underway with MariTide, collectively designed to deliver a comprehensive evidence base. In addition, as we shared last month, we've completed part two of the MariTide phase 2 chronic weight management study. We also completed the first 24 weeks of the phase 2 type 2 diabetes study that enrolled participants with and without obesity. Results from these two studies further increase our confidence that MariTide can represent a new paradigm in obesity, type 2 diabetes, and other obesity-related conditions. We believe MariTide has the potential to expand what's possible for patients, availing an opportunity for monthly or less frequent dosing. MariTide's strong efficacy, infrequent dosing, and excellent tolerability at target dose have the potential to further enhance the patient experience, and therefore, treatment persistence, a major unmet need in the field.
James Bradner: Altogether, we now have six global phase 3 studies underway with MariTide, collectively designed to deliver a comprehensive evidence base. In addition, as we shared last month, we've completed part two of the MariTide phase 2 chronic weight management study. We also completed the first 24 weeks of the phase 2 type 2 diabetes study that enrolled participants with and without obesity. Results from these two studies further increase our confidence that MariTide can represent a new paradigm in obesity, type 2 diabetes, and other obesity-related conditions. We believe MariTide has the potential to expand what's possible for patients, availing an opportunity for monthly or less frequent dosing. MariTide's strong efficacy, infrequent dosing, and excellent tolerability at target dose have the potential to further enhance the patient experience, and therefore, treatment persistence, a major unmet need in the field.
Speaker #3: In addition, as we shared last month, we've completed part two of the Maritide Phase 2 chronic weight management study. We also completed the first 24 weeks of the Phase 2 type 2 diabetes study, that enrolled participants with and without obesity.
Speaker #3: Results from these two studies further increase our confidence that Maritide can represent a new paradigm in obesity, type 2 diabetes, and other obesity-related conditions.
Speaker #3: We believe Maritide has the potential to expand what's possible for patients, availing an opportunity for monthly or less frequent dosing. Maritide's strong dose have the potential to further enhance the excellent tolerability at target efficacy, infrequent dosing, and patient experience and therefore treatment persistence, a major unmet need in the field.
Speaker #3: Beyond obesity and general medicine, the fourth quarter brought a landmark contribution to cardiovascular health from Repatha. In November, full results from the Phase 3 Vesalius CV trial were presented at the American Heart Association Scientific Sessions in simultaneously published in the New England Journal of Medicine.
James Bradner: Beyond obesity and general medicine, the fourth quarter brought a landmark contribution to cardiovascular health from Repatha. In November, full results from the phase 3 VESALIUS-CV trial were presented at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine. This study enrolled more than 12,000 patients without a prior heart attack or stroke, testing the impact of Repatha for LDL-C lowering when added to optimized lipid therapy, namely statins, with a median follow-up of approximately 4.5 years. In VESALIUS-CV, Repatha demonstrated a 25% relative risk reduction in the composite of coronary heart disease, death, heart attack, or ischemic stroke, and delivered a 36% reduction in heart attack, with no new safety signals observed.
James Bradner: Beyond obesity and general medicine, the fourth quarter brought a landmark contribution to cardiovascular health from Repatha. In November, full results from the phase 3 VESALIUS-CV trial were presented at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine. This study enrolled more than 12,000 patients without a prior heart attack or stroke, testing the impact of Repatha for LDL-C lowering when added to optimized lipid therapy, namely statins, with a median follow-up of approximately 4.5 years. In VESALIUS-CV, Repatha demonstrated a 25% relative risk reduction in the composite of coronary heart disease, death, heart attack, or ischemic stroke, and delivered a 36% reduction in heart attack, with no new safety signals observed.
Jay Olson: Altogether, we now have six global phase III studies underway with MariTide, collectively designed to deliver a comprehensive evidence base. In addition, as we shared last month, we've completed part 2 of the MariTide phase II chronic weight management study. We also completed the first 24 weeks of the phase II Type 2 diabetes study that enrolled participants with and without obesity. Results from these two studies further increase our confidence that MariTide can represent a new paradigm in obesity, Type 2 diabetes, and other obesity-related conditions. We believe MariTide has the potential to expand what's possible for patients, availing an opportunity for monthly or less frequent dosing. MariTide's strong efficacy, infrequent dosing, and excellent tolerability at target dose, have the potential to further enhance the patient experience, and therefore, treatment persistence, a major unmet need in the field.
Jay Bradner: Altogether, we now have six global phase III studies underway with MariTide, collectively designed to deliver a comprehensive evidence base. In addition, as we shared last month, we've completed part 2 of the MariTide phase II chronic weight management study. We also completed the first 24 weeks of the phase II Type 2 diabetes study that enrolled participants with and without obesity. Results from these two studies further increase our confidence that MariTide can represent a new paradigm in obesity, Type 2 diabetes, and other obesity-related conditions. We believe MariTide has the potential to expand what's possible for patients, availing an opportunity for monthly or less frequent dosing. MariTide's strong efficacy, infrequent dosing, and excellent tolerability at target dose, have the potential to further enhance the patient experience, and therefore, treatment persistence, a major unmet need in the field.
Speaker #3: This study enrolled more than 12,000 patients without a prior heart attack or stroke, testing the impact of Repatha for LDL-C lowering when added to optimize lipid therapy, namely statins, with a median follow-up of approximately 4.5 years.
Altogether, we now have six global phase 3 studies underway with Maritime collectively, designed to deliver a comprehensive evidence base.
In addition, as we shared last month, we've completed part 2 of the MARITIME Phase 2 chronic weight management study.
We also completed the first 24 weeks of the phase 2, type 2 diabetes study that enrolled participants with and without obesity.
Speaker #3: In Vesalius CV, Repatha demonstrated a 25% relative risk reduction in the composite of coronary heart disease death, heart attack, or ischemic stroke, and delivered a 36% reduction in heart attack, with no new safety signals observed.
Results from these two studies further increase our confidence. The maritime can represent a new paradigm in obesity, type 2 diabetes, and other obesity-related conditions.
Speaker #3: These data clearly demonstrate that intensive LDL-C lowering with Repatha can meaningfully reduce the risk of a first cardiovascular event, reinforcing its role across the full continuum of cardiovascular risk.
James Bradner: These data clearly demonstrate that intensive LDL-C lowering with Repatha can meaningfully reduce the risk of a first cardiovascular event, reinforcing its role across the full continuum of cardiovascular risk. Turning to Olpasiran, our potentially best-in-class small interfering RNA medicine targeting Lp(a), the fully enrolled OCEANA outcomes study continues to progress. As previously discussed, this is an event-driven study, and the aggregate endpoint accrual rate remains lower than initial predictions. As this study matures, we will update on the date for primary analysis as appropriate. Our conviction in Olpasiran to reduce cardiovascular risk conferred by elevated Lp(a) remains strong, grounded in compelling genetic and epidemiologic evidence that establish elevated Lp(a) as an independent risk factor for heart disease. Moving to rare disease, Q4 was highlighted by important regulatory momentum for Uplizna.
James Bradner: These data clearly demonstrate that intensive LDL-C lowering with Repatha can meaningfully reduce the risk of a first cardiovascular event, reinforcing its role across the full continuum of cardiovascular risk. Turning to Olpasiran, our potentially best-in-class small interfering RNA medicine targeting Lp(a), the fully enrolled OCEANA outcomes study continues to progress. As previously discussed, this is an event-driven study, and the aggregate endpoint accrual rate remains lower than initial predictions. As this study matures, we will update on the date for primary analysis as appropriate. Our conviction in Olpasiran to reduce cardiovascular risk conferred by elevated Lp(a) remains strong, grounded in compelling genetic and epidemiologic evidence that establish elevated Lp(a) as an independent risk factor for heart disease. Moving to rare disease, Q4 was highlighted by important regulatory momentum for Uplizna.
We believe Maritime has the potential to expand what's possible for patients availing. It's an opportunity for monthly or less frequent dosing.
Speaker #3: Turning to Olpazolam, our potentially best-in-class small interfering RNA medicine targeting Lp(a) to fully enrolled OceanA outcome study continues to progress. As previously discussed, this is an event-driven study, and the aggregate endpoint, accrual rate, remains lower than initial predictions.
Maritime shows strong efficacy in frequent dosing, and excellent tolerability at target dose. It has the potential to further enhance the patient experience and, therefore, treatment persistence—a major unmet need in the field.
Jay Olson: Beyond obesity and general medicine, the fourth quarter brought a landmark contribution to cardiovascular health from Repatha. In November, full results from the Phase III VESALIUS-CV trial were presented at the American Heart Association scientific session, and simultaneously published in the New England Journal of Medicine. This study enrolled more than 12,000 patients without a prior heart attack or stroke, testing the impact of Repatha for LDL-C lowering when added to optimized lipid therapy, namely statins, with a median follow-up of approximately 4.5 years. In VESALIUS-CV, Repatha demonstrated a 25% relative risk reduction in the composite of coronary heart disease, death, heart attack, or ischemic stroke, and delivered a 36% reduction in heart attack, with no new safety signals observed.
Jay Bradner: Beyond obesity and general medicine, the fourth quarter brought a landmark contribution to cardiovascular health from Repatha. In November, full results from the Phase III VESALIUS-CV trial were presented at the American Heart Association scientific session, and simultaneously published in the New England Journal of Medicine. This study enrolled more than 12,000 patients without a prior heart attack or stroke, testing the impact of Repatha for LDL-C lowering when added to optimized lipid therapy, namely statins, with a median follow-up of approximately 4.5 years. In VESALIUS-CV, Repatha demonstrated a 25% relative risk reduction in the composite of coronary heart disease, death, heart attack, or ischemic stroke, and delivered a 36% reduction in heart attack, with no new safety signals observed.
Beyond obesity and general medicine, the fourth quarter brought a landmark contribution to cardiovascular health from HER PASA.
Speaker #3: As the study matures, we will update on the date for primary analysis as appropriate. Our conviction in Olpazolam to reduce cardiovascular risk conferred by elevated Lp(a) remains strong.
In November, full results from the phase 3 VISELIA-CV trial were presented at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine.
This study enrolled more than 12,000 patients without a prior heart attack or stroke.
Speaker #3: Grounded in compelling genetic and epidemiologic evidence that establish elevated Lp(a) as an independent risk factor for heart to rare disease, the fourth quarter was disease.
Testing the impact of HER. PAATA for LDL-C lowering when added to optimized lipid therapy, namely statins, with a median follow-up of approximately 4.5 years.
Speaker #3: Moving highlighted by important regulatory momentum for Eplizna. In November, the European Commission approved Eplizna for the treatment of adults with active IgG4-related disease, and in December, the FDA approved Eplizna for the treatment of generalized myasthenia gravis.
James Bradner: In November, the European Commission approved Uplizna for the treatment of adults with active IgG4-related disease, and in December, the FDA approved Uplizna for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-Musk antibody positive. These approvals built on strong phase 3 data, demonstrating durable efficacy, a steroid-sparing benefit with every six-month dosing. This research further extends the impact of CD19-directed B-cell depletion across serious autoimmune diseases. More broadly, in B-cell depletion, where we have a number of proof-of-concept studies underway, we expect to initiate two pivotal studies this year. The first is for patients with autoimmune hepatitis, a serious disease characterized by persistent liver inflammation that can lead to progressive scarring, loss of liver function, and ultimately, liver failure.
James Bradner: In November, the European Commission approved Uplizna for the treatment of adults with active IgG4-related disease, and in December, the FDA approved Uplizna for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-Musk antibody positive. These approvals built on strong phase 3 data, demonstrating durable efficacy, a steroid-sparing benefit with every six-month dosing. This research further extends the impact of CD19-directed B-cell depletion across serious autoimmune diseases. More broadly, in B-cell depletion, where we have a number of proof-of-concept studies underway, we expect to initiate two pivotal studies this year. The first is for patients with autoimmune hepatitis, a serious disease characterized by persistent liver inflammation that can lead to progressive scarring, loss of liver function, and ultimately, liver failure.
In the MISELLIA CV or PAATA, it demonstrated a 25% relative risk reduction in the composite of coronary heart disease, death, heart attack, or ischemic stroke, and delivered a 36% reduction in heart attack, with no new safety signals observed.
Jay Olson: These data clearly demonstrate that intensive LDL-C lowering with Repatha can meaningfully reduce the risk of a first cardiovascular event, reinforcing its role across the full continuum of cardiovascular risk. Turning to olpasiran, our potentially best-in-class, small interfering RNA medicine targeting Lp(a), the fully enrolled OCEAN(a)-Outcomes study continues to progress. As previously discussed, this is an event-driven study, and the aggregate endpoint accrual rate remains lower than initial predictions. As this study matures, we will update on the date for primary analysis as appropriate. Our conviction in olpasiran to reduce cardiovascular risk conferred by elevated Lp(a) remains strong, grounded in compelling genetic and epidemiologic evidence that established elevated Lp(a) as an independent risk factor for heart disease. Moving to rare disease, the fourth quarter was highlighted by important regulatory momentum for Uplizna.
Jay Bradner: These data clearly demonstrate that intensive LDL-C lowering with Repatha can meaningfully reduce the risk of a first cardiovascular event, reinforcing its role across the full continuum of cardiovascular risk. Turning to olpasiran, our potentially best-in-class, small interfering RNA medicine targeting Lp(a), the fully enrolled OCEAN(a)-Outcomes study continues to progress. As previously discussed, this is an event-driven study, and the aggregate endpoint accrual rate remains lower than initial predictions. As this study matures, we will update on the date for primary analysis as appropriate. Our conviction in olpasiran to reduce cardiovascular risk conferred by elevated Lp(a) remains strong, grounded in compelling genetic and epidemiologic evidence that established elevated Lp(a) as an independent risk factor for heart disease. Moving to rare disease, the fourth quarter was highlighted by important regulatory momentum for UPLIZNA.
Speaker #3: In adults who are anti-acetylcholine receptor or anti-MUSK antibody positive, these approvals built on strong Phase 3 data demonstrating durable efficacy, a steroid-sparing benefit with every six-month dosing.
These data clearly demonstrate that intensive LDL-C lowering with Repatha can meaningfully reduce the risk of a first cardiovascular event.
Reinforcing its role across the full continuum of cardiovascular risk.
Speaker #3: This research further extends the impact of CD19-directed B-cell depletion across serious autoimmune diseases. More broadly in B-cell depletion, where we have a number of proof-of-concept studies underway, we expect to initiate two pivotal studies this year.
Turning to paths around our potentially best-in-class small interfering RNA medicine, targeting Lp(a), the fully enrolled OCEAN(a) outcome study continues to progress.
As previously discussed, this is an event-driven study and the aggregate endpoint or cruel rate remains lower than initial predictions.
Speaker #3: The first is for patients with autoimmune hepatitis, a serious disease, characterized by persistent liver inflammation that can lead to progressive scarring, loss of liver function, and ultimately liver failure.
As this study matures, we will update on the date for primary analysis as appropriate.
Our conviction in olpasiran to reduce cardiovascular risk, conferred by elevated Lp(a), remains strong.
Speaker #3: The second study is chronic inflammatory demyelinating polyneuropathy, or CIDP, a disabling immune-mediated neuropathy that damages peripheral nerve myelin resulting in worsening strength, worsening sensation, and for many patients, substantial impairment in daily activities.
James Bradner: The second studies chronic inflammatory demyelinating polyneuropathy, or CIDP, a disabling immune-mediated neuropathy that damages peripheral nerve myelin, resulting in worsening strength, worsening sensation, and for many patients, substantial impairment in daily activities. With Uplizna, we are targeting these diseases at their root cause by depleting pathologic B cells that drive disease through secreted autoantibodies. Given the strong efficacy of Uplizna in other settings, we're excited about the potential to bring a meaningful new option to patients with these two devastating conditions. We are also advancing dazodalibep, our CD40 ligand-targeting biotherapeutic, with both phase 3 studies in Sjogren's disease now fully enrolled and study completion expected in the second half of 2026. We're pleased today to announce positive phase 2 data with daxdilimab, a first-in-class plasmacytoid dendritic cell-depleting monoclonal antibody targeting ILT-7, or the immunoglobulin-like transcript seven protein.
James Bradner: The second studies chronic inflammatory demyelinating polyneuropathy, or CIDP, a disabling immune-mediated neuropathy that damages peripheral nerve myelin, resulting in worsening strength, worsening sensation, and for many patients, substantial impairment in daily activities. With Uplizna, we are targeting these diseases at their root cause by depleting pathologic B cells that drive disease through secreted autoantibodies. Given the strong efficacy of Uplizna in other settings, we're excited about the potential to bring a meaningful new option to patients with these two devastating conditions. We are also advancing dazodalibep, our CD40 ligand-targeting biotherapeutic, with both phase 3 studies in Sjogren's disease now fully enrolled and study completion expected in the second half of 2026. We're pleased today to announce positive phase 2 data with daxdilimab, a first-in-class plasmacytoid dendritic cell-depleting monoclonal antibody targeting ILT-7, or the immunoglobulin-like transcript seven protein.
Grounded in compelling genetic and epidemiologic evidence that establish elevated LP little a as an independent risk factor for heart disease.
Jay Olson: In November, the European Commission approved Uplizna for the treatment of adults with active IgG4-related disease, and in December, the FDA approved Uplizna for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-MuSK antibody positive. These approvals built on strong Phase III data, demonstrating durable efficacy, a steroid-sparing benefit with every six-month dosing. This research further extends the impact of CD19-directed B-cell depletion across serious autoimmune diseases. More broadly, in B-cell depletion, where we have a number of proof-of-concept studies underway, we expect to initiate two pivotal studies this year. The first is for patients with autoimmune hepatitis, a serious disease characterized by persistent liver inflammation that can lead to progressive scarring, loss of liver function, and ultimately, liver failure.
Jay Bradner: In November, the European Commission approved UPLIZNA for the treatment of adults with active IgG4-related disease, and in December, the FDA approved UPLIZNA for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-MuSK antibody positive. These approvals built on strong Phase III data, demonstrating durable efficacy, a steroid-sparing benefit with every six-month dosing. This research further extends the impact of CD19-directed B-cell depletion across serious autoimmune diseases. More broadly, in B-cell depletion, where we have a number of proof-of-concept studies underway, we expect to initiate two pivotal studies this year. The first is for patients with autoimmune hepatitis, a serious disease characterized by persistent liver inflammation that can lead to progressive scarring, loss of liver function, and ultimately, liver failure.
Moving to rare disease, the fourth quarter was highlighted by important regulatory momentum for a plasma.
Speaker #3: With Eplizna, we are targeting these diseases at their root cause. By depleting pathologic B cells that drive disease, through secreted autoantibodies. Given the strong efficacy of Eplizna and other settings, we're excited about the potential to bring a meaningful new option to patients with these two devastating conditions.
In November, the European Commission approved the plasma for the treatment of adults with active IgG4-related disease. And in December, the FDA approved the plasma for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-MuSK antibody positive.
These approvals built on strong Phase 3 data, demonstrating durable efficacy and a steroid-sparing benefit with every six-month dosing.
Speaker #3: We are also advancing dasodolibeb, our CD40 ligand targeting biotherapeutic with both Phase 3 studies in Sjogren's disease now fully enrolled and study completion expected in the second half of 2026.
This research further extends the impact of CD19-directed B cell depletion across serious autoimmune diseases.
Speaker #3: We're pleased today to announce positive Phase 2 data with Daxdilimab, a first-in-class plasmacytoid dendritic cell-depleting monoclonal antibody targeting ILT7 for the immunoglobulin-like transcript 7 protein.
More broadly in B-cell depletion, where we have a number of proof-of-concept studies underway, we expect to initiate two pivotal studies this year.
Jay Olson: The second studies chronic inflammatory demyelinating polyneuropathy, or CIDP, a disabling immune-mediated neuropathy that damages peripheral nerve myelin, resulting in worsening strength, worsening sensation, and for many patients, substantial impairment in daily activities. With UPLIZNA, we are targeting these diseases at their root cause by depleting pathologic B-cells that drive disease through secreted autoantibodies. Given the strong efficacy of UPLIZNA in other settings, we're excited about the potential to bring a meaningful new option to patients with these two devastating conditions. We are also advancing dazodalibep, our CD40 ligand-targeting biotherapeutic, with both phase III studies in Sjogren's disease now fully enrolled and study completion expected in the second half of 2026. We're pleased today to announce positive phase II data with daxdilimab, a first-in-class plasmacytoid dendritic cell-depleting monoclonal antibody, targeting ILT7, or the immunoglobulin-like transcript 7 protein.
Jay Bradner: The second studies chronic inflammatory demyelinating polyneuropathy, or CIDP, a disabling immune-mediated neuropathy that damages peripheral nerve myelin, resulting in worsening strength, worsening sensation, and for many patients, substantial impairment in daily activities. With UPLIZNA, we are targeting these diseases at their root cause by depleting pathologic B-cells that drive disease through secreted autoantibodies. Given the strong efficacy of UPLIZNA in other settings, we're excited about the potential to bring a meaningful new option to patients with these two devastating conditions. We are also advancing dazodalibep, our CD40 ligand-targeting biotherapeutic, with both phase III studies in Sjogren's disease now fully enrolled and study completion expected in the second half of 2026. We're pleased today to announce positive phase II data with daxdilimab, a first-in-class plasmacytoid dendritic cell-depleting monoclonal antibody, targeting ILT7, or the immunoglobulin-like transcript 7 protein.
The first is for patients with autoimmune hepatitis, a serious disease characterized by persistent liver inflammation that can lead to progressive scarring, loss of liver function, and ultimately liver failure.
Speaker #3: This study in patients with primary discoid lupus erythematosus met both primary and key secondary endpoints with an attractive safety profile. Encouraged by these data, we are working to advance Daxdilimab to the next phase of development in this setting.
James Bradner: This study in patients with primary discoid lupus erythematosus met both primary and key secondary endpoints with an attractive safety profile. Encouraged by these data, we are working to advance daxdilimab to the next phase of development in this setting. In inflammation, the Tezspire phase III program continues to advance, with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, where we expect study completion in the second half of this year. We recently announced the decision to terminate the rocatinlimab development and commercialization collaboration with Kyowa Kirin. With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs. Rocatinlimab will return to our partners at Kyowa Kirin, who will assume full ownership of the program....
James Bradner: This study in patients with primary discoid lupus erythematosus met both primary and key secondary endpoints with an attractive safety profile. Encouraged by these data, we are working to advance daxdilimab to the next phase of development in this setting. In inflammation, the Tezspire phase III program continues to advance, with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, where we expect study completion in the second half of this year. We recently announced the decision to terminate the rocatinlimab development and commercialization collaboration with Kyowa Kirin. With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs. Rocatinlimab will return to our partners at Kyowa Kirin, who will assume full ownership of the program....
The second is chronic inflammatory demyelinating polyneuropathy, or CIDP, a disabling immune-mediated neuropathy that damages peripheral nerve myelin, resulting in worsening strength, worsening sensation, and for many patients, substantial impairment in daily activity.
Speaker #3: In inflammation, the test by our Phase 3 program continues to advance. With ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, where we expect study completion in the second half of this year.
With the plasma, we are targeting these diseases at their root cause by depleting pathologic B cells that drive disease through secreted autoantibodies.
Speaker #3: We recently announced the decision to terminate the rocitinib development in commercialization collaboration with Kioakirin. With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs.
Given the strong efficacy of a pleasant, and other settings, we’re excited about the potential to bring a meaningful new option to patients with these two devastating conditions.
Speaker #3: Rocatinib will return to our partners at Kioakirin who will assume full ownership of the program. Turning to oncology, in November, the FDA granted full approval to Imdeltra for the treatment of adult patients with extensive stage small cell lung cancer.
We are also advancing Daiso Dolly bed, our cd40 Lian targeting bio therapeutic with both phase 3 studies in shogun's disease now fully enrolled and study completion expected in the second half of 2026.
James Bradner: Turning to oncology, in November, the FDA granted full approval to Imdelltra for the treatment of adult patients with extensive stage small cell lung cancer, with disease progression on or after platinum-based chemotherapy. This approval represents a meaningful advancement for patients facing a disease that has seen very little innovation for decades. To extend the impact of Imdelltra, we are presently advancing this medicine as combination therapy in frontline extensive stage small cell, where we observed unprecedented survival in early phase clinical trials. Further, we are also advancing Imdelltra with an ongoing phase 3 study of limited stage small cell lung cancer. It's a joy to see Imdelltra, like Blincyto, becoming a standard of care in the management of advanced cancer. Our first-in-class, STEAP1-directed bispecific T-cell engager, Xaluritamig, continues to advance through phase 3 development in prostate cancer.
James Bradner: Turning to oncology, in November, the FDA granted full approval to Imdelltra for the treatment of adult patients with extensive stage small cell lung cancer, with disease progression on or after platinum-based chemotherapy. This approval represents a meaningful advancement for patients facing a disease that has seen very little innovation for decades. To extend the impact of Imdelltra, we are presently advancing this medicine as combination therapy in frontline extensive stage small cell, where we observed unprecedented survival in early phase clinical trials. Further, we are also advancing Imdelltra with an ongoing phase 3 study of limited stage small cell lung cancer. It's a joy to see Imdelltra, like Blincyto, becoming a standard of care in the management of advanced cancer. Our first-in-class, STEAP1-directed bispecific T-cell engager, Xaluritamig, continues to advance through phase 3 development in prostate cancer.
Speaker #3: With disease progression on or after platinum-based chemotherapy, this approval represents a meaningful advancement for patients facing a disease that has seen very little innovation for decades.
Jay Olson: This study in patients with primary discoid lupus erythematosus met both primary and key secondary endpoints with an attractive safety profile. Encouraged by these data, we are working to advance daxdilimab to the next phase of development in this setting. In inflammation, the Tezspire Phase III program continues to advance, with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, where we expect study completion in the second half of this year. We recently announced the decision to terminate the rocatinlimab development and commercialization collaboration with Kyowa Kirin. With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs. Rocatinlimab will return to our partners at Kyowa Kirin, who will assume full ownership of the program....
Jay Bradner: This study in patients with primary discoid lupus erythematosus met both primary and key secondary endpoints with an attractive safety profile. Encouraged by these data, we are working to advance daxdilimab to the next phase of development in this setting. In inflammation, the Tezspire Phase III program continues to advance, with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, where we expect study completion in the second half of this year. We recently announced the decision to terminate the rocatinlimab development and commercialization collaboration with Kyowa Kirin. With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs. Rocatinlimab will return to our partners at Kyowa Kirin, who will assume full ownership of the program....
Class: plasmacytoid dendritic cell depleting monoclonal antibodies targeting T7 for the immunoglobulin-like transcripts 7 protein.
Speaker #3: To extend the impact of Imdeltra, we are presently advancing this medicine as combination therapy in frontline extensive stage small cell where we observed unprecedented survival in early-phase clinical trials.
This study in patients with primary discoid lupus,
Encouraged by these data, we are working to advance Dax Dilla to the next phase of development in this setting.
Speaker #3: Further, we are also advancing Imdeltra with an ongoing Phase 3 study of limited stage small cell lung cancer. It's a joy to see Imdeltra likable in situ, becoming a standard of care in the management of advanced cancer.
An inflammation, the test by our Phase 3 program continues to advance with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, where we expect study completion in the second half of this year.
Speaker #3: Our first-in-class SteepOne-directed bispecific T-cell engager zalaritamide continues to advance through Phase 3 development in prostate cancer beyond prostate cancer. We have recently initiated a Phase 1B study in relapsed or refractory Ewing sarcoma, a rare malignancy with high SteepOne expression in patients in an urgent need for targeted therapy.
We recently announced the decision to terminate the Rocatinlimab development and commercialization collaboration with Kyowa Kirin.
James Bradner: Beyond prostate cancer, we have recently initiated a phase 1b study in relapsed or refractory Ewing sarcoma, a rare malignancy with high STEAP1 expression in patients in an urgent need for targeted therapy. Across Imdeltra, Blincyto, and Xaluritamig, we continue to see meaningful long-term impact from our bispecific T-cell engager platform. We remain committed to bringing transformative and innovative therapies like these to patients with cancer. To close out oncology, given the previously announced results from Fortitude 101 and Fortitude 102, we have decided not to pursue regulatory approval for Bemarituzumab, our FGFR2b targeting monoclonal antibody in first-line gastric cancer. Though overall efficacy did not meet our expectations, we observed an emerging signal of putative survival benefit in a subset of biomarker-defined patients. We expect to share these findings with the scientific community in the future.
James Bradner: Beyond prostate cancer, we have recently initiated a phase 1b study in relapsed or refractory Ewing sarcoma, a rare malignancy with high STEAP1 expression in patients in an urgent need for targeted therapy. Across Imdeltra, Blincyto, and Xaluritamig, we continue to see meaningful long-term impact from our bispecific T-cell engager platform. We remain committed to bringing transformative and innovative therapies like these to patients with cancer. To close out oncology, given the previously announced results from Fortitude 101 and Fortitude 102, we have decided not to pursue regulatory approval for Bemarituzumab, our FGFR2b targeting monoclonal antibody in first-line gastric cancer. Though overall efficacy did not meet our expectations, we observed an emerging signal of putative survival benefit in a subset of biomarker-defined patients. We expect to share these findings with the scientific community in the future.
With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs.
Rokat will return to our partners at Kyowa Kirin, who will assume full ownership of the program.
Jay Olson: Turning to oncology, in November, the FDA granted full approval to IMDELTRA for the treatment of adult patients with extensive-stage small cell lung cancer, with disease progression on or after platinum-based chemotherapy. This approval represents a meaningful advancement for patients facing a disease that has seen very little innovation for decades. To extend the impact of IMDELTRA, we are presently advancing this medicine as combination therapy in frontline extensive-stage small cell, where we observed unprecedented survival in early phase clinical trials. Further, we are also advancing IMDELTRA with an ongoing phase III study of limited-stage small cell lung cancer. It's a joy to see IMDELTRA, like BLINCITO, becoming a standard of care in the management of advanced cancer. Our first-in-class STEAP1-directed bispecific T-cell engager, Xaluritamig, continues to advance through phase III development in prostate cancer.
Jay Bradner: Turning to oncology, in November, the FDA granted full approval to IMDELTRA for the treatment of adult patients with extensive-stage small cell lung cancer, with disease progression on or after platinum-based chemotherapy. This approval represents a meaningful advancement for patients facing a disease that has seen very little innovation for decades. To extend the impact of IMDELTRA, we are presently advancing this medicine as combination therapy in frontline extensive-stage small cell, where we observed unprecedented survival in early phase clinical trials. Further, we are also advancing IMDELTRA with an ongoing phase III study of limited-stage small cell lung cancer. It's a joy to see IMDELTRA, like BLINCITO, becoming a standard of care in the management of advanced cancer. Our first-in-class STEAP1-directed bispecific T-cell engager, Xaluritamig, continues to advance through phase III development in prostate cancer.
Speaker #3: Across Imdeltra, Linzido, and zalaritamide, we continue to see meaningful long-term impact from our bispecific T-cell engager platform. We remain committed to bringing transformative and innovative therapies like these to patients with cancer.
Turning to oncology, in November the FDA granted full approval to IMDELTY, for the treatment of adult patients with extensive-stage small cell lung cancer, with disease progression on or after platinum-based chemotherapy.
Speaker #3: To close out oncology, given the previously announced results from Fortitude 101 and Fortitude 102, we have decided not to pursue regulatory approval for bumeratuzumab.
Disapproval represents a meaningful advancement for patients facing a disease that has seen very little innovation for decades.
Speaker #3: Our FGFR 2B targeting monoclonal antibody in first-line gastric cancer. Though overall efficacy did not meet our expectations, we observed an emerging signal of putative survival benefit in a subset of biomarker-defined patients.
To extend the impact of in Delta, we are presently advancing this medicine as combination therapy in frontline, extensive-stage small cell, where we observed unprecedented survival in early phase clinical trials.
Further, we are also advancing in Delta with an ongoing Phase 3 study of limited-stage small cell lung cancer.
Speaker #3: We expect to share these findings with the scientific community in the future. As with rocitinib, we took a portfolio decision to focus resources on our other late-stage programs.
It's a joy to see them delta-like blind Saito, becoming a standard of care in the management of advanced cancer.
James Bradner: As with rocatinlimab, we took a portfolio decision to focus resources on our other late-stage programs. Across biosimilars, both ABP 206 and ABP 234 biosimilar candidates to Opdivo and Keytruda, respectively, have completed enrollment in each of their comparative clinical studies, supporting continued progress of the next wave of our biosimilar portfolio. Before closing, as described in our press release, we are engaged in an ongoing dialogue with the FDA regarding TAVNEOS, our medicine for the treatment of a rare and severe disease, ANCA-associated vasculitis. We will update you on those discussions as necessary. Now, let me finish by saying that 2025 was a year of consistent execution, real scientific progress, and disciplined decision-making. We expect 2026 to bring another year of strong execution, disciplined data generation, and new scientific advances as we continue to progress our robust pipeline.
James Bradner: As with rocatinlimab, we took a portfolio decision to focus resources on our other late-stage programs. Across biosimilars, both ABP 206 and ABP 234 biosimilar candidates to Opdivo and Keytruda, respectively, have completed enrollment in each of their comparative clinical studies, supporting continued progress of the next wave of our biosimilar portfolio. Before closing, as described in our press release, we are engaged in an ongoing dialogue with the FDA regarding TAVNEOS, our medicine for the treatment of a rare and severe disease, ANCA-associated vasculitis. We will update you on those discussions as necessary. Now, let me finish by saying that 2025 was a year of consistent execution, real scientific progress, and disciplined decision-making. We expect 2026 to bring another year of strong execution, disciplined data generation, and new scientific advances as we continue to progress our robust pipeline.
Speaker #3: Across biosimilars, both ABP206 and ABP234 biosimilar candidates to Opdivo and Keytruda, respectively, have completed enrollment in each of their comparative clinical studies. Supporting continued progress of the next wave of our biosimilar portfolio.
Jay Olson: Beyond prostate cancer, we have recently initiated a Phase I B study in relapsed or refractory Ewing sarcoma, a rare malignancy with high STEAP1 expression in patients in an urgent need for targeted therapy. Across IMDELTRA, BLINCYTO, and Xaluritamig, we continue to see meaningful long-term impact from our bispecific T-cell engager platform. We remain committed to bringing transformative and innovative therapies like these to patients with cancer. To close out oncology, given the previously announced results from FORTITUDE-101 and FORTITUDE-102, we have decided not to pursue regulatory approval for Bemarituzumab, our FGFR2b-targeting monoclonal antibody in first-line gastric cancer. Though overall efficacy did not meet our expectations, we observed an emerging signal of putative survival benefit in a subset of biomarker-defined patients. We expect to share these findings with the scientific community in the future. As with rocatinlimab, we took a portfolio decision to focus resources on our other late-stage programs.
Jay Bradner: Beyond prostate cancer, we have recently initiated a Phase I B study in relapsed or refractory Ewing sarcoma, a rare malignancy with high STEAP1 expression in patients in an urgent need for targeted therapy. Across IMDELTRA, BLINCYTO, and Xaluritamig, we continue to see meaningful long-term impact from our bispecific T-cell engager platform. We remain committed to bringing transformative and innovative therapies like these to patients with cancer. To close out oncology, given the previously announced results from FORTITUDE-101 and FORTITUDE-102, we have decided not to pursue regulatory approval for Bemarituzumab, our FGFR2b-targeting monoclonal antibody in first-line gastric cancer. Though overall efficacy did not meet our expectations, we observed an emerging signal of putative survival benefit in a subset of biomarker-defined patients. We expect to share these findings with the scientific community in the future. As with rocatinlimab, we took a portfolio decision to focus resources on our other late-stage programs.
Our first in-class, step 1, directed by specific T-cell engager. Zeler continues to advance through Phase 3 development in prostate cancer.
Beyond prostate cancer, we have recently initiated a Phase 1b study in relapsed or refractory Ewing sarcoma, a rare malignancy with high STEAP1 expression and patients in urgent need of targeted therapy.
Speaker #3: Before closing, as described in our press release, we are engaged in an ongoing dialogue with the FDA regarding Tavnios. Our medicine for the treatment of a rare and severe disease ANCA-associated vasculitis.
Across in DELTA-blendo and X-ero2 to make. We continue to see meaningful long-term impacts from our bispecific T-cell engager platform.
Speaker #3: We will update you on those discussions as necessary. Now let me finish by saying the 2025 was a year of consistent execution, real decision-making.
We remain committed to bringing transformative and innovative therapies like these to patients with cancer.
Speaker #3: scientific progress, and disciplined We expect 2026 to bring another year of strong execution, disciplined data generation, and new scientific advances as we continue to progress our robust
To close out oncology given the previously announced results from 4 to 2 101 and 4 to 2 102. We have decided not to pursue regulatory approval for varitas map, our fgfr 2B targeting, monoclonal antibody in first-line, gastric cancer.
Speaker #1: The pipeline . I want to thank our colleagues across the for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases .
James Bradner: I want to thank our colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases. With a broad and deep pipeline, we are well positioned to deliver sustained long-term growth. I'll now turn it over to Murdo for the commercial update.
James Bradner: I want to thank our colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases. With a broad and deep pipeline, we are well positioned to deliver sustained long-term growth. I'll now turn it over to Murdo for the commercial update.
The overall efficacy did not meet our expectations. We observed an emerging signal of a potential survival benefit in a subset of biomarker-defined patients.
We expect to share these findings with the scientific community in the future.
Speaker #1: With a broad and deep pipeline , we are well positioned and their commitment to advancing innovative medicines for serious diseases with a broad and deep pipeline , we are well positioned to deliver sustained term long growth .
As with Roat, we took a portfolio decision to focus resources on our other late-stage programs.
Jay Olson: Across biosimilars, both ABP 206 and ABP 234 biosimilar candidates to Opdivo and Keytruda, respectively, have completed enrollment in each of their comparative clinical studies, supporting continued progress of the next wave of our biosimilar portfolio. Before closing, as described in our press release, we are engaged in an ongoing dialogue with the FDA regarding TAVNEOS, our medicine for the treatment of a rare and severe disease, ANCA-associated vasculitis. We will update you on those discussions as necessary. Now, let me finish by saying that 2025 was a year of consistent execution, real scientific progress, and disciplined decision-making. We expect 2026 to bring another year of strong execution, disciplined data generation, and new scientific advances as we continue to progress our robust pipeline. I want to thank our colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases.
Jay Bradner: Across biosimilars, both ABP 206 and ABP 234 biosimilar candidates to Opdivo and Keytruda, respectively, have completed enrollment in each of their comparative clinical studies, supporting continued progress of the next wave of our biosimilar portfolio. Before closing, as described in our press release, we are engaged in an ongoing dialogue with the FDA regarding TAVNEOS, our medicine for the treatment of a rare and severe disease, ANCA-associated vasculitis. We will update you on those discussions as necessary. Now, let me finish by saying that 2025 was a year of consistent execution, real scientific progress, and disciplined decision-making. We expect 2026 to bring another year of strong execution, disciplined data generation, and new scientific advances as we continue to progress our robust pipeline. I want to thank our colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases.
Murdo Gordon: Thanks very much, Jay. In 2025, we delivered 10% sales growth, with 13 products achieving double-digit or better performance. Fourteen products exceeded $1 billion in annual sales, and 18 products achieved record sales. These results underscore the strength and growth potential of our portfolio and demonstrate the disciplined execution of our teams serving patients globally. Starting with general medicine, Repatha sales grew 36% year-over-year in 2025, surpassing $3 billion. This performance was driven by growing urgency to treat patients in both secondary and primary prevention. Today, more than 100 million people around the world still need effective LDL cholesterol lowering, and Repatha remains the first and only PCSK9 inhibitor with outcomes data for patients in both high-risk primary and secondary prevention.
Murdo Gordon: Thanks very much, Jay. In 2025, we delivered 10% sales growth, with 13 products achieving double-digit or better performance. Fourteen products exceeded $1 billion in annual sales, and 18 products achieved record sales. These results underscore the strength and growth potential of our portfolio and demonstrate the disciplined execution of our teams serving patients globally. Starting with general medicine, Repatha sales grew 36% year-over-year in 2025, surpassing $3 billion. This performance was driven by growing urgency to treat patients in both secondary and primary prevention. Today, more than 100 million people around the world still need effective LDL cholesterol lowering, and Repatha remains the first and only PCSK9 inhibitor with outcomes data for patients in both high-risk primary and secondary prevention.
Speaker #1: I'll now turn it over to Murdo for the commercial update .
Speaker #2: Thanks .
Speaker #1: Very much , Jay .
Speaker #2: In 2025 , we delivered 10% sales growth with 13 products , double achieving digit or better performance . 14 products exceeded $1 billion in annual sales and achieved 18 products sales .
across biosimilars, both ABP 206 and ABP 234, biosimilar candidates to opdivo, and kru to respectively have completed enrollment in each of their comparative, clinical studies,
Supporting continued progress of the next wave of our biosimilar portfolio.
Speaker #2: These results underscore the strength and growth potential of our portfolio and demonstrate the disciplined execution of our teams serving patients globally . general Starting with medicine , Repatha sales grew 36% year over year in 2025 , surpassing $3 billion .
Before closing as described in our press release, we are engaged in an ongoing dialogue with the FDA regarding tabio. Our medicine for the treatment of a rare and severe disease. Anchor Associated vasculitis,
We will update you on those discussions as necessary.
Speaker #2: This performance was driven by growing urgency to treat patients in both secondary and primary prevention . Today , more than 100 million people around the world still need effective LDL cholesterol , lowering repatha remains the first and only inhibitor Pcsk9 with outcomes data for patients in both high risk primary and secondary prevention .
Now, let me finish by saying that 2025 was the year of consistent execution, real scientific progress, and disciplined decision-making. We expect 2026 to bring another year of strong execution, disciplined data generation, and new scientific advances as we continue to progress our robust pipeline.
I want to thank our colleagues across Amgen for their continued focus on patients.
Murdo Gordon: As Jay mentioned, the landmark VESALIUS-CV trial showed a reduction in the risk of first major cardiovascular events by 25% in high-risk patients. These data strengthen Repatha's position as the most evidence-backed therapy in the PCSK9 class and support this critical role in earlier and more intensive LDL cholesterol management. Given these results and our leadership in this category, we believe there's now a clear opportunity to update clinical guidelines and quality measures. We expect these changes will encourage cardiologists and primary care physicians to manage LDL cholesterol more proactively, alongside lifestyle modification, and reduce cardiovascular risk in both primary and secondary prevention. In the US, we continue to improve patient access to Repatha with broad formulary coverage and the launch of Amgen Now, our new direct-to-patient program. Amgen Now offers a simplified, lower-cost, cash pay option for patients to access Repatha.
Murdo Gordon: As Jay mentioned, the landmark VESALIUS-CV trial showed a reduction in the risk of first major cardiovascular events by 25% in high-risk patients. These data strengthen Repatha's position as the most evidence-backed therapy in the PCSK9 class and support this critical role in earlier and more intensive LDL cholesterol management. Given these results and our leadership in this category, we believe there's now a clear opportunity to update clinical guidelines and quality measures. We expect these changes will encourage cardiologists and primary care physicians to manage LDL cholesterol more proactively, alongside lifestyle modification, and reduce cardiovascular risk in both primary and secondary prevention. In the US, we continue to improve patient access to Repatha with broad formulary coverage and the launch of Amgen Now, our new direct-to-patient program. Amgen Now offers a simplified, lower-cost, cash pay option for patients to access Repatha.
Jay Olson: With a broad and deep pipeline, we are well-positioned to deliver sustained long-term growth. I'll now turn it over to Murdo for the commercial update.
Jay Bradner: With a broad and deep pipeline, we are well-positioned to deliver sustained long-term growth. I'll now turn it over to Murdo for the commercial update.
And their commitment to advancing innovative medicines for serious diseases.
Speaker #2: As Jay mentioned , the landmark Vesalius CV showed a reduction in the risk of first major cardiovascular events by 25% in high risk patients .
Murdo Gordon: Thanks very much, Jay. In 2025, we delivered 10% sales growth, with 13 products achieving double-digit or better performance. 14 products exceeded $1 billion in annual sales, and 18 products achieved record sales. These results underscore the strength and growth potential of our portfolio and demonstrate the disciplined execution of our teams serving patients globally. Starting with general medicine, REPATHA sales grew 36% year-over-year in 2025, surpassing $3 billion. This performance was driven by growing urgency to treat patients in both secondary and primary prevention. Today, more than 100 million people around the world still need effective LDL cholesterol lowering, and REPATHA remains the first and only PCSK9 inhibitor with outcomes data for patients in both high-risk primary and secondary prevention.
Murdo Gordon: Thanks very much, Jay. In 2025, we delivered 10% sales growth, with 13 products achieving double-digit or better performance. 14 products exceeded $1 billion in annual sales, and 18 products achieved record sales. These results underscore the strength and growth potential of our portfolio and demonstrate the disciplined execution of our teams serving patients globally. Starting with general medicine, REPATHA sales grew 36% year-over-year in 2025, surpassing $3 billion. This performance was driven by growing urgency to treat patients in both secondary and primary prevention. Today, more than 100 million people around the world still need effective LDL cholesterol lowering, and REPATHA remains the first and only PCSK9 inhibitor with outcomes data for patients in both high-risk primary and secondary prevention.
With a broad ME pipeline, we are well positioned to deliver sustained long-term growth. I'll now turn it over to Murdo for the commercial update.
Speaker #2: These data strengthen Rapadas position as the most evidence backed therapy in the Pcsk9 class , and support this critical role in earlier and more intensive LDL cholesterol management .
Speaker #2: Given these and our results leadership in this category , we believe there's now a clear opportunity to update clinical guidelines and quality measures .
Thanks very much. In 2025, we delivered 10% sales growth with 13 products, achieving double-digit or better performance in 14 products. We surpassed $1 billion in annual sales, and 18 products achieved record sales. These results underscore the strength and growth potential of our portfolio and demonstrate the disciplined execution of our teams serving patients globally.
Speaker #2: We expect these changes will encourage cardiologists and primary care physicians to manage LDL cholesterol more proactively , alongside lifestyle modification and reduce cardiovascular both risk in primary and prevention secondary .
6% year-over-year in 2025, surpassing $3 billion. This performance was driven by growing urgency to treat patients in both secondary and primary prevention.
Today more than a 100 million people around the world. Still need effective LDL cholesterol luring.
Speaker #2: In the US , we continue to improve patient access to Repatha with broad formulary coverage and the launch of Amgen . Now , our new direct to patient program .
Murdo Gordon: Following a successful launch, we've announced plans to expand this program to additional medicines, and we're excited to make our therapies available through TrumpRx, helping improve affordability for Americans. Evenity sales increased 34% in 2025, reaching $2.1 billion in sales. Evenity remains the only treatment that simultaneously builds new bone and reduces bone resorption, a dual mechanism that is proven to rapidly reduce fracture risk in the post-menopausal women. In the US, Evenity sales grew 41%, driven by higher volumes from both established and new prescribers. Evenity leads the bone builder segment with over 60% market share and is now growing faster than the category overall. To date, approximately 300,000 US patients have been treated with Evenity, with a 33% increase of new patients in just one year.
Murdo Gordon: Following a successful launch, we've announced plans to expand this program to additional medicines, and we're excited to make our therapies available through TrumpRx, helping improve affordability for Americans. Evenity sales increased 34% in 2025, reaching $2.1 billion in sales. Evenity remains the only treatment that simultaneously builds new bone and reduces bone resorption, a dual mechanism that is proven to rapidly reduce fracture risk in the post-menopausal women. In the US, Evenity sales grew 41%, driven by higher volumes from both established and new prescribers. Evenity leads the bone builder segment with over 60% market share and is now growing faster than the category overall. To date, approximately 300,000 US patients have been treated with Evenity, with a 33% increase of new patients in just one year.
Murdo Gordon: As Jay mentioned, the landmark VESALIUS-CV trial showed a reduction in the risk of first major cardiovascular events by 25% in high-risk patients. These data strengthen REPATHA's position as the most evidence-backed therapy in the PCSK9 class, and support this critical role in earlier and more intensive LDL cholesterol management. Given these results and our leadership in this category, we believe there's now a clear opportunity to update clinical guidelines and quality measures. We expect these changes will encourage cardiologists and primary care physicians to manage LDL cholesterol more proactively, alongside lifestyle modification, and reduce cardiovascular risk in both primary and secondary prevention. In the US, we continue to improve patient access to REPATHA with broad formulary coverage and the launch of Amgen Now, our new direct-to-patient program. Amgen Now offers a simplified, lower-cost, cash pay option for patients to access REPATHA.
Murdo Gordon: As Jay mentioned, the landmark VESALIUS-CV trial showed a reduction in the risk of first major cardiovascular events by 25% in high-risk patients. These data strengthen REPATHA's position as the most evidence-backed therapy in the PCSK9 class, and support this critical role in earlier and more intensive LDL cholesterol management. Given these results and our leadership in this category, we believe there's now a clear opportunity to update clinical guidelines and quality measures. We expect these changes will encourage cardiologists and primary care physicians to manage LDL cholesterol more proactively, alongside lifestyle modification, and reduce cardiovascular risk in both primary and secondary prevention. In the US, we continue to improve patient access to REPATHA with broad formulary coverage and the launch of Amgen Now, our new direct-to-patient program. Amgen Now offers a simplified, lower-cost, cash pay option for patients to access REPATHA.
And repatha Remains the first and only pcsk9 inhibitor with outcomes data for patients in both high-risk primary and secondary prevention.
Speaker #2: Amgen now offers a simplified , lower cost cash pay option for patients to access Repatha following a successful launch . We've announced plans to expand this program to additional medicines , and we're excited to make our therapies available through Trump RX , helping improve affordability for Americans .
as Jane mentioned, the landmark viselia CV trial showed a reduction in the risk of first major cardiovascular events by 25%, in high-risk patients,
These data strength and repatha position is the most evidence-backed therapy in the pcsk9 class.
Speaker #2: Affinity sales increased 34% in 2025 , reaching $2.1 billion in sales . Affinity remains the only treatment that simultaneously builds bone new and reduces bone resorption .
And support this critical role in earlier and more intensive LDL cholesterol management.
Speaker #2: A dual mechanism that is proven to rapidly reduce fracture risk in postmenopausal women in the US , the vanity sales grew 41% , driven by higher volumes from both established and new prescribers .
Given these results and our leadership in this category, we believe there's now a clear opportunity to update clinical guidelines and quality measures.
We expect these changes will encourage cardiologists. And primary care. Physicians to manage LDL cholesterol. More proactively.
Speaker #2: Evenity leads the Bone Builder segment with over 60% market share , and is now growing . Faster than the category overall to date , approximately 300,000 US patients have been treated with affinity , with a 33% increase of new patients in just one year , increased investment has helped accelerate this growth , which we expect to continue despite strong progress .
Alongside lifestyle modification and reduce cardiovascular risk in both primary and secondary prevention.
Murdo Gordon: Increased investment has helped accelerate this growth, which we expect to continue. Despite strong progress, nearly 90% of the 2 million women at very high risk of fracture remain untreated, presenting a clear opportunity for Evenity to drive growth and impact. Prolia delivered $4.4 billion in sales in 2025, an increase of 1% year-over-year. In 2026, we expect accelerated sales erosion, driven by increased competition as multiple biosimilars have launched globally. Our rare disease portfolio grew 14% year-over-year to nearly $5.2 billion and 19% in the quarter, with strong performance across the portfolio. Uplizna sales increased 73% year-over-year to $655 million, reflecting growing patient demand across all three approved indications.
Murdo Gordon: Increased investment has helped accelerate this growth, which we expect to continue. Despite strong progress, nearly 90% of the 2 million women at very high risk of fracture remain untreated, presenting a clear opportunity for Evenity to drive growth and impact. Prolia delivered $4.4 billion in sales in 2025, an increase of 1% year-over-year. In 2026, we expect accelerated sales erosion, driven by increased competition as multiple biosimilars have launched globally. Our rare disease portfolio grew 14% year-over-year to nearly $5.2 billion and 19% in the quarter, with strong performance across the portfolio. Uplizna sales increased 73% year-over-year to $655 million, reflecting growing patient demand across all three approved indications.
In the US, we continue to improve patient access to Repatha with broad formulary coverage and the launch of Amgen. Now, our new direct-to-patient program.
Murdo Gordon: Following a successful launch, we've announced plans to expand this program to additional medicines, and we're excited to make our therapies available through Trump Rx, helping improve affordability for Americans. EVENITY sales increased 34% in 2025, reaching $2.1 billion in sales. EVENITY remains the only treatment that simultaneously builds new bone and reduces bone resorption, a dual mechanism that is proven to rapidly reduce fracture risk in postmenopausal women. In the US, EVENITY sales grew 41%, driven by higher volumes from both established and new prescribers. EVENITY leads the bone builder segment with over 60% market share, and is now growing faster than the category overall. To date, approximately 300,000 US patients have been treated with EVENITY, with a 33% increase of new patients in just one year. Increased investment has helped accelerate this growth, which we expect to continue.
Murdo Gordon: Following a successful launch, we've announced plans to expand this program to additional medicines, and we're excited to make our therapies available through Trump Rx, helping improve affordability for Americans. EVENITY sales increased 34% in 2025, reaching $2.1 billion in sales. EVENITY remains the only treatment that simultaneously builds new bone and reduces bone resorption, a dual mechanism that is proven to rapidly reduce fracture risk in postmenopausal women. In the US, EVENITY sales grew 41%, driven by higher volumes from both established and new prescribers. EVENITY leads the bone builder segment with over 60% market share, and is now growing faster than the category overall. To date, approximately 300,000 US patients have been treated with EVENITY, with a 33% increase of new patients in just one year. Increased investment has helped accelerate this growth, which we expect to continue.
And Amgen now offers a simplified, lower-cost cash pay option for patients to access Repatha.
Speaker #2: Nearly 90% of the 2 million women at very high risk of fracture remain untreated , presenting a clear opportunity for vanity to drive growth and impact .
Following a successful launch, we've announced plans to expand this program to additional medicines, and we're excited to make our therapies available through TRUMP.RX, helping improve affordability for Americans.
Speaker #2: Prolia delivered $4.4 billion in sales in 2025 , an increase of 1% year over year in accelerated 2026 . We sales , expect erosion driven by increased competition as multiple biosimilars have launched globally .
Speaker #2: disease Our rare portfolio grew 14% year over year to nearly $5.2 billion and 19% in the quarter , with strong performance across the portfolio , we sales increased 73% year over year to $655 million , reflecting growing patient demand across all three approved indications .
If entity sales, increase 34% in 2025, reaching 2.1 billion dollars in sales. If anything Remains the only treatment that simultaneously builds new bone and reduces bone resorption. A dual mechanism that is proven to rapidly reduce fracture risk in the post-menopausal women.
In the U.S., Otezla sales grew 41%, driven by higher volumes from both established and new prescribers.
Murdo Gordon: In December, Uplizna received FDA approval for the treatment of generalized myasthenia gravis, marking an important milestone for patients with this chronic debilitating disease. Early physician response has been strong across both bio-naive and switch patients. Prescribers have noted the benefits of Uplizna's upstream B-cell mechanism, targeting the root cause of the disease, and it also has demonstrated safety profile and the convenience of its twice-yearly dosing. Uptake of Uplizna for use in IgG4-related disease continues to grow. Since the launch in the US, nearly 500 specialists, including rheumatologists, gastroenterologists, among others, have prescribed Uplizna. In addition to the more recent launches, Uplizna continues to lead in NMOSD and remains the most prescribed FDA-approved therapy in the US for this condition, supported by consistent new patient growth and strong adherence across treatment cycles.
Murdo Gordon: In December, Uplizna received FDA approval for the treatment of generalized myasthenia gravis, marking an important milestone for patients with this chronic debilitating disease. Early physician response has been strong across both bio-naive and switch patients. Prescribers have noted the benefits of Uplizna's upstream B-cell mechanism, targeting the root cause of the disease, and it also has demonstrated safety profile and the convenience of its twice-yearly dosing. Uptake of Uplizna for use in IgG4-related disease continues to grow. Since the launch in the US, nearly 500 specialists, including rheumatologists, gastroenterologists, among others, have prescribed Uplizna. In addition to the more recent launches, Uplizna continues to lead in NMOSD and remains the most prescribed FDA-approved therapy in the US for this condition, supported by consistent new patient growth and strong adherence across treatment cycles.
Evenity leads the bone builder segment with over 60% market share, and is now growing faster than the category overall.
Speaker #2: In December , a prisoner received FDA approval for the treatment of generalized myasthenia gravis , marking an important milestone for patients . With this chronic , debilitating disease , our physician response has been strong across both bio naive and switch patient's prescribers have noted the benefits of uplizna upstream B cell mechanism targeting the root cause of the disease and its also , it's demonstrated safety profile and the convenience of his twice yearly dosing uptake of a plasma for use in IgG4 related disease continues to grow .
To date, approximately 300,000 US patients have been treated with Otezla, with a 33% increase in new patients in just one year.
Murdo Gordon: Despite strong progress, nearly 90% of the 2 million women at very high risk of fracture remain untreated, presenting a clear opportunity for Evenity to drive growth and impact. Prolia delivered $4.4 billion in sales in 2025, an increase of 1% year-over-year. In 2026, we expect accelerated sales erosion, driven by increased competition as multiple biosimilars have launched globally. Our rare disease portfolio grew 14% year-over-year to nearly $5.2 billion and 19% in the quarter, with strong performance across the portfolio. Uplizna sales increased 73% year-over-year to $655 million, reflecting growing patient demand across all three approved indications. In December, Uplizna received FDA approval for the treatment of generalized myasthenia gravis, marking an important milestone for patients with this chronic, debilitating disease.
Murdo Gordon: Despite strong progress, nearly 90% of the 2 million women at very high risk of fracture remain untreated, presenting a clear opportunity for Evenity to drive growth and impact. Prolia delivered $4.4 billion in sales in 2025, an increase of 1% year-over-year. In 2026, we expect accelerated sales erosion, driven by increased competition as multiple biosimilars have launched globally. Our rare disease portfolio grew 14% year-over-year to nearly $5.2 billion and 19% in the quarter, with strong performance across the portfolio. UPLIZNA sales increased 73% year-over-year to $655 million, reflecting growing patient demand across all three approved indications. In December, UPLIZNA received FDA approval for the treatment of generalized myasthenia gravis, marking an important milestone for patients with this chronic, debilitating disease.
Increase investment has helped accelerate this growth which we expect to continue.
Despite strong progress, nearly 90% of the 2 million women at very high risk of fracture remain untreated, presenting a clear opportunity for Vani to drive growth and impact.
Chronia delivered $4.4 billion in sales in 2025, an increase of 1% year-over-year.
Speaker #2: Since the launch in the US , nearly 500 specialists , including rheumatologists , gastroenterologists , among others , have prescribed uplizna in addition to the more recent launches of Uplizna , continues to lead in Nmosd and remains the most prescribed FDA approved therapy in the US .
In 2026, we expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally.
Speaker #2: For this condition . Supported by consistent new patient growth and strong adherence across treatment cycles , Pepega grew 3% to $1.9 billion in 2025 , driven by higher net selling price over 25,000 patients have received treatment since launch in the US , with growing interest from both new and returning prescribers .
Murdo Gordon: Tepezza grew 3% to $1.9 billion in 2025, driven by higher net selling price. Over 25,000 patients have received treatment since launch in the US, with growing interest from both new and returning prescribers. We continue to see increased prescribing by endocrinologists and a broadening base of specialists. In Japan, approximately 1,200 patients have been treated since launch, reflecting growing awareness of the burden of thyroid eye disease among both patients and prescribers. We plan to launch Tepezza in additional markets in 2026, expanding access to this important therapy globally. Tavneos sales were $459 million in 2025, an increase of 62% year-over-year, driven by strong volume growth.
Murdo Gordon: Tepezza grew 3% to $1.9 billion in 2025, driven by higher net selling price. Over 25,000 patients have received treatment since launch in the US, with growing interest from both new and returning prescribers. We continue to see increased prescribing by endocrinologists and a broadening base of specialists. In Japan, approximately 1,200 patients have been treated since launch, reflecting growing awareness of the burden of thyroid eye disease among both patients and prescribers. We plan to launch Tepezza in additional markets in 2026, expanding access to this important therapy globally. Tavneos sales were $459 million in 2025, an increase of 62% year-over-year, driven by strong volume growth.
Our rare disease portfolio grew 14% year-over-year to nearly $5.2 billion, and 19% in the quarter, with strong performance across the portfolio.
The business sales increased 73% year-over-year to $655 million, reflecting growing patient demand across all three approved indications.
Murdo Gordon: Early physician response has been strong across both bio-naive and switch patients. Prescribers have noted the benefits of Uplizna's upstream B-cell mechanism, targeting the root cause of the disease, and it also has demonstrated safety profile and the convenience of its twice-yearly dosing. Uptake of Uplizna for use in IgG4-related disease continues to grow. Since the launch in the US, nearly 500 specialists, including rheumatologists, gastroenterologists, among others, have prescribed Uplizna. In addition to the more recent launches, Uplizna continues to lead in NMOSD, and remains the most prescribed FDA-approved therapy in the US for this condition, supported by consistent new patient growth and strong adherence across treatment cycles. TEPEZZA grew 3% to $1.9 billion in 2025, driven by higher net selling price. Over 25,000 patients have received treatment since launch in the US, with growing interest from both new and returning prescribers.
Murdo Gordon: Early physician response has been strong across both bio-naive and switch patients. Prescribers have noted the benefits of UPLIZNA's upstream B-cell mechanism, targeting the root cause of the disease, and it also has demonstrated safety profile and the convenience of its twice-yearly dosing. Uptake of UPLIZNA for use in IgG4-related disease continues to grow. Since the launch in the US, nearly 500 specialists, including rheumatologists, gastroenterologists, among others, have prescribed UPLIZNA. In addition to the more recent launches, UPLIZNA continues to lead in NMOSD, and remains the most prescribed FDA-approved therapy in the US for this condition, supported by consistent new patient growth and strong adherence across treatment cycles. TEPEZZA grew 3% to $1.9 billion in 2025, driven by higher net selling price. Over 25,000 patients have received treatment since launch in the US, with growing interest from both new and returning prescribers.
In December, a prisoner received FDA approval for the treatment of generalized myasthenia gravis, marking an important milestone for patients with this chronic, debilitating disease.
Speaker #2: We continue to see increased prescribing by endocrinologists and a broadening base of in Japan . specialists Approximately 1200 patients have been treated since launch , reflecting growing awareness of the burden of thyroid eye disease both among and prescribers patients .
Early physician response has been strong across both bio-naive and switch patients.
Speaker #2: plan to launch Tepsa . We In additional markets in 2026 , expanding access to this important therapy globally . Tavneos sales were $459 million in 2025 , an increase of 62% year over year , driven by strong volume growth more 7000 patients than with Anca associated vasculitis have now been treated with tavneos , with over 4000 healthcare professionals prescribing the therapy since its launch in 2021 , Anca associated vasculitis is a serious , potentially life threatening disease that can cause significant organ damage .
Prescribers have noted the benefits of a PrOsigna's upstream MOA, mechanism targeting the root cause of the disease. And also its demonstrated safety profile, and the convenience of its twice-yearly dosing.
Murdo Gordon: More than 7,000 patients with ANCA-associated vasculitis have now been treated with TAVNEOS, with over 4,000 healthcare professionals prescribing the therapy since its launch in 2021. ANCA-associated vasculitis is a serious, potentially life-threatening disease that can cause significant organ damage, if not well controlled, and has limited therapeutic options. We remain confident that TAVNEOS is an important and effective medicine based on clinical data, real-world evidence, and its favorable benefit-risk profile. In inflammation, TEZSPIRE sales grew 52% year-over-year to nearly $1.5 billion for the full year. TEZSPIRE is well-positioned to reach more patients in the United States due to its differentiated TSLP mechanism that targets multiple inflammatory pathways, driving severe uncontrolled asthma, including in those with coexisting chronic rhinosinusitis with rhinosinusitis with nasal polyps. TEZSPIRE substantially reduced the need for surgery in this population, reinforcing its value in eosinophilic disease.
Murdo Gordon: More than 7,000 patients with ANCA-associated vasculitis have now been treated with TAVNEOS, with over 4,000 healthcare professionals prescribing the therapy since its launch in 2021. ANCA-associated vasculitis is a serious, potentially life-threatening disease that can cause significant organ damage, if not well controlled, and has limited therapeutic options. We remain confident that TAVNEOS is an important and effective medicine based on clinical data, real-world evidence, and its favorable benefit-risk profile. In inflammation, TEZSPIRE sales grew 52% year-over-year to nearly $1.5 billion for the full year. TEZSPIRE is well-positioned to reach more patients in the United States due to its differentiated TSLP mechanism that targets multiple inflammatory pathways, driving severe uncontrolled asthma, including in those with coexisting chronic rhinosinusitis with rhinosinusitis with nasal polyps. TEZSPIRE substantially reduced the need for surgery in this population, reinforcing its value in eosinophilic disease.
Uptake of a prescriber for use in IgG4-related disease continues to grow since the launch in the US. Nearly 500 specialists, including rheumatologists, gastroenterologists, among others, have prescribed Plasma.
In addition to the more recent launches, Plasma continues to lead in NMOSD and remains the most prescribed, FDA-approved therapy in the US for this condition, supported by consistent new patient growth and strong adherence across treatment cycles.
Speaker #2: If not well and controlled limited therapeutic options . We remain confident that Tavneos is an important and effective medicine based on clinical data , real world evidence and its favorable benefit risk profile in inflammation test by our sales grew 52% year over year to $1.5 billion for the full year nearly test buyers .
Murdo Gordon: We continue to see increased prescribing by endocrinologists and a broadening base of specialists. In Japan, approximately 1,200 patients have been treated since launch, reflecting growing awareness of the burden of thyroid eye disease among both patients and prescribers. We plan to launch TEPEZZA in additional markets in 2026, expanding access to this important therapy globally. TAVNEOS sales were $459 million in 2025, an increase of 62% year over year, driven by strong volume growth. More than 7,000 patients with ANCA-associated vasculitis have now been treated with TAVNEOS, with over 4,000 healthcare professionals prescribing the therapy since its launch in 2021. ANCA-associated vasculitis is a serious, potentially life-threatening disease that can cause significant organ damage, if not well controlled, and has limited therapeutic options.
Murdo Gordon: We continue to see increased prescribing by endocrinologists and a broadening base of specialists. In Japan, approximately 1,200 patients have been treated since launch, reflecting growing awareness of the burden of thyroid eye disease among both patients and prescribers. We plan to launch TEPEZZA in additional markets in 2026, expanding access to this important therapy globally. TAVNEOS sales were $459 million in 2025, an increase of 62% year over year, driven by strong volume growth. More than 7,000 patients with ANCA-associated vasculitis have now been treated with TAVNEOS, with over 4,000 healthcare professionals prescribing the therapy since its launch in 2021. ANCA-associated vasculitis is a serious, potentially life-threatening disease that can cause significant organ damage, if not well controlled, and has limited therapeutic options.
100 patients have been treated since launch reflecting. Growing awareness of the burden of thyroid eye disease, among both patients and prescribers.
Speaker #2: positioned to reach more Well patients in the States due to United its differentiated tslp mechanism that targets multiple inflammatory pathways driving severe , uncontrolled asthma , including in those with coexisting chronic rhinosinusitis with with rhinosinusitis nasal polyps , tezspire substantially reduced the need for surgery in this population , reinforcing its value in eosinophilic disease .
We plan to launch to pezza an additional markets in 2026 expanding access to this important therapy globally.
Murdo Gordon: Tezspire is now the leading therapy for new-to-brand patients among allergists in severe uncontrolled asthma, fueled by strong prescriber confidence and continued expansion across respiratory specialties. Otezla sales increased 7% year-over-year to nearly $2.3 billion for 2026. We expect sales erosion driven by unfavorable pricing in the US and generic launches, particularly in the EU. Our innovative oncology portfolio, which includes Blincyto, Imdelltra, Lumakras, Vectibix, Kyprolis, Nplate, and Jextova, grew 11% year-over-year, generating $8.7 billion in full-year sales. Imdelltra delivered $627 million in full-year sales, fueled by strong clinical conviction and rapid adoption across care settings. Over 1,600 US sites now administer Imdelltra, with the majority of doses provided in the community setting.
Murdo Gordon: Tezspire is now the leading therapy for new-to-brand patients among allergists in severe uncontrolled asthma, fueled by strong prescriber confidence and continued expansion across respiratory specialties. Otezla sales increased 7% year-over-year to nearly $2.3 billion for 2026. We expect sales erosion driven by unfavorable pricing in the US and generic launches, particularly in the EU. Our innovative oncology portfolio, which includes Blincyto, Imdelltra, Lumakras, Vectibix, Kyprolis, Nplate, and Jextova, grew 11% year-over-year, generating $8.7 billion in full-year sales. Imdelltra delivered $627 million in full-year sales, fueled by strong clinical conviction and rapid adoption across care settings. Over 1,600 US sites now administer Imdelltra, with the majority of doses provided in the community setting.
Speaker #2: now the leading Tezspire is therapy for new to brand patients amongst allergists uncontrolled asthma fueled by strong prescriber confidence and continued expansion across respiratory specialties .
Tabio sales were $459 million in 2025, an increase of 62% year-over-year, driven by strong volume growth. More than 7,000 patients with ANCA-associated vasculitis have now been treated with Tabio, with over 4,000 healthcare professionals prescribing the therapy since its launch in 2021.
Speaker #2: sales Otezla increased 7% year over year to nearly $2.3 billion for 2026 , we expect sales erosion driven by unfavorable pricing in the US and generic launches , particularly in the EU .
Murdo Gordon: We remain confident that TAVNEOS is an important and effective medicine based on clinical data, real-world evidence, and its favorable benefit-risk profile. In inflammation, TEZSPIRE sales grew 52% year-over-year to nearly $1.5 billion for the full year. TEZSPIRE is well-positioned to reach more patients in the United States due to its differentiated TSLP mechanism that targets multiple inflammatory pathways, driving severe uncontrolled asthma, including in those with coexisting chronic rhinosinusitis with nasal polyps. TEZSPIRE substantially reduced the need for surgery in this population, reinforcing its value in eosinophilic disease. TEZSPIRE is now the leading therapy for new-to-brand patients amongst allergists in severe uncontrolled asthma, fueled by strong prescriber confidence and continued expansion across respiratory specialties. Otezla sales increased 7% year-over-year to nearly $2.3 billion for 2026.
Murdo Gordon: We remain confident that TAVNEOS is an important and effective medicine based on clinical data, real-world evidence, and its favorable benefit-risk profile. In inflammation, TEZSPIRE sales grew 52% year-over-year to nearly $1.5 billion for the full year. TEZSPIRE is well-positioned to reach more patients in the United States due to its differentiated TSLP mechanism that targets multiple inflammatory pathways, driving severe uncontrolled asthma, including in those with coexisting chronic rhinosinusitis with nasal polyps. TEZSPIRE substantially reduced the need for surgery in this population, reinforcing its value in eosinophilic disease. TEZSPIRE is now the leading therapy for new-to-brand patients amongst allergists in severe uncontrolled asthma, fueled by strong prescriber confidence and continued expansion across respiratory specialties. Otezla sales increased 7% year-over-year to nearly $2.3 billion for 2026.
Anchor-associated vasculitis is a serious, potentially life-threatening disease that can cause significant organ damage if not well controlled and has limited therapeutic options.
Speaker #2: Our innovative oncology which includes Blincyto portfolio , and Lumakras , Vectibix , Nplate 11% year over Kyprolis , and grew Xgeva , year , generating $8.7 billion in full year sales in Delta delivered $627 million in full year sales , fueled by strong clinical conviction and rapid adoption across care settings .
We remain confident that Tavneos is an important and effective medicine, based on clinical data, real-world evidence, and its favorable benefit-risk profile.
Murdo Gordon: Imdelltra was granted full FDA approval in Q4, supported by compelling data from the Phase 3 DeLLphi-304 trial. NCCN guidelines also recognize Imdelltra as the highest recommended therapy, and it has become the standard of care in the second-line setting, reinforcing its leadership position in small cell lung cancer. Blincyto grew 28% year-over-year to over $1.5 billion in full year sales, driven by broad prescribing across both academic and community settings. Blincyto is widely recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome negative B-cell ALL. Our biosimilar portfolio delivered another strong year, with sales increasing 37% to $3 billion. Our expanding biosimilar portfolio provides meaningful top-line growth, durable cash flow, and broad patient access to high-quality, cost-saving biologic medicines.
Murdo Gordon: Imdelltra was granted full FDA approval in Q4, supported by compelling data from the Phase 3 DeLLphi-304 trial. NCCN guidelines also recognize Imdelltra as the highest recommended therapy, and it has become the standard of care in the second-line setting, reinforcing its leadership position in small cell lung cancer. Blincyto grew 28% year-over-year to over $1.5 billion in full year sales, driven by broad prescribing across both academic and community settings. Blincyto is widely recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome negative B-cell ALL. Our biosimilar portfolio delivered another strong year, with sales increasing 37% to $3 billion. Our expanding biosimilar portfolio provides meaningful top-line growth, durable cash flow, and broad patient access to high-quality, cost-saving biologic medicines.
Speaker #2: Over 1600 US sites now administer in Delta . With the majority of doses provided in the community setting . Imdelltra was granted full FDA approval in the fourth quarter , supported by compelling data from the phase Delphi three 304 trial .
In inflammation, test by our sales. Grew 52% year-over-year to nearly 1.5 billion dollars for the full year. Test buyers, well, positioned to reach more patients in the United States. Due to, its differentiated tslp mechanism, that targets multiple inflammatory Pathways driving severe uncontrolled asthma including in those with co-existing chronic rhinos with Nate rhinosinusitis with nasal bulbs.
Speaker #2: NCCN guidelines also recognize Imdelltra as the highest recommended and it has become the standard of care in the second line setting , reinforcing its leadership position in small cell lung cancer .
Test buyer, substantially reduced the need for surgery in this population, reinforcing its value in eosinophilic disease. Test buyer is now the leading therapy for new-to-brand patients amongst allergists in severe uncontrolled asthma.
Fueled by strong prescriber confidence, and continued expansion across respiratory specialties.
Murdo Gordon: We expect sales erosion driven by unfavorable pricing in the US and generic launches, particularly in the EU. Our innovative oncology portfolio, which includes BLINCYTO, IMDELTRA, LUMAKRAS, Vectibix, Kyprolis, Nplate, and XGEVA, grew 11% year-over-year, generating $8.7 billion in full-year sales. IMDELTRA delivered $627 million in full-year sales, fueled by strong clinical conviction and rapid adoption across care settings. Over 1,600 US sites now administer IMDELTRA, with the majority of doses provided in the community setting. IMDELTRA was granted full FDA approval in Q4, supported by compelling data from the Phase III DeLLphi-304 trial. NCCN guidelines also recognize IMDELTRA as the highest recommended therapy, and it has become the standard of care in the second-line setting, reinforcing its leadership position in small cell lung cancer.
Murdo Gordon: We expect sales erosion driven by unfavorable pricing in the US and generic launches, particularly in the EU. Our innovative oncology portfolio, which includes BLINCYTO, IMDELTRA, LUMAKRAS, Vectibix, KYPROLIS Nplate, and XGEVA, grew 11% year-over-year, generating $8.7 billion in full-year sales. IMDELTRA delivered $627 million in full-year sales, fueled by strong clinical conviction and rapid adoption across care settings. Over 1,600 US sites now administer IMDELTRA, with the majority of doses provided in the community setting. IMDELTRA was granted full FDA approval in Q4, supported by compelling data from the Phase III DeLLphi-304 trial. NCCN guidelines also recognize IMDELTRA as the highest recommended therapy, and it has become the standard of care in the second-line setting, reinforcing its leadership position in small cell lung cancer.
Speaker #2: Blincyto grew 28% year over year to over $1.5 billion in full year sales , driven by broad prescribing across both and segments academic community .
Oh, Tesla sales increased 7% year-over-year to nearly $2.3 billion for 2026. We expect sales erosion driven by unfavorable prices in the US and generic launches, particularly in the EU.
Speaker #2: Blincyto is widely recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome negative B-cell all our biosimilar portfolio delivered another strong year , with sales increasing 37% to $3 billion .
Our innovative Oncology portfolio, which includes Blincyto, Deltyv, Alunbrig, Kyprolis, Blate, and Ekstra, grew 11% year-over-year, generating $8.7 billion in full-year sales.
Speaker #2: Our expanding biosimilar portfolio provides meaningful top line growth , durable cash flow , and broad patient access to high quality , cost saving biologic medicines .
Deltro delivered $627 million in full-year sales, fueled by strong clinical conviction and rapid adoption across care settings.
Murdo Gordon: Pavblu, a biosimilar to EYLEA, continues to gain momentum, reaching $700 million in sales in 2025. Adoption continues to build among retina specialists who value the product's ready-to-use, prefilled syringe format and the reliability of Amgen's manufacturing and supply chain. We deliver strong results in 2025, with continued momentum across our priority growth brands, and we look forward to serving even more patients with Amgen products in 2026. Now I'd like to hand it over to Peter.
Murdo Gordon: Pavblu, a biosimilar to EYLEA, continues to gain momentum, reaching $700 million in sales in 2025. Adoption continues to build among retina specialists who value the product's ready-to-use, prefilled syringe format and the reliability of Amgen's manufacturing and supply chain. We deliver strong results in 2025, with continued momentum across our priority growth brands, and we look forward to serving even more patients with Amgen products in 2026. Now I'd like to hand it over to Peter.
Over 1,600 U.S. sites. Now administered in Delta, with the majority of doses provided in the community setting.
Speaker #2: Have a biosimilar to Eylea continues to gain momentum , reaching $700 million in sales in 2025 . Adoption continues to build among retina specialists who value the product's ready to use prefilled syringe format , and the reliability of amgen's manufacturing and supply chain .
In Delta was granted full FDA approval in the fourth quarter, supported by compelling data from the Phase 3 DEL 5304 trial.
Speaker #2: We delivered strong results in 2025 with continued momentum across our priority growth brands , and we look forward to serving even more patients with Amgen to Peter Now , I'd like products to hand it over in 2026 .
Murdo Gordon: BLINCYTO grew 28% year-over-year to over $1.5 billion in full-year sales, driven by broad prescribing across both academic and community settings. BLINCYTO is widely recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome negative B-cell ALL. Our biosimilar portfolio delivered another strong year, with sales increasing 37% to $3 billion. Our expanding biosimilar portfolio provides meaningful top-line growth, durable cash flow, and broad patient access to high-quality, cost-saving biologic medicines. PAVBLU, a biosimilar to Eylea, continues to gain momentum, reaching $700 million in sales in 2025. Adoption continues to build among retina specialists who value the product's ready-to-use, prefilled syringe format and the reliability of Amgen's manufacturing and supply chain.
Murdo Gordon: BLINCYTO grew 28% year-over-year to over $1.5 billion in full-year sales, driven by broad prescribing across both academic and community settings. BLINCYTO is widely recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome negative B-cell ALL. Our biosimilar portfolio delivered another strong year, with sales increasing 37% to $3 billion. Our expanding biosimilar portfolio provides meaningful top-line growth, durable cash flow, and broad patient access to high-quality, cost-saving biologic medicines. PAVBLU, a biosimilar to Eylea, continues to gain momentum, reaching $700 million in sales in 2025. Adoption continues to build among retina specialists who value the product's ready-to-use, prefilled syringe format and the reliability of Amgen's manufacturing and supply chain.
NCCN guidelines also recognize them Delta as the highest recommended therapy, and it has become the standard of care in the second-line setting, reinforcing its leadership position in small cell lung cancer.
Peter Griffith: Thank you, Murdo. We're pleased with our execution and performance in the Q4 and for the full year 2025, and we remain on track with our long-term objectives. The financial results are shown on slides 34 to 36 of the slide deck. Murdo's covered our strong revenue growth across the portfolio. For the full year, we delivered a non-GAAP operating margin of 46%. We continued to invest in advancing our pipeline, with non-GAAP R&D spending increased 22% year-over-year for the full year to a record $7.2 billion. This reflects increased spending on an unprecedented number of opportunities in our late-stage pipeline, including continued investments in MariTide, Otezla, Xaluritamig, and rare disease. In addition, we closed several business development transactions in the Q3 and Q4, resulting in roughly $300 million in incremental R&D spending.
Peter Griffith: Thank you, Murdo. We're pleased with our execution and performance in the Q4 and for the full year 2025, and we remain on track with our long-term objectives. The financial results are shown on slides 34 to 36 of the slide deck. Murdo's covered our strong revenue growth across the portfolio. For the full year, we delivered a non-GAAP operating margin of 46%. We continued to invest in advancing our pipeline, with non-GAAP R&D spending increased 22% year-over-year for the full year to a record $7.2 billion. This reflects increased spending on an unprecedented number of opportunities in our late-stage pipeline, including continued investments in MariTide, Otezla, Xaluritamig, and rare disease. In addition, we closed several business development transactions in the Q3 and Q4, resulting in roughly $300 million in incremental R&D spending.
Saito grew 28% year-over-year to over $1.5 billion in full-year sales, driven by broad prescribing across both academic and community segments.
Speaker #2: .
Speaker #3: Thank you . Murdo . We're pleased with our execution and in the fourth performance quarter . And for the full year 2025 . And we remain on track with our long term objectives .
Blinatumomab is widely recognized as a standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome-negative B-cell ALL.
Speaker #3: The financial results are shown on slide 34 to 36 of the slide deck . Is revenue strong Our covered . growth across the portfolio for the full year , we delivered a non-GAAP operating margin of 46% .
Our biosimilar portfolio delivered another strong year, with sales increasing 37% to $3 billion.
Speaker #3: We continued to invest in advancing our pipeline with non-GAAP R&D spending increased 22% year over year for the full year to a record $7.2 billion .
Our expanding biosimilar portfolio provides meaningful topline growth, durable cash flow, and broad patient access to high-quality, cost-saving biologic medicines.
Speaker #3: This reflects increased spending on an unprecedented number of opportunities in our late stage pipeline , including continued investments in merited Opus and Eurythmic , and rare disease .
Murdo Gordon: We delivered strong results in 2025, with continued momentum across our priority growth brands, and we look forward to serving even more patients with Amgen products in 2026. Now, I'd like to hand it over to Peter.
Murdo Gordon: We delivered strong results in 2025, with continued momentum across our priority growth brands, and we look forward to serving even more patients with Amgen products in 2026. Now, I'd like to hand it over to Peter.
Speaker #3: In addition , we closed several business development transactions in the third and fourth quarters , resulting in roughly $300 million in incremental R&D spending .
Have Blue, a biosimilar to Eylea, continues to gain momentum. Reaching $700 million in sales in 2025, adoption continues to build among retina specialists who value the product's ready-to-use pre-filled syringe format and the reliability of Amgen's manufacturing and supply chain.
Peter Griffith: Full-year non-GAAP other income and expense was $2.1 billion. We continued to strengthen our balance sheet with $6 billion of debt retired in 2025. Our non-GAAP tax rate increased 1.4 percentage points year over year to 15.9% for the full year, primarily due to changes in earnings mix. We generated $8.1 billion in free cash flow for the full year, reflecting operational momentum across the business and rigorous management of working capital, all while continuing to invest in innovation. We're leveraging AI across the value chain to accelerate therapeutic discovery and late-stage development, optimize manufacturing, and improve customer engagement, allowing us to drive productivity at speed and scale. We executed capital expenditures of $2.2 billion in 2025.
Peter Griffith: Full-year non-GAAP other income and expense was $2.1 billion. We continued to strengthen our balance sheet with $6 billion of debt retired in 2025. Our non-GAAP tax rate increased 1.4 percentage points year over year to 15.9% for the full year, primarily due to changes in earnings mix. We generated $8.1 billion in free cash flow for the full year, reflecting operational momentum across the business and rigorous management of working capital, all while continuing to invest in innovation. We're leveraging AI across the value chain to accelerate therapeutic discovery and late-stage development, optimize manufacturing, and improve customer engagement, allowing us to drive productivity at speed and scale. We executed capital expenditures of $2.2 billion in 2025.
Speaker #3: Full year non-GAAP other income and expense was $2.1 billion . We continued to strengthen our balance sheet with $6 billion of debt retired in 2025 .
Peter Griffith: Thank you, Murdo. We're pleased with our execution and performance in the fourth quarter and for the full year 2025, and we remain on track with our long-term objectives. The financial results are shown on slides 34 to 36 of the slide deck. Murdo's covered our strong revenue growth across the portfolio. For the full year, we delivered a non-GAAP operating margin of 46%. We continued to invest in advancing our pipeline, with non-GAAP R&D spending increased 22% year-over-year for the full year to a record $7.2 billion. This reflects increased spending on an unprecedented number of opportunities in our late-stage pipeline, including continued investments in MariTide, Olpasiran, Xaluritamig, and rare disease. In addition, we closed several business development transactions in the third and fourth quarters, resulting in roughly $300 million in incremental R&D spending.
Peter Griffith: Thank you, Murdo. We're pleased with our execution and performance in the fourth quarter and for the full year 2025, and we remain on track with our long-term objectives. The financial results are shown on slides 34 to 36 of the slide deck. Murdo's covered our strong revenue growth across the portfolio. For the full year, we delivered a non-GAAP operating margin of 46%. We continued to invest in advancing our pipeline, with non-GAAP R&D spending increased 22% year-over-year for the full year to a record $7.2 billion. This reflects increased spending on an unprecedented number of opportunities in our late-stage pipeline, including continued investments in MariTide, Olpasiran, Xaluritamig, and rare disease. In addition, we closed several business development transactions in the third and fourth quarters, resulting in roughly $300 million in incremental R&D spending.
We delivered strong results in 2025 with continued momentum across our priority growth brands, and we look forward to serving even more patients with Amgen products in 2026. Now, I'd like to hand it over to Peter.
Speaker #3: Our non-GAAP tax rate increased 1.4 percentage points year over year to 15.9% for the full year , primarily due to changes in earnings mix .
Thank you, Murdo. We're pleased with our execution and performance in the fourth quarter and for the full year 2025, and we remain on track with our long-term objectives. The financial results are shown on slides 34 to 36 of the slide deck.
Speaker #3: We generated $8.1 billion in free cash flow for the full year , reflecting operational momentum across the business and rigorous management of working capital , all while continuing to invest in innovation .
Speaker #3: We're leveraging AI across the value chain to accelerate therapeutic discovery , and late stage development , optimize manufacturing improve customer engagement , allowing us to drive productivity speed and at scale .
Peter Griffith: Our capital expenditures reflect significant investments across the United States, including Ohio, North Carolina, Puerto Rico, Rhode Island, and California, to support continued volume growth in our commercial brands and to prepare for pipeline product launches, including MariTide. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024. Let's turn to the 2026 outlook on slide 37. We expect our 2026 total revenues in the range of $37.0 billion to $38.4 billion, and non-GAAP earnings per share between $21.60 to $23. Our revenue range reflects continuing strong performance from our 6 key growth drivers, Repatha, Evenity, Tezspire, our rare disease, innovative oncology, and biosimilars portfolios, positioning 2026 as a springboard year for future growth.
Peter Griffith: Our capital expenditures reflect significant investments across the United States, including Ohio, North Carolina, Puerto Rico, Rhode Island, and California, to support continued volume growth in our commercial brands and to prepare for pipeline product launches, including MariTide. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024. Let's turn to the 2026 outlook on slide 37. We expect our 2026 total revenues in the range of $37.0 billion to $38.4 billion, and non-GAAP earnings per share between $21.60 to $23. Our revenue range reflects continuing strong performance from our 6 key growth drivers, Repatha, Evenity, Tezspire, our rare disease, innovative oncology, and biosimilars portfolios, positioning 2026 as a springboard year for future growth.
Speaker #3: executed We capital expenditures of $2.2 billion in 2025 . Our capital expenditures reflect significant investments States , including across the Ohio United , North Carolina , Puerto Rico , Rhode Island and California to support continued volume growth in our commercial brands to prepare for and pipeline product launches , including maritime .
Peter Griffith: Full-year non-GAAP other income and expense was $2.1 billion. We continued to strengthen our balance sheet with $6 billion of debt retired in 2025. Our non-GAAP tax rate increased 1.4 percentage points year-over-year to 15.9% for the full year, primarily due to changes in earnings mix. We generated $8.1 billion in free cash flow for the full year, reflecting operational momentum across the business and rigorous management of working capital, all while continuing to invest in innovation. We're leveraging AI across the value chain to accelerate therapeutic discovery and late-stage development, optimize manufacturing, and improve customer engagement, allowing us to drive productivity at speed and scale. We executed capital expenditures of $2.2 billion in 2025.
Peter Griffith: Full-year non-GAAP other income and expense was $2.1 billion. We continued to strengthen our balance sheet with $6 billion of debt retired in 2025. Our non-GAAP tax rate increased 1.4 percentage points year-over-year to 15.9% for the full year, primarily due to changes in earnings mix. We generated $8.1 billion in free cash flow for the full year, reflecting operational momentum across the business and rigorous management of working capital, all while continuing to invest in innovation. We're leveraging AI across the value chain to accelerate therapeutic discovery and late-stage development, optimize manufacturing, and improve customer engagement, allowing us to drive productivity at speed and scale. We executed capital expenditures of $2.2 billion in 2025.
Sansa, you’re ready to make and rare disease. In addition, we closed several business development transactions in the third and fourth quarters, resulting in roughly $100 million in incremental R&D spending,
Pulling your non-GAAP other income and expense, it was $2.1 billion. We continue to strengthen our balance sheet, with $6 billion of debt retired in 2025.
Speaker #3: addition , we returned In capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter , representing a 6% increase compared to 2024 .
Speaker #3: Let's turn to the 2026 outlook on slide 37 . We expect our 2026 total revenues in the range of 37.0 billion to 38.4 billion and non-GAAP earnings per share between $21.60 to $23 .
Our non-GAAP tax rate increased 1.4 percentage points year-over-year to 15.9% for the full year, primarily due to changes in earnings mix. We generated $8.1 billion in free cash flow for the full year, reflecting operational momentum across the business and rigorous management of working capital, all while continuing to invest in innovation.
Speaker #3: Our range revenue reflects continuing strong performance from our six key growth drivers . Repatha , affinity Tezspire , our rare disease , Innovative oncology and biosimilars portfolios .
We're leveraging AI across the value chain to accelerate therapeutic discovery and late-stage development, optimize manufacturing, and improve customer engagement, allowing us to drive productivity at speed and scale.
Peter Griffith: Our capital expenditures reflect significant investments across the United States, including Ohio, North Carolina, Puerto Rico, Rhode Island, and California, to support continued volume growth in our commercial brands and to prepare for pipeline product launches, including MariTide. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024. Let's turn to the 2026 outlook on slide 37. We expect our 2026 total revenues in the range of $37.0 billion to $38.4 billion, and non-GAAP earnings per share between $21.60 and $23. Our revenue range reflects continuing strong performance from our six key growth drivers: Repatha, EVENITY, TEZSPIRE, our rare disease, innovative oncology, and biosimilars portfolios, positioning 2026 as a springboard year for future growth.
Peter Griffith: Our capital expenditures reflect significant investments across the United States, including Ohio, North Carolina, Puerto Rico, Rhode Island, and California, to support continued volume growth in our commercial brands and to prepare for pipeline product launches, including MariTide. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024. Let's turn to the 2026 outlook on slide 37. We expect our 2026 total revenues in the range of $37.0 billion to $38.4 billion, and non-GAAP earnings per share between $21.60 and $23. Our revenue range reflects continuing strong performance from our six key growth drivers: Repatha, EVENITY, TEZSPIRE, our rare disease, innovative oncology, and biosimilars portfolios, positioning 2026 as a springboard year for future growth.
We executed capital expenditures of $2.2 billion in 2025.
Peter Griffith: We expect this growth in 2026 to more than offset anticipated declines from increased denosumab biosimilar competition, price declines for certain other products in 2026, and continued increases in 340B program utilization. As you model Q1 2026, consistent with historical trends tied to the annual United States health insurance cycle, we expect a seasonal headwind to sales driven by benefit plan changes, insurance reverifications, and higher patient co-pay obligations. We also expect Otezla and Enbrel to follow their historical pattern of lower sales in Q1 relative to subsequent quarters, and expect additional impact from denosumab biosimilar competition in Q1. Additionally, note that we saw roughly $250 million of inventory build in Q4 2025 that could potentially impact Q1 sales.
Peter Griffith: We expect this growth in 2026 to more than offset anticipated declines from increased denosumab biosimilar competition, price declines for certain other products in 2026, and continued increases in 340B program utilization. As you model Q1 2026, consistent with historical trends tied to the annual United States health insurance cycle, we expect a seasonal headwind to sales driven by benefit plan changes, insurance reverifications, and higher patient co-pay obligations. We also expect Otezla and Enbrel to follow their historical pattern of lower sales in Q1 relative to subsequent quarters, and expect additional impact from denosumab biosimilar competition in Q1. Additionally, note that we saw roughly $250 million of inventory build in Q4 2025 that could potentially impact Q1 sales.
Speaker #3: Positioning 2026 as a springboard year for future growth . We expect this growth in 2026 to more than offset anticipated declines from increased denosumab , biosimilar competition , price declines for certain other products in 2026 , and continued increases in 340 B program utilization .
Our capital expenditures reflect significant investments across the United States.
Including Ohio, North Carolina, Puerto Rico, Rhode Island, and California to support continued volume growth in our commercial brands, and to prepare for pipeline product launches, including maritime.
Speaker #3: model the As you first quarter of 2026 , consistent with historical trends tied to the annual United States insurance Health cycle , we expect a seasonal headwind to sales driven by benefit plan changes , insurance verifications , and higher patient copay obligations .
In addition, we return capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024.
Let's turn to the 2026 outlook on slide 37.
Speaker #3: We also expect Otezla and Enbrel to follow their historical pattern of lower sales in the first quarter . Relative to quarters , and subsequent expect additional from denosumab , biosimilar competition impact in Q1 note that we .
We expect our 2026 total revenues in the range of $37.0 billion to $38.4 billion, and non-GAAP earnings per share between $21.60 to $23.00.
Speaker #3: saw Additionally , roughly $250 million of inventory build in the fourth quarter of 2025 . That could potentially impact first quarter sales for total company revenues .
Peter Griffith: For total company revenues, we expect lower mid-single digit year-over-year growth in the first quarter. For the full year, we expect other revenue in the range of $1.6 to 1.8 billion, reflecting our commitment to investing in the best innovation, while also driving execution excellence, efficiency, and prioritization across the organization. We project the full-year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%. This guidance does not include any potential business development transactions that may occur throughout the year. We expect non-GAAP R&D expense to grow low single digits, excluding the roughly $300 million of business development transactions in 2025. We continue to execute 6 global Phase III clinical trials for MariTide, advance additional late-stage assets, and invest in the best innovation while maintaining disciplined resource allocation.
Peter Griffith: For total company revenues, we expect lower mid-single digit year-over-year growth in the first quarter. For the full year, we expect other revenue in the range of $1.6 to 1.8 billion, reflecting our commitment to investing in the best innovation, while also driving execution excellence, efficiency, and prioritization across the organization. We project the full-year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%. This guidance does not include any potential business development transactions that may occur throughout the year. We expect non-GAAP R&D expense to grow low single digits, excluding the roughly $300 million of business development transactions in 2025. We continue to execute 6 global Phase III clinical trials for MariTide, advance additional late-stage assets, and invest in the best innovation while maintaining disciplined resource allocation.
Peter Griffith: We expect this growth in 2026 to more than offset anticipated declines from increased denosumab biosimilar competition, price declines for certain other products in 2026, and continued increases in 340B program utilization. As you model Q1 2026, consistent with historical trends tied to the annual United States health insurance cycle, we expect a seasonal headwind to sales driven by benefit plan changes, insurance reverifications, and higher patient co-pay obligations. We also expect Otezla and Enbrel to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters, and expect additional impact from denosumab biosimilar competition in Q1. Additionally, note that we saw roughly $250 million of inventory build in Q4 2025 that could potentially impact first quarter sales.
Peter Griffith: We expect this growth in 2026 to more than offset anticipated declines from increased denosumab biosimilar competition, price declines for certain other products in 2026, and continued increases in 340B program utilization. As you model Q1 2026, consistent with historical trends tied to the annual United States health insurance cycle, we expect a seasonal headwind to sales driven by benefit plan changes, insurance reverifications, and higher patient co-pay obligations. We also expect Otezla and Enbrel to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters, and expect additional impact from denosumab biosimilar competition in Q1. Additionally, note that we saw roughly $250 million of inventory build in Q4 2025 that could potentially impact first quarter sales.
Our revenue range reflects continuing strong performance from our six key growth drivers: Repatha, Otezla, Enbrel, Prolia, EVENITY, and TEZSPIRE. Our rare disease, innovative oncology, and biosimilar portfolios position 2026 as a springboard year for future growth.
Speaker #3: We expect lower mid-single digit year over year growth in the first quarter . For the full year , we expect other revenue in the range of 1.6 to $1.8 billion , reflecting our commitment to investing in the best innovation .
We expect this growth in 2026 to more than offset anticipated declines from increased denosumab biosimilar competition.
Speaker #3: While while also driving execution excellence . Efficiency and prioritization across the organization . We project the full year non-GAAP operating margin as a percentage of product sales to be roughly 45 to 46% .
Price declines for certain other products in 2026 and continued increases in 340B program utilization.
Speaker #3: guidance does This not include any potential business development transactions that occur throughout the may year we expect non-GAAP R&D expense to grow low single digits , excluding the roughly $300 million of business development transactions 2025 .
As we model the first quarter of 2026, consistent with historical trends tied to the annual United States health insurance cycle, we expect a seasonal headwind to sales driven by benefit plan changes, insurance reverification, and higher patient co-pay obligations.
We also expect those, Tesla and Emerald, to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters, and expect additional impact from denosumab biosimilar competition in Q1.
Speaker #3: We in continue to execute global phase three clinical six trials for merited advance , additional late stage assets and invest in the best innovation while maintaining disciplined resource allocation in line with sales .
Peter Griffith: In line with lower product sales in the first quarter, we expect Q1 non-GAAP operating margin to be the lowest of the year and roughly the same as Q4 of 2025.
Peter Griffith: In line with lower product sales in the first quarter, we expect Q1 non-GAAP operating margin to be the lowest of the year and roughly the same as Q4 of 2025.
Peter Griffith: For total company revenues, we expect lower mid-single-digit year-over-year growth in Q1. For the full year, we expect other revenue in the range of $1.6 to 1.8 billion, reflecting our commitment to investing in the best innovation, while also driving execution excellence, efficiency, and prioritization across the organization. We project the full-year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%. This guidance does not include any potential business development transactions that may occur throughout the year. We expect non-GAAP R&D expense to grow low single digits, excluding the roughly $300 million of business development transactions in 2025. We continue to execute six global phase 3 clinical trials for MariTide, advance additional late-stage assets, and invest in the best innovation while maintaining disciplined resource allocation.
Peter Griffith: For total company revenues, we expect lower mid-single-digit year-over-year growth in Q1. For the full year, we expect other revenue in the range of $1.6 to 1.8 billion, reflecting our commitment to investing in the best innovation, while also driving execution excellence, efficiency, and prioritization across the organization. We project the full-year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%. This guidance does not include any potential business development transactions that may occur throughout the year. We expect non-GAAP R&D expense to grow low single digits, excluding the roughly $300 million of business development transactions in 2025. We continue to execute six global phase 3 clinical trials for MariTide, advance additional late-stage assets, and invest in the best innovation while maintaining disciplined resource allocation.
Additionally, note that we saw roughly $250 million of inventory builds in the fourth quarter of 2025 that could potentially impact first quarter sales.
Speaker #3: In the first quarter , product lower we expect Q1 non-GAAP operating margin to be the lowest of the year and roughly the same as Q4 of 2025 .
James Bradner: ... We anticipate non-GAAP other income and expense to be about $2.3 to 2.4 billion in 2026. We expect a non-GAAP tax rate of 16% to 17.5%. We expect share repurchases not to exceed $3 billion in 2026. We expect capital expenditures of about $2.6 billion in 2026. This is consistent with our capital allocation priority to invest in our business and scale manufacturing capacity for volume growth, including preparing for MariTide's launch. We remain focused on delivering sustained long-term growth and creating value for patients and shareholders by doing what we said we would do, advancing innovation in areas of high unmet medical need and maintaining rigorous financial discipline. I'm grateful to work with all of our colleagues worldwide in serving patients.
Peter Griffith: ... We anticipate non-GAAP other income and expense to be about $2.3 to 2.4 billion in 2026. We expect a non-GAAP tax rate of 16% to 17.5%. We expect share repurchases not to exceed $3 billion in 2026. We expect capital expenditures of about $2.6 billion in 2026. This is consistent with our capital allocation priority to invest in our business and scale manufacturing capacity for volume growth, including preparing for MariTide's launch. We remain focused on delivering sustained long-term growth and creating value for patients and shareholders by doing what we said we would do, advancing innovation in areas of high unmet medical need and maintaining rigorous financial discipline. I'm grateful to work with all of our colleagues worldwide in serving patients.
For total company revenues, we expect lower mid-single-digit year-over-year growth in the first quarter. For the full year, we expect Other Revenue in the range of $1.6 to $1.8 billion.
Speaker #3: We anticipate non-GAAP other income and expense to be about in We 2026 . 2.3 to $2.4 billion expect a non-GAAP tax rate of 16% to 17.5% .
Speaker #3: We share expect repurchases not to exceed $3 billion in 2026 . We expect capital of expenditures about $2.6 billion in 2026 . This is consistent with our capital allocation priority to invest in our business and scale manufacturing capacity for growth , volume including preparing for maritime launch .
Reflecting our commitment to investing in the best Innovation while other all while. Also driving execution, Excellence, efficiency and prioritization across the organization, we project the full year non-gaap operating margin, as a percentage of product sales to be roughly 45 to 46%.
This guidance does not include any potential business development transactions that may occur throughout the year.
Speaker #3: We remain focused on delivering sustained , long term growth in creating value for patients and shareholders . By doing what we said we would do , advancing innovation in areas of high unmet medical need and maintaining rigorous financial discipline .
We expect non-gaap R&D expenses to grow low, single digits, excluding the roughly million dollars of Business Development transactions in 2025.
James Bradner: This concludes the financial update, and now I'll hand it back to Bob for Q&A.
Peter Griffith: This concludes the financial update, and now I'll hand it back to Bob for Q&A.
Peter Griffith: In line with lower product sales in the first quarter, we expect Q1 non-GAAP operating margin to be the lowest of the year and roughly the same as Q4 of 2025.
Peter Griffith: In line with lower product sales in the first quarter, we expect Q1 non-GAAP operating margin to be the lowest of the year and roughly the same as Q4 of 2025.
We continue to execute six global phase 3 clinical trials for maritimes, advance additional late-stage assets, and invest in the best innovation while maintaining disciplined resource allocation.
Speaker #3: I'm grateful to work with all of our colleagues worldwide in serving patients . This concludes the financial update . And now I'll hand it back to Bob for Q&A .
Robert Bradway: Okay, thank you, Peter, and as I hope you all appreciate now, I think we ended 25 with our track record intact for having delivered against the objectives that we set for you at the beginning of the year, and we're determined to do the same now in 2026. So we're entering the year with momentum excited about what we see ahead. Let's open up the call to questions. Julianne, we'd be happy to entertain any of our callers now.
Robert Bradway: Okay, thank you, Peter, and as I hope you all appreciate now, I think we ended 25 with our track record intact for having delivered against the objectives that we set for you at the beginning of the year, and we're determined to do the same now in 2026. So we're entering the year with momentum excited about what we see ahead. Let's open up the call to questions. Julianne, we'd be happy to entertain any of our callers now.
Jay Olson: ... We anticipate non-GAAP other income and expense to be about $2.3 to 2.4 billion in 2026. We expect a non-GAAP tax rate of 16% to 17.5%. We expect share repurchases not to exceed $3 billion in 2026. We expect capital expenditures of about $2.6 billion in 2026. This is consistent with our capital allocation priority to invest in our business and scale manufacturing capacity for volume growth, including preparing for MariTide launch. We remain focused on delivering sustained long-term growth and creating value for patients and shareholders by doing what we said we would do, advancing innovation in areas of high unmet medical need and maintaining rigorous financial discipline. I'm grateful to work with all of our colleagues worldwide in serving patients.
Peter Griffith: We anticipate non-GAAP other income and expense to be about $2.3 to 2.4 billion in 2026. We expect a non-GAAP tax rate of 16% to 17.5%. We expect share repurchases not to exceed $3 billion in 2026. We expect capital expenditures of about $2.6 billion in 2026. This is consistent with our capital allocation priority to invest in our business and scale manufacturing capacity for volume growth, including preparing for MariTide launch. We remain focused on delivering sustained long-term growth and creating value for patients and shareholders by doing what we said we would do, advancing innovation in areas of high unmet medical need and maintaining rigorous financial discipline. I'm grateful to work with all of our colleagues worldwide in serving patients.
Speaker #4: Thank you Peter . And hope you as I Okay . all appreciate now , I think we ended 25 with our track record intact for having delivered against the objectives that we set for you at the beginning of the year .
Speaker #4: And we're determined to do the same now in 2026 . So we're entering the year with momentum , excited about what we see ahead .
Operator: 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. Our first question comes from Michael Yee from UBS Financial. Please go ahead. Your line is open.
Operator: 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. Our first question comes from Michael Yee from UBS Financial. Please go ahead. Your line is open.
Speaker #4: Let's open up the call to questions , Julianne . We'd be happy to entertain any of our callers now .
We expect share repurchases not to exceed 3 billion dollars in 2026. We expect Capital expenditures of about
Speaker #5: you . If you would Thank like to ask a question , please press star , followed by . If telephone one on your for any reason you please press that remove by again to ask question , star question , press star one .
Speaker #5: one
Michael Yee: Hey, guys. Good afternoon, and thanks for all the color, and looks like guidance is growth for the year, despite the biosimilars. Obviously, obesity is top of mind for everybody, and you've disclosed some information on MariTide recently. I was wondering and curious to ask your view of the portfolio overall in obesity, given that folks like today are disclosing combinations with monthly or monthly and then combinations, and how you see this playing out, given you're focused on MariTide, but not so sure about the rest of the portfolio there. Thank you.
Michael Yee: Hey, guys. Good afternoon, and thanks for all the color, and looks like guidance is growth for the year, despite the biosimilars. Obviously, obesity is top of mind for everybody, and you've disclosed some information on MariTide recently. I was wondering and curious to ask your view of the portfolio overall in obesity, given that folks like today are disclosing combinations with monthly or monthly and then combinations, and how you see this playing out, given you're focused on MariTide, but not so sure about the rest of the portfolio there. Thank you.
Speaker #5: Our go ahead . would like to Michael Ye . From a followed
Speaker #5: first question comes from
Speaker #5: financial .
Speaker #5: is open
Speaker #5: . all the
Speaker #6: guys . Hey , Good Please color growth for the looks like Your line the the year . Despite afternoon and biosimilars obviously obesity is top of mind for everybody .
Speaker #6: thanks for guidance and
Jay Olson: This concludes the financial update, and now I'll hand it back to Bob for Q&A.
Peter Griffith: This concludes the financial update, and now I'll hand it back to Bob for Q&A.
Speaker #6: you've And disclosed some information on maritime recently I was wondering and curious to ask your view portfolio of the overall and obesity , given that folks like today are disclosing combinations with monthly or monthly and then combinations , and how you see this playing out given your focused on maritime .
Robert Bradway: Okay, thank you, Peter, and as I hope you all appreciate now, I think we ended 25 with our track record intact for having delivered against the objectives that we set for you at the beginning of the year, and we're determined to do the same now in 2026. So we're entering the year with momentum, excited about what we see ahead. Let's open up the call to questions. Julianne, we'd be happy to entertain any of our callers now.
Robert Bradway: Okay, thank you, Peter, and as I hope you all appreciate now, I think we ended 25 with our track record intact for having delivered against the objectives that we set for you at the beginning of the year, and we're determined to do the same now in 2026. We're entering the year with momentum, excited about what we see ahead. Let's open up the call to questions. Julianne, we'd be happy to entertain any of our callers now.
2.6 billion dollars in 2026. This is consistent with our Capital, allocation priority to invest in our business and scale, manufacturing capacity for volume growth, including preparing for maritime launch. We remain focused on delivering sustained, long-term growth in creating value for patients and shareholders by doing what we said. We would do advancing innovation in areas of high unmet medical needs and maintaining rigorous Financial discipline. I'm grateful to work with all of our colleagues worldwide and serving patients. This concludes the financial update and now I'll hand it back to Bob for Q&A.
Robert Bradway: Okay. Thank you, Michael. We'll take a stab at answering your question. Connection wasn't great, but I think we got most of what you were trying to ask. Jay, you want to kick off?
Robert Bradway: Okay. Thank you, Michael. We'll take a stab at answering your question. Connection wasn't great, but I think we got most of what you were trying to ask. Jay, you want to kick off?
Speaker #6: But not so sure about the rest portfolio there . Thank you of the .
James Bradner: Yeah, I'd be happy to. Thanks, Michael. Amgen's really made for this moment of developing MariTide across so many different indications, a leading cardiovascular company, also a leading respiratory disease company, and there are so many opportunities there for MariTide. We've been in obesity, as you know, a long while, all the way back to the leptin days, and enjoyed stable discovery leadership team since that time. Internally, we have another clinical stage asset called AMG 513. We have yet to disclose the mechanism of that medicine. It is progressing in Phase I clinical investigation. And preclinically, we have a rather exciting set of rising programs that are both incretin-based as well as non-incretin-based, both injectable as well as oral medicines, and the aperture is always open for innovation on the outside.
James Bradner: Yeah, I'd be happy to. Thanks, Michael. Amgen's really made for this moment of developing MariTide across so many different indications, a leading cardiovascular company, also a leading respiratory disease company, and there are so many opportunities there for MariTide. We've been in obesity, as you know, a long while, all the way back to the leptin days, and enjoyed stable discovery leadership team since that time. Internally, we have another clinical stage asset called AMG 513. We have yet to disclose the mechanism of that medicine. It is progressing in Phase I clinical investigation. And preclinically, we have a rather exciting set of rising programs that are both incretin-based as well as non-incretin-based, both injectable as well as oral medicines, and the aperture is always open for innovation on the outside.
Speaker #4: you Michael . We'll take a Okay . Thank stab at questions answering your . Connection wasn't great , but I think we got most of what you were trying to ask .
Okay. Thank you, Peter, and as I hope you all appreciate. Now, I think we ended '25 with our track record intact for having delivered against the objectives that we set for you at the beginning of the year. And, uh, we're determined to do the same now in 2026. So, we're entering the year with momentum, uh, excited about what we see ahead. Let's open up the call to questions. Julianne, we'd be happy to.
Speaker #4: Jay . You
Speaker #4: want to kick off ?
Speaker #1: happy to . Thanks , Michael Yeah , I'd be . The amgen's really made for this moment . Developing across so many different A leading indications .
Operator: 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. Our first question comes from Michael Yee from Jefferies. Please go ahead. Your line is open.
Operator: 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. Our first question comes from Michael Yee from Jefferies. Please go ahead. Your line is open.
Entertain any of our callers now.
Followed by.
Speaker #1: maritime cardiovascular company , also a leading respiratory disease company . And there are so many opportunities there for maritime . We've been in obesity , as you know , a long while , all the way back to the leptin days and enjoyed stable discovery leadership team .
For any reason, you would like to remove that question.
Press star, followed by 1.
Again, to ask a question, press star 1.
Our first question comes from Michael G. from UBS Financial. Please go ahead, your line is open.
Michael Yee: Hey, guys. Good afternoon, and thanks for all the color, and looks like guidance is growth for the year, despite the biosimilars. Obviously, obesity is top of mind for everybody, and you've disclosed some information on MariTide recently. I was wondering and curious to ask your view of the portfolio overall in obesity, given that folks like today are disclosing combinations with monthly or monthly and then combinations, and how you see this playing out, given you're focused on MariTide, but not so sure about the rest of the portfolio there. Thank you.
Michael Yee: Hey, guys. Good afternoon, and thanks for all the color, and looks like guidance is growth for the year, despite the biosimilars. Obviously, obesity is top of mind for everybody, and you've disclosed some information on MariTide recently. I was wondering and curious to ask your view of the portfolio overall in obesity, given that folks like today are disclosing combinations with monthly or monthly and then combinations, and how you see this playing out, given you're focused on MariTide, not so sure about the rest of the portfolio there. Thank you.
Speaker #1: time . Internally , we have Since that another clinical stage asset called AMG 513 . We have yet to disclose the mechanism of that medicine is progressing in phase one clinical investigation .
Hey guys, good afternoon, and thanks for all the color. It looks like guidance is growth for the year, despite the biosimilars.
Speaker #1: And preclinically . We have a rather exciting set of rising programs that are both incretin based as well as non incretin based , both injectable as well as medicines oral aperture is .
Obviously, obesity is top of mind for everybody, and
information on Maritime recently. I was wondering, uh, and curious to ask your view of the portfolio.
Robert Bradway: I think you should expect us to be competing broadly in the field, Michael. Okay, let's move on. Next question.
Robert Bradway: I think you should expect us to be competing broadly in the field, Michael. Okay, let's move on. Next question.
Given that.
Speaker #1: open expect outside
Speaker #1: for always
Speaker #1: for always the
Speaker #1: innovation . And on And the in the .
Operator: Thank you, Michael. Our next question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open.
Operator: Thank you, Michael. Our next question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open.
Speaker #4: competing us to be broadly
Speaker #4: competing us to be broadly
Speaker #4: competing us to be broadly
Speaker #4: . Okay , field . I question think you should let's move on . Next .
Robert Bradway: Okay. Thank you, Michael. We'll take a stab at answering your question. Connection wasn't great, but I think we got most of what you were trying to ask. Jay, you want to kick off?
Robert Bradway: Okay. Thank you, Michael. We'll take a stab at answering your question. Connection wasn't great, I think we got most of what you were trying to ask. Jay, you want to kick off?
And then combinations. And how do you see this playing out, given your focus on MARITIME, but not so sure about the rest of the portfolio there. Thank you.
Yaron Werber: Great. Thanks so much. I have a question actually about Dazodalibep for primary Sjögren's syndrome. It looks like both studies are now fully enrolled, and you're saying completion in the second half. You're the only company with both the systemic and the symptomatic study in phase III based on the phase IIs. Should we expect the data this year, and do you want to give us any color on the reliability of the phase II into the phase III, just given it's a tough condition? Thank you.
Yaron Werber: Great. Thanks so much. I have a question actually about Dazodalibep for primary Sjögren's syndrome. It looks like both studies are now fully enrolled, and you're saying completion in the second half. You're the only company with both the systemic and the symptomatic study in phase III based on the phase IIs. Should we expect the data this year, and do you want to give us any color on the reliability of the phase II into the phase III, just given it's a tough condition? Thank you.
Speaker #5: Thank you . Michael . Our next question comes from Yaron Werber from TD Cowen . Please go line is ahead . Your open .
Jay Olson: Yeah, I'd be happy to. Thanks, Michael. Amgen's really made for this moment of developing MariTide across so many different indications, a leading cardiovascular company, also a leading respiratory disease company, and there are so many opportunities there for MariTide. We've been in obesity, as you know, a long while, all the way back to the leptin days, and enjoyed stable discovery leadership team since that time. Internally, we have another clinical stage asset, called AMG 513. We have yet to disclose the mechanism of that medicine; it is progressing in phase I clinical investigation. And preclinically, we have a rather exciting set of rising programs that are both in incretin-based as well as non-increatin-based, both injectable as well as oral medicines, and the aperture is always open for innovation on the outside.
Jay Bradner: Yeah, I'd be happy to. Thanks, Michael. Amgen's really made for this moment of developing MariTide across so many different indications, a leading cardiovascular company, also a leading respiratory disease company, and there are so many opportunities there for MariTide. We've been in obesity, as you know, a long while, all the way back to the leptin days, and enjoyed stable discovery leadership team since that time. Internally, we have another clinical stage asset, called AMG 513. We have yet to disclose the mechanism of that medicine; it is progressing in phase I clinical investigation. And preclinically, we have a rather exciting set of rising programs that are both in incretin-based as well as non-increatin-based, both injectable as well as oral medicines, and the aperture is always open for innovation on the outside.
Speaker #7: Great . Thanks so much . I have a question actually about days of daily map for primary Sjogren's syndrome . It looks like both studies fully are now enrolled .
Speaker #7: And you're saying completion in the second half . The only company with both a systemic and asymptomatic study in phase three , based on the phase two , what should we expect ?
Speaker #7: The data this year ? And do you want to give us any color on the reliability of the phase two into the phase three just given ?
James Bradner: Thanks, Yaron, and thanks for noticing about dazodalibep. This is a very exciting medicine in the portfolio. This is a CD40 ligand targeting biotherapeutic, and the CD40 pathway has long been postulated to be driving the inflammatory cascade in Sjögren's syndrome. The challenge is only that the biology is somewhat ambiguous, and so we take a really nice and incisive approach with dazodalibep in this disease. As you noted, the two phase III that we have open in Sjögren's syndrome will be in moderate to severe symptomatic activity. That's our population one, as well as in patients with a very high symptom burden. That's population two. Sjögren's has been very challenging for drug development, but we find this hypothesis quite compelling. The second study has already completed enrollment of patients.
James Bradner: Thanks, Yaron, and thanks for noticing about dazodalibep. This is a very exciting medicine in the portfolio. This is a CD40 ligand targeting biotherapeutic, and the CD40 pathway has long been postulated to be driving the inflammatory cascade in Sjögren's syndrome. The challenge is only that the biology is somewhat ambiguous, and so we take a really nice and incisive approach with dazodalibep in this disease. As you noted, the two phase III that we have open in Sjögren's syndrome will be in moderate to severe symptomatic activity. That's our population one, as well as in patients with a very high symptom burden. That's population two. Sjögren's has been very challenging for drug development, but we find this hypothesis quite compelling. The second study has already completed enrollment of patients.
Okay. Thank you, Michael. We'll take a stab at answering your questions. Uh, connection wasn't great, but I think we got most of what you were trying to ask Jay. You want to kick off. Yeah, I'd be happy to thanks. Michael. Um, the um, amen's really made for this moment, um, developing Maritime across so many different indications leading, cardiovascular company. Also a leading respiratory disease company, and there's so many opportunities there for maritime. Um, we've been in obesity as you know, a long while all the way back to the left in days and enjoyed stable. Discovery leadership teams since that time internally we have another clinical stage asset called
Speaker #7: It's a tough condition . Thank you .
Speaker #1: Thanks , Jaren . And thanks noticing about about this is a very exciting medicine in the portfolio . This is a cd40 ligand targeting Biotherapeutic Cd40 pathway has long been postulated to be driving the inflammatory cascade in Sjogren's syndrome .
AMG 513 we have yet to disclose the mechanism of that medicine is progressing in Phase 1 clinical investigation.
Robert Bradway: I think you should expect us to be competing broadly in the field, Michael. Okay, let's move on. Next question.
Robert Bradway: I think you should expect us to be competing broadly in the field, Michael. Okay, let's move on. Next question.
Speaker #1: The challenge is only that the biology is somewhat ambiguous , and so we take a really nice and incisive approach with in this disease , as you noted , the open we have two phase three , in Chauvin's will syndrome moderate to severe symptomatic activity .
Operator: Thank you, Michael. Our next question comes from Yaron Werber, from TD Cowen. Please go ahead. Your line is open.
Operator: Thank you, Michael. Our next question comes from Yaron Werber, from TD Cowen. Please go ahead. Your line is open.
And pre clinically we have a rather exciting, um, set of arising programs that are both increasing based, as well as non increased in base, both injectable as well as oral medicines and the aperture resolve is open. Um, for Innovation, um, on the outside. All right, I think you should expect us to be competing, broadly in the field, Michael? Okay, let's move on. Next question.
Yaron Werber: Great. Thanks so much. I have a question actually about Dazodalibep for primary Sjögren's syndrome. It looks like both studies are now fully enrolled, and you're saying completion in the second half. You're the only company with both a systemic and a symptomatic study in phase 3, based on the phase 2s. Should we expect the data this year, and do you want to give us any color on the reliability of the phase 2 into the phase 3? Just given it's a tough condition. Thank you.
Yaron Werber: Great. Thanks so much. I have a question actually about Dazodalibep for primary Sjögren's syndrome. It looks like both studies are now fully enrolled, and you're saying completion in the second half. You're the only company with both a systemic and a symptomatic study in phase 3, based on the phase 2s. Should we expect the data this year, and do you want to give us any color on the reliability of the phase 2 into the phase 3? Just given it's a tough condition. Thank you.
Thank you, Michael. Our next question comes from your own Warber from TD Cowen. Please go ahead, your line is open.
Speaker #1: That's our population , one as well as in patients with a very high symptom burden burden . That's population two . Sjogren's has been very challenging for drug development .
James Bradner: This is the moderate to high symptom burden group with low systemic disease activity, and we expect completion of the trials later this year, and we'll inform later about our plan to communicate this information. As for reading through the reliability of phase II into phase III, there have been historic challenges here, but the performance against this SDI score, which is the clinically utilized as well as regulatory paradigm for approval, you know, was one of the first medicines ever to improve an SDI score in that disease space. So, we're confident going into phase III and can't wait to look at the results.
James Bradner: This is the moderate to high symptom burden group with low systemic disease activity, and we expect completion of the trials later this year, and we'll inform later about our plan to communicate this information. As for reading through the reliability of phase II into phase III, there have been historic challenges here, but the performance against this SDI score, which is the clinically utilized as well as regulatory paradigm for approval, you know, was one of the first medicines ever to improve an SDI score in that disease space. So, we're confident going into phase III and can't wait to look at the results.
Speaker #1: we But find this hypothesis quite compelling . The second study is already completed . Enrollment of patients . This is the moderate to high symptom burden group with low systemic disease activity .
Speaker #1: And we expect completion of the trials later this year and will inform later about our plan to communicate these information . As for reading through the reliability of phase two into phase three , been there have historic challenges here , but the performance against this SDI score , which is the clinically utilized as well as regulatory paradigm for approval , you know , was one of the first medicines ever to improve in status score in that disease space .
Great, uh, thanks so much. Uh, I have a question actually about, uh, days of daily B for primary Sjögren’s syndrome. It looks like both studies are not fully enrolled and you’re saying completion in the second half. The only company with both a systemic and a symptomatic, uh, study in Phase 3. Based on the Phase 2s, should we expect the data this year? And do you want to give us any color on the, um, reliability of the Phase 2 and to the Phase 3, just given it’s a tough condition? Thank you.
Jay Olson: Thanks, Yaron. And thanks for noticing about Dazodalibep. This is a very exciting medicine in the portfolio. This is a CD40 ligand targeting biotherapeutic, and the CD40 pathway has long been postulated to be driving the inflammatory cascade in Sjögren's syndrome. The challenge is only that the biology is somewhat ambiguous, and so we take a really nice and incisive approach with Dazodalibep in this disease. As you noted, the 2 phase 3s that we have open in Sjögren's syndrome will be in moderate to severe symptomatic activity. That's our population 1, as well as in patients with a very high symptom burden. That's population 2. Sjögren's has been very challenging for drug development, but we find this hypothesis quite compelling. The second study has already completed enrollment of patients.
Jay Bradner: Thanks, Yaron. And thanks for noticing about Dazodalibep. This is a very exciting medicine in the portfolio. This is a CD40 ligand targeting biotherapeutic, and the CD40 pathway has long been postulated to be driving the inflammatory cascade in Sjögren's syndrome. The challenge is only that the biology is somewhat ambiguous, and we take a really nice and incisive approach with Dazodalibep in this disease. As you noted, the 2 phase 3s that we have open in Sjögren's syndrome will be in moderate to severe symptomatic activity. That's our population 1, as well as in patients with a very high symptom burden. That's population 2. Sjögren's has been very challenging for drug development, we find this hypothesis quite compelling. The second study has already completed enrollment of patients.
Speaker #1: So we're confident going into phase three . Can't wait to look at the results .
Operator: Thank you, Yaron.
Operator: Thank you, Yaron.
Robert Bradway: Our next question-
Robert Bradway: Our next question-
Jan. Um, and thanks for um, noticing about days with Daly. But this is a very exciting medicine in the portfolio. This is a cd40 lan targeting, bio therapeutic. And the cd40 pathway has long been postulated to be driving the, um, inflammatory Cascade in children. The challenge is only that the biology is someone ambiguous. And so, we take a really nice and incisive.
Operator: Our next question comes from David Amsellem from Piper Sandler. Please go ahead. Your line is open.
Operator: Our next question comes from David Amsellem from Piper Sandler. Please go ahead. Your line is open.
Speaker #5: you . Thank Our next question our next question comes from David Amsellem from Piper Sandler . Please go ahead . Your line is open .
David Amsellem: Hey, thanks. So I had a couple of Uplizna-related questions. Can you talk about the extent to which the underlying IgG4-related disease population is larger than what literature has suggested historically and what that means for the underlying opportunity? And then secondly, I know it's early in GMG, but can you talk about how the product's being used to date, and what kind of role do you think it's gonna have in the, in an admittedly more crowded treatment armamentarium? Thanks.
David Amsellem: Hey, thanks. So I had a couple of Uplizna-related questions. Can you talk about the extent to which the underlying IgG4-related disease population is larger than what literature has suggested historically and what that means for the underlying opportunity? And then secondly, I know it's early in GMG, but can you talk about how the product's being used to date, and what kind of role do you think it's gonna have in the, in an admittedly more crowded treatment armamentarium? Thanks.
Speaker #8: thanks . So Hey , I had a couple of uplizna related questions . Can you talk about the extent to which the underlying IgG4 related disease population is larger than what literature has suggested historically , and what that means for the underlying opportunity ?
Approach with data in this disease. Um as you noted uh the 2 phase 3 is that we have open and show and syndrome. Um, will be in moderate to severe symptomatic activity. That's our population 1 as well as in patients with a very high symptom version that's population 2.
um, children has been very challenging for drug development, but where we find this hypothesis quite compelling
Jay Olson: This is the moderate to high symptom burden group with low systemic disease activity, and we expect completion of the trials later this year, and we'll inform later about our plan to communicate this information. As for reading through the reliability of phase 2, into phase 3, there have been historic challenges here, but the performance against this SI score, which is the clinically utilized as well as regulatory paradigm for approval, it was one of the first medicines ever to improve an SI score in that disease space. So, we're confident going into phase 3 and can't wait to look at the results.
Jay Bradner: This is the moderate to high symptom burden group with low systemic disease activity, and we expect completion of the trials later this year, and we'll inform later about our plan to communicate this information. As for reading through the reliability of phase 2, into phase 3, there have been historic challenges here, the performance against this SI score, which is the clinically utilized as well as regulatory paradigm for approval, it was one of the first medicines ever to improve an SI score in that disease space. So, we're confident going into phase 3 and can't wait to look at the results.
Speaker #8: And then secondly , I know it's early in gmmg , but can just can you talk about how the product is being used to date and what kind of role do you think it's going to have in the in an admittedly more crowded treatment armamentarium .
Um the second study is already completed enrollment of patients, this is the moderate to high symptom, burden group with low, systemic disease, activity and uh we use that completion of the trials later this year and will inform later about our plan to communicate these information.
Robert Bradway: Yeah, let's. Why don't we tackle this in two parts? Jay, if you take the first part, and then maybe, Murdo, you can jump in on the second. Go ahead.
Robert Bradway: Yeah, let's. Why don't we tackle this in two parts? Jay, if you take the first part, and then maybe, Murdo, you can jump in on the second. Go ahead.
James Bradner: You know, there is, in medicine, an experience where the availability of a targeted therapy, a really effective therapy, can actually increase the incidence of a disease through awareness of the disease. Why take a diagnosis unless you have reason to, to intervene effectively? And, and that may, in the fullness of time, be the case here. Limiting a precise description of the epidemiology, even over the last 5 to 10 years, is the lack of really coherent registry data, as well as appropriate coding that would allow, such an analysis from, electronic medical record data. And so I think it's a good question. I think it's a moving object, and we'll have better precision on that in a few years to come. Myrtle, what are your instincts?
James Bradner: You know, there is, in medicine, an experience where the availability of a targeted therapy, a really effective therapy, can actually increase the incidence of a disease through awareness of the disease. Why take a diagnosis unless you have reason to, to intervene effectively? And, and that may, in the fullness of time, be the case here. Limiting a precise description of the epidemiology, even over the last 5 to 10 years, is the lack of really coherent registry data, as well as appropriate coding that would allow, such an analysis from, electronic medical record data. And so I think it's a good question. I think it's a moving object, and we'll have better precision on that in a few years to come. Murdo, what are your instincts?
Speaker #8: Thanks .
Speaker #4: Yeah . Why ? We tackle this in two parts . J . If you take the first part and then maybe you can jump in on the second , go ahead .
Speaker #1: You know there is in medicine an experience where the availability of a targeted really therapy effective therapy can increase the incidence of a awareness of the actually disease .
3. There have been historic challenges here, um, but the performance against this esti score, which is the clinically utilized as well as regulatory Paradigm for approval. Um, you know, was 1 of the first medicines ever to improve an SI score in that disease space. So, uh, we're confident going into phase 3 and can't wait to look at the results.
Operator: Thank you, Yaron.
Operator: Thank you, Yaron.
Robert Bradway: Our next question-
Operator: Our next question- Our next question comes from David Amsellem, from Piper Sandler. Please go ahead. Your line is open.
Speaker #1: diagnosis Why unless you have reason to to intervene effectively . And that may , in the fullness of time , be the case here .
Operator: Our next question comes from David Amsellem, from Piper Sandler. Please go ahead. Your line is open.
Thank you, your own our next question.
Our next question comes from David Anselm from Piper Sandler. Please go ahead, your line is open.
David Amsellem: Hey, thanks. So I had a couple of Uplizna-related questions. Can you talk about the extent to which the underlying IgG4-related disease population is larger than what literature has suggested historically, and what that means for the underlying opportunity? And then secondly, I know it's early in GMG, but can you talk about how the product's being used today, and what kind of role do you think it's gonna have in an admittedly more crowded treatment armamentarium? Thanks.
David Amsellem: Hey, thanks. I had a couple of UPLIZNA-related questions. Can you talk about the extent to which the underlying IgG4-related disease population is larger than what literature has suggested historically, and what that means for the underlying opportunity? And then secondly, I know it's early in GMG, can you talk about how the product's being used today, and what kind of role do you think it's gonna have in an admittedly more crowded treatment armamentarium? Thanks.
Speaker #1: Limiting a precise description of the epidemiology even over the last 5 to 10 years , is the really lack of coherent registry data , as well as appropriate coding that would allow such an analysis from electronic medical record data .
Murdo Gordon: I think that's a very clear description, Jay. I think the availability of the ICD-ten coding, as you alluded to, is really about a three-year presence in the market. Right now, we estimate the diagnosed population to be in the neighborhood of 35,000, and that could grow. As you outlined, there are mentions in the literature of higher numbers. However, we're obviously focused on those that are already diagnosed, already in care, and we're trying to build that awareness that you spoke of, Jay. And so far, so good. Uplizna is doing extremely well in its uptake in IgG4-related diseases. We see a nice breadth of prescribing across a number of different specialties that see these patients because of the end organ involvement in the inflammatory condition.
Speaker #1: And so I think it's a good question . I think it's a moving object and we'll have better precision on that in a few years to come .
Murdo Gordon: I think that's a very clear description, Jay. I think the availability of the ICD-ten coding, as you alluded to, is really about a three-year presence in the market. Right now, we estimate the diagnosed population to be in the neighborhood of 35,000, and that could grow. As you outlined, there are mentions in the literature of higher numbers. However, we're obviously focused on those that are already diagnosed, already in care, and we're trying to build that awareness that you spoke of, Jay. And so far, so good. Uplizna is doing extremely well in its uptake in IgG4-related diseases. We see a nice breadth of prescribing across a number of different specialties that see these patients because of the end organ involvement in the inflammatory condition.
Speaker #1: Myrtle , what are your instincts ?
Speaker #2: think that's I a very clear . Description . J I think the the availability of the ICD ten coding , as you alluded to , is really about a three year presence in the market .
Robert Bradway: Yeah, why don't we tackle this in two parts. Jay, if you take the first part, and then maybe, Murdo, you can jump in on the second. Go ahead.
Robert Bradway: Yeah, why don't we tackle this in two parts. Jay, if you take the first part, and then maybe, Murdo, you can jump in on the second. Go ahead.
Um, hey, thanks. So, I had a couple of opposed, no, related questions. Can you talk about the extent to which the underlying IgG4-related disease population is larger than what, uh, literature has suggested historically, and what that means for the underlying opportunity? And then, secondly, I know it's early in GMG, but can you just talk about, um, how the product is being used today? And what kind of role do you think it's going to have in the, uh, in an admittedly more crowded treatment armamentarium? Thanks.
Speaker #2: Right now . We estimate the diagnosed population to be in the neighborhood of 35,000 . And that could grow you . There are as literature mentions in of higher the outlined numbers .
Jay Olson: You know, there is, in medicine, an experience where the availability of a targeted therapy, a really effective therapy, can actually increase the incidence of a disease through awareness of the disease. Why take a diagnosis unless you have reason to, to intervene effectively? And that may, in the fullness of time, be the case here. Limiting a precise description of the epidemiology, even over the last 5 to 10 years, is the lack of really coherent registry data, as well as appropriate coding that would allow such an analysis from electronic medical record data. So I think it's a good question. I think it's a moving object, and we'll have better precision on that in a few years to come. Myrtle, what are your instincts?
Jay Bradner: You know, there is, in medicine, an experience where the availability of a targeted therapy, a really effective therapy, can actually increase the incidence of a disease through awareness of the disease. Why take a diagnosis unless you have reason to, to intervene effectively? And that may, in the fullness of time, be the case here. Limiting a precise description of the epidemiology, even over the last 5 to 10 years, is the lack of really coherent registry data, as well as appropriate coding that would allow such an analysis from electronic medical record dataI think it's a good question. I think it's a moving object, and we'll have better precision on that in a few years to come. Murdo, what are your instincts?
Yeah, let's—before we tackle this in two parts—J, if you take the first part, and then maybe Moreau, you can jump in on the second. Go ahead, you know, there is, um,
Speaker #2: However , we're we're obviously focused on those that are already diagnosed already in care . And we're trying to build that awareness that you that you spoke of .
Speaker #2: Jane . So far , so good . Uplizna is doing extremely well and its uptake in IgG4 related diseases . We see a nice breadth of prescribing across a number of different specialties that that see these patients because of the end organ involvement and the inflammatory condition .
Murdo Gordon: We'll continue to make sure that we do our part to improve that awareness, improve that diagnosis. These patients undergo a very complicated patient journey, in that this disease can masquerade as many other things. But so far, so good, and we're happy to be able to help these patients finally get a treatment, the only one FDA approved, that can help with their symptoms and obviously the long-term health outcomes, particularly for their target organs. Just on Uplizna and gMG, we're very pleased with the initial uptake. As you said, David, it's very early in the launch, but what we're pleased about, and I mentioned this in my opening remarks, is that roughly half of the patients who are being treated are bio-naive patients, and the other half coming from switches from other therapies.
Murdo Gordon: We'll continue to make sure that we do our part to improve that awareness, improve that diagnosis. These patients undergo a very complicated patient journey, in that this disease can masquerade as many other things. But so far, so good, and we're happy to be able to help these patients finally get a treatment, the only one FDA approved, that can help with their symptoms and obviously the long-term health outcomes, particularly for their target organs. Just on Uplizna and gMG, we're very pleased with the initial uptake. As you said, David, it's very early in the launch, but what we're pleased about, and I mentioned this in my opening remarks, is that roughly half of the patients who are being treated are bio-naive patients, and the other half coming from switches from other therapies.
Speaker #2: And we'll continue to make sure that we do our part to improve that awareness and improve that diagnosis . These patients undergo a very complicated patient journey in that this disease can masquerade as many other things .
Murdo Gordon: I think that's a very clear description, Jay. I think the availability of the ICD-10 coding, as you alluded to, is really about a three-year presence in the market. Right now, we estimate the diagnosed population to be in the neighborhood of 35,000, and that could grow. As you outlined, there are mentions in the literature of higher numbers. However, we're obviously focused on those that are already diagnosed, already in care, and we're trying to build that awareness that you spoke of, Jay. So far, so good. Uplizna is doing extremely well in its uptake in IgG4-related diseases. We see a nice breadth of prescribing across a number of different specialties that see these patients because of the end organ involvement in the inflammatory condition.
Murdo Gordon: I think that's a very clear description, Jay. I think the availability of the ICD-10 coding, as you alluded to, is really about a three-year presence in the market. Right now, we estimate the diagnosed population to be in the neighborhood of 35,000, and that could grow. As you outlined, there are mentions in the literature of higher numbers. However, we're obviously focused on those that are already diagnosed, already in care, and we're trying to build that awareness that you spoke of, Jay. So far, so good. UPLIZNA is doing extremely well in its uptake in IgG4-related diseases. We see a nice breadth of prescribing across a number of different specialties that see these patients because of the end organ involvement in the inflammatory condition.
In medicine an experience where the availability of a targeted therapy, a really effective therapy can actually increase the incidence of a disease through awareness of the disease. Why take a diagnosis? Unless you have reason to, um, to intervene effectively, um, and, and that may in the fullness of time, be the case here, um, limiting a precise description of the epidemiology even over the last 5 to ten years is the lack of really coherent registry data as well as appropriate coding that would allow, um, such an analysis from um, electronic medical record data. And so I I think it's a good question. I think it's a, a moving object and we'll have better Precision on that in the few years to come Myrtle. What are your instincts?
Speaker #2: But so far , so good , and we're happy to be able to help these patients . Finally get a treatment . The only one FDA approved that can help with their symptoms .
Speaker #2: And obviously the long term health outcomes , particularly for their plasma and we're very with , just on GMG , the target the organs initial uptake .
Speaker #2: David , it's you said , As very early in the launch , but what we're pleased about and I mentioned this in my opening remarks , is that roughly half of the patients who are being treated are bio naive patients other and the half coming from switches from other therapies , as we've said before , this is a large but still quite dissatisfied category where the current treatments have limitations , whether that be dosing inconvenience , whether that be duration of efficacy , and perhaps some waning efficacy in this category .
Murdo Gordon: As we've said before, this is a large but still quite dissatisfied category, where the current treatments have limitations, whether that be dosing inconvenience, whether that be duration of efficacy, and perhaps some waning efficacy in this category. And so far, what we've seen is a very strong interest in Uplizna for its mechanism, as well as for the convenience that it represents for patients. So, so far, so good. Excited about Uplizna overall in the broader rare disease portfolio.
Murdo Gordon: As we've said before, this is a large but still quite dissatisfied category, where the current treatments have limitations, whether that be dosing inconvenience, whether that be duration of efficacy, and perhaps some waning efficacy in this category. And so far, what we've seen is a very strong interest in Uplizna for its mechanism, as well as for the convenience that it represents for patients. So, so far, so good. Excited about Uplizna overall in the broader rare disease portfolio.
Uh, I think that's a very clear. Um, description, J. I think the, the availability of the ICD 10 coding as you alluded, to is really about a 3 year, um, presence in the market. Right now, we estimate the diagnosed population to be in the neighborhood of 35,000, um, and that could grow as you outlined. Um, there are, um, mentions in the literature of higher numbers. However, we're, we're obviously focused on those that are already diagnosed already in care. And we're trying to build that awareness that you that you, uh, spoke of Jane so far, so good. The plasma is doing extremely well and has uptake in igg4 related diseases. Um, we see, uh, a nice, uh, breath
Murdo Gordon: And we'll continue to make sure that we do our part to improve that awareness, improve that diagnosis. These patients undergo a very complicated patient journey, in that this disease can masquerade as many other things. But, so far, so good, and, and we're happy to be able to help these patients finally, get a treatment, the only one FDA approved, that can help with their symptoms and obviously the long-term health outcomes, particularly for their target, organs. Just on Uplizna and GMG, we're, we're very pleased with the initial uptake. As you said, David, it's very early in the launch, but, what we're pleased about, and I, I mentioned this in, in my opening remarks, is that roughly half of the patients who are being treated are bio-naive patients, and the other half coming from switches from other therapies.
Murdo Gordon: And we'll continue to make sure that we do our part to improve that awareness, improve that diagnosis. These patients undergo a very complicated patient journey, in that this disease can masquerade as many other things. But, so far, so good, and, and we're happy to be able to help these patients finally, get a treatment, the only one FDA approved, that can help with their symptoms and obviously the long-term health outcomes, particularly for their target, organs. Just on UPLIZNA and GMG, we're, we're very pleased with the initial uptake. As you said, David, it's very early in the launch, but, what we're pleased about, and I, I mentioned this in, in my opening remarks, is that roughly half of the patients who are being treated are bio-naive patients, and the other half coming from switches from other therapies.
Speaker #2: And so far , what we've seen is a very strong interest in Uplizna for its mechanism as well as for the convenience that it represents for patients .
Speaker #2: So so far , so good . Excited about Uplizna overall in the rare broader disease portfolio
Robert Bradway: Okay, thanks. Let's go to the next question.
Robert Bradway: Okay, thanks. Let's go to the next question.
Operator: Thank you, David. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead, your line is open.
Operator: Thank you, David. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead, your line is open.
Speaker #2: .
Speaker #4: the next Okay . Thanks . Let's go to question .
Salveen Richter: Good afternoon, thanks for taking my question. Just a follow-up here on UPLIZNA. Walk us through what's giving you confidence here in moving forward with a phase 3 study in CIDP and the opportunity in that indication. And if you could also just separately touch on Repatha, and how you're thinking about potential impact from the launch of Merck's oral PCSK9, and how you're adapting your commercial strategy there. Thank you.
Salveen Richter: Good afternoon, thanks for taking my question. Just a follow-up here on UPLIZNA. Walk us through what's giving you confidence here in moving forward with a phase 3 study in CIDP and the opportunity in that indication. And if you could also just separately touch on Repatha, and how you're thinking about potential impact from the launch of Merck's oral PCSK9, and how you're adapting your commercial strategy there. Thank you.
Speaker #5: David . Thank you . Our next question comes from Salveen Richter from Goldman Sachs . Please go ahead . Your line is open .
Speaker #9: afternoon . Good Thanks for taking my question . Just a follow up here on the walk us through what's given you confidence here in moving forward with a phase three study in Cidp and the opportunity in that indication .
Of prescribing across a number of different Specialties that, that see these patients because of the end, organ involvement in the inflammatory condition, and we'll continue to make sure that we do our part to improve that awareness improve that diagnosis. Um, these patients undergo a very complicated patient Journey, uh, in that, this disease can masquerade as many other things but, uh, so far so good and, and we're happy to be able to help these patients. Finally, uh, get a treatment. The only 1 FDA approved that can help with their symptoms and obviously the long-term Health outcomes, uh, particularly for their target, uh, organs. Um, just on the plaza in GMG we're we're very pleased with the initial uptake. Uh as you said, Dave is very early in the launch but um what we're pleased about and I I mentioned this in, in My Hope May remark is that roughly half of the patients who are being treated are bio, naive patients and the other half coming from switches from
Murdo Gordon: As we've said before, this is a large but still quite dissatisfied category, where the current treatments have limitations, whether that be dosing inconvenience, whether that be duration of efficacy, and perhaps some waning efficacy in this category. And so far, what we've seen is a very strong interest in Uplizna for its mechanism, as well as for the convenience that it represents for patients. So, so far, so good. Excited about Uplizna overall in the broader rare disease portfolio.
Murdo Gordon: As we've said before, this is a large but still quite dissatisfied category, where the current treatments have limitations, whether that be dosing inconvenience, whether that be duration of efficacy, and perhaps some waning efficacy in this category. So far, what we've seen is a very strong interest in UPLIZNA for its mechanism, as well as for the convenience that it represents for patients. So, so far, so good. Excited about UPLIZNA overall in the broader rare disease portfolio.
Speaker #9: And if you could also just separately touch on Repatha and how you're thinking about potential impact from the launch of Merck's oral Pcsk9 and how you're adapting your commercial strategy there .
Robert Bradway: With two ends of the spectrum there, from the very rare to the very common. So let's do, Jay, you do the first question, and then, Murdo, you can take the second.
Robert Bradway: With two ends of the spectrum there, from the very rare to the very common. So let's do, Jay, you do the first question, and then, Murdo, you can take the second.
Speaker #9: Thank you .
James Bradner: Okay. Thanks, Salveen. We are, as Myrtle shared, very bullish about Uplizna. Specifically, this unique mechanism of action that targets and depletes the CD19 pathologic B-cell. These, as you surely know, CD19, the B-cell compartment, is evident on mature B-cells, like CD20, targeted by rituximab and other medicines of that type, but also the pre-B-cell, the more naive B-cell, the cell that expands and elaborates many of these autoantibodies. And so now, seeing efficacy of Uplizna in so many immunoglobulin-related disorders, like IgG4-related disease, like myasthenia gravis, the chance to bring it to additional autoantibody-mediated immune conditions is just a great chance to help patients on with these severe diseases. In some cases, there are signals from CD20 that we intend to follow up with a broader, more active, and hopefully, much more convenient Uplizna.
James Bradner: Okay. Thanks, Salveen. We are, as Murdo shared, very bullish about Uplizna. Specifically, this unique mechanism of action that targets and depletes the CD19 pathologic B-cell. These, as you surely know, CD19, the B-cell compartment, is evident on mature B-cells, like CD20, targeted by rituximab and other medicines of that type, but also the pre-B-cell, the more naive B-cell, the cell that expands and elaborates many of these autoantibodies. And so now, seeing efficacy of Uplizna in so many immunoglobulin-related disorders, like IgG4-related disease, like myasthenia gravis, the chance to bring it to additional autoantibody-mediated immune conditions is just a great chance to help patients on with these severe diseases. In some cases, there are signals from CD20 that we intend to follow up with a broader, more active, and hopefully, much more convenient Uplizna.
Speaker #4: Two ends of the spectrum there , from the very rare to the to the very common . So let's do J you do the first question and then you can take second .
Speaker #1: Okay . Thanks . Alvin . We are as Murdo shared , very bullish about Uplizna specifically this unique mechanism of action that targets and depletes the Cd19 pathologic B cell .
From other therapies. Um, as we've said before this is a a large, but still quite dissatisfied category where the current uh, treatments have limitations. Uh whether that be uh, dosing inconvenience whether that be duration of efficacy and perhaps some waning efficacy in this category and so far what we've seen is a very strong interest in the plasma for its mechanism as well as for the
Speaker #1: These as you , Cd19 , compartment , the B is surely know evident on mature B cells like Cd20 , targeted by rituximab and other medicines of that type , but also the pre-b cell .
Robert Bradway: Okay, thanks. Let's go to the next question.
Robert Bradway: Okay, thanks. Let's go to the next question.
Convenience that it represents for patients. So so far so good, excited about a plasma overall in the broader, um rare disease portfolio.
Operator: Thank you, David. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead, your line is open.
Operator: Thank you, David. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead, your line is open.
Okay, thanks. Let's go to the next question.
Salveen Richter: Good afternoon, thanks for taking my question. Just a follow-up here on Uplizna. Walk us through, what's giving you confidence here in moving forward with a phase three study in CIDP and the opportunity in that indication. And if you could also just separately touch on Repatha, and how you're thinking about potential impact from the launch of Merck's oral PCSK9, and how you're adapting your commercial strategy there. Thank you.
Salveen Richter: Good afternoon, thanks for taking my question. Just a follow-up here on UPLIZNA. Walk us through, what's giving you confidence here in moving forward with a phase three study in CIDP and the opportunity in that indication. If you could also just separately touch on Repatha, and how you're thinking about potential impact from the launch of Merck's oral PCSK9, and how you're adapting your commercial strategy there. Thank you.
Thank you, David. Our next question comes from Salvian Richter from Goldman Sachs. Please go ahead. Your line is open.
Speaker #1: The more naive B cell , the cell that expands and elaborates many of these autoantibodies . And so now seeing efficacy of a in so many immunoglobulin related disorders like IgG4 related disease , like myasthenia gravis , the chance to bring it to additional autoantibody mediated immune conditions is just a great chance to help patients with these severe diseases .
Robert Bradway: With two ends of the spectrum there, from the very rare to the very common. So let's do, Jay, you do the first question, and then, Murdo, you can take second.
Robert Bradway: With two ends of the spectrum there, from the very rare to the very common. Let's do, Jay, you do the first question, and then, Murdo, you can take second.
From the launch of mercs oral pcsk9 and how you're adapting your commercial strategy there. Thank you.
Speaker #1: In some cases , there are signals from Cd20 that we intend to follow up with a broader , more active and hopefully much more convenient Uplizna autoimmune hepatitis , which I mentioned earlier , is associated with autoantibodies .
James Bradner: Autoimmune hepatitis, which I mentioned earlier, is associated with autoantibodies. You see ANA, you see anti-smooth muscle, you see anti-actin, you see anti-LC1. And the same is true, though to a lower proportion, with CIDP as well, where maybe 5 to 10% of patients will have autoantibodies to what are called perinodal proteins, NF-155, CMTN-1. I could go on for a long time. And so this biology being driven by the compartment that Uplizna targets makes for a really great chance to extend the benefits of targeting B-cells in both of these conditions. Myrtle?
James Bradner: Autoimmune hepatitis, which I mentioned earlier, is associated with autoantibodies. You see ANA, you see anti-smooth muscle, you see anti-actin, you see anti-LC1. And the same is true, though to a lower proportion, with CIDP as well, where maybe 5 to 10% of patients will have autoantibodies to what are called perinodal proteins, NF-155, CMTN-1. I could go on for a long time. And so this biology being driven by the compartment that Uplizna targets makes for a really great chance to extend the benefits of targeting B-cells in both of these conditions. Murdo?
Jay Olson: Okay. Thanks, Salveen. We are, as Myrtle shared, very bullish about Uplizna, specifically this unique mechanism of action that targets and depletes the CD19 pathologic B cell. These, as you surely know, CD19, the B-cell compartment, is evident on mature B cells, like CD20, targeted by rituximab and other medicines of that type, but also the pre-B cell, the more naive B cell, the cell that expands and elaborates many of these autoantibodies. And so now, seeing efficacy of Uplizna in so many immunoglobulin related disorders, like IgG4-related disease, like myasthenia gravis, the chance to bring it to additional autoantibody-mediated immune conditions, is just a great chance to help patients with these severe diseases.
Jay Bradner: Okay. Thanks, Salveen. We are, as Murdo shared, very bullish about UPLIZNA, specifically this unique mechanism of action that targets and depletes the CD19 pathologic B cell. These, as you surely know, CD19, the B-cell compartment, is evident on mature B cells, like CD20, targeted by rituximab and other medicines of that type, also the pre-B cell, the more naive B cell, the cell that expands and elaborates many of these autoantibodies. Now, seeing efficacy of UPLIZNA in so many immunoglobulin related disorders, like IgG4-related disease, like myasthenia gravis, the chance to bring it to additional autoantibody-mediated immune conditions, is just a great chance to help patients with these severe diseases.
Speaker #1: You see , see Ana , you anti-smooth muscle , you see anti-actin , you see Anti-lc1 . And the same is true , though to a lower proportion with Cidp as well , where maybe 5 to 10% of patients will have autoantibodies to what are called perinodal proteins .
Speaker #1: And if 155 cntn1 , I could go on for a long time . And so this biology being driven by the compartment that applies to targets makes for a really great chance to extend the benefits of targeting B cells in both of these conditions .
With two ends of a spectrum there, from the very rare to the very common. So let's do J. You do the first question and then Myrtle, you can take a second. Okay, um, take saline, um, we are, um, as Murdo shared, very bullish about a plasma, specifically this unique mechanism of action that targets and depletes the CD19 pathologic B cell. These, as you surely know, um, CD19, the B cell compartment, is evident on mature B cells, like CD20 targeted by Ritu and other medicines of that type, but also the pre-B cell.
Murdo Gordon: ... Yeah, just the size of the opportunity here is interesting. Roughly, the prevalent pool in the US is estimated to be about 35,000 patients, maybe 7,000 to 10,000 incident new diagnosed cases per year in the US. So, hopefully, we can develop this drug and offer some benefit for these patients, which is yet another steroid-intensive condition, and we believe that we can do better than that. So let's hope for that best outcome in those clinical trials. On Repatha, I alluded to what our strategy is in my opening remarks.
Murdo Gordon: ... Yeah, just the size of the opportunity here is interesting. Roughly, the prevalent pool in the US is estimated to be about 35,000 patients, maybe 7,000 to 10,000 incident new diagnosed cases per year in the US. So, hopefully, we can develop this drug and offer some benefit for these patients, which is yet another steroid-intensive condition, and we believe that we can do better than that. So let's hope for that best outcome in those clinical trials. On Repatha, I alluded to what our strategy is in my opening remarks.
Speaker #1: Myrtle .
Speaker #2: Yeah , just the size of the opportunity here is interesting . Roughly the prevalent pool in the US is estimated to be about 35,000 patients .
Speaker #2: Maybe 7 to 10,000 incident new diagnosed cases per year in the US . So hopefully we can develop this drug and offer some benefit for for these patients , which is yet another steroid intensive condition .
Jay Olson: In some cases, there are signals from CD20 that we intend to follow up with a broader, more active, and hopefully, much more convenient, Uplizna. Autoimmune hepatitis, which I mentioned earlier, is associated with autoantibodies. You see ANA, you see anti-smooth muscle, you see anti-actin, you see anti-LC1. And the same is true, though to a lower proportion, with CIDP as well, where maybe 5 to 10% of patients will have autoantibodies to what are called parenodal proteins, NF155, CNTM-1. I could go on for a long time. And so this biology being driven by the compartment that Uplizna targets makes for a really great chance to extend the benefits of targeting B cells in both of these conditions. Myrtle?
Jay Bradner: In some cases, there are signals from CD20 that we intend to follow up with a broader, more active, and hopefully, much more convenient, UPLIZNA. Autoimmune hepatitis, which I mentioned earlier, is associated with autoantibodies. You see ANA, you see anti-smooth muscle, you see anti-actin, you see anti-LC1. The same is true, though to a lower proportion, with CIDP as well, where maybe 5 to 10% of patients will have autoantibodies to what are called parenodal proteins, NF155, CNTM-1. I could go on for a long time. This biology being driven by the compartment that UPLIZNA targets makes for a really great chance to extend the benefits of targeting B cells in both of these conditions. Murdo?
The more naive, B cells, the cell that expands and elaborates, many of these Auto antibodies. And so, now seeing efficacy of a plasma in so many immunoglobulin Related Disorders like igg4 related disease, like my senior gravis, the chance to bring it to additional um, Auto antibody mediated immune conditions. Um, it's just a great chance to help patients um, with these severe diseases.
in some cases, there are signals from CD 20s that we intend to follow up with a a broader more active, um and hopefully much more convenient, um, a plasma
Speaker #2: And we believe that we can do better than that . So let's let's hope for that best outcome in those clinical trials on Repatha , I alluded to what our strategy is .
Murdo Gordon: We are excited by the landmark data that were revealed at the American Heart Association last year in November, where we can now clearly promote Repatha for the prevention of first heart attack or first stroke in a high-risk patient population or and/or a high-risk primary prevention population. And so, that is our focus right now, and we are the only PCSK9 that has both secondary and primary prevention data in our label. The VESALIUS data are being met very positively by both cardiologists and primary care physicians, in particular for the primary care physician, for the diabetes patients that were enrolled in the trial, who did very well. So we are focused on making sure there's high awareness of these data.
Murdo Gordon: We are excited by the landmark data that were revealed at the American Heart Association last year in November, where we can now clearly promote Repatha for the prevention of first heart attack or first stroke in a high-risk patient population or and/or a high-risk primary prevention population. And so, that is our focus right now, and we are the only PCSK9 that has both secondary and primary prevention data in our label. The VESALIUS data are being met very positively by both cardiologists and primary care physicians, in particular for the primary care physician, for the diabetes patients that were enrolled in the trial, who did very well. So we are focused on making sure there's high awareness of these data.
Speaker #2: In my opening remarks . We are excited by the landmark data that were revealed at the American Heart Association last year . In November , where we can now clearly promote Repatha for the prevention of first heart attack or first stroke in a high risk patient population or or a high risk primary prevention population .
Autoimmune hepatitis, which I mentioned earlier, is, associated with auto antibodies. You see, Ana, you see anti smooth muscle, you see Auntie Acton, you see, Auntie Elsie 1. Um, and the same is true, though to a lower proportion with cidp as well, where maybe 5 to 10% of patients will have Auto antibodies to what our calls are paranoid proteins. Um and of 155,
Murdo Gordon: Yeah, just the size of the opportunity here is interesting. Roughly, the prevalent pool in the US is estimated to be about 35,000 patients, maybe 7 to 10,000 incident new diagnosed cases per year in the US. So, hopefully we can develop this drug and offer some benefit for these patients, which is yet another steroid-intensive condition, and we believe that we can do better than that. So let's hope for that best outcome in those clinical trials. On Repatha, I alluded to what our strategy is in my opening remarks.
Murdo Gordon: Yeah, just the size of the opportunity here is interesting. Roughly, the prevalent pool in the US is estimated to be about 35,000 patients, maybe 7 to 10,000 incident new diagnosed cases per year in the US. So, hopefully we can develop this drug and offer some benefit for these patients, which is yet another steroid-intensive condition, and we believe that we can do better than that. Let's hope for that best outcome in those clinical trials. On Repatha, I alluded to what our strategy is in my opening remarks.
Speaker #2: And so that is our focus right now . And we are the only Pcsk9 that has both secondary and primary prevention data in our label .
CNT and 1, I could go on for a long time. And so, this biology being driven by the compartment that a plasma targets makes for a really great chance to extend the benefits of targeting B cells. Um, in both of these conditions, Moreau.
Speaker #2: The Vesalius data are being met very positively by both cardiologists and primary care physicians in particular for the primary care physician for the diabetes patients that were enrolled in the trial , who did very well we .
Murdo Gordon: Repatha enjoys great access broadly, preferred on national template formularies by PBMs and health plans around the country and around the world. And of course, we know that there's an immense amount of trust now in the profile by prescribers, and for the millions of patients that have received treatment and are taking Repatha, there's strong acceptance that every 2-week injection to lower cholesterol to the 45 mg/dL target dose that was achieved in the Repatha arm in VESALIUS, so that patients can reduce their cardiovascular risk. So we've got a lot to talk about.
Murdo Gordon: Repatha enjoys great access broadly, preferred on national template formularies by PBMs and health plans around the country and around the world. And of course, we know that there's an immense amount of trust now in the profile by prescribers, and for the millions of patients that have received treatment and are taking Repatha, there's strong acceptance that every 2-week injection to lower cholesterol to the 45 mg/dL target dose that was achieved in the Repatha arm in VESALIUS, so that patients can reduce their cardiovascular risk. So we've got a lot to talk about.
Speaker #2: So are sure making on focused there's high awareness of these data enjoys . Repatha great access broadly preferred on national template formularies by PBMs and health plans around the country and around the world .
Murdo Gordon: We are excited by the landmark data that were revealed at the American Heart Association last year in November, where we can now clearly promote Repatha for the prevention of first heart attack or first stroke in a high-risk patient population or and/or a high-risk primary prevention population. That is our focus right now, and we are the only PCSK9 that has both secondary and primary prevention data in our label. The VESALIUS data are being met very positively by both cardiologists and primary care physicians, in particular for the primary care physician, for the diabetes patients that were enrolled in the trial, who did very well. We are focused on making sure there's high awareness of these data.
Murdo Gordon: We are excited by the landmark data that were revealed at the American Heart Association last year in November, where we can now clearly promote Repatha for the prevention of first heart attack or first stroke in a high-risk patient population or and/or a high-risk primary prevention population. That is our focus right now, and we are the only PCSK9 that has both secondary and primary prevention data in our label. The VESALIUS data are being met very positively by both cardiologists and primary care physicians, in particular for the primary care physician, for the diabetes patients that were enrolled in the trial, who did very well. We are focused on making sure there's high awareness of these data.
Speaker #2: And of course , we we know that there's an immense amount of trust now in the profile by prescribers . And for the millions of patients that have received treatment and are taking repatha their strong acceptance that a every two week injection to lower cholesterol to the 45mg per deciliter target dose that was achieved in the repatha arm in basileus , so that patients can reduce their cardiovascular risk .
Yeah, just the size of the opportunity here is interesting. Um, roughly the prevalent pool in the US is estimated to be about 35,000 patients, maybe 7 to 10 thousand incident, new diagnosed cases per year in the US. So, um, hopefully we can, uh, develop this drug and offer some benefit for, for these patients, um, which is yet another steroid intensive condition and, uh, we believe that we can do better than that. So let's let's let's hope for that best. Uh, I would come in those clinical trials on repatha. Um, I I alluded to what our strategy is. In my opening remarks. We are
Murdo Gordon: We've maintained all along that there is a lot of room in this market for other therapies to come in, but they will not have the data, package, and profile that Repatha has established, and we'll continue to remind prescribers and others about that. Thank you.
Murdo Gordon: We've maintained all along that there is a lot of room in this market for other therapies to come in, but they will not have the data, package, and profile that Repatha has established, and we'll continue to remind prescribers and others about that. Thank you.
Speaker #2: So we've got a lot to talk about . I we've maintained all along that there is a lot of room in this market for other therapies to come in , but they they will not have the data package .
Speaker #2: And profile that Repatha has established . And we'll continue to remain others about and you . that . prescribers
Robert Bradway: Okay, let's go to the next question.
Robert Bradway: Okay, let's go to the next question.
Operator: Thank you, Salveen. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.
Operator: Thank you, Salveen. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.
Speaker #4: go to the Okay . Let's question next .
Murdo Gordon: Repatha enjoys great access, broadly preferred on national template formularies by PBMs and health plans around the country and around the world. And of course, we, we know that there's an immense amount of trust now in the profile by prescribers, and for the millions of patients that have received treatment and are taking Repatha, there's strong acceptance that a every two-week injection to lower cholesterol to the 45 mg/dL target dose that was achieved in the Repatha arm in VESALIUS-CV, so that patients can reduce their cardiovascular risk. So we've got a lot to talk about. I, I...
Murdo Gordon: Repatha enjoys great access, broadly preferred on national template formularies by PBMs and health plans around the country and around the world. And of course, we, we know that there's an immense amount of trust now in the profile by prescribers, and for the millions of patients that have received treatment and are taking Repatha, there's strong acceptance that a every two-week injection to lower cholesterol to the 45 mg/dL target dose that was achieved in the Repatha arm in VESALIUS-CV, that patients can reduce their cardiovascular risk. We've got a lot to talk about. I, I...
Mohit Bansal: Great, thank you very much for taking my question, and congrats on all the good progress here. Maybe, like, just, again, the question on PCSK9, and Repatha at this point. So Murdo, can you please remind us what percentage of your prescriptions are coming from primary care at this point? And with the VESALIUS data, like, how do you see, the primary care segment of the market evolving over time? Thank you.
Mohit Bansal: Great, thank you very much for taking my question, and congrats on all the good progress here. Maybe, like, just, again, the question on PCSK9, and Repatha at this point. So Murdo, can you please remind us what percentage of your prescriptions are coming from primary care at this point? And with the VESALIUS data, like, how do you see, the primary care segment of the market evolving over time? Thank you.
Speaker #5: you . Thank question comes from Mohit Bansal from Wells Fargo . Please go ahead . Your line is open .
Are, uh, excited by The Landmark data that were revealed, that the American Heart Association, uh, last year in November, um, where we can now um uh, clearly promote repatha for the prevention of first heart attack, or first stroke in a high-risk patient population or and or a high-risk primary prevention population. And so, um, that is our Focus right now and we are the only pcsk9 that has both secondary and primary prevention data in our label. Um, the velious data are being met, very positively, by both cardiologists and primary care. Physicians, in particular, for the primary care, physician for the diabetes patients, that were enrolled in the trial, who did very well. Um, so we are focused on making sure there's High awareness of these data.
Speaker #10: Great . Thank you very much for taking my question . And congrats on all the great progress here . Maybe just again , the question on Pcsk9 and this point .
Speaker #10: can you Repatha at remind us what percentage of your So prescriptions are coming from primary care at this point ? And with the data , how do you see ?
Murdo Gordon: Yeah, thanks, Mohit. I put a number out before the VESALIUS data promotion started, where roughly 40% of our prescriptions were coming from patients who were considered primary prevention, patients who have not yet had an event, where physicians were looking to lower those patients' LDL cholesterol. I would imagine that that will increase and grow over time. What we're seeing is equal interest, quite frankly, from cardiologists who are excited by the VESALIUS data and the consistency of both the primary endpoint, the secondary endpoint, the MI subgroup. Quite frankly, the overall incidence of death in the trial was also something that attracted attention from specialists. So, the cardiology group has seen this as an affirmation of what they were already doing and being aggressive in treating LDL cholesterol.
Murdo Gordon: Yeah, thanks, Mohit. I put a number out before the VESALIUS data promotion started, where roughly 40% of our prescriptions were coming from patients who were considered primary prevention, patients who have not yet had an event, where physicians were looking to lower those patients' LDL cholesterol. I would imagine that that will increase and grow over time. What we're seeing is equal interest, quite frankly, from cardiologists who are excited by the VESALIUS data and the consistency of both the primary endpoint, the secondary endpoint, the MI subgroup. Quite frankly, the overall incidence of death in the trial was also something that attracted attention from specialists. So, the cardiology group has seen this as an affirmation of what they were already doing and being aggressive in treating LDL cholesterol.
Speaker #10: The primary care segment of the market evolving over time ? Thank you .
Speaker #2: Yeah , thanks . I put a number out before the Vesalius data promotion started , where roughly 40% of our prescriptions were coming for from patients who were considered primary prevention patients who have not yet had an event where looking were physicians to lower those patients .
Uh, repatha enjoys great access. Um, broadly, uh, preferred on National template formulas by pbms and health plans around the country and around the world. And of course, um, we we know that there's an immense amount of trust. Now, in the profile by prescribers and for the millions of patients that have, uh, received treatment and are taking repatha. They're strong acceptance that a, uh, every 2 week injection, um, to lower cholesterol to the 45 milligrams, per deciliter, Target dose, that was achieved in the repatha arm in basilius, so that patients can reduce their cardiovascular risk.
Murdo Gordon: We've maintained all along that there is a lot of room in this market for other, therapies to come in, but they, they will not have the data, package, and profile that Repatha has established, and we'll continue to remind prescribers and others, about that. Thank you.
Murdo Gordon: We've maintained all along that there is a lot of room in this market for other, therapies to come in, they, they will not have the data, package, and profile that Repatha has established, and we'll continue to remind prescribers and others, about that. Thank you.
Speaker #2: LDL cholesterol . I would imagine that that will increase . And grow over time . What we're seeing is equal interest , quite frankly , from cardiologists who are excited by the Vesalius data and the consistency of both the primary endpoint , the secondary endpoint , the MI subgroup .
Robert Bradway: Okay, let's go to the next question.
Robert Bradway: Okay, let's go to the next question.
So we've got a lot to talk about. I I we've maintained all along that there is a lot of room in this market for other uh, therapies to come in. But they they will not have the data package and profile, that repatha has established and we'll continue to remain prescribers and others uh about that.
Operator: Thank you, Salveen. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.
Operator: Thank you, Salveen. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.
Thank you. Okay, let's go to the next question.
Mohit Bansal: Great, thank you very much for taking my question, and congrats on all the good progress here. Maybe, like, just again, the question on PCSK9, and Repatha at this point. So Murdo, can you please remind us what percentage of your prescriptions are coming from primary care at this point? And with the VESALIUS data, like, how do you see the primary care segment of the market evolving over time? Thank you.
Mohit Bansal: Great, thank you very much for taking my question, and congrats on all the good progress here. Maybe, like, just again, the question on PCSK9, and Repatha at this point. Murdo, can you please remind us what percentage of your prescriptions are coming from primary care at this point? With the VESALIUS data, like, how do you see the primary care segment of the market evolving over time? Thank you.
Thank you saline. Our next question comes from Mohit, bansal from Wells. Fargo, please go ahead. Your line is open.
Speaker #2: Quite frankly , the overall incidence of death in the trial was also something that attracted attention from specialists . So the cardiology group has seen this as an affirmation of what they were already doing .
Murdo Gordon: Primary care physicians, as I mentioned, are much more intent and aligned to adding Repatha to the optimized statin therapy that most patients are on. As for how much, we don't give product specific guidance, but hopefully you can tell I am extremely excited about the momentum that we have on Repatha right now. I'm really pleased with the execution of our teams around the world. We've made incremental investments in advance of the opportunity of promoting the VESALIUS data, and I expect that momentum to continue.
Murdo Gordon: Primary care physicians, as I mentioned, are much more intent and aligned to adding Repatha to the optimized statin therapy that most patients are on. As for how much, we don't give product specific guidance, but hopefully you can tell I am extremely excited about the momentum that we have on Repatha right now. I'm really pleased with the execution of our teams around the world. We've made incremental investments in advance of the opportunity of promoting the VESALIUS data, and I expect that momentum to continue.
Speaker #2: And being aggressive in treating LDL cholesterol and primary care physicians . As I mentioned , are much more intent and aligned to adding repatha to the the optimized statin therapy that most patients are on .
Murdo Gordon: Yeah, thanks, Mohit. I put a number out before the VESALIUS data promotion started, where roughly 40% of our prescriptions were coming from patients who were considered primary prevention, patients who have not yet had an event, where physicians were looking to lower those patients' LDL cholesterol. I would imagine that that will increase and grow over time. What we're seeing is equal interest, quite frankly, from cardiologists who are excited by the VESALIUS data and the consistency of both the primary endpoint, the secondary endpoint, the MI subgroup. Quite frankly, the overall incidence of death in the trial was also something that attracted attention from specialists. So, the cardiology group has seen this as an affirmation of what they were already doing and being aggressive in treating LDL cholesterol.
Murdo Gordon: Yeah, thanks, Mohit. I put a number out before the VESALIUS data promotion started, where roughly 40% of our prescriptions were coming from patients who were considered primary prevention, patients who have not yet had an event, where physicians were looking to lower those patients' LDL cholesterol. I would imagine that that will increase and grow over time. What we're seeing is equal interest, quite frankly, from cardiologists who are excited by the VESALIUS data and the consistency of both the primary endpoint, the secondary endpoint, the MI subgroup. Quite frankly, the overall incidence of death in the trial was also something that attracted attention from specialists. So, the cardiology group has seen this as an affirmation of what they were already doing and being aggressive in treating LDL cholesterol.
What percentage of your prescriptions are coming from primary care at this point, and with the Vasilius data, how do you see the primary care segment of the market evolving over time? Thank you.
Speaker #2: for how As much we don't give product specific guidance , hopefully can you but tell I am the excited about extremely momentum that we have on Repatha right now .
Speaker #2: I'm really pleased with the execution of our teams around the world . We've made incremental investments in advance of the opportunity of promoting the Vesalius data , expect that and I momentum to continue .
Robert Bradway: Okay, thank you. Let's go to the next question.
Robert Bradway: Okay, thank you. Let's go to the next question.
Operator: Thank you, Mohit. Our next question comes from Louise Chen from Scotiabank. Please go ahead. Your line is open.
Operator: Thank you, Mohit. Our next question comes from Louise Chen from Scotiabank. Please go ahead. Your line is open.
Speaker #4: Okay . Let's go to the next question .
Louise Chen: Hi, thanks for taking my question. I wanted to ask you about TEPEZZA and your thoughts on another potential competitor coming to market, and then also where you stand with AMG 732 for TED. Thank you.
Louise Chen: Hi, thanks for taking my question. I wanted to ask you about TEPEZZA and your thoughts on another potential competitor coming to market, and then also where you stand with AMG 732 for TED. Thank you.
Speaker #5: Thank you . Our next question comes from Louise Chen from Scotiabank . Please go ahead . Your line is open .
Speaker #11: Hi . Thanks for taking my question . I wanted to ask you about Capezza and your thoughts on another potential competitor coming to market .
Robert Bradway: Okay, great. Maybe, again, we could do this in two, two chunks. Jay, you want to talk about the-
Robert Bradway: Okay, great. Maybe, again, we could do this in two, two chunks. Jay, you want to talk about the-
Speaker #11: And then also where you stand with AMG 732 for Ted . Thank you .
James Bradner: Sure.
James Bradner: Sure.
Robert Bradway: clinical piece, and then Murdo, talk about the commercial piece.
Robert Bradway: clinical piece, and then Murdo, talk about the commercial piece.
Murdo Gordon: And primary care physicians, as I mentioned, are much more intent and aligned to adding Repatha to the optimized statin therapy that most patients are on. As for how much, we don't give product specific guidance, but hopefully you can tell I am extremely excited about the momentum that we have on Repatha right now. I'm really pleased with the execution of our teams around the world. We've made incremental investments in advance of the opportunity of promoting the VESALIUS data, and I expect that momentum to continue.
Murdo Gordon: Primary care physicians, as I mentioned, are much more intent and aligned to adding Repatha to the optimized statin therapy that most patients are on. As for how much, we don't give product specific guidance, hopefully you can tell I am extremely excited about the momentum that we have on Repatha right now. I'm really pleased with the execution of our teams around the world. We've made incremental investments in advance of the opportunity of promoting the VESALIUS data, and I expect that momentum to continue.
Speaker #4: Okay , great . Maybe we can we can do this in two , two chunks . Jay , you want to talk about the clinical piece and then talk about the commercial piece .
James Bradner: Thanks, Louise. Tepezza is proving to be just a very important medicine for the management of thyroid eye disease. We have established a very strong evidence base in both the high clinical activity score and lower clinical activity score patient populations, and are quite proud of this data generation, and also the apparent impact that it's having on patients being treated today. We have an ongoing subcutaneous phase III clinical study in moderate to severe active TED, fully enrolled, as we had shared, and we expect to complete this study in the second half of this year. So we have a really terrific medicine that's increasingly a standard of care, that's helping a lot of patients, and a strong data set that it sits on top of. Before handing off to Murdo, I'll just quickly comment on AMG 732.
James Bradner: Thanks, Louise. Tepezza is proving to be just a very important medicine for the management of thyroid eye disease. We have established a very strong evidence base in both the high clinical activity score and lower clinical activity score patient populations, and are quite proud of this data generation, and also the apparent impact that it's having on patients being treated today. We have an ongoing subcutaneous phase III clinical study in moderate to severe active TED, fully enrolled, as we had shared, and we expect to complete this study in the second half of this year. So we have a really terrific medicine that's increasingly a standard of care, that's helping a lot of patients, and a strong data set that it sits on top of. Before handing off to Murdo, I'll just quickly comment on AMG 732.
Yeah. Thanks Mo. I I put a number before the vassilios data promotion started where roughly 40% of our prescriptions were coming for from patients who were considered primary prevention patients, who have not yet had an event where Physicians were looking to, uh, lower those patients, uh, LDL cholesterol. Um, I would imagine that, that will increase and grow over time. Uh, what we are seeing is equal interest, quite frankly from cardiologists who are excited by the vasilia's data and the consistency of, um, both the primary endpoint, the secondary endpoint, the me subgroup, uh, quite frankly, the the overall incidence of of death in the trial, was also something that attracted attention from Specialists. So, um, the the cardiology group has seen this as an affirmation of what they were already doing and being aggressive and treating LDL cholesterol and primary care. Physicians, as I mentioned,
Speaker #1: Thanks , Louise . It's is proving to be just a very important medicine for the management of thyroid eye disease . We have established a very strong evidence base .
Speaker #1: the In high clinical activity score and lower clinical score . Patient populations , and are quite of this data proud generation . And also the apparent impact that it's having on patients being treated today .
Speaker #1: We have an ongoing subcutaneous phase three clinical study in moderate to severe active Ted , a fully enrolled as we had shared , and we expect to complete this study in the second half of this year .
Robert Bradway: Okay, thank you. Let's go to the next question.
Robert Bradway: Okay, thank you. Let's go to the next question.
Um are much more uh intent and uh aligned to adding roopatha to the the the optimized Statin therapy that most patients are on um, as for how much we don't give uh product uh, specific guidance. But hopefully you can tell I am extremely excited about the momentum that we have on repatha right now. I'm really pleased with the execution of our teams around the world. Uh, We've made incremental investments in advance of the opportunity of promoting the velas data, and I expect that momentum to continue.
Operator: Thank you, Mohit. Our next question comes from Louise Chen from Scotiabank. Please go ahead. Your line is open.
Operator: Thank you, Mohit. Our next question comes from Louise Chen from Scotiabank. Please go ahead. Your line is open.
Okay, thank you. Let's go to the next question.
Speaker #1: So we have a really terrific medicine that's increasingly a standard of care . That's helping a lot of patients . And a strong data sits on top of set that it before heading off to murder .
Louise Chen: Hi, thanks for taking my question. I wanted to ask you about TEPEZZA and your thoughts on another potential competitor coming to market, and then also where you stand with AMG 732 for TED. Thank you.
Louise Chen: Hi, thanks for taking my question. I wanted to ask you about TEPEZZA and your thoughts on another potential competitor coming to market, and then also where you stand with AMG 732 for TED. Thank you.
Thank you Mohit. Our next question, comes from Louise Chen from Scotia Bank, please go ahead. Your line is open
James Bradner: Thank you for noticing. This is an IGF-1R-targeting monoclonal antibody, also achieves subcutaneous administration. Phase 2 study's enrolling, initially studied in moderate to severe and active TED, and we'll have more to say on that in the future. Murdo?
James Bradner: Thank you for noticing. This is an IGF-1R-targeting monoclonal antibody, also achieves subcutaneous administration. Phase 2 study's enrolling, initially studied in moderate to severe and active TED, and we'll have more to say on that in the future. Murdo?
Speaker #1: I'll just quickly comment on AMG 732 . Thank for you noticing . This is an igf1-r targeting monoclonal antibody . Also achieves subcutaneous administration Phase two studies enrolling initially studied in moderate to severe and active Ted .
Robert Bradway: Okay, great. Maybe, again, we could do this in two, two chunks. Jay, you want to talk about the-
Robert Bradway: Okay, great. Maybe, again, we could do this in two, two chunks. Jay, you want to talk about the-
And another potential competitor coming to Market and then also where you stand with AMG 732 for Ted. Thank you.
Jay Olson: Sure.
Jay Bradner: Sure.
Murdo Gordon: Yeah, thanks, Jay. As Jay mentioned, we're expanding our treatment for patients with thyroid eye disease into the lower clinical activity score patient population, who tend to be managed by different specialists than the higher clinical activity score patients. We have historically been able to drive very strong penetration with oculoplastic surgeons and general ophthalmologists. We're expanding our prescribing base to include endocrinologists. We made investments at the beginning of last year, and those investments are starting to return now by an increased base of endocrinologists prescribing. So that's in the US, and we expect that we'll continue to broaden our treatment of the low clinical activity score patients while maintaining our share of the higher clinical activity score patients. But also our international launches. Our launch in Japan has gone extremely well.
Murdo Gordon: Yeah, thanks, Jay. As Jay mentioned, we're expanding our treatment for patients with thyroid eye disease into the lower clinical activity score patient population, who tend to be managed by different specialists than the higher clinical activity score patients. We have historically been able to drive very strong penetration with oculoplastic surgeons and general ophthalmologists. We're expanding our prescribing base to include endocrinologists. We made investments at the beginning of last year, and those investments are starting to return now by an increased base of endocrinologists prescribing. So that's in the US, and we expect that we'll continue to broaden our treatment of the low clinical activity score patients while maintaining our share of the higher clinical activity score patients. But also our international launches. Our launch in Japan has gone extremely well.
Robert Bradway: clinical piece, and then Murdo, talk about the commercial piece?
Robert Bradway: clinical piece, and then Murdo, talk about the commercial piece?
Jay Olson: Thanks, Louise. Tepezza is proving to be just a very important medicine for the management of thyroid eye disease. We have established a very strong evidence base in both the high clinical activity score and lower clinical activity score patient populations, and are quite proud of this data generation, and also the apparent impact that it's having on patients being treated today. We have an ongoing subcutaneous phase III clinical study in moderate to severe active TED, fully enrolled, as we had shared, and we expect to complete this study in the second half of this year. So we have a really terrific medicine that's increasingly a standard of care, that's helping a lot of patients, and a strong data set that it sits on top of. Before handing off to Murdo, I'll just quickly comment on AMG 732.
Jay Bradner: Thanks, Louise. TEPEZZA is proving to be just a very important medicine for the management of thyroid eye disease. We have established a very strong evidence base in both the high clinical activity score and lower clinical activity score patient populations, and are quite proud of this data generation, and also the apparent impact that it's having on patients being treated today. We have an ongoing subcutaneous phase III clinical study in moderate to severe active TED, fully enrolled, as we had shared, and we expect to complete this study in the second half of this year. So we have a really terrific medicine that's increasingly a standard of care, that's helping a lot of patients, and a strong data set that it sits on top of. Before handing off to Murdo, I'll just quickly comment on AMG 732.
Speaker #1: And we'll have more to say on that in the future .
Speaker #2: Yeah , thanks Jay , Jay . . We're mentioned expanding our for treatment patients with thyroid eye disease the lower into clinical score .
Speaker #2: Yeah , thanks Jay , Jay . . We're mentioned expanding our for treatment patients with thyroid eye disease the lower into clinical activity Patient population who tend to be managed by different specialists than the higher clinical activity score .
Speaker #2: Patients . We have historically been able to drive very strong penetration with oculoplastic surgeons and general ophthalmologists . We are expanding our prescribing base to include endocrinologists .
Okay, great. Maybe we can we could do this in 2 2 chunks J. You want to talk about the clinical piece and then Moreau talk about the commercial piece. Thanks Louise. Um, to pezza is proving to be just a very important medicine for the management of thyroid eye disease. Um, we have, um, established a very strong evidence base. Um, in both the high clinical activity, score and lower clinical activity score, patient, populations and are quite proud of this data generation and also the apparent.
Speaker #2: We made the beginning of last year , and those investments are starting to return now by an increased base of endocrinologists prescribing . So that's in the US and we expect that we'll continue to broaden our treatment of the low clinical activity score .
Jay Olson: Thank you for noticing. This is an IGF-1R-targeting monoclonal antibody that also achieves subcutaneous administration. Phase II study is enrolling, initially studied in moderate to severe inactive TED, and we'll have more to say on that in the future. Murdo?
Jay Bradner: Thank you for noticing. This is an IGF-1R-targeting monoclonal antibody that also achieves subcutaneous administration. Phase II study is enrolling, initially studied in moderate to severe inactive TED, and we'll have more to say on that in the future. Murdo?
Speaker #2: Patients while maintaining our share of the higher clinical activity score . Patients , also our but international launches , our launch in Japan has gone extremely well .
Murdo Gordon: We're seeing nice uptake there. We're seeing a very well-received product for higher clinical activity score patients, and we're in the process of launching in multiple markets around the world as we speak. So, overall, Tepezza will be a good growth driver for us this year.
Murdo Gordon: We're seeing nice uptake there. We're seeing a very well-received product for higher clinical activity score patients, and we're in the process of launching in multiple markets around the world as we speak. So, overall, Tepezza will be a good growth driver for us this year.
Speaker #2: We're seeing nice uptake there . We're seeing very well received product for activity score patients . higher clinical And we're in the process of launching in multiple markets around the world as we speak .
Murdo Gordon: Yeah. Thanks, Jay. As Jay mentioned, we're expanding our treatment for patients with thyroid eye disease into the lower clinical activity score patient population, who tend to be managed by different specialists than the higher clinical activity score patients. We have historically been able to drive very strong penetration with oculoplastic surgeons and general ophthalmologists. We're expanding our prescribing base to include endocrinologists. We made investments at the beginning of last year, and those investments are starting to return now by an increased base of endocrinologists prescribing. So that's in the US, and we expect that we'll continue to broaden our treatment of the low clinical activity score patients while maintaining our share of the higher clinical activity score patients. But also our international launches. Our launch in Japan's gone extremely well.
Murdo Gordon: Yeah. Thanks, Jay. As Jay mentioned, we're expanding our treatment for patients with thyroid eye disease into the lower clinical activity score patient population, who tend to be managed by different specialists than the higher clinical activity score patients. We have historically been able to drive very strong penetration with oculoplastic surgeons and general ophthalmologists. We're expanding our prescribing base to include endocrinologists. We made investments at the beginning of last year, and those investments are starting to return now by an increased base of endocrinologists prescribing. So that's in the US, and we expect that we'll continue to broaden our treatment of the low clinical activity score patients while maintaining our share of the higher clinical activity score patients. Also our international launches. Our launch in Japan's gone extremely well.
Robert Bradway: Thank you. Let's go to the next question.
Robert Bradway: Thank you. Let's go to the next question.
Speaker #2: So overall , will Topaza be a good growth driver for us this year .
Operator: Thank you, Louise. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead, your line is open.
Operator: Thank you, Louise. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead, your line is open.
Speaker #4: Thank you . Let's go to the next question .
Terence Flynn: Hi, thanks for taking the question. I had one on the MariTide phase 3 program. Appreciate all the details today, but just was wondering if you have any update in terms of how to think about the design of the type 2 diabetes CVOT trial, particularly the control arm, as I know that's something that you guys were debating here post the, you know, seeing some of the data from some of the competitors, but just wondering how you're thinking about control arm in that setting. Thank you.
Terence Flynn: Hi, thanks for taking the question. I had one on the MariTide phase 3 program. Appreciate all the details today, but just was wondering if you have any update in terms of how to think about the design of the type 2 diabetes CVOT trial, particularly the control arm, as I know that's something that you guys were debating here post the, you know, seeing some of the data from some of the competitors, but just wondering how you're thinking about control arm in that setting. Thank you.
Speaker #5: Thank you . Our next question comes from Terence Flynn from Morgan Stanley . Please go ahead . Your line is open .
Impact that it's having on patients being treated today. Um, we um, have a ongoing subcutaneous phase 3, clinical study in moderate to severe active. Ted a fully enrolled as we had shared and we expect to complete this study in the second half of this year. So we have a really terrific medicine that's increasingly a standard of care, that's helping a lot of patience um and a strong data set that it sits on top of before handing off to murder, I'll just quickly. Comment on AMG 732, thank you for noticing. This is an igf1r targeting. Monoclonal antibody also achieves. Um, subcutaneous Administration based 2 studies enrolling, um, initially studied in moderate to severe and active Ted and we'll have more to say on that in the future or up. Yep, thanks t. As Jay mentioned, um, we're expanding our, uh, treatment, uh, or patients with thyroid eye disease, into the lower clinical activity score, patient population, who tend to be managed by different Specialists than the higher clinical activities.
Speaker #12: for taking the Hi . Thanks question . I had one on the phase three program . I appreciate all the details today , but just was wondering if you have any update in terms of how about the to think design of the type two diabetes Cvot trial , particularly the control arm , as I know that you that's debating here .
Robert Bradway: Sure. Jay, you wanna-
Robert Bradway: Sure. Jay, you wanna-
Speaker #12: Post the something that you know , seeing some guys were of the data from some of the competitors , but just wondering how you're thinking about control arm in that Thank setting .
James Bradner: Sure, I'm happy to share, Terence. We're just thrilled by the opportunity to develop MariTide for patients with type 2 diabetes, and this is really where we see a potential paradigm shift in the management of that disease. In my medical training, we practiced with insulin and insufficient orals and titrating dosing, and here we have a medicine that can be dosed monthly. We've seen efficacy in chronic weight management bimonthly. We've recently described maintenance approach using quarterly dosing. This is just a new paradigm in management of diabetes. We've shared the major insights at J.P. Morgan from the phase 2 type 2 diabetes study, which is ongoing. There are additional parts to this trial. It's importantly given us an experience with low BMI patients and also seeing A1C across the dose range.
James Bradner: Sure, I'm happy to share, Terence. We're just thrilled by the opportunity to develop MariTide for patients with type 2 diabetes, and this is really where we see a potential paradigm shift in the management of that disease. In my medical training, we practiced with insulin and insufficient orals and titrating dosing, and here we have a medicine that can be dosed monthly. We've seen efficacy in chronic weight management bimonthly. We've recently described maintenance approach using quarterly dosing. This is just a new paradigm in management of diabetes. We've shared the major insights at J.P. Morgan from the phase 2 type 2 diabetes study, which is ongoing. There are additional parts to this trial. It's importantly given us an experience with low BMI patients and also seeing A1C across the dose range.
Speaker #12: you .
They score patients. Um, we have historically been able to drive very strong penetration with oculoplastic surgeons and general ophthalmologists. We are expanding our prescribing base to include endocrinologists. We made investments at the beginning of last year, and those investments are starting to return now by an increased base of endocrinologists prescribing. So that's in the US, and we expect that we'll continue to broaden our treatment of the—
Speaker #4: Sure . Jay , you want to . Sure .
Speaker #1: I'm share , happy to Terrance . We're just thrilled by the opportunity to develop maritime for patients with type two diabetes . And this is really we where see a potential paradigm shift in the management of that disease .
Murdo Gordon: We're seeing nice uptake there. We're seeing a very well-received product for higher clinical activity score patients, and we're in the process of launching in multiple markets around the world as we speak. So, overall, TEPEZZA will be a good growth driver for us this year.
Murdo Gordon: We're seeing nice uptake there. We're seeing a very well-received product for higher clinical activity score patients, and we're in the process of launching in multiple markets around the world as we speak. So, overall, TEPEZZA will be a good growth driver for us this year.
Speaker #1: training , In my medical we practiced with and insulin insufficient And orals . titrating dosing and here we have a medicine that can be dosed monthly .
Speaker #1: We've seen efficacy in chronic weight management bimonthly . recently We've described maintenance approach using quarterly dosing . This is just a new paradigm in the management of diabetes .
Robert Bradway: Thank you. Let's go to the next question.
Robert Bradway: Thank you. Let's go to the next question.
Clinical activity score patients while maintaining, uh, our share of the, the higher clinical activity score patients. But also our International launches are launched in Japan's gone, extremely well. Uh, we're seeing nice uptake there. We're seeing a very, um, uh, well-received product, uh, for higher clinical activity, score patients. And we're in the process of launching in multiple markets around the world as we speak. So, um, uh, overall teza will be a a good growth driver for us this year.
Operator: Thank you, Louise. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.
Operator: Thank you, Louise. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.
Thank you. Let's go to the next question.
Terence Flynn: Hi. Thanks for taking the question. I had one on the MariTide phase 3 program. Appreciate all the details today, but just was wondering if you have any update in terms of how to think about the design of the type 2 diabetes CVOT trial, particularly the control arm, as I know that's something that you guys were debating here post the, you know, seeing some of the data from some of the competitors, but just wondering how you're thinking about control arm in that setting. Thank you.
Terence Flynn: Hi. Thanks for taking the question. I had one on the MariTide phase 3 program. Appreciate all the details today, just was wondering if you have any update in terms of how to think about the design of the type 2 diabetes CVOT trial, particularly the control arm, as I know that's something that you guys were debating here post the, you know, seeing some of the data from some of the competitors, just wondering how you're thinking about control arm in that setting. Thank you.
Thank you, Louise. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.
Speaker #1: We've shared the major insights at J.P. Morgan from phase two type two diabetes study , which is ongoing . There are additional parts to this trial .
James Bradner: So, the robust findings of this trial position us very well to start to pursue phase three clinical investigation. The specific design of these studies, control arms, and the patients recruited will be a subject for a future engagement.
Speaker #1: It's importantly given us an experience with low BMI patients and also seeing a1-c across the dose range . And so the robust findings of this trial position us very well to start to pursue phase three clinical investigation .
James Bradner: So, the robust findings of this trial position us very well to start to pursue phase three clinical investigation. The specific design of these studies, control arms, and the patients recruited will be a subject for a future engagement.
Um, appreciate all the details today. But just was wondering if you have any update in terms of how to think about the design of the type 2 diabetes CVOT trial, particularly the control arm. As I know that's something that you guys were debating here, post the, um, you know, seeing some of the data from some of the competitors. But just wondering how you're thinking about the control arm in that setting. Thank you.
Robert Bradway: Sure. Jay, you wanna-
Robert Bradway: Sure. Jay, you wanna-
Jay Olson: Sure, I'm happy to share, Terence. We're just thrilled by the opportunity to develop MariTide for patients with type 2 diabetes, and this is really where we see a potential paradigm shift in the management of that disease. In my medical training, we practiced with insulin and insufficient orals and titrating dosing, and here we have a medicine that can be dosed monthly. We've seen efficacy in chronic weight management bimonthly. We've recently described a maintenance approach using quarterly dosing. This is just a new paradigm in management of diabetes. We've shared the major insights at J.P. Morgan from the phase II type 2 diabetes study, which is ongoing. There are additional parts to this trial. It's importantly given us an experience with low BMI patients, and also seeing A1C across the dose range.
Jay Bradner: Sure, I'm happy to share, Terence. We're just thrilled by the opportunity to develop MariTide for patients with type 2 diabetes, and this is really where we see a potential paradigm shift in the management of that disease. In my medical training, we practiced with insulin and insufficient orals and titrating dosing, and here we have a medicine that can be dosed monthly. We've seen efficacy in chronic weight management bimonthly. We've recently described a maintenance approach using quarterly dosing. This is just a new paradigm in management of diabetes. We've shared the major insights at J.P. Morgan from the phase II type 2 diabetes study, which is ongoing. There are additional parts to this trial. It's importantly given us an experience with low BMI patients, and also seeing A1C across the dose range.
Speaker #1: The specific design of these studies control arms and the patients recruited will be a subject for a future engagement .
Robert Bradway: Okay, thank you. Let's go to the next question.
Robert Bradway: Okay, thank you. Let's go to the next question.
Operator: Thank you, Terence. Our next question comes from Chris Schott from J.P. Morgan. Please go ahead, your line is open.
Operator: Thank you, Terence. Our next question comes from Chris Schott from JPMorgan. Please go ahead, your line is open.
Speaker #4: Okay . Thank you . the next Let's go to question .
Chris Schott: Great. Thanks so much. Just another MiratiTide question, and just on the topic of less frequent than monthly dosing. It certainly seems like there could be a trade-off here, where even more infrequent dosing, you know, would obviously be a huge benefit, even if it was associated with a bit less weight loss. I guess, so as you're thinking about just pushing the program beyond monthly, what profile do you think you'd need to see for that to have a role in the market? Are there minimum efficacy bars you're looking at? And just in general, what is your confidence about the ability to push this beyond monthly? Thanks so much.
Chris Schott: Great. Thanks so much. Just another MiratiTide question, and just on the topic of less frequent than monthly dosing. It certainly seems like there could be a trade-off here, where even more infrequent dosing, you know, would obviously be a huge benefit, even if it was associated with a bit less weight loss. I guess, so as you're thinking about just pushing the program beyond monthly, what profile do you think you'd need to see for that to have a role in the market? Are there minimum efficacy bars you're looking at? And just in general, what is your confidence about the ability to push this beyond monthly? Thanks so much.
Speaker #5: Thank you . Our next comes from Chris Schott from JP Morgan . Please go ahead . Your line is open .
Speaker #13: Great . Thanks so much . Just another question . And just on the topic of less frequent than monthly dosing , and certainly seems like there could be a trade off here where even more infrequent dosing would huge obviously be a benefit , even if it was associated bit with a less weight loss .
Speaker #13: I guess . So as you think about just pushing the program beyond monthly , what profile do you you'd need think to see for that to have a role in the market ?
Speaker #13: Are there minimum efficacy bars you're looking at ? And just in general , what is your confidence about the ability to push this beyond monthly ?
Robert Bradway: Okay, that's an interesting question. Murdo, do you want to take a shot at what we think we see in the marketplace, and why we believe MariTide has the potential to address what is emerging as a very large unmet need in the field?
Robert Bradway: Okay, that's an interesting question. Murdo, do you want to take a shot at what we think we see in the marketplace, and why we believe MariTide has the potential to address what is emerging as a very large unmet need in the field?
Sure. Jay, you want to sure I'm happy to share Terence. Um we're just thrilled by the opportunity to develop Maritime for patients, with type 2 diabetes. And this is really where we see a potential paradigm shift in the management of that disease. Um, in my medical training, we practice with insulin and and insufficient orals, and titrating dosing. And um, here we have a medicine that can be built monthly. Uh, we've seen epic has seen chronically management, by monthly we've recently described um maintenance approach. Um, using quarterly dosing, this is just the new paradigm in management of diabetes. Um, we've shared the major insights and see if you Morgan from The Phase 2. Type 2 diabetes study which is ongoing there are additional parts to this trial.
Speaker #13: Thanks so much .
Speaker #4: That's an Okay . interesting question . Do you want to take a shot at what we think we see in marketplace , and why we the believe maritime has a potential to address what is emerging as a very large unmet need in the field ?
Jay Olson: The robust findings of this trial position us very well to start to pursue Phase Three clinical investigation. The specific design of these studies, control arms, and the patients recruited will be a subject for a future engagement.
Jay Bradner: The robust findings of this trial position us very well to start to pursue Phase Three clinical investigation. The specific design of these studies, control arms, and the patients recruited will be a subject for a future engagement.
Murdo Gordon: Yeah, I’ll make a few comments here, Bob. Thanks for the opportunity. I think it’s pretty clear, as we look at the market as it exists today, that there’s dissatisfaction with the weekly GLP-1s. And I think you can actually see that in a fairly dramatic way with the advent of oral sema and how rapidly it’s been taken up in the market. That tells you that clearly, patients and prescribers are looking for other opportunities. Now, what I like is the opportunity that we have to deliver at what has been mentioned a couple of times in this call as a paradigm-changing therapy. And that’s, you know, the ability to come into a weekly market, bring a monthly therapy that can achieve similar weight loss in a very well-tolerated regimen.
Murdo Gordon: Yeah, I’ll make a few comments here, Bob. Thanks for the opportunity. I think it’s pretty clear, as we look at the market as it exists today, that there’s dissatisfaction with the weekly GLP-1s. And I think you can actually see that in a fairly dramatic way with the advent of oral sema and how rapidly it’s been taken up in the market. That tells you that clearly, patients and prescribers are looking for other opportunities. Now, what I like is the opportunity that we have to deliver at what has been mentioned a couple of times in this call as a paradigm-changing therapy. And that’s, you know, the ability to come into a weekly market, bring a monthly therapy that can achieve similar weight loss in a very well-tolerated regimen.
Speaker #2: Yeah , I'll make a comments here . few Bob , thanks for the opportunity . I think it's pretty clear as we look at the market as it exists today , that there's dissatisfaction with the one , weekly GLP can and I think you actually see that in a fairly dramatic .
Um, it's importantly giving us an experience with low BMI patients. Um, and also I'm seeing A1C across the dose range. And so, um, the robust findings of this trial position us very well, um, to start to pursue Phase 3 clinical investigation. The specific design of these studies—control arms and the patients, um, recruited—will be a
Robert Bradway: Okay, thank you. Let's go to the next question.
Robert Bradway: Okay, thank you. Let's go to the next question.
Subject for a future engagement.
Operator: Thank you, Terence. Our next question comes from Chris Schott from J.P. Morgan. Please go ahead, your line is open.
Operator: Thank you, Terence. Our next question comes from Chris Schott from J.P. Morgan. Please go ahead, your line is open.
Okay, thank you. Let's go to the next question.
Speaker #2: With the advent of way oral semma and how rapidly it's been taken up in the market , that tells you that clearly patients and prescribers are looking for other opportunities .
Chris Schott: Great. Thanks so much. Just another, Mirati question, and just on the topic of less frequent than monthly dosing. It certainly seems like there could be a trade-off here, where even more infrequent dosing, you know, would obviously be a huge benefit, even if it was associated with a bit less weight loss. I guess, so as you're thinking about just pushing the program beyond monthly, what profile do you think you'd need to see, for that to have a role in the market? Are there minimum efficacy bars you're looking at? And just in general, what is your confidence about the ability to push this beyond monthly? Thanks so much.
Chris Schott: Great. Thanks so much. Just another, MariTide question, and just on the topic of less frequent than monthly dosing. It certainly seems like there could be a trade-off here, where even more infrequent dosing, you know, would obviously be a huge benefit, even if it was associated with a bit less weight loss. I guess, so as you're thinking about just pushing the program beyond monthly, what profile do you think you'd need to see, for that to have a role in the market? Are there minimum efficacy bars you're looking at? Just in general, what is your confidence about the ability to push this beyond monthly? Thanks so much.
Thank you Terrence. Our next question comes from Chris shot from JP Morgan. Please go ahead. Your line is open.
Speaker #2: Now , what I like is the opportunity that we have to deliver what has been mentioned a couple of times in this call as a paradigm changing therapy .
Speaker #2: And that's , you know , the ability to come into a weekly market , bring a monthly therapy that can achieve similar weight loss in a very well tolerated regimen , and then for those who patients achieve their weight goal , for them to convert to every eight week or every 12 week dosing regimen , to maintain that weight and or the metabolic benefits of and I therapy their think that's a pretty compelling offering .
Murdo Gordon: And then for those patients who achieve their weight goal, for them to convert to every 8-week or every 12-week dosing regimen to maintain that weight and/or the metabolic benefits of their therapy. And I think that's a pretty compelling offering. I think that we're targeting that kind of profile, and we'll have multiple ways of generating data to that effect.
Murdo Gordon: And then for those patients who achieve their weight goal, for them to convert to every 8-week or every 12-week dosing regimen to maintain that weight and/or the metabolic benefits of their therapy. And I think that's a pretty compelling offering. I think that we're targeting that kind of profile, and we'll have multiple ways of generating data to that effect.
All right. Great. Uh, thanks so much. Just another uh, Maritime question and just on the topic of less frequent than monthly dosing. It certainly seems like there could be a trade-off here where even more infrequent dosing, you know, would obviously be a huge benefit even if it was associated with a bit less weight loss, I guess. So, as you think about just pushing the program, Beyond monthly, what profile do you think you'd need to see, uh, for that to have a role in the market are there? Minimum, efficacy bars. You're looking at, and just in general. What is your confidence about the ability to push this Beyond monthly? Thanks so much.
Robert Bradway: Okay, that's an interesting question. Murdo, do you want to take a shot at what we think we see in the marketplace, and why we believe MariTide has the potential to address what is emerging as a very large unmet need in the field?
Robert Bradway: Okay, that's an interesting question. Murdo, do you want to take a shot at what we think we see in the marketplace, and why we believe MariTide has the potential to address what is emerging as a very large unmet need in the field?
Murdo Gordon: Yeah. I'll make a few comments here, Bob. Thanks for the opportunity. I think it's pretty clear, as we look at the market as it exists today, that there's dissatisfaction with the weekly GLP-1s. And I think you can actually see that in a fairly dramatic way with the advent of oral semaglutide and how rapidly it's been taken up in the market. That tells you that clearly patients and prescribers are looking for other opportunities. Now, what I like is the opportunity that we have to deliver what has been mentioned a couple of times in this call as a paradigm-changing therapy. And that's, you know, the ability to come into a weekly market, bring a monthly therapy that can achieve similar weight loss in a very well-tolerated regimen.
Murdo Gordon: Yeah. I'll make a few comments here, Bob. Thanks for the opportunity. I think it's pretty clear, as we look at the market as it exists today, that there's dissatisfaction with the weekly GLP-1s. I think you can actually see that in a fairly dramatic way with the advent of oral semaglutide and how rapidly it's been taken up in the market. That tells you that clearly patients and prescribers are looking for other opportunities. Now, what I like is the opportunity that we have to deliver what has been mentioned a couple of times in this call as a paradigm-changing therapy. That's, you know, the ability to come into a weekly market, bring a monthly therapy that can achieve similar weight loss in a very well-tolerated regimen.
Okay, that's an interesting question Moreau. Do you want to take a a shot at what we think we see in the marketplace and why we believe meride has a potential to address. What is emerging as a very large uh, unmet need in the field.
Speaker #2: I think that we're targeting that kind of profile , and we'll have multiple ways of generating data to that effect .
Robert Bradway: Chris, maybe we have Jay just address a piece as well. Go ahead.
Robert Bradway: Chris, maybe we have Jay just address a piece as well. Go ahead.
James Bradner: Yeah, Chris, thanks for the question. If you don't mind, I'm gonna reject part of the premise of your question. This idea of less frequent dosing being an absolute trade-off for efficacy, we're not certain that we will see that. Having observed the large majority of patients maintaining weight on low dose and on quarterly dosing, in the field of obesity, they call this the defended fat mass, and the capacity to avoid weight regain is a sign that the reset of body weight has been achieved. We have seen with all medicines to date, dose-ranging effects on weight loss, and here we might expect to see schedule-ranging effects on weight loss that would be individualized, for patients. And so I, I wouldn't necessarily assume that we'll see a big trade-off, with less frequent dosing of MariTide.
James Bradner: Yeah, Chris, thanks for the question. If you don't mind, I'm gonna reject part of the premise of your question. This idea of less frequent dosing being an absolute trade-off for efficacy, we're not certain that we will see that. Having observed the large majority of patients maintaining weight on low dose and on quarterly dosing, in the field of obesity, they call this the defended fat mass, and the capacity to avoid weight regain is a sign that the reset of body weight has been achieved. We have seen with all medicines to date, dose-ranging effects on weight loss, and here we might expect to see schedule-ranging effects on weight loss that would be individualized, for patients. And so I, I wouldn't necessarily assume that we'll see a big trade-off, with less frequent dosing of MariTide.
Speaker #4: Chris , maybe we have Jay just address a piece as well . Go ahead .
Speaker #1: Yeah . Chris , thanks for the question . If you don't mind , I'm going to reject part of the premise of your question .
Speaker #1: This idea of less frequent dosing being an absolute trade off for efficacy . We're not certain that we will see that , having observed the large majority of patients maintaining weight on low dose and on quarterly dosing , some in the field of obesity , they call this the defended fat mass and the capacity to avoid weight regain is a sign that the reset of body weight has been achieved .
Yeah, I I I'll make a few comments here, Bob, thanks for the opportunity. I think it's pretty clear as we look at the market as it exists today, that there's this satisfaction with the weekly glp ones and I think you can actually see that in a fairly dramatic way with the Advent of um, oral Seema and how rapidly it's been taken up in the market. That tells you that clearly patients and prescribers are looking for other opportunities. Now, what I like is the the opportunity that we have to deliver
Murdo Gordon: Then for those patients who achieve their weight goal, for them to convert to every 8-week or every 12-week dosing regimen to maintain that weight and/or the metabolic benefits of their therapy. I think that's a pretty compelling offering. I think that, we're targeting that kind of profile, and we'll have multiple ways of generating data to that effect.
Murdo Gordon: Then for those patients who achieve their weight goal, for them to convert to every 8-week or every 12-week dosing regimen to maintain that weight and/or the metabolic benefits of their therapy. I think that's a pretty compelling offering. I think that, we're targeting that kind of profile, and we'll have multiple ways of generating data to that effect.
Speaker #1: We have seen with all medicines to date , dose ranging effects on weight loss , and here we might expect to see schedule ranging effects on weight loss .
Speaker #1: That would be individualized patients for . And so I wouldn't assume necessarily we'll see a big trade that off with less frequent dosing of maritime .
Robert Bradway: Okay, thank you. Let's go to the next question.
Robert Bradway: Okay, thank you. Let's go to the next question.
Operator: Thank you, Chris. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.
Operator: Thank you, Chris. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.
Speaker #4: Okay . Thank you . Let's go . Next question .
Umer Raffat: Hi, guys. Thanks for taking my question. I'm really, really lost today. I'm trying to figure out what happened all of a sudden. Why did FDA decide to ask you to pull the ChemoCentryx drug? Was there some litigation or some correspondence? Like, what prompted it in the first place? Then, if I dig in a little more specifically, they're saying that nine patients need to be readjudicated. Is that referring to the primary endpoint on week 26 remission or the week 52 sustained remission? I ask because the week 26 endpoint was non-inferior anyway, so even if you readjudicate those, it's still non-inferior. So I'm just really lost today.
Umer Raffat: Hi, guys. Thanks for taking my question. I'm really, really lost today. I'm trying to figure out what happened all of a sudden. Why did FDA decide to ask you to pull the ChemoCentryx drug? Was there some litigation or some correspondence? Like, what prompted it in the first place? Then, if I dig in a little more specifically, they're saying that nine patients need to be readjudicated. Is that referring to the primary endpoint on week 26 remission or the week 52 sustained remission? I ask because the week 26 endpoint was non-inferior anyway, so even if you readjudicate those, it's still non-inferior. So I'm just really lost today.
Speaker #5: Thank you Chris . Our question comes next from Umer Raffat from Evercore ISI . Please go ahead . Your line is open .
Robert Bradway: Chris, maybe we have Jay just address a piece as well. Go ahead.
Robert Bradway: Chris, maybe we have Jay just address a piece as well. Go ahead.
What has been mentioned? A couple of times in this call as a paradigm changing therapy. And that's, you know, the ability to come into a weekly Market, um, bring a monthly therapy that can um achieve similar uh weight loss in a very well tolerated regimen. And then for those patients who achieve their weight goal for them to convert to every 8 week or every 12 week, dosing regimen to maintain that weight and or the metabolic benefits of their therapy. And, um, I think that's a pretty compelling offering. I think that, um, uh, we're targeting that, uh, kind of profile and, uh, we'll have multiple ways of generating data to that effect.
Jay Olson: Yeah, Chris, thanks for the question. If you don't mind, I'm gonna reject part of the premise of your question, this idea of less frequent dosing being an absolute trade-off for efficacy. We're not certain that we will see that. Having observed the large majority of patients maintaining weight on low dose and on quarterly dosing, in the field of obesity, they call this the defended fat mass, and the capacity to avoid weight regain is a sign that the reset of body weight has been achieved. We have seen with all medicines to date, dose-ranging effects on weight loss, and here we might expect to see schedule-ranging effects on weight loss that would be individualized for patients. And so I wouldn't necessarily assume that we'll see a big trade-off with less frequent dosing of MariTide.
Jay Bradner: Yeah, Chris, thanks for the question. If you don't mind, I'm gonna reject part of the premise of your question, this idea of less frequent dosing being an absolute trade-off for efficacy. We're not certain that we will see that. Having observed the large majority of patients maintaining weight on low dose and on quarterly dosing, in the field of obesity, they call this the defended fat mass, and the capacity to avoid weight regain is a sign that the reset of body weight has been achieved. We have seen with all medicines to date, dose-ranging effects on weight loss, and here we might expect to see schedule-ranging effects on weight loss that would be individualized for patients. I wouldn't necessarily assume that we'll see a big trade-off with less frequent dosing of MariTide.
Speaker #7: Hi guys . Thanks for taking my question .
Chris, maybe we have Jay just address a piece as well. Go ahead. Yeah, Chris, thanks for the question. If
Speaker #14: I'm really , really lost today . I'm trying to figure out what happened all of a sudden . Why did FDA decide to ask you to pull the Chemocentryx Was there some litigation or some correspondence , like what prompted it in the first place ?
You don't mind, I'm going to reject part of the premise of your question—this idea of less frequent dosing being an absolute trade-off for efficacy.
Um we're not certain that we will see that um having observed
Speaker #14: And then if I dig in a little more specifically , they're saying that nine patients need to be re adjudicated . Is that referring to the primary endpoint on week 26 , remission or the week 52 sustained remission ?
Speaker #14: I asked because the week 26 endpoint was non-inferior anyway . So even adjudicate if you So just non-inferior . still lost those , it's .
Robert Bradway: Okay, well, Jay, as Jay, you addressed the question. You may wanna just start at the high altitude, remind people what TAVNEOS is, and say a few words about the disease that it addresses. It's obviously a very small product in our portfolio relative to the other things we have going on, but it may be a medicine that's less familiar to most of our callers.
Robert Bradway: Okay, well, Jay, as Jay, you addressed the question. You may wanna just start at the high altitude, remind people what TAVNEOS is, and say a few words about the disease that it addresses. It's obviously a very small product in our portfolio relative to the other things we have going on, but it may be a medicine that's less familiar to most of our callers.
Speaker #4: Okay , well , Jay , as Jay , you address the question , you may want to just start at the high remind people altitude , what Tavneos is , say a few words about the disease that it addresses .
Speaker #4: Its obviously a very small product in our portfolio relative to the we other things have going on , but it may be a medicine that's less most of our callers .
Robert Bradway: Okay, thank you. Let's go to the next question.
Robert Bradway: Okay, thank you. Let's go to the next question.
James Bradner: Yes, sir. Thanks, Umer. And just by way of background then, ANCA-associated vasculitis is a group of very serious, rare, and destructive inflammatory illnesses that targets blood vessels and can therefore damage vital organs like kidneys, lungs, skin, nerves, and even heart. The prior treatment paradigm before Tavneos was quite toxic. Cyclophosphamide chemotherapy with azathioprine and rituximab, accompanied by long-term steroid use, and chronic use of steroids proved very common, but also very challenging. Hyperglycemia, lipodystrophy, bone health, mood disorders, and immune suppression. And then enter Tavneos, or avacopan. This is an oral complement C5a receptor blocker, and so it blocks complement-mediated destruction.
James Bradner: Yes, sir. Thanks, Umer. And just by way of background then, ANCA-associated vasculitis is a group of very serious, rare, and destructive inflammatory illnesses that targets blood vessels and can therefore damage vital organs like kidneys, lungs, skin, nerves, and even heart. The prior treatment paradigm before Tavneos was quite toxic. Cyclophosphamide chemotherapy with azathioprine and rituximab, accompanied by long-term steroid use, and chronic use of steroids proved very common, but also very challenging. Hyperglycemia, lipodystrophy, bone health, mood disorders, and immune suppression. And then enter Tavneos, or avacopan. This is an oral complement C5a receptor blocker, and so it blocks complement-mediated destruction.
Uh the large majority of patients, maintaining weight on low dose and on quarterly, dosing in the field of obesity. They call this, the defended fat mass and the capacity to avoid weight regain is a sign that the reset of body weight has been achieved. Um, we have seen with all medicines to date dose, ranging effects on weight loss. And here we might expect to see schedule ranging effects on weight loss. That would be individualized um for patients. Um and so I I wouldn't necessarily assume that we'll see a big trade-off with less frequent dosing of maritime.
Operator: Thank you, Chris. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.
Operator: Thank you, Chris. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.
Okay, thank you. Let's go to the next question.
Speaker #1: Yes , sir . Thanks , Umer and just by way of background , then Anca associated vasculitis is a group of serious very , rare and destructive inflammatory illnesses that targets blood vessels therefore and can damage vital organs like kidneys , lungs , skin , nerves , even heart .
Umer Raffat: Hi, guys. Thanks for taking my question. I'm really, really lost today. I'm trying to figure out what happened all of a sudden. Why did FDA decide to ask you to pull the ChemoCentryx drug? Was there some litigation or some correspondence? Like, what prompted it in the first place? And then, if I dig in a little more specifically, they're saying that nine patients need to be readjudicated. Is that referring to the primary endpoint on week 26 remission or the week 52 sustained remission? I ask because the week 26 endpoint was non-inferior anyway, so even if you readjudicate those, it's still non-inferior. So I'm just really lost today.
Umer Raffat: Hi, guys. Thanks for taking my question. I'm really, really lost today. I'm trying to figure out what happened all of a sudden. Why did FDA decide to ask you to pull the ChemoCentryx drug? Was there some litigation or some correspondence? Like, what prompted it in the first place? Then, if I dig in a little more specifically, they're saying that nine patients need to be readjudicated. Is that referring to the primary endpoint on week 26 remission or the week 52 sustained remission? I ask because the week 26 endpoint was non-inferior anyway, even if you readjudicate those, it's still non-inferior. I'm just really lost today.
From evercore isi, please go ahead. Your line is open.
Speaker #1: The prior treatment paradigm for tavneos was quite toxic chemotherapy with azathioprine and rituximab , accompanied by long term steroid use and chronic use of steroids , prove very common , but also very challenging , lipodystrophy , .
Speaker #1: Hyperglycemia bone health , mood disorders , immune suppression and then enter tavneos or avacopan . This is an oral complement factor . Five , a receptor blocker .
Hi guys, thanks for taking my question. I'm really, really lost today. Um, I'm trying to figure out what happened. All of a sudden why did FDA decide to ask you to pull the chemocentryx drug? Was there some litigation or some correspondence? Like what prompted it in the first place. And then if I dig in a little more specifically, they're saying that 9 patients need to be read. Adjudicated is that referring to the primary endpoint on week, 26 or Mission or the week 52 sustained remission. I asked because the week 26 endpoint was not inferior anyway, so even if you read adjudicate those, it's still not inferior. So I'm just really lost today.
Robert Bradway: Okay. Well, Jay, as Jay, you addressed the question. You may wanna just start at the high altitude, remind people what TAVNEOS is, and say a few words about the disease that it addresses. It's obviously a very small product in our portfolio relative to the other things we have going on, but it may be a medicine that's less familiar to most of our callers.
Robert Bradway: Okay. Well, Jay, as Jay, you addressed the question. You may wanna just start at the high altitude, remind people what TAV, it may be a medicine that's less familiar to most of our callers.
Okay. Well, Jay
James Bradner: We acquired TAVNEOS from ChemoCentryx in 2022 after it had been on the market for a year, based on approval for the ADVOCATE phase 3 study that you referenced, as published in the New England Journal. This established the efficacy of TAVNEOS over prednisone steroid tapering for sustained remission out to 52 weeks, when it was added to induction therapy with, at that time, standard of care rituximab and cyclophosphamide. As we shared, the FDA requested a voluntary withdrawal on 16 January. We were surprised by this. There were concerns raised about a process followed by ChemoCentryx to readjudicate primary endpoint results for 9 of the 331 patients. We're in discussions with FDA, and we'll answer questions as we talk with them.
James Bradner: We acquired TAVNEOS from ChemoCentryx in 2022 after it had been on the market for a year, based on approval for the ADVOCATE phase 3 study that you referenced, as published in the New England Journal. This established the efficacy of TAVNEOS over prednisone steroid tapering for sustained remission out to 52 weeks, when it was added to induction therapy with, at that time, standard of care rituximab and cyclophosphamide. As we shared, the FDA requested a voluntary withdrawal on 16 January. We were surprised by this. There were concerns raised about a process followed by ChemoCentryx to readjudicate primary endpoint results for 9 of the 331 patients. We're in discussions with FDA, and we'll answer questions as we talk with them.
Speaker #1: And so it blocks complement mediated destruction . We acquired Tavneos from Chemocentryx in 2022 after it had been on the market for a Based on year .
Speaker #1: approval for the advocate phase three study that you referenced as published in the New England Journal . This established the efficacy of Tavneos over prednisone , steroid tapering for sustained remission out to 52 weeks when it was added to induction therapy with at that time , standard of care .
Jay Olson: Yes, sir. Thanks, Umer, and just by way of background then, ANCA-associated vasculitis is a group of very serious, rare, and destructive inflammatory illnesses that targets blood vessels and can therefore damage vital organs like kidneys, lungs, skin, nerves, even heart. The prior treatment paradigm before TAVNEOS was quite toxic. Cyclophosphamide chemotherapy with azathioprine and rituximab, accompanied by long-term steroid use. And chronic use of steroids proved very common, but also very challenging: hyperglycemia, lipodystrophy, bone health, mood disorders, immune suppression. And then enter TAVNEOS or avacopan. This is an oral complement C5a receptor blocker, and so it blocks complement-mediated destruction.
Jay Bradner: Yes, sir. Thanks, Umer, and just by way of background then, ANCA-associated vasculitis is a group of very serious, rare, and destructive inflammatory illnesses that targets blood vessels and can therefore damage vital organs like kidneys, lungs, skin, nerves, even heart. The prior treatment paradigm before TAVNEOS was quite toxic. Cyclophosphamide chemotherapy with azathioprine and rituximab, accompanied by long-term steroid use. Chronic use of steroids proved very common, also very challenging: hyperglycemia, lipodystrophy, bone health, mood disorders, immune suppression. Then enter TAVNEOS or avacopan. This is an oral complement C5a receptor blocker, and so it blocks complement-mediated destruction.
SJ. You addressed a question you may want to just um start at the High Altitude to remind people what to have NEOS is is say a few words about the disease that IT addresses. It's obviously a very small product in our portfolio, relative to the other things we have going on but uh it may be a medicine that's less familiar to most of our callers.
Customer. And, um,
Speaker #1: Rituximab and cyclophosphamide . As we shared , the FDA requested a voluntary withdrawal on January 16th . We were surprised by this . There were concerns raised about a process followed by chemocentryx to adjudicate primary endpoint results for nine of the 331 patients .
By way of background, then um, uh, ANCA-associated vasculitis is a group of very serious, rare, and destructive inflammatory illnesses that targets blood vessels and can therefore damage vital organs like kidneys, lungs, skin, nerves, even hearts.
Robert Bradway: Okay, let's go on to the next question.
Robert Bradway: Okay, let's go on to the next question.
Speaker #1: And we're in discussions with FDA and we'll answer questions as we talk with them .
Operator: Thank you, Umer. Our next question comes from Alex Hammond from Wolfe Research. Please go ahead. Your line is open.
Operator: Thank you, Umer. Our next question comes from Alex Hammond from Wolfe Research. Please go ahead. Your line is open.
Speaker #4: Okay , let's go on to the next question .
Um the prior treatment, Paradigm for tabos um was quite toxic cycle. Fosfomicina
Alex Hammond: Hey, guys. Thanks for taking the question. So you had another strong quarter with Pavblu. I guess, how do you kind of expect to maintain this leadership position when other manufacturers launch their biosimilars in the second half of the year? I guess, essentially, can you kind of help level-set growth expectations for this year?
Alex Hammond: Hey, guys. Thanks for taking the question. So you had another strong quarter with Pavblu. I guess, how do you kind of expect to maintain this leadership position when other manufacturers launch their biosimilars in the second half of the year? I guess, essentially, can you kind of help level-set growth expectations for this year?
Speaker #5: Thank you . Umar . question Our next comes from Alex Hammond from Wolfe Research . Please go ahead . Your line is open .
Glycemia droopy bone health. Mood disorders. Immune suppression.
And then enter tabio sort of acupan.
Speaker #15: guys . Thanks Hey for taking the question . So you know they're strong quarter with Pavlu I guess . How do you kind of expect to maintain this leadership when other manufacturers launch their biosimilars in the second half of the year ?
Jay Olson: We acquired TAVNEOS from ChemoCentryx in 2022 after it had been on the market for a year, based on approval for the ADVOCATE phase 3 study that you referenced, as published in the New England Journal. This established the efficacy of TAVNEOS over prednisone steroid tapering for sustained remission out to 52 weeks when it was added to induction therapy with, at that time, standard of care rituximab and cyclophosphamide. As we shared, the FDA requested a voluntary withdrawal on 16 January. We were surprised by this. There were concerns raised about the process followed by ChemoCentryx to readjudicate primary endpoint results for nine of the 331 patients. We're in discussions with FDA, and we'll answer questions as we talk with them.
Jay Bradner: We acquired TAVNEOS from ChemoCentryx in 2022 after it had been on the market for a year, based on approval for the ADVOCATE phase 3 study that you referenced, as published in the New England Journal. This established the efficacy of TAVNEOS over prednisone steroid tapering for sustained remission out to 52 weeks when it was added to induction therapy with, at that time, standard of care rituximab and cyclophosphamide. As we shared, the FDA requested a voluntary withdrawal on 16 January. We were surprised by this. There were concerns raised about the process followed by ChemoCentryx to readjudicate primary endpoint results for nine of the 331 patients. We're in discussions with FDA, and we'll answer questions as we talk with them.
Um, this is an oral complement 5A receptor blocker. And so it blocks complement-mediated destruction.
Robert Bradway: Well, obviously, we're not giving guidance on an individual product, Alexandria, but Murdo, go ahead and talk a little bit about the strong performance that we've observed so far for our biosimilar to Pavblu.
Robert Bradway: Well, obviously, we're not giving guidance on an individual product, Alexandria, but Murdo, go ahead and talk a little bit about the strong performance that we've observed so far for our biosimilar to Pavblu.
Speaker #15: I guess , essentially , can you kind of level set help growth expectations for this year ?
Speaker #4: Well , obviously we're not giving guidance on an individual product , Alexander . But go ahead and talk a little bit about the strong performance that we've observed so far .
Murdo Gordon: Yes, I think what we've been able to do thus far is establish good inroads with the largest national retina specialist networks. I think what I would say is they tend to want to pick a product that they know allows them to manage their patients effectively. We think we've got a great device that helps them do that. We obviously are competing effectively against the innovator, and given that, we have a lot of biosimilar experience; we'll compete effectively when others enter the market, whenever that may be.
Murdo Gordon: Yes, I think what we've been able to do thus far is establish good inroads with the largest national retina specialist networks. I think what I would say is they tend to want to pick a product that they know allows them to manage their patients effectively. We think we've got a great device that helps them do that. We obviously are competing effectively against the innovator, and given that, we have a lot of biosimilar experience; we'll compete effectively when others enter the market, whenever that may be.
Speaker #4: Our biosimilar pathway .
Speaker #2: Yes , I think what we've been able to do thus far is establish good inroads with the largest national retina , retina specialist networks and the I think what what I would say is they they tend to want to pick a product that they know allows them to their patients manage effectively .
We acquired Tavneos from ChemoCentryx and Otezla.
Speaker #2: a great We think helps them do device we've got that . We obviously are competing effectively against the innovator and given that we have a lot of biosimilar experience , we'll we'll compete effectively when others enter the market , whenever that may be .
Um as we shared the FDA requested, a voluntary withdrawal on January 16th, we were surprised by this. There were concerns raised about a process followed by chemotherapy to read adjudicate a primary input results for 9 of the 3331 patients and we were discussions with FDA and and we'll answer questions as we talk with them.
Robert Bradway: Okay, let's go on to the next question.
Robert Bradway: Okay, let's go on to the next question.
Operator: Thank you, Umar. Our next question comes from Alex Hammond from Wolfe Research. Please go ahead. Your line is open.
Operator: Thank you, Umar. Our next question comes from Alex Hammond from Wolfe Research. Please go ahead. Your line is open.
Okay, what's going on in the next question?
Robert Bradway: Okay, we'll take one last question as we're right up against the bottom of the 30-minute mark here of the hour. So, why don't we take one last question, and then, as always, Casey and his team will be around to answer questions if we didn't get to you on this call. Julianne, last question.
Robert Bradway: Okay, we'll take one last question as we're right up against the bottom of the 30-minute mark here of the hour. So, why don't we take one last question, and then, as always, Casey and his team will be around to answer questions if we didn't get to you on this call. Julianne, last question.
Alex Hammond: Hey, guys, thanks for taking the question. So you had another strong quarter with PAVBLU. I guess, how do you kind of expect to maintain this leadership position when other manufacturers launch their biosimilars in the second half of the year? I guess, essentially, can you kind of help level-set growth expectations for this year?
Alex Hammond: Hey, guys, thanks for taking the question. You had another strong quarter with PAVBLU. I guess, how do you kind of expect to maintain this leadership position when other manufacturers launch their biosimilars in the second half of the year? I guess, essentially, can you kind of help level-set growth expectations for this year?
Thank you. Umar our next question. Comes from Alex Hammond. From Wolfe research. Please go ahead. Your line is open.
Hey guys. Thanks
Speaker #4: Okay . We'll take one last question as we're right up against the the bottom of the 30 minute mark here of the hour .
Speaker #4: So why don't we take one last question and then , as always , Casey and his team will be around to answer questions .
Operator: Thank you, Alex. Our last question will come from Courtney Breen from Bernstein. Please go ahead. Your line is open.
Operator: Thank you, Alex. Our last question will come from Courtney Breen from Bernstein. Please go ahead. Your line is open.
Speaker #4: If we didn't get to you on this call , Julianne , last .
Robert Bradway: Well, obviously, we're not giving guidance on an individual product, Alex, but Murdo, go ahead and talk a little bit about the strong performance that we've observed so far for our biosimilar to PAVBLU.
Robert Bradway: Well, obviously, we're not giving guidance on an individual product, Alex, Murdo, go ahead and talk a little bit about the strong performance that we've observed so far for our biosimilar to PAVBLU.
So, you did a strong quarter with Pablo, I guess. How do you kind of expect to maintain his leadership position? When other manufacturers volunteer biosimilars in the second half of the year, I guess, essentially, can you kind of help level sight growth expectations for this year?
Speaker #4: question
Robert Bradway: Okay, Courtney, bring it home.
Robert Bradway: Okay, Courtney, bring it home.
Speaker #5: Thank
Speaker #5: you . Alex . Our last question will come from Courtney Breen , from Bernstein . Please go ahead . Your line is open .
Courtney Breen: Thanks so much. Fantastic. Thanks so much for squeezing this in. I am gonna bounce you back to MariTide, and just as we think about maintenance and that kind of less frequent dosing opportunity, can you describe how you might think about the role of this product in the market? Is it only post-MariTide weight loss, or how should we be thinking about kind of that switching opportunity and the type of data that you might demonstrate for that positioning over time? Thanks so much.
Courtney Breen: Thanks so much. Fantastic. Thanks so much for squeezing this in. I am gonna bounce you back to MariTide, and just as we think about maintenance and that kind of less frequent dosing opportunity, can you describe how you might think about the role of this product in the market? Is it only post-MariTide weight loss, or how should we be thinking about kind of that switching opportunity and the type of data that you might demonstrate for that positioning over time? Thanks so much.
Murdo Gordon: Yes, I think what we've been able to do thus far is establish good inroads with the largest national retina specialist networks. I think what I would say is, they tend to want to pick a product that they know allows them to manage their patients effectively. We think we've got a great device that helps them do that. We obviously are competing effectively against the innovator, and given that we have a lot of biosimilar experience, we'll compete effectively when others enter the market, whenever that may be.
Murdo Gordon: Yes, I think what we've been able to do thus far is establish good inroads with the largest national retina specialist networks. I think what I would say is, they tend to want to pick a product that they know allows them to manage their patients effectively. We think we've got a great device that helps them do that. We obviously are competing effectively against the innovator, and given that we have a lot of biosimilar experience, we'll compete effectively when others enter the market, whenever that may be.
Well, obviously, we're not giving guidance on an individual product, Alexander, but M, go ahead and talk a little bit about the strong performance that we've observed so far, and for our bios.
Speaker #4: Okay . Courtney , bring us home much .
Speaker #16: Fantastic . Thanks so much for squeezing this in . I am bounce going to you back to to maritime and just as we think about maintenance and that kind of less frequent dosing opportunity , can you describe how you might think about the role of this in the market ?
Speaker #16: Is it only product post maritime weight loss or how should we be thinking about kind of that switching opportunity and the type of data that you might demonstrate for that positioning over time ?
Robert Bradway: Yeah, I can imagine there's probably a lot of interest in that. Murdo, do you wanna share any thoughts at this point?
Robert Bradway: Yeah, I can imagine there's probably a lot of interest in that. Murdo, do you wanna share any thoughts at this point?
Murdo Gordon: Well, thanks, Courtney. Obviously, we think we've got, as has been said now many times, and I'll repeat it again, a product that changes the paradigm of weight loss, diabetes, ASCVD, heart failure management. And, we see it as both a, an effective product to start patients on, to get to weight goal, and also, for patients who, to receive the medical benefit of their treatment, need to be on these therapies for multiple years. This opportunity for MariTide's profile to deliver a convenient, well-tolerated, efficacious regimen that could be monthly, could be every 8 weeks, and could be quarterly. We think that's really exciting. And then, of course, as you hinted at, there may be patients out there on other therapies that want to switch to something as convenient and as well-tolerated as MariTide.
Murdo Gordon: Well, thanks, Courtney. Obviously, we think we've got, as has been said now many times, and I'll repeat it again, a product that changes the paradigm of weight loss, diabetes, ASCVD, heart failure management. And, we see it as both a, an effective product to start patients on, to get to weight goal, and also, for patients who, to receive the medical benefit of their treatment, need to be on these therapies for multiple years. This opportunity for MariTide's profile to deliver a convenient, well-tolerated, efficacious regimen that could be monthly, could be every 8 weeks, and could be quarterly. We think that's really exciting. And then, of course, as you hinted at, there may be patients out there on other therapies that want to switch to something as convenient and as well-tolerated as MariTide.
Speaker #16: Thanks so much .
Speaker #4: Yeah , I can imagine there's probably a lot of interest in that . Do you want to share any thoughts at this point ?
Speaker #2: Well thanks , Courtney . Obviously we think we've got , as has been said many times , and I'll repeat it again , a product that changes the paradigm of weight loss , diabetes Ascvd heart failure management and we see it as both an effective product to start patients on , to get to weight goal .
Robert Bradway: Okay, we'll take one last question as we're right up against the bottom of the 30-minute mark here of the hour. So, why don't we take one last question, and then, as always, Casey and his team will be around to answer questions if we didn't get to you on this call. Julianne, last question.
Robert Bradway: Okay, we'll take one last question as we're right up against the bottom of the 30-minute mark here of the hour. So, why don't we take one last question, and then, as always, Casey and his team will be around to answer questions if we didn't get to you on this call. Julianne, last question.
Yes, I I think what we've been able to do thus far is establish um good inroads with the largest national retina retina, specialist networks. And, um, uh, the I think, what, what I would say is they, they tend to want to pick a product that they know allows them to manage their patients. Effectively, we think we've got a great device that helps them do that. Uh, we obviously are competing effectively against the innovator. And given that, uh, we have a lot of Bio similar experience. We'll, we'll compete effectively when others enter the market, whenever that may be
Okay, we'll take 1 last question as we're right up against the the bottom of the uh the 30 minute Mark here the hour. So why don't we take 1 last question? And then as always uh, Casey and his team will be around to answer questions, if we didn't get to you on this call,
Operator: Thank you, Alex. Our last question will come from Courtney Breen from Bernstein. Please go ahead. Your line is open.
Operator: Thank you, Alex. Our last question will come from Courtney Breen from Bernstein. Please go ahead. Your line is open.
Julian last question.
Speaker #2: And also for patients who to receive the medical benefit of their treatment need to be on these therapies for multiple years . This opportunity for maritime profile to deliver a convenient , well-tolerated , efficacious regimen that could be monthly could be every eight weeks , and could be .
Thank you, Alex. Our last question will come from Courtney Brain from Bernstein. Please go ahead, your line is open.
Robert Bradway: Okay, Courtney, bring it home.
Robert Bradway: Okay, Courtney, bring it home.
Courtney Breen: Thanks so much. Fantastic. Thanks so much for squeezing this in. I am gonna bounce you back to MariTide, and just as we think about maintenance and that kind of less frequent dosing opportunity, can you describe how you might think about the role of this product in the market? Is it only post-MariTide weight loss, or how should we be thinking about kind of that switching opportunity and the type of data that you might demonstrate for that positioning over time? Thanks so much.
Courtney Breen: Thanks so much. Fantastic. Thanks so much for squeezing this in. I am gonna bounce you back to MariTide, and just as we think about maintenance and that kind of less frequent dosing opportunity, can you describe how you might think about the role of this product in the market? Is it only post-MariTide weight loss, or how should we be thinking about kind of that switching opportunity and the type of data that you might demonstrate for that positioning over time? Thanks so much.
Okay, Courtney, bring us home.
Speaker #2: quarterly We think that's that's exciting . really And then , of course , as you hinted at , there may be patients out there on other therapies that want to switch to as something convenient and as well tolerated as maritime .
Murdo Gordon: So, the answer is all of the above.
Murdo Gordon: So, the answer is all of the above.
Robert Bradway: Okay. So, again, thank you all for your interest. We appreciate you joining our call. I'll just reiterate, if we didn't get to you, please reach out directly to Casey and his team. In the meanwhile, I hope we've left you confident about the momentum that we're carrying into 2026. And again, I would just reiterate that we're excited about the year that we have in prospect here, a year, which, as Peter has described, we view as a springboard to the future growth here at Amgen. So excited about the hand that we have, and look forward to sharing it with you during the course of the year. Thank you.
Robert Bradway: Okay. So, again, thank you all for your interest. We appreciate you joining our call. I'll just reiterate, if we didn't get to you, please reach out directly to Casey and his team. In the meanwhile, I hope we've left you confident about the momentum that we're carrying into 2026. And again, I would just reiterate that we're excited about the year that we have in prospect here, a year, which, as Peter has described, we view as a springboard to the future growth here at Amgen. So excited about the hand that we have, and look forward to sharing it with you during the course of the year. Thank you.
Speaker #2: So the of the above answer is all .
Robert Bradway: Yeah, I can imagine there's probably a lot of interest in that. Murdo, do you wanna share any thoughts at this point?
Robert Bradway: Yeah, I can imagine there's probably a lot of interest in that. Murdo, do you wanna share any thoughts at this point?
Fantastic. Thanks so much for for squeezing. This in um I am going to bounce you back to uh to Maritime and just as we think about maintenance and that kind of less frequent dosing opportunity. Can you uh, describe how you might think about the role of this product in the market? Is it only post-marital weight loss, or how should we be thinking about kind of that switching opportunity and the type of data that you might demonstrate for that positioning over time. Thanks so much.
Speaker #4: Okay . So again , thank you all for your interest . We appreciate you joining our call . I'll just reiterate , if we didn't get to you , please reach out directly to Casey and his team .
Murdo Gordon: Well, thanks, Courtney. Obviously, we think we've got, as has been said now many times, and I'll repeat it again, a product that changes the paradigm of weight loss, diabetes, ASCVD, heart failure management. And, we see it as both a, an effective product to start patients on, to get to weight goal, and also, for patients who, to receive the medical benefit of their treatment, need to be on these therapies for multiple years. This, opportunity for MariTide's profile to, deliver a convenient, well-tolerated, efficacious regimen that could be monthly, could be every 8 weeks, and could be quarterly. We think that's, that's really exciting. And then, of course, as you hinted at, there may be patients out there on other therapies that want to switch to something as convenient and as well-tolerated as MariTide.
Murdo Gordon: Well, thanks, Courtney. Obviously, we think we've got, as has been said now many times, and I'll repeat it again, a product that changes the paradigm of weight loss, diabetes, ASCVD, heart failure management. And, we see it as both a, an effective product to start patients on, to get to weight goal, and also, for patients who, to receive the medical benefit of their treatment, need to be on these therapies for multiple years. This, opportunity for MariTide's profile to, deliver a convenient, well-tolerated, efficacious regimen that could be monthly, could be every 8 weeks, and could be quarterly. We think that's, that's really exciting. And then, of course, as you hinted at, there may be patients out there on other therapies that want to switch to something as convenient and as well-tolerated as MariTide.
Speaker #4: In the meanwhile , I hope we've left you confident about the momentum that we're carrying into 2026 . And again , I would just reiterate that we're excited about the year that we have in prospect here , a year which , as Peter's described , we view as a springboard to the future growth here at Amgen .
Speaker #4: So excited about the hand that we have . And we look forward to sharing it with you during the course of the year .
Murdo Gordon: The answer is all of the above.
Murdo Gordon: The answer is all of the above.
You want to share any thoughts at this point? Well, thanks Courtney. Um, we think we've got as has been said, now many times and I'll repeat it again, a product that changes, the Paradigm of weight loss, diabetes ascvd, heart failure management. And, um, we see it as both an effective product to start patients on, um, to get to weight goal. And also, uh, for patients who to receive the medical benefit of their treatment, need to be on these therapies for multiple years, uh, this, uh, opportunity for maritime profile to, uh, deliver a convenient. Well, tolerated efficacious regimen, that could be monthly could be every 8 weeks and could be quarterly. Um, we think that's, that's really exciting. And then, of course, as you hinted at there may be patients out there on other therapies that want to switch to something as convenient and as well, tolerated as Maritime. So, um, the answer is all of
Robert Bradway: Okay. So, again, thank you all for your interest. We appreciate you joining our call. I'll just reiterate, if we didn't get to you, please reach out directly to Casey and his team. In the meanwhile, I hope we've left you confident about the momentum that we're carrying into 2026. And again, I would just reiterate that we're excited about the year that we have in prospect here, a year, which, as Peter has described, we view as a springboard to the future growth here at Amgen. So excited about the hand that we have and look forward to sharing it with you during the course of the year. Thank you.
Robert Bradway: Okay. So, again, thank you all for your interest. We appreciate you joining our call. I'll just reiterate, if we didn't get to you, please reach out directly to Casey and his team. In the meanwhile, I hope we've left you confident about the momentum that we're carrying into 2026. Again, I would just reiterate that we're excited about the year that we have in prospect here, a year, which, as Peter has described, we view as a springboard to the future growth here at Amgen. Excited about the hand that we have and look forward to sharing it with you during the course of the year. Thank you.
The above.
Okay. So, uh, again, thank you all for your interest. We appreciate your joining our call. I'll just reiterate if we didn't get to you, please reach out directly to Casey and his team, uh, in the meanwhile, I hope we've left you, uh, confident about the momentum that we're carrying into 2026. And again, I would just reiterate that we're excited about the year that we have in Prospect here, uh, a year which is Peter, is described. We, we view as a springboard, uh, to the, uh, future growth here at amen. So excited about, uh, the hand that we have and look forward to sharing.
With you during the course of the year, thank you.
Operator: This concludes our Amgen Q4 2025 Earnings Conference Call. You may now disconnect.
Operator: This concludes our Amgen Q4 2025 Earnings Conference Call. You may now disconnect.
This concludes our Amgen Q4 2025 earnings conference call. You may now disconnect.