Q1 2024 Amgen Inc Earnings Call

May 2, 2024

Justin Claeys: - will lead the call and be followed by a broader review of our performance by Jay Bradner, Murdo Gordon, Vikram Karnani 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. from our results, we're reaching many more patients around the world with our existing medicines, advancing a broad range of potential first-in-class medicines in our mid- and late-stage pipeline, and redefining what's possible in research as we integrate wet and dry lab capabilities and harness transformative technologies.

Robert A. Bradway: Okay. Thank you, Justin, and thank you to our callers for joining us today. This is a busy and exciting time here at Amgen. And as you can see from our results, we're reaching many more patients around the world with our existing medicines, advancing a broad range of potential first-in-class medicines in our mid- and late-stage pipeline, and redefining what's possible in research as we integrate wet and dry lab capabilities and harness transformative technologies. I'll touch on a few highlights from the quarter that give me great confidence that we're on a path to deliver attractive long-term growth. First, we have a number of products across general medicine, oncology and inflammation that have strong momentum and still plenty of room to grow. These include REPATHA, which was up 33%; EVENITY, up 35%; BLINCYTO, up 26%; and TEZSPIRE, up 80%. With BLINCYTO, we expect an approval in June that should accelerate our efforts to integrate into earlier treatment lines for acute lymphoblastic leukemia.

I'll touch on a few highlights from the quarter that give me great confidence that we're on a path to deliver attractive long-term growth. First, we have a number of products across general medicine, oncology and inflammation that have strong momentum and still plenty of room to grow. These include rapatha, which was up 33 percent. Invenity, up 35 percent. Lincyto, up 26 percent. And Tess Spire, up 80 percent. With Lincito, we expect an approval in June that should accelerate our efforts to integrate into earlier treatment lines for acute lymphoblastic leukemia.

First, we have a number of products across general medicine, oncology and inflammation that have strong momentum and still plenty of room to grow. These include rapatha, which was up 33 percent. Invenity, up 35 percent. Lincyto, up 26 percent. And Tess Spire, up 80 percent. With Lincito, we expect an approval in June that should accelerate our efforts to integrate into earlier treatment lines for acute lymphoblastic leukemia.

With Lincito, we expect an approval in June that should accelerate our efforts to integrate into earlier treatment lines for acute lymphoblastic leukemia.

Robert A. Bradway: With TEZSPIRE, we'll share data later this month that reflect the attractive potential of this medicine in chronic obstructive pulmonary disease. COPD is the world's third leading cause of death. Clearly, new treatments are very much needed, and we're excited by TEZSPIRE's potential to make a difference there. Second, our newest pillar of growth, rare disease, contributed nearly $1 billion of sales in the quarter, up 14% compared with the sales of these products from a year ago. We see significant upside potential for first-in-class early-life cycle medicines like TEPEZZA, KRYSTEXXA, UPLIZNA and TAVNEOS. And we're pursuing launches in new geographic markets, new indications and/or new formulations for each. As an example, we announced last week our imminent plans to file TEPEZZA for approval in the European Union.

COPD is the world's third leading cause of death. Clearly, new treatments are very much needed, and we're excited by Ted Spire's potential to make a difference there. Second, our newest pillar of growth, rare disease, contributed nearly a billion dollars of sales in the quarter, up 14 percent, compared with the sales of these products from a year ago. We see significant upside potential for first-in-class early in-life-cycle medicines like Tepeza, Christexa, Uplizna, and Tavnios, and we're pursuing launches in new geographic markets, new indications, and or new formulations for each. As an example, we announced last week our imminent plans to file Tepeza for approval in the European Union.

Second, our newest pillar of growth, rare disease, contributed nearly a billion dollars of sales in the quarter, up 14 percent, compared with the sales of these products from a year ago. We see significant upside potential for first-in-class early in-life-cycle medicines like Tepeza, Christexa, Uplizna, and Tavnios, and we're pursuing launches in new geographic markets, new indications, and or new formulations for each. As an example, we announced last week our imminent plans to file Tepeza for approval in the European Union.

We see significant upside potential for first-in-class early in-life-cycle medicines like Tepeza, Christexa, Uplizna, and Tavnios, and we're pursuing launches in new geographic markets, new indications, and or new formulations for each. As an example, we announced last week our imminent plans to file Tepeza for approval in the European Union.

As an example, we announced last week our imminent plans to file Tepeza for approval in the European Union.

Robert A. Bradway: Overall, the integration of Horizon, its people, products and pipeline is proceeding well, reflecting the strong fit between our organizations. Third, we are rapidly advancing a number of promising new medicines in our mid and late-stage pipeline, spanning all 4 of our therapeutic areas. We are awaiting approval for tarlatamab, for example, and look forward to bringing this transformative innovation to patients with small cell lung cancer. Tarlatamab is the first T-cell-engaging therapy to demonstrate significant clinical activity against a common solid tumor, a watershed moment in a field that Amgen pioneered and continues to lead. Looking to the rest of the year, we anticipate data readouts from 5 Phase III trials. In addition, we announced today the development of a biosimilar to KEYTRUDA as we look to build upon the global leadership we have established in biosimilars. In sum, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond.

Third, we're rapidly advancing a number of promising new medicines in our mid and late stage pipeline spanning all four of our therapeutic areas. We are awaiting approval for tarlatomab, for example, and look forward to bringing this transformative innovation to patients with small cell lung cancer. Tarlatomab is the first T-cell engaging therapy to demonstrate significant clinical activity against a common solid tumor, a watershed moment in a field that Amgen pioneered and continues to lead. Looking to the rest of the year, we anticipate data readouts from five phase three trials. In addition, we announced today the development of a biosimilar to Ktruda as we look to build upon the global leadership we've established in biosimilars. In some, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond.

We are awaiting approval for tarlatomab, for example, and look forward to bringing this transformative innovation to patients with small cell lung cancer. Tarlatomab is the first T-cell engaging therapy to demonstrate significant clinical activity against a common solid tumor, a watershed moment in a field that Amgen pioneered and continues to lead. Looking to the rest of the year, we anticipate data readouts from five phase three trials. In addition, we announced today the development of a biosimilar to Ktruda as we look to build upon the global leadership we've established in biosimilars. In some, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond.

Tarlatomab is the first T-cell engaging therapy to demonstrate significant clinical activity against a common solid tumor, a watershed moment in a field that Amgen pioneered and continues to lead. Looking to the rest of the year, we anticipate data readouts from five phase three trials. In addition, we announced today the development of a biosimilar to Ktruda as we look to build upon the global leadership we've established in biosimilars. In some, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond.

Looking to the rest of the year, we anticipate data readouts from five phase three trials. In addition, we announced today the development of a biosimilar to Ktruda as we look to build upon the global leadership we've established in biosimilars. In some, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond.

In some, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond.

Robert A. Bradway: Now let me just add one other important update. Whereas we don't normally comment on interim data, especially for our Phase II trial, we recognize there is significant interest in obesity in MariTide, so we'll provide additional commentary today. The interim Phase II analysis for this study is complete, and we are very encouraged with the results that we've seen thus far and with the conduct of the trial. Following the interim analysis, I would say we're confident in MariTide's differentiated profile and believe it will address important unmet medical needs. We are actively planning a broad Phase III program including obesity, obesity-related conditions and diabetes. Obviously, we expect to carefully complete our ongoing Phase II trial before then moving as swiftly as appropriate to establish the safety and efficacy of this potential medicine in Phase III trials. We've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study. And I would ask you to recognize that to protect the integrity of the study beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'll turn it over to you.

The interim phase two analysis for this study is complete and we are very encouraged with the results that we've seen thus far and with the conduct of the trial. Following the interim analysis, I would say we're confident in Maritides differentiated profile and believe it will address important unmet medical needs. We are actively planning a broad phase three program, including obesity, obesity-related conditions, and diabetes. Obviously, we expect to carefully complete our ongoing phase two trial before then moving as swiftly as appropriate to establish the safety and efficacy of this potential medicine in phase three trials. We've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study. I would ask you to recognize that to protect the integrity of the study, beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'll turn it over to you.

Following the interim analysis, I would say we're confident in Maritides differentiated profile and believe it will address important unmet medical needs. We are actively planning a broad phase three program, including obesity, obesity-related conditions, and diabetes. Obviously, we expect to carefully complete our ongoing phase two trial before then moving as swiftly as appropriate to establish the safety and efficacy of this potential medicine in phase three trials. We've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study. I would ask you to recognize that to protect the integrity of the study, beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'll turn it over to you.

We are actively planning a broad phase three program, including obesity, obesity-related conditions, and diabetes. Obviously, we expect to carefully complete our ongoing phase two trial before then moving as swiftly as appropriate to establish the safety and efficacy of this potential medicine in phase three trials. We've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study. I would ask you to recognize that to protect the integrity of the study, beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'll turn it over to you.

Obviously, we expect to carefully complete our ongoing phase two trial before then moving as swiftly as appropriate to establish the safety and efficacy of this potential medicine in phase three trials. We've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study. I would ask you to recognize that to protect the integrity of the study, beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'll turn it over to you.

We've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study. I would ask you to recognize that to protect the integrity of the study, beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'll turn it over to you.

Jay will provide a few additional remarks with respect to this ongoing study. I would ask you to recognize that to protect the integrity of the study, beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'll turn it over to you.

As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'll turn it over to you.

James E. Bradner: Thank you, Bob, and good afternoon, everyone. Let me start with MariTide. Reiterating Bob's comments, we are very pleased with the results seen with MariTide thus far. And we're very pleased with the overall conduct of the ongoing Phase II trial. All arms remain active, patient dropout has not been an issue, and we're fully on track for top line 52-week data from this 11-arm Phase II study in late 2024. We're seeing a differentiated profile of MariTide and are confident that it will address important unmet medical needs, obesity, obesity-related conditions and diabetes. We look forward to completing the ongoing Phase II study and working with regulators to move rapidly to the broad Phase III program. Later this year, we plan to initiate an additional dedicated Phase II trial investigating MariTide for the treatment of diabetes in patients with and without obesity. This new trial is not a gating step for our Phase III program in patients with obesity. Informed by dose and schedule insights from the ongoing Phase II obesity study, the dedicated Phase II study in diabetes conforms to regulatory requirements for Phase III and is the next step towards a diabetes indication for MariTide.

And we're very pleased with the overall conduct of the ongoing phase two trial. All arms remain active, patient dropout has not been an issue, and we're fully on track for top-line 52-week data from this 11-arm phase two study in late 2024. We're seeing a differentiated profile with Maritide and are confident that it will address important unmet medical needs in obesity, obesity-related conditions, and diabetes. We look forward to completing the ongoing phase two study and working with regulators to move rapidly to the broad phase three program. Later this year, we plan to initiate an additional dedicated phase two trial investigating meritite for the treatment of diabetes in patients with and without obesity. This new trial is not a gating step for our Phase 3 program in patients with obesity. Informed by dose and schedule insights from the ongoing Phase 2 obesity study, the dedicated Phase 2 study in diabetes conforms to regulatory requirements for Phase 3 and is the next step towards the diabetes indication for Maritide.

We're seeing a differentiated profile with Maritide and are confident that it will address important unmet medical needs in obesity, obesity-related conditions, and diabetes. We look forward to completing the ongoing phase two study and working with regulators to move rapidly to the broad phase three program. Later this year, we plan to initiate an additional dedicated phase two trial investigating meritite for the treatment of diabetes in patients with and without obesity. This new trial is not a gating step for our Phase 3 program in patients with obesity. Informed by dose and schedule insights from the ongoing Phase 2 obesity study, the dedicated Phase 2 study in diabetes conforms to regulatory requirements for Phase 3 and is the next step towards the diabetes indication for Maritide.

We look forward to completing the ongoing phase two study and working with regulators to move rapidly to the broad phase three program. Later this year, we plan to initiate an additional dedicated phase two trial investigating meritite for the treatment of diabetes in patients with and without obesity. This new trial is not a gating step for our Phase 3 program in patients with obesity. Informed by dose and schedule insights from the ongoing Phase 2 obesity study, the dedicated Phase 2 study in diabetes conforms to regulatory requirements for Phase 3 and is the next step towards the diabetes indication for Maritide.

James E. Bradner: In terms of patient experience, we expect to deliver MariTide in a convenient, handheld, patient-friendly auto-injector device with a monthly or even less frequent single-injection administration, assuming eventual approval. Across the portfolio, we are presently prioritizing differentiated medicines, those that stand to provide the greatest benefit for patients. Given the profile we've seen with AMG 786, we will not pursue further development. Instead, in obesity, we're differentially investing in MariTide and a number of preclinical assets. Beyond MariTide, in the first quarter, we rapidly advanced our diverse clinical pipeline of potentially first-in-class or best-in-class programs. Looking ahead, the remainder of 2024 promises to be an exciting time for research and development with 2 PDUFA dates in June for tarlatamab in small cell lung cancer and BLINCYTO in adult acute lymphoblastic leukemia, as well as 5 Phase III data readouts. Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need.

James Bradner: Will lead the call and be followed.

Justin Claeys: Will lead the call and be followed.

Peter Griffith: By a broader review of our performance.

By a broader review of our performance.

With three trials.

James Bradner: By Jay Bradner, Murdo Gordon, Vikram Karnani, and Peter Griffith. Through the course of our discussion today, we will use non-GAAP financial measures, 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.

By Jay Bradner, Murdo Gordon, Vikram Karnani, and Peter Griffith. Through the course of our discussion today, we will use non-GAAP financial measures, 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.

We've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind.

Jay will provide a few additional remarks with respect to this ongoing study.

Across the portfolio, we are presently prioritizing differentiated medicine, those that stand to provide the greatest benefit for patients. Given the profile we've seen with AMG 786, we will not pursue further development. Instead, in obesity, we're differentially investing in Maritide and a number of preclinical assets. Beyond Maritide, in the first quarter, we rapidly advanced our diverse clinical pipeline of potentially first-in-class or best-in-class programs. Looking ahead, the remainder of 2024 promises to be an exciting time for research and development. The two pedophidates in June for tarlatomine and small cell lung cancer and blincito, in adult acute lymphoblastic leukemia, as well as five phase three data readouts. Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need.

Jay: I'd ask you to recognize that to protect the integrity of the study beyond this update we would not expect to discuss these data in further detail before completion.

Given the profile we've seen with AMG 786, we will not pursue further development. Instead, in obesity, we're differentially investing in Maritide and a number of preclinical assets. Beyond Maritide, in the first quarter, we rapidly advanced our diverse clinical pipeline of potentially first-in-class or best-in-class programs. Looking ahead, the remainder of 2024 promises to be an exciting time for research and development. The two pedophidates in June for tarlatomine and small cell lung cancer and blincito, in adult acute lymphoblastic leukemia, as well as five phase three data readouts. Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need.

Peter Griffith: Materially.

Materially. Over to you, Bob.

Jay: As always I want to thank our employees around the world for their commitment to our business and to the patients we serve Jay I'll turn it over to you. Thank.

Robert Bradway: Over to you, Bob. Okay, thank you, Justin, and thank you to our callers for joining us today. This is a busy and exciting time here at Amgen, and as you can see from our results, we're reaching many more patients around the world with our existing medicines, advancing a broad range of potential first in class medicines in our mid and late stage pipeline, and redefining what's possible in research as we integrate wet and dry lab capabilities and harness transformative technologies. I'll touch on a few highlights from the quarter that give me great confidence that we're on a path to deliver attractive long term growth. First, we have a number of products across general medicine, oncology, and inflammation that have strong momentum and still plenty of room to grow. These include Repatha, which was up 33%, BLINCYTO up 26%, and TEZSPIRE up 80%.

Bob Bradway: Okay, thank you, Justin, and thank you to our callers for joining us today. This is a busy and exciting time here at Amgen, and as you can see from our results, we're reaching many more patients around the world with our existing medicines, advancing a broad range of potential first in class medicines in our mid and late stage pipeline, and redefining what's possible in research as we integrate wet and dry lab capabilities and harness transformative technologies. I'll touch on a few highlights from the quarter that give me great confidence that we're on a path to deliver attractive long term growth. First, we have a number of products across general medicine, oncology, and inflammation that have strong momentum and still plenty of room to grow. These include Repatha, which was up 33%, BLINCYTO up 26%, and TEZSPIRE up 80%.

Beyond Maritide, in the first quarter, we rapidly advanced our diverse clinical pipeline of potentially first-in-class or best-in-class programs. Looking ahead, the remainder of 2024 promises to be an exciting time for research and development. The two pedophidates in June for tarlatomine and small cell lung cancer and blincito, in adult acute lymphoblastic leukemia, as well as five phase three data readouts. Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need.

Jay: Thank you Bob and good afternoon, everyone, let me start with maritime.

Looking ahead, the remainder of 2024 promises to be an exciting time for research and development. The two pedophidates in June for tarlatomine and small cell lung cancer and blincito, in adult acute lymphoblastic leukemia, as well as five phase three data readouts. Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need.

Jay: We are reiterating Bob's comments, we are very pleased with the results came with maritime thus far and we're very pleased with the overall conduct of the ongoing phase II trial.

Jay: Alarms remain active patient dropout has not been an issue and we're fully on track for top line 52 week data from this 11 arm phase II study in late 2024.

Jay: We're seeing a differentiated profile with maritime and are confident that it will address important unmet medical needs and obesity obesity related conditions in diabetes.

James E. Bradner: Moving to olpasiran. We're pleased to announce that we've completed enrollment of the OCEAN(a)-Outcomes trial, a Phase III cardiovascular outcome study of olpasiran, our potentially best-in-class Lp(a)-targeting small interfering RNA medicine. Reflecting both our commitment to patients suffering from cardiovascular disease and the strong interest of the medical community, we successfully enrolled 7,297 patients across the globe in just 15.5 months. To our knowledge, this is the fastest-enrolling Phase III outcome study of its size. And to remind, Lp(a) is a genetically defined cardiovascular risk factor, which is elevated in approximately 20% of individuals and for whom no effective or targeted therapies currently exist. In oncology, we continue to deliver on high-conviction targets with differentiated therapies capable of delivering a large effect size for patients. Starting with tarlatamab, a first-in-class BiTE molecule targeting DLL3 for small cell lung cancer. We remain on track with an FDA priority review for a June 12th PDUFA date.

We look forward to completing the ongoing phase II study and working with regulators to move rapidly to the broad phase III program.

Reflecting both our commitment to patients suffering from cardiovascular disease and the strong interest of the medical community, we successfully enrolled 7,297 patients across the globe in just 15 and a half months. It's our knowledge this is the fastest enrolling phase three outcome study of its size. And to remind, L.P. L.P. L.P. L.A is a genetically defined cardiovascular risk factor, which is elevated in approximately 20 percent of individuals and for whom no effective or targeted therapies currently exist. In oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering large effect size for patients. Starting with tarlatomab, a first-in-class bite molecule targeting DLL 3 for small cell lung cancer, we remain on track with an FDA priority review for a June 12th, PDUFA date.

Later this year, we plan to initiate an additional dedicated phase II trial investigating maritime for the treatment of diabetes and patients with and without obesity. This new trial is not a gating step for our phase III program in patients with obesity and.

Robert Bradway: With BLINCYTO. We expect an approval in June that should accelerate our efforts to integrate into earlier treatment lines for acute lymphoblastic leukemia with TEZSPIRE. We'll share data later this month that reflect the attractive potential of this medicine in chronic obstructive pulmonary disease. COPD is the world's third leading cause of death. Clearly, new treatments are very much needed, and we're excited by TEZSPIRE's potential to make a difference there. Second, our newest pillar of growth, Rare Disease, contributed nearly $1 billion of sales in the quarter, up 14% compared with the sales of these products from a year ago. We see significant upside potential for first-in-class early life cycle medicines like TEPEZZA, KRYSTEXXA, UPLIZNA, and TAVNEOS, and we're pursuing launches in new geographic markets, new indications, and/or new formulations for each.

With BLINCYTO. We expect an approval in June that should accelerate our efforts to integrate into earlier treatment lines for acute lymphoblastic leukemia with TEZSPIRE. We'll share data later this month that reflect the attractive potential of this medicine in chronic obstructive pulmonary disease. COPD is the world's third leading cause of death. Clearly, new treatments are very much needed, and we're excited by TEZSPIRE's potential to make a difference there. Second, our newest pillar of growth, Rare Disease, contributed nearly $1 billion of sales in the quarter, up 14% compared with the sales of these products from a year ago. We see significant upside potential for first-in-class early life cycle medicines like TEPEZZA, KRYSTEXXA, UPLIZNA, and TAVNEOS, and we're pursuing launches in new geographic markets, new indications, and/or new formulations for each.

It's our knowledge this is the fastest enrolling phase three outcome study of its size. And to remind, L.P. L.P. L.P. L.A is a genetically defined cardiovascular risk factor, which is elevated in approximately 20 percent of individuals and for whom no effective or targeted therapies currently exist. In oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering large effect size for patients. Starting with tarlatomab, a first-in-class bite molecule targeting DLL 3 for small cell lung cancer, we remain on track with an FDA priority review for a June 12th, PDUFA date.

Jay: Informed by dose and schedule insights from the ongoing phase II obesity study the dedicated phase II study in diabetes conforms to regulatory requirements for phase III and as the next step towards the diabetes indication for maritime.

Jay: In terms of patient experience, we expect to deliver maritime that convenient handheld patient friendly auto injector device with a monthly or even less frequent single injection administration, assuming eventual approval.

In oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering large effect size for patients. Starting with tarlatomab, a first-in-class bite molecule targeting DLL 3 for small cell lung cancer, we remain on track with an FDA priority review for a June 12th, PDUFA date.

Starting with tarlatomab, a first-in-class bite molecule targeting DLL 3 for small cell lung cancer, we remain on track with an FDA priority review for a June 12th, PDUFA date. We're excited about tarlatomab as potentially the first selective therapy for small cell lung cancer.

Starting with tarlatomab, a first-in-class bite molecule targeting DLL 3 for small cell lung cancer, we remain on track with an FDA priority review for a June 12th, PDUFA date.

Jay: Across the portfolio, we are presently prioritizing differentiated medicine, those that stand to provide the greatest benefit for patients.

Given the profile, we've seen with AMG 786, we will not pursue further development instead.

James E. Bradner: We're excited about tarlatamab as potentially the first selective therapy for small cell lung cancer. undefinedd on the remarkable activity observed as a single agent in patients receiving second and third-line therapy, we are rapidly advancing tarlatamab in a frontline treatment with 3 Phase III studies now initiated in both extensive stage and limited stage disease. The rationale for studying tarlatamab in earlier lines of the context of lower tumor burden draws from our experience with BLINCYTO in B-cell ALL. There, we saw a dramatic improvement in overall survival in minimal residual disease-negative patients. These BLINCYTO data provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells, which are primarily the drivers of recurrent disease. We're hopeful we can build on this insight with tarlatamab, where comparable activity in early-stage small cell lung cancer patients would very meaningfully improve outcomes for patients facing the challenge of this aggressive cancer.

Jay: <unk>, we're differentially investing in maritime and a number of preclinical assets.

Based on the remarkable activity observed as a single agent in patients receiving second and third line therapy, we are rapidly advancing tarlatomab in a frontline treatment, with three phase three studies now initiated in both extensive stage and limited stage disease. The rationale for studying tarlatomab in earlier lines of the context of lower term of burden draws from our experience with Blincyto and B-S-A-LLL. There we saw dramatic improvement in overall survival in minimal residual disease negative patients. These Blincitodata provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells, which are primarily the drivers of recurrent disease. We're hopeful we can build on this insight with tarlatomab, where comparable activity in early stage small cell lung cancer patients would very meaningfully improve outcomes for patients facing the challenge of this aggressive cancer.

Jay: Beyond <unk> in the first quarter, we rapidly advanced our diverse clinical pipeline of potentially first in class or best in class programs.

Jay: Looking ahead, the remainder of 2024 promises to be an exciting time for research and development with <unk> dates in June for <unk> in small cell lung cancer <unk> in adult acute lymphoblastic leukemia, as well as five phase III data readouts each.

Robert Bradway: As an example, we announced last week our imminent plans to file Tepezza for approval in the European Union. Overall, the integration of Horizon, its people, products, and pipeline is proceeding well, reflecting the strong fit between our organizations. Third, we're rapidly advancing a number of promising new medicines in our mid- and late-stage pipeline spanning all four of our therapeutic areas. We are awaiting approval for tarlatamab, for example, and look forward to bringing this transformative innovation to patients with small cell lung cancer. Tarlatamab is the first T cell engagement therapy to demonstrate significant clinical activity against a common solid tumor. A watershed moment in a field that Amgen pioneered and continues to lead. Looking to the rest of the year, we anticipate data readouts from five phase 3 trials.

As an example, we announced last week our imminent plans to file Tepezza for approval in the European Union. Overall, the integration of Horizon, its people, products, and pipeline is proceeding well, reflecting the strong fit between our organizations. Third, we're rapidly advancing a number of promising new medicines in our mid- and late-stage pipeline spanning all four of our therapeutic areas. We are awaiting approval for tarlatamab, for example, and look forward to bringing this transformative innovation to patients with small cell lung cancer. Tarlatamab is the first T cell engagement therapy to demonstrate significant clinical activity against a common solid tumor. A watershed moment in a field that Amgen pioneered and continues to lead. Looking to the rest of the year, we anticipate data readouts from five phase 3 trials.

The rationale for studying tarlatomab in earlier lines of the context of lower term of burden draws from our experience with Blincyto and B-S-A-LLL. There we saw dramatic improvement in overall survival in minimal residual disease negative patients. These Blincitodata provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells, which are primarily the drivers of recurrent disease. We're hopeful we can build on this insight with tarlatomab, where comparable activity in early stage small cell lung cancer patients would very meaningfully improve outcomes for patients facing the challenge of this aggressive cancer.

Jay: Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need.

These Blincitodata provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells, which are primarily the drivers of recurrent disease. We're hopeful we can build on this insight with tarlatomab, where comparable activity in early stage small cell lung cancer patients would very meaningfully improve outcomes for patients facing the challenge of this aggressive cancer.

Moving to El Paso, and we're pleased to announce that we've completed enrollment of the <unk> outcomes trial, a phase III cardiovascular outcome study of all pass ran our potentially best in class LP Little a targeting small interfering RNA medicines.

We're hopeful we can build on this insight with tarlatomab, where comparable activity in early stage small cell lung cancer patients would very meaningfully improve outcomes for patients facing the challenge of this aggressive cancer.

Jay: Reflecting both our commitment to patients suffering from cardiovascular disease and the strong interest to the medical community. We successfully enrolled 7297 patients across the globe in just 15 five months or.

James E. Bradner: In sum, we regard tarlatamab as a major advance as the first bispecific T-cell engager to demonstrate efficacy in a common solid tumor, further establishing the broad potential of our bispecific T-cell engager platform. Our first-in-class STEAP1 CD3 bispecific molecule, xaluritamig, has also demonstrated unambiguous activity in the solid tumor, namely prostate cancer, continues to advance following a presentation of encouraging Phase I data last fall. We have now fully enrolled the monotherapy Phase I dose expansion and continue to enroll patients in reduced monitoring and outpatient cohorts. Further, combination studies with xaluritamig in novel hormonal therapies are progressing in dose escalation studies with near-term plans to initiate dose expansion cohorts. To round out oncology, we are rapidly advancing AMG 193, our oral PRMT5 inhibitor targeting MTAP null solid tumors. We've moved forward with monotherapy dose expansion studies and have initiated 2 additional Phase I studies targeting MTAP null tumors in thoracic, gastrointestinal, biliary tract and pancreatic cancers, exploring relevant combinations with standard of care.

Jay: Our knowledge. This is the fastest enrolling phase III outcome study of its size and to remind LP little a is a genetically defined cardiovascular risk factor, which is elevated and approximately 20% of individuals and for whom no effective or targeted therapies currently exists.

Our first in class steep 1 CD3 bispecific molecule, is alleridymic, has also demonstrated an ambiguous activity in a solid tumor, namely prostate cancer. It continues to advance following a presentation of encouraging phase one data last fall. We have now fully enrolled the monotherapy phase one dose expansion and continue to enroll patients in reduced monitoring and outpatient cohorts. Further, combination studies with Zaluritomig and novel hormonal therapies are progressing in dose escalation studies with near-term plans to initiate dose expansion cohorts. To round out oncology, we are rapidly advancing AMG193, our oral PRMT-5 inhibitor targeting M-Tap-Nol solid tumors. We've moved forward with monotherapy dose expansion studies and have initiated two additional phase one studies targeting mtapinal tumors in thoracic, gastrointestinal, billiary tract, and pancreatic cancers, explore in relevant combinations with standard of care.

Robert Bradway: In addition, we announced today the development of a biosimilar to Keytruda as we look to build upon the global leadership we've established in biosimilars. In sum, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond. Now, let me just add one other important update. Whereas we don't normally comment on interim data, especially for a phase 2 trial, we recognize there's significant interest in obesity and MariTide. So we'll provide additional commentary today.

In addition, we announced today the development of a biosimilar to Keytruda as we look to build upon the global leadership we've established in biosimilars. In sum, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond. Now, let me just add one other important update. Whereas we don't normally comment on interim data, especially for a phase 2 trial, we recognize there's significant interest in obesity and MariTide. So we'll provide additional commentary today.

In oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering large effect size for patients.

We have now fully enrolled the monotherapy phase one dose expansion and continue to enroll patients in reduced monitoring and outpatient cohorts. Further, combination studies with Zaluritomig and novel hormonal therapies are progressing in dose escalation studies with near-term plans to initiate dose expansion cohorts. To round out oncology, we are rapidly advancing AMG193, our oral PRMT-5 inhibitor targeting M-Tap-Nol solid tumors. We've moved forward with monotherapy dose expansion studies and have initiated two additional phase one studies targeting mtapinal tumors in thoracic, gastrointestinal, billiary tract, and pancreatic cancers, explore in relevant combinations with standard of care.

Starting with <unk>, a first in class bite molecule targeting DLL three for small cell lung cancer, we remain on track with an FDA priority review for a June <unk> date.

Further, combination studies with Zaluritomig and novel hormonal therapies are progressing in dose escalation studies with near-term plans to initiate dose expansion cohorts. To round out oncology, we are rapidly advancing AMG193, our oral PRMT-5 inhibitor targeting M-Tap-Nol solid tumors. We've moved forward with monotherapy dose expansion studies and have initiated two additional phase one studies targeting mtapinal tumors in thoracic, gastrointestinal, billiary tract, and pancreatic cancers, explore in relevant combinations with standard of care.

We're excited about our land map as potentially the first selective therapy for small cell lung cancer.

To round out oncology, we are rapidly advancing AMG193, our oral PRMT-5 inhibitor targeting M-Tap-Nol solid tumors. We've moved forward with monotherapy dose expansion studies and have initiated two additional phase one studies targeting mtapinal tumors in thoracic, gastrointestinal, billiary tract, and pancreatic cancers, explore in relevant combinations with standard of care.

Jay: Based on the remarkable activity observed as a single agent in patients receiving second and third line therapy. We are rapidly advancing <unk> in a frontline treatment with three phase III studies now initiated and both extensive stage and limited stage disease.

We've moved forward with monotherapy dose expansion studies and have initiated two additional phase one studies targeting mtapinal tumors in thoracic, gastrointestinal, billiary tract, and pancreatic cancers, explore in relevant combinations with standard of care. At our inflammation portfolio, we are encouraged by the results of the course Phase 2A proof of concept study.

Robert Bradway: The interim Phase 2 analysis for this study is complete, and we are very encouraged with the results that we've seen thus far and with the conduct of the trial. Following the interim analysis, I would say we're confident in MariTide's differentiated profile and believe it will address important unmet medical needs. We are actively planning a broad Phase 3 program including obesity, obesity-related conditions, and diabetes. Obviously, we expect to carefully complete our ongoing Phase 2 trial before then moving as swiftly as appropriate to establish the safety and efficacy of this potential medicine. In Phase 3 trials, we've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study.

The interim Phase 2 analysis for this study is complete, and we are very encouraged with the results that we've seen thus far and with the conduct of the trial. Following the interim analysis, I would say we're confident in MariTide's differentiated profile and believe it will address important unmet medical needs. We are actively planning a broad Phase 3 program including obesity, obesity-related conditions, and diabetes. Obviously, we expect to carefully complete our ongoing Phase 2 trial before then moving as swiftly as appropriate to establish the safety and efficacy of this potential medicine. In Phase 3 trials, we've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study.

Jay: The rationale for studying <unk> in earlier lines of the context of lower term a burden draws from our experience with <unk> and B cell ALLL. There, we saw dramatic improvement and overall survival and minimal residual disease negative patients.

James E. Bradner: In our inflammation portfolio, we are encouraged by the results of the COURSE Phase IIa proof-of-concept study, which investigated TEZSPIRE in patients with moderate to very severe COPD. This study was designed to test TSLP inhibition across an intentionally broad range of eosinophil levels, irrespective of inflammatory drivers, emphysema, chronic bronchitis and smoking status. While TEZSPIRE achieved a clinically meaningful 17% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo, this result fell short of statistical significance likely owing to the broad overall patient demographic. However, even greater reductions in COPD exacerbations were observed in a planned subgroup of patients with baseline blood eosinophil counts greater than 150 cells per microliter with a trend for further reduction in a small number of subjects with baseline counts greater than 300. We're excited by these data, which will be presented in an oral session of the American Thoracic Society Annual Meeting later this month. Together with our partner, AstraZeneca, we are actively planning for Phase III development of TEZSPIRE in COPD. Beyond COPD, we continue to explore TEZSPIRE in separate Phase III studies in eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps, where top line data are expected in the second half of this year.

which investigated TESPIRE in patients with moderate, the very severe COPD. This study was designed to test TSLP inhibition across an intentionally broad range of eosinophil levels, irrespective of inflammatory drivers, emphysema, chronic bronchitis, and smoking status. While test buyer achieved a clinically meaningful 17% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo, this result felt short of statistical significance likely owing to the broad overall patient demographic. However, even greater reductions in COPD exacerbations were observed in a planned subgroup of patients with baseline blood-eacinophil counts greater than 150 cells per microliter, with a trend for further reduction in a small number of subjects with baseline counts greater than 300. We're excited by these data, which will be presented in an oral session of the American Theractic Society annual meeting later this month. Together with our partner, AstraZeneca, we're actively planning for phase three development of Ted Spire and COPD. Beyond COPD, we continue to explore test spire in separate phase three studies in eosinophilic esophagitis and in chronic rhinocytis with nasal polyps, where top line data are expected in the second half of this year.

Eastland Siloed data provide evidence that directing the T cell in this manner as an effective means of finding and eliminating residual cancer cells, which are primarily the drivers of recurrent disease.

Jay: We're hopeful we can build on this insight, what's our Latam where comparable activity in early stage small cell lung cancer patients would vary meaningfully improve outcomes for patients facing the challenge of this aggressive cancer.

While test buyer achieved a clinically meaningful 17% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo, this result felt short of statistical significance likely owing to the broad overall patient demographic. However, even greater reductions in COPD exacerbations were observed in a planned subgroup of patients with baseline blood-eacinophil counts greater than 150 cells per microliter, with a trend for further reduction in a small number of subjects with baseline counts greater than 300. We're excited by these data, which will be presented in an oral session of the American Theractic Society annual meeting later this month. Together with our partner, AstraZeneca, we're actively planning for phase three development of Ted Spire and COPD. Beyond COPD, we continue to explore test spire in separate phase three studies in eosinophilic esophagitis and in chronic rhinocytis with nasal polyps, where top line data are expected in the second half of this year.

In sum, we regard sorry, <unk> is a major advance as the first bi specific T cell engage are to demonstrate efficacy in a common solid tumor further establishing the broad potential of our bi specific T cell engagement platform.

Robert Bradway: I would ask you to recognize that to protect the integrity of the study beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'm going to turn it over to you.

I would ask you to recognize that to protect the integrity of the study beyond this update, we would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, I'm going to turn it over to you.

However, even greater reductions in COPD exacerbations were observed in a planned subgroup of patients with baseline blood-eacinophil counts greater than 150 cells per microliter, with a trend for further reduction in a small number of subjects with baseline counts greater than 300. We're excited by these data, which will be presented in an oral session of the American Theractic Society annual meeting later this month. Together with our partner, AstraZeneca, we're actively planning for phase three development of Ted Spire and COPD. Beyond COPD, we continue to explore test spire in separate phase three studies in eosinophilic esophagitis and in chronic rhinocytis with nasal polyps, where top line data are expected in the second half of this year.

Jay: Our first in class steep one CD three by specific molecules algorithmic has also demonstrated an unambiguous activity in a solid tumor, namely prostate cancer continues to.

We're excited by these data, which will be presented in an oral session of the American Theractic Society annual meeting later this month. Together with our partner, AstraZeneca, we're actively planning for phase three development of Ted Spire and COPD. Beyond COPD, we continue to explore test spire in separate phase three studies in eosinophilic esophagitis and in chronic rhinocytis with nasal polyps, where top line data are expected in the second half of this year.

James Bradner: Thank you, Bob, and good afternoon, everyone. Let me start with MariTide. Reiterating Bob's comments, we are very pleased with the results to date of MariTide thus far, and we're very pleased with the overall conduct of the ongoing Phase 2 trial. All arms remain active, patient dropout has not been an issue, and we're fully on track for top-line 52-week data from this 11-arm Phase 2 study in late 2024. We're seeing a differentiated profile with MariTide and are confident that it will address important unmet medical needs, obesity, obesity-related conditions, and diabetes. We look forward to completing the ongoing Phase 2 study and working with regulators to move rapidly to the broad Phase 3 program. Later this year, we plan to initiate an additional dedicated Phase 2 trial investigating MariTide for the treatment of diabetes in patients with and without obesity.

Jay Bradner: Thank you, Bob, and good afternoon, everyone. Let me start with MariTide. Reiterating Bob's comments, we are very pleased with the results to date of MariTide thus far, and we're very pleased with the overall conduct of the ongoing Phase 2 trial. All arms remain active, patient dropout has not been an issue, and we're fully on track for top-line 52-week data from this 11-arm Phase 2 study in late 2024. We're seeing a differentiated profile with MariTide and are confident that it will address important unmet medical needs, obesity, obesity-related conditions, and diabetes. We look forward to completing the ongoing Phase 2 study and working with regulators to move rapidly to the broad Phase 3 program. Later this year, we plan to initiate an additional dedicated Phase 2 trial investigating MariTide for the treatment of diabetes in patients with and without obesity.

Jay: To advance following the presentation of encouraging phase one data last fall.

We have now fully enrolled the monotherapy phase one dose expansion and continue to enroll patients and reduce monitoring and outpatient cohorts.

Together with our partner, AstraZeneca, we're actively planning for phase three development of Ted Spire and COPD. Beyond COPD, we continue to explore test spire in separate phase three studies in eosinophilic esophagitis and in chronic rhinocytis with nasal polyps, where top line data are expected in the second half of this year.

Jay: Further combination studies with <unk> to make a novel hormonal therapies are progressing in dose escalation study with near term plans to initiate dose expansion cohorts.

Jay: To round out oncology, we are rapidly advancing AMG 193, our oral <unk> inhibitor targeting <unk> solid tumors. We've moved forward with monotherapy dose expansion studies and have initiated two additional phase one studies targeting <unk> tumors and thoracic gastrointestinal biliary tract in pancreatic.

James E. Bradner: The ROCKET Phase III program for rocatinlimab, a first-in-class anti-OX40 monoclonal antibody, has successfully enrolled over 2,800 patients with moderate to severe atopic dermatitis. Indeed, 3 of the 8 studies in the rocatinlimab ROCKET study program are now fully enrolled. The Phase III Horizon study, part of this ROCKET program, evaluates rocatinlimab monotherapy versus placebo in adults with moderate to severe atopic dermatitis and remains on track for top line data readout in the second half of this year. Beyond atopic dermatitis, we continue to broadly explore rocatinlimab in additional indications and have initiated a Phase II study in moderate to severe asthma with plans to initiate a Phase III study in prurigo nodularis in the second half of this year. We're encouraged by the advancements of our rare disease pipeline as well with several mid to late-stage opportunities. Starting with UPLIZNA, we anticipate important Phase III data readouts this year in myasthenia gravis and IgG4-related disease, both diseases with significant unmet need and where we have the potential to make a real difference for patients.

Jay: Cancers exploring relevant combinations with standard of care.

The Phase 3 Horizon Study, part of this rocket program, evaluates rocatinlamab monotherapy versus placebo in adults with moderate to severe atopic dermatitis and remains on track for top-line data readout in the second half of this year. Beyond A top of dermatitis, we continue to broadly explore ralcopatinellumab in additional indications and have initiated a phase two study in moderates of severe asthma with plans to initiate a phase three study in Perrigo nodularis in the second half of this year. We're encouraged by the advancements of our rare disease pipeline as well, with several mid-to-late stage opportunities. Starting with a plizna, we anticipate important phase three data readouts this year in Myasthenia Gravis and IGG4 related disease. Both diseases with significant unmet need and where we have the potential to make a real difference for patients.

Jay: And our inflammation portfolio, we're encouraged by the results of the course phase Iia proof of concept study, which investigated Ted spire in patients with moderate to very severe COPD.

James Bradner: This new trial is not a gating step for our Phase 3 program in patients with obesity. Informed by dose and schedule insights from the ongoing Phase 2 obesity study, the dedicated Phase 2 study in diabetes conforms to regulatory requirements for Phase 3 and is the next step towards the diabetes indication for MariTide. In terms of patient experience, we expect to deliver MariTide in a convenient handheld patient-friendly auto injector device with a monthly or even less frequent single injection administration. Assuming eventual approval across the portfolio, we are presently prioritizing differentiated medicines, those that stand to provide the greatest benefit for patients. Given the profile we've seen with AMG 786, we will not pursue further development. Instead, in obesity, we're differentially investing in MariTide and a number of preclinical assets beyond MariTide.

This new trial is not a gating step for our Phase 3 program in patients with obesity. Informed by dose and schedule insights from the ongoing Phase 2 obesity study, the dedicated Phase 2 study in diabetes conforms to regulatory requirements for Phase 3 and is the next step towards the diabetes indication for MariTide. In terms of patient experience, we expect to deliver MariTide in a convenient handheld patient-friendly auto injector device with a monthly or even less frequent single injection administration. Assuming eventual approval across the portfolio, we are presently prioritizing differentiated medicines, those that stand to provide the greatest benefit for patients. Given the profile we've seen with AMG 786, we will not pursue further development. Instead, in obesity, we're differentially investing in MariTide and a number of preclinical assets beyond MariTide.

Beyond A top of dermatitis, we continue to broadly explore ralcopatinellumab in additional indications and have initiated a phase two study in moderates of severe asthma with plans to initiate a phase three study in Perrigo nodularis in the second half of this year. We're encouraged by the advancements of our rare disease pipeline as well, with several mid-to-late stage opportunities. Starting with a plizna, we anticipate important phase three data readouts this year in Myasthenia Gravis and IGG4 related disease. Both diseases with significant unmet need and where we have the potential to make a real difference for patients.

Jay: This study was designed to test <unk> inhibition across an intentionally broad range of eosinophil levels irrespective of inflammatory drivers emphysema chronic bronchitis and smoking status.

Jay: While test by our achieved a clinically meaningful 17% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo. This results fell short of statistical significance likely owing to the broad overall patient demographic.

Starting with a plizna, we anticipate important phase three data readouts this year in Myasthenia Gravis and IGG4 related disease. Both diseases with significant unmet need and where we have the potential to make a real difference for patients.

Jay: Ever even greater reductions in COPD exacerbations were observed in a planned subgroup of patients with baseline blood eosinophil counts greater than a 150 cells per micro leader with a trend for further reduction in a small number of subjects with baseline counts greater than 300.

James E. Bradner: Dazodalibep, an innovative CD40 ligand inhibitor fusion protein, has entered Phase III for Sjogren's disease with 2 studies now enrolling patients. This follows encouraging Phase II data with efficacy across patients with moderate to severe systemic disease and patients with high symptom burden. Dazodalibep is the first therapy to demonstrate efficacy in the latter patient population. Lastly, in our biosimilars portfolio, we've initiated a Phase III study of ABP 234, a biosimilar candidate to KEYTRUDA, in subjects with advanced or metastatic non-squamous non-small cell lung cancer. We're also pleased to announce that WEZLANA, our biosimilar candidate to STELARA, has received a positive CHMP opinion. In closing, I'd like to thank my Amgen colleagues for their strong sense of service to patients facing serious illness and their commitment to growing the impact of both our research and our business to our portfolio of potential first-in-class and best-in-class medicines. And I'll now turn it over to Murdo.

James Bradner: In the first quarter, we rapidly advanced our diverse clinical pipeline of potentially first-in-class or best-in-class programs. Looking ahead, the remainder of 2024 promises to be an exciting time for research and development with two PDUFA dates in June for tarlatamab in small cell lung cancer and Blincyto in adult acute lymphoblastic leukemia, as well as five phase 3 data readouts. Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need. Moving to olpasiran, we're pleased to announce we've completed enrollment of the Ocean A Outcomes trial, a phase 3 cardiovascular outcome study of olpasiran, our potentially best-in-class Lp(a) targeting small interfering RNA medicine.

In the first quarter, we rapidly advanced our diverse clinical pipeline of potentially first-in-class or best-in-class programs. Looking ahead, the remainder of 2024 promises to be an exciting time for research and development with two PDUFA dates in June for tarlatamab in small cell lung cancer and Blincyto in adult acute lymphoblastic leukemia, as well as five phase 3 data readouts. Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need. Moving to olpasiran, we're pleased to announce we've completed enrollment of the Ocean A Outcomes trial, a phase 3 cardiovascular outcome study of olpasiran, our potentially best-in-class Lp(a) targeting small interfering RNA medicine.

This follows encouraging phase two data with efficacy across patients with moderate to severe systemic disease and patients with high symptom burden. Dave of Dalibap is the first therapy to demonstrate efficacy in the latter patient population. Lastly, in our biosimilers portfolio, we've initiated a phase three study of ABP-234, a biosimilar candidate to Katrina in subjects with advanced or metastatic non-squamous, non-small cell lung cancer. We're also pleased to announce that with Lana, our biosimilar candidate to Stellara, has received a positive CHMP opinion. In closing, I'd like to thank my N-GEN colleagues for the strong sense of service to patients facing serious illness and their commitment to growing the impact of both our research and our business to our portfolio of potential first-in-class and best-in-class medicines, and I'll now turn it over to Murdo.

Jay: We're excited by these data, which will be presented in an oral session of the American thoracic Society annual meeting later this month.

Speaker Change: Together with our partner Astrazeneca, we are actively planning for phase III development of test Byron COPD.

Lastly, in our biosimilers portfolio, we've initiated a phase three study of ABP-234, a biosimilar candidate to Katrina in subjects with advanced or metastatic non-squamous, non-small cell lung cancer. We're also pleased to announce that with Lana, our biosimilar candidate to Stellara, has received a positive CHMP opinion. In closing, I'd like to thank my N-GEN colleagues for the strong sense of service to patients facing serious illness and their commitment to growing the impact of both our research and our business to our portfolio of potential first-in-class and best-in-class medicines, and I'll now turn it over to Murdo.

Speaker Change: Beyond COPD, we continue to explore test buyer in separate phase III studies in eosinophilic esophagitis, and chronic rhinosinusitis with nasal polyps, where topline data are expected in the second half of this year.

Speaker Change: The rocket Phase III program for <unk>, a first in class anti <unk> monoclonal antibody has successfully enrolled over 2800 patients with moderate to severe atopic dermatitis.

In closing, I'd like to thank my N-GEN colleagues for the strong sense of service to patients facing serious illness and their commitment to growing the impact of both our research and our business to our portfolio of potential first-in-class and best-in-class medicines, and I'll now turn it over to Murdo.

Speaker Change: Indeed, three of the eight studies in the <unk> study program are now fully enrolled.

James Bradner: Reflecting both our commitment to patients suffering from cardiovascular disease and the strong interest of the medical community, we successfully enrolled 7,297 patients across the globe in just 15 and a half months. To our knowledge, this is the fastest enrolling phase 3 outcome study of its size. To remind, Lp(a) is a genetically defined cardiovascular risk factor which is elevated in approximately 20% of individuals and for whom no effective or targeted therapies currently exist in oncology. We continue to deliver on high conviction targets with differentiated therapies capable of delivering large effect size for patients. Starting with tarlatamab, a first-in-class BiTE molecule targeting DLL3 for small cell lung cancer. We remain on track with an FDA priority review for a 12 June PDUFA date.

Reflecting both our commitment to patients suffering from cardiovascular disease and the strong interest of the medical community, we successfully enrolled 7,297 patients across the globe in just 15 and a half months. To our knowledge, this is the fastest enrolling phase 3 outcome study of its size. To remind, Lp(a) is a genetically defined cardiovascular risk factor which is elevated in approximately 20% of individuals and for whom no effective or targeted therapies currently exist in oncology. We continue to deliver on high conviction targets with differentiated therapies capable of delivering large effect size for patients. Starting with tarlatamab, a first-in-class BiTE molecule targeting DLL3 for small cell lung cancer. We remain on track with an FDA priority review for a 12 June PDUFA date.

Speaker Change: The phase III Horizon study part of this rocket program.

Speaker Change: <unk> monotherapy versus placebo in adults with moderate to severe atopic dermatitis and remains on track for topline data readout in the second half of this year.

Murdo Gordon: Thanks, Jay. I'm pleased with our performance in the first quarter. Strong execution resulted in sales growth of 22% year-over-year, with robust volume growth across the 4 therapeutic pillars of our business. We drove compelling growth across our regions with 10 products delivering at least double-digit volume growth, including REPATHA, EVENITY, TEZSPIRE, TAVNEOS and BLINCYTO. Our integration of the legacy Horizon business continues to progress well with that portfolio generating $914 million in the quarter. Sales in our general medicines business, including REPATHA, PROLIA, EVENITY and AIMOVIG grew 18% year-over-year in the first quarter, driven by volume growth. REPATHA sales increased 33% year-over-year to a record of $517 million for the first quarter, and REPATHA is now well on its way to becoming a multibillion-dollar business. In the quarter, we saw year-over-year volume growth of 44%, partially offset with 13% lower net selling price.

Speaker Change: Beyond atopic dermatitis, we continue to broadly explore <unk> in additional indications and have initiated a phase II study in moderate to severe asthma with plans to initiate a phase III study and Perrigo Nigel Arris in the second half of this year we.

We drove compelling growth across our regions with 10 products delivering at least double-digit volume growth, including Rapassa, Ivenity, Tespire, Tabneos, and Blinzaito. Our integration of the Legacy Horizon business continues to progress well with that portfolio generating $914 million in the quarter. Sales in our general medicines business, including Rapatha, Prolia, Evenity, and Eimovig grew 18% year over year in the first quarter, driven by volume growth. Repatha sales increased 33% year over year to a record of $517 million for the first quarter. And Repatha is now well on its way to becoming a multi-billion dollar business. In the quarter, we saw a year-over-year volume growth of 44% partially offset with 13% lower net selling price.

Speaker Change: We're encouraged by the advancements of our rare disease pipeline as well with several mid to late stage opportunities.

Our integration of the Legacy Horizon business continues to progress well with that portfolio generating $914 million in the quarter. Sales in our general medicines business, including Rapatha, Prolia, Evenity, and Eimovig grew 18% year over year in the first quarter, driven by volume growth. Repatha sales increased 33% year over year to a record of $517 million for the first quarter. And Repatha is now well on its way to becoming a multi-billion dollar business. In the quarter, we saw a year-over-year volume growth of 44% partially offset with 13% lower net selling price.

Speaker Change: Starting with the prisoner, we anticipate important phase III data Readouts. This year in myasthenia gravis and ITG for related disease, both diseases with significant unmet need and where we have the potential to make a real difference for patients.

Sales in our general medicines business, including Rapatha, Prolia, Evenity, and Eimovig grew 18% year over year in the first quarter, driven by volume growth. Repatha sales increased 33% year over year to a record of $517 million for the first quarter. And Repatha is now well on its way to becoming a multi-billion dollar business. In the quarter, we saw a year-over-year volume growth of 44% partially offset with 13% lower net selling price.

James Bradner: We're excited about tarlatamab as potentially the first selective therapy for small cell lung cancer based on the remarkable activity observed as a single agent in patients receiving second- and third-line therapy. We are rapidly advancing tarlatamab into frontline treatment with three phase 3 studies now initiated in both extensive-stage and limited-stage disease. The rationale for studying tarlatamab in earlier lines in the context of lower tumor burden draws from our experience with BLINCYTO and B-cell ALL, where we saw a dramatic improvement in overall survival in minimal residual disease-negative patients. These BLINCYTO data provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells, which are primarily the drivers of recurrent disease.

We're excited about tarlatamab as potentially the first selective therapy for small cell lung cancer based on the remarkable activity observed as a single agent in patients receiving second- and third-line therapy. We are rapidly advancing tarlatamab into frontline treatment with three phase 3 studies now initiated in both extensive-stage and limited-stage disease. The rationale for studying tarlatamab in earlier lines in the context of lower tumor burden draws from our experience with BLINCYTO and B-cell ALL, where we saw a dramatic improvement in overall survival in minimal residual disease-negative patients. These BLINCYTO data provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells, which are primarily the drivers of recurrent disease.

Speaker Change: <unk>, an innovative CD 40 ligand inhibitor or a fusion protein has entered phase III for Shoguns disease with two studies now enrolling patients.

Repatha sales increased 33% year over year to a record of $517 million for the first quarter. And Repatha is now well on its way to becoming a multi-billion dollar business. In the quarter, we saw a year-over-year volume growth of 44% partially offset with 13% lower net selling price.

Speaker Change: This follows encouraging phase II data with efficacy across patients with moderate to severe systemic disease and patients with high symptom burden.

In the quarter, we saw a year-over-year volume growth of 44% partially offset with 13% lower net selling price.

Speaker Change: Data <unk> is the first therapy to demonstrate efficacy in the latter patient population.

Murdo Gordon: Expanded formulary coverage for REPATHA in the U.S. has accelerated volume growth. This was partially offset by lower net selling price resulting from higher rebates to support and expand access for patients. We expect this expanded formulary coverage, along with the removal of prior authorization requirements by several payers, will lead to increased cardiologist and primary care physician adoption. Outside the U.S., we also delivered strong growth, helping even more patients reduce their cardiovascular risk. EVENITY had record sales of $342 million for the quarter. And in the U.S., volume growth was supported by an expansion of EVENITY prescribers. In Japan, EVENITY continues to be the segment leader with 46% of the bone builder market. And while we're happy with the growth of EVENITY, there are many women who remain at risk of a fracture due to their postmenopausal osteoporosis. And we see exciting growth potential for EVENITY to combat this risk, and we'll continue to apply our proven experience in bone health to ensure EVENITY reaches all the patients who need it.

Speaker Change: Lastly, in our Biosimilars portfolio, we've initiated a phase III study of ABP $2 34, a biosimilar candidate to Keytruda in subjects with advanced or metastatic non squamous non small cell lung cancer.

We expect this expanded formulaic coverage along with the removal of prior authorization requirements by several pairs will lead to increase cardiologists and primary care physician adoption. Outside the US, we also delivered strong growth, helping even more patients reduce their cardiovascular risk. Venety had record sales of $342 million for the quarter, and in the US volume growth was supported by an expansion of the Venety prescribers. In Japan, Evinity continues to be the segment leader, with 46% of the bone builder market. And while we're happy with the growth of Evernity, there are many women who remain at risk of a fracture due to their postmenopausal osteoporosis. And we see exciting growth potential for Evernity to combat this risk, and we'll continue to apply our proven experience in bone health to ensure Evernity reaches all the patients who need it.

Speaker Change: We're also pleased to announce that was Lana our biosimilar candidates. The Solara has received a positive <unk> opinion.

James Bradner: We're hopeful we can build on this insight with Tarlatamab where comparable activity in early stage small cell lung cancer patients would very meaningfully improve outcomes for patients facing the challenge of this aggressive cancer. In sum, we regard Tarlatamab as a major advance as the first bispecific T cell engager to demonstrate efficacy in a common solid tumor, further establishing the broad potential of our bispecific T cell engager platform. Our first-in-class STEAP1 CD3 bispecific molecule Xaluritamig has also demonstrated unambiguous activity in a solid tumor, namely prostate cancer, continues to advance following the presentation of encouraging phase I data last fall. We have now fully enrolled the monotherapy phase I dose expansion and continue to enroll patients in reduced monitoring and outpatient cohorts.

We're hopeful we can build on this insight with Tarlatamab where comparable activity in early stage small cell lung cancer patients would very meaningfully improve outcomes for patients facing the challenge of this aggressive cancer. In sum, we regard Tarlatamab as a major advance as the first bispecific T cell engager to demonstrate efficacy in a common solid tumor, further establishing the broad potential of our bispecific T cell engager platform. Our first-in-class STEAP1 CD3 bispecific molecule Xaluritamig has also demonstrated unambiguous activity in a solid tumor, namely prostate cancer, continues to advance following the presentation of encouraging phase I data last fall. We have now fully enrolled the monotherapy phase I dose expansion and continue to enroll patients in reduced monitoring and outpatient cohorts.

Speaker Change: Closing I would like to thank my Amgen colleagues for the strong sense of service to patients facing serious illness and their commitment to growing the impact of both our research and our business to our portfolio of potential first in class and best in class medicines, and I will now turn it over to Murdo.

Venety had record sales of $342 million for the quarter, and in the US volume growth was supported by an expansion of the Venety prescribers. In Japan, Evinity continues to be the segment leader, with 46% of the bone builder market. And while we're happy with the growth of Evernity, there are many women who remain at risk of a fracture due to their postmenopausal osteoporosis. And we see exciting growth potential for Evernity to combat this risk, and we'll continue to apply our proven experience in bone health to ensure Evernity reaches all the patients who need it.

Murdo: Thanks, Jay I am pleased with our performance in the first quarter strong execution resulted in sales growth of 22% year over year with robust volume growth across the four therapeutic pillars of our business. We drove compete compelling growth across our regions with 10 products delivering at least double digit volume growth, including <unk>.

And while we're happy with the growth of Evernity, there are many women who remain at risk of a fracture due to their postmenopausal osteoporosis. And we see exciting growth potential for Evernity to combat this risk, and we'll continue to apply our proven experience in bone health to ensure Evernity reaches all the patients who need it.

Speaker Change: As entity tests by our top Niels and blend cycle.

Speaker Change: Our integration of the legacy Horizon business continues to progress well with that portfolio generating $914 million in the quarter.

Murdo Gordon: PROLIA sales grew 8% year-over-year. Volume growth continues to be supported by real-world evidence, reaffirming PROLIA's superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with postmenopausal osteoporosis, who are at high risk of fracture. In our inflammation business, OTEZLA sales increased 1% year-over-year for the first quarter. In the U.S., we saw strong new patient volume growth early in the quarter. This was disrupted in February and March by the Change Healthcare cybersecurity issue, which created challenges for some patients trying to fill prescriptions at specialty pharmacies. We've seen a return to accelerating new patient prescription growth in recent weeks. We see significant potential for future growth of OTEZLA, given its established efficacy and safety profile, excellent payer coverage with limited prior authorization requirements and, of course, ease of administration. To realize this potential, we've increased our investment in dermatology field force and OTEZLA direct-to-consumer media, focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically and the safety and efficacy profile of OTEZLA.

Volume growth continues to be supported by real-world evidence reaffirming prolius superiority and reducing fracture risk when compared to allendronate in treatment-native patients with postmenopausal osteoporosis who are at high risk of fracture. In our inflammation business, OTesla sales increased 1% year over year for the first quarter. In the US, we saw strong new patient volume growth early in the quarter. This was disrupted in February and March by the Change Healthcare Cybersecurity issue, which created challenges for some patients trying to fill prescriptions at specialty pharmacies. We've seen a return to accelerating new patient prescription growth in recent weeks. We see significant potential for future growth of Otazila given its established efficacy and safety profile, excellent payer coverage with limited prior authorization requirements, and of course, ease of administration. To realize this potential, we've increased our investment in dermatology field force and OTesla direct-to-consumer media, focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically and the safety and efficacy profile of O Tesla.

James Bradner: Further combination studies with Xaluritamig and novel hormonal therapies are progressing in dose escalation studies with near term plans to initiate dose expansion cohorts. To round out oncology, we are rapidly advancing AMG 193, our oral PRMT5 inhibitor targeting MTAP-null solid tumors. We've moved forward with monotherapy dose expansion studies and have initiated two additional phase 1 studies targeting MTAP-null tumors in thoracic, gastrointestinal, biliary tract, and pancreatic cancers, exploring relevant combinations with standard of care in our inflammation portfolio. We're encouraged by the results of the phase 2a proof of concept study which investigated Tezspire in patients with moderate to very severe COPD. This study was designed to test TSLP inhibition across an intentionally broad range of eosinophil levels irrespective of inflammatory drivers, emphysema, chronic bronchitis, and smoking status.

Further combination studies with Xaluritamig and novel hormonal therapies are progressing in dose escalation studies with near term plans to initiate dose expansion cohorts. To round out oncology, we are rapidly advancing AMG 193, our oral PRMT5 inhibitor targeting MTAP-null solid tumors. We've moved forward with monotherapy dose expansion studies and have initiated two additional phase 1 studies targeting MTAP-null tumors in thoracic, gastrointestinal, biliary tract, and pancreatic cancers, exploring relevant combinations with standard of care in our inflammation portfolio. We're encouraged by the results of the phase 2a proof of concept study which investigated Tezspire in patients with moderate to very severe COPD. This study was designed to test TSLP inhibition across an intentionally broad range of eosinophil levels irrespective of inflammatory drivers, emphysema, chronic bronchitis, and smoking status.

Speaker Change: Sales in our general medicines business, including <unk> Prolia as NSE and <unk> grew 18% year over year in the first quarter driven by volume growth.

Speaker Change: <unk> sales increased 33% year over year to a record of $517 million for the first quarter and <unk> is now well on its way to becoming a multibillion dollar business in.

In our inflammation business, OTesla sales increased 1% year over year for the first quarter. In the US, we saw strong new patient volume growth early in the quarter. This was disrupted in February and March by the Change Healthcare Cybersecurity issue, which created challenges for some patients trying to fill prescriptions at specialty pharmacies. We've seen a return to accelerating new patient prescription growth in recent weeks. We see significant potential for future growth of Otazila given its established efficacy and safety profile, excellent payer coverage with limited prior authorization requirements, and of course, ease of administration. To realize this potential, we've increased our investment in dermatology field force and OTesla direct-to-consumer media, focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically and the safety and efficacy profile of O Tesla.

Speaker Change: In the quarter, we saw a year over year volume growth of 44%, partially offset with 13% lower net selling price.

We've seen a return to accelerating new patient prescription growth in recent weeks. We see significant potential for future growth of Otazila given its established efficacy and safety profile, excellent payer coverage with limited prior authorization requirements, and of course, ease of administration. To realize this potential, we've increased our investment in dermatology field force and OTesla direct-to-consumer media, focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically and the safety and efficacy profile of O Tesla.

Speaker Change: Expanded formulary coverage for patent in the U S has accelerated volume growth. This was partially offset by lower net selling price, resulting from higher rebates to support and expand access for patients. We expect this expanded formulary coverage along with the removal of prior authorization requirements by several payers will lead to increased cardiology.

We see significant potential for future growth of Otazila given its established efficacy and safety profile, excellent payer coverage with limited prior authorization requirements, and of course, ease of administration. To realize this potential, we've increased our investment in dermatology field force and OTesla direct-to-consumer media, focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically and the safety and efficacy profile of O Tesla.

To realize this potential, we've increased our investment in dermatology field force and OTesla direct-to-consumer media, focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically and the safety and efficacy profile of O Tesla.

Speaker Change: <unk> and primary care physician adoption.

Speaker Change: Outside the U S. We also delivered strong growth, helping even more patients reduce their cardiovascular risk.

James Bradner: While Tezspire achieved a clinically meaningful 17% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo. This result fell short of statistical significance, likely owing to the broad overall patient demographic. However, even greater reductions in COPD exacerbations were observed in a planned subgroup of patients with baseline blood eosinophil counts greater than 150 cells per microliter, with a trend for further reduction in a small number of subjects with baseline counts greater than 300. We're excited by these data, which will be presented in an oral session of the American Thoracic Society Annual Meeting later this month. Together with our partner AstraZeneca, we're actively planning for phase 3 development of Tezspire and COPD.

While Tezspire achieved a clinically meaningful 17% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo. This result fell short of statistical significance, likely owing to the broad overall patient demographic. However, even greater reductions in COPD exacerbations were observed in a planned subgroup of patients with baseline blood eosinophil counts greater than 150 cells per microliter, with a trend for further reduction in a small number of subjects with baseline counts greater than 300. We're excited by these data, which will be presented in an oral session of the American Thoracic Society Annual Meeting later this month. Together with our partner AstraZeneca, we're actively planning for phase 3 development of Tezspire and COPD.

Speaker Change: <unk> had record sales of $342 million for the quarter.

Speaker Change: And in the U S volume growth was supported by an expansion of this entity prescribers and Japan <unk> continues to be the segment leader with 46% of the bone builder market.

Murdo Gordon: I'm also pleased that OTEZLA was recently granted pediatric exclusivity and approved by the FDA for the treatment of pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This is the first pediatric indication for OTEZLA. Enbrel sales decreased 2% year-over-year for the first quarter, driven by volume decline, partially offset by higher inventory levels. Moving forward, we expect modest volume growth offset by declining net selling price. TEZSPIRE continues its strong trajectory with $173 million in sales in the first quarter. Sales increased 80% year-over-year, primarily driven by uptake of the prefilled single-use pen. In our rare disease business, sales of TAVNEOS were $51 million in the first quarter. Sales increased 122% year-over-year, driven by volume growth. In the U.S., more than 3,000 patients have now been treated with TAVNEOS by over 2,000 health care professionals. Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring TAVNEOS to even more patients with ANCA-associated vasculitis.

Speaker Change: And while we're happy with the growth of that entity. There are many women who remain at risk of a fracture due to their post menopausal osteoporosis, and we see exciting growth potential for <unk> to combat this risk and we will continue to apply our proven experience in bone health to ensure the entity reaches all the patients who need it.

Embrel sales decreased 2% year over year for the first quarter driven by volume decline, partially offset by higher inventory levels. Moving forward, we expect modest volume growth offset by declining net selling price. Test buyer continues its strong trajectory with $173 million in sales in the first quarter. Sales increased 80% year over year, primarily driven by uptake of the pre-filled single-use pen. In our rare disease business, sales of Tadneos were $51 million in the first quarter. Sales increased 122% year over year, driven by volume growth. In the US, more than 3,000 patients have now been treated with tabneos by over 2,000 healthcare professionals. Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring tablios to even more patients with ANCA-associated vasculitis.

Speaker Change: Prolia sales grew 8% year over year volume growth continues to be supported by real world evidence reaffirming prolia superiority and reducing fracture risk when compared to alendronate in treatment naive patients with postmenopausal osteoporosis.

James Bradner: Beyond COPD, we continue to explore Tezspire in separate phase 3 studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top-line data are expected in the second half of this year. The Rocatinlimab Rocket Phase 3 program for rocatinlimab, a first-in-class anti-OX40 monoclonal antibody, has successfully enrolled over 2,800 patients with moderate to severe atopic dermatitis. Indeed, three of the eight studies in the rocatinlimab Rocket Study Program are now fully enrolled. The Phase 3 Horizons Study, part of this Rocket Program, evaluates rocatinlimab monotherapy versus placebo in adults with moderate to severe atopic dermatitis and remains on track for top-line data readout in the second half of this year.

Beyond COPD, we continue to explore Tezspire in separate phase 3 studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top-line data are expected in the second half of this year. The Rocatinlimab Rocket Phase 3 program for rocatinlimab, a first-in-class anti-OX40 monoclonal antibody, has successfully enrolled over 2,800 patients with moderate to severe atopic dermatitis. Indeed, three of the eight studies in the rocatinlimab Rocket Study Program are now fully enrolled. The Phase 3 Horizons Study, part of this Rocket Program, evaluates rocatinlimab monotherapy versus placebo in adults with moderate to severe atopic dermatitis and remains on track for top-line data readout in the second half of this year.

Test buyer continues its strong trajectory with $173 million in sales in the first quarter. Sales increased 80% year over year, primarily driven by uptake of the pre-filled single-use pen. In our rare disease business, sales of Tadneos were $51 million in the first quarter. Sales increased 122% year over year, driven by volume growth. In the US, more than 3,000 patients have now been treated with tabneos by over 2,000 healthcare professionals. Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring tablios to even more patients with ANCA-associated vasculitis.

Speaker Change: At high risk of fracture.

In our rare disease business, sales of Tadneos were $51 million in the first quarter. Sales increased 122% year over year, driven by volume growth. In the US, more than 3,000 patients have now been treated with tabneos by over 2,000 healthcare professionals. Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring tablios to even more patients with ANCA-associated vasculitis.

Speaker Change: In our inflammation business, Oh, Tesla sales increased 1% year over year for the first quarter.

Speaker Change: In the U S. We saw strong new patient volume growth early in the quarter.

In the US, more than 3,000 patients have now been treated with tabneos by over 2,000 healthcare professionals. Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring tablios to even more patients with ANCA-associated vasculitis.

Speaker Change: This was disrupted in February and March by the change healthcare cyber security issue, which created challenges for some patients trying to fill prescriptions at specialty pharmacies.

Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring tablios to even more patients with ANCA-associated vasculitis. Sales for our biosimilars portfolio grew 12% year-over-year for the first quarter, with volume growth partially offset by lower inventory levels and net selling price to climb. We expect continued growth in our biosimilar's business to be driven by the addition of new molecules and additional launches.

Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring tablios to even more patients with ANCA-associated vasculitis.

Speaker Change: We've seen a return to accelerating new patient prescription growth in recent weeks.

Murdo Gordon: Sales for our biosimilars portfolio grew 12% year-over-year for the first quarter, with volume growth partially offset by lower inventory levels and net selling price decline. We expect continued growth in our biosimilars business to be driven by the addition of new molecules and additional launches. In oncology, sales of our 6 innovative products, BLINCYTO, LUMAKRAS, VECTIBIX, KYPROLIS, NPLATE and XGEVA, grew 4% year-over-year for the first quarter, driven by volume growth. BLINCYTO sales grew 26% year-over-year to a record $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B-cell precursor acute lymphoblastic leukemia. The U.S. Food and Drug Administration has set a PDUFA date of June 21st of this year for its decision on approving BLINCYTO as a treatment for patients with early-stage CD19-positive, B-cell ALL. We see significant growth potential for BLINCYTO from utilization in frontline treatment.

Speaker Change: We see significant potential for future growth Tesla given its established efficacy and safety profile excellent payer coverage with limited prior authorization requirements and of course ease of administration.

James Bradner: Beyond atopic dermatitis, we continue to broadly explore rocatinlimab in additional indications and have initiated a phase 2 study in moderate to severe asthma with plans to initiate a phase 3 study in Prurigo Nodularis in the second half of this year. We're encouraged by the advancements of our rare disease pipeline as well with several mid- to late-stage opportunities starting with Uplizna. We anticipate important phase 3 data readouts this year in Myasthenia Gravis and IgG4-related disease, both diseases with significant unmet need and where we have the potential to make a real difference for patients. Dazodalibep, an innovative CD40 ligand inhibitor fusion protein, has entered phase 3 for Sjogren's Disease with two studies now enrolling patients. This follows encouraging phase 2 data with efficacy across patients with moderate to severe systemic disease and patients with high symptom burden.

Beyond atopic dermatitis, we continue to broadly explore rocatinlimab in additional indications and have initiated a phase 2 study in moderate to severe asthma with plans to initiate a phase 3 study in Prurigo Nodularis in the second half of this year. We're encouraged by the advancements of our rare disease pipeline as well with several mid- to late-stage opportunities starting with Uplizna. We anticipate important phase 3 data readouts this year in Myasthenia Gravis and IgG4-related disease, both diseases with significant unmet need and where we have the potential to make a real difference for patients. Dazodalibep, an innovative CD40 ligand inhibitor fusion protein, has entered phase 3 for Sjogren's Disease with two studies now enrolling patients. This follows encouraging phase 2 data with efficacy across patients with moderate to severe systemic disease and patients with high symptom burden.

Speaker Change: To realize this potential we've increased our investment in dermatology field force and <unk> direct to consumer media.

In oncology, sales of our six innovative products, Blinzytoc, Lumacraz, Vectadix, Kiprolis, N-Plate and Excheva grew 4% year-over-year for the first quarter, driven by volume growth. Lincitos sales grew 26% year over year to a record $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B-cell precursor acute lymphoblastic leukemia. The US Food and Drug Administration has set a PDUFA date of June 21st of this year for its decision on approving BlinSito is a treatment for patients with early stage CD-19 positive B-Cell-A-L. We see significant growth potential for Blin-Sito from utilization in frontline treatment.

Speaker Change: Focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically.

Speaker Change: And the safety and efficacy profile of a Tesla.

Lincitos sales grew 26% year over year to a record $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B-cell precursor acute lymphoblastic leukemia. The US Food and Drug Administration has set a PDUFA date of June 21st of this year for its decision on approving BlinSito is a treatment for patients with early stage CD-19 positive B-Cell-A-L. We see significant growth potential for Blin-Sito from utilization in frontline treatment.

Speaker Change: I'm also pleased that Tesla was recently granted pediatric exclusivity and approved by the FDA for the treatment of pediatric patients six years of age and older with moderate to severe plaque psoriasis, who are candidates for photo therapy or systemic therapy. This is the first pediatric indication thorough Tesla.

The US Food and Drug Administration has set a PDUFA date of June 21st of this year for its decision on approving BlinSito is a treatment for patients with early stage CD-19 positive B-Cell-A-L. We see significant growth potential for Blin-Sito from utilization in frontline treatment.

Speaker Change: Enbrel sales decreased 2% year over year for the first quarter driven by volume decline, partially offset by higher inventory levels moving forward, we expect modest volume growth offset by declining net selling price.

James Bradner: Bemarituzumab is the first therapy to demonstrate efficacy in the latter patient population. Lastly, in our biosimilars portfolio, we've initiated a phase 3 study of ABP 234, a biosimilar candidate to Keytruda, in subjects with advanced or metastatic non-squamous non-small cell lung cancer. We're also pleased to announce that Wezlana, our biosimilar candidate to Stelara, has received a positive CHMP opinion. In closing, I'd like to thank my Amgen colleagues for their strong sense of service to patients facing serious illness and their commitment to growing the impact of both our research and our business to our portfolio of potential first-in-class and best-in-class medicines, and I'll now turn it over to Murdo. Thanks, Jay.

Bemarituzumab is the first therapy to demonstrate efficacy in the latter patient population. Lastly, in our biosimilars portfolio, we've initiated a phase 3 study of ABP 234, a biosimilar candidate to Keytruda, in subjects with advanced or metastatic non-squamous non-small cell lung cancer. We're also pleased to announce that Wezlana, our biosimilar candidate to Stelara, has received a positive CHMP opinion. In closing, I'd like to thank my Amgen colleagues for their strong sense of service to patients facing serious illness and their commitment to growing the impact of both our research and our business to our portfolio of potential first-in-class and best-in-class medicines, and I'll now turn it over to Murdo.

Murdo Gordon: LUMAKRAS sales increased 11% year-over-year for the first quarter to a record $82 million. We see future growth opportunities for LUMAKRAS coming from the launches in new markets and additional indications. VECTIBIX sales increased 6% year-over-year, driven by higher net selling price and volume growth, partially offset by unfavorable foreign exchange impact. KYPROLIS sales grew 5% year-over-year to a record $376 million for the first quarter, primarily driven by volume growth outside the U.S. NPLATE sales decreased 12% year-over-year for the first quarter, primarily driven by volume decline in comparison to the first quarter of 2023, which included a U.S. government order of $82 million. Excluding the Q1 2023 U.S. government order, NPLATE sales grew 13% year-over-year. I'm pleased with our execution in the quarter and the momentum across the 4 pillars of our business. And we look forward to serving many more patients around the world who can benefit from our innovative therapies. And with that, I'll turn it over to Vikram.

Speaker Change: Test buyer continues its strong trajectory with $173 million in sales in the first quarter sales.

Speaker Change: Sales increased 80% year over year, primarily driven by uptake of the pre filled single use pad.

Vecta-Bix sales increased 6% year-over-year driven by higher net selling price and volume growth, partially offset by unfavorable foreign exchange impact. Caprolous sales grew 5% year-over-year to a record $376 million for the first quarter, primarily driven by volume growth outside the US. End plate sales decreased 12% year over year for the first quarter, primarily driven by volume decline in comparison to the first quarter of 2023, which included a US government order of $82 million. excluding the Q1, 2023 US government order, end plate sales grew 13% year over year. I'm pleased with our execution in the quarter and the momentum across the four pillars of our business, and we look forward to serving many more patients around the world who can benefit from our innovative therapies. With that, I'll turn it over to VICRO.

Speaker Change: And our rare disease business sales of <unk> were $51 million in the first quarter sales increased 122% year over year, driven by volume growth in the U S. More than 3000 patients have now been treated with tab neil's by over 2000 health care professionals looking forward, we will continue to leverage our expertise in nephrology.

End plate sales decreased 12% year over year for the first quarter, primarily driven by volume decline in comparison to the first quarter of 2023, which included a US government order of $82 million. excluding the Q1, 2023 US government order, end plate sales grew 13% year over year. I'm pleased with our execution in the quarter and the momentum across the four pillars of our business, and we look forward to serving many more patients around the world who can benefit from our innovative therapies. With that, I'll turn it over to VICRO.

Speaker Change: In inflammation to bring <unk> to even more patients with anchor associated vasculitis.

Murdo Gordon: Thanks, Jay. I'm pleased with our performance in the first quarter. Strong execution resulted in sales growth of 22% year over year, which, with robust volume growth across the four therapeutic pillars of our business, we drove compelling growth across our regions with 10 products delivering at least double-digit volume growth, including Repatha, Evenity, Tezspire, Tavneos, and Blincyto.

Murdo Gordon: I'm pleased with our performance in the first quarter. Strong execution resulted in sales growth of 22% year over year, which, with robust volume growth across the four therapeutic pillars of our business, we drove compelling growth across our regions with 10 products delivering at least double-digit volume growth, including Repatha, Evenity, Tezspire, Tavneos, and Blincyto. Our integration of the Legacy Horizon business continues to progress well with that portfolio generating $914 million in the quarter. Sales in our general medicines business, including Repatha, Prolia, Evenity, and Imovig, grew 18% year over year in the first quarter, driven by volume growth. Repatha sales increased 33% year over year to a record of $517 million for the first quarter, and Repatha is now well on its way to becoming a multibillion-dollar business.

Speaker Change: Sales for our Biosimilars portfolio grew 12% year over year for the first quarter with volume growth, partially offset by lower inventory levels and net selling price decline. We expect continued growth in our biosimilars business to be driven by the addition of new molecules and additional launches.

excluding the Q1, 2023 US government order, end plate sales grew 13% year over year. I'm pleased with our execution in the quarter and the momentum across the four pillars of our business, and we look forward to serving many more patients around the world who can benefit from our innovative therapies. With that, I'll turn it over to VICRO.

Speaker Change: And oncology sales of our six innovative products Blitt insightful, <unk>, Vectibix, Kyprolis and plate and ex Java grew 4% year over year for the first quarter driven by volume growth.

Our integration of the Legacy Horizon business continues to progress well with that portfolio generating $914 million in the quarter. Sales in our general medicines business, including Repatha, Prolia, Evenity, and Imovig, grew 18% year over year in the first quarter, driven by volume growth. Repatha sales increased 33% year over year to a record of $517 million for the first quarter, and Repatha is now well on its way to becoming a multibillion-dollar business.

Vikram Karnani: Thank you, Murdo. I am pleased to provide an update on rare disease, Amgen's fourth therapeutic pillar of growth, which delivered product sales of over $950 million in Q1. Beginning with TEPEZZA for the treatment of thyroid eye disease, or TED, first quarter sales were $424 million, reflecting growth of 5% year-over-year when compared to results from the legacy Horizon business. As we discussed at our rare disease investor meeting a few months back, TED is often assessed using the clinical activity score, or CAS, which covers a number of different signs and symptoms, including pain, redness, swelling and function. And we now refer to TED in terms of high and low clinical activity score or high and low CAS. For the approximately 100,000 TED patients in the U.S. who could benefit from TEPEZZA, the majority of these patients, roughly 80%, are in low CAS settings. We continue to focus on this large number of low CAS patients not being appropriately treated.

Speaker Change: <unk> sales grew 26% year over year to a record $244 million for the first quarter driven by broad prescribing across academic and community segments for patients with B cell precursor acute lymphoblastic leukemia.

Beginning with Tepeza for the treatment of thyroid eye disease or TED, First quarter sales were $424 million, reflecting growth of 5% year over year when compared to results from the Legacy Horizon business. As we discussed at our rare disease investor meeting a few months back, TED is often assessed using the clinical activity score. or CAS, which covers a number of different signs and symptoms, including pain, redness, swelling, and function. And we now refer to TED in terms of high and low clinical activities for, or high and low CAS. For the approximately 100,000 TED patients in the U.S. who could benefit from Tepeza, The majority of these patients, roughly 80%, are in low-cast settings. We continue to focus on this large number of low-cast patients not being appropriately treated.

First quarter sales were $424 million, reflecting growth of 5% year over year when compared to results from the Legacy Horizon business. As we discussed at our rare disease investor meeting a few months back, TED is often assessed using the clinical activity score. or CAS, which covers a number of different signs and symptoms, including pain, redness, swelling, and function. And we now refer to TED in terms of high and low clinical activities for, or high and low CAS. For the approximately 100,000 TED patients in the U.S. who could benefit from Tepeza, The majority of these patients, roughly 80%, are in low-cast settings. We continue to focus on this large number of low-cast patients not being appropriately treated.

Speaker Change: U S food and drug administration has set a <unk> date of June 21st of this year for its decision on approving blend sites. So as a treatment for patients with early stage <unk> 19 positive b cell ALLL, we see significant growth potential for billing cycle from utilization and frontline treatment.

Murdo Gordon: In the quarter we saw year over year volume growth of 44% partially offset with 13% lower net selling price.

In the quarter we saw year over year volume growth of 44% partially offset with 13% lower net selling price.

TED is often assessed using the clinical activity score. or CAS, which covers a number of different signs and symptoms, including pain, redness, swelling, and function. And we now refer to TED in terms of high and low clinical activities for, or high and low CAS. For the approximately 100,000 TED patients in the U.S. who could benefit from Tepeza, The majority of these patients, roughly 80%, are in low-cast settings. We continue to focus on this large number of low-cast patients not being appropriately treated.

or CAS, which covers a number of different signs and symptoms, including pain, redness, swelling, and function. And we now refer to TED in terms of high and low clinical activities for, or high and low CAS. For the approximately 100,000 TED patients in the U.S. who could benefit from Tepeza, The majority of these patients, roughly 80%, are in low-cast settings. We continue to focus on this large number of low-cast patients not being appropriately treated.

Speaker Change: <unk> sales increased 11% year over year for the first quarter to a record $82 million.

Murdo Gordon: Expanded formulary coverage for Repatha in the US has accelerated volume growth. This was partially offset by lower net selling price resulting from higher rebates to support and expand access for patients. We expect this expanded formulary coverage, along with the removal of prior authorization requirements by several payers, will lead to increased cardiologist and primary care physician adoption. Outside the US, we also delivered strong growth helping even more patients reduce their cardiovascular risk. Evenity had record sales of $342 million for the quarter, and in the US volume growth was supported by an expansion of Evenity prescribers.

Expanded formulary coverage for Repatha in the US has accelerated volume growth. This was partially offset by lower net selling price resulting from higher rebates to support and expand access for patients. We expect this expanded formulary coverage, along with the removal of prior authorization requirements by several payers, will lead to increased cardiologist and primary care physician adoption. Outside the US, we also delivered strong growth helping even more patients reduce their cardiovascular risk. Evenity had record sales of $342 million for the quarter, and in the US volume growth was supported by an expansion of Evenity prescribers.

Speaker Change: We see future growth opportunities for <unk> coming from launches in new markets and additional indications.

For the approximately 100,000 TED patients in the U.S. who could benefit from Tepeza, The majority of these patients, roughly 80%, are in low-cast settings. We continue to focus on this large number of low-cast patients not being appropriately treated.

Speaker Change: <unk> sales increased 6% year over year, driven by higher net selling price and volume growth, partially offset by unfavorable foreign exchange impact Kyprolis sales grew 5% year over year to a record $376 million for the first quarter, primarily driven by volume growth outside of the U S.

The majority of these patients, roughly 80%, are in low-cast settings. We continue to focus on this large number of low-cast patients not being appropriately treated.

Vikram Karnani: As we previously discussed, one of the main hurdles in the patient journey in this setting is access. To help patients overcome that challenge, we have generated favorable medical policy changes for greater than 50% of U.S. covered lives, and we expect to continue this momentum throughout 2024. In addition, we are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists who manage many low CAS patients. The impact of TED on quality of life is often underestimated. So, our focus is on educating health care providers about the significant effects on patients, even those with less visible symptoms. In addition to our focus on educating ocular surgeons and ophthalmologists, we are increasing our strategic focus in endocrinology and creating a dedicated sales force to engage in this important space.

Speaker Change: And place sales decreased 12% year over year for the first quarter, primarily driven by volume declined in comparison to the first quarter of 2023, which included a U S government order of $82 million.

Murdo Gordon: In Japan, Evenity continues to be the segment leader with 46% of the bone builder market, and while we're happy with the growth of Evenity, this, there are many women who remain at risk of a fracture due to their postmenopausal osteoporosis, and we see exciting growth potential for Evenity to combat this risk, and we'll continue to apply our proven experience in bone health to ensure Evenity reaches all the patients who need it. Prolia sales grew 8% year over year. Volume growth continues to be supported by real-world evidence reaffirming Prolia's superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with postmenopausal osteoporosis who are at high risk of fracture. In our inflammation business, Otezla sales increased 1% year over year for Q1. In the US, we saw strong new patient volume growth early in the quarter.

In Japan, Evenity continues to be the segment leader with 46% of the bone builder market, and while we're happy with the growth of Evenity, this, there are many women who remain at risk of a fracture due to their postmenopausal osteoporosis, and we see exciting growth potential for Evenity to combat this risk, and we'll continue to apply our proven experience in bone health to ensure Evenity reaches all the patients who need it. Prolia sales grew 8% year over year. Volume growth continues to be supported by real-world evidence reaffirming Prolia's superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with postmenopausal osteoporosis who are at high risk of fracture. In our inflammation business, Otezla sales increased 1% year over year for Q1. In the US, we saw strong new patient volume growth early in the quarter.

Speaker Change: Excluding the Q1 2023 U S government order and place sales grew 13% year over year.

In addition, we are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists who manage many low-cast patients. The impact of TED on quality of life is often underestimated, so our focus is on educating healthcare providers about the significant effects on patients, even those with less visible symptoms. In addition to our focus on educating ocular surgeons and ophthalmologists, we are increasing our strategic focus in endocrinology and creating a dedicated sales force to engage in this important space.

Speaker Change: I am pleased with our execution in the quarter and the momentum across the four pillars of our business and we look forward to serving many more patients around the world, who can benefit from our innovative therapies and with that I'll turn it over to that group.

The impact of TED on quality of life is often underestimated, so our focus is on educating healthcare providers about the significant effects on patients, even those with less visible symptoms. In addition to our focus on educating ocular surgeons and ophthalmologists, we are increasing our strategic focus in endocrinology and creating a dedicated sales force to engage in this important space.

Speaker Change: Thank you Murdo.

Murdo: Im pleased to provide an update on rare disease, Andrew fourth therapeutic pillar of growth, which delivered product sales of over $950 million in Q1.

In addition to our focus on educating ocular surgeons and ophthalmologists, we are increasing our strategic focus in endocrinology and creating a dedicated sales force to engage in this important space.

Andrew: Beginning with the peso for the treatment of disease or <unk> first quarter sales were $424 million.

Andrew: Reflecting growth of 5% year over year, when compared to results from the legacy horizon business as.

Vikram Karnani: International expansion remains a meaningful long-term growth opportunity for TEPEZZA, which is currently approved in Brazil and Saudi Arabia. As a reminder, in January, we filed for high CAS approval in Japan. And our Phase III trial in low CAS is continuing to enroll. We have completed additional regulatory submissions in Australia, Canada, Great Britain and most recently with the European Medicines Agency. We initiated a Phase III subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation. KRYSTEXXA, for patients with chronic refractory gout, delivered $235 million in sales in Q1, representing 26% year-over-year growth, driven by volume growth from strong commercial execution. UPLIZNA, the fastest-growing biologic in NMOSD, delivered a record $80 million in net sales in Q1, representing 49% year-over-year growth. International expansion is also underway with UPLIZNA now launched in multiple ex-U.S. markets including Canada, which launched in January of this year.

Andrew: As we discussed at our rare disease Investor meeting a few months back.

Murdo Gordon: This was disrupted in February and March by the Change Healthcare cybersecurity issue which created challenges for some patients trying to fill prescriptions at specialty pharmacies. We've seen a return to accelerating new patient prescription growth in recent weeks. We see significant potential for future growth of Otezla given its established efficacy and safety profile, excellent payer coverage with limited prior authorization requirements, and of course ease of administration. To realize this potential, we've increased our investment in dermatology field force and Otezla direct-to-consumer media, focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically, and the safety and efficacy profile of Otezla.

This was disrupted in February and March by the Change Healthcare cybersecurity issue which created challenges for some patients trying to fill prescriptions at specialty pharmacies. We've seen a return to accelerating new patient prescription growth in recent weeks. We see significant potential for future growth of Otezla given its established efficacy and safety profile, excellent payer coverage with limited prior authorization requirements, and of course ease of administration. To realize this potential, we've increased our investment in dermatology field force and Otezla direct-to-consumer media, focusing on efforts to educate physicians and patients on the importance of treating psoriasis systemically, and the safety and efficacy profile of Otezla.

Andrew: <unk> is often assessed using the clinical activity score or Cas, which covers a number of different signs and symptoms, including pain redness swelling and function.

We have completed additional regulatory submissions in Australia, Canada, Great Britain, and most recently with the European Medicines Agency. We initiated a phase three subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation. Christexa for patients with chronic refractory gout delivered $235 million in sales in Q1, representing 26% year-over-year growth, driven by volume growth from strong commercial execution. Aplizna, the fastest growing biologic in NMOSD, delivered a record $80 million in net sales in Q1, representing 49% year-over-year growth. International expansion is also underway with the Blisna now launched in multiple XUS markets, including Canada, which launched in January of this year.

Andrew: We now refer to <unk> in terms of high and low clinical activities for our high and low cost power.

We initiated a phase three subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation. Christexa for patients with chronic refractory gout delivered $235 million in sales in Q1, representing 26% year-over-year growth, driven by volume growth from strong commercial execution. Aplizna, the fastest growing biologic in NMOSD, delivered a record $80 million in net sales in Q1, representing 49% year-over-year growth. International expansion is also underway with the Blisna now launched in multiple XUS markets, including Canada, which launched in January of this year.

Speaker Change: For the approximately 100000 <unk> patients in the U S who could benefit from the peso.

Speaker Change: The majority of these patients roughly 80% are in low cost settings. We continue to focus on this large number of low caste patients not being appropriately accretive.

Christexa for patients with chronic refractory gout delivered $235 million in sales in Q1, representing 26% year-over-year growth, driven by volume growth from strong commercial execution. Aplizna, the fastest growing biologic in NMOSD, delivered a record $80 million in net sales in Q1, representing 49% year-over-year growth. International expansion is also underway with the Blisna now launched in multiple XUS markets, including Canada, which launched in January of this year.

Speaker Change: As we've previously discussed one of the main hurdles and the patient journey. In this setting is access to help patients overcome that challenge we have generated favorable medical policy changes, both greater than 50% of U S covered lives and we expect to continue this momentum throughout 2024.

Murdo Gordon: I'm also pleased that Otezla was recently granted pediatric exclusivity and approved by the FDA for the treatment of pediatric patients six years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This is the first pediatric indication for Otezla. Enbrel sales decreased 2% year over year for Q1 driven by volume decline, partially offset by higher inventory levels. Moving forward, we expect modest volume growth offset by declining net selling price. Tezspire continues its strong trajectory with $173 million in sales in Q1. Sales increased 80% year over year primarily driven by uptake of the prefilled single-use pen. In our rare disease business, sales of Tavneos were $51 million in Q1. Sales increased 122% year over year driven by volume growth.

I'm also pleased that Otezla was recently granted pediatric exclusivity and approved by the FDA for the treatment of pediatric patients six years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This is the first pediatric indication for Otezla. Enbrel sales decreased 2% year over year for Q1 driven by volume decline, partially offset by higher inventory levels. Moving forward, we expect modest volume growth offset by declining net selling price. Tezspire continues its strong trajectory with $173 million in sales in Q1. Sales increased 80% year over year primarily driven by uptake of the prefilled single-use pen. In our rare disease business, sales of Tavneos were $51 million in Q1. Sales increased 122% year over year driven by volume growth.

Aplizna, the fastest growing biologic in NMOSD, delivered a record $80 million in net sales in Q1, representing 49% year-over-year growth. International expansion is also underway with the Blisna now launched in multiple XUS markets, including Canada, which launched in January of this year.

Speaker Change: In addition, we are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists, who manage many low caste patients.

International expansion is also underway with the Blisna now launched in multiple XUS markets, including Canada, which launched in January of this year.

Speaker Change: The impact of <unk> on quality of life is often underestimated. So our focus is on educating healthcare providers about the significant effects on patients even those with less visible symptoms.

Vikram Karnani: The integration of the legacy Horizon business continues to be on track as we leverage Amgen's leadership in inflammation, world-class manufacturing and process development and extensive global footprint. Now I will pass it over to Peter for our financial update.

as we leverage Amgen's leadership in inflammation, lower class manufacturing and process development, and extensive global footprint. Now I will pass it over to Peter for our financial update.

Speaker Change: In addition to our focus on educating ocular surgeons ophthalmologists, we are increasing our strategic focus in endocrinology and creating a dedicated sales force to engage in this important space.

Now I will pass it over to Peter for our financial update. Thank you, Vicar. We're pleased with our performance and on track to meet our 2024 full goals and long-term objectives.

Now I will pass it over to Peter for our financial update.

Peter H. Griffith: Thank you, Vikram. We're pleased with our performance and on track to meet our 2024 full goals and long-term objectives. Our strong growth outlook is driven across each of our 4 therapeutic pillars by our innovative pipeline and in-market portfolio products, which serve patients with serious illnesses around the globe. I'll review our first quarter results before discussing our 2024 guidance. As shown on Slide 23 of the slide deck, in the first quarter, we delivered $7.4 billion in total revenue, a 22% increase year-over-year. This reflects 25% volume growth, including over $900 million from acquired Horizon products and also key brands, including REPATHA, TEZSPIRE, EVENITY, PROLIA and BLINCYTO. Excluding the addition of Horizon, product sales increased 6% year-over-year, driven by 9% volume growth.

Speaker Change: International expansion remains a meaningful long term growth opportunity foot to peso, which is currently approved in Brazil, and Saudi Arabia.

Our strong growth outlook is driven across each of our four therapeutic pillars by our innovative pipeline and in-market portfolio products, which serve patients with serious illnesses around the globe. I'll review our first quarter results before discussing our 2024 guidance. As shown on slide 23 of the slide deck, in the first quarter we delivered 7.4 billion in total revenue, a 22% increase year over year. This reflects 25% volume growth, including over $900 million from acquired Horizon products, and also key brands including Repathus Aspire of Enity, Prolia, N, BlinSito. Excluding the addition of Horizon, product sales increased 6% year-over-year, driven by 9% volume growth.

Murdo Gordon: In the US, more than 3,000 patients have now been treated with TAVNEOS by over 2,000 healthcare professionals. Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring TAVNEOS to even more patients with ANCA-associated vasculitis. Sales for our biosimilars portfolio grew 12% year over year for Q1, with volume growth partially offset by lower inventory levels and net selling price decline. We expect continued growth in our biosimilars business to be driven by the addition of new molecules and additional launches in oncology. Sales of our six innovative products BLINCYTO, LUMAKRAS, Vectibix, Kyprolis, Nplate, and Xgeva grew 4% year over year for Q1 driven by volume growth.

In the US, more than 3,000 patients have now been treated with TAVNEOS by over 2,000 healthcare professionals. Looking forward, we'll continue to leverage our expertise in nephrology and inflammation to bring TAVNEOS to even more patients with ANCA-associated vasculitis. Sales for our biosimilars portfolio grew 12% year over year for Q1, with volume growth partially offset by lower inventory levels and net selling price decline. We expect continued growth in our biosimilars business to be driven by the addition of new molecules and additional launches in oncology. Sales of our six innovative products BLINCYTO, LUMAKRAS, Vectibix, Kyprolis, Nplate, and Xgeva grew 4% year over year for Q1 driven by volume growth.

Speaker Change: As a reminder, in January we filed for high test approval in Japan, and our phase III trial in low cost is continuing to enroll.

Speaker Change: We have completed additional regulatory submissions in Australia, Canada, Great Britain, and most recently with the European Medicines Agency.

As shown on slide 23 of the slide deck, in the first quarter we delivered 7.4 billion in total revenue, a 22% increase year over year. This reflects 25% volume growth, including over $900 million from acquired Horizon products, and also key brands including Repathus Aspire of Enity, Prolia, N, BlinSito. Excluding the addition of Horizon, product sales increased 6% year-over-year, driven by 9% volume growth.

Speaker Change: We initiated a phase III subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation.

Excluding the addition of Horizon, product sales increased 6% year-over-year, driven by 9% volume growth.

Speaker Change: KRYSTEXXA for patients with chronic refractory gout delivered $235 million in.

Speaker Change: <unk> sales in Q1, representing 26% year over year growth driven by volume growth from strong commercial execution.

Peter H. Griffith: Our non-GAAP operating expenses rose by 33%, reflecting investments in Horizon acquired products, along with other late-stage pipeline medicines, including rocatinlimab, MariTide and tarlatamab. As a result, our Q1 operating margin was 43%, consistent with our guidance on the fourth quarter earnings call. Our non-GAAP OI&E resulted in $549 million expense, up $334 million year-over-year, almost entirely due to increased interest expense from debt issued for the Horizon acquisition, partially offset by higher interest income and gains from debt repurchases. Our non-GAAP tax rate decreased 2.4 percentage points year-over-year to 15.4%, primarily due to the change in earnings mix, the inclusion of the Horizon business, and net favorable items in the quarter. In the first quarter, the company generated $0.5 billion in free cash flow, a decrease from $0.7 billion in the previous year, primarily impacted by a planned $800 million tax deposit to the IRS to stop the accrual of interest on uncertain tax positions, as we discussed on our fourth quarter earnings call.

Murdo Gordon: Blincyto sales grew 26% year over year to a record $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B cell precursor acute lymphoblastic leukemia. The US Food and Drug Administration has set a PDUFA date of 21 June 2024 for its decision on approving Blincyto as a treatment for patients with early CD19 positive B cell. As we see significant growth potential for Blincyto from utilization in frontline treatment. Lumakras sales increased 11% year over year for the first quarter to a record $82 million. We see future growth opportunities for Lumakras coming from launches in new markets and additional indications. Vectibix sales increased 6% year over year driven by higher net selling price, and volume growth partially offset by unfavorable foreign exchange impact.

Blincyto sales grew 26% year over year to a record $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B cell precursor acute lymphoblastic leukemia. The US Food and Drug Administration has set a PDUFA date of 21 June 2024 for its decision on approving Blincyto as a treatment for patients with early CD19 positive B cell. As we see significant growth potential for Blincyto from utilization in frontline treatment. Lumakras sales increased 11% year over year for the first quarter to a record $82 million. We see future growth opportunities for Lumakras coming from launches in new markets and additional indications. Vectibix sales increased 6% year over year driven by higher net selling price, and volume growth partially offset by unfavorable foreign exchange impact.

Speaker Change: <unk> the fastest growing biologic in animal SD delivered a record $80 million in net sales in Q1, representing 49% year over year growth.

Speaker Change: International expansion is also underway with a plus now launched in multiple ex U S markets, including Canada, which launched in January of this year.

Our non-GAP OI&E resulted in $549 million expense, up $334 million year over year, almost entirely due to increased interest expense from debt issued for the Horizon acquisition, partially offset by higher interest income and gains from debt repurchases. Our non-gap tax rate decreased 2.4 percentage points year-over-year to 15.4 percent, primarily due to the change in earnings mix, the inclusion of the horizon business, and net favorable items in the quarter. In the first quarter, the company generated .5 billion in free cash flow, a decrease from . .7 billion in the previous year, primarily impacted by a planned $800 million tax deposit to the IRS. to stop the accrual of interest on uncertain tax positions. as we discussed on our fourth quarter earnings call.

Speaker Change: The integration of the legacy Horizon business continues to be on track as we leverage Amgen leadership and inflammation World class manufacturing and process development and extensive global footprint now.

Our non-gap tax rate decreased 2.4 percentage points year-over-year to 15.4 percent, primarily due to the change in earnings mix, the inclusion of the horizon business, and net favorable items in the quarter. In the first quarter, the company generated .5 billion in free cash flow, a decrease from . .7 billion in the previous year, primarily impacted by a planned $800 million tax deposit to the IRS. to stop the accrual of interest on uncertain tax positions. as we discussed on our fourth quarter earnings call.

Speaker Change: Now I will pass it over to Peter for a financial update.

Peter: You Vikram.

Peter: We're pleased with our performance.

Peter: On track to meet our 2024 full goals and long term objectives.

In the first quarter, the company generated .5 billion in free cash flow, a decrease from . .7 billion in the previous year, primarily impacted by a planned $800 million tax deposit to the IRS. to stop the accrual of interest on uncertain tax positions. as we discussed on our fourth quarter earnings call.

Peter: Our strong growth outlook is driven across each of our four therapeutic pillars by our innovative pipeline and end market portfolio products, which serve patients with serious illnesses around the globe.

Murdo Gordon: Kyprolis sales grew 5% year over year to a record $376 million for Q1, primarily driven by volume growth outside the US. Enbrel sales decreased 12% year over year for Q1, primarily driven by volume decline. In comparison to Q1 2023, which included a US government order of $82 million. Excluding the Q1 2023 US government order, Enbrel sales grew 13% year over year. I'm pleased with our execution in the quarter and the momentum across the four pillars of our business, and we look forward to serving many more patients around the world who can benefit from our innovative therapies. With that, I'll turn it over to Vikram.

Kyprolis sales grew 5% year over year to a record $376 million for Q1, primarily driven by volume growth outside the US. Enbrel sales decreased 12% year over year for Q1, primarily driven by volume decline. In comparison to Q1 2023, which included a US government order of $82 million. Excluding the Q1 2023 US government order, Enbrel sales grew 13% year over year. I'm pleased with our execution in the quarter and the momentum across the four pillars of our business, and we look forward to serving many more patients around the world who can benefit from our innovative therapies. With that, I'll turn it over to Vikram.

to stop the accrual of interest on uncertain tax positions. as we discussed on our fourth quarter earnings call.

Peter: Review of our first quarter results before discussing our 2020 for guidance.

as we discussed on our fourth quarter earnings call.

Peter: As shown on slide 23 of the slide deck in the first quarter, we delivered $7 4 billion and total revenue at 22% increase year over year. This reflects a 25% volume growth, including over $900 million from acquired Horizon products and also key brands, including where Pathet this buyer of entity Prolia.

Peter H. Griffith: As a reminder, there is no change in our belief in the merits of our legal position as we prepare for trial later this year. This impact on free cash flow was partially offset by the timing of working capital items. The Horizon integration is on track, and we expect to reach our pretax $500 million synergy target by year 3 post acquisition. We also expect to achieve roughly 50% of this synergy target in our annual run rate by the end of this year 2024. We expect accretion to non-GAAP EPS in 2024 and anticipate maintaining strong cash flow generation while we continue to execute on our deleveraging plan to return to our pre-acquisition efficient capital structure by the end of 2025. We remain on track to achieve the pre-acquisition leverage ratio, normalized for certain other noncash items, including fair value, market value adjustment of equity investments and Horizon acquisition-related costs. We remain committed to our multiple capital allocation priorities. We continue to prioritize investing in the best innovation, both internally and externally, with increased spending on late-stage programs, including olpasiran, bemarituzumab, MariTide and rocatinlimab.

The Horizon integration is on track and we expect to reach our pre-tax $500 million synergy target by year three post-acquisition. We also expect to achieve roughly 50% of this energy target In our annual run rate by the end of this year, 2024, we expect accretion to Nogap EPS in 2024 and anticipate maintaining strong cash flow generation while we continue to execute on our de-leverging plan to return to our pre-acquisition efficient capital structure by the end of 2025. We remain on track to achieve the pre-acquisition leverage ratio, normalize for certain other non-cash items, including fair value, market value adjustment of equity investments and horizon acquisition-related costs. we remain committed to our multiple capital allocation priorities we continue to prioritize investing in the best innovation both internally and externally with increased spending on late stage programs including opacaranth ameeratuzamap

Peter: In <unk>.

Peter: Excluding the addition of horizon product sales increased 6% year over year, driven by 9% volume growth are.

We also expect to achieve roughly 50% of this energy target In our annual run rate by the end of this year, 2024, we expect accretion to Nogap EPS in 2024 and anticipate maintaining strong cash flow generation while we continue to execute on our de-leverging plan to return to our pre-acquisition efficient capital structure by the end of 2025. We remain on track to achieve the pre-acquisition leverage ratio, normalize for certain other non-cash items, including fair value, market value adjustment of equity investments and horizon acquisition-related costs. we remain committed to our multiple capital allocation priorities we continue to prioritize investing in the best innovation both internally and externally with increased spending on late stage programs including opacaranth ameeratuzamap

Vikram Karnani: Thank you, Myrto. I am pleased to provide an update on Rare Disease, Andrew's fourth therapeutic Pillar of Growth, which delivered product sales of over $950 million in Q1, beginning with TEPEZZA for the treatment of thyroid eye disease or TED. First quarter sales were $424 million, reflecting growth of 5% year over year when compared to results from the Legacy Horizon business. As we discussed at our Rare Disease Investor meeting a few months back, TED is often assessed using the Clinical Activity Score or CAS, which covers a number of different signs and symptoms including pain, redness, swelling, and function. We now refer to TED in terms of High and Low Clinical Activity Score or high and low CAS for the approximately 100,000 TED patients in the US who could benefit from TEPEZZA. The majority of these patients, roughly 80%, are in low CAS settings.

Thank you, Myrto. I am pleased to provide an update on Rare Disease, Andrew's fourth therapeutic Pillar of Growth, which delivered product sales of over $950 million in Q1, beginning with TEPEZZA for the treatment of thyroid eye disease or TED. First quarter sales were $424 million, reflecting growth of 5% year over year when compared to results from the Legacy Horizon business. As we discussed at our Rare Disease Investor meeting a few months back, TED is often assessed using the Clinical Activity Score or CAS, which covers a number of different signs and symptoms including pain, redness, swelling, and function. We now refer to TED in terms of High and Low Clinical Activity Score or high and low CAS for the approximately 100,000 TED patients in the US who could benefit from TEPEZZA. The majority of these patients, roughly 80%, are in low CAS settings.

Peter: Our non-GAAP operating expenses rose by 33%, reflecting investments in horizon acquired products, along with other late stage pipeline medicines, including <unk> Maritime and <unk> as a.

In our annual run rate by the end of this year, 2024, we expect accretion to Nogap EPS in 2024 and anticipate maintaining strong cash flow generation while we continue to execute on our de-leverging plan to return to our pre-acquisition efficient capital structure by the end of 2025. We remain on track to achieve the pre-acquisition leverage ratio, normalize for certain other non-cash items, including fair value, market value adjustment of equity investments and horizon acquisition-related costs. we remain committed to our multiple capital allocation priorities we continue to prioritize investing in the best innovation both internally and externally with increased spending on late stage programs including opacaranth ameeratuzamap

Peter: Our Q1 operating margin was 43%.

Peter: Consistent with our guidance on the fourth quarter earnings call or.

Peter: Our non-GAAP <unk> resulted in $549 million expense up $334 million year over year almost entirely due to increased interest expense from debt issued for the horizon acquisition, partially offset by higher interest income and gains from debt repurchases.

We remain on track to achieve the pre-acquisition leverage ratio, normalize for certain other non-cash items, including fair value, market value adjustment of equity investments and horizon acquisition-related costs. we remain committed to our multiple capital allocation priorities we continue to prioritize investing in the best innovation both internally and externally with increased spending on late stage programs including opacaranth ameeratuzamap

we remain committed to our multiple capital allocation priorities we continue to prioritize investing in the best innovation both internally and externally with increased spending on late stage programs including opacaranth ameeratuzamap

Peter: Our non-GAAP tax rate decreased two four percentage points.

Peter: Year over year to 15, 4%, primarily due to the change in earnings mix, the inclusion of the horizon business and net favorable items in the quarter.

Peter: In the first quarter the company generated <unk> 5 billion in free cash flow a decrease from <unk> 7 billion in the previous year, primarily impacted by a planned $800 million tax deposit to the IRS.

Peter H. Griffith: Second, we continue investing in our business for long-term growth, including expanding capacity in our state-of-the-art manufacturing facilities. Our North Carolina site is expected to be operational by 2026. And Amgen Ohio opened in the first quarter and is utilizing artificial intelligence and extensive robotics to boost operational efficiencies. We're actively integrating generative AI across the enterprise to spearhead innovation and reinforce our leadership in the industry. This strategic commitment to innovative technology enables us to lead advancements, streamline drug development and enhance patient care more effectively. Finally, we returned capital to shareholders as we paid dividends of $2.25 per share in the first quarter. This represented a 6% increase over that paid in each of 2023's four quarters.

Vikram Karnani: We continue to focus on this large number of low CAS patients not being appropriately treated. As we previously discussed, one of the main hurdles in the patient journey in this setting is access. To help patients overcome that challenge, we have generated favorable medical policy changes for greater than 50% of US covered lives, and we expect to continue this momentum throughout 2024. In addition, we are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists who manage many low CAS patients. The impact of TED on quality of life is often underestimated, so our focus is on educating healthcare providers about the significant effects on patients and even those with less visible symptoms. In addition to our focus on educating ocular surgeons and ophthalmologists, we are increasing our strategic focus in endocrinology and creating a dedicated sales force to engage in this important space.

We continue to focus on this large number of low CAS patients not being appropriately treated. As we previously discussed, one of the main hurdles in the patient journey in this setting is access. To help patients overcome that challenge, we have generated favorable medical policy changes for greater than 50% of US covered lives, and we expect to continue this momentum throughout 2024. In addition, we are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists who manage many low CAS patients. The impact of TED on quality of life is often underestimated, so our focus is on educating healthcare providers about the significant effects on patients and even those with less visible symptoms. In addition to our focus on educating ocular surgeons and ophthalmologists, we are increasing our strategic focus in endocrinology and creating a dedicated sales force to engage in this important space.

and Amgen, Ohio opened in the first quarter and is utilizing artificial intelligence and extensive robotics to boost operational efficiencies. We're actively integrating generative AI across the enterprise to spearhead innovation and reinforce our leadership in the industry. This strategic commitment to innovative technology enables us to lead advancements, streamline drug development, and enhance patient care more effectively. Finally, we returned capital to shareholders as we pay dividends of $2.25 per share in the first quarter. This represented a 6% increase over that paid in each of 2023 four quarters.

Peter: The accrual of interest on uncertain tax positions as we discussed on our fourth quarter earnings call. As a reminder, there is no change in our belief in the merits of our legal position as we prepare for trial. Later this year. This impact on free cash flow was partially offset by the timing of working cap.

We're actively integrating generative AI across the enterprise to spearhead innovation and reinforce our leadership in the industry. This strategic commitment to innovative technology enables us to lead advancements, streamline drug development, and enhance patient care more effectively. Finally, we returned capital to shareholders as we pay dividends of $2.25 per share in the first quarter. This represented a 6% increase over that paid in each of 2023 four quarters.

Peter: It'll items.

Peter: The horizon integration is on track and we expect to reach our pre tax $500 million synergy target by year three post acquisition.

Finally, we returned capital to shareholders as we pay dividends of $2.25 per share in the first quarter. This represented a 6% increase over that paid in each of 2023 four quarters.

Peter: We also expect to achieve roughly 50% of this synergy target and our annual run rate by the end of this year 2024, we expect accretion to non-GAAP EPS in 2024, and anticipate maintaining strong cash flow generation, while we continue to execute on our deleveraging plan to return to.

Peter H. Griffith: Turning to the outlook for the business for 2024 on Slide 25. We expect our 2024 total revenues in the range of $32.5 billion to $33.8 billion and anticipate non-GAAP earnings per share between $19 and $20.20. I'll mention a few considerations as you model the remainder of 2024. Our non-GAAP R&D expenses are expected to increase by approximately 25% year-over-year versus our prior guidance to you roughly 20% year-over-year. We're making incremental investments based on our confidence in our late-stage pipeline. Our R&D investment reflects our commitment to innovation, accelerating our pipeline, focusing on advancing multiple potentially first-in-class and best-in-class medicines, including supporting MariTide, 2 PDUFA dates scheduled for June and 5 Phase III data readouts throughout the year. Total non-GAAP operating expenses over the second and third quarters are expected to grow at a rate comparable to the first quarter. The fourth quarter rate will normalize with a comparable expense based in the fourth quarter of 2023 since the Horizon transaction completed in early October 2023.

We expect our 2024 total revenues in the range of $32.5 billion to $33.8 billion and anticipate non-gap earnings per share between $19 and $20.20. I'll mention a few considerations as you model the remainder of 2024. Our non-GAP R&D expenses are expected to increase by approximately 25% year-over-year versus our prior guidance to you of roughly 20% year-over-year. We're making incremental investments based on our confidence in our late stage pipeline. Our R&D investment reflects our commitment to innovation, accelerating our pipeline, focusing on advancing multiple potentially first-in-class and best-in-class medicines, including supporting Maritide, two Padoufa dates scheduled for June , and five, phase three data readouts throughout the year. Total non-gap operating expenses over the second and third quarters are expected to grow at a rate comparable to the first quarter. The fourth quarter rate will normalize with a comparable expense base in the fourth quarter of 2023 since the Horizon transaction completed in early October , 2023.

Peter: Pre acquisition efficient capital structure by the end of 2025.

Vikram Karnani: International expansion remains a meaningful long-term growth opportunity for Tepezza, which is currently approved in Brazil and Saudi Arabia. As a reminder, in January we filed for high CAS approval in Japan and our phase 3 trial in low CAS is continuing to enroll. We have completed additional regulatory submissions in Australia, Canada, Great Britain, and most recently with the European Medicines Agency. We initiated a phase 3 subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation.

International expansion remains a meaningful long-term growth opportunity for Tepezza, which is currently approved in Brazil and Saudi Arabia. As a reminder, in January we filed for high CAS approval in Japan and our phase 3 trial in low CAS is continuing to enroll. We have completed additional regulatory submissions in Australia, Canada, Great Britain, and most recently with the European Medicines Agency. We initiated a phase 3 subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation.

Peter: We remain on track to achieve the pre acquisition leverage ratio normalized for certain other noncash items, including fair value market value adjustment of equity investments and horizon acquisition related costs.

I'll mention a few considerations as you model the remainder of 2024. Our non-GAP R&D expenses are expected to increase by approximately 25% year-over-year versus our prior guidance to you of roughly 20% year-over-year. We're making incremental investments based on our confidence in our late stage pipeline. Our R&D investment reflects our commitment to innovation, accelerating our pipeline, focusing on advancing multiple potentially first-in-class and best-in-class medicines, including supporting Maritide, two Padoufa dates scheduled for June , and five, phase three data readouts throughout the year. Total non-gap operating expenses over the second and third quarters are expected to grow at a rate comparable to the first quarter. The fourth quarter rate will normalize with a comparable expense base in the fourth quarter of 2023 since the Horizon transaction completed in early October , 2023.

Our non-GAP R&D expenses are expected to increase by approximately 25% year-over-year versus our prior guidance to you of roughly 20% year-over-year. We're making incremental investments based on our confidence in our late stage pipeline. Our R&D investment reflects our commitment to innovation, accelerating our pipeline, focusing on advancing multiple potentially first-in-class and best-in-class medicines, including supporting Maritide, two Padoufa dates scheduled for June , and five, phase three data readouts throughout the year. Total non-gap operating expenses over the second and third quarters are expected to grow at a rate comparable to the first quarter. The fourth quarter rate will normalize with a comparable expense base in the fourth quarter of 2023 since the Horizon transaction completed in early October , 2023.

Peter: We remain committed to our multiple capital allocation priorities, we continue to prioritize investing in the best innovation, both internally and externally with increased spending on late stage programs, including El Paso, and <unk> Maritime Rocha tantalum App.

We're making incremental investments based on our confidence in our late stage pipeline. Our R&D investment reflects our commitment to innovation, accelerating our pipeline, focusing on advancing multiple potentially first-in-class and best-in-class medicines, including supporting Maritide, two Padoufa dates scheduled for June , and five, phase three data readouts throughout the year. Total non-gap operating expenses over the second and third quarters are expected to grow at a rate comparable to the first quarter. The fourth quarter rate will normalize with a comparable expense base in the fourth quarter of 2023 since the Horizon transaction completed in early October , 2023.

Our R&D investment reflects our commitment to innovation, accelerating our pipeline, focusing on advancing multiple potentially first-in-class and best-in-class medicines, including supporting Maritide, two Padoufa dates scheduled for June , and five, phase three data readouts throughout the year. Total non-gap operating expenses over the second and third quarters are expected to grow at a rate comparable to the first quarter. The fourth quarter rate will normalize with a comparable expense base in the fourth quarter of 2023 since the Horizon transaction completed in early October , 2023.

Peter: We continue investing in our business for long term growth, including expanding capacity in our state of the art manufacturing facilities, Our North Carolina site is expected to be operational by 2026, and Amgen, Ohio opened in the first quarter and is utilizing artificial intelligence and extensive robots.

Vikram Karnani: Krystexxa for patients with chronic refractory gout delivered $235 million in sales in Q1, representing 26% year-over-year growth driven by volume growth from strong commercial execution. Uplizna, the fastest growing biologic in NMOSD, delivered a record $80 million in net sales in Q1, representing 49% year-over-year growth. International expansion is also underway with Uplizna now launched in multiple ex-US markets, including Canada, which launched in January of this year.

Krystexxa for patients with chronic refractory gout delivered $235 million in sales in Q1, representing 26% year-over-year growth driven by volume growth from strong commercial execution. Uplizna, the fastest growing biologic in NMOSD, delivered a record $80 million in net sales in Q1, representing 49% year-over-year growth. International expansion is also underway with Uplizna now launched in multiple ex-US markets, including Canada, which launched in January of this year.

Total non-gap operating expenses over the second and third quarters are expected to grow at a rate comparable to the first quarter. The fourth quarter rate will normalize with a comparable expense base in the fourth quarter of 2023 since the Horizon transaction completed in early October , 2023.

Peter: To boost operational efficiencies.

Peter: Actively integrating generative AI across the enterprise to spearhead innovation and reinforce our leadership in the industry. This strategic commitment to innovative technology enables us to lead advancements streamline drug development and enhanced patient care more effectively.

Peter H. Griffith: We continue to anticipate our operating margin will improve over the next 3 quarters. We expect OI&E to be roughly $2.6 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition. We expect the non-GAAP tax rate to be in the range of 15% to 16%, primarily being driven by a more favorable jurisdictional mix of income, which includes the full year benefits associated with the inclusion of the Horizon business. Our capital expenditures guidance remains unchanged at approximately $1.1 billion in 2024. We've initiated activities to further expand manufacturing capacity for MariTide. We project full year NEULASTA sales of approximately $500 million. Our long-term outlook remains robust. I am grateful to our 27,000-plus colleagues worldwide for their dedication to serving patients. So, this concludes the financial update. I'll hand it now back to Bob for our Q&A session.

We expect a non-gap tax rate to be in the range of 15 to 16 percent, primarily being driven by a more favorable jurisdictional mix of income, which includes the full-year benefits associated with the inclusion of the Horizon business. Our capital expenditures guidance remains unchanged at approximately $1.1 billion in 2024. We've initiated activities to further expand manufacturing capacity for maritime. We project full year in the last of sales of approximately $500 million. Our long-term outlook remains robust. I am grateful to our 27,000-plus colleagues worldwide for their dedication to serving patients. So this concludes the financial update. I'll hand it now back to Bob for our Q&A session.

Peter: We returned capital to shareholders as we paid dividends of $2 25 per share in the first quarter. This represented a 6% increase over that paid in each of 2023 to four quarters.

Vikram Karnani: The integration of the Legacy Horizon business continues to be on track as we leverage Amgen's leadership in inflammation, world-class manufacturing, process development, and extensive global footprint. Now I will pass it over to Peter for our financial update.

The integration of the Legacy Horizon business continues to be on track as we leverage Amgen's leadership in inflammation, world-class manufacturing, process development, and extensive global footprint. Now I will pass it over to Peter for our financial update.

Peter: Turning to the outlook for the business for 2024 on slide 25.

Our capital expenditures guidance remains unchanged at approximately $1.1 billion in 2024. We've initiated activities to further expand manufacturing capacity for maritime. We project full year in the last of sales of approximately $500 million. Our long-term outlook remains robust. I am grateful to our 27,000-plus colleagues worldwide for their dedication to serving patients. So this concludes the financial update. I'll hand it now back to Bob for our Q&A session.

Peter: We expect our 2020 for total revenues in the range of $32 $5 billion to $33 8 billion and anticipate non-GAAP earnings per share between $19 and $20 20.

Peter Griffith: Thank you, Vikram. We're pleased with our performance and on track to meet our 2024 full goals and long-term objectives. Our strong growth outlook is driven across each of our four therapeutic pillars by our innovative pipeline and in-market portfolio products, which serve patients with serious illnesses around the globe. I'll review our first quarter results before discussing our 2024 guidance as shown on slide 23 of the slide deck. In the first quarter, we delivered $7.4 billion in total revenue, a 22% increase year over year. This reflects 25% volume growth including over $900 million from acquired Horizon products and also key brands including Repatha, Tezspire, Evenity, Prolia, and Blincyto. Excluding the addition of Horizon products, sales increased 6% year over year driven by 9% volume growth.

Speaker Change: I'll mention a few considerations as you model the remainder of 2024.

Our long-term outlook remains robust. I am grateful to our 27,000-plus colleagues worldwide for their dedication to serving patients. So this concludes the financial update. I'll hand it now back to Bob for our Q&A session.

Speaker Change: Our non-GAAP R&D expenses are expected to increase by approximately 25% year over year versus our prior guidance to you of roughly 20% year over year.

Robert A. Bradway: Okay. Thank you, Peter. And before you open the line, Julianne, let me just point out that, obviously, we have a lot of exciting opportunities here. And we're excited about the ways we think we can make a difference for patients. In terms of the opportunity in obesity, again, we recognize that there's significant interest. And we provided today's update to keep you apprised of our plans in this area. But I would just reiterate, we're focused on successfully completing and maintaining the integrity of the ongoing Phase II studies. So, as we turn to Q&A, just bear in mind that we're going to have to be very limited in what we can say beyond what we've already delivered in our prepared remarks on obesity and MariTide. But with that in mind, Julianne, maybe you could remind our callers of the process for asking questions.

Peter: We're making incremental investments based on our confidence in our late stage pipeline.

Peter: Our R&D investment reflects our commitment to innovation accelerating our pipeline focusing on advancing multiple potentially first in class and best in class medicines, including supporting Maritime <unk> date scheduled for June and five phase III data readouts throughout the year.

In terms of the opportunity and obesity, again, we recognize that there's significant interest and we provided today's update. to keep you apprised of our plans in this area. But I would just reiterate we're focused on successfully completing and maintaining the integrity of the ongoing phase two studies. So as we turn to Q&A, just bear in mind that we're going to have to be very limited in what we can say beyond what we've already delivered in our prepared remarks on obesity and maritime. But with that in mind, Julianne, maybe you could remind our callers of the process for asking questions.

to keep you apprised of our plans in this area. But I would just reiterate we're focused on successfully completing and maintaining the integrity of the ongoing phase two studies. So as we turn to Q&A, just bear in mind that we're going to have to be very limited in what we can say beyond what we've already delivered in our prepared remarks on obesity and maritime. But with that in mind, Julianne, maybe you could remind our callers of the process for asking questions.

Peter: Total non-GAAP operating expenses over the second and third quarters are expected to grow at a rate comparable to the first quarter.

Peter Griffith: Our non-GAAP operating expenses rose by 33% reflecting investments in Horizon-acquired products along with other late-stage pipeline medicines including rocatinlimab, MariTide, and tarlatamab. As a result, our Q1 operating margin was 43% consistent with our guidance on the fourth quarter earnings call. Our non-GAAP OI&E resulted in $549 million expense, up $334 million year over year, almost entirely due to increased interest expense from debt issued for the Horizon acquisition, partially offset by higher interest income and gains from debt repurchases. Our non-GAAP tax rate decreased 2.4 percentage points year over year to 15.4% primarily due to the change in earnings mix, the inclusion of the Horizon business, and net favorable items in the quarter.

Our non-GAAP operating expenses rose by 33% reflecting investments in Horizon-acquired products along with other late-stage pipeline medicines including rocatinlimab, MariTide, and tarlatamab. As a result, our Q1 operating margin was 43% consistent with our guidance on the fourth quarter earnings call. Our non-GAAP OI&E resulted in $549 million expense, up $334 million year over year, almost entirely due to increased interest expense from debt issued for the Horizon acquisition, partially offset by higher interest income and gains from debt repurchases. Our non-GAAP tax rate decreased 2.4 percentage points year over year to 15.4% primarily due to the change in earnings mix, the inclusion of the Horizon business, and net favorable items in the quarter.

Peter: <unk> fourth quarter rate will normalize with a comparable expense base in the fourth quarter of 2023 since the horizon transaction completed in early October 2023.

Operator: Thank you. If you would like to ask a question, please press star followed by 1 on your telephone keypad. If for any reason you would like to remove that question, please press star followed by 1. Again, to ask a question, press star 1. Our first question comes from Salveen Richter from Goldman Sachs. Please go ahead, your line is open.

Peter: We continue to anticipate our operating margin will improve over the next three quarters, we expect <unk> to be roughly $2 6 billion, which includes the interest expense related to the $28 billion of debt raise for the horizon acquisition, we expect our non-GAAP tax rate to be in the range of 15% to 16% primarily being driven by a more.

Salveen Richter: Good afternoon. Thanks for taking my question. On MariTide here, just given the move forward to Phase III, can you just remind us what you were looking to learn in the Phase II trial and likely did here, but that enabled you to kind of get confident here with the program on the fourth?

Peter: Favorable jurisdictional mix of income, which includes the full year benefits associated with the inclusion of the horizon business.

Peter: Our capital expenditures.

Peter: Our guidance remains unchanged at approximately $1 1 billion in 2024, we have initiated activities to further expand manufacturing capacity for maritime.

Sure, Selvine, thanks to the question. What does you jump in, Jay? Yeah, thanks, Alveen, for your question.

Robert A. Bradway: Sure. Salveen, thanks for the question. Why don't you jump in, Jay?

Peter Griffith: In Q1 the company generated $0.5 billion in free cash flow, a decrease from $0.7 billion in the previous year, primarily impacted by a planned $800 million tax deposit to the IRS to stop the accrual of interest on uncertain tax positions as we discussed on our Q4 earnings call. As a reminder, there is no change in our belief in the merits of our legal position as we prepare for trial later this year. This impact on free cash flow was partially offset by the timing of working capital items. The Horizon integration is on track and we expect to reach our pre-tax $500 million synergy target by year three post acquisition. We also expect to achieve roughly 50% of this synergy target in our annual run rate by the end of this year 2024.

In Q1 the company generated $0.5 billion in free cash flow, a decrease from $0.7 billion in the previous year, primarily impacted by a planned $800 million tax deposit to the IRS to stop the accrual of interest on uncertain tax positions as we discussed on our Q4 earnings call. As a reminder, there is no change in our belief in the merits of our legal position as we prepare for trial later this year. This impact on free cash flow was partially offset by the timing of working capital items. The Horizon integration is on track and we expect to reach our pre-tax $500 million synergy target by year three post acquisition. We also expect to achieve roughly 50% of this synergy target in our annual run rate by the end of this year 2024.

James E. Bradner: Yes. Thanks, Salveen, for your question. Look, we're benefiting from a really well-designed and well-executed Phase II study, a study that can teach us a lot about this medicine and how it's best dosed and received. And we're seeing from these data in aggregate a broad and differentiated profile that will guide and also encourage a Phase III clinical investigation.

Peter: We project full year and the last of sales of approximately $500 million.

Look, we're benefiting from a really well-designed and well-Isecuted phase two study, a study that can teach us a lot about this medicine and how it's best dose and received. And we're seeing from these data in aggregate abroad and differentiated profile that will guide and also encourage phase three clinical investigation.

Peter: Our long term outlook remains robust.

Peter: I'm grateful to our 27000 plus colleagues worldwide for their dedication to serving patients.

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

Bob: Okay. Thank you Peter.

Bob: Or are you open the line Julien let me just point out that obviously, we have a lot of exciting opportunities here.

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

Bob: We're excited about the ways, we think we can make a difference for patients in.

Michael Yee: Hey guys, thanks. I appreciate the update. I think we all do. Just to clarify or to ease any investor concerns, is it safe to say that your interim looked at all doses and you feel comfortable including the highest doses and safety metrics, including bone? And all of that was looked at to date? Thank you.

Bob: In terms of the opportunity in obesity again, we recognize that there is significant interest and we provided today's update to keep you apprised of our plans in this area, but I would just reiterate we're focused on successfully completing and maintaining the integrity of the ongoing phase II study. So as we turn to Q&A just bear in mind that we're going to have to be very limited in what.

James E. Bradner: Thanks a lot, Michael. I'll take this one as well. Again, a very well-designed and well-executed study, a study that's replete with measurements. This is an ongoing study, so we have to be careful to avoid in introducing an inadvertent bias or unblinding. And so, we just can't comment on individual characteristics, but we're very pleased with the results to date. We're moving rapidly forward with the Phase III program, as well as the diabetes Phase II. I would reiterate that all the arms remain active, and we haven't had an issue with patient dropout to date.

Bob: We can say beyond what we've already delivered on our prepared remarks on obesity and maritime but with that in mind, Julian maybe you could remind our callers of the process for asking questions.

Peter Griffith: We expect accretion to non-GAAP EPS in 2024 and anticipate maintaining strong cash flow generation. While we continue to execute on our deleveraging plan to return to our pre-acquisition efficient capital structure by the end of 2025. We remain on track to achieve the pre-acquisition leverage ratio normalized for certain other non-cash items including fair value, market value adjustment of equity investments, and Horizon acquisition-related costs. We remain committed to our multiple capital allocation priorities. We continue to prioritize investing in the best innovation both internally and externally with increased spending on late-stage programs including Olpasiran, Bemarituzumab, MariTide, and Rocatinlimab. Second, we continue investing in our business for long-term growth including expanding capacity in our state-of-the-art manufacturing facilities.

We expect accretion to non-GAAP EPS in 2024 and anticipate maintaining strong cash flow generation. While we continue to execute on our deleveraging plan to return to our pre-acquisition efficient capital structure by the end of 2025. We remain on track to achieve the pre-acquisition leverage ratio normalized for certain other non-cash items including fair value, market value adjustment of equity investments, and Horizon acquisition-related costs. We remain committed to our multiple capital allocation priorities. We continue to prioritize investing in the best innovation both internally and externally with increased spending on late-stage programs including Olpasiran, Bemarituzumab, MariTide, and Rocatinlimab. Second, we continue investing in our business for long-term growth including expanding capacity in our state-of-the-art manufacturing facilities.

Again, a very well-designed and well-executed study, a study that's replete with measurements. This is an ongoing study, so we have to be careful to avoid in introducing an inadvertent bias or unblinding. And so we just can't comment on individual characteristics, but we're very pleased with the results to date. We're moving rapidly forward with the Phase 3 program. as well as the diabetes phase two. I would reiterate that all the arms remain active and we haven't had an issue with patient dropout to date. I think, again, Michael, as Jay said, it's a well-designed study and you can be sure that we reviewed the data carefully.

avoid in introducing an inadvertent bias or unblinding. And so we just can't comment on individual characteristics, but we're very pleased with the results to date. We're moving rapidly forward with the Phase 3 program. as well as the diabetes phase two. I would reiterate that all the arms remain active and we haven't had an issue with patient dropout to date. I think, again, Michael, as Jay said, it's a well-designed study and you can be sure that we reviewed the data carefully.

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

Julian: If for any reason you would like to turn that question. Please press star followed by one again to ask a question press Star one.

as well as the diabetes phase two. I would reiterate that all the arms remain active and we haven't had an issue with patient dropout to date. I think, again, Michael, as Jay said, it's a well-designed study and you can be sure that we reviewed the data carefully.

Salveen Richter: Our first question comes from <unk> Richter from Goldman Sachs. Please go ahead. Your line is now open.

Salveen Richter: Good afternoon. Thanks for taking my question on Merit tied here just given the move forward to phase III can you just remind us what you are looking to learn in the phase two trial and likely data here, but that enable you to kind of get confident here with the program on the court.

Robert A. Bradway: I think, again, Michael, as Jay said, it's a well-designed study, and you can be sure that we review the data carefully. Okay, let's go ahead. Take the next question.

Robert A. Bradway: I think, again, Michael, as Jay said, it's a well-designed study, and you can be sure that we review the data carefully.

Justin Claeys: Okay, let's go ahead. Take the next question.

Operator: Thank you, Michael. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Speaker Change: Sure. Thanks for the question I'll, let you jump in and Jay Yes.

Terence C. Flynn: Great. Thanks for taking the question. Jay, you mentioned on MariTide seeing a differentiated profile. Recognize you're limited in what you can say. But as we think about areas of differentiation, it's clearly efficacy, tolerability and dosing interval. So, just wondering if you can comment on which of those areas you're differentiated on? And then, what benchmark are you looking to? Is it semaglutide, tirzepatide, both of those? Thank you.

Speaker Change: <unk> for your question.

Speaker Change: Look we're benefiting from a really well designed and well.

Speaker Change: <unk> phase two study the study that can teach us a lot about this medicine and.

Peter Griffith: Our North Carolina site is expected to be operational by 2026, and Amgen Ohio opened in the first quarter and is utilizing artificial intelligence and extensive robotics to boost operational efficiencies. We're actively integrating generative AI across the enterprise to spearhead innovation and reinforce our leadership in the industry. This strategic commitment to innovative technology enables us to lead advancements, streamline drug development, and enhance patient care more effectively. Finally, we returned capital to shareholders as we paid dividends of $2.25 per share in the first quarter. This represented a 6% increase over that paid in each of 2023's four quarters. Turning to the outlook for the business for 2024 on Slide 25, we expect our 2024 total revenues in the range of $32.5 billion to $33.8 billion and anticipate non-GAAP earnings per share between $19 and $20.20.

Our North Carolina site is expected to be operational by 2026, and Amgen Ohio opened in the first quarter and is utilizing artificial intelligence and extensive robotics to boost operational efficiencies. We're actively integrating generative AI across the enterprise to spearhead innovation and reinforce our leadership in the industry. This strategic commitment to innovative technology enables us to lead advancements, streamline drug development, and enhance patient care more effectively. Finally, we returned capital to shareholders as we paid dividends of $2.25 per share in the first quarter. This represented a 6% increase over that paid in each of 2023's four quarters. Turning to the outlook for the business for 2024 on Slide 25, we expect our 2024 total revenues in the range of $32.5 billion to $33.8 billion and anticipate non-GAAP earnings per share between $19 and $20.20.

Speaker Change: And how its best dose and received and we're seeing from these data in aggregate abroad, and differentiated profile that will guide and also encourage a phase III clinical investigation.

Robert Bradway: Thanks, Terence. Again, we can appreciate the desire to get into that detail. But maybe, Murdo, do you want to speak to the competitive differentiation? And then Jay, if there's anything you feel appropriate to elaborate on, you can jump in after Murdo.

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

Michael J. Yee: Hey, guys. Thanks, and I appreciate the update I think we all do just to clarify or to ease any investor concerns is it safe to say that your interim look at all doses and you feel comfortable including the highest dose and.

Murdo Gordon: Yes. Thanks for the question, Terence. Thanks, Bob. Obviously, we're watching the in-market products very closely with respect to differentiation. And we're also looking at products that are in the clinic being developed. And we continue to feel very confident in our ability to have a differentiated and broad profile for MariTide as we develop it in this Phase II and as we consider our broader Phase III development program.

Michael J. Yee: And safety metrics, including Thong and all of that was looked at to date. Thank you.

And we continue to feel very confident in our ability to have a differentiated and broad profile for Maritide as we develop it in this phase two and as we consider a broader phase three development program.

Speaker Change: Thanks, a lot Michael I'll take this one as well.

Speaker Change: Again, a very well designed and well executed study a study that's replete with measurements. This is an ongoing study. So we have to be careful to avoid and introducing innovative bias or on blinding and so we just can't comment on individual characteristics, but we're very pleased with the results to date, we're moving rapidly forward with a phase III program.

James E. Bradner: Yeah. I'd just add, this is, Terence, a very exciting, very dynamic area. We follow the development of obesity medicines very closely. And I think in this case, the actions we're taking speak for themselves. We're hard at work planning a comprehensive and competitive Phase III program.

Peter Griffith: I'll mention a few considerations as you model the remainder of 2024. Our non-GAAP R&D expenses are expected to increase by approximately 25% year-over-year versus our prior guidance to you of roughly 20% year-over-year. We're making incremental investments based on our confidence in our late-stage pipeline. Our R&D investment reflects our commitment to innovation, accelerating our pipeline, focusing on advancing multiple potentially first-in-class and best-in-class medicines, including supporting MariTide, two PDUFA dates scheduled for June, and five phase 3 data readouts throughout the year. Total non-GAAP operating expenses over Q2 and Q3 are expected to grow at a rate comparable to Q1. The Q4 rate will normalize with a comparable expense base in Q4 2023.

I'll mention a few considerations as you model the remainder of 2024. Our non-GAAP R&D expenses are expected to increase by approximately 25% year-over-year versus our prior guidance to you of roughly 20% year-over-year. We're making incremental investments based on our confidence in our late-stage pipeline. Our R&D investment reflects our commitment to innovation, accelerating our pipeline, focusing on advancing multiple potentially first-in-class and best-in-class medicines, including supporting MariTide, two PDUFA dates scheduled for June, and five phase 3 data readouts throughout the year. Total non-GAAP operating expenses over Q2 and Q3 are expected to grow at a rate comparable to Q1. The Q4 rate will normalize with a comparable expense base in Q4 2023.

Speaker Change: As well as the diabetes phase III I would reiterate that all of the arms remain active and we haven't had an issue with patient drop out to date.

Great, Julie, answer the next question. Thank you, Terrence. Our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Justin Claeys: Great. Julianne, take the next question.

Operator: Thank you, Terrence. Our next question comes from Jay Olson from Oppenheimer. Please go ahead, your line is open.

Speaker Change: I think again, Michael is as Jay said, it's a well designed study and you can be sure that we reviewed the data carefully.

Jay Olson: Oh, hey, congrats on all the progress and thanks for providing the update. Maybe just to shift gears a little bit to tarlatamab. With the potential launch rapidly approaching, can you just talk about the work you're doing to prepare for that launch and the strategy behind the initial launch in the late line and then the clinical and commercial work to go behind expanding the profile and potential for tarlatamab? Thank you.

Speaker Change: Okay. Let's go ahead and take the next question.

Speaker Change: Thank you Michael our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Maybe just to shift gears a little bit to charlatomab with the potential launch rapidly approaching. Can you just talk about the work you're doing to prepare for that launch and the strategy behind the initial launch and the late line and then the clinical and commercial work to go behind expanding the profile and potential for tarlatomab. Thank you.

Terence C. Flynn: Great. Thanks for taking the question.

Terence C. Flynn: Jay you mentioned on Maritime has seen a differentiated profile recognize youre limited in what you can say, but as we think about areas of differentiation, that's clearly efficacy tolerability and dosing interval. So just wondering if you can comment on which of those areas Youre differentiated on and then what benchmark are you looking to or is it some time.

strategy behind the initial launch and the late line and then the clinical and commercial work to go behind expanding the profile and potential for tarlatomab. Thank you.

Robert A. Bradway: Yes, let's take that in 2 pieces. And maybe, Murdo, you can talk about the launch. And then, I'm sure, Jay, you'd like to elaborate on the thinking for the clinical development of this.

Speaker Change: Turns appetite both on those thank you.

Peter Griffith: Since the Horizon transaction completed in early October 2023, we continue to anticipate our operating margin will improve over the next three quarters. We expect OIE to be roughly $2.6 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition. We expect a non-GAAP tax rate to be in the range of 15% to 16%, primarily being driven by a more favorable jurisdictional mix of income, which includes the full year benefits associated with the inclusion of the Horizon business. Our capital expenditures guidance remains unchanged at approximately $1.1 billion in 2024. We've initiated activities to further expand manufacturing capacity for MariTide. We project full year Enbrel sales of approximately $500 million. Our long-term outlook remains robust. I am grateful to our 27,000-plus colleagues worldwide for their dedication to serving patients. So this concludes the financial update.

Since the Horizon transaction completed in early October 2023, we continue to anticipate our operating margin will improve over the next three quarters. We expect OIE to be roughly $2.6 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition. We expect a non-GAAP tax rate to be in the range of 15% to 16%, primarily being driven by a more favorable jurisdictional mix of income, which includes the full year benefits associated with the inclusion of the Horizon business. Our capital expenditures guidance remains unchanged at approximately $1.1 billion in 2024. We've initiated activities to further expand manufacturing capacity for MariTide. We project full year Enbrel sales of approximately $500 million. Our long-term outlook remains robust. I am grateful to our 27,000-plus colleagues worldwide for their dedication to serving patients. So this concludes the financial update.

Speaker Change: Thanks, Karen again, where you can appreciate the desire to get into that detail, but maybe murdo you want to speak to the to the competitive differentiation and then Jay if there is anything you feel appropriate to elaborate on you can jump in after murdo.

Murdo Gordon: Sure. Jay, thank you for the question on another exciting product in our portfolio, one that I think will deliver a lot of benefit for patients with small cell lung cancer, which is a very, very difficult diagnosis with very little in the way of highly effective treatments that deliver any kind of durable response in small cell. So, we're anxiously awaiting approval from the FDA, but we are well prepared and have been for some time across our field organizations. All our field personnel, including their medical teams, are trained and prepared. We have very clear plans to reach treating physicians in very short order post approval. We have a very clear understanding of making sure that we can provide broad access to tarlatamab when it's approved. And we feel really good about this. This is a very important moment not just for Amgen but for the treatment of patients with small cell lung cancer where, quite frankly, the survival in the late-stage setting is really dismal and is a matter of single-digit months. And so, we have a huge opportunity here to impact, and we're not wasting any minute, any hour or any day in our planning to do that.

Murdo: Yes. Thanks for the question Terence Thanks, Bob obviously, we're watching the in market products very closely with respect to differentiation and we're also looking at products that are in the clinic being developed and we continue to feel very confident in our ability to have a differentiated and broad profile for <unk>.

Murdo: As we develop in this phase II and as we consider a broader phase III development program.

Speaker Change: Yes, I'd just add this is.

Speaker Change: So very exciting very dynamic area, we follow the development of obesity medicines very closely.

plans to reach treating physicians in very short order post approval. We have a very clear understanding of making sure that we can provide broad access to tarlatomab when it's approved. And we feel really good about this. This is a very important moment not just for Amgen, but for the treatment of patients with small cell lung cancer, where quite frankly the survival in the late stage setting is really dismal and as a matter of single-digit months. And so we have a huge opportunity here to impact and we're not wasting any minute, any hour or any day in our planning to do that.

Speaker Change: And I think in this case the actions were taken speak for themselves. We're hard at work planning, a comprehensive and competitive phase III program.

Speaker Change: Great Julien So next question.

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

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

Julien: Thank you Terence our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Robert Bradway: Okay, thank you, Peter. Before you open the line, Julieann, let me just point out that obviously we have a lot of exciting opportunities here and we're excited about the ways we think we can make a difference for patients in terms of the opportunity and obesity. Again, we recognize that there's significant interest, and we provided today's update to keep you apprised of our plans in this area. I would just reiterate, we're focused on successfully completing and maintaining the integrity of the ongoing phase 2 study. As we turn to Q&A, just bear in mind that we're going to have to be very limited in what we can say beyond what we've already delivered in our prepared remarks on obesity and MariTide. With that in mind, Julianne, maybe you could remind our callers of the process for asking questions.

Bob Bradway: Okay, thank you, Peter. Before you open the line, Julieann, let me just point out that obviously we have a lot of exciting opportunities here and we're excited about the ways we think we can make a difference for patients in terms of the opportunity and obesity. Again, we recognize that there's significant interest, and we provided today's update to keep you apprised of our plans in this area. I would just reiterate, we're focused on successfully completing and maintaining the integrity of the ongoing phase 2 study. As we turn to Q&A, just bear in mind that we're going to have to be very limited in what we can say beyond what we've already delivered in our prepared remarks on obesity and MariTide. With that in mind, Julianne, maybe you could remind our callers of the process for asking questions.

Jay Olson: Oh, Hey, congrats on all the progress and thanks for providing the update.

not just for Amgen, but for the treatment of patients with small cell lung cancer, where quite frankly the survival in the late stage setting is really dismal and as a matter of single-digit months. And so we have a huge opportunity here to impact and we're not wasting any minute, any hour or any day in our planning to do that.

Jay Olson: Maybe just to shift gears, a little bit to Charles <unk> with the potential launch rapidly approaching can you just talk about that.

Jay Olson: The work Youre doing to prepare for that launch and the strategy behind the initial launch in the late line and then the clinical and commercial work to go behind expanding the profile and potential for latter Matt. Thank you.

And so we have a huge opportunity here to impact and we're not wasting any minute, any hour or any day in our planning to do that.

James E. Bradner: And Jay, thanks for highlighting the potential of this medicine, which we consider a major advance. The treatment of this disease has really not meaningfully evolved since I trained as an oncologist in the mid-90s with upfront chemotherapy and meaningful but incremental benefit to immuno-oncology therapy with PD-L1 agents today. And so, this is the case where time just can't move fast enough to get this medicine into earlier lines of therapy. And so, we have initiated 3 Phase III studies. And as you asked, I'll just give an architecture of them briefly. We have a study that will compare to tarlatamab to standard of care chemotherapy. And this is in the second line dedicated patients with a primary endpoint of overall survival, and this study is enrolling. We really want to get this medicine tested in frontline therapy, where, as you must know, patients progress so quickly that a great many of them never reach the chance to receive second and third-line therapy. And so, in a pair of trials, one for extensive-stage small cell lung cancer and one for limited-stage small cell lung cancer, we'll study the contribution of tarlatamab immediately following upfront therapy with response.

Charles: Yes, let's take those two pieces.

The treatment of this disease has really not meaningfully evolved since I trained as an oncologist in the mid-90s with upfront chemotherapy and meaningful but incremental benefit to immunoncology therapy with PDL-1 agents today. And so this is a case where time just can't move fast enough to get this medicine into earlier lines of therapy. And so we have initiated three phase three studies. And as you ask, I'll just give an architecture of them briefly. We have a study that will compare tarlatomab to standard of care chemotherapy. And this is a in the second line dedicated patients with a primary employment of overall survival. And this is this study is enrolling. We really want to get this medicine tested in frontline therapy where, as you must know, patients progress so quickly that a great many of them never reached the chance to receive second and third line therapy. And so in a pair of trials, one for extensive stage small cell lung cancer and one for limited stage small cell lung cancer, will study the contribution of tarlatomab immediately following upfront therapy with response.

Jay Olson: And maybe Murdo you can talk about the launch and then.

Murdo: I'm sure you'd like to elaborate on the thinking for the clinical development of this.

I trained as an oncologist in the mid-90s with upfront chemotherapy and meaningful but incremental benefit to immunoncology therapy with PDL-1 agents today. And so this is a case where time just can't move fast enough to get this medicine into earlier lines of therapy. And so we have initiated three phase three studies. And as you ask, I'll just give an architecture of them briefly. We have a study that will compare tarlatomab to standard of care chemotherapy. And this is a in the second line dedicated patients with a primary employment of overall survival. And this is this study is enrolling. We really want to get this medicine tested in frontline therapy where, as you must know, patients progress so quickly that a great many of them never reached the chance to receive second and third line therapy. And so in a pair of trials, one for extensive stage small cell lung cancer and one for limited stage small cell lung cancer, will study the contribution of tarlatomab immediately following upfront therapy with response.

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 Salveen Richter from Goldman Sachs. Please go ahead. Your line is open. Good afternoon. Thanks for taking my question on MariTide here. Just given the move forward to Phase.

Murdo: Sure Jay Thank you for the question on another exciting product in our portfolio one that I think will.

Murdo: To deliver a lot of benefit for patients with small cell lung cancer, which is.

And so we have initiated three phase three studies. And as you ask, I'll just give an architecture of them briefly. We have a study that will compare tarlatomab to standard of care chemotherapy. And this is a in the second line dedicated patients with a primary employment of overall survival. And this is this study is enrolling. We really want to get this medicine tested in frontline therapy where, as you must know, patients progress so quickly that a great many of them never reached the chance to receive second and third line therapy. And so in a pair of trials, one for extensive stage small cell lung cancer and one for limited stage small cell lung cancer, will study the contribution of tarlatomab immediately following upfront therapy with response.

Murdo: Very very difficult diagnosis with very little in the way of highly effective treatments that deliver any kind of durable.

Salveen Richter: Good afternoon. Thanks for taking my question on MariTide here. Just given the move forward to Phase.

Jay Olson: Our response in small cells.

James Bradner: Three, can you just remind us what?

Three, can you just remind us what?

Operator: You were looking to learn in the phase 2 trial and likely did here, but that enabled you to kind of get confident here with the program on the Ford?

You were looking to learn in the phase 2 trial and likely did here, but that enabled you to kind of get confident here with the program on the Ford?

Jay Olson: We are anxiously awaiting approval from the FDA, but we.

Jay Olson: We are well prepared and have been for some time across our field organizations.

We really want to get this medicine tested in frontline therapy where, as you must know, patients progress so quickly that a great many of them never reached the chance to receive second and third line therapy. And so in a pair of trials, one for extensive stage small cell lung cancer and one for limited stage small cell lung cancer, will study the contribution of tarlatomab immediately following upfront therapy with response.

Robert Bradway: Sure, Alvin, thanks for the question. Why don't you jump in, Jay?

Bob Bradway: Sure, Alvin, thanks for the question. Why don't you jump in, Jay?

Jay Olson: All our field personnel, including our medical teams are trained and prepared.

James Bradner: Yeah, thanks, Alvin, for your question. Look, we're benefiting from a really well designed and well executed phase 2 study, a study that can teach us a lot about this medicine and how it's best dosed and received. We're seeing from these data in aggregate a broad and differentiated profile that will guide and also encourage a phase 3 clinical investigation.

Jay Bradner: Yeah, thanks, Alvin, for your question. Look, we're benefiting from a really well designed and well executed phase 2 study, a study that can teach us a lot about this medicine and how it's best dosed and received. We're seeing from these data in aggregate a broad and differentiated profile that will guide and also encourage a phase 3 clinical investigation.

Jay Olson: We have very clear plans to reach treating physicians in very short order post approval.

And so in a pair of trials, one for extensive stage small cell lung cancer and one for limited stage small cell lung cancer, will study the contribution of tarlatomab immediately following upfront therapy with response.

Jay Olson: We have very clear understanding of making sure that we can provide broad access the timeline on that when it's approved and.

James E. Bradner: We've learned through the development of these BiTE molecules that they work best when they're given as early as possible in the course of treatment for a disease. That has been the case with ALL as we move into frontline. And we've also learned that they work best when there is a low burden of disease. And so, the design of these 3 Phase III studies will bring this medicine to earlier patient therapy lines. And I'll say there's been intense interest and great hope in this community. And so, we expect to enroll these studies expeditiously.

Jay Olson: We feel really good about this this is a very important moment.

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

Jay Olson: No just for Amgen, but for the treatment of patients with small cell lung cancer, where quite frankly the survival in.

James Bradner: Hey guys, thanks and appreciate the update.

Michael Yee: Hey guys, thanks and appreciate the update.

Jay Olson: The.

Peter Griffith: I think we all do.

I think we all do.

Jay Olson: The late stage setting is really dismal and as a matter of single digit months and so we have a huge opportunity here to impact and we're not wasting any minute any hour or any day and are planning to do that.

James Bradner: Just to clarify or to ease any investor concerns, is it safe to say that your interim looked at all doses and you feel comfortable, including the highest doses and safety metrics, including bone and all of that was looked at to date? Thank you.

Just to clarify or to ease any investor concerns, is it safe to say that your interim looked at all doses and you feel comfortable, including the highest doses and safety metrics, including bone and all of that was looked at to date? Thank you.

Justin Claeys: Julianne, go to the next question, please.

Jay Olson: And Jay.

Operator: Thank you, Jay. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Jay Olson: Thanks for highlighting that.

James Bradner: Thanks a lot, Michael. I'll take this one as well. Again, a very well designed and well executed study. A study that's replete with measurements. This is an ongoing study, so we have to be careful to avoid introducing an inadvertent bias or unblinding. And so we just can't comment on individual characteristics. But we're very pleased with the results to date. We're moving rapidly forward with the phase 3 program.

Jay Bradner: Thanks a lot, Michael. I'll take this one as well. Again, a very well designed and well executed study. A study that's replete with measurements. This is an ongoing study, so we have to be careful to avoid introducing an inadvertent bias or unblinding. And so we just can't comment on individual characteristics. But we're very pleased with the results to date. We're moving rapidly forward with the phase 3 program.

Jay Olson: The potential of this medicine, which we consider a major advance the.

Jay Olson: The treatment of this disease has really not meaningfully evolved since I trained as an oncologist in the mid nineties with upfront chemotherapy in.

Mohit Bansal: Great. Thank you for taking my question and congrats on the progress. I have a question regarding the manufacturing of AMG 133. Could you help us understand how complicated or simpler it is versus the traditional GLP-1s peptide is in terms of complexity as well as cost? And what kind of investment do you think we should be expecting as you go - as you embark on this journey? Thank you.

Jay Olson: Meaningful, but incremental benefit to immuno oncology therapy with PD lone agents today and so this is a case where at times just can't move fast enough to get this medicine into earlier lines of therapy and so we have initiated three phase III studies and as you asked I'll just given architecture of them briefly and.

James Bradner: As well as the diabetes phase two. I would reiterate that all the arms remain active, and we haven't had an issue with patient dropout to date.

As well as the diabetes phase two. I would reiterate that all the arms remain active, and we haven't had an issue with patient dropout to date.

And what kind of investment do you think we should be expecting as you go, as you embark on this journey? Thank you.

Robert A. Bradway: Mohit, I don't think we're intimidated about the challenge on the manufacturing or the process development front. I think, again, we've established ourselves firmly as a world leader in biotherapeutic manufacturing. And as you know, this is a therapy that's brd on a antibody backbone. So, it's right down the middle of the fairway for us. We've - not lost on us that these competitors who are in the market now have found it difficult to maintain supply of these medicines, and I'm sure that's not lost in the patients either. And we're determined to do our best to make sure that we uphold our long tradition of supplying every patient, every time in the marketplace. So again, we think this is down the middle of the fairway in terms of the technical challenges that we need to address. We think that - we look forward to being able to do that. And again, as I said, maintaining our track record of every patient, every time.

Robert Bradway: I think. Again, Michael, as Jay said, it's a well designed study and you can be sure that we reviewed the data carefully. Okay, let's go ahead and take the next question.

Bob Bradway: I think. Again, Michael, as Jay said, it's a well designed study and you can be sure that we reviewed the data carefully.

Jay Olson: We have a study that will compare <unk> to standard of care <unk> chemotherapy and this is in the second line dedicated patients with a primary endpoint of overall survival. In this is this study is enrolling we really want to get this medicine tested and frontline therapy, where as you must know patients progressed so quickly.

Justin Claeys: Okay, let's go ahead and take the next question.

Operator: Thank you, Michael. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

James Bradner: Great.

Terence Flynn: Great.

Robert Bradway: Thanks for taking the question. Jay, you mentioned on MariTide, seeing a differentiated profile, recognize you're limited in what you can say, but as we think about, you know, areas of differentiation, it's clearly efficacy, tolerability, and dosing interval. So just wondering if you can comment on which of those areas you're differentiated on. And then what benchmark are you looking to? Is it Semaglutide, Tirzepatide?

Thanks for taking the question. Jay, you mentioned on MariTide, seeing a differentiated profile, recognize you're limited in what you can say, but as we think about, you know, areas of differentiation, it's clearly efficacy, tolerability, and dosing interval. So just wondering if you can comment on which of those areas you're differentiated on. And then what benchmark are you looking to? Is it Semaglutide, Tirzepatide?

Jay Olson: Many of them never reach the chance to receive second and third line therapy.

The competitors who are in the market now have found it difficult to maintain supply of these medicines, and I'm sure that's not lost on the patients either. And we're determined to do our best to make sure that we uphold our long tradition of supplying every patient every time in the marketplace. So, again, we think this is... down the middle of the fairway in terms of the technical challenges that we need to address. We think that we look forward to being able to do that. And again, as I said, maintaining our track record of every patient every time.

Jay Olson: And so in a pair of trials one for extensive stage small cell lung cancer and one for limited stage small cell lung cancer study.

Jay Olson: Study the contribution of <unk> immediately following upfront therapy with response, we've learned through the development of these bite molecules that they work best when they are given but as early as possible in the course of treatment for a disease that has been the case with <unk> as we move into frontline and we've also learned that they work best when there is a low burden.

down the middle of the fairway in terms of the technical challenges that we need to address. We think that we look forward to being able to do that. And again, as I said, maintaining our track record of every patient every time.

Murdo Gordon: Both of those.

Both of those.

Robert Bradway: Thank you.

Thank you.

Robert Bradway: Thanks, Terence. Again, we can appreciate the desire to get into that detail, but maybe Myrto, you want to speak to the competitive differentiation, and then Jay, if there's anything you feel appropriate to elaborate on, you can jump in after Myrto.

Bob Bradway: Thanks, Terence. Again, we can appreciate the desire to get into that detail, but maybe Myrto, you want to speak to the competitive differentiation, and then Jay, if there's anything you feel appropriate to elaborate on, you can jump in after Myrto.

Robert A. Bradway: In terms of your question about what it will require from us over time, obviously, to the extent that, that becomes meaningful, Mohit, we'll have the opportunity to address it down the road. But as Peter said in his remarks, our capital expenditure guidance for the year embraces the activity that we have underway to make ourselves ready for the clinical and commercial challenge that we see imminently. Julianne, next question, please?

Jay Olson: Disease and so the design of these three phase III studies will bring this medicine to earlier patient therapy lines and I will say there has been intense interest in great hope in this community and so we expect to enroll these studies expeditiously.

your question about what it will require from us over time. Obviously to the extent that that becomes meaningful, MoHit will have the opportunity to address it down the road. But as Peter said in his remarks, our capital expenditure guidance for the year embraces the activity that we have underway to make ourselves ready for the clinical and commercial challenge that we see imminently.

Murdo Gordon: Yeah, thanks for the question, Terence.

Robert Bradway: Thanks, Bob.

Thanks, Bob.

Murdo Gordon: Obviously, we're watching the in-market products very closely with respect to differentiation. We're also looking at products that are in the clinic being developed. We continue to feel very confident in our ability to have a differentiated and broad profile for MariTide as we develop it in this phase 2 and as we consider a broader phase 3 development program.

Obviously, we're watching the in-market products very closely with respect to differentiation. We're also looking at products that are in the clinic being developed. We continue to feel very confident in our ability to have a differentiated and broad profile for MariTide as we develop it in this phase 2 and as we consider a broader phase 3 development program.

Speaker Change: Julian go to next question please.

Jay Olson: Thank you J. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Mohit Bansal: Great. Thank you for taking my question and congrats on the progress I have a question regarding the manufacturing of AMG 133.

Julian, next question please?

Operator: Thank you, Mohit. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead, your line is open.

James Bradner: Yeah, I'd just add, you know, this is, Terence, a very exciting, very dynamic area. We follow the development of obesity medicines very closely. I think in this case the actions we're taking speak for themselves. We're hard at work planning a comprehensive and competitive phase 3 program.

Jay Bradner: Yeah, I'd just add, you know, this is, Terence, a very exciting, very dynamic area. We follow the development of obesity medicines very closely. I think in this case the actions we're taking speak for themselves. We're hard at work planning a comprehensive and competitive phase 3 program.

Mohit Bansal: Could you help us understand how complicated it is.

Umer Raffat: Hi guys, thanks for taking my question. I'll spare all my curiosities on your ongoing trial. But I will ask this. One, on manufacturing capacity. I'm curious, is your aim to have 1 million to 2 million patients worth of capacity or 5 million to 10 million? You can imagine from a modeling perspective, from a CapEx side, this would be relevant, knowing obviously how much manufacturing experience and capacity you guys have. And then secondly, is it a pen device? I know you mentioned it's a "handheld patient-friendly auto-injector" which is a single injection. But is it a pen device or is it something else? Thank you.

Mohit Bansal: The traditional big box.

Mohit Bansal: In terms of complexity as well as cost and what kind of investment do you think we should be expecting as you go as you embark on this journey. Thank you.

Peter Griffith: Great, Julian.

Justin Claeys: Great, Julian.

James Bradner: Next question.

Next question.

Speaker Change: Mohit I don't think were intimidated about the challenge on the manufacturing or the process development front I think again, we've established ourselves firmly as a world leader in <unk>.

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

James Bradner: Oh, hey, congrats on all the progress and thanks for providing the update.

Jay Olson: Oh, hey, congrats on all the progress and thanks for providing the update.

Jay Olson: Therapeutic manufacturing.

Jay Olson: You know this is a therapy that's based on.

Robert Bradway: Maybe just to shift gears a little.

Maybe just to shift gears a little.

Jay Olson: Antibody backbone, so it's right down the middle of the fairway for us.

James Bradner: Back to Tarlatamab. With the potential launch rapidly approaching, can you just talk about the work you're doing to prepare for that launch and the strategy behind the initial launch in the late line and then the clinical and commercial work to go behind expanding the profile and potential for Tarlatamab. Thank you.

Back to Tarlatamab. With the potential launch rapidly approaching, can you just talk about the work you're doing to prepare for that launch and the strategy behind the initial launch in the late line and then the clinical and commercial work to go behind expanding the profile and potential for Tarlatamab. Thank you.

Robert A. Bradway: Yes. So Umer, I don't think we're going to say anything more about the delivery - expected delivery device at this point. I think we were as clear as we could be. And we think it will be patient-friendly and convenient. And with respect to the quantity of patients that we expect to serve, we recognize that the unmet need here is very large, and we want to be in position to supply the patients that we think will be interested in the differentiated profile of our medicine. I would point out to you and I hope you're aware that we are already serving millions of patients today around the globe with our biotherapeutics. So again, we're used to supplying many millions of patients with antibody-brd therapies. I think we're pushing up on 8 million PROLIA patients right now worldwide. So, we understand what it takes to supply large quantities of antibody therapies and what it means to do that with successful delivery devices. And I'm sure it's not lost on all of you that the fact that, as Jay said, the delivery dosing schedule is likely to be monthly or less frequently implies far fewer injection devices than competitors who, for example, are administering a weekly therapy. So again, all in all, we recognize the reasons for your questions on supply. But I hope you recognize as well the reasons why we're confident that we'll be up to that challenge. Julianne, next question please?

Jay Olson: We've not lost on us that this competitors.

Jay Olson: Competitors, who are in the market now have found it difficult to maintain supply of these medicines.

Speaker Change: Sure that's not lost on the patients either.

Jay Olson: We are determined to do our best to make sure that we uphold our long tradition of supplying every patient every time in the marketplace. So.

Robert Bradway: Yeah, let's take that in two pieces and maybe Murdo, you can talk about the launch and then I'm sure, Jay, you'd like to elaborate on the thinking for the clinical development of this.

Bob Bradway: Yeah, let's take that in two pieces and maybe Murdo, you can talk about the launch and then I'm sure, Jay, you'd like to elaborate on the thinking for the clinical development of this.

Jay Olson: Again, we think this is done in the middle of the fairway in terms of the technical challenges that we need to address we think.

Jay Olson: We look forward to being able to do that and again as I said, maintaining our track record of every patient every time.

Murdo Gordon: Sure, Jay, thank you for the question on another exciting product in our portfolio, one that I think will deliver a lot of benefit for patients with small cell lung cancer, which is a very, very difficult diagnosis with very little in the way of highly effective treatments that deliver any kind of durable response in small cells. So we're, we're anxiously awaiting approval from.

Jay Olson: In terms of the in terms of.

Jay Olson: Your question about what it will require from us over time, obviously to the extent that that.

Jay Olson: It becomes meaningful motor will have the opportunity to address it down the road.

pushing up on 8 million prolia patients right now worldwide. So, you know, we understand what it takes to supply large quantities of antibody therapies and what it means to do that with successful delivery devices. And, you know, I'm sure it's not lost in all of you that the fact that, as Jay said, that delivery dosing schedule is likely to be monthly or less frequently implies, you know, far fewer injection devices than competitors who, for example, are administering a weekly therapy. So again, all in all, we recognize the reasons for your questions on supply, but I hope you recognize as well the reasons why we're confident that we'll be up to that challenge.

Jay Olson: As Peter said.

James Bradner: The FDA, but we are well prepared.

The FDA, but we are well prepared.

Murdo Gordon: Have been for some time across our field organizations. All our field personnel, including our medical teams, are trained and prepared. We have very clear plans to reach treating physicians in very short order post approval. We have very clear understanding of making sure that we can provide broad access to Tarlatamab when it's approved. We feel really good about this. This is a very important moment, not just for Amgen, but for the treatment of patients with small cell lung cancer where quite frankly, the survival in the late stage setting is really dismal and as a matter of single digit months. So we have a huge opportunity here to impact, and we're not wasting any minute, any hour, or any day in our planning to do that.

Have been for some time across our field organizations. All our field personnel, including our medical teams, are trained and prepared. We have very clear plans to reach treating physicians in very short order post approval. We have very clear understanding of making sure that we can provide broad access to Tarlatamab when it's approved. We feel really good about this. This is a very important moment, not just for Amgen, but for the treatment of patients with small cell lung cancer where quite frankly, the survival in the late stage setting is really dismal and as a matter of single digit months. So we have a huge opportunity here to impact, and we're not wasting any minute, any hour, or any day in our planning to do that.

Julia, next question please?

Justin Claeys: Julianne, next question please?

Operator: Thank you, Umer. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead, your line is open.

Gregory Renza: Hey, great. Good afternoon, Bob and team. Congrats on the updates as well. And just a question on your larger obesity and cardiometabolic strategy. Certainly, with the news on 786 and as you speak to MariTide's efforts on convenience, how are you thinking about oral options within your portfolio now that you are certainly levered towards MariTide as the lead asset? I'm just curious how oral options should fit in with the portfolio longer term. Thank you.

James Bradner: Jay, thanks for highlighting the potential of this medicine, which we consider a major advance. The treatment of this disease has really not meaningfully evolved since I trained as an oncologist in the mid-90s with upfront chemotherapy and meaningful but incremental benefit to immuno-oncology therapy with PD-L1 agents today. So this is a case where time just can't move fast enough to get this medicine into earlier lines of therapy. We have initiated three phase 3 studies, and as you asked, I'll just give an architecture of them. Briefly, we have a study that will compare Tarlatamab to standard of care chemotherapy. This is in the second line, for patients with a primary endpoint of overall survival. This study is enrolling.

Jay Bradner: Jay, thanks for highlighting the potential of this medicine, which we consider a major advance. The treatment of this disease has really not meaningfully evolved since I trained as an oncologist in the mid-90s with upfront chemotherapy and meaningful but incremental benefit to immuno-oncology therapy with PD-L1 agents today. So this is a case where time just can't move fast enough to get this medicine into earlier lines of therapy. We have initiated three phase 3 studies, and as you asked, I'll just give an architecture of them. Briefly, we have a study that will compare Tarlatamab to standard of care chemotherapy. This is in the second line, for patients with a primary endpoint of overall survival. This study is enrolling.

James E. Bradner: Gregory, thank you. This differentiated profile that we're seeing with MariTide really raises the bar for Amgen obesity medicines. And the profile for 786 just did not meet that bar in our assessment. We do have a pipeline, a strong pipeline of earlier assets. There are incretin as well as non-incretin based. Some are injectable and some are oral. And we believe that the heterogeneity, the diversity of the marketplace of - and honestly, the different types of patients that will need medicines for obesity and all the obesity-related conditions demands medicines with different profiles, and we are hard at work on that.

for Amgen obesity medicines and the profile for 786 just did not meet that bar in our assessment. We do have a pipeline, a strong pipeline of earlier assets They're in Cretan as well as not in Cretan-based. Some are injectable and some are oral. And we believe that the heterogeneity, the diversity of the marketplace of, honestly, the different types of patients that will need medicines for obesity and all the obesity-related conditions demands medicines with different profiles, and we are hard to work on that.

We do have a pipeline, a strong pipeline of earlier assets They're in Cretan as well as not in Cretan-based. Some are injectable and some are oral. And we believe that the heterogeneity, the diversity of the marketplace of, honestly, the different types of patients that will need medicines for obesity and all the obesity-related conditions demands medicines with different profiles, and we are hard to work on that.

They're in Cretan as well as not in Cretan-based. Some are injectable and some are oral. And we believe that the heterogeneity, the diversity of the marketplace of, honestly, the different types of patients that will need medicines for obesity and all the obesity-related conditions demands medicines with different profiles, and we are hard to work on that.

Some are injectable and some are oral. And we believe that the heterogeneity, the diversity of the marketplace of, honestly, the different types of patients that will need medicines for obesity and all the obesity-related conditions demands medicines with different profiles, and we are hard to work on that.

James Bradner: We really want to get this medicine tested in frontline therapy, whereas you must know, patients progress so quickly that a great many of them never reach the chance to receive second- and third-line therapy. So in a pair of trials, one for extensive-stage small cell lung cancer, and one for limited-stage small cell lung cancer, we'll study the contribution of tarlatamab immediately following upfront therapy with response. We've learned through the development of these BiTE molecules that they work best when they're given as early as possible in the course of treatment for a disease. That has been the case with ALL as we move into frontline. We've also learned that they work best when there's a low burden of disease. So the design of these three phase 3 studies will bring this medicine to earlier patient therapy lines.

We really want to get this medicine tested in frontline therapy, whereas you must know, patients progress so quickly that a great many of them never reach the chance to receive second- and third-line therapy. So in a pair of trials, one for extensive-stage small cell lung cancer, and one for limited-stage small cell lung cancer, we'll study the contribution of tarlatamab immediately following upfront therapy with response. We've learned through the development of these BiTE molecules that they work best when they're given as early as possible in the course of treatment for a disease. That has been the case with ALL as we move into frontline. We've also learned that they work best when there's a low burden of disease. So the design of these three phase 3 studies will bring this medicine to earlier patient therapy lines.

Justin Claeys: Julianne, next question please.

Operator: Thank you, Gregory. Our next question comes from Tim Anderson from Wolfe Research. Please go ahead, your line is open.

Timothy Minton Anderson: Thank you so much. On MariTide, I'll ask a question on differentiation that I think you should be able to answer, which is, can you remind us what in the past you felt would be differentiating based on what the Phase I showed? So, I'm not asking you to comment on what you just recently saw, but just a reminder of past comments on what you felt the data seemed to show in that front. Less frequent dosing frequency, of course, is the obvious one, but what else? Thank you.

you felt would be differentiating based on what the phase one showed. So I'm not asking you to comment on what you just recently saw, but just a reminder of past comments on what you felt the data seemed to show in that front. Less frequent dosing frequency, of course, is the obvious one, but what else? Thank you.

Murdo Gordon: Yes. Tim, I think we've been fairly consistent on what we believe an opportunity is to differentiate in the market, both in the past and obviously as we see the interim analysis of these results. We think that we have a broad opportunity to differentiate with MariTide. And by that, I mean a broad differentiated profile on a number of fronts. And we continue to believe that we will be able to move into the market with a differentiated product, establish MariTide as a really good opportunity to address unmet medical needs and provide access for millions of patients as we go forward.

James Bradner: I'll say there's been intense interest and great hope in this community. So we expect to enroll these studies expeditiously. Julianne, let's go to the next question, please.

I'll say there's been intense interest and great hope in this community. So we expect to enroll these studies expeditiously.

Justin Claeys: Julianne, let's go to the next question, please.

Operator: Thank you, Jay. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Murdo Gordon: Great.

Mohit Bansal: Great.

James Bradner: Thank you for taking my question and congrats on the progress. I have a question regarding the manufacturing of AMG 133. Could you help us understand how complicated or simpler it is versus the traditional GLP-1 once-weekly peptide-based in terms of complexity, as well as cost, and what kind of investment do you think we should be expecting as you go, as you embark on this journey?

Thank you for taking my question and congrats on the progress. I have a question regarding the manufacturing of AMG 133. Could you help us understand how complicated or simpler it is versus the traditional GLP-1 once-weekly peptide-based in terms of complexity, as well as cost, and what kind of investment do you think we should be expecting as you go, as you embark on this journey?

Justin Claeys: Next question, please, Julianne?

Operator: Thank you, Tim. Our next question comes from Yaron Werber from T.D. Cowan. Please go ahead, your line is open.

Robert Bradway: Thank you, Mohit. I don't think we're intimidated about the challenge on the manufacturing or the process development front. I think again, we've established ourselves firmly as a world leader in biotherapeutic manufacturing. And as you know, this is a therapy that's based on antibody backbone. So it's right down the middle of the fairway for us. It's not lost on us that these competitors who are in the market now have found it difficult to maintain supply of these medicines. And I'm sure that's not lost on the patients either. And we're determined to do our best to make sure that we uphold our long tradition of supplying every patient every time in the marketplace. So again, we think this is down the middle of the fairway in terms of the technical challenges that we need to address.

Bob Bradway: Thank you, Mohit. I don't think we're intimidated about the challenge on the manufacturing or the process development front. I think again, we've established ourselves firmly as a world leader in biotherapeutic manufacturing. And as you know, this is a therapy that's based on antibody backbone. So it's right down the middle of the fairway for us. It's not lost on us that these competitors who are in the market now have found it difficult to maintain supply of these medicines. And I'm sure that's not lost on the patients either. And we're determined to do our best to make sure that we uphold our long tradition of supplying every patient every time in the marketplace. So again, we think this is down the middle of the fairway in terms of the technical challenges that we need to address.

Yaron Werber: Great, and congrats on the update. So, I'm just going to ask a question I think you can answer on - it's a little technical in nature. In the interim analysis for MariTide, was it blinded or not blinded? And then just remind us, is there a dose titration in that study? Thank you.

James E. Bradner: Sure. This is Jay, Yaron. Thank you. The interim analysis - we as R&D leaders have had an ability to see the assigned treatment arms of the study. But importantly, this interim analysis is blinded to investigators and to participants to preserve the integrity of the study.

Robert Bradway: We think that we look forward to being able to do that. Again, as I said, maintaining our track record of every patient every time.

We think that we look forward to being able to do that. Again, as I said, maintaining our track record of every patient every time.

Justin Claeys: All right, Julianne, go to the next question please.

Operator: Thank you, Yaron. Our next question comes from Geoff Meacham from Bank of America. Please go ahead, your line is open.

Robert Bradway: In terms of your question about what it will require from us over time, obviously, to the extent that that becomes meaningful, Mohit will have the opportunity to address it down the road. But as Peter said in his remarks, our capital expenditure guidance for the year embraces the activity that we have underway to make ourselves ready for the clinical and commercial challenge that we see imminently.

In terms of your question about what it will require from us over time, obviously, to the extent that that becomes meaningful, Mohit will have the opportunity to address it down the road. But as Peter said in his remarks, our capital expenditure guidance for the year embraces the activity that we have underway to make ourselves ready for the clinical and commercial challenge that we see imminently.

Geoff Meacham: Hi, guys. Thanks for the question. Yet another one on MariTide. Just given Amgen's cardio portfolio and focus, do you have any updated thoughts on expanding the program beyond just diabetes and obesity? Obviously, recognizing that you now have a better picture of the safety and tolerability profile. Thank you.

James E. Bradner: Yes. Thank you, Geoff, for asking and allowing a clarification. What we're observing with MariTide and what we intended for the development of MariTide continues at pace. And we're preparing for a broad Phase III program that can work to address the unmet needs in obesity and a number of obesity-related conditions and, as you heard, in diabetes as well.

Peter Griffith: Julian, next question.

Justin Claeys: Julian, next question.

James Bradner: Please.

Please.

Operator: Thank you, Mohit. Our next question comes from Umer Raffat from Evercore ISI, please go ahead, your line is open.

Murdo Gordon: Hi guys, thanks for taking my question, and I'll spare all my curiosities on your ongoing trial, but I will ask this one on manufacturing capacity.

Umer Raffat: Hi guys, thanks for taking my question, and I'll spare all my curiosities on your ongoing trial, but I will ask this one on manufacturing capacity.

Peter Griffith: I'm curious, is your aim to have?

I'm curious, is your aim to have?

Murdo Gordon: One to two million patients worth of capacity or five to 10 million? You can imagine from a modeling perspective, from a CapEx side this would be relevant knowing obviously how much manufacturing experience and capacity you guys have.

One to two million patients worth of capacity or five to 10 million? You can imagine from a modeling perspective, from a CapEx side this would be relevant knowing obviously how much manufacturing experience and capacity you guys have.

Operator: Thank you, Geoff. Our next question comes from Evan Seigerman from BMO Capital Markets. Please go ahead, your line is open.

Evan Seigerman: Hi guys, thank you so much for taking my question. I'm not going to ask on MariTide, although I am tempted to. I actually want to ask one on rocatinlimab. So, with the Horizon ROCKET studies upcoming, can you just talk us through what the differentiations you want to see? And how would you position this asset versus, say, the entrenched DUPIXENT and RINVOQ in the atopic dermatitis space? Thank you.

James Bradner: And then secondly.

And then secondly.

James Bradner: Is it a pen device?

Is it a pen device?

Murdo Gordon: I know you mentioned it's a quote.

I know you mentioned it's a quote.

James Bradner: Unquote, handheld, patient-friendly auto-injector, which.

Unquote, handheld, patient-friendly auto-injector, which.

Murdo Gordon: Is a single injection? But is it a pen device or?

Is a single injection? But is it a pen device or?

James Bradner: Is it something else? Thank you.

Is it something else? Thank you.

Robert Bradway: Yeah. So Umer, I don't think we're going to say anything more about the delivery expected delivery device at this point. I think we were as clear as we could be that we think it'll be patient-friendly, convenient, and. Sorry, with respect to the quantity of patients that we expect to serve, we recognize that the unmet need here is very large, and we want to be in position to supply the patients that we think will be interested in the differentiated profile of our medicine. I would point out to you, and I hope you're aware that we are already serving millions of patients today around the globe with our biotherapeutics. So again, we're used to supplying many millions of patients with antibody-based therapies. I think we're pushing up on eight million Prolia patients right now worldwide.

Bob Bradway: Yeah. So Umer, I don't think we're going to say anything more about the delivery expected delivery device at this point. I think we were as clear as we could be that we think it'll be patient-friendly, convenient, and. Sorry, with respect to the quantity of patients that we expect to serve, we recognize that the unmet need here is very large, and we want to be in position to supply the patients that we think will be interested in the differentiated profile of our medicine. I would point out to you, and I hope you're aware that we are already serving millions of patients today around the globe with our biotherapeutics. So again, we're used to supplying many millions of patients with antibody-based therapies. I think we're pushing up on eight million Prolia patients right now worldwide.

Robert A. Bradway: Two pieces. Maybe Jay can address the clinical perspective on differentiation. And then Murdo, to the extent it's appropriate, you can jump in on how to think about positioning it.

James E. Bradner: Yes. It sounds as though, Evan, you're close to this work. But as you know, rocatinlimab is an OX40-directed monoclonal antibody, afucosylated IgG1, a strong ADCC. We have a program called ROCKET that has over 2,800 patients enrolled. And so, to address differentiation, I'm going to limit that maybe scope to the atopic dermatitis space. And here in the Horizon, the so called Horizon study, it's a Phase III randomized controlled trial. It's in moderate to severe atopic dermatitis. It's 726 patients actually enrolled. And in this case, it's rocatinlimab every 4 weeks against placebo with a 24-week treatment readout. We have endpoints at 16 and 24 weeks. We will - it's always apples to oranges to compare between trials, but we hope to observe and expect to observe in moderate to severe atopic dermatitis a very competitive profile with strong efficacy and excellent patient experience and tolerability. Here, we think about DUPIXENT and follow that work in its development closely. And Murdo, I leave it to you to talk through how to best think about differentiation.

We have a program called Rocket that has over 2,800 patients enrolled. And so to address differentiation, I'm going to limit that maybe scope to the atopic dermatitis space. And here in the Horizon, so-called Horizon Study, it's a phase three randomized controlled trial. It's in moderate to severe atopic dermatitis. It's 726 patients actually enrolled. And in this case, it's rocatinlomab every four weeks against placebo for the 24-week treatment and readout. We have end points at 16 and 24 weeks. We will, you know, it's always apples to oranges to compare between trials. But we hope to observe and expect to observe in moderate to severe atopic dermatitis of a very competitive profile with strong efficacy and excellent patient experience and tolerability. Here we think about DuPixson and follow that work in its development closely and Mervo I leave it to you to talk through how to best think about differentiation.

And here in the Horizon, so-called Horizon Study, it's a phase three randomized controlled trial. It's in moderate to severe atopic dermatitis. It's 726 patients actually enrolled. And in this case, it's rocatinlomab every four weeks against placebo for the 24-week treatment and readout. We have end points at 16 and 24 weeks. We will, you know, it's always apples to oranges to compare between trials. But we hope to observe and expect to observe in moderate to severe atopic dermatitis of a very competitive profile with strong efficacy and excellent patient experience and tolerability. Here we think about DuPixson and follow that work in its development closely and Mervo I leave it to you to talk through how to best think about differentiation.

Robert Bradway: We understand what it takes to supply large quantities of antibody therapies and what it means to do that with successful delivery devices. I'm sure it's not lost on all of you that the fact that, as Jay said, the delivery dosing schedule is likely to be monthly or less frequently implies far fewer injection devices than competitors who, for example, are administering a weekly therapy. Again, all in all, we recognize the reasons for your questions on supply, but I hope you recognize as well the reasons why we're confident that we'll be up to that challenge.

We understand what it takes to supply large quantities of antibody therapies and what it means to do that with successful delivery devices. I'm sure it's not lost on all of you that the fact that, as Jay said, the delivery dosing schedule is likely to be monthly or less frequently implies far fewer injection devices than competitors who, for example, are administering a weekly therapy. Again, all in all, we recognize the reasons for your questions on supply, but I hope you recognize as well the reasons why we're confident that we'll be up to that challenge.

We have end points at 16 and 24 weeks. We will, you know, it's always apples to oranges to compare between trials. But we hope to observe and expect to observe in moderate to severe atopic dermatitis of a very competitive profile with strong efficacy and excellent patient experience and tolerability. Here we think about DuPixson and follow that work in its development closely and Mervo I leave it to you to talk through how to best think about differentiation.

We will, you know, it's always apples to oranges to compare between trials. But we hope to observe and expect to observe in moderate to severe atopic dermatitis of a very competitive profile with strong efficacy and excellent patient experience and tolerability. Here we think about DuPixson and follow that work in its development closely and Mervo I leave it to you to talk through how to best think about differentiation.

But we hope to observe and expect to observe in moderate to severe atopic dermatitis of a very competitive profile with strong efficacy and excellent patient experience and tolerability. Here we think about DuPixson and follow that work in its development closely and Mervo I leave it to you to talk through how to best think about differentiation.

Here we think about DuPixson and follow that work in its development closely and Mervo I leave it to you to talk through how to best think about differentiation.

James Bradner: Julia, next question please.

Justin Claeys: Julia, next question please.

Operator: Thank you, Umer. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open.

Murdo Gordon: Yes. Thanks, Jay. And thanks for the question, Evan. We are studying, as Jay mentioned, a broad population of patients in atopic dermatitis. So, we will have some patients that will have previous biologic experience as well as bio-naive. So, we will know how to position this product effectively in the market. I would just - I would perhaps use the recent experience of how we launched TEZSPIRE and differentiated against DUPIXENT in a different indication using a highly differentiated mechanism and the fact that prescribers in this area are looking for alternatives to nonresponsive patients and to bio-naive patients. So, we feel good about the opportunity here. But obviously, we have to await data and see the readouts of the clinical trials.

James Bradner: Hey, great.

Gregory Renza: Hey, great.

Peter Griffith: Good afternoon Bob and team.

Good afternoon Bob and team.

James Bradner: Congrats on the updates as well. Just a question on your larger obesity and cardio metabolic strategy. Certainly with the news on 786 and.

Congrats on the updates as well. Just a question on your larger obesity and cardio metabolic strategy. Certainly with the news on 786 and.

in atopic dermatitis. So we will have some patients that will have previous biology experience as well as bio naïve. So we will know how to position this product effectively in the market. I would just, I would perhaps use the recent experience of how we launched test spire and differentiated against the Pixin and a different indication using a highly differentiated mechanism. And the fact is the prescribers in this area are looking for alternatives to non-responsive patients and to bi-naive patients. So we feel good about the opportunity here, but obviously we have to await data and see the redescentral clinical trials.

previous biology experience as well as bio naïve. So we will know how to position this product effectively in the market. I would just, I would perhaps use the recent experience of how we launched test spire and differentiated against the Pixin and a different indication using a highly differentiated mechanism. And the fact is the prescribers in this area are looking for alternatives to non-responsive patients and to bi-naive patients. So we feel good about the opportunity here, but obviously we have to await data and see the redescentral clinical trials.

Murdo Gordon: As you speak to MariTide's efforts on.

As you speak to MariTide's efforts on.

I would just, I would perhaps use the recent experience of how we launched test spire and differentiated against the Pixin and a different indication using a highly differentiated mechanism. And the fact is the prescribers in this area are looking for alternatives to non-responsive patients and to bi-naive patients. So we feel good about the opportunity here, but obviously we have to await data and see the redescentral clinical trials.

James Bradner: Convenience, how are you thinking about oral options within your portfolio now that you are certainly levered towards MariTide as the lead asset? I'm just curious how oral options should fit in with the portfolio longer term. Thank you. Yeah, Gregory, thank you. This differentiated profile that we're seeing with MariTide really raises the bar for Amgen obesity medicines. The profile for 786 just did not meet that bar in our assessment. We do have a pipeline, a strong pipeline of earlier assets. They're incretin as well as non-incretin based. Some are injectable and some are oral. We believe that the heterogeneity, the diversity of the marketplace, of, honestly, the different types of patients that will need medicines for obesity and all the obesity-related conditions, demands medicines with different profiles, and we are hard at work on that.

Convenience, how are you thinking about oral options within your portfolio now that you are certainly levered towards MariTide as the lead asset? I'm just curious how oral options should fit in with the portfolio longer term. Thank you.

test spire and differentiated against the Pixin and a different indication using a highly differentiated mechanism. And the fact is the prescribers in this area are looking for alternatives to non-responsive patients and to bi-naive patients. So we feel good about the opportunity here, but obviously we have to await data and see the redescentral clinical trials.

Jay Bradner: Yeah, Gregory, thank you. This differentiated profile that we're seeing with MariTide really raises the bar for Amgen obesity medicines. The profile for 786 just did not meet that bar in our assessment. We do have a pipeline, a strong pipeline of earlier assets. They're incretin as well as non-incretin based. Some are injectable and some are oral. We believe that the heterogeneity, the diversity of the marketplace, of, honestly, the different types of patients that will need medicines for obesity and all the obesity-related conditions, demands medicines with different profiles, and we are hard at work on that.

Justin Claeys: Julianne, let's go the next question, please.

Operator: Thank you, Evan. Our next question comes from Chris Schott from JP Morgan. Please go ahead, your line is open.

Chris Schott: Great, thanks so much. Can you just elaborate a little bit more on TEZSPIRE and its potential role in COPD post the Phase II data? And maybe as part of that, how broadly do you expect to study this compound in Phase III, I guess, given the efficacy across the different eosinophil counts that we saw in the Phase II program? Thank you.

James E. Bradner: Yes. Thanks for the question, Chris. It's Jay again. And so, the Phase II COPD data will be presented in an oral presentation, as I mentioned, at the American Thoracic Society Meeting later this month. And so, as that work and its abstract are presently embargoed, there is a natural limit to what I'm able to share. But what I will remind, as you asked more mechanistically, is that TSLP comes from this family of what are called alarmins. And they do just what it sounds like they do. An epithelium, inflamed or irritated or activated, that's inflamed releases TSLP and triggers what's called type 2 inflammation. There are a number of signaling factors that participate in type 2 inflammation. But then, TSLP then converges down in this type 2 T-cell inflammatory milieu in response also involving eosinophils. And that's why we often invoke that measurement in clinical investigation.

James Bradner: Julia, next question please.

Justin Claeys: Julia, next question please.

Operator: Thank you. Thank you, Gregory. Our next question comes from Tim Anderson from Wolfe Research. Please go ahead. Your line is open.

American Therastic Society meeting later this month. And so as that work at its abstract or presently embargoed, there's a natural limit to what I'm able to share. But what I will remind, as you ask more mechanistically, is that TSLP comes from this family of what are called alarmins, and they do just what it sounds like they do. An epithelium, inflamed or irritated or activated that's inflamed releases TSPP and triggers what's called type 2 inflammation. There are a number of signaling factors that participate in type 2 inflammation, but then TSP then converges down in this type 2 T-cell inflammatory milieu in response, also involving eosinophils, and that's why we often invoke that measurement in clinical investigation.

Robert Bradway: Thank you so much. On MariTide, I'll ask a question on differentiation that I think you should be able to answer, which is, can you remind us what in the past you felt would be differentiating based on what the Phase 1 showed? So I'm not asking you to comment on what you just recently saw, but just a reminder of past comments on what you felt the data seemed to.

Tim Anderson: Thank you so much. On MariTide, I'll ask a question on differentiation that I think you should be able to answer, which is, can you remind us what in the past you felt would be differentiating based on what the Phase 1 showed? So I'm not asking you to comment on what you just recently saw, but just a reminder of past comments on what you felt the data seemed to.

But what I will remind, as you ask more mechanistically, is that TSLP comes from this family of what are called alarmins, and they do just what it sounds like they do. An epithelium, inflamed or irritated or activated that's inflamed releases TSPP and triggers what's called type 2 inflammation. There are a number of signaling factors that participate in type 2 inflammation, but then TSP then converges down in this type 2 T-cell inflammatory milieu in response, also involving eosinophils, and that's why we often invoke that measurement in clinical investigation.

James Bradner: Show on that front.

Show on that front.

Robert Bradway: Less frequent dosing frequency, of course, is the obvious one, but what else? Thank you.

Less frequent dosing frequency, of course, is the obvious one, but what else? Thank you.

There are a number of signaling factors that participate in type 2 inflammation, but then TSP then converges down in this type 2 T-cell inflammatory milieu in response, also involving eosinophils, and that's why we often invoke that measurement in clinical investigation.

Murdo Gordon: Yes, Tim, I think we've been fairly consistent on what we believe an opportunity is to differentiate in the market. Both in the past and obviously as we see the interim analysis of these results, we think that we have a broad opportunity to differentiate with MariTide. And by that I mean a broad differentiated profile on a number of fronts. And we continue to believe that we will be able to move into the market with a differentiated product, establish.

James E. Bradner: The rationale for COPD is as strong as it is for asthma. But COPD, if you must know, is a much more heterogeneous disease than asthma. And so, the design of this clinical trial appreciated and understood that and built into it some predefined stratifications for analysis, one of which was this eosinophil threshold of 150 cells per microliter. And so, we look forward to sharing the full data. We have already disclosed that there's clinically meaningful activity of the molecule in this randomized controlled trial. And so, please expect more at the ATS. You asked about the more broad development. You are right that TSLP is not only a feature of an inflamed airway epithelium but other epithelial surfaces as well. Hence, our interest to develop it in eosinophilic esophagitis as well as chronic rhinosinusitis with nasal polyps. And both of these diseases are characterized molecularly by type 2 inflammation.

And so the design of this clinical trial appreciated and understood that and built into it some predefined stratifications for analysis, one of which was this eosinophil threshold of 150 cells per microliter. And so we look forward to sharing the full data. We have already disclosed that there's clinically meaningful activity of the molecule in this randomized control trial. And so please expect more at the ATS. You ask about the more broad development. You are right that TSLP is not only a feature of an inflamed airway epithelium, but other epithelial surfaces as well. Hence, our interest to develop it in eocinophilic esophagitis, as well as chronic rhinocytitis with nasal polyps. And both of these diseases are characterized molecularly by type 2 inflammation.

James Bradner: Maritide.

Maritide.

Murdo Gordon: As a really good opportunity and address unmet medical need and provide access for millions of patients as we go forward.

As a really good opportunity and address unmet medical need and provide access for millions of patients as we go forward.

And so we look forward to sharing the full data. We have already disclosed that there's clinically meaningful activity of the molecule in this randomized control trial. And so please expect more at the ATS. You ask about the more broad development. You are right that TSLP is not only a feature of an inflamed airway epithelium, but other epithelial surfaces as well. Hence, our interest to develop it in eocinophilic esophagitis, as well as chronic rhinocytitis with nasal polyps. And both of these diseases are characterized molecularly by type 2 inflammation.

James Bradner: Next question please, Jillian.

Justin Claeys: Next question please, Jillian.

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

James Bradner: Great.

Yaron Werber: Great.

Robert Bradway: And congrats on the update. So I'm just going to ask a question to see if you can answer. It's a little technical in nature. In the interim analysis for MariTide, was.

And congrats on the update. So I'm just going to ask a question to see if you can answer. It's a little technical in nature. In the interim analysis for MariTide, was.

You ask about the more broad development. You are right that TSLP is not only a feature of an inflamed airway epithelium, but other epithelial surfaces as well. Hence, our interest to develop it in eocinophilic esophagitis, as well as chronic rhinocytitis with nasal polyps. And both of these diseases are characterized molecularly by type 2 inflammation.

Peter Griffith: it blinded, or not blinded?

it blinded, or not blinded?

Robert Bradway: Just remind us, is there dose titration in that study?

Just remind us, is there dose titration in that study?

Vikram Karnani: Thank you.

Thank you.

Robert Bradway: Sure.

Jay Bradner: Sure.

James Bradner: This is Jay Eran.

This is Jay Eran. Thank you.

Robert Bradway: Thank you.

James Bradner: The.

The we, as RD leaders, have had an ability to see the assigned treatment arms of the study. But importantly, this interim analysis is blinded to investigators and to participants to preserve the integrity of the study.

And both of these diseases are characterized molecularly by type 2 inflammation.

James Bradner: We, as RD leaders, have had an ability to see the assigned treatment arms of the study. But importantly, this interim analysis is blinded to investigators and to participants to preserve the integrity of the study.

Justin Claeys: Okay, Julianne, let's move on.

Operator: Thank you, Chris. Our next question comes from James Shin from Deutsche Bank. Please go ahead, your line is open.

James Shin: Hi, thanks for taking my question. This one is a little bit off the reservation. It's for Jay and on oncology. It's for AMG 651, the EGFR CD3. Just wanted to get your thoughts on that. I think there's going to be some data coming up soon, and there's some other data that's come out recently from peers.

James Bradner: All right, Julianne, let's go to the next question, please.

Justin Claeys: All right, Julianne, let's go to the next question, please.

Operator: Thank you, Jerome. Our next question comes from Geoff Meacham from Bank of America. Please go ahead. Your line is open. Hi, guys.

Operator: Thank you, Jerome. Our next question comes from Geoff Meacham from Bank of America. Please go ahead. Your line is open.

Geoff Meacham: Hi, guys.

James Bradner: Thanks for the question. Yet another one on MariTide. Just given Amgen's cardio portfolio and focus, do you have any updated thoughts on expanding the program beyond just diabetes and obesity? Obviously recognizing that you now have a better picture of the safety and tolerability profile.

Thanks for the question. Yet another one on MariTide. Just given Amgen's cardio portfolio and focus, do you have any updated thoughts on expanding the program beyond just diabetes and obesity? Obviously recognizing that you now have a better picture of the safety and tolerability profile.

James E. Bradner: Yes. Well, I would say this, James - thanks for the question - we have a large experience of developing CD3 bispecifics. And we have learned over time to tune the potency of engagement to the cell surface antigen to the degree of engagement and activation of the CD3. And there is no news to share with you at this moment. We continue to study this and other solid tumor-targeting T-cell-engaging bispecifics, really buoyed by the confidence and the guidance from tarlatamab and xaluritamig. So, I would expect more in the future on that medicine as well as other solid tumor-targeting bispecific T-cell engagers.

Well, I would say this, James. Thanks for the question. You know, we have a large experience of developing CD3 bispecifics, and we have learned over time to tune the potency of engagement to the cell surface antigen to the degree of engagement and activation of the CD3. And there is no news to share with you at this moment. We continue to study this and other solid tumor targeting T-cell engaging by specifics really buoyed by the confidence and the guidance from tarlatomab and Zellaritomac. So I would expect more in the future on that medicine as well as other solid tumor targeting by specific T-cell engagers.

I would say this, James. Thanks for the question. You know, we have a large experience of developing CD3 bispecifics, and we have learned over time to tune the potency of engagement to the cell surface antigen to the degree of engagement and activation of the CD3. And there is no news to share with you at this moment. We continue to study this and other solid tumor targeting T-cell engaging by specifics really buoyed by the confidence and the guidance from tarlatomab and Zellaritomac. So I would expect more in the future on that medicine as well as other solid tumor targeting by specific T-cell engagers.

Peter Griffith: Thank you.

Thank you.

James Bradner: Yeah, thank you, Jeff, for asking and allowing a clarification. What we're observing with MariTide and what we intended for the development of MariTide continues at pace, and we're preparing for a broad phase 3 program that can work to address the unmet needs in obesity in a number of obesity-related conditions, and as you heard, in diabetes as well.

Jay Bradner: Yeah, thank you, Jeff, for asking and allowing a clarification. What we're observing with MariTide and what we intended for the development of MariTide continues at pace, and we're preparing for a broad phase 3 program that can work to address the unmet needs in obesity in a number of obesity-related conditions, and as you heard, in diabetes as well.

And there is no news to share with you at this moment. We continue to study this and other solid tumor targeting T-cell engaging by specifics really buoyed by the confidence and the guidance from tarlatomab and Zellaritomac. So I would expect more in the future on that medicine as well as other solid tumor targeting by specific T-cell engagers.

T-cell engaging by specifics really buoyed by the confidence and the guidance from tarlatomab and Zellaritomac. So I would expect more in the future on that medicine as well as other solid tumor targeting by specific T-cell engagers.

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

Justin Claeys: Julianne, let's go to the next question, please.

James Bradner: Hi, guys.

Evan Seigerman: Hi, guys.

Operator: Thank you, James. Our next question comes from Kripa Devarakonda from Truis Securities. Please go ahead, your line is open.

Peter Griffith: Thank you so much for taking my question.

Thank you so much for taking my question.

James Bradner: I'm not going to ask one on MariTide, although I am tempted to. I actually want to ask one on Rocatinlimab. So with the Horizon and Rocket studies, you know, upcoming, can you just talk us through what the differentiation is you want to see and how would you position this asset versus, say, the entrenched Dupixent and Rinvoq in the atopic dermatitis space? Thank you.

I'm not going to ask one on MariTide, although I am tempted to. I actually want to ask one on Rocatinlimab. So with the Horizon and Rocket studies, you know, upcoming, can you just talk us through what the differentiation is you want to see and how would you position this asset versus, say, the entrenched Dupixent and Rinvoq in the atopic dermatitis space? Thank you.

Kripa Devarakonda: Hey, guys, thank you so much for taking my question. I have a question on TEPEZZA in TED. Can you please talk about where you are with this subcu program? I think the Phase III is ongoing. Just a little bit of update on that. And as you continue to treat more patients with TED, what are you hearing about concerns around safety concerns? And is that having any impact on uptake? Thank you.

Robert Bradway: Just in two pieces. Maybe Jay can address the clinical perspective on differentiation, and then to the extent it's appropriate, you can jump in on how to think about positioning it.

Bob Bradway: Just in two pieces. Maybe Jay can address the clinical perspective on differentiation, and then to the extent it's appropriate, you can jump in on how to think about positioning it.

James Bradner: Yeah, it sounds as though, Evan, you're close to this work, but as you know, rocatinlimab's an OX40 directed monoclonal antibody, a fucosylated IgG1 strong ADCC. We have a program called Rocket that has over 2,800 patients enrolled. So to address differentiation, I'm going to limit that, maybe scope to the atopic dermatitis space. And here in the Horizon, so called Horizon study, it's a phase 3 randomized controlled trial. It's in moderate to severe atopic dermatitis. It's 726 patients actually enrolled. And in this case it's rocatinlimab every four weeks against placebo for the 24-week treatment and readout. We have endpoints at 16 and 24 weeks. We will, you know, it's always apples to oranges to compare between trials, but we hope to observe and expect to observe in moderate to severe atopic dermatitis, a very competitive profile with strong efficacy and excellent patient experience and tolerability.

Jay Bradner: Yeah, it sounds as though, Evan, you're close to this work, but as you know, rocatinlimab's an OX40 directed monoclonal antibody, a fucosylated IgG1 strong ADCC. We have a program called Rocket that has over 2,800 patients enrolled. So to address differentiation, I'm going to limit that, maybe scope to the atopic dermatitis space. And here in the Horizon, so called Horizon study, it's a phase 3 randomized controlled trial. It's in moderate to severe atopic dermatitis. It's 726 patients actually enrolled. And in this case it's rocatinlimab every four weeks against placebo for the 24-week treatment and readout. We have endpoints at 16 and 24 weeks. We will, you know, it's always apples to oranges to compare between trials, but we hope to observe and expect to observe in moderate to severe atopic dermatitis, a very competitive profile with strong efficacy and excellent patient experience and tolerability.

Robert A. Bradway: We'll take it in 2 parts. Jay, you can address the clinical questions. And then to the extent that, Vikram, you want to share any thoughts on the marketplace, jump in.

James E. Bradner: Yes, thanks for the question. The development of a subcutaneous administration of TEPEZZA is a major priority for Amgen R&D in the program. We have initiated a Phase III study. This will be - this is in moderate to severe active TED. And the design is akin to what we have reported already with the intravenous label-enabling studies completed to date. And Vikram, if you want to speak to the clinical experience.

Vikram Karnani: Yes, I think - so thanks for the question. I think the question was around AEs and if that is limiting growth. And I imagine, Kripa, that you're maybe specifically referring to hearing loss or about hearing loss. So, let's start at the top. TEPEZZA, it very effectively treats TED, which we all now is a pretty severe and debilitating disease. IGF-1, we know is going to be involved in hearing function. So, during the clinical assessment and the clinical development of TEPEZZA, we very carefully have - we looked at - we assessed hearing function. We now have included this in the warnings and precautions section of the PI, along with a recommendation for assessment and monitoring. It's important because patients who use TEPEZZA should be monitored for any specific experience with hearing impairment. We're also working with professional societies to increase education. And while many physicians do use a brline hearing assessment, getting it in the label helps standardize this approach, okay? So after working through the management of this with HCPs, this has not generally turned to be a barrier for growth as physicians generally understand the favorable risk-benefit profile of TEPEZZA.

TED, which we all know as a pretty severe and debilitating disease. IGF1, we know, is can be involved in hearing function. So during the clinical assessment and the clinical development of TEPA, we very carefully We have we looked at, we assessed hearing function. We now have included this in the warnings and precautions section of the PI, along with the recommendation for assessment and monitoring. It's important because patients who use to PESA should be monitored for any any specific experience with hearing impairment. We're also working with professional societies to increase education, And while many physicians do use a baseline hearing assessment, getting it in the label health standardizes approach. Okay? So after working through the management of this with HCPs, this has not generally turned to be a barrier for growth as physicians generally understand the favorable risk benefit profile of SEPA.

James Bradner: Here we think about Dupixent and follow that work and its development closely. Myrtle, I'd leave it to you to talk through how to best think about differentiation.

Here we think about Dupixent and follow that work and its development closely. Myrtle, I'd leave it to you to talk through how to best think about differentiation.

Murdo Gordon: Yeah, thanks Jay. Thanks for the question, Evan. We are studying, as Jay mentioned, a broad population of patients in atopic dermatitis. So we will have some patients that will have previous biologic experience as well as bio-naive. So we will know how to position this product effectively in the market.

We have we looked at, we assessed hearing function. We now have included this in the warnings and precautions section of the PI, along with the recommendation for assessment and monitoring. It's important because patients who use to PESA should be monitored for any any specific experience with hearing impairment. We're also working with professional societies to increase education, And while many physicians do use a baseline hearing assessment, getting it in the label health standardizes approach. Okay? So after working through the management of this with HCPs, this has not generally turned to be a barrier for growth as physicians generally understand the favorable risk benefit profile of SEPA.

James Bradner: I would perhaps use.

I would perhaps use.

Murdo Gordon: The recent experience of how we launched Tezspire and differentiated against Dupixent in a different indication using a highly differentiated mechanism. The fact is prescribers in this area are looking for alternatives to non-responsive patients and to bio-naive patients. So we feel good about the opportunity here, but obviously we have to await data and see the readouts of the clinical trials.

The recent experience of how we launched Tezspire and differentiated against Dupixent in a different indication using a highly differentiated mechanism. The fact is prescribers in this area are looking for alternatives to non-responsive patients and to bio-naive patients. So we feel good about the opportunity here, but obviously we have to await data and see the readouts of the clinical trials.

any specific experience with hearing impairment. We're also working with professional societies to increase education, And while many physicians do use a baseline hearing assessment, getting it in the label health standardizes approach. Okay? So after working through the management of this with HCPs, this has not generally turned to be a barrier for growth as physicians generally understand the favorable risk benefit profile of SEPA.

We're also working with professional societies to increase education, And while many physicians do use a baseline hearing assessment, getting it in the label health standardizes approach. Okay? So after working through the management of this with HCPs, this has not generally turned to be a barrier for growth as physicians generally understand the favorable risk benefit profile of SEPA.

And while many physicians do use a baseline hearing assessment, getting it in the label health standardizes approach. Okay? So after working through the management of this with HCPs, this has not generally turned to be a barrier for growth as physicians generally understand the favorable risk benefit profile of SEPA.

Jay Olson: The development of a subcutaneous administration of <unk> is a major priority for Amgen R&D in the program. We've initiated a phase III study this will be and this is in moderate to severe active Ted and the design is akin to what we have ripped.

James Bradner: Julianne, let's go to the next question please.

Justin Claeys: Julianne, let's go to the next question please.

Operator: Thank you, Evan. Our next question comes from Chris Schott from JP Morgan. Please go ahead. Your line is open.

Robert A. Bradway: Thank you. So Julianne, we're pushing up to the appointed bottom of the hour here, but we still have a few questions in the queue. So, we'll take a couple more to try to get through your questions. If we don't get to everybody, obviously, Justin and his team will be around this evening to answer any questions. But let's try and click through these - the ones we can quickly, Julianne.

So, Julianne, we're pushing up to the appointed bottom of the hour here, but we still have a few questions in the queue, so we'll take a couple more and try to get through your questions. If we don't get to everybody, obviously, Justin and his team will be around this evening to answer any questions. But let's try and click through these ones we can quickly, Julian.

Robert Bradway: Great, thanks so much.

Chris Schott: Great, thanks so much.

James Bradner: Could you just elaborate a little bit more on Tezspire and its potential role in COPD post the phase 2 data? And maybe as part of that, how broadly do you expect to study this compound in phase 3? I guess, given the efficacy across the different eosinophil counts that we saw in the phase 2 program. Thank you.

Could you just elaborate a little bit more on Tezspire and its potential role in COPD post the phase 2 data? And maybe as part of that, how broadly do you expect to study this compound in phase 3? I guess, given the efficacy across the different eosinophil counts that we saw in the phase 2 program. Thank you.

Jay Olson: Reported already with the intravenous.

Jay Olson: Label, enabling studies completed to date and Vikram do you want to speak to the clinical experience. Yes, I think so thanks for the question I think I think the question was around.

Operator: Certainly. Thank you, Kripa. Our next question comes from Michael Schmidt from Guggenheim Partners. Please go ahead, your line is open.

James Bradner: Yeah, thanks for the question, Chris. It's Jay again. And so the phase 2 COPD data will be presented in an oral presentation, as I mentioned, at the American Thoracic Society meeting later this month. And so as that work and its abstract are presently embargoed, there's a natural limit to what I'm able to share. But what I will remind, as you ask more mechanistically, is that TSLP comes from this family of what are called alarmins. And they do just what it sounds like they do. An epithelium inflamed, or irritated, or activated that's inflamed releases TSLP and triggers what's called type 2 inflammation. There are a number of signaling factors that participate in type 2 inflammation, but then TSLP then converges down in this type 2 T cell inflammatory milieu in response, also involving eosinophils. And that's why we often invoke that measurement in clinical investigation.

Jay Bradner: Yeah, thanks for the question, Chris. It's Jay again. And so the phase 2 COPD data will be presented in an oral presentation, as I mentioned, at the American Thoracic Society meeting later this month. And so as that work and its abstract are presently embargoed, there's a natural limit to what I'm able to share. But what I will remind, as you ask more mechanistically, is that TSLP comes from this family of what are called alarmins. And they do just what it sounds like they do. An epithelium inflamed, or irritated, or activated that's inflamed releases TSLP and triggers what's called type 2 inflammation. There are a number of signaling factors that participate in type 2 inflammation, but then TSLP then converges down in this type 2 T cell inflammatory milieu in response, also involving eosinophils. And that's why we often invoke that measurement in clinical investigation.

Vikram: And if that is limiting growth in I imagine quicker that you, maybe specifically referring to hearing loss.

Michael Schmidt: Hey, guys. Thanks for taking my question. I had one on BLINCYTO, which has recently gained some commercial momentum recently. And there was some interesting academic data reported last week in Nature Medicine showing some activity in RA. And so, I was just wondering if you have any plans? Or how are you thinking about potentially developing BLINCYTO or maybe other BiTEs in autoimmune? Thanks so much.

Vikram: Sure.

Vikram: About hearing loss.

Vikram: Let's start at the top the president is.

Vikram: It's very effectively treats.

Jay Olson: <unk>, which we all know is a pretty severe and debilitating disease.

Jay Olson: IGF one we know is going to be involved in hearing function.

if you have any plans or how you're thinking about potentially developing influenza sites or maybe other bites in autoimmune diseases. Thanks so much. Sorry, in autoimmune disorders?

Jay Olson: So during the clinical assessment and the clinical development of the peso.

Jay Olson: Very carefully.

Yes. Yes.

Robert A. Bradway: Sorry. In autoimmune disorders?

Jay Olson: We looked at.

Michael Schmidt: Yes.

James E. Bradner: Thanks for your question. With very deep expertise here in CD19-directed therapeutics, with deep and committed expertise in inflammation and autoimmunity, we've been following this space very closely, the early suggestive evidence from CAR-T cell therapy and, more recently, this work that's been reported in systemic sclerosis. And as you noted, 6 patients with quite refractory rheumatoid arthritis is very exciting to see. And so, you can imagine that we're well organized around this opportunity. And we found that work quite inspiring and we'll have more to report in the future.

Jay Olson: We assessed hearing function.

Jay Olson: We now have included this in the warnings and precautions section of the pie along with a recommendation for assessment and monitoring it's important because patients who use a peso.

We've been following this space very closely. the early suggestive evidence from cartiesel therapy, and more recently this work that's been reported in systemic sclerosis, and as you noted, ticks patients with quite refractory rheumatoid arthritis. is very exciting to see. So you can imagine that we're well organized around this opportunity, and we found that we're quite inspiring, and we'll have more to report in the future.

Jay Olson: Should be monitored for any.

the early suggestive evidence from cartiesel therapy, and more recently this work that's been reported in systemic sclerosis, and as you noted, ticks patients with quite refractory rheumatoid arthritis. is very exciting to see. So you can imagine that we're well organized around this opportunity, and we found that we're quite inspiring, and we'll have more to report in the future.

Jay Olson: Any specific.

Jay Olson: Experience with hearing impairment.

Speaker Change: We're also working with professional societies.

James Bradner: The rationale for COPD is as strong as it is for asthma. But COPD, as you must know, is a much more heterogeneous disease than asthma. And so the design of this clinical trial appreciated and understood that and built into it some predefined stratifications for analysis, one of which was this eosinophil threshold of 150 cells per microliter. And so we look forward to sharing the full data. We have already disclosed that there's clinically meaningful activity of the molecule in this randomized controlled trial. And so please expect more at the ATS. You ask about the more broad development. You are right that TSLP is not only a feature of an inflamed airway epithelium, but other epithelium epithelial surfaces as well. Hence our interest to develop it in Eosinophilic Esophagitis as well as chronic rhinosinusitis with nasal polyps.

The rationale for COPD is as strong as it is for asthma. But COPD, as you must know, is a much more heterogeneous disease than asthma. And so the design of this clinical trial appreciated and understood that and built into it some predefined stratifications for analysis, one of which was this eosinophil threshold of 150 cells per microliter. And so we look forward to sharing the full data. We have already disclosed that there's clinically meaningful activity of the molecule in this randomized controlled trial. And so please expect more at the ATS. You ask about the more broad development. You are right that TSLP is not only a feature of an inflamed airway epithelium, but other epithelium epithelial surfaces as well. Hence our interest to develop it in Eosinophilic Esophagitis as well as chronic rhinosinusitis with nasal polyps.

Speaker Change: Education and.

Jay Olson: While many physicians do use it basically getting assessment.

Jay Olson: Getting it in the label help standardize this approach.

is very exciting to see. So you can imagine that we're well organized around this opportunity, and we found that we're quite inspiring, and we'll have more to report in the future.

Jay Olson: So after working through the management of this with Hcp's.

Jay Olson: This is not generally tend to be a barrier for growth.

Jay Olson: Physicians generally understand the favorable risk benefit profile of bezel.

Justin Claeys: Julianne, I think we've got time for one more question.

Operator: Thank you, Michael. Our last question will come from Gary Nachman from Raymond James. Please go ahead, your line is open.

Speaker Change: Thank you so Julian we're pushing up to the point.

Jay Olson: Pointed.

Jay Olson: Some of the hour here.

Speaker Change: But we still have a few questions in the queue. So we'll take a couple more.

Gary Nachman: Great. Thanks and good afternoon. So, back to MariTide, I have to finish with that. As you're planning for the Phase III studies, do you have a sense of when you could start those? How big those might be? And anything about design and overall timing relative to other Phase III studies in this space? And any strategies you have to accelerate those studies as quickly as possible? And how you'll incorporate both U.S. and ex U.S. in the program? Thank you.

Speaker Change: Try to get through your questions. If we don't get to everybody, obviously, Justin and his team will be around this evening to answer any questions, but let's try and click throughs.

Speaker Change: Once we can quickly Julien.

Julien: Certainly thank you. Our next question comes from Michael Schmidt from Guggenheim Partners. Please go ahead. Your line is open hey, guys. Thanks for taking my question I had one on <unk>, which has we think and some commercial momentum recently.

James Bradner: And both of these diseases are characterized molecularly by type 2 inflammation.

And both of these diseases are characterized molecularly by type 2 inflammation.

Robert A. Bradway: So Gary, again, we appreciate it. I can understand why you'd be asking those questions. As I said in my remarks, we will do our level best now to successfully complete the Phase II study and then work swiftly with regulators to agree the program that establishes safety and efficacy in Phase III, and we'll do that as swiftly as we can. We recognize there's a huge unmet need still in the marketplace, and we believe we have an asset that can help address that. But Jay, I don't know whether you feel you can say anything more specific, but jump in if you do.

Michael Werner Schmidt: There was some interesting academic data reported last week in nature medicine, showing some activity in RA and so just wondering if you have any plans or how you're thinking about potentially developing glen sites or maybe other bites and audit.

Robert Bradway: Hey Julianne, let's move on.

Bob Bradway: Hey Julianne, let's move on.

Operator: Thank you, Chris. Our next question comes from James Shin from Deutsche Bank. Please go ahead. Your line is open.

James Bradner: Hi, thanks for taking my question. This one is a little bit off the reservation.

James Shin: Hi, thanks for taking my question. This one is a little bit off the reservation.

Speaker Change: So much.

Peter Griffith: It's for Jay and oncology.

It's for Jay and oncology.

Speaker Change: Sorry, and autoimmune disorders.

James Bradner: It's for AMG651, the EGFR CD3. Just want to get your thoughts on that. I think there's going to be some data coming up soon and there's some other data that's come out recently from peers.

It's for AMG651, the EGFR CD3. Just want to get your thoughts on that. I think there's going to be some data coming up soon and there's some other data that's come out recently from peers.

Julien: Yes.

And we believe we have an asset that can help address that. But Jay, I don't know whether you feel you can say anything more specific, but jump in if you do. Yeah, I'd say the same, Bob. Gary, as you know, this is one part collecting the data that regulators rightly expect and ongoing conversations around the design. This study is moving as rapidly as possible within this program is moving as rapidly as possible within the organization. You can rest assured.

And we believe we have an asset that can help address that. But Jay, I don't know whether you feel you can say anything more specific, but jump in if you do.

Julien: Yes.

Speaker Change: Well thanks for your question.

Julien: With very deep expertise here in CD 19, directed therapeutics with deep and committed expertise in inflammation and autoimmunity.

James E. Bradner: Yes, I'd say the same, Bob. Gary, as you know, this is one part, collecting the data that regulators rightly expect, and ongoing conversations around the design. This study is moving as rapidly as possible within - this program is moving as rapidly as possible within the organization, you can rest assured. Okay. Well, again, let me thank you all for joining the call and reiterate that Justin and his team will be around if you have any further questions. We look forward to having an opportunity to talk to you in the summer after the second quarter and provide update on the flow of information that we expect to generate between now and then on the many programs that we've referred to on the call. So thank you for your interest. Appreciate it. This concludes our 2024 Q1 earnings call. You may now disconnect.

James Bradner: Yeah, well, I would say this, James, thanks for the question. You know, we have a large experience developing CD3 bispecifics, and we have learned over time to tune the potency of engagement to the cell surface antigen to the degree of engagement and activation of the CD3. And there is no news to share with you at this moment. We continue to study this and other solid tumor targeting T cell engaging bispecifics. Really buoyed by the confidence and the guidance from tarlatamab and xaluritamig. So I would expect more in the future on that medicine as well as other solid tumor targeting bispecific T cell engagers. Julianne, let's go to the next question please.

Jay Bradner: Yeah, well, I would say this, James, thanks for the question. You know, we have a large experience developing CD3 bispecifics, and we have learned over time to tune the potency of engagement to the cell surface antigen to the degree of engagement and activation of the CD3. And there is no news to share with you at this moment. We continue to study this and other solid tumor targeting T cell engaging bispecifics. Really buoyed by the confidence and the guidance from tarlatamab and xaluritamig. So I would expect more in the future on that medicine as well as other solid tumor targeting bispecific T cell engagers.

Julien: We've been following this space very closely.

Robert A. Bradway: Okay. Well, again, let me thank you all for joining the call and reiterate that Justin and his team will be around if you have any further questions. We look forward to having an opportunity to talk to you in the summer after the second quarter and provide update on the flow of information that we expect to generate between now and then on the many programs that we've referred to on the call. So thank you for your interest. Appreciate it. This concludes our 2024 Q1 earnings call. You may now disconnect.

Julien: The early suggested evidence from car T cell therapy and more recently on this work that's been reported in systemic sclerosis, and as you noted six patients with quite refractory rheumatoid arthritis.

Operator: This concludes our 2024 Q1 earnings call. You may now disconnect.

Jay Olson: It's very exciting to see so you can imagine that we are well organized around this opportunity and.

Jay Olson: We found that we're quite inspiring and we'll have more to report in the future.

Speaker Change: Julian I think we've got time for one more question.

Julian: Thank you Michael our last question will come from Gary Nachman from Raymond James. Please go ahead. Your line is open.

Gary Jay Nachman: Great. Thanks, and good afternoon, so back to maritime has to finish with that as.

Justin Claeys: Julianne, let's go to the next question please.

Gary Jay Nachman: As Youre planning for the Phase III studies do you have a sense of when you could start how big those might be and anything about this on an overall timing relative to other phase III studies in this space.

Operator: Thank you, James. Our next question comes from Kripa Devarakonda from Truist Securities.

James Bradner: Please go ahead.

Please go ahead.

Operator: Your line is open. Hey guys, thank you so much for taking my question. I have a question on Tepezza and TED. Can you please talk about where you are with this Sub Q program? I think the Phase 3 is ongoing. Just a little bit of update on that. And as you continue to treat more patients with TED, what are you hearing about concerns around safety concerns, and is that having any impact on uptake? Thank you.

Your line is open.

Kripa Devarakonda: Hey guys, thank you so much for taking my question. I have a question on Tepezza and TED. Can you please talk about where you are with this Sub Q program? I think the Phase 3 is ongoing. Just a little bit of update on that. And as you continue to treat more patients with TED, what are you hearing about concerns around safety concerns, and is that having any impact on uptake? Thank you.

Gary Jay Nachman: The strategies you have to accelerate the studies as quickly as possible.

Gary Jay Nachman: And how do you incorporate both U S and ex U S and the program. Thank you.

Speaker Change: So Gary and John we appreciate it and I can understand why you'd be asking those questions. As I said in my remarks, we will do our level best now to successfully complete the phase II study and then worked swiftly.

Speaker Change: With regulators to agree the program that establish the safety and efficacy in phase III.

Robert Bradway: Let's take it in two parts. Jay, you can address the clinical questions, and then, to the extent that Vikram, you want to share any thoughts on the marketplace, jump in.

Bob Bradway: Let's take it in two parts. Jay, you can address the clinical questions, and then, to the extent that Vikram, you want to share any thoughts on the marketplace, jump in.

Gary Jay Nachman: And we will do that as swiftly as we can we will recognize there's a huge unmet need still in the marketplace.

James Bradner: Yeah, thanks for the question. The development of a subcutaneous administration of Tepezza is a major priority for Amgen RD in the program. We've initiated a phase 3 study. This will be and this is in moderate to severe active TED, and the design is akin to what we have reported already with the intravenous label enabling studies completed to date. Vikram, if you want to speak.

Jay Bradner: Yeah, thanks for the question. The development of a subcutaneous administration of Tepezza is a major priority for Amgen RD in the program. We've initiated a phase 3 study. This will be and this is in moderate to severe active TED, and the design is akin to what we have reported already with the intravenous label enabling studies completed to date. Vikram, if you want to speak.

Speaker Change: And we believe we have an asset that can help address that but Jay I don't know whether you feel you can say anything more specific but jump in if you do yes, I'd say the same Bob I'm, Gary as you know this is one part of collecting the data that regulators are rightly expect an ongoing conversations around the design. This study is moving as rapidly as possible within this program.

Speaker Change: <unk> is moving as rapidly as possible within the organization you can rest assured.

Speaker Change: Okay, well again, let me. Thank you all for joining the call and.

Murdo Gordon: To the clinical experience.

To the clinical experience.

Vikram Karnani: Yeah, I think so. Thanks for the question. I think the question was around.

Speaker Change: Reiterate adjustments and this team will be around if you have any further questions. We look forward to having an opportunity to talk to you in the summer after the second quarter and provide an update on the flow of information that we expect to generate between now and then on the many programs that we've referred to on the call. So thank you for your interest appreciate it.

Vikram Karnani: AES and if that is limiting growth. I imagine, Kripa, that you're maybe specifically referring to hearing loss or.

AES and if that is limiting growth. I imagine, Kripa, that you're maybe specifically referring to hearing loss or.

Vikram Karnani: About hearing loss. So let's start at the top. Tepezza as it very effectively treats TED, which we all know is a pretty severe and debilitating disease. IGF1 we know can be involved in hearing function. So during the clinical assessment and the clinical development of Tepezza, we very carefully.

About hearing loss. So let's start at the top. Tepezza as it very effectively treats TED, which we all know is a pretty severe and debilitating disease. IGF1 we know can be involved in hearing function. So during the clinical assessment and the clinical development of Tepezza, we very carefully.

Speaker Change: This concludes our 2020 for Q1 earnings call you may now disconnect.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Sure.

Vikram Karnani: We assessed hearing function. We now have included this in the warnings and precautions section of the PI along with the recommendation for assessment and monitoring. It's important because patients who use Tepezza should be monitored for.

We assessed hearing function. We now have included this in the warnings and precautions section of the PI along with the recommendation for assessment and monitoring. It's important because patients who use Tepezza should be monitored for.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: Okay.

Vikram Karnani: Any specific experience with hearing impairment? We're also working with professional societies to increase education. While many physicians do use a baseline hearing assessment, getting it in the label helps standardize this approach. After working through the management of this with HCPs, this has not generally turned out to be a barrier for growth as physicians generally understand the favorable risk-benefit profile of Tezspire.

Any specific experience with hearing impairment? We're also working with professional societies to increase education. While many physicians do use a baseline hearing assessment, getting it in the label helps standardize this approach. After working through the management of this with HCPs, this has not generally turned out to be a barrier for growth as physicians generally understand the favorable risk-benefit profile of Tezspire.

Robert Bradway: Thank you. So Julianne, we're pushing up to the point at bottom of the hour here, but we still have a few questions in the queue. So we'll take a couple more and try to get through your questions. If we don't get to everybody, oh, Justin and his team will be around this evening to answer any questions, but let's try and click through these ones we can quickly, Julia.

Bob Bradway: Thank you. So Julianne, we're pushing up to the point at bottom of the hour here, but we still have a few questions in the queue. So we'll take a couple more and try to get through your questions. If we don't get to everybody, oh, Justin and his team will be around this evening to answer any questions, but let's try and click through these ones we can quickly, Julia.

Operator: Certainly. Thank you, Kripa. Our next question comes from Michael Schmidt from Guggenheim Partners. Please go ahead. Your line is open.

Murdo Gordon: Hey guys, thanks for taking my question.

Michael Schmidt: Hey guys, thanks for taking my question.

James Bradner: I had one on Blincito, which has recently gained some commercial momentum recently, and there was some interesting academic data reported last week in Nature Medicine showing some activity in RA, and so obvious.

I had one on Blincito, which has recently gained some commercial momentum recently, and there was some interesting academic data reported last week in Nature Medicine showing some activity in RA, and so obvious.

Murdo Gordon: Just wondering if you have any plans.

Just wondering if you have any plans.

James Bradner: Or how you're thinking about potentially developing glynsites or maybe other BiTEs in autoimmune diseases?

Or how you're thinking about potentially developing glynsites or maybe other BiTEs in autoimmune diseases?

Murdo Gordon: Thanks so much.

Thanks so much.

Robert Bradway: Sorry. In autoimmune disorders.

Bob Bradway: Sorry. In autoimmune disorders.

Peter Griffith: Yes.

Michael Schmidt: Yes.

James Bradner: Yeah, thanks for your question. You know, with very deep expertise here in CD19 directed therapeutics, with deep and committed expertise in inflammation autoimmunity, we've been following this space very closely. The early suggestive evidence from CAR T cell therapy and, more recently, this work that's been reported in systemic sclerosis. And as you noted, six patients with quite refractory rheumatoid arthritis is very exciting to see. So you can imagine that we're well organized around this opportunity and we found that work quite inspiring and we'll have more to report in the future. Julianne, I think we've got time for one more question.

Jay Bradner: Yeah, thanks for your question. You know, with very deep expertise here in CD19 directed therapeutics, with deep and committed expertise in inflammation autoimmunity, we've been following this space very closely. The early suggestive evidence from CAR T cell therapy and, more recently, this work that's been reported in systemic sclerosis. And as you noted, six patients with quite refractory rheumatoid arthritis is very exciting to see. So you can imagine that we're well organized around this opportunity and we found that work quite inspiring and we'll have more to report in the future.

Justin Claeys: Julianne, I think we've got time for one more question.

Operator: Thank you, Michael. Our last question will come from Gary Nachman, from Raymond James, please.

Vikram Karnani: Go ahead.

Go ahead.Your line is open.

Operator: Your line is open.

James Bradner: Great.

Gary Nachman: Great.

Robert Bradway: Thanks and good afternoon.

Thanks and good afternoon. So back to MariTide. Have to finish with that.

James Bradner: So back to MariTide.

Murdo Gordon: Have to finish with that.

James Bradner: As you're planning for the phase 3 studies, do you have a sense of?

As you're planning for the phase 3 studies, do you have a sense of?

Murdo Gordon: When could you start those, how big?

When could you start those, how big?

James Bradner: Those might be, and anything about design.

Those might be, and anything about design.

Murdo Gordon: Overall timing relative to other phase.

Overall timing relative to other phase.

James Bradner: Three studies in the space and any strategies you have to accelerate those studies as quickly as possible and how you'll incorporate both US and ex-US in the program? Thank you.

Three studies in the space and any strategies you have to accelerate those studies as quickly as possible and how you'll incorporate both US and ex-US in the program? Thank you.

Robert Bradway: So, Gary, again, we appreciate it and can understand why you'd be asking those questions. As I said in my remarks, we will do our level best now to successfully complete the phase 2 study and then work swiftly with regulators to agree the program that establishes safety and efficacy in phase 3. And we'll do that as swiftly as we can. We recognize there's a huge unmet need still in the marketplace and we believe we have an asset that can help address that. But, Jay, I don't know whether you feel you can say anything more specific, but jump in if you do.

Bob Bradway: So, Gary, again, we appreciate it and can understand why you'd be asking those questions. As I said in my remarks, we will do our level best now to successfully complete the phase 2 study and then work swiftly with regulators to agree the program that establishes safety and efficacy in phase 3. And we'll do that as swiftly as we can. We recognize there's a huge unmet need still in the marketplace and we believe we have an asset that can help address that. But, Jay, I don't know whether you feel you can say anything more specific, but jump in if you do.

James Bradner: Yeah, I'd say the same, Bob. Gary, as you know, this is one part collecting the data that regulators rightly expect, and ongoing conversations around the design. This study is moving as rapidly as possible within this program, is moving as rapidly as possible within the organization. You can rest assured.

Jay Bradner: Yeah, I'd say the same, Bob. Gary, as you know, this is one part collecting the data that regulators rightly expect, and ongoing conversations around the design. This study is moving as rapidly as possible within this program, is moving as rapidly as possible within the organization. You can rest assured.

Robert Bradway: Okay. Well, again, let me thank you all for joining the call and reiterate that Justin and his team will be around if you have any further questions. We look forward to having an opportunity to talk to you in the summer after the Q2 and provide update on the flow of information that we expect to generate between now and then on the many programs that we've referred to on the call, so thank you for your interest. Appreciate.

Bob Bradway: Okay. Well, again, let me thank you all for joining the call and reiterate that Justin and his team will be around if you have any further questions. We look forward to having an opportunity to talk to you in the summer after the Q2 and provide update on the flow of information that we expect to generate between now and then on the many programs that we've referred to on the call, so thank you for your interest. Appreciate.

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