Q3 2023 Merck & Co Inc Earnings Call

October 26, 2023

Julie Louise Gerberding: Thank you for standing by Welcome to the Merck and company Q3 sales and earnings conference call at this time, all participants are in a listen only mode until the question and answer session of today's conference, at that time to ask a question press star one on your phone and record your name at the prompt, this call is being recorded if you have any objections you may disconnect, at this time I will now turn the call over to Mr. Peter Dannenbaum, Vice President Investor Relations, Sir you may begin.

At that time to ask a question press star one on your phone and record your name at the prompt.

This call is being recorded if you have any objections you may disconnect. At this time I will now turn the call over to Mr. Peter Danon Mom, Vice President Investor Relations, Sir you may begin.

Operator: Thank you, Julie, and good morning, everyone. Welcome to Merck's Q3 2023 conference call. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Li, President of Merck Research Labs. Before we get started, I'd like to point out a few items. You will see that we have items in our GAAP results such as acquisition-related charges, restructuring costs, and certain other items. You should note that we have excluded these from our non-GAAP results and provide a reconciliation in our press release. I would like to remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the safe harbor provision of the US Private Securities Litigation Reform Act of 1995.

Peter Dannenbaum: Thank you, Julie, and good morning, everyone. Welcome to Merck's Q3 2023 conference call. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Li, President of Merck Research Labs. Before we get started, I'd like to point out a few items. You will see that we have items in our GAAP results such as acquisition-related charges, restructuring costs, and certain other items. You should note that we have excluded these from our non-GAAP results and provide a reconciliation in our press release.

Peter Dannenbaum: Thank you Julie and good morning, everyone. Welcome to Merck's third quarter 2023 conference call speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Lee President of Merck Research Labs. Before we get started I'd like to point out a few items you will see that we have items in our GAAP results such as acquisition related charges restructuring costs and certain other items you should note that we've excluded these from our non-GAAP results and provide a reconciliation in our press release.

Peter Dannenbaum: Before we get started I'd like to point out a few items, you will see that we have items in our GAAP results such as acquisition related charges, restructuring costs and certain other items you should note that we've excluded these from our non-GAAP results and provided reconciliation in our press release. I would like to remind you that some of the statements that we make today may be considered forward looking statements within the meaning of the safe Harbor provision of the U S. Private Securities Litigation Reform Act of 1995, such.

Before we get started I'd like to point out a few items you will see that we have items in our GAAP results such as acquisition related charges restructuring costs and certain other items you should note that we've excluded these from our non-GAAP results and provide a reconciliation in our press release.

Peter Dannenbaum: I would like to remind you that some of the statements that we make today may be considered forward looking statements within the meaning of the safe Harbor provision of the U.S. Private Securities Litigation Reform Act of 1995, such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward looking statements. Our SEC filings including item 1A and the 2022 10K, identified certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward looking statements made this morning. Merck undertakes no obligation of publicly update any forward looking statements, during today's call slide presentation, a couple of our speakers prepared remarks, these slides along with the earnings release, today's prepare remarks and our SEC filings are all posted to the investor relations section of Merck's website.

I would like to remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the safe harbor provision of the US Private Securities Litigation Reform Act of 1995.

I would like to remind you that some of the statements that we make today may be considered forward looking statements within the meaning of the safe Harbor provision of the U S. Private Securities Litigation Reform Act of 1995, such.

Operator: Such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A in the 2022 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck undertakes no obligation to publicly update any forward-looking statements. During today's call, slide presentation will accompany our speaker's prepared remarks. These slides, along with the earnings release, today's prepared remarks, and our SEC filings, are all posted to the Investor Relations section of Merck's website. With that, I'd like to turn the call over to Rob.

Such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A in the 2022 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck undertakes no obligation to publicly update any forward-looking statements.

Such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties.

If our underlying assumptions prove inaccurate or uncertainties materialize actual results may differ materially from those set forth in the forward looking statements.

Our SEC filings, including item one a in the 2022 10-K identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward looking statements made this morning, Merck undertakes no obligation to publicly update any forward looking statements during.

Peter Dannenbaum: Our SEC filings including item 1A and the 2022 10K, identified certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward looking statements made this morning. Merck undertakes no obligation of publicly update any forward looking statements, during today's call slide presentation, a couple of our speakers prepared remarks, these slides along with the earnings release, today's prepare remarks and our SEC filings are all posted to the investor relations section of Merck's website, with that I'd like to turn the call over to Rob.

During today's call, slide presentation will accompany our speaker's prepared remarks. These slides, along with the earnings release, today's prepared remarks, and our SEC filings, are all posted to the Investor Relations section of Merck's website. With that, I'd like to turn the call over to Rob.

During today's call slide presentation will accompany our speaker's prepared remarks. These slides along with the earnings release, today's prepared remarks, and our SEC filings or all posted to the Investor Relations section of Merck's website.

With that I'd like to turn the call over to Rob.

Chris Shibutani: Thanks, Peter. Good morning, and thank you for joining today's call. We continue to bring forward innovation that can save and improve the lives of patients and animals around the world. We're advancing our broad pipeline and executing in support of our key growth drivers, enabling strong progress for our business and providing tangible benefits to patients. To that end, I want to acknowledge the efforts of our talented global team. Their passion and commitment to our science-led strategy are fundamental to our continued success. Scientific innovation is truly the foundation of our strategy, and it drives everything we do. We're pushing the boundaries of science through the significant investments we're making across our deep pipeline, augmented by strategic business development. I'm pleased by the continued progress with these programs and our growing diversity across new therapeutic areas and modalities.

Rob Davis: Thanks, Peter. Good morning, and thank you for joining today's call. We continue to bring forward innovation that can save and improve the lives of patients and animals around the world. We're advancing our broad pipeline and executing in support of our key growth drivers, enabling strong progress for our business and providing tangible benefits to patients. To that end, I want to acknowledge the efforts of our talented global team. Their passion and commitment to our science-led strategy are fundamental to our continued success. Scientific innovation is truly the foundation of our strategy, and it drives everything we do.

Rob Davis: Thanks Peter, Good morning, and thank you for joining today's call, We continue to bring forward innovation that can save and improve the lives of patients and animals around the world, we're advancing our broad pipeline and executing in support of our key growth drivers, enabling strong progress for our business and providing tangible benefits to patients, to that end I want to acknowledge the efforts of our talented global team, their passion and commitment to our science led strategy are fundamental to our continued success. Scientific innovation is truly the foundation of our strategy and it drives everything we do. We're pushing the boundaries of science through the significant investments, we're making across our deep pipeline augmented by strategic business development. I am pleased by the continued progress with these programs and our growing diversity across new therapeutic areas and modalities. Along these lines, we're particularly excited by our recently announced clinical and commercial collaboration with Daiichi Sankyo for three potentially first in class antibody drug conjugates. The scientists the Daiichi sankyo are proven innovators in this space, having developed proprietary ADC technology that has resulted in an approved product, which is being rapidly adopted for patients with certain cancers. We're privileged to begin working alongside them to advance this important science and achieve both company's objectives of addressing the significant unmet patient need in oncology. Based on our strong conviction in these programs and the profound benefit they may bring to patients. We believe each has multibillion dollar commercial revenue potential for mark on the non risk adjusted basis approaching the mid twenties thirties. We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development.

We continue to bring forward innovation that can save and improve the lives of patients and animals around the world.

We're advancing our broad pipeline and executing in support of our key growth drivers, enabling strong progress for our business and providing tangible benefits to patients to that end I want to acknowledge the efforts of our talented global team their passion and commitment to our science led strategy are fundamental to our continued success.

Scientific innovation is truly the foundation of our strategy and it drives everything we do.

Rob Davis: Scientific innovation is truly the foundation of our strategy and it drives everything we do, We're pushing the boundaries of science through the significant investments we're making across our deep pipeline, augmented by strategic business development, I am pleased by the continued progress with these programs and our growing diversity across new therapeutic areas and modalities. Along these lines, we're particularly excited by our recently announced clinical and commercial collaboration with Daiichi Sankyo for three potentially first in class antibody drug conjugates. The scientists the Daiichi sankyo are proven innovators in this space, having developed proprietary ADC technology that has resulted in an approved product, which is being rapidly adopted for patients with certain cancers. We're privileged to begin working alongside them to advance this important science and achieve both company's objectives of addressing the significant unmet patient need in oncology. Based on our strong conviction in these programs and the profound benefit they may bring to patients. We believe each has multibillion dollar commercial revenue potential for mark on the non risk adjusted basis approaching the mid twenties thirties. We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development.

We're pushing the boundaries of science through the significant investments we're making across our deep pipeline, augmented by strategic business development. I'm pleased by the continued progress with these programs and our growing diversity across new therapeutic areas and modalities.

We're pushing the boundaries of science through the significant investments, we're making across our deep pipeline augmented by strategic business development.

I am pleased by the continued progress with these programs and our growing diversity across new therapeutic areas and modalities.

Chris Shibutani: Along these lines, we're particularly excited by our recently announced clinical and commercial collaboration with Daiichi Sankyo for three potentially first-in-class antibody-drug conjugates. The scientists at Daiichi Sankyo are proven innovators in this space, having developed proprietary ADC technology that has resulted in an approved product which is being rapidly adopted for patients with certain cancers. We're privileged to begin working alongside them to advance this important science and achieve both companies' objectives of addressing the significant unmet patient need in oncology. Based on our strong conviction in these programs and the profound benefit they may bring to patients, we believe each has multi-billion-dollar commercial revenue potential for Merck on a non-risk-adjusted basis approaching the mid-2030s.

Along these lines, we're particularly excited by our recently announced clinical and commercial collaboration with Daiichi Sankyo for three potentially first-in-class antibody-drug conjugates. The scientists at Daiichi Sankyo are proven innovators in this space, having developed proprietary ADC technology that has resulted in an approved product which is being rapidly adopted for patients with certain cancers. We're privileged to begin working alongside them to advance this important science and achieve both companies' objectives of addressing the significant unmet patient need in oncology.

Along these lines, we're particularly excited by our recently announced clinical and commercial collaboration with Daiichi Sankyo for three potentially first in class antibody drug conjugates.

Rob Davis: Along these lines, we're particularly excited by our recently announced clinical and commercial collaboration with Daiichi Sankyo for three potentially first in class antibody drug conjugates, the scientists the Daiichi Sankyo are proven innovators in this space, having developed proprietary ADC technology that has resulted in an approved product, which is being rapidly adopted for patients with certain cancers, We're privileged to begin working alongside them to advance this important science and achieve both company's objectives of addressing the significant unmet patient need in oncology. Based on our strong conviction in these programs and the profound benefit they may bring to patients. We believe each has multibillion dollar commercial revenue potential for mark on the non risk adjusted basis approaching the mid twenties thirties. We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development.

The scientists the Daiichi sankyo are proven innovators in this space, having developed proprietary ADC technology that has resulted in an approved product, which is being rapidly adopted for patients with certain cancers.

We're privileged to begin working alongside them to advance this important science and achieve both company's objectives of addressing the significant unmet patient need in oncology.

Rob Davis: We're privileged to begin working alongside them to advance this important science and achieve both company's objectives of addressing the significant unmet patient need in oncology, based on our strong conviction in these programs and the profound benefit they may bring to patients, We believe each has multibillion dollar commercial revenue potential for Merk on the non risk adjusted basis approaching the mid twenty-thirties. We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development.

Rob Davis: We're privileged to begin working alongside them to advance this important science and achieve both company's objectives of addressing the significant unmet patient need in oncology, based on our strong conviction in these programs and the profound benefit they may bring to patients, We believe each has multibillion dollar commercial revenue potential for Merck on the non risk adjusted basis approaching the mid twenty-thirties.

Based on our strong conviction in these programs and the profound benefit they may bring to patients, we believe each has multi-billion-dollar commercial revenue potential for Merck on a non-risk-adjusted basis approaching the mid-2030s.

Based on our strong conviction in these programs and the profound benefit they may bring to patients.

We believe each has multibillion dollar commercial revenue potential for mark on the non risk adjusted basis approaching the mid twenties thirties.

Chris Shibutani: We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development, such as Sotatercept for pulmonary arterial hypertension and MK-7240, our TL1A inhibitor for ulcerative colitis and Crohn's disease. This is complemented by our strong commercial execution capabilities, which we expect to amplify the impact of these life-changing medicines and enable the creation of sustainable value for patients and shareholders over the long term. Turning to this quarter's performance, we delivered robust growth driven by demand for our innovative portfolio. We're confident that we will close out 2023 with continued strong performance, which is reflected in the updated full-year outlook that Caroline will speak to in a few minutes. Moving to our research organization, as I mentioned, we're making remarkable progress across multiple therapeutic areas in our promising late-phase pipeline.

We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development, such as Sotatercept for pulmonary arterial hypertension and MK-7240, our TL1A inhibitor for ulcerative colitis and Crohn's disease. This is complemented by our strong commercial execution capabilities, which we expect to amplify the impact of these life-changing medicines and enable the creation of sustainable value for patients and shareholders over the long term. Turning to this quarter's performance, we delivered robust growth driven by demand for our innovative portfolio.

We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development.

Rob Davis: We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development such as Sotatercept for pulmonary arterial hypertension and MK-7240, our TL1A inhibitor for ulcerative colitis and Crohn's disease. This is complemented by our strong commercial execution capabilities, which we expect to amplify the impact of these life changing medicines and enable the creation of sustainable value for patients and shareholders over the long term. Turning to this quarter's performance. We delivered robust growth driven by demand for our innovative portfolio. We're confident that we will close out 2023 with continued strong performance, which is reflected in the updated full year outlook that Caroline will speak to in a few minutes. Moving to our research organization as I mentioned, we're making remarkable progress across multiple therapeutic areas and a promising late phase pipeline. And oncology Dean will speak to the significant success, we're having in broadly leveraging the foundational position that we've achieved with keytruda. This includes the continued advancements we're making in the treatment of early stage cancers. We're very excited by the recent FDA approval of a contributor regimen for the neo adjuvant and adjuvant treatment of certain patients with resectable and non small cell lung cancer based on the keynote 671 trial results, which notably demonstrated an improvement in overall survival compared to placebo and chemotherapy regimens. In addition, we presented numerous important datasets at last week's European Society for medical oncology meetings across a wide range of molecules tumor types and indications. Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardio metabolic pipeline. Most significantly the FDA accepted for priority review, our filing for <unk> based on the unprecedented results of the stellar trial and we look forward to the potential approval and launch in early 2024. We remain confident that so tired receptor has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension.

Just a cat or sept for pulmonary arterial hypertension.

And N K 70, 240, <unk> inhibitor for ulcerative colitis and Crohn's disease.

Rob Davis: This is complemented by our strong commercial execution capabilities, which we expect to amplify the impact of these life changing medicines and enable the creation of sustainable value for patients and shareholders over the long term. Turning to this quarter's performance. We delivered robust growth driven by demand for our innovative portfolio. We're confident that we will close out 2023 with continued strong performance, which is reflected in the updated full year outlook that Caroline will speak to in a few minutes. Moving to our research organization as I mentioned, we're making remarkable progress across multiple therapeutic areas and a promising late phase pipeline. And oncology Dean will speak to the significant success, we're having in broadly leveraging the foundational position that we've achieved with keytruda. This includes the continued advancements we're making in the treatment of early stage cancers. We're very excited by the recent FDA approval of a contributor regimen for the neo adjuvant and adjuvant treatment of certain patients with resectable and non small cell lung cancer based on the keynote 671 trial results, which notably demonstrated an improvement in overall survival compared to placebo and chemotherapy regimens. In addition, we presented numerous important datasets at last week's European Society for medical oncology meetings across a wide range of molecules tumor types and indications. Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardio metabolic pipeline. Most significantly the FDA accepted for priority review, our filing for <unk> based on the unprecedented results of the stellar trial and we look forward to the potential approval and launch in early 2024. We remain confident that so tired receptor has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension.

This is complemented by our strong commercial execution capabilities, which we expect to amplify the impact of these life changing medicines and enable the creation of sustainable value for patients and shareholders over the long term.

Rob Davis: Turning to this quarter's performance, We delivered robust growth driven by demand for our innovative portfolio, We're confident that we will close out 2023 with continued strong performance, which is reflected in the updated full year outlook that Caroline will speak to in a few minutes. Moving to our research organization as I mentioned, we're making remarkable progress across multiple therapeutic areas and a promising late phase pipeline. And oncology Dean will speak to the significant success, we're having in broadly leveraging the foundational position that we've achieved with keytruda. This includes the continued advancements we're making in the treatment of early stage cancers. We're very excited by the recent FDA approval of a contributor regimen for the neo adjuvant and adjuvant treatment of certain patients with resectable and non small cell lung cancer based on the keynote 671 trial results, which notably demonstrated an improvement in overall survival compared to placebo and chemotherapy regimens. In addition, we presented numerous important datasets at last week's European Society for medical oncology meetings across a wide range of molecules tumor types and indications. Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardio metabolic pipeline. Most significantly the FDA accepted for priority review, our filing for <unk> based on the unprecedented results of the stellar trial and we look forward to the potential approval and launch in early 2024. We remain confident that so tired receptor has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension.

Turning to this quarter's performance.

We delivered robust growth driven by demand for our innovative portfolio.

We're confident that we will close out 2023 with continued strong performance, which is reflected in the updated full-year outlook that Caroline will speak to in a few minutes. Moving to our research organization, as I mentioned, we're making remarkable progress across multiple therapeutic areas in our promising late-phase pipeline.

We're confident that we will close out 2023 with continued strong performance, which is reflected in the updated full year outlook that Caroline will speak to in a few minutes.

Rob Davis: Moving to our research organization as I mentioned, we're making remarkable progress across multiple therapeutic areas and our promising late phase pipeline, in oncology Dean will speak to the significant success we're having in broadly leveraging the foundational position that we've achieved with Keytruda, this includes the continued advancements we're making in the treatment of early stage cancers. We're very excited by the recent FDA approval of a contributor regimen for the neo adjuvant and adjuvant treatment of certain patients with resectable and not small cell lung cancer based on the keynote 671 trial results, which notably demonstrated an improvement in overall survival compared to placebo and chemotherapy regimens. In addition, we presented numerous important datasets at last week's European Society for medical oncology meetings across a wide range of molecules tumor types and indications. Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardio metabolic pipeline. Most significantly the FDA accepted for priority review, our filing for <unk> based on the unprecedented results of the stellar trial and we look forward to the potential approval and launch in early 2024. We remain confident that so tired receptor has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension.

Moving to our research organization as I mentioned, we're making remarkable progress across multiple therapeutic areas and a promising late phase pipeline.

Chris Shibutani: In oncology, Dean will speak to the significant success we're having in broadly leveraging the foundational position that we've achieved with Keytruda. This includes the continued advancements we're making in the treatment of early-stage cancers. We're very excited by the recent FDA approval of a Keytruda regimen for the neoadjuvant and adjuvant treatment of certain patients with resectable non-small cell lung cancer based on the KEYNOTE-671 trial results, which notably demonstrated an improvement in overall survival compared to a placebo and chemotherapy regimen. In addition, we presented numerous important data sets at last week's European Society for Medical Oncology meeting across a wide range of molecules, tumor types, and indications. Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardiometabolic pipeline.

In oncology, Dean will speak to the significant success we're having in broadly leveraging the foundational position that we've achieved with Keytruda. This includes the continued advancements we're making in the treatment of early-stage cancers. We're very excited by the recent FDA approval of a Keytruda regimen for the neoadjuvant and adjuvant treatment of certain patients with resectable non-small cell lung cancer based on the KEYNOTE-671 trial results, which notably demonstrated an improvement in overall survival compared to a placebo and chemotherapy regimen.

And oncology Dean will speak to the significant success, we're having in broadly leveraging the foundational position that we've achieved with keytruda.

This includes the continued advancements we're making in the treatment of early stage cancers.

Rob Davis: We're very excited by the recent FDA approval of a Keytruda regimen for the neoadjuvant and adjuvant treatment of certain patients with resectable not small cell lung cancer based on the keynote 671 trial results, which notably demonstrated an improvement in overall survival compared to placebo and chemotherapy regimens. In addition, we presented numerous important datasets at last week's European Society for medical oncology meetings across a wide range of molecules tumor types and indications. Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardio metabolic pipeline. Most significantly the FDA accepted for priority review, our filing for <unk> based on the unprecedented results of the stellar trial and we look forward to the potential approval and launch in early 2024. We remain confident that so tired receptor has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension.

We're very excited by the recent FDA approval of a contributor regimen for the neo adjuvant and adjuvant treatment of certain patients with resectable and non small cell lung cancer based on the keynote 671 trial results, which notably demonstrated an improvement in overall survival compared to placebo and chemotherapy regimens.

In addition, we presented numerous important data sets at last week's European Society for Medical Oncology meeting across a wide range of molecules, tumor types, and indications. Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardiometabolic pipeline.

Rob Davis: In addition, we presented numerous important datasets at last week's European Society for medical oncology meetings across a wide range of molecules, tumor types and indications, our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardio metabolic pipeline. Most significantly the FDA accepted for priority review, our filing for <unk> based on the unprecedented results of the stellar trial and we look forward to the potential approval and launch in early 2024. We remain confident that so tired receptor has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension.

In addition, we presented numerous important datasets at last week's European Society for medical oncology meetings across a wide range of molecules tumor types and indications.

Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade.

Rob Davis: We're also making exciting progress in our cardio metabolic pipeline, most significantly the FDA accepted for priority review, our filing for Sotatercept based on the unprecedented results of the STELLAR trial and we look forward to the potential approval and launch in early 2024, we remain confident that Sotatercept has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension. We also initiated phase III clinical trials for all P. C. S canine candidates M K 0616.

We're also making exciting progress in our cardio metabolic pipeline.

Chris Shibutani: Most significantly, the FDA accepted priority review of our filing for sotatercept based on the unprecedented results of the STELLAR trial, and we look forward to the potential approval and launch in early 2024. We remain confident that sotatercept has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension. We also initiated phase 3 clinical trials for our oral PCSK9 candidate, MK-0616. We believe MK-0616 has the potential to provide significant benefit to patients with elevated cholesterol and impact cardiovascular disease on a global scale. We're very pleased with our progress and what we've achieved this quarter as we continue to focus on advancing and expanding Merck's pipeline, and I want to thank Dean and his team for their unwavering commitment to addressing unmet patient needs.

Most significantly, the FDA accepted priority review of our filing for sotatercept based on the unprecedented results of the STELLAR trial, and we look forward to the potential approval and launch in early 2024. We remain confident that sotatercept has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension. We also initiated phase 3 clinical trials for our oral PCSK9 candidate, MK-0616. We believe MK-0616 has the potential to provide significant benefit to patients with elevated cholesterol and impact cardiovascular disease on a global scale.

Most significantly the FDA accepted for priority review, our filing for <unk> based on the unprecedented results of the stellar trial and we look forward to the potential approval and launch in early 2024.

We remain confident that so tired receptor has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension.

Rob Davis: We also initiated Phase III clinical trials for all PCSK9 candidates MK-0616, We believe MK-0616 has the potential to provide significant benefit to patients with elevated cholesterol and impact cardiovascular disease on a global scale, we're very pleased with our progress and what we've achieved this quarter as we continue to focus on advancing and expanding Merck's pipeline and I want to thank Dean and his team for their unwavering commitment to addressing unmet patient needs. In summary, we continue to move with urgency to deliver on our purpose pursuing transformative science to save and improve lives around the world. We're executing scientifically commercially and operationally on the significant opportunities now in front of US while also making the disciplined investments needed to sustain strong growth well into the future. With the efforts of our global team, we've increased confidence that we will deliver value to patients shareholders and to all of our stakeholders with that I'll turn the call over to Caroline. Thank you Rob good morning. As Rob highlighted we achieved very strong growth this quarter driven by robust underlying demand across our innovative portfolio and we remain confident in our ability to continue to deliver strong results in the near term. We are also making disciplined investments to leverage leading edge science to save and improve lives around the world well into the future. Turning off to deliver long term value for patients and shareholders. Now turning to our third quarter results. Total company revenues were $16 billion, excluding the impacts from the guests and foreign exchange the business delivered strong growth of 8%. The remainder of my revenue comments will be on an ex exchange basis. Our human health business sustained its strong momentum excluding legal growth was 10% driven by oncology and vaccines. Sales in our animal health business increased 2%. Turning to the performance of our key brands. In oncology sales of Keytruda grew 17% to $6 3 billion. And by increased uptake from early stage cancers, and continued strong global demand for metastatic indications.

We also initiated phase III clinical trials for all P. C. S canine candidates M K 0616.

We believe NK 0616 has the potential to provide significant benefit to patients with elevated cholesterol and impact cardiovascular disease on a global scale.

We're very pleased with our progress and what we've achieved this quarter as we continue to focus on advancing and expanding Merck's pipeline, and I want to thank Dean and his team for their unwavering commitment to addressing unmet patient needs.

We're very pleased with our progress and what we've achieved this quarter as we continue to focus on advancing and expanding merck's pipeline.

Want to thank Dean and his team for their unwavering commitment to addressing unmet patient needs.

Chris Shibutani: In summary, we continue to move with urgency to deliver on our purpose, pursuing transformative science to save and improve lives around the world. We're executing scientifically, commercially, and operationally on the significant opportunities now in front of us while also making the disciplined investments needed to sustain strong growth well into the future. With the efforts of our global team, we've increased confidence that we will deliver value to patients, shareholders, and to all of our stakeholders. With that, I'll turn the call over to Caroline.

In summary, we continue to move with urgency to deliver on our purpose, pursuing transformative science to save and improve lives around the world. We're executing scientifically, commercially, and operationally on the significant opportunities now in front of us while also making the disciplined investments needed to sustain strong growth well into the future. With the efforts of our global team, we've increased confidence that we will deliver value to patients, shareholders, and to all of our stakeholders. With that, I'll turn the call over to Caroline.

In summary, we continue to move with urgency to deliver on our purpose pursuing transformative science to save and improve lives around the world.

Rob Davis: In summary, we continue to move with urgency to deliver on our purpose, pursuing transformative science to save and improve lives around the world, We're executing scientifically commercially and operationally on the significant opportunities now in front of us while also making the disciplined investments needed to sustain strong growth well into the future. With the efforts of our global team, we've increased confidence that we will deliver value to patients shareholders and to all of our stakeholders with that I'll turn the call over to Caroline. Thank you Rob good morning. As Rob highlighted we achieved very strong growth this quarter driven by robust underlying demand across our innovative portfolio and we remain confident in our ability to continue to deliver strong results in the near term. We are also making disciplined investments to leverage leading edge science to save and improve lives around the world well into the future. Turning off to deliver long term value for patients and shareholders. Now turning to our third quarter results. Total company revenues were $16 billion, excluding the impacts from the guests and foreign exchange the business delivered strong growth of 8%. The remainder of my revenue comments will be on an ex exchange basis. Our human health business sustained its strong momentum excluding legal growth was 10% driven by oncology and vaccines. Sales in our animal health business increased 2%. Turning to the performance of our key brands. In oncology sales of Keytruda grew 17% to $6 3 billion. And by increased uptake from early stage cancers, and continued strong global demand for metastatic indications.

We're executing scientifically commercially and operationally on the significant opportunities now in front of US while also making the disciplined investments needed to sustain strong growth well into the future.

With the efforts of our global team, we've increased confidence that we will deliver value to patients shareholders and to all of our stakeholders with that I'll turn the call over to Caroline.

Caroline Litchfield: Thank you, Rob. Good morning. As Rob highlighted, we achieved very strong growth this quarter driven by robust underlying demand across our innovative portfolio, and we remain confident in our ability to continue to deliver strong results in the near term. We are also making disciplined investments to leverage leading-edge science to save and improve lives around the world well into the future, positioning us to deliver long-term value for patients and shareholders. Now, turning to our Q3 results, total company revenues were $16 billion. Excluding the impact from Lagevrio and foreign exchange, the business delivered strong growth of 8%. The remainder of my revenue comments will be on an ex-exchange basis. Our human health business sustained its strong momentum. Excluding Lagevrio, growth was 10% driven by oncology and vaccines. Sales in our animal health business increased 2%.

Thank you Rob good morning.

As Rob highlighted we achieved very strong growth this quarter driven by robust underlying demand across our innovative portfolio and we remain confident in our ability to continue to deliver strong results in the near term.

Caroline Litchfield: Thank you Rob, good morning, as Rob highlighted we achieved very strong growth this quarter driven by robust underlying demand across our innovative portfolio and we remain confident in our ability to continue to deliver strong results in the near term, We are also making disciplined investments to leverage leading edge science to save and improve lives around the world well into the future, positioning us to deliver long term value for patients and shareholders. Now turning to our third quarter results. Total company revenues were $16 billion, excluding the impacts from the guests and foreign exchange the business delivered strong growth of 8%. The remainder of my revenue comments will be on an ex exchange basis. Our human health business sustained its strong momentum excluding legal growth was 10% driven by oncology and vaccines. Sales in our animal health business increased 2%. Turning to the performance of our key brands. In oncology sales of Keytruda grew 17% to $6 3 billion. And by increased uptake from early stage cancers, and continued strong global demand for metastatic indications.

We are also making disciplined investments to leverage leading edge science to save and improve lives around the world well into the future.

Turning off to deliver long term value for patients and shareholders.

Now turning to our third quarter results.

Total company revenues were $16 billion, excluding the impacts from the guests and foreign exchange the business delivered strong growth of 8%.

Caroline Litchfield: Now turning to our third quarter results. Total company revenues were $16 billion dollars, excluding the impacts from Lagevrio and foreign exchange, the business delivered strong growth of 8%, the remainder of my revenue comments will be on an ex exchange basis, our human health business sustained its strong momentum excluding Lagevrio, growth was 10% driven by oncology and vaccines, sales in our animal health business increased 2%. Turning to the performance of our key brands. In oncology sales of Keytruda grew 17% to $6 3 billion. And by increased uptake from early stage cancers, and continued strong global demand for metastatic indications.

Caroline Litchfield: The remainder of my revenue comments will be on an ex-exchange basis. Our human health business sustained its strong momentum. Excluding Lagevrio, growth was 10% driven by oncology and vaccines. Sales in our animal health business increased 2%.

The remainder of my revenue comments will be on an ex exchange basis.

Our human health business sustained its strong momentum excluding legal growth was 10% driven by oncology and vaccines.

Sales in our animal health business increased 2%.

Caroline Litchfield: Turning to the performance of our key brands, in oncology, sales of Keytruda grew 17% to $6.3 billion, driven by increased uptake from earlier stage cancers and continued strong global demand for metastatic indications. In the US, Keytruda growth was driven by increased utilization in both metastatic indications and earlier stage cancers, such as triple-negative breast cancer. Uptake in earlier stages of non-small cell lung cancer remains strong, and Keytruda has now achieved brand leadership in this setting, reflecting the significant impact it is having as adjuvant treatment for patients with stage 1B to 3A disease. Our recently approved KEYNOTE-671 indication provides an important additional treatment option to patients and physicians by including usage in the neoadjuvant and adjuvant setting. We remain exceptionally well-positioned to serve patients with non-small cell lung cancer and extend our leadership to the earlier stage setting.

Turning to the performance of our key brands, in oncology, sales of Keytruda grew 17% to $6.3 billion, driven by increased uptake from earlier stage cancers and continued strong global demand for metastatic indications. In the US, Keytruda growth was driven by increased utilization in both metastatic indications and earlier stage cancers, such as triple-negative breast cancer. Uptake in earlier stages of non-small cell lung cancer remains strong, and Keytruda has now achieved brand leadership in this setting, reflecting the significant impact it is having as adjuvant treatment for patients with stage 1B to 3A disease.

Turning to the performance of our key brands.

Caroline Litchfield: Turning to the performance of our key brands, in oncology sales of Keytruda grew 17% to $6.3 billion dollars, driven by increased uptake from early stage cancers, and continued strong global demand for metastatic indications, in the U.S. Keytruda growth was driven by increased utilization in both metastatic indication and early stage cancers, such as triple negative breast cancer, Uptake in earlier stages of non small cell lung cancer remains strong and Keytruda has now achieved brand leadership in this setting, reflecting the significant impact it is having as adjuvant treatment for patients with stage 1B to three A,B,C. Our recently approved keynote 671 indication provides an important additional treatment options for patients and physicians by including usage in the neo adjuvant and adjuvant setting. We remain exceptionally well positioned to serve patients with non small cell lung cancer and extend our leadership to be earlier stage setting. In bladder cancer, we are excited to potentially expand usage of keytruda. Latin eligible patients based on the compelling results from the keynote 839 study. If approved this study with more than double the eligible patient population for Keytruda in first line bladder cancer. Outside the U S. Keytruda growth was driven by uptake in earlier stage cancers, including high risk early stage triple negative breast cancer, and renal cell carcinoma, as well as increased demand in metastatic renal cell carcinoma, and certain types of head and neck cancer. <unk> remains the market, leading PARP inhibitor with alliance revenue growing 6% this quarter. Then FEMA alliance revenues had growth of 30% driven by shipment timings in China, which we expect will negatively impact growth in the fourth quarter. Growth was also driven by increased demand for the treatment of certain patients with advanced renal cell carcinoma, and endometrial cancer in the U S. Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2 $6 billion driven by underlying global demand, particularly in China. In the U S gardasil sales decreased due to CDC purchasing patterns. Vaccine sales also benefited from continued uptake in the pediatric indication effects me thoughts in the U S and its launch in key European markets.

In oncology sales of Keytruda grew 17% to $6 3 billion.

And by increased uptake from early stage cancers, and continued strong global demand for metastatic indications.

In the U S. Keytruda growth was driven by increased utilization in both metastatic indication and early stage cancers, such as triple negative breast cancer.

Uptake in earlier stages of non small cell lung cancer remains strong and Keytruda has now achieved brand leadership in this setting reflecting the significant impact it is having as adjuvant treatment for patients with stage one to three a disease.

Our recently approved KEYNOTE-671 indication provides an important additional treatment option to patients and physicians by including usage in the neoadjuvant and adjuvant setting. We remain exceptionally well-positioned to serve patients with non-small cell lung cancer and extend our leadership to the earlier stage setting.

Our recently approved keynote 671 indication provides an important additional treatment options for patients and physicians by including usage in the neo adjuvant and adjuvant setting.

Caroline Litchfield: Our recently approved keynote 671 indication provides an important additional treatment options for patients and physicians by including usage in the neoadjuvant and adjuvant setting, We remain exceptionally well positioned to serve patients with non small cell lung cancer and extend our leadership to the earlier stage setting. In bladder cancer, we are excited to potentially expand usage of keytruda. Latin eligible patients based on the compelling results from the keynote 839 study. If approved this study with more than double the eligible patient population for Keytruda in first line bladder cancer. Outside the U S. Keytruda growth was driven by uptake in earlier stage cancers, including high risk early stage triple negative breast cancer, and renal cell carcinoma, as well as increased demand in metastatic renal cell carcinoma, and certain types of head and neck cancer. <unk> remains the market, leading PARP inhibitor with alliance revenue growing 6% this quarter. Then FEMA alliance revenues had growth of 30% driven by shipment timings in China, which we expect will negatively impact growth in the fourth quarter. Growth was also driven by increased demand for the treatment of certain patients with advanced renal cell carcinoma, and endometrial cancer in the U S. Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2 $6 billion driven by underlying global demand, particularly in China. In the U S gardasil sales decreased due to CDC purchasing patterns. Vaccine sales also benefited from continued uptake in the pediatric indication effects me thoughts in the U S and its launch in key European markets.

We remain exceptionally well positioned to serve patients with non small cell lung cancer and extend our leadership to be earlier stage setting.

Caroline Litchfield: In bladder cancer, we are excited to potentially expand usage of Keytruda to cisplatin-eligible patients based on the compelling results from the KEYNOTE-A39 study. If approved, this study would more than double the eligible patient population for Keytruda in first-line bladder cancer. Outside the US, Keytruda growth was driven by uptake in earlier stage cancers, including high-risk early-stage triple-negative breast cancer and renal cell carcinoma, as well as increased demand in metastatic renal cell carcinoma and certain types of head and neck cancer. Lynparza remains the market-leading PARP inhibitor, with Alliance revenue growing 6% this quarter. Lenvima Alliance revenue had growth of 30%, driven by shipment timings in China, which we expect will negatively impact growth in Q4. Growth was also driven by increased demand for the treatment of certain patients with advanced renal cell carcinoma and endometrial cancer in the US.

In bladder cancer, we are excited to potentially expand usage of Keytruda to cisplatin-eligible patients based on the compelling results from the KEYNOTE-A39 study. If approved, this study would more than double the eligible patient population for Keytruda in first-line bladder cancer. Outside the US, Keytruda growth was driven by uptake in earlier stage cancers, including high-risk early-stage triple-negative breast cancer and renal cell carcinoma, as well as increased demand in metastatic renal cell carcinoma and certain types of head and neck cancer. Lynparza remains the market-leading PARP inhibitor, with Alliance revenue growing 6% this quarter.

In bladder cancer, we are excited to potentially expand usage of keytruda.

Caroline Litchfield: In bladder cancer, we are excited to potentially expand usage of Keytruda to Latin eligible patients based on the compelling results from the keynote 839 study, if approved this study will more than double the eligible patient population for Keytruda in first line bladder cancer. Outside the U S. Keytruda growth was driven by uptake in earlier stage cancers, including high risk early stage triple negative breast cancer, and renal cell carcinoma, as well as increased demand in metastatic renal cell carcinoma, and certain types of head and neck cancer. <unk> remains the market, leading PARP inhibitor with alliance revenue growing 6% this quarter. Then FEMA alliance revenues had growth of 30% driven by shipment timings in China, which we expect will negatively impact growth in the fourth quarter. Growth was also driven by increased demand for the treatment of certain patients with advanced renal cell carcinoma, and endometrial cancer in the U S. Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2 $6 billion driven by underlying global demand, particularly in China. In the U S gardasil sales decreased due to CDC purchasing patterns. Vaccine sales also benefited from continued uptake in the pediatric indication effects me thoughts in the U S and its launch in key European markets.

Latin eligible patients based on the compelling results from the keynote 839 study.

If approved this study with more than double the eligible patient population for Keytruda in first line bladder cancer.

Outside the U S. Keytruda growth was driven by uptake in earlier stage cancers, including high risk early stage triple negative breast cancer, and renal cell carcinoma, as well as increased demand in metastatic renal cell carcinoma, and certain types of head and neck cancer.

Caroline Litchfield: Outside the U.S. Keytruda growth was driven by uptake in earlier stage cancers, including high risk, early stage triple negative breast cancer, and renal cell carcinoma, as well as increased demand in metastatic renal cell carcinoma, and certain types of head and neck cancer. Lynparza remains the market, leading PARP inhibitor with alliance revenue growing 6% this quarter. Then FEMA alliance revenues had growth of 30% driven by shipment timings in China, which we expect will negatively impact growth in the fourth quarter. Growth was also driven by increased demand for the treatment of certain patients with advanced renal cell carcinoma, and endometrial cancer in the U S. Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2 $6 billion driven by underlying global demand, particularly in China. In the U S gardasil sales decreased due to CDC purchasing patterns. Vaccine sales also benefited from continued uptake in the pediatric indication effects me thoughts in the U S and its launch in key European markets.

<unk> remains the market, leading PARP inhibitor with alliance revenue growing 6% this quarter.

Caroline Litchfield: Lynparza remains the market, leading PARP inhibitor with alliance revenue growing 6% this quarter. Lenvima alliance revenues have growth of 30% driven by shipment timings in China, which we expect will negatively impact growth in the fourth quarter. Growth was also driven by increased demand for the treatment of certain patients with advanced renal cell carcinoma, and endometrial cancer in the U.S. Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2 $6 billion driven by underlying global demand, particularly in China. In the U S gardasil sales decreased due to CDC purchasing patterns. Vaccine sales also benefited from continued uptake in the pediatric indication effects me thoughts in the U S and its launch in key European markets.

Lenvima Alliance revenue had growth of 30%, driven by shipment timings in China, which we expect will negatively impact growth in Q4. Growth was also driven by increased demand for the treatment of certain patients with advanced renal cell carcinoma and endometrial cancer in the US.

Then FEMA alliance revenues had growth of 30% driven by shipment timings in China, which we expect will negatively impact growth in the fourth quarter.

Growth was also driven by increased demand for the treatment of certain patients with advanced renal cell carcinoma, and endometrial cancer in the U S.

Caroline Litchfield: Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2.6 billion, driven by underlying global demand, particularly in China. In the US, Gardasil sales decreased due to CDC purchasing patterns. Vaccine sales also benefited from continued uptake in the pediatric indication of Vaxneuvance in the US and its launch in key European markets. In our hospital acute care portfolio, Bridion sales were flat as increased market share among neuromuscular blockade reversal agents in the US was offset by the impact of generic entry in Europe. Sales in our animal health business grew 2%. Livestock sales grew 7%, reflecting price actions as well as higher demand for ruminant products. Companion animal sales declined due to a reduction in vet visits in the US, partially offset by pricing actions.

Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2.6 billion, driven by underlying global demand, particularly in China. In the US, Gardasil sales decreased due to CDC purchasing patterns. Vaccine sales also benefited from continued uptake in the pediatric indication of Vaxneuvance in the US and its launch in key European markets. In our hospital acute care portfolio, Bridion sales were flat as increased market share among neuromuscular blockade reversal agents in the US was offset by the impact of generic entry in Europe.

Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2 $6 billion driven by underlying global demand, particularly in China.

Caroline Litchfield: Our vaccines portfolio delivered strong growth led by Gardasil, which increased 16% to $2.6 billion dollars, driven by underlying global demand particularly in China, in the U.S Gardasil sales decreased due to CDC purchasing patterns, vaccine sales also benefited from continued uptake in the pediatric indication of Vaxneuvance in the U.S. and its launch in key European markets. In our hospital acute care portfolio.

In the U S gardasil sales decreased due to CDC purchasing patterns.

Vaccine sales also benefited from continued uptake in the pediatric indication effects me thoughts in the U S and its launch in key European markets.

In our hospital acute care portfolio.

Caroline Litchfield: In our hospital acute care portfolio Bridion sales were flat, as increased market share among neuromuscular blockade reversal agents in the U.S. was offset by the impact of generic entry in Europe, sales in our animal health business grew 2%, Livestock sales grew 7%, reflecting price actions, as well as higher demand for ruminant products, companion animal sales declined due to a reduction in vet visits in the U.S. partially offset by pricing actions. I will now walk you through the remainder of our pans out and my comments will be on a non-GAAP basis. Gross margin was 77% consistent with last year as the impact from unfavorable foreign exchange was offset by product mix. Operating expenses decreased 4% to five $8 billion. There were no significant business development expenses in the quarter compared with $619 million of charges a year ago. Excluding these charges operating expenses grew 9%. This growth reflects increased investments in support of a robust early and late phase pipeline with research and development expenses increasing 17%. Other expense was $133 million. Our tax rate was 15%. Taken together our earnings per share were $2 13. Before I cover the outlook for the balance of the year I wanted to briefly touch upon the recently announced strategic collaboration with Daiichi Sankyo. This transaction follows a similar derisked and disciplined financial structure as we have employees in prior successful collaborations and we are very excited about the opportunity to create meaningful value for patients and shareholders. Now turning to our 2023 non-GAAP guidance, which includes the strategic collaboration with Daiichi. The continuing operational strength of our business has enabled us to raise and narrow our full year revenue guidance. We now expect revenue to be between $59, seven and $62 billion, an increase of approximately $900 million. <unk> point.

<unk> sales were flat as increased market share among neuromuscular blockade with vessel agents in the U S was offset by the impact of generic entry in Europe.

Sales in our animal health business grew 2%. Livestock sales grew 7%, reflecting price actions as well as higher demand for ruminant products. Companion animal sales declined due to a reduction in vet visits in the US, partially offset by pricing actions.

Sales in our animal health business grew 2%.

<unk> sales grew 7%, reflecting pricing actions as well as higher demand for ruminant products.

Companion animal sales declined due to a reduction in vet visits in the U S, partially offset by pricing actions.

Caroline Litchfield: I will now walk you through the remainder of our P&L, and my comments will be on a Non-GAAP basis. Gross margin was 77%, consistent with last year, as the impact from unfavorable foreign exchange was offset by product mix. Operating expenses decreased 4% to $5.8 billion. There were no significant business development expenses in the quarter compared with $690 million of charges a year ago. Excluding these charges, operating expenses grew 9%. This growth reflects increased investments in support of a robust early and late-phase pipeline, with research and development expenses increasing 17%. Other expense was $133 million. Our tax rate was 15%. Taken together, earnings per share were $2.13. Before I cover the outlook for the balance of the year, I wanted to briefly touch upon the recently announced strategic collaboration with Daiichi Sankyo.

I will now walk you through the remainder of our P&L, and my comments will be on a Non-GAAP basis. Gross margin was 77%, consistent with last year, as the impact from unfavorable foreign exchange was offset by product mix. Operating expenses decreased 4% to $5.8 billion. There were no significant business development expenses in the quarter compared with $690 million of charges a year ago. Excluding these charges, operating expenses grew 9%. This growth reflects increased investments in support of a robust early and late-phase pipeline, with research and development expenses increasing 17%.

I will now walk you through the remainder of our pans out and my comments will be on a non-GAAP basis.

Caroline Litchfield: I will now walk you through the remainder of our P&L and my comments will be on a non-GAAP basis, Gross margin was 77% consistent with last year as the impact from unfavorable foreign exchange was offset by product mix, operating expenses decreased 4% to $5.8 billion dollars, there were no significant business development expenses in the quarter, compared with $619 million of charges a year ago, excluding these charges, operating expenses grew 9%, this growth reflects increased investments in support of our robust early and late phase pipeline with research and development expenses increasing 17%. Other expense was $133 million. Our tax rate was 15%. Taken together our earnings per share were $2 13. Before I cover the outlook for the balance of the year I wanted to briefly touch upon the recently announced strategic collaboration with Daiichi Sankyo. This transaction follows a similar derisked and disciplined financial structure as we have employees in prior successful collaborations and we are very excited about the opportunity to create meaningful value for patients and shareholders. Now turning to our 2023 non-GAAP guidance, which includes the strategic collaboration with Daiichi. The continuing operational strength of our business has enabled us to raise and narrow our full year revenue guidance. We now expect revenue to be between $59, seven and $62 billion, an increase of approximately $900 million. <unk> point.

Gross margin was 77% consistent with last year as the impact from unfavorable foreign exchange was offset by product mix.

Operating expenses decreased 4% to five $8 billion.

There were no significant business development expenses in the quarter compared with $619 million of charges a year ago.

Caroline Litchfield: There were no significant business development expenses in the quarter, compared with $619 million of charges a year ago. Excluding these charges, operating expenses grew 9%, this growth reflects increased investments in support of our robust early and late phase pipeline with research and development expenses increasing 17%. Other expense was $133 million dollars, our tax rate was 15%, taken together, earnings per share were $2.13 USD.

Caroline Litchfield: There were no significant business development expenses in the quarter, compared with $619 million of charges a year ago.

Excluding these charges operating expenses grew 9%. This growth reflects increased investments in support of a robust early and late phase pipeline with research and development expenses increasing 17%.

Caroline Litchfield: Excluding these charges, operating expenses grew 9%, this growth reflects increased investments in support of our robust early and late phase pipeline with research and development expenses increasing 17%. Other expense was $133 million dollars, our tax rate was 15%, taken together, earnings per share were $2.13 USD.

Other expense was $133 million. Our tax rate was 15%. Taken together, earnings per share were $2.13. Before I cover the outlook for the balance of the year, I wanted to briefly touch upon the recently announced strategic collaboration with Daiichi Sankyo.

Other expense was $133 million.

Caroline Litchfield: Other expense was $133 million dollars, our tax rate was 15%, taken together, earnings per share were $2.13. Before I cover the outlook for the balance of the year I wanted to briefly touch upon the recently announced strategic collaboration with Daiichi Sankyo. This transaction follows a similar derisked and disciplined financial structure as we have employees in prior successful collaborations and we are very excited about the opportunity to create meaningful value for patients and shareholders. Now turning to our 2023 non-GAAP guidance, which includes the strategic collaboration with Daiichi. The continuing operational strength of our business has enabled us to raise and narrow our full year revenue guidance. We now expect revenue to be between $59, seven and $62 billion, an increase of approximately $900 million. <unk> point.

Caroline Litchfield: Other expense was $133 million dollars, our tax rate was 15%, taken together, earnings per share were $2.13.

Our tax rate was 15%.

Taken together our earnings per share were $2 13.

Caroline Litchfield: Before I cover the outlook for the balance of the year I wanted to briefly touch upon the recently announced strategic collaboration with Daiichi Sankyo, this transaction follows a similar de-risked and disciplined financial structure as we have employees in prior successful collaborations and we are very excited about the opportunity to create meaningful value for patients and shareholders. Now turning to our 2023 non-GAAP guidance, which includes the strategic collaboration with Daiichi. The continuing operational strength of our business has enabled us to raise and narrow our full year revenue guidance. We now expect revenue to be between $59, seven and $62 billion, an increase of approximately $900 million. <unk> point.

Before I cover the outlook for the balance of the year I wanted to briefly touch upon the recently announced strategic collaboration with Daiichi Sankyo.

Caroline Litchfield: This transaction follows a similar de-risked and disciplined financial structure as we have employed in prior successful collaborations, and we are very excited about the opportunity to create meaningful value for patients and shareholders. Now, turning to our 2023 non-GAAP guidance, which includes the strategic collaboration with Daiichi, the continuing operational strength of our business has enabled us to raise and narrow our full-year revenue guidance. We now expect revenue to be between $59.7 and $60.2 billion, an increase of approximately $900 million at the midpoint. This range reflects strong double-digit underlying year-over-year revenue growth of 11% to 12%, excluding Lagevrio, and an approximate 2 percentage point negative impact from foreign exchange using mid-October rates. Our gross margin assumption is unchanged at approximately 77%. We now estimate operating expenses to be between $39.8 and $40.4 billion.

This transaction follows a similar de-risked and disciplined financial structure as we have employed in prior successful collaborations, and we are very excited about the opportunity to create meaningful value for patients and shareholders. Now, turning to our 2023 non-GAAP guidance, which includes the strategic collaboration with Daiichi, the continuing operational strength of our business has enabled us to raise and narrow our full-year revenue guidance. We now expect revenue to be between $59.7 and $60.2 billion, an increase of approximately $900 million at the midpoint.

This transaction follows a similar derisked and disciplined financial structure as we have employees in prior successful collaborations and we are very excited about the opportunity to create meaningful value for patients and shareholders.

Now turning to our 2023 non-GAAP guidance, which includes the strategic collaboration with Daiichi.

Caroline Litchfield: Now turning to our 2023 non-GAAP guidance, which includes the strategic collaboration with Daiichi, the continuing operational strength of our business has enabled us to raise and narrow our full year revenue guidance, We now expect revenue to be between $59.7 and $60.2 billion dollars, an increase of approximately $900 million dollars at the mid point. This range reflects strong double digit underlying year over year revenue growth of 11% to 12%. Excluding the gifts. We are at an approximate two percentage point negative impact from foreign exchange using mid October rates. Our gross margin assumption is unchanged at approximately 77%. We now estimate operating expenses to be between 39.8 and $44 billion. This range reflects $17 $1 billion in acquisition and upfront collaboration research and development expenses, including $5 $5 billion for the collaboration with Daiichi as well as those associated with Prometheus Imago and <unk>. Our guidance does not assume additional significant potential business development transactions. We now assume other expense of approximately $200 million, which reflects updated foreign exchange expectations, given recent dollar strengthening and higher net interest expense related to Daiichi. Our full year tax rate is expected to be between 39, and 40%, which includes an approximate 24 five percentage point impact related to our business development activity. Our underlying tax rate is approximately 14 five to 15, 5%. We assume approximately 2.55 billion shares outstanding. Taken together, we expect EPS of $1 33 to. One dollar and 38 cents. This range includes a negative impact from foreign exchange of approximately six percentage points versus 2022 using mid October rates.

The continuing operational strength of our business has enabled us to raise and narrow our full year revenue guidance.

We now expect revenue to be between $59, seven and $62 billion, an increase of approximately $900 million.

<unk> point.

This range reflects strong double-digit underlying year-over-year revenue growth of 11% to 12%, excluding Lagevrio, and an approximate 2 percentage point negative impact from foreign exchange using mid-October rates. Our gross margin assumption is unchanged at approximately 77%. We now estimate operating expenses to be between $39.8 and $40.4 billion.

This range reflects strong double digit underlying year over year revenue growth of 11% to 12%. Excluding the gifts. We are at an approximate two percentage point negative impact from foreign exchange using mid October rates.

Caroline Litchfield: This range reflects strong double digit underlying year over year revenue growth of 11% to 12% excluding Lagevrio and an approximate two percentage point negative impact from foreign exchange using mid October rates, our gross margin assumption is unchanged at approximately 77%. We now estimate operating expenses to be between 39.8 and $40.4 billion dollars. This range reflects $17 $1 billion in acquisition and upfront collaboration research and development expenses, including $5 $5 billion for the collaboration with Daiichi as well as those associated with Prometheus Imago and <unk>. Our guidance does not assume additional significant potential business development transactions. We now assume other expense of approximately $200 million, which reflects updated foreign exchange expectations, given recent dollar strengthening and higher net interest expense related to Daiichi. Our full year tax rate is expected to be between 39, and 40%, which includes an approximate 24 five percentage point impact related to our business development activity. Our underlying tax rate is approximately 14 five to 15, 5%. We assume approximately 2.55 billion shares outstanding. Taken together, we expect EPS of $1 33 to. One dollar and 38 cents. This range includes a negative impact from foreign exchange of approximately six percentage points versus 2022 using mid October rates.

Our gross margin assumption is unchanged at approximately 77%.

We now estimate operating expenses to be between 39.8 and $44 billion.

Caroline Litchfield: We now estimate operating expenses to be between 39.8 and $40.4 billion dollars, this range reflects $17.1 billion dollars in acquisition and upfront collaboration research and development expenses, including $5.5 billion dollars for the collaboration with Daiichi, as well as those associated with Prometheus, Imago and Kelun, our guidance does not assume additional significant potential business development transactions. We now assume other expense of approximately $200 million, which reflects updated foreign exchange expectations, given recent dollar strengthening and higher net interest expense related to Daiichi. Our full year tax rate is expected to be between 39, and 40%, which includes an approximate 24 five percentage point impact related to our business development activity. Our underlying tax rate is approximately 14 five to 15, 5%. We assume approximately 2.55 billion shares outstanding. Taken together, we expect EPS of $1 33 to. One dollar and 38 cents. This range includes a negative impact from foreign exchange of approximately six percentage points versus 2022 using mid October rates.

Caroline Litchfield: This range reflects $17.1 billion in acquisition and upfront collaboration research and development expenses, including $5.5 billion for the collaboration with Daiichi, as well as those associated with Prometheus, Imago, and Kelun-Biotech. Our guidance does not assume additional significant potential business development transactions. We now assume other expense of approximately $200 million, which reflects updated foreign exchange expectations given recent dollar strengthening and higher net interest expense related to Daiichi. Our full-year tax rate is expected to be between 39% and 40%, which includes an approximate 24.5 percentage point impact related to our business development activity. Our underlying tax rate is approximately 14.5% to 15.5%. We assume approximately 2.55 billion shares outstanding. Taken together, we expect EPS of $1.33 to $1.38. This range includes a negative impact from foreign exchange of approximately 6 percentage points versus 2022 using mid-October rates.

This range reflects $17.1 billion in acquisition and upfront collaboration research and development expenses, including $5.5 billion for the collaboration with Daiichi, as well as those associated with Prometheus, Imago, and Kelun-Biotech. Our guidance does not assume additional significant potential business development transactions. We now assume other expense of approximately $200 million, which reflects updated foreign exchange expectations given recent dollar strengthening and higher net interest expense related to Daiichi.

This range reflects $17 $1 billion in acquisition and upfront collaboration research and development expenses, including $5 $5 billion for the collaboration with Daiichi as well as those associated with Prometheus Imago and <unk>.

Caroline Litchfield: This range reflects $17 $1 billion in acquisition and upfront collaboration research and development expenses, including $5 $5 billion for the collaboration with Daiichi as well as those associated with Prometheus Imago and <unk>. Our guidance does not assume additional significant potential business development transactions. We now assume other expense of approximately $200 million, which reflects updated foreign exchange expectations, given recent dollar strengthening and higher net interest expense related to Daiichi. Our full year tax rate is expected to be between 39, and 40%, which includes an approximate 24 five percentage point impact related to our business development activity. Our underlying tax rate is approximately 14 five to 15, 5%. We assume approximately 2.55 billion shares outstanding. Taken together, we expect EPS of $1 33 to. One dollar and 38 cents. This range includes a negative impact from foreign exchange of approximately six percentage points versus 2022 using mid October rates.

Our guidance does not assume additional significant potential business development transactions.

We now assume other expense of approximately $200 million, which reflects updated foreign exchange expectations, given recent dollar strengthening and higher net interest expense related to Daiichi.

Caroline Litchfield: We now assume other expense of approximately $200 million dollars, which reflects updated foreign exchange expectations, given recent dollar strengthening and higher net interest expense related to Daiichi. our full year tax rate is expected to be between 39, and 40%, which includes an approximate 24.5 percentage point impact related to our business development activity, our underlying tax rate is approximately 14 five to 15, 5%. We assume approximately 2.55 billion shares outstanding. Taken together, we expect EPS of $1 33 to. One dollar and 38 cents. This range includes a negative impact from foreign exchange of approximately six percentage points versus 2022 using mid October rates.

Our full-year tax rate is expected to be between 39% and 40%, which includes an approximate 24.5 percentage point impact related to our business development activity. Our underlying tax rate is approximately 14.5% to 15.5%. We assume approximately 2.55 billion shares outstanding. Taken together, we expect EPS of $1.33 to $1.38. This range includes a negative impact from foreign exchange of approximately 6 percentage points versus 2022 using mid-October rates.

Our full year tax rate is expected to be between 39, and 40%, which includes an approximate 24 five percentage point impact related to our business development activity.

Caroline Litchfield: Our full year tax rate is expected to be between 39 and 40%, which includes an approximate 24.5 percentage point impact related to our business development activity, our underlying tax rate is approximately 14.5 to 15, 5%, We assume approximately 2.55 billion shares outstanding, taken together, we expect EPS of $1.33 cents to $1.38 cents, this range includes a negative impact from foreign exchange of approximately six percentage points versus 2022 using mid October rates. Recall our pre. Our guidance range with $2.95 to $3.05. Including the one time charge of $5 $5 billion or $1 70 per share and an estimated four said who advanced the assets and financing costs from the collaboration with Daiichi. Our prior guidance range would have been $1.21 to one dollar and 31 cents with a midpoint of $1.26. Our current guidance midpoint of one dollar and 36% represents an increase resulting from the strength in our business of approximately 15 cents, partially offset by an incremental headwind from foreign exchange of approximately 5%. Now turning to capital allocation, our priorities remain unchanged. We will continue to prioritize investments in our business to drive near and long term growth. We are proud of the significant progress our team is making to advance and augment our pipeline, including our collaboration with Daiichi. We will continue to invest in our pipeline, which contains many assets with tremendous potential to address significant unmet medical needs. <unk> got the strong performance well into the future. We remain committed to our dividend and plan to increase it over time. Business development continues to be a high priority. Record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care access such opportunities in a disciplined and capital efficient manner, and importantly to rapidly progress the opportunities for the benefit of the patients we serve and. As shareholders.

Our underlying tax rate is approximately 14 five to 15, 5%.

We assume approximately 2.55 billion shares outstanding.

Taken together, we expect EPS of $1 33 to.

Caroline Litchfield: This range includes a negative impact from foreign exchange of approximately six percentage points versus 2022 using mid October rates, recall, our prior guidance range with $2.95 cents to $3.05 cents Including the one time charge of $5.5 billion or $1.70 cents per share and an estimated four said who advanced the assets and financing costs from the collaboration with Daiichi, our prior guidance range would have been $1.21 to $1 dollar and 31 cents with a midpoint of $1.26 cents. Our current guidance midpoint of one dollar and 36% represents an increase resulting from the strength in our business of approximately 15 cents, partially offset by an incremental headwind from foreign exchange of approximately 5%. Now turning to capital allocation, our priorities remain unchanged. We will continue to prioritize investments in our business to drive near and long term growth. We are proud of the significant progress our team is making to advance and augment our pipeline, including our collaboration with Daiichi. We will continue to invest in our pipeline, which contains many assets with tremendous potential to address significant unmet medical needs. <unk> got the strong performance well into the future. We remain committed to our dividend and plan to increase it over time. Business development continues to be a high priority. Record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care access such opportunities in a disciplined and capital efficient manner, and importantly to rapidly progress the opportunities for the benefit of the patients we serve and. As shareholders.

One dollar and 38 cents.

This range includes a negative impact from foreign exchange of approximately six percentage points versus 2022 using mid October rates.

Caroline Litchfield: Recall, our prior guidance range was $2.95 to 3.05, including the one-time charge of $5.5 billion, or $1.70 per share, and an estimated $0.04 to advance the assets and financing costs from the collaboration with Daiichi. Our prior guidance range would have been $1.21 to 1.31, with a midpoint of $1.26. Our current guidance midpoint of $1.36 represents an increase resulting from the strength in our business of approximately $0.15, partially offset by an incremental headwind from foreign exchange of approximately $0.05. Now, turning to capital allocation, where our priorities remain unchanged. We will continue to prioritize investments in our business to drive near and long-term growth. We are proud of the significant progress our team is making to advance and augment our pipeline, including our collaboration with Daiichi.

Recall, our prior guidance range was $2.95 to 3.05, including the one-time charge of $5.5 billion, or $1.70 per share, and an estimated $0.04 to advance the assets and financing costs from the collaboration with Daiichi. Our prior guidance range would have been $1.21 to 1.31, with a midpoint of $1.26. Our current guidance midpoint of $1.36 represents an increase resulting from the strength in our business of approximately $0.15, partially offset by an incremental headwind from foreign exchange of approximately $0.05. Now, turning to capital allocation, where our priorities remain unchanged.

Recall our pre.

Our guidance range with $2.95 to $3.05.

Including the one time charge of $5 $5 billion or $1 70 per share and an estimated four said who advanced the assets and financing costs from the collaboration with Daiichi.

Our prior guidance range would have been $1.21 to one dollar and 31 cents with a midpoint of $1.26.

Caroline Litchfield: Our current guidance midpoint of one dollar and 36 cents represents an increase, resulting from the strength in our business of approximately 15 cents, partially offset by an incremental headwind from foreign exchange of approximately 5 cents. Now turning to capital allocation, our priorities remain unchanged. We will continue to prioritize investments in our business to drive near and long term growth. We are proud of the significant progress our team is making to advance and augment our pipeline, including our collaboration with Daiichi. We will continue to invest in our pipeline, which contains many assets with tremendous potential to address significant unmet medical needs. <unk> got the strong performance well into the future. We remain committed to our dividend and plan to increase it over time. Business development continues to be a high priority. Record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care access such opportunities in a disciplined and capital efficient manner, and importantly to rapidly progress the opportunities for the benefit of the patients we serve and. As shareholders.

Our current guidance midpoint of one dollar and 36% represents an increase resulting from the strength in our business of approximately 15 cents, partially offset by an incremental headwind from foreign exchange of approximately 5%.

Caroline Litchfield: Now turning to capital allocation, where our priorities remain unchanged, We will continue to prioritize investments in our business to drive near and long term growth, We are proud of the significant progress our team is making to advance and augment our pipeline, including our collaboration with Daiichi, We will continue to invest in our pipeline, which contains many assets with tremendous potential to address significant unmet medical needs positioning us in strong performance well into the future. We remain committed to our dividend and plan to increase it over time. Business development continues to be a high priority. Record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care access such opportunities in a disciplined and capital efficient manner, and importantly to rapidly progress the opportunities for the benefit of the patients we serve and. As shareholders.

Now turning to capital allocation, our priorities remain unchanged.

We will continue to prioritize investments in our business to drive near and long-term growth. We are proud of the significant progress our team is making to advance and augment our pipeline, including our collaboration with Daiichi.

We will continue to prioritize investments in our business to drive near and long term growth.

We are proud of the significant progress our team is making to advance and augment our pipeline, including our collaboration with Daiichi.

Caroline Litchfield: We will continue to invest in our pipeline, which contains many assets with tremendous potential to address significant unmet medical needs, positioning us for strong performance well into the future. We remain committed to our dividend and plan to increase it over time. Business development continues to be a high priority. Our track record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care, access such opportunities in a disciplined and capital-efficient manner, and, importantly, to rapidly progress the opportunities for the benefit of the patients we serve and our shareholders. We maintain ample capacity, given our strong investment-grade credit rating and cash flow, to pursue additional science-driven, value-enhancing transactions going forward. We continue to execute a modest level of share repurchases.

We will continue to invest in our pipeline, which contains many assets with tremendous potential to address significant unmet medical needs, positioning us for strong performance well into the future. We remain committed to our dividend and plan to increase it over time. Business development continues to be a high priority. Our track record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care, access such opportunities in a disciplined and capital-efficient manner, and, importantly, to rapidly progress the opportunities for the benefit of the patients we serve and our shareholders.

We will continue to invest in our pipeline, which contains many assets with tremendous potential to address significant unmet medical needs.

<unk> got the strong performance well into the future.

Caroline Litchfield: We remain committed to our dividend and plan to increase it over time, business development continues to be a high priority. Record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care access such opportunities in a disciplined and capital efficient manner, and importantly to rapidly progress the opportunities for the benefit of the patients we serve and. As shareholders. We maintain ample capacity given our strong investment grade credit rating and cash flow to pursue additional science driven value enhancing transactions going forward. We continue to execute a modest level of share repurchases. To conclude as we finished the year, we remain very confident in the outlook of our business in the near and long term driven by the global demand for our innovative medicines and vaccines and our exceptional pipeline. We are in a position of financial and operational strength and a continued excellent execution will enable us to deliver value to patients customers and shareholders well into the future. With that I'd now like to turn the call over to Dave. Thank you Caroline good morning, everyone. Today, I will start with our oncology programs, followed by vaccines immunology and conclude with cardio metabolic disease. Over the last few years, our oncology strategy is focused on leveraging the remarkable properties of Keytruda. Tablets are diverse clinical pipeline of candidates with novel mechanisms and modalities. This is broadly based on three strategic pillars, immuno oncology precision oncology and tissue targeting and immuno oncology. In college, we continue to evaluate keytruda in the metastatic and increasingly in earlier stage disease settings. While also investigating multiple novel immuno oncology combinations amcor formulations. With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth and in tissue targeting we are developing agents such as antibody drug conjugates designed to increased cancer cell sensitivity and Kelly. The ladder as exemplified by our recently announced collaboration with Daiichi Sankyo Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III. And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

Caroline Litchfield: We remain committed to our dividend and plan to increase it over time,

We remain committed to our dividend and plan to increase it over time.

Caroline Litchfield: Business development continues to be a high priority, a trek Record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care, access such opportunities in a disciplined and capital efficient manner, and importantly to rapidly progress the opportunities for the benefit of the patients we serve and our shareholders. We maintain ample capacity given our strong investment grade credit rating and cash flow to pursue additional science driven value enhancing transactions going forward. We continue to execute a modest level of share repurchases. To conclude as we finished the year, we remain very confident in the outlook of our business in the near and long term driven by the global demand for our innovative medicines and vaccines and our exceptional pipeline. We are in a position of financial and operational strength and a continued excellent execution will enable us to deliver value to patients customers and shareholders well into the future. With that I'd now like to turn the call over to Dave. Thank you Caroline good morning, everyone. Today, I will start with our oncology programs, followed by vaccines immunology and conclude with cardio metabolic disease. Over the last few years, our oncology strategy is focused on leveraging the remarkable properties of Keytruda. Tablets are diverse clinical pipeline of candidates with novel mechanisms and modalities. This is broadly based on three strategic pillars, immuno oncology precision oncology and tissue targeting and immuno oncology. In college, we continue to evaluate keytruda in the metastatic and increasingly in earlier stage disease settings. While also investigating multiple novel immuno oncology combinations amcor formulations. With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth and in tissue targeting we are developing agents such as antibody drug conjugates designed to increased cancer cell sensitivity and Kelly. The ladder as exemplified by our recently announced collaboration with Daiichi Sankyo Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III. And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

Business development continues to be a high priority.

Record demonstrates our ability to identify compelling science and technologies that have the potential to advance standard of care access such opportunities in a disciplined and capital efficient manner, and importantly to rapidly progress the opportunities for the benefit of the patients we serve and.

Caroline Litchfield: We maintain ample capacity, given our strong investment grade credit rating and cash flow to pursue additional science-driven value enhancing transactions going forward, we continue to execute a modest level of share repurchase. to conclude as we finished the year, we remain very confident in the outlook of our business in the near and long term driven by the global demand for our innovative medicines and vaccines and our exceptional pipeline. We are in a position of financial and operational strength and a continued excellent execution will enable us to deliver value to patients customers and shareholders well into the future. With that I'd now like to turn the call over to Dave. Thank you Caroline good morning, everyone. Today, I will start with our oncology programs, followed by vaccines immunology and conclude with cardio metabolic disease. Over the last few years, our oncology strategy is focused on leveraging the remarkable properties of Keytruda. Tablets are diverse clinical pipeline of candidates with novel mechanisms and modalities. This is broadly based on three strategic pillars, immuno oncology precision oncology and tissue targeting and immuno oncology. In college, we continue to evaluate keytruda in the metastatic and increasingly in earlier stage disease settings. While also investigating multiple novel immuno oncology combinations amcor formulations. With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth and in tissue targeting we are developing agents such as antibody drug conjugates designed to increased cancer cell sensitivity and Kelly. The ladder as exemplified by our recently announced collaboration with Daiichi Sankyo Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III. And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

As shareholders.

We maintain ample capacity, given our strong investment-grade credit rating and cash flow, to pursue additional science-driven, value-enhancing transactions going forward. We continue to execute a modest level of share repurchases.

We maintain ample capacity given our strong investment grade credit rating and cash flow to pursue additional science driven value enhancing transactions going forward.

Caroline Litchfield: To conclude as we finished the year, we remain very confident in the outlook of our business in the near and long term, driven by the global demand for our innovative medicines and vaccines and our exceptional pipeline, we are in a position of financial and operational strength and our continued excellent execution will enable us to deliver value to patients, customers and shareholders well into the future, with that I'd now like to turn the call over to Dave. Thank you Caroline good morning, everyone. Today, I will start with our oncology programs, followed by vaccines immunology and conclude with cardio metabolic disease. Over the last few years, our oncology strategy is focused on leveraging the remarkable properties of Keytruda. Tablets are diverse clinical pipeline of candidates with novel mechanisms and modalities. This is broadly based on three strategic pillars, immuno oncology precision oncology and tissue targeting and immuno oncology. In college, we continue to evaluate keytruda in the metastatic and increasingly in earlier stage disease settings. While also investigating multiple novel immuno oncology combinations amcor formulations. With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth and in tissue targeting we are developing agents such as antibody drug conjugates designed to increased cancer cell sensitivity and Kelly. The ladder as exemplified by our recently announced collaboration with Daiichi Sankyo Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III. And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

We continue to execute a modest level of share repurchases.

Caroline Litchfield: To conclude, as we finish the year, we remain very confident in the outlook of our business in the near and long term, driven by the global demand for our innovative medicines, vaccines, and our exceptional pipeline. We are in a position of financial and operational strength, and our continued excellent execution will enable us to deliver value to patients, customers, and shareholders well into the future. With that, I'd now like to turn the call over to Dean. Thank you, Caroline. Good morning, everyone. Today, I will start with our oncology programs followed by vaccines, immunology, and conclude with cardiometabolic disease. Over the last few years, our oncology strategy has focused on leveraging the remarkable properties of Keytruda to establish a diverse clinical pipeline of candidates with novel mechanisms and modalities. This is broadly based on three strategic pillars: immuno-oncology, precision oncology, and tissue targeting.

To conclude, as we finish the year, we remain very confident in the outlook of our business in the near and long term, driven by the global demand for our innovative medicines, vaccines, and our exceptional pipeline. We are in a position of financial and operational strength, and our continued excellent execution will enable us to deliver value to patients, customers, and shareholders well into the future. With that, I'd now like to turn the call over to Dean.

To conclude as we finished the year, we remain very confident in the outlook of our business in the near and long term driven by the global demand for our innovative medicines and vaccines and our exceptional pipeline.

We are in a position of financial and operational strength and a continued excellent execution will enable us to deliver value to patients customers and shareholders well into the future.

Dean Y. Li: Thank you Caroline, good morning everyone, today I will start with our oncology programs, followed by vaccines, immunology and conclude with cardio metabolic disease, over the last few years, our oncology strategy has focused on leveraging the remarkable properties of Keytruda to establish a diverse clinical pipeline of candidates with novel mechanisms and modalities. This is broadly based on three strategic pillars, immuno oncology precision oncology and tissue targeting and immuno oncology. In college, we continue to evaluate keytruda in the metastatic and increasingly in earlier stage disease settings. While also investigating multiple novel immuno oncology combinations amcor formulations. With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth and in tissue targeting we are developing agents such as antibody drug conjugates designed to increased cancer cell sensitivity and Kelly. The ladder as exemplified by our recently announced collaboration with Daiichi Sankyo Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III. And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

With that I'd now like to turn the call over to Dave.

Dean Li: Thank you, Caroline. Good morning, everyone. Today, I will start with our oncology programs followed by vaccines, immunology, and conclude with cardiometabolic disease. Over the last few years, our oncology strategy has focused on leveraging the remarkable properties of Keytruda to establish a diverse clinical pipeline of candidates with novel mechanisms and modalities. This is broadly based on three strategic pillars: immuno-oncology, precision oncology, and tissue targeting.

Thank you Caroline good morning, everyone. Today, I will start with our oncology programs, followed by vaccines immunology and conclude with cardio metabolic disease.

Over the last few years, our oncology strategy is focused on leveraging the remarkable properties of Keytruda.

Tablets are diverse clinical pipeline of candidates with novel mechanisms and modalities.

Dean Y. Li: This is broadly based on three strategic pillars, immuno-oncology, precision oncology and tissue targeting, in immuno-oncology we continue to evaluate Keytruda in the metastatic and increasingly, in earlier stage disease settings while also investigating multiple novel immuno-oncology combinations and co-formulations. With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth and in tissue targeting we are developing agents such as antibody drug conjugates designed to increased cancer cell sensitivity and Kelly. The ladder as exemplified by our recently announced collaboration with Daiichi Sankyo Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III. And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

This is broadly based on three strategic pillars, immuno oncology precision oncology and tissue targeting and immuno oncology.

Caroline Litchfield: In immuno-oncology, we continue to evaluate Keytruda in the metastatic and increasingly in earlier stage disease settings, while also investigating multiple novel immuno-oncology combinations and co-formulations. With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth, and in tissue targeting, we are developing agents such as antibody-drug conjugates designed to increase cancer cell sensitivity and killing. The latter is exemplified by our recently announced collaboration with Daiichi Sankyo. Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody-drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well-positioned to accelerate three clinical-stage, potentially first-in-class candidates with the goal of transforming the treatment paradigm. These include Patritumab deruxtecan, an investigational fully humanized anti-HER3 ADC in phase 3, Ifinatamab deruxtecan, an investigational humanized anti-B7-H3 ADC in phase 2, and Raludotatug deruxtecan, an investigational humanized anti-CDH6 targeted ADC in phase 1.

In immuno-oncology, we continue to evaluate Keytruda in the metastatic and increasingly in earlier stage disease settings, while also investigating multiple novel immuno-oncology combinations and co-formulations. With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth, and in tissue targeting, we are developing agents such as antibody-drug conjugates designed to increase cancer cell sensitivity and killing. The latter is exemplified by our recently announced collaboration with Daiichi Sankyo.

In college, we continue to evaluate keytruda in the metastatic and increasingly in earlier stage disease settings. While also investigating multiple novel immuno oncology combinations amcor formulations.

Dean Y. Li: With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth and in tissue targeting we are developing agents such as antibody drug conjugates designed to increase cancer cell sensitivity and Kelly. The ladder as exemplified by our recently announced collaboration with Daiichi Sankyo Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III. And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

With precision oncology, we are selectively targeting pathways to inhibit cancer cell growth and in tissue targeting we are developing agents such as antibody drug conjugates designed to increased cancer cell sensitivity and Kelly.

Dean Y. Li: The ladder is exemplified by our recently announced collaboration with Daiichi Sankyo, Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients, by combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III. And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

The ladder as exemplified by our recently announced collaboration with Daiichi Sankyo Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody drug conjugate technology with proven benefit to patients.

Daiichi Sankyo scientists have made pioneering contributions in advancing novel antibody-drug conjugate technology with proven benefit to patients. By combining our company's respective strengths, we are well-positioned to accelerate three clinical-stage, potentially first-in-class candidates with the goal of transforming the treatment paradigm. These include Patritumab deruxtecan, an investigational fully humanized anti-HER3 ADC in phase 3, Ifinatamab deruxtecan, an investigational humanized anti-B7-H3 ADC in phase 2, and Raludotatug deruxtecan, an investigational humanized anti-CDH6 targeted ADC in phase 1.

By combining our company's respective strengths, we are well positioned to accelerate three clinical stage potentially first in class candidates with the goal of transforming the treatment paradigm. These include Patricia map the roots to can and investigational fully humanized anti her three ADC in phase III.

Dean Y. Li: These include Patritumab Deruxtecan an investigational fully humanized anti HER3-ADC in Phase III, Infinatamab Deruxtecan an investigational humanized anti B7-H3 ADC in Phase II and Raludotatug Deruxtecan an investigational humanized anti CDH6 targeted ADC in Phase I, We provided details during our investor event earlier this week and are eager to begin working with the team. Daiichi Sankyo collaboration complements our important ongoing alliance with <unk> biotech, who is talented scientists have developed their own innovative ADC platform. At ESMO, New phase two data for M. K 28, 74 S gave me two six for a trop two targeting ADC in patients with previously treated metastatic hormone receptor positive <unk> negative breast cancer showed encouraging anti tumor activity with an objective response rate of 30. Six 8%. This builds on existing data for MTA 28, 70, both in triple negative breast and non small cell lung cancer. We're now poised to initiate larger studies, starting with non small cell lung cancer and expand into additional tumor types. We are also advancing clinical development of M. K 1200. And ADC targeting cloud, an 18 point too. Recognizing the proven benefit of Keytruda in combination with chemotherapy and shortened tumor types, we're exploring the tissue targeting concept by evaluating regimens, combining adcs and immunotherapy. As well in collaboration with CJ and Astellas potentially practice changing survival data were presented from keynote 839, EV 302, evaluating keytruda plus in Fordham abdomen as first line treatment for patients with locally advanced or metastatic <unk> carcinoma. This regiment represent the first approval of a combination of a checkpoint inhibitor and an ADC.

And finish your math, there rich the can and investigation of humanized anti <unk> ADC in phase III and rallied to tag directs the can and investigation or humanized anti CD H six targeted ADC in phase one we.

Caroline Litchfield: We provided details during our investor event earlier this week and are eager to begin working with the team. The Daiichi Sankyo collaboration complements our important ongoing alliance with Kelun-Biotech, whose talented scientists have developed their own innovative ADC platform. At ESMO, new phase 2 data for MK-2870, or SKB264, a TROP2 targeting ADC in patients with previously treated metastatic hormone-receptor-positive, HER2-negative breast cancer showed encouraging antitumor activity with an objective response rate of 36.8%. This builds on existing data for MK-2870, both in triple-negative breast cancer and non-small cell lung cancer. We are now poised to initiate larger studies starting with non-small cell lung cancer and expand into additional tumor types. We are also advancing clinical development of MK-1200 and ADC targeting Claudin 18.2.

We provided details during our investor event earlier this week and are eager to begin working with the team. The Daiichi Sankyo collaboration complements our important ongoing alliance with Kelun-Biotech, whose talented scientists have developed their own innovative ADC platform. At ESMO, new phase 2 data for MK-2870, or SKB264, a TROP2 targeting ADC in patients with previously treated metastatic hormone-receptor-positive, HER2-negative breast cancer showed encouraging antitumor activity with an objective response rate of 36.8%. This builds on existing data for MK-2870, both in triple-negative breast cancer and non-small cell lung cancer.

We provided details during our investor event earlier this week and are eager to begin working with the team.

Dean Y. Li: The Daiichi Sankyo collaboration complements our important ongoing alliance with Kelun biotech, who's talented scientists have developed their own innovative ADC platform. At ESMO, New phase two data for M. K 28, 74 S gave me two six for a trop two targeting ADC in patients with previously treated metastatic hormone receptor positive <unk> negative breast cancer showed encouraging anti tumor activity with an objective response rate of 30. Six 8%. This builds on existing data for MTA 28, 70, both in triple negative breast and non small cell lung cancer. We're now poised to initiate larger studies, starting with non small cell lung cancer and expand into additional tumor types. We are also advancing clinical development of M. K 1200. And ADC targeting cloud, an 18 point too. Recognizing the proven benefit of Keytruda in combination with chemotherapy and shortened tumor types, we're exploring the tissue targeting concept by evaluating regimens, combining adcs and immunotherapy. As well in collaboration with CJ and Astellas potentially practice changing survival data were presented from keynote 839, EV 302, evaluating keytruda plus in Fordham abdomen as first line treatment for patients with locally advanced or metastatic <unk> carcinoma. This regiment represent the first approval of a combination of a checkpoint inhibitor and an ADC.

Dean Y. Li: The Daiichi Sankyo collaboration complements our important ongoing alliance with Kelun biotech, who's talented scientists have developed their own innovative ADC platform.

Daiichi Sankyo collaboration complements our important ongoing alliance with <unk> biotech, who is talented scientists have developed their own innovative ADC platform.

Dean Y. Li: At ESMO, new Phase II data for MK-2870 or SKB-264 a TROP2 targeting ADC in patients with previously treated metastatic hormone receptor positive, HER2-negative breast cancer showed encouraging anti-tumor activity with an objective response rate of 36.8%, this builds on existing data for MK-2870, both in triple negative breast and non small cell lung cancer, We're now poised to initiate larger studies, starting with non small cell lung cancer and expand into additional tumor types. We are also advancing clinical development of M. K 1200. And ADC targeting cloud, an 18 point too. Recognizing the proven benefit of Keytruda in combination with chemotherapy and shortened tumor types, we're exploring the tissue targeting concept by evaluating regimens, combining adcs and immunotherapy. As well in collaboration with CJ and Astellas potentially practice changing survival data were presented from keynote 839, EV 302, evaluating keytruda plus in Fordham abdomen as first line treatment for patients with locally advanced or metastatic <unk> carcinoma. This regiment represent the first approval of a combination of a checkpoint inhibitor and an ADC.

At ESMO, New phase two data for M. K 28, 74 S gave me two six for a trop two targeting ADC in patients with previously treated metastatic hormone receptor positive <unk> negative breast cancer showed encouraging anti tumor activity with an objective response rate of 30.

Six 8%.

This builds on existing data for MTA 28, 70, both in triple negative breast and non small cell lung cancer. We're now poised to initiate larger studies, starting with non small cell lung cancer and expand into additional tumor types. We are also advancing clinical development of M. K 1200.

We are now poised to initiate larger studies starting with non-small cell lung cancer and expand into additional tumor types. We are also advancing clinical development of MK-1200 and ADC targeting Claudin 18.2.

Dean Y. Li: We are also advancing clinical development of MK-1200 an ADC targeting Claudin-18.2. Recognizing the proven benefit of Keytruda in combination with chemotherapy and shortened tumor types, we're exploring the tissue targeting concept by evaluating regimens, combining ADCs and immunotherapy, at ESMO in collaboration with Seagen and Astellas, potentially practice changing survival data were presented from Keynote A39/EV302, evaluating Keytruda plus Enfortumab vedotin as first line treatment for patients with locally advanced or metastatic Urothelial Carcinoma, this regiment represent the first approval of a combination of a checkpoint inhibitor and an ADC. Turning to immuno oncology.

And ADC targeting cloud, an 18 point too.

Caroline Litchfield: Recognizing the proven benefit of Keytruda in combination with chemotherapy in certain tumor types, we are exploring the tissue-targeting concept by evaluating regimens combining ADCs and immunotherapy. At ESMO, in collaboration with Seagen and Astellas, potentially practice-changing survival data were presented from KEYNOTE-A39, EV-302, evaluating Keytruda plus enfortumab vedotin as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma. This regimen represents the first approval of a combination of a checkpoint inhibitor and an ADC. Turning to immuno-oncology, evidence continues to emerge for the benefit of Keytruda in the treatment of earlier stage cancer.

Recognizing the proven benefit of Keytruda in combination with chemotherapy in certain tumor types, we are exploring the tissue-targeting concept by evaluating regimens combining ADCs and immunotherapy. At ESMO, in collaboration with Seagen and Astellas, potentially practice-changing survival data were presented from KEYNOTE-A39, EV-302, evaluating Keytruda plus enfortumab vedotin as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma. This regimen represents the first approval of a combination of a checkpoint inhibitor and an ADC.

Recognizing the proven benefit of Keytruda in combination with chemotherapy and shortened tumor types, we're exploring the tissue targeting concept by evaluating regimens, combining adcs and immunotherapy.

As well in collaboration with CJ and Astellas potentially practice changing survival data were presented from keynote 839, EV 302, evaluating keytruda plus in Fordham abdomen as first line treatment for patients with locally advanced or metastatic <unk> carcinoma.

This regiment represent the first approval of a combination of a checkpoint inhibitor and an ADC.

Turning to immuno-oncology, evidence continues to emerge for the benefit of Keytruda in the treatment of earlier stage cancer.

Turning to immuno oncology.

Dean Y. Li: Turning to immuno-oncology, evidence continues to emerge for the benefit of Keytruda in the treatment of earlier stage cancer, positive survival data from Keynote 671 evaluating Keytruda in combination with platinum doublet chemotherapy as neoadjuvant therapy, followed by adjuvant Keytruda in patients with Resectable stage II, IIIA or IIIB non small cell lung cancer compared to pre-operative chemotherapy, were presented at ESMO, further reinforcing the benefits of routine lung cancer screening for certain populations to enable early intervention. Based on the keynote 671 result last week. The FDA approved this indication with a differentiated label that includes overall survival Keytruda has now been approved for six indications to treat patients with non small cell lung cancer. You know 671, representing the Asa approval for Keytruda in earlier stage cancer. Positive data from additional early stage studies in women's cancer were also presented at ESMO. For keynote 796 in patients with estrogen receptor positive her two negative breast cancer or <unk>. 0522, and high risk early stage triple negative breast cancer and keynote a one eight for patients with high risk locally advanced cervical cancer. M D. A recently granted priority review for Keytruda based upon this study with a target action date of January 20th. We also announced keytruda significantly improved disease free survival for the adjuvant treatment of patients with localized muscle invasive and locally advanced Urothelium carcinoma based on keynote 123. And finally in collaboration with Madonna the Phase III trial for Keytruda in combination with the 940 and individualized neo antigen therapy and earlier stage non small cell lung cancer has now been posted and is poised to start soon. Precision oncology, our efforts continued to yield progress well read our <unk> two alpha inhibitor is approved for treatment of certain cancers in patients with von Hippel Lindau disease, a rare cancer prone genetic disorder. Studies, evaluating well rag and broader populations of patients whose tumors display analogous genetic underpinnings are ongoing.

Evidence continues to emerge for the benefit of Keytruda in the treatment of earlier stage cancer.

Caroline Litchfield: Positive survival data from KEYNOTE-671, evaluating Keytruda in combination with platinum doublet chemotherapy as neoadjuvant therapy, followed by adjuvant Keytruda in patients with resectable stage 2, 3A, or 3B non-small cell lung cancer compared to preoperative chemotherapy, were presented at ESMO, further reinforcing the benefit of routine lung cancer screening for certain populations to enable early intervention. Based on the KEYNOTE-671 results, last week, the FDA approved this indication with a differentiated label that includes overall survival. Keytruda has now been approved for six indications to treat patients with non-small cell lung cancer. KEYNOTE-671 represents the eighth approval for Keytruda in earlier stage cancer.

Positive survival data from KEYNOTE-671, evaluating Keytruda in combination with platinum doublet chemotherapy as neoadjuvant therapy, followed by adjuvant Keytruda in patients with resectable stage 2, 3A, or 3B non-small cell lung cancer compared to preoperative chemotherapy, were presented at ESMO, further reinforcing the benefit of routine lung cancer screening for certain populations to enable early intervention. Based on the KEYNOTE-671 results, last week, the FDA approved this indication with a differentiated label that includes overall survival. Keytruda has now been approved for six indications to treat patients with non-small cell lung cancer.

Positive survival data from keynote 671 evaluating keytruda in combination with platinum doublet chemotherapy as neo adjuvant therapy, followed by adjuvant Keytruda in patients with Resectable stage 238, or three be non small cell lung cancer compared to pre operative chemotherapy where it.

<unk> at ESMO further reinforcing the benefits of routine lung cancer screening for certain populations to enable early intervention.

Dean Y. Li: Based on the Keynote 671 result, last week the FDA approved this indication with a differentiated label that includes overall survival, Keytruda has now been approved for six indications to treat patients with non small cell lung cancer. Keynote-671, representing the As approval for Keytruda in earlier stage cancer. Positive data from additional early stage studies in women's cancer were also presented at ESMO. For keynote 796 in patients with estrogen receptor positive her two negative breast cancer or <unk>. 0522, and high risk early stage triple negative breast cancer and keynote a one eight for patients with high risk locally advanced cervical cancer. M D. A recently granted priority review for Keytruda based upon this study with a target action date of January 20th. We also announced keytruda significantly improved disease free survival for the adjuvant treatment of patients with localized muscle invasive and locally advanced Urothelium carcinoma based on keynote 123. And finally in collaboration with Madonna the Phase III trial for Keytruda in combination with the 940 and individualized neo antigen therapy and earlier stage non small cell lung cancer has now been posted and is poised to start soon. Precision oncology, our efforts continued to yield progress well read our <unk> two alpha inhibitor is approved for treatment of certain cancers in patients with von Hippel Lindau disease, a rare cancer prone genetic disorder. Studies, evaluating well rag and broader populations of patients whose tumors display analogous genetic underpinnings are ongoing.

Based on the keynote 671 result last week. The FDA approved this indication with a differentiated label that includes overall survival Keytruda has now been approved for six indications to treat patients with non small cell lung cancer.

KEYNOTE-671 represents the eighth approval for Keytruda in earlier stage cancer.

You know 671, representing the Asa approval for Keytruda in earlier stage cancer.

Dean Y. Li: Positive data from additional early stage studies in women's cancer were also presented at ESMO, For Keynote-756 in patients with estrogen receptor positive HER2-negative breast cancer or Keynote-522, in high risk early stage triple negative breast cancer and Keynote A18 for patients with high risk locally advanced cervical cancer. The FDA recently granted priority review for Keytruda based upon this study with a target action date of January 20th. We also announced keytruda significantly improved disease free survival for the adjuvant treatment of patients with localized muscle invasive and locally advanced Urothelium carcinoma based on keynote 123. And finally in collaboration with Madonna the Phase III trial for Keytruda in combination with the 940 and individualized neo antigen therapy and earlier stage non small cell lung cancer has now been posted and is poised to start soon. Precision oncology, our efforts continued to yield progress well read our <unk> two alpha inhibitor is approved for treatment of certain cancers in patients with von Hippel Lindau disease, a rare cancer prone genetic disorder. Studies, evaluating well rag and broader populations of patients whose tumors display analogous genetic underpinnings are ongoing.

Caroline Litchfield: Positive data from additional early stage studies in women's cancer were also presented at ESMO for KEYNOTE-756 in patients with estrogen-receptor-positive HER2-negative breast cancer, for KEYNOTE-522 in high-risk early stage triple-negative breast cancer, and KEYNOTE-A18 for patients with high-risk locally advanced cervical cancer. Now, the FDA recently granted priority review for Keytruda based upon this study with a target action date of 20 January. We also announced Keytruda significantly improved disease-free survival for the adjuvant treatment of patients with localized muscle-invasive and locally advanced urothelial carcinoma based on KEYNOTE-123. And finally, in collaboration with Moderna, the phase 3 trial for Keytruda in combination with V940 and individualized neoantigen therapy in earlier stage non-small cell lung cancer has now been posted and is poised to start soon. Precision oncology, our efforts continue to yield progress.

Positive data from additional early stage studies in women's cancer were also presented at ESMO for KEYNOTE-756 in patients with estrogen-receptor-positive HER2-negative breast cancer, for KEYNOTE-522 in high-risk early stage triple-negative breast cancer, and KEYNOTE-A18 for patients with high-risk locally advanced cervical cancer. Now, the FDA recently granted priority review for Keytruda based upon this study with a target action date of 20 January. We also announced Keytruda significantly improved disease-free survival for the adjuvant treatment of patients with localized muscle-invasive and locally advanced urothelial carcinoma based on KEYNOTE-123.

Positive data from additional early stage studies in women's cancer were also presented at ESMO.

For keynote 796 in patients with estrogen receptor positive her two negative breast cancer or <unk>.

0522, and high risk early stage triple negative breast cancer and keynote a one eight for patients with high risk locally advanced cervical cancer.

Dean Y. Li: The FDA recently granted priority review for Keytruda based upon this study with a target action date of January 20th, We also announced Keytruda significantly improved disease free survival for the adjuvant treatment of patients with localized, muscle invasive and locally advanced Urothelium carcinoma based on keynote 123. And finally in collaboration with Madonna the Phase III trial for Keytruda in combination with the 940 and individualized neo antigen therapy and earlier stage non small cell lung cancer has now been posted and is poised to start soon. Precision oncology, our efforts continued to yield progress well read our <unk> two alpha inhibitor is approved for treatment of certain cancers in patients with von Hippel Lindau disease, a rare cancer prone genetic disorder. Studies, evaluating well rag and broader populations of patients whose tumors display analogous genetic underpinnings are ongoing.

M D. A recently granted priority review for Keytruda based upon this study with a target action date of January 20th.

We also announced keytruda significantly improved disease free survival for the adjuvant treatment of patients with localized muscle invasive and locally advanced Urothelium carcinoma based on keynote 123.

Dean Y. Li: And finally in collaboration with Moderna, the Phase III trial for Keytruda in combination with V940 an individualized neo antigen therapy in earlier stage non small cell lung cancer has now been posted and is poised to start soon, precision oncology, our efforts continued to yield progress Welireg, our HIF-2 alpha inhibitor is approved for treatment of certain cancers in patients with von Hippel-Lindau disease, a rare cancer prone genetic disorder. Studies, evaluating well rag and broader populations of patients whose tumors display analogous genetic underpinnings are ongoing.

Dean Y. Li: And finally in collaboration with Moderna, the Phase III trial for Keytruda in combination with V940 an individualized neo antigen therapy in earlier stage non small cell lung cancer has now been posted and is poised to start soon. Precision oncology, our efforts continued to yield progress Welireg, our HIF-2 alpha inhibitor is approved for treatment of certain cancers in patients with von Hippel-Lindau disease, a rare cancer prone genetic disorder.

And finally, in collaboration with Moderna, the phase 3 trial for Keytruda in combination with V940 and individualized neoantigen therapy in earlier stage non-small cell lung cancer has now been posted and is poised to start soon. Precision oncology, our efforts continue to yield progress.

And finally in collaboration with Madonna the Phase III trial for Keytruda in combination with the 940 and individualized neo antigen therapy and earlier stage non small cell lung cancer has now been posted and is poised to start soon.

Dean Y. Li: Precision oncology, our efforts continued to yield progress Welireg, our HIF-2 alpha inhibitor is approved for treatment of certain cancers in patients with von Hippel-Lindau disease, a rare cancer prone genetic disorder, studies evaluating Welireg in broader populations of patients whose tumors display analogous genetic underpinnings are ongoing, data presented at ESMO from LITESPARK-005, evaluating Welireg for adult patients with advanced renal cell carcinoma, following immune checkpoint and anti-angiogenic therapies showed statistically significant and clinically meaningful improvement in progression free survival versus the standard of care.

Precision oncology, our efforts continued to yield progress well read our <unk> two alpha inhibitor is approved for treatment of certain cancers in patients with von Hippel Lindau disease, a rare cancer prone genetic disorder.

Caroline Litchfield: Welireg, our HIF-2 alpha inhibitor, is approved for treatment of certain cancers in patients with von Hippel-Lindau disease, a rare cancer-prone genetic disorder. Studies evaluating Welireg in broader populations of patients whose tumors display analogous genetic underpinnings are ongoing. Data presented at ESMO from LITESPARK-005, evaluating Welireg for adult patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies, showed statistically significant and clinically meaningful improvement in progression-free survival versus the standard of care. These findings support our supplemental new drug application for Welireg, which was granted priority review by the FDA with a target action date of 17 January. Additional phase 3 studies in combination with Keytruda and/or Lenvima in advanced and adjuvant renal cell carcinoma are proceeding.

Welireg, our HIF-2 alpha inhibitor, is approved for treatment of certain cancers in patients with von Hippel-Lindau disease, a rare cancer-prone genetic disorder. Studies evaluating Welireg in broader populations of patients whose tumors display analogous genetic underpinnings are ongoing. Data presented at ESMO from LITESPARK-005, evaluating Welireg for adult patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies, showed statistically significant and clinically meaningful improvement in progression-free survival versus the standard of care.

Dean Y. Li: Studies evaluating Welireg in broader populations of patients whose tumors display analogous genetic underpinnings are ongoing, data presented at ESMO from LITESPARK-005, evaluating Welireg for adult patients with advanced renal cell carcinoma, following immune checkpoint and anti-angiogenic therapies showed statistically significant and clinically meaningful improvement in progression free survival versus the standard of care. These. Finding support our supplemental new drug application for well, Iraq, which was granted priority review by the FDA with a target action date of January 2017. Additional phase III studies in combination with Keytruda, and <unk> and advancing an adjuvant renal cell carcinoma are proceeding. First time safety and preliminary efficacy data for MK 10, 84 are oral K Ras inhibitor, both as monotherapy in patients with solid tumors and in combination with keytruda for metastatic non small cell lung cancer, whose tumors harbored K Ras G 12 see mutations were presented at ESMO. Notably the combination arm showed a compelling objective response rate of 71%. The data are early we are encouraged by the potential to combine M. K 10, 84 with Keytruda. And the hematologic space, we will begin enrolling patients in our phase III study evaluating M pay $35 43, or BOMA dance that a second line treatment for central Thrombocythemia, an area with tremendous patient need from a dance that is derived from our acquisition of imago. Outside of the U S. European Union granted approval for Keytruda for adjuvant treatment of patients with non small cell lung cancer, who are at high risk of recurrence following complete resection and platinum based chemotherapy based on keynote <unk> 91, and for Keytruda in combination with Trastuzumab and chemotherapy. As first line treatment for patients with certain gastric or gastroesophageal junction adenocarcinoma based on keynote 811. In Japan, and then part of it in combination with Aboriginal and pregnant and so was approved for BRCA mutated metastatic castration resistant prostate cancer with distant metastasis based on the propel study. Now to our broader pipeline building. Building on the ongoing launch of Bax, New vans, which Caroline mentioned progress continues in our population focused pneumococcal conjugate vaccine program. The one one fix our investigational pneumococcal conjugate vaccine specifically designed for adult has demonstrated a robust immune responses to all 21 serotypes in the stride three and stride six studies.

Studies, evaluating well rag and broader populations of patients whose tumors display analogous genetic underpinnings are ongoing.

Data presented at ESMO from like Spark 005, evaluating whether erg for adult patients with advanced renal cell carcinoma, following immune checkpoint and anti angiogenic therapies showed statistically significant and clinically meaningful improvement in progression free survival versus the standard of care. These.

Dean Y. Li: These findings support our supplemental new drug application for Welireg, which was granted priority review by the FDA with a target action date of January 17th, additional Phase III studies in combination with Keytruda, and our Lenvatinib in advanced and adjuvant renal cell carcinoma are proceeding. First time safety and preliminary efficacy data for MK 1084 our oral K Ras inhibitor, both as monotherapy in patients with solid tumors and in combination with keytruda for metastatic non small cell lung cancer, whose tumors harbored K Ras G 12 see mutations were presented at ESMO. Notably the combination arm showed a compelling objective response rate of 71%. The data are early we are encouraged by the potential to combine M. K 10, 84 with Keytruda. And the hematologic space, we will begin enrolling patients in our phase III study evaluating M pay $35 43, or BOMA dance that a second line treatment for central Thrombocythemia, an area with tremendous patient need from a dance that is derived from our acquisition of imago. Outside of the U S. European Union granted approval for Keytruda for adjuvant treatment of patients with non small cell lung cancer, who are at high risk of recurrence following complete resection and platinum based chemotherapy based on keynote <unk> 91, and for Keytruda in combination with Trastuzumab and chemotherapy. As first line treatment for patients with certain gastric or gastroesophageal junction adenocarcinoma based on keynote 811. In Japan, and then part of it in combination with Aboriginal and pregnant and so was approved for BRCA mutated metastatic castration resistant prostate cancer with distant metastasis based on the propel study. Now to our broader pipeline building. Building on the ongoing launch of Bax, New vans, which Caroline mentioned progress continues in our population focused pneumococcal conjugate vaccine program. The one one fix our investigational pneumococcal conjugate vaccine specifically designed for adult has demonstrated a robust immune responses to all 21 serotypes in the stride three and stride six studies.

These findings support our supplemental new drug application for Welireg, which was granted priority review by the FDA with a target action date of 17 January. Additional phase 3 studies in combination with Keytruda and/or Lenvima in advanced and adjuvant renal cell carcinoma are proceeding.

Finding support our supplemental new drug application for well, Iraq, which was granted priority review by the FDA with a target action date of January 2017.

Additional phase III studies in combination with Keytruda, and <unk> and advancing an adjuvant renal cell carcinoma are proceeding.

Dean Y. Li: First time safety and preliminary efficacy data for MK-1084 our oral KRAS inhibitor, both as monotherapy in patients with solid tumors and in combination with Keytruda for metastatic non small cell lung cancer, whose tumors harbored KRAS G12C mutations were presented at ESMO, notably the combination arm showed a compelling objective response rate of 71%. The data are early we are encouraged by the potential to combine M. K 10, 84 with Keytruda. And the hematologic space, we will begin enrolling patients in our phase III study evaluating M pay $35 43, or BOMA dance that a second line treatment for central Thrombocythemia, an area with tremendous patient need from a dance that is derived from our acquisition of imago. Outside of the U S. European Union granted approval for Keytruda for adjuvant treatment of patients with non small cell lung cancer, who are at high risk of recurrence following complete resection and platinum based chemotherapy based on keynote <unk> 91, and for Keytruda in combination with Trastuzumab and chemotherapy. As first line treatment for patients with certain gastric or gastroesophageal junction adenocarcinoma based on keynote 811. In Japan, and then part of it in combination with Aboriginal and pregnant and so was approved for BRCA mutated metastatic castration resistant prostate cancer with distant metastasis based on the propel study. Now to our broader pipeline building. Building on the ongoing launch of Bax, New vans, which Caroline mentioned progress continues in our population focused pneumococcal conjugate vaccine program. The one one fix our investigational pneumococcal conjugate vaccine specifically designed for adult has demonstrated a robust immune responses to all 21 serotypes in the stride three and stride six studies.

Caroline Litchfield: First-time safety and preliminary efficacy data for MK-1084, our oral KRAS inhibitor, both as monotherapy in patients with solid tumors and in combination with Keytruda for metastatic non-small cell lung cancer whose tumors harbored KRAS G12C mutations, were presented at ESMO. Notably, the combination arm showed a compelling objective response rate of 71%. While the data are early, we are encouraged by the potential to combine MK-1084 with Keytruda. In the hematologic space, we will begin enrolling patients in our phase 3 study evaluating MK-3543 or Bomedemstat, a second-line treatment for essential thrombocythemia, an area with tremendous patient need. Bomedemstat is derived from our acquisition of Imago. Outside of the US, the European Union granted approval for Keytruda for adjuvant treatment of patients with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy based on KEYNOTE-091.

First-time safety and preliminary efficacy data for MK-1084, our oral KRAS inhibitor, both as monotherapy in patients with solid tumors and in combination with Keytruda for metastatic non-small cell lung cancer whose tumors harbored KRAS G12C mutations, were presented at ESMO. Notably, the combination arm showed a compelling objective response rate of 71%. While the data are early, we are encouraged by the potential to combine MK-1084 with Keytruda. In the hematologic space, we will begin enrolling patients in our phase 3 study evaluating MK-3543 or Bomedemstat, a second-line treatment for essential thrombocythemia, an area with tremendous patient need.

First time safety and preliminary efficacy data for MK 10, 84 are oral K Ras inhibitor, both as monotherapy in patients with solid tumors and in combination with keytruda for metastatic non small cell lung cancer, whose tumors harbored K Ras G 12 see mutations were presented at ESMO.

Notably the combination arm showed a compelling objective response rate of 71%.

Dean Y. Li: Of the data R early, we are encouraged by the potential to combine MK-1084 with Keytruda And the hematologic space, we will begin enrolling patients in our phase III study evaluating M pay $35 43, or BOMA dance that a second line treatment for central Thrombocythemia, an area with tremendous patient need from a dance that is derived from our acquisition of imago. Outside of the U S. European Union granted approval for Keytruda for adjuvant treatment of patients with non small cell lung cancer, who are at high risk of recurrence following complete resection and platinum based chemotherapy based on keynote <unk> 91, and for Keytruda in combination with Trastuzumab and chemotherapy. As first line treatment for patients with certain gastric or gastroesophageal junction adenocarcinoma based on keynote 811. In Japan, and then part of it in combination with Aboriginal and pregnant and so was approved for BRCA mutated metastatic castration resistant prostate cancer with distant metastasis based on the propel study. Now to our broader pipeline building. Building on the ongoing launch of Bax, New vans, which Caroline mentioned progress continues in our population focused pneumococcal conjugate vaccine program. The one one fix our investigational pneumococcal conjugate vaccine specifically designed for adult has demonstrated a robust immune responses to all 21 serotypes in the stride three and stride six studies.

Dean Y. Li: Of the data R early, we are encouraged by the potential to combine MK-1084 with Keytruda

The data are early we are encouraged by the potential to combine M. K 10, 84 with Keytruda.

Dean Y. Li: In the hematologic space, we will begin enrolling patients in our Phase III study evaluating MK-3543, or Bomedemstat a second line treatment for Essential Thrombocythaemia an area with tremendous patient need, Bomedemstat is derived from our acquisition of Imago. outside of the U.S. European Union granted approval for Keytruda for adjuvant treatment of patients with non small cell lung cancer, who are at high risk of recurrence following complete resection and platinum based chemotherapy based on keynote <unk> 91, and for Keytruda in combination with Trastuzumab and chemotherapy. As first line treatment for patients with certain gastric or gastroesophageal junction adenocarcinoma based on keynote 811. In Japan, and then part of it in combination with Aboriginal and pregnant and so was approved for BRCA mutated metastatic castration resistant prostate cancer with distant metastasis based on the propel study. Now to our broader pipeline building. Building on the ongoing launch of Bax, New vans, which Caroline mentioned progress continues in our population focused pneumococcal conjugate vaccine program. The one one fix our investigational pneumococcal conjugate vaccine specifically designed for adult has demonstrated a robust immune responses to all 21 serotypes in the stride three and stride six studies.

And the hematologic space, we will begin enrolling patients in our phase III study evaluating M pay $35 43, or BOMA dance that a second line treatment for central Thrombocythemia, an area with tremendous patient need from a dance that is derived from our acquisition of imago.

Bomedemstat is derived from our acquisition of Imago. Outside of the US, the European Union granted approval for Keytruda for adjuvant treatment of patients with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy based on KEYNOTE-091.

Dean Y. Li: Outside of the U.S. European Union granted approval for Keytruda for adjuvant treatment of patients with non small cell lung cancer who are at high risk of recurrence, following complete resection and platinum based chemotherapy based on Keynote-091, and for Keytruda in combination with Trastuzumab and chemotherapy as first line treatment for patients with certain gastric or Gastroesophageal junction adenocarcinoma based on Keynote-811. In Japan, and then part of it in combination with Aboriginal and pregnant and so was approved for BRCA mutated metastatic castration resistant prostate cancer with distant metastasis based on the propel study. Now to our broader pipeline building. Building on the ongoing launch of Bax, New vans, which Caroline mentioned progress continues in our population focused pneumococcal conjugate vaccine program. The one one fix our investigational pneumococcal conjugate vaccine specifically designed for adult has demonstrated a robust immune responses to all 21 serotypes in the stride three and stride six studies.

Outside of the U S.

European Union granted approval for Keytruda for adjuvant treatment of patients with non small cell lung cancer, who are at high risk of recurrence following complete resection and platinum based chemotherapy based on keynote <unk> 91, and for Keytruda in combination with Trastuzumab and chemotherapy.

Caroline Litchfield: For Keytruda, in combination with trastuzumab and chemotherapy as first-line treatment for patients with certain gastric or gastroesophageal junction adenocarcinoma based on KEYNOTE-811. In Japan, Lynparza, in combination with abiraterone and prednisone, was approved for BRCA-mutated metastatic castration-resistant prostate cancer with distant metastasis based on the PROpel study. Now, to our broader pipeline. Building on the ongoing launch of Vaxneuvance, which Caroline mentioned, progress continues in our population-focused pneumococcal conjugate vaccine program. V116, our investigational pneumococcal conjugate vaccine, specifically designed for adults, has demonstrated a robust immune response to all 21 serotypes in the STRIDE-3 and STRIDE-6 studies. Detailed findings from the STRIDE-3 study will be presented at the World Vaccine Congress West Coast in November. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address serotypes responsible for the majority of adult invasive pneumococcal disease in adults.

For Keytruda, in combination with trastuzumab and chemotherapy as first-line treatment for patients with certain gastric or gastroesophageal junction adenocarcinoma based on KEYNOTE-811. In Japan, Lynparza, in combination with abiraterone and prednisone, was approved for BRCA-mutated metastatic castration-resistant prostate cancer with distant metastasis based on the PROpel study. Now, to our broader pipeline. Building on the ongoing launch of Vaxneuvance, which Caroline mentioned, progress continues in our population-focused pneumococcal conjugate vaccine program.

As first line treatment for patients with certain gastric or gastroesophageal junction adenocarcinoma based on keynote 811.

Dean Y. Li: In Japan, Lynparza in combination with Abiraterone and Prednisolone and so was approved for BRCA-mutated metastatic castration-resistant prostate cancer with distant metastasis based on the propel study. Now to our broader pipeline building. Building on the ongoing launch of Bax, New vans, which Caroline mentioned progress continues in our population focused pneumococcal conjugate vaccine program. The one one fix our investigational pneumococcal conjugate vaccine specifically designed for adult has demonstrated a robust immune responses to all 21 serotypes in the stride three and stride six studies.

In Japan, and then part of it in combination with Aboriginal and pregnant and so was approved for BRCA mutated metastatic castration resistant prostate cancer with distant metastasis based on the propel study.

Dean Y. Li: Now to our broader pipeline, building on the ongoing launch of Vaxneuvance, which Caroline mentioned, progress continues in our population-focused pneumococcal conjugate vaccine program, V116 our investigational pneumococcal conjugate vaccine, specifically designed for adults has demonstrated a robust immune response to all 21 serotypes in the stride three and stride six studies detailed findings from the stride three study will be presented at the World vaccine Congress West Coast in November. If approved V116 would be the first pneumococcal conjugate vaccine specifically designed to address serotypes responsible for the majority of adult invasive pneumococcal disease in adults. Our company has deep expertise, given our breadth and depth of knowledge, both in immuno oncology and vaccines. We are leveraging these capabilities in immunology, where the first patient is ready to be enrolled in the phase III trial for M 70, 240, and ulcerative colitis. Turning to cardio metabolic disease programs last month at the European Respiratory Society International Congress, we presented data for <unk> currently under review by the FDA for the treatment of adults with pulmonary arterial hypertension. In an exploratory post hoc analysis of right heart catheterization and Echocardiographer data from patients in the phase III stellar study patients with ph treated which is Patterson for 24 weeks on top of background therapy showed a reduction in right heart size and improved right ventricular function. In hemodynamics status. In addition, we presented promising data from an analysis of the phase III criteria open label extension study in P. A H the results support the potential long term durability of the responses to tighter Sep and represent the longest safety and efficacy analysis for this compound to date.

Now to our broader pipeline building.

Building on the ongoing launch of Bax, New vans, which Caroline mentioned progress continues in our population focused pneumococcal conjugate vaccine program.

V116, our investigational pneumococcal conjugate vaccine, specifically designed for adults, has demonstrated a robust immune response to all 21 serotypes in the STRIDE-3 and STRIDE-6 studies. Detailed findings from the STRIDE-3 study will be presented at the World Vaccine Congress West Coast in November. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address serotypes responsible for the majority of adult invasive pneumococcal disease in adults.

The one one fix our investigational pneumococcal conjugate vaccine specifically designed for adult has demonstrated a robust immune responses to all 21 serotypes in the stride three and stride six studies.

Tailed findings from the stride three study will be presented at the World vaccine Congress West Coast in November.

If approved <unk>.

One six would be the first pneumococcal conjugate vaccine specifically designed to address serotypes responsible for the majority of adult invasive pneumococcal disease in adults.

Dean Y. Li: Our company has deep expertise, given our breadth and depth of knowledge, both in immuno-oncology and vaccines, we are leveraging these capabilities in immunology, where the first patient is ready to be enrolled in the Phase III trial for MK-7240 in ulcerative colitis. Turning to cardio metabolic disease programs last month at the European Respiratory Society International Congress, we presented data for <unk> currently under review by the FDA for the treatment of adults with pulmonary arterial hypertension. In an exploratory post hoc analysis of right heart catheterization and Echocardiographer data from patients in the phase III stellar study patients with ph treated which is Patterson for 24 weeks on top of background therapy showed a reduction in right heart size and improved right ventricular function. In hemodynamics status. In addition, we presented promising data from an analysis of the phase III criteria open label extension study in P. A H the results support the potential long term durability of the responses to tighter Sep and represent the longest safety and efficacy analysis for this compound to date.

Caroline Litchfield: Our company has deep expertise given our breadth and depth of knowledge both in immuno-oncology and vaccines. We are leveraging these capabilities in immunology where the first patient is ready to be enrolled in the phase 3 trial for MK-7240 in ulcerative colitis. Turning to cardiometabolic disease programs, last month at the European Respiratory Society International Congress, we presented data for sotatercept, currently under review by the FDA for the treatment of adults with pulmonary arterial hypertension. In an exploratory post-hoc analysis of right heart catheterization and echocardiography data from patients in the phase 3 STELLAR study, patients with PAH treated with sotatercept for 24 weeks on top of background therapy showed a reduction in right heart size, and improved right ventricular function and hemodynamic status. In addition, we presented promising data from an analysis of the phase 3 SOTERIA open-label extension study in PAH.

Our company has deep expertise given our breadth and depth of knowledge both in immuno-oncology and vaccines. We are leveraging these capabilities in immunology where the first patient is ready to be enrolled in the phase 3 trial for MK-7240 in ulcerative colitis. Turning to cardiometabolic disease programs, last month at the European Respiratory Society International Congress, we presented data for sotatercept, currently under review by the FDA for the treatment of adults with pulmonary arterial hypertension.

Our company has deep expertise, given our breadth and depth of knowledge, both in immuno oncology and vaccines. We are leveraging these capabilities in immunology, where the first patient is ready to be enrolled in the phase III trial for M 70, 240, and ulcerative colitis.

Dean Y. Li: Turning to cardio metabolic disease programs, last month at the European Respiratory Society International Congress, we presented data for Sotatercept, currently under review by the FDA for the treatment of adults with pulmonary arterial hypertension, in an exploratory post hoc analysis of right heart catheterization and echocardiography data from patients in the Phase III STELLAR study, patients with PH treated with Sotatercept for 24 weeks on top of background therapy showed a reduction in right heart size and improved right ventricular function in hemodynamics status. In addition, we presented promising data from an analysis of the phase III criteria open label extension study in P. A H the results support the potential long term durability of the responses to tighter Sep and represent the longest safety and efficacy analysis for this compound to date.

Turning to cardio metabolic disease programs last month at the European Respiratory Society International Congress, we presented data for <unk> currently under review by the FDA for the treatment of adults with pulmonary arterial hypertension.

In an exploratory post-hoc analysis of right heart catheterization and echocardiography data from patients in the phase 3 STELLAR study, patients with PAH treated with sotatercept for 24 weeks on top of background therapy showed a reduction in right heart size, and improved right ventricular function and hemodynamic status. In addition, we presented promising data from an analysis of the phase 3 SOTERIA open-label extension study in PAH.

In an exploratory post hoc analysis of right heart catheterization and Echocardiographer data from patients in the phase III stellar study patients with ph treated which is Patterson for 24 weeks on top of background therapy showed a reduction in right heart size and improved right ventricular function.

Dean Y. Li: In addition, we presented promising data from an analysis of the Phase III criteria open label extension study in P.A.H. the results support the potential long term durability of the response to Sotatercept and represent the longest safety and efficacy analysis for this compound to date, given the serious patient need in pulmonary arterial hypertension, our regulatory and clinical teams worked swiftly to submit the necessary regulatory filings for Sotatercept. The FDA has accepted the biologic license application under priority review with a target action date of March 26th. In addition, the submission to the committee for medicinal products for human use in the European Union has been completed. Also in cardiology momentum continues in the clinical development program for M. K 061, and six are all P. C. S. Canine inhibitor, we have initiated the coral reef lipid study in a broad patient population and coral reef outcomes, a randomized double blind study evaluating the efficacy. A M K 0616 with respect to major atherosclerotic cardiovascular events as well as a separate core week study in patients with heterozygous familial hypercholesterolemia. Over the last three years, we have moved with rigor and urgency to advance the best science, while carefully coordinating our efforts internally and externally. We have and continue to leverage the foundational properties of Keytruda, while adding promising candidates with novel mechanisms and modalities in oncology at. At the same time, we have expanded in our focused areas of excellent excellent to establish a diverse pipeline of promising candidates spanning multiple additional disease areas. We understand there is still work to be done, but the tangible advances we are making underscore our purpose of creating innovative medicines and vaccines that say.

In hemodynamics status.

In addition, we presented promising data from an analysis of the phase III criteria open label extension study in P. A H the results support the potential long term durability of the responses to tighter Sep and represent the longest safety and efficacy analysis for this compound to date.

Caroline Litchfield: The results support the potential long-term durability of the response to sotatercept and represent the longest safety and efficacy analysis for this compound to date. Given the serious patient need in pulmonary arterial hypertension, our regulatory and clinical teams worked swiftly to submit the necessary regulatory filings for sotatercept. The FDA has accepted the biologic license application under priority review with a target action date of 26 March 2024. In addition, the submission to the Committee for Medicinal Products for Human Use in the European Union has been completed. Also in cardiology, momentum continues in the clinical development program for MK-0616, our oral PCSK9 inhibitor.

The results support the potential long-term durability of the response to sotatercept and represent the longest safety and efficacy analysis for this compound to date. Given the serious patient need in pulmonary arterial hypertension, our regulatory and clinical teams worked swiftly to submit the necessary regulatory filings for sotatercept. The FDA has accepted the biologic license application under priority review with a target action date of 26 March 2024. In addition, the submission to the Committee for Medicinal Products for Human Use in the European Union has been completed.

Given the serious patient need in pulmonary arterial hypertension, our regulatory and clinical teams worked swiftly to submit the necessary regulatory filings for <unk>. The FDA has accepted the biologic license application under priority review with a target action date of March 20.

Dean Y. Li: The FDA has accepted the biologic license application under priority review with a target action date of March 26th, in addition, the submission to the committee for medicinal products for human use in the European Union has been completed, also in cardiology, momentum continues in the clinical development program for MK-0616 our oral PCSK9 inhibitor, we have initiated the CORALreef lipid study in a broad patient population and coral reef outcomes, a randomized double line study evaluating the efficacy of MK-0616 with respect to major atherosclerotic cardiovascular events as well as a separate core week study in patients with heterozygous familial hypercholesterolemia. Over the last three years, we have moved with rigor and urgency to advance the best science, while carefully coordinating our efforts internally and externally. We have and continue to leverage the foundational properties of Keytruda, while adding promising candidates with novel mechanisms and modalities in oncology at. At the same time, we have expanded in our focused areas of excellent excellent to establish a diverse pipeline of promising candidates spanning multiple additional disease areas. We understand there is still work to be done, but the tangible advances we are making underscore our purpose of creating innovative medicines and vaccines that say.

Six.

In addition, the submission to the committee for medicinal products for human use in the European Union has been completed.

Also in cardiology, momentum continues in the clinical development program for MK-0616, our oral PCSK9 inhibitor.

Also in cardiology momentum continues in the clinical development program for M. K 061, and six are all P. C. S. Canine inhibitor, we have initiated the coral reef lipid study in a broad patient population and coral reef outcomes, a randomized double blind study evaluating the efficacy.

Caroline Litchfield: We have initiated the CORALreef Lipid study in a broad patient population and CORALreef Outcomes, a randomized double-blind study evaluating the efficacy of MK-0616 with respect to major atherosclerotic cardiovascular events, as well as a separate CORALreef study in patients with heterozygous familial hypercholesterolemia. Over the last three years, we have moved with rigor and urgency to advance the best science while carefully coordinating our efforts internally and externally. We have and continue to leverage the foundational properties of Keytruda while adding promising candidates with novel mechanisms and modalities in oncology. At the same time, we have expanded in our focused areas of excellence to establish a diverse pipeline of promising candidates spanning multiple additional disease areas. We understand there is still work to be done, but the tangible advances we are making underscore our purpose of creating innovative medicines and vaccines that save and improve lives.

We have initiated the CORALreef Lipid study in a broad patient population and CORALreef Outcomes, a randomized double-blind study evaluating the efficacy of MK-0616 with respect to major atherosclerotic cardiovascular events, as well as a separate CORALreef study in patients with heterozygous familial hypercholesterolemia. Over the last three years, we have moved with rigor and urgency to advance the best science while carefully coordinating our efforts internally and externally. We have and continue to leverage the foundational properties of Keytruda while adding promising candidates with novel mechanisms and modalities in oncology.

A M K 0616 with respect to major atherosclerotic cardiovascular events as well as a separate core week study in patients with heterozygous familial hypercholesterolemia.

Dean Y. Li: Over the last three years, we have moved with rigor and urgency to advance the best science, while carefully coordinating our efforts internally and externally, We have and continue to leverage the foundational properties of Keytruda, while adding promising candidates with novel mechanisms and modalities in oncology, at the same time, we have expanded in our focused areas of excellence to establish a diverse pipeline of promising candidates spanning multiple additional disease areas, We understand there is still work to be done, but the tangible advances we are making underscore our purpose of creating innovative medicines and vaccines that save and improve lives, and now I turn the call back to Peter.

Over the last three years, we have moved with rigor and urgency to advance the best science, while carefully coordinating our efforts internally and externally.

We have and continue to leverage the foundational properties of Keytruda, while adding promising candidates with novel mechanisms and modalities in oncology at.

At the same time, we have expanded in our focused areas of excellence to establish a diverse pipeline of promising candidates spanning multiple additional disease areas. We understand there is still work to be done, but the tangible advances we are making underscore our purpose of creating innovative medicines and vaccines that save and improve lives.

At the same time, we have expanded in our focused areas of excellent excellent to establish a diverse pipeline of promising candidates spanning multiple additional disease areas. We understand there is still work to be done, but the tangible advances we are making underscore our purpose of creating innovative medicines and vaccines that say.

And improve lives and now I turn the call back to Peter.

Caroline Litchfield: Now I turn the call back to Peter.

Now I turn the call back to Peter.

Peter Dannenbaum: Thanks, Dean. Julie, we're ready to take questions. And as usual, we request that analysts limit themselves to a single question, please.

Peter Dannenbaum: Thanks Dean, Julie we're ready to take questions and as usual, we request that analysts limit themselves to a single question. Please.

Operator: Ladies and gentlemen, if you wish to ask a question, press star 1 on your telephone keypad. You may withdraw your question at any time by pressing star 2. If you are on a speakerphone, please pick up the handset before pressing the numbers. Once again, if you have a question, you may press star 1. One moment, please, for our first question. Our first question comes from Chris Shibutani with Goldman Sachs. Your line is open.

Julie Louise Gerberding: Ladies and gentlemen, if you wish to ask a question, press star one on your telephone keypad you may withdraw your question at any time by pressing star too, if you are on speakerphone, please pick up the handset before pressing the numbers, once again, if you have a question you May press Star one one moment please for our first question. Our first question comes from Chris Shibutani with Goldman Sachs. Your line is open.

If you are on speakerphone, please pick up the handset before pressing the numbers. Once again, if you have a question you May press Star one one moment. Please for our first question.

Our first question comes from Chris she'd be tiny with Goldman Sachs. Your line is open.

Chris Shibutani: Thank you. Good morning. The comments from the capital allocation standpoint seem to indicate that you feel you've done some critical math, and certainly some of the deals that you've done have been very important and meaningful. You set the cardiovascular revenue goal in 2030 at $10 billion. Do you think you've done enough there? And then, to provoke relatedly, animal health: do you still feel that that fits within the portfolio you've been building, but is there reshaping that still could come? Thank you.

Chris Shibutani: Thank you and good morning, the comments from the capital allocation standpoint, seem to indicate that you feel that you've done some critical mass and certainly some of the deals that you've done have been very important and meaningful, You set the cardiovascular revenue goal in 2030 at $10 billion, do you think you've done enough there? and then to provoke relatedly animal health do you still feel that that fits within the portfolio you've been building, but its the reshaping that still could come? Thank you.

Common from.

The capital allocation standpoint seem to indicate that you feel that you've done some critical mass and certainly some of the deals that you've done have been very important and meaningful.

You set the cardiovascular revenue goal in 2030 that $10 billion do you think you've done enough there and then to provoke Relatedly animal health do you still feel that that fits within the portfolio you've been building, but its the reshaping that still could come. Thank you.

Robert Davis: Great, Chris. This is Rob. I'll maybe start, and Dean or Caroline can jump in if they'd like. But first and foremost, I appreciate the comments. And as we sit here today, and Dean made reference to it, we feel very good about the progress we've made over the last couple of years through the assets we've brought in. You mentioned cardiometabolic, but also immunology, the progress we're making to broaden our position in oncology. And I'll get to it in a moment. But as you mentioned, the durable growth drivers we have with vaccines and animal health.

Rob Davis: Great, Chris. This is Rob. I'll maybe start, and Dean or Caroline can jump in if they'd like. But first and foremost, I appreciate the comments. And as we sit here today, and Dean made reference to it, we feel very good about the progress we've made over the last couple of years through the assets we've brought in. You mentioned cardiometabolic, but also immunology, the progress we're making to broaden our position in oncology. And I'll get to it in a moment. But as you mentioned, the durable growth drivers we have with vaccines and animal health.

Rob Davis: Great Chris This is Rob and I'll, maybe start and Dean or Caroline can jump in if they'd like but first and foremost I appreciate the comments and you know as we sit here today and Dean made reference to it, we feel very good about the progress we've made over the last couple of years, through the assets we brought in, You mentioned cardio metabolic but also immunology the progress, we're making to broaden our position in oncology and I'll get to in a moment, but as you mentioned the durable growth drivers we have with vaccines and animal health, but specifically to the cardio metabolic. Area, you know I can tell you that today as we sit here and just to remind people. What we had commented on in the past we've said based on both what we received through the acquisition of like so plus other programs you've been developing internally, we expected that we could be in a position to have greater than. The $10 billion of revenue potential in the mid twenties thirties, and I'd remind everyone that was on a non risk adjusted basis, but I would tell you as we sit here today, given what we've seen with the remarkable data from Stella. Excitement that is coming. Coming and where we're seeing from key opinion leaders with the potential launch of Chicago. So that hopefully early next year and approval even in Europe next year.

We've made over the last couple of years.

Assets, we brought Dan you'd mentioned cardio metabolic.

Also immunology the progress, we're making to broaden our position in oncology and I'll get to in a moment, but as you mentioned the durable growth drivers we have.

With vaccines and animal health, but specifically to the cardio metabolic.

Robert Davis: But specifically to the cardiometabolic area, I can tell you that today, as we sit here, and just to remind people what we had commented on in the past, we'd said, based on both what we received through the acquisition of Acceleron plus other programs we've been developing internally, we expected that we could be in a position to have greater than $10 billion of revenue potential in the mid-2030s. I'd remind everyone that was on a non-risk-adjusted basis.

But specifically to the cardiometabolic area, I can tell you that today, as we sit here, and just to remind people what we had commented on in the past, we'd said, based on both what we received through the acquisition of Acceleron plus other programs we've been developing internally, we expected that we could be in a position to have greater than $10 billion of revenue potential in the mid-2030s. I'd remind everyone that was on a non-risk-adjusted basis.

Rob Davis: But specifically to the cardio metabolic area, you know I can tell you that today as we sit here and just to remind people what we had commented on in the past, we've said based on both what we received through the acquisition of Acceleron plus other programs we've been developing internally, we expected that we could be in a position to have greater than $10 billion dollars of revenue in potential in the mid 20-30's, and I'd remind everyone that was on a non risk adjusted basis, but I would tell you as we sit here today, given what we've seen with the remarkable data from STELLAR, the excitement that is coming. Coming and where we're seeing from key opinion leaders with the potential launch of Sotatercept hopefully early next year and approval even in Europe next year, our confidence that we will achieve that 10 plus billion dollars is higher today than it was when we made the original comments, so we feel very good, it doesn't mean we feel like we're done but we feel very good about the progress and then as you reflected on animal health, we continue to see the animal health business as an important business for us, it is a durable growth driver as we look forward to it continues to be a business that we think will be accretive to our growth long term and it has strategic value to us where we are both benefiting from the synergies that it brings to us and that it benefits from the synergies coming from the science that we have on the human health side so, as we sit here today we remain committed that it is a strategic part of the company, but as I've often said its just not a philosophical view that is unchangeable, it's something were very objective about and we look at regularly but I can tell you is we've continued to look at it our view has not changed. I would just add one thing Chris in relationship to your question, but not related to revenue or finance I would just remind that we have made incredible advances in cancer, and where no one else on oncology company, but but but. The unmet need the unmet patient need in cardiovascular and metabolic diseases in the U S and in the World is quite substantial and I don't know that we're ever going to be done with that field in the near term. So we are still very committed to do more right.

Rob Davis: But specifically to the cardio metabolic area, you know I can tell you that today as we sit here and just to remind people what we had commented on in the past, we've said based on both what we received through the acquisition of Acceleron plus other programs we've been developing internally, we expected that we could be in a position to have greater than $10 billion dollars of revenue in potential in the mid 20-30's, and I'd remind everyone that was on a non risk adjusted basis. But I would tell you as we sit here today, given what we've seen with the remarkable data from STELLAR, the excitement that is coming and where we're seeing from key opinion leaders with the potential launch of Sotatercept hopefully early next year and approval even in Europe next year, our confidence that we will achieve that 10 plus billion dollars is higher today than it was when we made the original comments, so we feel very good, it doesn't mean we feel like we're done but we feel very good about the progress and then as you reflected on animal health, we continue to see the animal health business as an important business for us, it is a durable growth driver as we look forward to it continues to be a business that we think will be accretive to our growth long term and it has strategic value to us where we are both benefiting from the synergies that it brings to us and that it benefits from the synergies coming from the science that we have on the human health side so, as we sit here today we remain committed that it is a strategic part of the company, but as I've often said its just not a philosophical view that is unchangeable, it's something were very objective about and we look at regularly but I can tell you is we've continued to look at it our view has not changed.

Area, you know I can tell you that today as we sit here and just to remind people. What we had commented on in the past we've said based on both what we received through the acquisition of like so plus other programs you've been developing internally, we expected that we could be in a position to have greater than.

The $10 billion of revenue potential in the mid twenties thirties, and I'd remind everyone that was on a non risk adjusted basis, but I would tell you as we sit here today, given what we've seen with the remarkable data from Stella.

Robert Davis: But I would tell you, as we sit here today, given what we've seen with the remarkable data from STELLAR, the excitement that is coming and we're seeing from key opinion leaders with the potential launch of sotatercept, hopefully early next year and approval even in Europe next year, our confidence that we will achieve that $10-plus billion is higher today than it was when we made the original comment. So we feel very good. It doesn't mean we feel like we're done, but we feel very good about the progress. And then, as you reflected on animal health, we continue to see the animal health business as an important business for us. It is a durable growth driver. As we look forward, it continues to be a business that we think will be a contributor to our growth long-term.

But I would tell you, as we sit here today, given what we've seen with the remarkable data from STELLAR, the excitement that is coming and we're seeing from key opinion leaders with the potential launch of sotatercept, hopefully early next year and approval even in Europe next year, our confidence that we will achieve that $10-plus billion is higher today than it was when we made the original comment. So we feel very good. It doesn't mean we feel like we're done, but we feel very good about the progress. And then, as you reflected on animal health, we continue to see the animal health business as an important business for us. It is a durable growth driver.

Rob Davis: But I would tell you as we sit here today, given what we've seen with the remarkable data from STELLAR, the excitement that is coming and where we're seeing from key opinion leaders with the potential launch of Sotatercept hopefully early next year and approval even in Europe next year, our confidence that we will achieve that 10 plus billion dollars is higher today than it was when we made the original comments, so we feel very good, it doesn't mean we feel like we're done but we feel very good about the progress. and then as you reflected on animal health, we continue to see the animal health business as an important business for us, it is a durable growth driver as we look forward to it continues to be a business that we think will be accretive to our growth long term and it has strategic value to us where we are both benefiting from the synergies that it brings to us and that it benefits from the synergies coming from the science that we have on the human health side so, as we sit here today we remain committed that it is a strategic part of the company, but as I've often said its just not a philosophical view that is unchangeable, it's something were very objective about and we look at regularly but I can tell you is we've continued to look at it our view has not changed.

Excitement that is coming.

Coming and where we're seeing from key opinion leaders with the potential launch of Chicago. So that hopefully early next year and approval even in Europe next year.

Our confidence that we will achieve that 10 plus billion dollars is higher today.

Than it was when we made the original comments. So we feel very good it doesn't mean, we feel like we're done.

But we feel very good about the progress and then as you reflected on animal health, we continue to see the animal health business doesn't important business for us It is a durable growth driver.

Rob Davis: And then as you reflected on animal health, we continue to see the animal health business as an important business for us, it is a durable growth driver as we look forward it continues to be a business that we think will be accretive to our growth long term and it has strategic value to us, where we are both benefiting from the synergies that it brings to us and that it benefits from the synergies coming from the science that we have on the human health side so, as we sit here today we remain committed that it is a strategic part of the company, but as I've often that's not a philosophical view that is unchangeable, it's something we're very objective about and we look at regularly but I can tell you as we've continued to look at it our view has not changed.

As we look forward, it continues to be a business that we think will be a contributor to our growth long-term.

As we look forward to it.

<unk> continues to be a business that we think will be accretive to our growth long term.

Robert Davis: It has strategic value to us where we're both benefiting from the synergies that it brings to us and that it benefits from the synergies coming from the science that we have on the human health side. As we sit here today, we remain committed that it is the strategic part of the company. As I've often said, that's not a philosophical view that is unchangeable. It's something we're very objective about, and we look at regularly. I can tell you, as we've continued to look at it, our view has not changed.

And in it has strategic value to us where we are both benefiting from the synergies does it brings to us and that it benefits from the synergies coming from the science that we have on the human health side. So as we sit here today.

It has strategic value to us where we're both benefiting from the synergies that it brings to us and that it benefits from the synergies coming from the science that we have on the human health side. As we sit here today, we remain committed that it is the strategic part of the company. As I've often said, that's not a philosophical view that is unchangeable. It's something we're very objective about, and we look at regularly. I can tell you, as we've continued to look at it, our view has not changed.

Remaining committed to do this as a strategic part of the company, but as I've often said its just not.

A philosophical views it as unchangeable, if something were very objective about and we look at regularly but I can tell you is we've continued to look at it our view has not changed.

Dean Li: I would just add one thing, Chris, in relationship to your question, but not related to revenue or finance. I would just remind that we have made incredible advances in cancer, and we're known as an oncology company. But the unmet need, the unmet patient need in cardiovascular and metabolic diseases in the US and in the world is quite substantial. And I don't know that we're ever going to be done with that field in the near term. So we are still very committed to do more.

I would just add one thing Chris in relationship to your question, but not related to revenue or finance I would just remind that we have made incredible advances in cancer, and where no one else on oncology company, but but but.

Dean Y. Li: I would just add one thing Chris, in relationship to your question, but not related to revenue or finance, I would just remind that we have made incredible advances in cancer, and we're known as an oncology company, but the unmet need, the unmet patient need in cardiovascular and metabolic diseases in the U.S. and in the World, is quite substantial and I don't know that we're ever going to be done with that field in the near term, so we are still very committed to do more right.

The unmet need the unmet patient need in cardiovascular and metabolic diseases in the U S and in the World is quite substantial and I don't know that we're ever going to be done with that field in the near term. So we are still very committed to do more right.

Peter Dannenbaum: Great. Thank you, Chris. Next question, please, Julie.

Peter Dannenbaum: Great. Thank you Chris next question please Julie.

Operator: Thank you. Our next question comes from Mara Goldstein with Mizuho. Your line is open.

Julie Louise Gerberding: Thank you, our next question comes from Mara Goldstein with Mizuho. Your line is open.

Our next question comes from Mara Goldstein with Mizuho. Your line is open.

Mara Goldstein: Great. Thanks so much for taking the question. I'm curious, the discussion around Keytruda and migrating components of the revenue to earlier lines of therapy, relative to when you first made statements about where you expected to be from a percentage, do you think you're ahead of that at this point in time or on track to where you originally thought you'd be today?

Mara Goldstein: Great. Thanks, so much for taking my question, I'm curious you know the discussion around Keytruda and migrating components of the revenue to earlier lines of therapy, relative to when you first made statements about where you expect it to be from a percentage, do you think you're ahead of that at this point in time or on track to where you originally thought you'd be today?

We're on track to where you originally thought you'd be today.

Robert Davis: Yeah. The short answer, Mara, is we are ahead of where we thought we would be. Just to remind everyone, we've been commenting that we expect 50% of our growth to come from movement into the earlier stages of disease in oncology as we look forward to ultimately get to a global mix with it being about 25% of our total revenues. But I can tell you, as we sit here today, we are tracking ahead of where we expected we would be. Obviously, not surprising when you see just the phenomenal results from keynote 671, what that's going to mean in the perioperative space for people in early-stage lung cancer, building on 091, the continued strength we're seeing across adjuvant, RCC, and melanoma. We're up now to eight approvals in the space. So we're in a very good position.

Rob Davis: Yeah. The short answer, Mara, is we are ahead of where we thought we would be. Just to remind everyone, we've been commenting that we expect 50% of our growth to come from movement into the earlier stages of disease in oncology as we look forward to ultimately get to a global mix with it being about 25% of our total revenues. But I can tell you, as we sit here today, we are tracking ahead of where we expected we would be. Obviously, not surprising when you see just the phenomenal results from keynote 671, what that's going to mean in the perioperative space for people in early-stage lung cancer, building on 091, the continued strength we're seeing across adjuvant, RCC, and melanoma. We're up now to eight approvals in the space. So we're in a very good position.

Rob Davis: Yeah, the short answer Mara is we, we're ahead of where we thought we would be and just to remind everyone, we've been commenting that we expect 50% of our growth to come from movement into the earlier stages of disease and oncology as we look forward to ultimately get to a global percent with that being about 25% of our total revenues, but I can tell you is where we sit here today, we are tracking ahead of where we expected we would be. And obviously not surprising when you see the just the phenomenal results from keynote 671, what that's going to mean in the peer real operative space or people in early stage lung cancer. We're building on the 191. The continued strength, we're seeing across adjuvant in RCC. The melanoma were up now to eight. The approvals in this space so we're. We're in a very good position, but I've made about S Carolina, she doesn't even things you'd like that. The only thing I'd add is to your point, we've made tremendous progress. We think this year, we will have 20% of all keytruda business coming from the earliest stage cancer setting and as we move forward given the tremendous stay too we've had and the indications coming we're really excited about the opportunity. The crowd in lung in potentially bladder and many other indications. I just wanted to make. Carlo because we had an investor discussion this past Sunday and we're really focused on the ADC and Daiichi Sankyo and Cleveland, but I just wanted to call out that for me keynote 671 is a watershed moment for the field I would remind everyone that a similar watershed happened in metal. Static lung cancer in 2018 keynote 189 in 2018 as when keynote 671 was initiated at an earlier stage and only after five five years. After only 5.5 years in an earlier stage trial, you have clear evidence of Etfs and <unk>. S benefit and I really think this will catalyze a change in how we treat early stage lung cancer, how we detect early. Cantor and how we screen do you think about treating early those patients with stage two and three you can reduce the mortality by 28% I think it will catalyze people really looking at any one going to surgery in stage, two and three not just in three.

We've been commenting that we expect 50% of our growth to come from movement into the earlier stages.

Of disease and oncology as we look forward to ultimately get to a global a percent wasn't being about 25% of our total revenues, but I can tell you is where we sit here today.

We were we were tracking ahead of where we expected we would be and obviously not surprising when you see the just the phenomenal results from keynote 671, what that's going to mean in the peer real operative space or people in early stage lung cancer. We're building on the 191. The continued strength, we're seeing across adjuvant in RCC.

Rob Davis: And obviously, not surprising when you see the just the phenomenal results from Keynote-671, what that's going to mean in the Perioperative space or people in early stage lung cancer we're building on the 091, the continued strength we're seeing across adjuvant in RCC, the melanoma we're up now to eight approvals in this space so, we're in a very good position, but I maybe now ask Caroline if she has anything she'd like to add. The only thing I'd add is to your point, we've made tremendous progress. We think this year, we will have 20% of all keytruda business coming from the earliest stage cancer setting and as we move forward given the tremendous stay too we've had and the indications coming we're really excited about the opportunity. The crowd in lung in potentially bladder and many other indications. I just wanted to make. Carlo because we had an investor discussion this past Sunday and we're really focused on the ADC and Daiichi Sankyo and Cleveland, but I just wanted to call out that for me keynote 671 is a watershed moment for the field I would remind everyone that a similar watershed happened in metal. Static lung cancer in 2018 keynote 189 in 2018 as when keynote 671 was initiated at an earlier stage and only after five five years. After only 5.5 years in an earlier stage trial, you have clear evidence of Etfs and <unk>. S benefit and I really think this will catalyze a change in how we treat early stage lung cancer, how we detect early. Cantor and how we screen do you think about treating early those patients with stage two and three you can reduce the mortality by 28% I think it will catalyze people really looking at any one going to surgery in stage, two and three not just in three.

The melanoma were up now to eight.

The approvals in this space so we're.

We're in a very good position, but I've made about S Carolina, she doesn't even things you'd like that.

Robert Davis: But maybe I'd ask Caroline if she has anything she'd like to add.

But maybe I'd ask Caroline if she has anything she'd like to add.

Caroline Litchfield: The only thing I'd add, Rob, is to your point, we've made tremendous progress. We think this year we will have 20% of our Keytruda business coming from the earliest stage cancer setting. And as we move forward, given the tremendous data we've had and the indications coming, we're really excited about the opportunity to further grow in lung, in potentially bladder, and many other indications.

The only thing I'd add is to your point, we've made tremendous progress. We think this year, we will have 20% of all keytruda business coming from the earliest stage cancer setting and as we move forward given the tremendous stay too we've had and the indications coming we're really excited about the opportunity.

Caroline Litchfield: The only thing I'd add Rob is to your point, we've made tremendous progress we think this year, we will have 20% of all Keytruda business coming from the earliest stage cancer setting and as we move forward given the tremendous stage we've had and the indications coming we're really excited about the opportunity (inaudible) in lung, in potentially bladder and many other indications. I just wanted to make a call out because we had an investor discussion this past Sunday and we're really focused on the ADC and Daiichi Sankyo and Cleveland, but I just wanted to call out that for me keynote 671 is a watershed moment for the field I would remind everyone that a similar watershed happened in metal. Static lung cancer in 2018 keynote 189 in 2018 as when keynote 671 was initiated at an earlier stage and only after five five years. After only 5.5 years in an earlier stage trial, you have clear evidence of Etfs and <unk>. S benefit and I really think this will catalyze a change in how we treat early stage lung cancer, how we detect early. Cantor and how we screen do you think about treating early those patients with stage two and three you can reduce the mortality by 28% I think it will catalyze people really looking at any one going to surgery in stage, two and three not just in three.

The crowd in lung in potentially bladder and many other indications.

Dean Li: Yeah. I just want to make a call out because we had an investor discussion this past Sunday, and it really focused on the ADC and Daiichi Sankyo and Kelun. But I just want to call out that for me, KEYNOTE-671 is a watershed moment for the field. I would remind everyone that a similar watershed happened in metastatic lung cancer in 2018, KEYNOTE-189. And 2018 is when KEYNOTE-671 was initiated. It's an earlier stage. And only after 5.5 years, after only 5.5 years in an earlier stage trial, you have clear evidence of EFS and OS benefit. And I really think this will catalyze a change in how we treat early-stage lung cancer, how we detect early lung cancer, and how we screen. If you think about treating early, those patients with stage 2 and 3, you can reduce their mortality by 28%.

I just wanted to make.

Carlo because we had an investor discussion this past Sunday and we're really focused on the ADC and Daiichi Sankyo and Cleveland, but I just wanted to call out that for me keynote 671 is a watershed moment for the field I would remind everyone that a similar watershed happened in metal.

Dean Y. Li: I just want to make a call out, because we had an investor discussion this past Sunday and we're really focused on the ADC and Daiichi Sankyo and Kelun, but I just wanted to call out that for me Keynote-671 is a watershed moment for the field, I would remind everyone that a similar watershed happened in metastatic lung cancer in 2018 Keynote-189 in 2018 as when Keynote-671 was initiated at an earlier stage and only after 5.5 years, after only 5.5 years in an earlier stage trial, you have clear evidence of EFS and OS benefit. And I really think this will catalyze a change in how we treat early stage lung cancer, how we detect early lung cancer and how we screen, do you think about treating early those patients with Stage II and III you can reduce the mortality by 28%, I think it will catalyze people really looking at anyone going to surgery in Stage II AND III, not just in III

Static lung cancer in 2018 keynote 189 in 2018 as when keynote 671 was initiated at an earlier stage and only after five five years. After only 5.5 years in an earlier stage trial, you have clear evidence of Etfs and <unk>.

S benefit and I really think this will catalyze a change in how we treat early stage lung cancer, how we detect early.

Cantor and how we screen do you think about treating early those patients with stage two and three you can reduce the mortality by 28% I think it will catalyze people really looking at any one going to surgery in stage, two and three not just in three.

If you think about treating early, those patients with stage 2 and 3, you can reduce their mortality by 28%.

Dean Li: I think it will catalyze people really looking at anyone going to surgery in stage 2 and 3, not just in 3. People are going to have to think very carefully of why someone should get this regimen. In terms of detecting early, I think it's really important. How many individuals have a chest CT or a chest X-ray with incidental findings, and there's little follow-up? In the day and age of electronic health records, it's very easy to figure out how many people have incidental nodules that never got followed up. I think that will change. And I think in screening early, we have guidelines where the adherence is only 6% to 7%. And these guidelines were set four or five years ago where the concept was it would reduce mortality by 20%. With the data that we have, that number is no longer at 20%. It's much lower.

I think it will catalyze people really looking at anyone going to surgery in stage 2 and 3, not just in 3. People are going to have to think very carefully of why someone should get this regimen. In terms of detecting early, I think it's really important. How many individuals have a chest CT or a chest X-ray with incidental findings, and there's little follow-up? In the day and age of electronic health records, it's very easy to figure out how many people have incidental nodules that never got followed up. I think that will change. And I think in screening early, we have guidelines where the adherence is only 6% to 7%.

Dean Y. Li: And I really think this will catalyze a change in how we treat early stage lung cancer, how we detect early lung cancer and how we screen, do you think about treating early those patients with Stage II and III you can reduce the mortality by 28%, I think it will catalyze people really looking at anyone going to surgery in Stage II AND III, not just in III people are going to have to think very carefuly of why someone should get this regimen. In terms of detecting early

People are going to have to think very carefully are why why someone should get this regiment in terms of detecting early I think it's really important how many individuals have a chassis T or a chest X ray with incidental findings and Theres a little follow up in day and age of electronic Health Records at very.

Easy to figure out how many people have incidental nodules that never got followed up I think that will change and I think in screening early we have guidelines, where the adherence is only 6% to 7% and these guidelines were set you know four or five years ago, where the concept, whereas it would reduce mortality by 20% with the data that we have.

And these guidelines were set four or five years ago where the concept was it would reduce mortality by 20%. With the data that we have, that number is no longer at 20%. It's much lower.

Dean Y. Li: In terms of detecting early I think it's really important, how many individuals have a chest CT or chest X-Ray with incidental findings and there's little follow-up and A&H or electronic health records is very easy to figure out how many people had incidental nodules that never got followed up, I think that will change, and I think in screening early we have guidelines where the adherence is only 67% and these guidelines were set 4 or 5 years ago where the concept was it would reduce mortality by 20%, whis this data that we have That number is no longer at 20%, it's much lower and so I think there will be a push by the American cancer Society, NCC and NCI NIH to simplify and what in those guidelines because that is the this is the inexorable March of <unk>. Oh into earlier stage and into the most important cancer, which is lung cancer, which is the number one cause of death for women and the number one cause for men and our commitment to this field is not just 671 and 91. It is also as we highlighted our interest of moving I N T. The.

That number is no longer at 20%, it's much lower and so I think there will be a push by the American cancer Society, NCC and NCI NIH to simplify and what in those guidelines because that is the this is the inexorable March of <unk>.

Dean Li: I think there will be a push by the American Cancer Society, NCCN, NCI, and NIH to simplify and broaden those guidelines because this is the inexorable march of IO into earlier stage and into the most important cancer, which is lung cancer, which is the number one cause of death for women and the number one cause for men. Our commitment to this field is not just 671 and 91. It is also, as we highlighted, our interest of moving INT, the individualized neoantigen, therapy into earlier stage in lung cancer.

I think there will be a push by the American Cancer Society, NCCN, NCI, and NIH to simplify and broaden those guidelines because this is the inexorable march of IO into earlier stage and into the most important cancer, which is lung cancer, which is the number one cause of death for women and the number one cause for men. Our commitment to this field is not just 671 and 91. It is also, as we highlighted, our interest of moving INT, the individualized neoantigen, therapy into earlier stage in lung cancer.

Dean Y. Li: And I think in screening early we have guidelines where the adherence is only 67% and these guidelines were set 4 or 5 years ago where the concept was it would reduce mortality by 20%, whit this data that we have, that number is no longer at 20%, it's much lower and so I think there will be a push by the American cancer Society, NCC and NCI, NIH to simplify and what in those guidelines because that is the, this is the inexorable march of IO into earlier stage and into the most important cancer, which is lung cancer, which is the number one cause of death for women and the number one cause for men and our commitment to this field is not just 671 and 91, It is also as we highlighted our interest of moving INT, the individualized neo antigen therapy into earlier stage in lung cancer. great. Great. Thank you Meera next question please drilling.

Oh into earlier stage and into the most important cancer, which is lung cancer, which is the number one cause of death for women and the number one cause for men and our commitment to this field is not just 671 and 91. It is also as we highlighted our interest of moving I N T. The.

Realize neo antigen therapy into earlier stage in lung cancer great.

Peter Dannenbaum: Great. Thank you, Mara. Next question, please, Julie.

Great. Thank you Meera next question please drilling.

Peter Dannenbaum: Great. Thank you Mara next question please Julie.

Operator: Thank you. Our next question comes from Carter Gould with Barclays. Your line is open.

Julie Louise Gerberding: Thank you. Our next question comes from Carter Gould with Barclays. Your line is open. Great. Good morning, Thanks for taking the question. Maybe at the risk of going back to the that ATC topic, one of the key questions and sort of the back and forth that's come out. And the Trop two space is just the ability to combine your choke too with I O going forward, but a lot of commentary in the Milo suppression, there and to the extent that may restrict your ability to combine with I O deemed love to get your thoughts there and any additional commentary you can provide. Specifically to two any ADC that we would we would advance in any tissue tumor. Tumor type one thinks about monotherapy and one thinks about a clearer indication and a line of sight. But one also think about how the field develops and in combinations and those combinations can be with PD ones, but I would also highlight it can be with chemo. It can be ras it can be with novel hormonal agents that can be with PARP. It can be with other adcs and you have to think from late in earlier in relationship to trope too specifically in non small. So lung cancer I believe that I have said in the past that one has to think about how the field has evolved there was a watershed moment. It was keynote 189 and <unk> plus chemo in a broad patient population along that indication do really well so those of US who want to advance what I would say an 80. See our Nextgen chemo, that's how I think about it has to think about a way to combine it with PD one in a way that is not just effective but substantially effective over keynote 189. We are very interested in advancing our trop two ADC in relationship to that in that combination like all chemotherapy based treatments, whether it's chemotherapy or with chemotherapy on a payload with ADC what has to think about adverse effects in combinatorial adverse effects and the ability to keep patients on the medicines.

Julie Louise Gerberding: Thank you. Our next question comes from Carter Gould with Barclays. Your line is open.

Carter Lewis Gould: Great, Good morning, Thanks for taking the question. Maybe at the risk of going back to the that ADC topic, one of the key questions and sort of the back and forth that's come out in the TROP2 space is just the ability to combine your TROP2 with IO going forward, but a lot of commentary in the Milo suppression, there and to the extent that may restrict your ability to combine with IO deemed, love to get your thoughts there and any additional commentary you can provide. Specifically to two any ADC that we would we would advance in any tissue tumor. Tumor type one thinks about monotherapy and one thinks about a clearer indication and a line of sight. But one also think about how the field develops and in combinations and those combinations can be with PD ones, but I would also highlight it can be with chemo. It can be ras it can be with novel hormonal agents that can be with PARP. It can be with other adcs and you have to think from late in earlier in relationship to trope too specifically in non small. So lung cancer I believe that I have said in the past that one has to think about how the field has evolved there was a watershed moment. It was keynote 189 and <unk> plus chemo in a broad patient population along that indication do really well so those of US who want to advance what I would say an 80. See our Nextgen chemo, that's how I think about it has to think about a way to combine it with PD one in a way that is not just effective but substantially effective over keynote 189. We are very interested in advancing our trop two ADC in relationship to that in that combination like all chemotherapy based treatments, whether it's chemotherapy or with chemotherapy on a payload with ADC what has to think about adverse effects in combinatorial adverse effects and the ability to keep patients on the medicines.

Carter Gould: Great. Good morning. Thanks for taking the question. Maybe at the risk of going back to that ADC topic, one of the key questions and sort of the back and forth that's come out in the TROP2 space is just the ability to combine your TROP2 with IO going forward. There's been a lot of commentary on the myelosuppression there, and to the extent that may restrict your ability to combine with IO. Dean, love to get your thoughts there and any additional commentary you can provide.

Great. Good morning, Thanks for taking the question.

Maybe at the risk of going back to the that ATC topic, one of the key questions and sort of the back and forth that's come out.

And the Trop two space is just the ability to combine your choke too with I O going forward, but a lot of commentary in the Milo suppression, there and to the extent that may restrict your ability to combine with I O deemed love to get your thoughts there and any additional commentary you can provide.

Dean Li: Yeah. Specifically to any ADC that we would advance in any tissue tumor type, one thinks about monotherapy, and one thinks about a clear indication and a line of sight. But one also has to think about how the field develops and in combinations. And those combinations can be with PD-1s, but I would also highlight it can be with chemo. It can be RAS. It can be with novel hormonal agents. It can be with PARP. It can be with other ADCs. And you have to think from late and earlier. In relationship to TROP2, specifically in non-small cell lung cancer, I believe that I have said in the past that one has to think about how the field has evolved. There was a watershed moment. It was KEYNOTE-189. And pembrolizumab plus chemo in a broad patient population along that indication do really well.

Specifically to two any ADC that we would we would advance in any tissue tumor.

Dean Y. Li: Specifically to any ADC that we would, we would advance in any tissue tumor type, one thinks about monotherapy and one thinks about a clear indication in a line of sight but one also think about how the field develops and in combinations and those combinations can be with PD-1's, but I would also highlight it can be with chemo, it can be Ras, it can be with novel hormonal agents, it can be with PARP, it can be with other ADCs and you have to think from late and earlier. in relationship to TROP2 specifically in non small. So lung cancer I believe that I have said in the past that one has to think about how the field has evolved there was a watershed moment. It was keynote 189 and <unk> plus chemo in a broad patient population along that indication do really well so those of US who want to advance what I would say an 80. See our Nextgen chemo, that's how I think about it has to think about a way to combine it with PD one in a way that is not just effective but substantially effective over keynote 189. We are very interested in advancing our trop two ADC in relationship to that in that combination like all chemotherapy based treatments, whether it's chemotherapy or with chemotherapy on a payload with ADC what has to think about adverse effects in combinatorial adverse effects and the ability to keep patients on the medicines.

Tumor type one thinks about monotherapy and one thinks about a clearer indication and a line of sight.

But one also think about how the field develops and in combinations and those combinations can be with PD ones, but I would also highlight it can be with chemo. It can be ras it can be with novel hormonal agents that can be with PARP. It can be with other adcs and you have to think from late in earlier in relationship to trope too specifically in non small.

Dean Y. Li: In relationship to TROP2 specifically in non small cell lung cancer, I believe that I have said in the past that one has to think about how the field has evolved, there was a watershed moment, it was Keynote-189 and Pembro plus chemo in a broad patient population along that indication do really well, so those of us who want to advance what I would say an ADC IN Nextgen chemo, that's how I think about it, has to think about a way to combine it with PD-1 in a way that is not just effective but substantially effective over keynote-189. We are very interested in advancing our trop two ADC in relationship to that in that combination like all chemotherapy based treatments, whether it's chemotherapy or with chemotherapy on a payload with ADC what has to think about adverse effects in combinatorial adverse effects and the ability to keep patients on the medicines.

So lung cancer I believe that I have said in the past that one has to think about how the field has evolved there was a watershed moment. It was keynote 189 and <unk> plus chemo in a broad patient population along that indication do really well so those of US who want to advance what I would say an 80.

There was a watershed moment. It was KEYNOTE-189. And pembrolizumab plus chemo in a broad patient population along that indication do really well.

Dean Li: So those of us who want to advance what I would say in ADC, a next-gen chemo, that's how I think about it, have to think about a way to combine it with PD-1 in a way that is not just effective, but substantially effective over KEYNOTE-189. We are very interested in advancing our TROP2 ADC in relationship to that, in that combination. Like all chemotherapy-based treatments, whether it's chemotherapy or whether it's chemotherapy on a payload with ADC, one has to think about adverse effects and combinatorial adverse effects and the ability to keep patients on the medicines. The data that we have shown with our partner, our valued partner, Kelun, is that we think that there is room to be able to advance MK-2870 and PD-1s in a variety of tumors and that they are combinable, tolerable, and will be effective.

So those of us who want to advance what I would say in ADC, a next-gen chemo, that's how I think about it, have to think about a way to combine it with PD-1 in a way that is not just effective, but substantially effective over KEYNOTE-189. We are very interested in advancing our TROP2 ADC in relationship to that, in that combination. Like all chemotherapy-based treatments, whether it's chemotherapy or whether it's chemotherapy on a payload with ADC, one has to think about adverse effects and combinatorial adverse effects and the ability to keep patients on the medicines.

See our Nextgen chemo, that's how I think about it has to think about a way to combine it with PD one in a way that is not just effective but substantially effective over keynote 189.

We are very interested in advancing our trop two ADC in relationship to that in that combination like all chemotherapy based treatments, whether it's chemotherapy or with chemotherapy on a payload with ADC what has to think about adverse effects in combinatorial adverse effects and the ability to keep patients on the medicines.

Dean Y. Li: We are very interested in advancing our TROP2 ADC in relationship to that in that combination, like all chemotherapy based treatments, whether it's chemotherapy or wether is chemotherapy on a payload with ADC, one has to think about adverse effects and combinatorial adverse effects and the ability to keep patients on the medicines, the data that we have shown with our partner, our valued partner Kalou is that we think that there is room to be able to advance MK-2870 and PD-1 in a variety of tumors and that they are combinable tolerable and will be effective but those are the trials that we're starting to do in phase III in in the ex China regulatory arena.

The data that we have shown with our partner, our valued partner, Kelun, is that we think that there is room to be able to advance MK-2870 and PD-1s in a variety of tumors and that they are combinable, tolerable, and will be effective.

The data that we have shown with our partner our valued partner Kalou is that we think that there is room to be able to advance.

M. K 28, 70, and PD one in a variety of tumors and that they are combinable tolerable and will be effective but those are the trials that we're starting to do in phase III in in the ex China.

Dean Li: But those are the trials that we're starting to do in phase 3 in the ex-China regulatory arena.

But those are the trials that we're starting to do in phase 3 in the ex-China regulatory arena.

Regulatory.

Arena. Thank.

Peter Dannenbaum: Thank you, Carter. Next question, please, Julie.

Peter Dannenbaum: Thank you Carter next question please Julie

Operator: Thank you. Our next question comes from Seamus Fernandez with Guggenheim. Your line is open.

Julie Louise Gerberding: Thank you. Our next question comes from Seamus Fernandez with Guggenheim. Your line is open.

Seamus Fernandez: Oh, thanks so much for the question. So just wanted to talk about margins and some of the margin targets that you've offered. I think historically, you called out a 2024 margin target of better than 42%. Just trying to get a better sense of how we're tracking towards that target, particularly in the context of the substantial reduction in your royalty burden, both for Keytruda and Gardasil. And if you wouldn't mind, would you perhaps disclose what that cumulative royalty burden was in Q3 of this year just so that we can provide some context for the upside case or at least what we should be anticipating there? Thanks so much.

Seamus Fernandez: Oh, thanks, so much for the question so, just wanted to talk about margins and some of the margin targets that you offered I think historically you called out a 2024 margin target of better than 42%, I'm just trying to get a better sense of how we're tracking towards that target, particularly in the context of the a substantial reduction in your royalty burden both for Keytruda and Gardasil and if you wouldn't mind would you perhaps disclose what that acumulative royalty burden was in the third quarter of this year are just so that we can provide some context for the upside case or at least that's what we should be anticipating there. Thanks so much. <unk>. Thank you for the question, we've seen really strong margin expansion in our company over the last several years and as we look forward. We expect continued margin expansion and that margin expansion really comes from the product mix on the revenue line. It also comes from the roll off of royalties that shift. Just noted knowing that we have the royalty on our global Keytruda sales going from six 5% to 5% at the start of next year and a royalty on gardasil going from 7% to zero percent on our global sales again at the start of next year will drive significant. Gross margin improvement at the same time, we will be investing in our business will be disciplined in that investment, but we're investing in the portfolio of products that we have in the market and that we will be launching as well as investing in a robust and growing pipeline and that obviously includes. The Daiichi collaboration while we've noted we expect about a 25 cent impact as a result of investing predominantly in the research and development of the wide range of programs that theme has partially outlined as well as the financing costs.

Particularly in the context of the a substantial reduction in your royalty burden both for Keytruda and Gardasil and if you wouldn't mind would you perhaps disclose what that.

Cumulative royalty burden was in the third quarter of this year are just so that we can provide some context for the.

The the upside case or at least that's what we should be anticipating there. Thanks so much.

Caroline Litchfield: Thank you for the question, we've seen really strong margin expansion in our company over the last several years and as we look forward, we expect continued margin expansion and that margin expansion really comes from the product mix on the revenue line, it also comes from the roll off of royalties that you just noted, knowing that we have the royalty on our global Keytruda sales going from 6.5% to 2.5% at the start of next year and a royalty on Gardasil going from 7% to zero percent on our global sales again at the start of next year will drive significant gross margin improvement. at the same time, we will be investing in our business will be disciplined in that investment, but we're investing in the portfolio of products that we have in the market and that we will be launching as well as investing in a robust and growing pipeline and that obviously includes. The Daiichi collaboration while we've noted we expect about a 25 cent impact as a result of investing predominantly in the research and development of the wide range of programs that theme has partially outlined as well as the financing costs.

Caroline Litchfield: Seamus, thank you for the question. We've seen really strong margin expansion in our company over the last several years. As we look forward, we expect continued margin expansion. That margin expansion really comes from the product mix on the revenue line. It also comes from the roll-off of royalties, as you've just noted, knowing that we have the royalty on our global Keytruda sales going from 6.5% to 2.5% at the start of next year. Our royalty on Gardasil going from 7% to 0% on our global sales again at the start of next year will drive significant growth margin improvement. At the same time, we will be investing in our business.

<unk>. Thank you for the question, we've seen really strong margin expansion in our company over the last several years and as we look forward. We expect continued margin expansion and that margin expansion really comes from the product mix on the revenue line. It also comes from the roll off of royalties that shift.

Just noted knowing that we have the royalty on our global Keytruda sales going from six 5% to 5% at the start of next year and a royalty on gardasil going from 7% to zero percent on our global sales again at the start of next year will drive significant.

Gross margin improvement at the same time, we will be investing in our business will be disciplined in that investment, but we're investing in the portfolio of products that we have in the market and that we will be launching as well as investing in a robust and growing pipeline and that obviously includes.

Caroline Litchfield: At the same time, we will be investing in our business we'll be disciplined in that investment, but we're investing in the portfolio of products that we have in the market and that we will be launching, as well as investing in a robust and growing pipeline and that obviously includes the Daiichi collaboration while we've noted we expect about a 25 cent impact as a result of investing predominantly in the research and development of the wide range of programs that Dean has partially outlined as well as the financing costs. We also have made significant progress across our pipeline with many other collaboration acquisition and the progress, we're making with our own internal assets. So altogether, we still do point to an operating margin of greater than 43% in the year $20 25, how with.

Caroline Litchfield: We'll be disciplined in that investment, but we're investing in the portfolio of products that we have in the market and that we will be launching, as well as investing in our robust and growing pipeline. And that obviously includes the Daiichi collaboration, where we've noted we expect about a 25% impact as a result of investing predominantly in the research and development of the wide range of programs that Dean has partially outlined, as well as the financing costs. We also have made significant progress across our pipeline with many other collaborations, acquisitions, and the progress we're making with our own internal assets. So altogether, we still do point to an operating margin of greater than 43% in the year 2025. However, we will not forgo necessary investments in our business to progress our pipeline to ensure that we advance healthcare and drive growth, which really is our priority.

We'll be disciplined in that investment, but we're investing in the portfolio of products that we have in the market and that we will be launching, as well as investing in our robust and growing pipeline. And that obviously includes the Daiichi collaboration, where we've noted we expect about a 25% impact as a result of investing predominantly in the research and development of the wide range of programs that Dean has partially outlined, as well as the financing costs. We also have made significant progress across our pipeline with many other collaborations, acquisitions, and the progress we're making with our own internal assets.

The Daiichi collaboration while we've noted we expect about a 25 cent impact as a result of investing predominantly in the research and development of the wide range of programs that theme has partially outlined as well as the financing costs.

We also have made significant progress across our pipeline with many other collaboration acquisition and the progress, we're making with our own internal assets. So altogether, we still do point to an operating margin of greater than 43% in the year $20 25, how with.

Caroline Litchfield: We also have made significant progress across our pipeline with many other collaborations, acquisitions and the progress we're making with our own internal assets, so altogether, we still do point to an operating margin of greater than 43% in the year 2025, however we will not full GARS necessary investments in our business to progress our pipeline to ensure that we advance health care and drive growth, which really is a priority. Great. Thank you Seamus next question please Julie. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks, so much for taking the question I guess another one for Dean on the trove to landscape I know you guys talked over the weekend about your first phase III trial in lung cancer here, maybe just any more context on the decision to pursue the Egfr mutant population given you know what you're seeing. From the landscape out there, including some of the Astra data and then what that means for the frontline setting as you try to craft a trial in that in that broader population. Thank you. Yes, so I just wanted to make sure that whether we're talking about are our wonderful partnership with collude her with Daiichi Sankyo, we sort of lay out certain indications that becomes public but I want to be very clear that those are not the only indications that where you would be interested so that's number one. Number two in relationship to a N K 2070, and advancing it more broadly and it relates to the other question. There. There is you know we still have small numbers, but but what's really interesting for us for who has 28 70. There are differences in the construct in terms of the payload in terms of the <unk>. Linker in terms of the Dol for that and one of the things that's interesting to US is Ed at least to date, we do not see serious ILD and that allows us to think broadly and and thoughtfully about its combinability in relationship to broader indications. So we're very interested in advancing in terms of 2070 and the specific first trial. That's been revealed its you know I would just tell you read it was driven because of the data that we have and the data that we have we think is quite good and should be advanced we are going to advance other ones, but the the advancement in the Egfr.

So altogether, we still do point to an operating margin of greater than 43% in the year 2025. However, we will not forgo necessary investments in our business to progress our pipeline to ensure that we advance healthcare and drive growth, which really is our priority.

We will not full GARS necessary investments in our business to progress our pipeline to ensure that we advance health care and drive growth, which really is a priority.

Caroline Litchfield: Great. Thank you Seamus next question please Julie. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks, so much for taking the question I guess another one for Dean on the trove to landscape I know you guys talked over the weekend about your first phase III trial in lung cancer here, maybe just any more context on the decision to pursue the Egfr mutant population given you know what you're seeing. From the landscape out there, including some of the Astra data and then what that means for the frontline setting as you try to craft a trial in that in that broader population. Thank you. Yes, so I just wanted to make sure that whether we're talking about are our wonderful partnership with collude her with Daiichi Sankyo, we sort of lay out certain indications that becomes public but I want to be very clear that those are not the only indications that where you would be interested so that's number one. Number two in relationship to a N K 2070, and advancing it more broadly and it relates to the other question. There. There is you know we still have small numbers, but but what's really interesting for us for who has 28 70. There are differences in the construct in terms of the payload in terms of the <unk>. Linker in terms of the Dol for that and one of the things that's interesting to US is Ed at least to date, we do not see serious ILD and that allows us to think broadly and and thoughtfully about its combinability in relationship to broader indications. So we're very interested in advancing in terms of 2070 and the specific first trial. That's been revealed its you know I would just tell you read it was driven because of the data that we have and the data that we have we think is quite good and should be advanced we are going to advance other ones, but the the advancement in the Egfr.

Peter Dannenbaum: Great. Thank you Seamus next question please Julie.

Caroline Litchfield: Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks, so much for taking the question I guess another one for Dean on the trove to landscape I know you guys talked over the weekend about your first phase III trial in lung cancer here, maybe just any more context on the decision to pursue the Egfr mutant population given you know what you're seeing. From the landscape out there, including some of the Astra data and then what that means for the frontline setting as you try to craft a trial in that in that broader population. Thank you. Yes, so I just wanted to make sure that whether we're talking about are our wonderful partnership with collude her with Daiichi Sankyo, we sort of lay out certain indications that becomes public but I want to be very clear that those are not the only indications that where you would be interested so that's number one. Number two in relationship to a N K 2070, and advancing it more broadly and it relates to the other question. There. There is you know we still have small numbers, but but what's really interesting for us for who has 28 70. There are differences in the construct in terms of the payload in terms of the <unk>. Linker in terms of the Dol for that and one of the things that's interesting to US is Ed at least to date, we do not see serious ILD and that allows us to think broadly and and thoughtfully about its combinability in relationship to broader indications. So we're very interested in advancing in terms of 2070 and the specific first trial. That's been revealed its you know I would just tell you read it was driven because of the data that we have and the data that we have we think is quite good and should be advanced we are going to advance other ones, but the the advancement in the Egfr.

Julie Louise Gerberding: Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Peter Dannenbaum: Great. Thank you, Seamus. Next question, please, Julie.

Great. Thank you Seamus next question please Julie.

Terence Flynn: Great thanks so much for taking the question, I guess another one for Dean on the TROP2 landscape, I know you guys talked over the weekend about your first Phase III trial in lung cancer here, maybe just any more context on the decision to pursue the EGFR mutant population, given you know what you're seeing from the landscape out there, including some of the Astra data and then what that means for the frontline setting as you try to craft a trial in that in that broader population. Thank you. Yes, so I just wanted to make sure that whether we're talking about are our wonderful partnership with collude her with Daiichi Sankyo, we sort of lay out certain indications that becomes public but I want to be very clear that those are not the only indications that where you would be interested so that's number one. Number two in relationship to a N K 2070, and advancing it more broadly and it relates to the other question. There. There is you know we still have small numbers, but but what's really interesting for us for who has 28 70. There are differences in the construct in terms of the payload in terms of the <unk>. Linker in terms of the Dol for that and one of the things that's interesting to US is Ed at least to date, we do not see serious ILD and that allows us to think broadly and and thoughtfully about its combinability in relationship to broader indications. So we're very interested in advancing in terms of 2070 and the specific first trial. That's been revealed its you know I would just tell you read it was driven because of the data that we have and the data that we have we think is quite good and should be advanced we are going to advance other ones, but the the advancement in the Egfr.

Operator: Thank you. Our next question comes from Terrence Flynn with Morgan Stanley. Your line is open.

Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Terrence Flynn: Great. Thanks so much for taking the question. I guess another one for Dean on the TROP2 landscape. I know you guys talked over the weekend about your first phase 3 trial in lung cancer here. Maybe just any more context on the decision to pursue the EGFR mutant population, given what you're seeing from the landscape out there, including some of the Astra data, and then what that means for the frontline setting as you try to craft a trial in that broader population. Thank you.

Terence Flynn: Great. Thanks so much for taking the question. I guess another one for Dean on the TROP2 landscape. I know you guys talked over the weekend about your first phase 3 trial in lung cancer here. Maybe just any more context on the decision to pursue the EGFR mutant population, given what you're seeing from the landscape out there, including some of the Astra data, and then what that means for the frontline setting as you try to craft a trial in that broader population. Thank you.

Great. Thanks, so much for taking the question I guess another one for Dean on the trove to landscape I know you guys talked over the weekend about your first phase III trial in lung cancer here, maybe just any more context on the decision to pursue the Egfr mutant population given you know what you're seeing.

From the landscape out there, including some of the Astra data and then what that means for the frontline setting as you try to craft a trial in that in that broader population. Thank you.

Dean Y. Li: Yes, so I just wanted to make sure that whether we're talking about are our wonderful partnership with Kelun or with Daiichi Sankyo, we sort of lay out certain indications that becomes public but I want to be very clear that those are not the only indications that where you would be interested so that's number one. Number two in relationship to a N K 2070, and advancing it more broadly and it relates to the other question. There. There is you know we still have small numbers, but but what's really interesting for us for who has 28 70. There are differences in the construct in terms of the payload in terms of the <unk>. Linker in terms of the Dol for that and one of the things that's interesting to US is Ed at least to date, we do not see serious ILD and that allows us to think broadly and and thoughtfully about its combinability in relationship to broader indications. So we're very interested in advancing in terms of 2070 and the specific first trial. That's been revealed its you know I would just tell you read it was driven because of the data that we have and the data that we have we think is quite good and should be advanced we are going to advance other ones, but the the advancement in the Egfr.

Dean Li: Yeah. So I just want to make sure that whether we're talking about our wonderful partnership with Kelun-Biotech or with Daiichi Sankyo, we sort of lay out certain indications that become public. But I want to be very clear that those are not the only indications that we would be interested. So that's number one. Number two, in relationship to MK-2870 and advancing it more broadly, and it relates to the other question, there is, we still have small numbers, but what's really interesting for us for 2870, there are differences in the construct, in terms of the payload, in terms of the linker, in terms of the DAR for that. And one of the things that's interesting to us is, at least to date, we do not see serious ILD. And that allows us to think broadly and thoughtfully about its combinability in relationship to broader indications.

Yes, so I just wanted to make sure that whether we're talking about are our wonderful partnership with collude her with Daiichi Sankyo, we sort of lay out certain indications that becomes public but I want to be very clear that those are not the only indications that where you would be interested so that's number one.

Dean Y. Li: Number two in relationship to a MK-2870, and advancing it more broadly and it relates to the other question, there is you know we still have small numbers, but what's really interesting for us for whereas 2870, there are differences in the construct in terms of the payload, in terms of the Linker, in terms of the Dol for that and one of the things that's interesting to us is, at least to date, we do not see serious ILD and that allows us to think broadly and and thoughtfully about its combinability in relationship to broader indications, so we're very interested in advancing. in terms of 2070 and the specific first trial. That's been revealed its you know I would just tell you read it was driven because of the data that we have and the data that we have we think is quite good and should be advanced we are going to advance other ones, but the the advancement in the Egfr.

Number two in relationship to a N K 2070, and advancing it more broadly and it relates to the other question. There. There is you know we still have small numbers, but but what's really interesting for us for who has 28 70. There are differences in the construct in terms of the payload in terms of the <unk>.

Linker in terms of the Dol for that and one of the things that's interesting to US is Ed at least to date, we do not see serious ILD and that allows us to think broadly and and thoughtfully about its combinability in relationship to broader indications.

And one of the things that's interesting to us is, at least to date, we do not see serious ILD. And that allows us to think broadly and thoughtfully about its combinability in relationship to broader indications.

Dean Y. Li: In terms of 2070 and the specific first trial that's been revealed its you know I'll just tell you, it was driven because of the data that we have and the data that we have we think is quite good and should be advanced, we are going to advance other ones, but the the advancement in the EGFR mutant Population is based on data that our partners Kelun and us have generated and we're very confident in advancing in that specific indication.

Dean Li: So we're very interested in advancing. In terms of MK-2870 and the specific first trial that's been revealed, I'll just tell you, it was driven because of the data that we have, and the data that we have, we think, is quite good and should be advanced. We are going to advance other ones, but the advancement in the EGFR mutant population is based on data that our partners, Kelun, and us have generated, and we're very confident in advancing in that specific indication.

So we're very interested in advancing. In terms of MK-2870 and the specific first trial that's been revealed, I'll just tell you, it was driven because of the data that we have, and the data that we have, we think, is quite good and should be advanced. We are going to advance other ones, but the advancement in the EGFR mutant population is based on data that our partners, Kelun, and us have generated, and we're very confident in advancing in that specific indication.

So we're very interested in advancing in terms of 2070 and the specific first trial. That's been revealed its you know I would just tell you read it was driven because of the data that we have and the data that we have we think is quite good and should be advanced we are going to advance other ones, but the the advancement in the Egfr.

Population is based on data that our partners <unk> and us have generated and we're very confident in advancing in that specific indication.

Peter Dannenbaum: Thanks, Terrence. Next question, please, Julie.

Peter Dannenbaum: Thanks Terence, next question please Julie.

Operator: Thank you. Our next question comes from Andrew Baum with Citi. Your line is open.

Julie Louise Gerberding: Thank you. Our next question comes from Andrew Baum with Citi. Your line is open.

Andrew Baum: Hi, thank you. Question in relation to TIGIT and vibostolimab and your KEYVIBE-003 trial. I'm assuming that you are using a similar type clinical design and template for the stats from KEYNOTE-042, where you have a hierarchy. Given this is a PD-L1 enriched trial and with that hierarchy in place, we're expecting an interim potentially the very end of next year, beginning of the following year. Any comments on either design or timing of interims? Thank you.

Andrew S. Baum: Thank you, It's a question in relation to Keytruda/Kibostolimab in your Keyvibe-003 trial I'm assuming that you are using a similar type clinical drug design and template for the stats from Keynotes-42, where you have a hierarchy, given this is a PD-L1 enriched Trial and with that hierarchy in place, we're expecting an interim potentially the very end of next year beginning of the following year any comments on either design or timing of entrants. Thank you. I would just say that in general principle your observations of how we develop. Drugs, especially in the I O. You know it has been something that we're known for and the structure was laid out by by great leaders from from from Merck, who laid the basis for that in relationship to timing of interim analysis. We have generally not commented not an interim analysis and we let those interim analysis. <unk> do what they need to do which is come in if they're significantly make that publicly known. If there are significant in relationship to public disclosure, that's when we do that but we generally do not lay out the timing of our interim analysis prior to them happening. Thanks, Andrew next question please Julie. Thank you. Our next question comes from Louise Chen with Cantor Your line is open. Hi, Thank you for taking my question I wanted to ask you about search hotter SAP, how you're preparing for that launch what's your go to market strategy and how quick do you expect uptake to be thank you. Yeah. Louise this is Rob I'll, maybe jump in and Caroline can add if I Miss anything. I would tell you that we feel well prepared so obviously.

Trial and with a hierarchy in place we were expecting an interim potentially the very end of next year beginning of the following year any comments on either design or timing of entrants. Thank you.

Dean Y. Li: I would just say that in general principle your observations of how we develop drugs, especially in the IO, You know it has been something that we're known for and the structure was laid out by great leaders from Merck who laid the basis for that, in relationship to timing of interim analysis, we have generally not commented on interim analysis and we let those interim analysis do what they need to do which is come in if they're significantly make that publicly known. If there are significant in relationship to public disclosure, that's when we do that but we generally do not lay out the timing of our interim analysis prior to them happening. Thanks, Andrew next question please Julie. Thank you. Our next question comes from Louise Chen with Cantor Your line is open. Hi, Thank you for taking my question I wanted to ask you about search hotter SAP, how you're preparing for that launch what's your go to market strategy and how quick do you expect uptake to be thank you. Yeah. Louise this is Rob I'll, maybe jump in and Caroline can add if I Miss anything. I would tell you that we feel well prepared so obviously.

Dean Li: I would just say that in general principle, your observations of how we develop drugs, especially in the IO, has been something that we're known for, and the structure was laid out by great leaders from Merck who laid the basis for that. In relationship to timing of interim analysis, we have generally not commented on interim analysis, and we let those interim analyses do what they need to do, which is come, and if they're significant, we make that publicly known. If there's significance in relationship to public disclosure, that's when we do that. But we generally do not lay out the timing of our interim analysis prior to them happening.

I would just say that in general principle your observations of how we develop.

Drugs, especially in the I O. You know it has been something that we're known for and the structure was laid out by by great leaders from from from Merck, who laid the basis for that in relationship to timing of interim analysis. We have generally not commented not an interim analysis and we let those interim analysis.

<unk> do what they need to do which is come in if they're significantly make that publicly known.

If there are significant in relationship to public disclosure, that's when we do that but we generally do not lay out the timing of our interim analysis prior to them happening.

Dean Y. Li: Thanks, Andrew next question please Julie. Thank you. Our next question comes from Louise Chen with Cantor Your line is open. Hi, Thank you for taking my question I wanted to ask you about search hotter SAP, how you're preparing for that launch what's your go to market strategy and how quick do you expect uptake to be thank you. Yeah. Louise this is Rob I'll, maybe jump in and Caroline can add if I Miss anything. I would tell you that we feel well prepared so obviously.

Peter Dannenbaum: Thanks, Andrew next question please Julie.

Peter Dannenbaum: Thanks, Andrew. Next question, please, Julie.

Thanks, Andrew next question please Julie.

Dean Y. Li: Thank you. Our next question comes from Louise Chen with Cantor Your line is open. Hi, Thank you for taking my question I wanted to ask you about search hotter SAP, how you're preparing for that launch what's your go to market strategy and how quick do you expect uptake to be thank you. Yeah. Louise this is Rob I'll, maybe jump in and Caroline can add if I Miss anything. I would tell you that we feel well prepared so obviously.

Julie Louise Gerberding: Thank you. Our next question comes from Louise Chen with Cantor Your line is open.

Operator: Thank you. Our next question comes from Louise Chen with Cantor. Your line is open.

Thank you. Our next question comes from Louise Chen with Cantor Your line is open.

Louise Alesandra Chen: Hi, Thank you for taking my question I wanted to ask you about search hotter SAP, how you're preparing for that launch what's your go to market strategy and how quick do you expect uptake to be thank you. Yeah. Louise this is Rob I'll, maybe jump in and Caroline can add if I Miss anything. I would tell you that we feel well prepared so obviously. We've been working to ensure we have supply.

Louise Alesandra Chen: Hi, Thank you for taking my question I wanted to ask you about Sotatercept, how you're preparing for that launch, what's your go to market strategy and how quick do you expect uptake to be thank you.

Louise Chen: Hi. Thank you for taking my question. I wanted to ask you about Sotatercept, how you're preparing for that launch, what's your go-to market strategy, and how quick do you expect uptake to be? Thank you.

Hi, Thank you for taking my question I wanted to ask you about search hotter SAP, how you're preparing for that launch what's your go to market strategy and how quick do you expect uptake to be thank you.

Robert Davis: Yeah, Louise, this is Rob. I'll maybe jump in, and Caroline can add if I miss anything. I would tell you that we feel well prepared. So obviously, we've been working to ensure we have supply to be able to supply the market upon launch. But as we sit here today, given what is happening in the marketplace, so you are seeing a warehousing of patients in anticipation of the launch of sotatercept in the United States. And from feedback from key opinion leaders and what we're hearing from the market, the demand for this will be quite high. So our expectation is we'll see a strong launch with this drug. And I can tell you we've invested and built an organization. We actually have a very focused group now within our US business whose sole job is to manage this launch.

Rob Davis: Yeah, Louise, this is Rob. I'll maybe jump in, and Caroline can add if I miss anything. I would tell you that we feel well prepared. So obviously, we've been working to ensure we have supply to be able to supply the market upon launch. But as we sit here today, given what is happening in the marketplace, so you are seeing a warehousing of patients in anticipation of the launch of sotatercept in the United States. And from feedback from key opinion leaders and what we're hearing from the market, the demand for this will be quite high. So our expectation is we'll see a strong launch with this drug. And I can tell you we've invested and built an organization.

Rob Davis: Yeah. Louise this is Rob I'll, maybe jump in and Caroline can add if I Miss anything, I would tell you that we feel well prepared so obviously, We've been working to ensure we have supply to be able to supply the market upon launch, but as we sit here today, given what is happening in the marketplace, so you are seeing warehousing of patients in anticipation of the launch of Sotatercept in the United States and from feedback from key opinion leaders and what we're hearing from the market, you know the demand for this will be quite high. So our expectation is you will see a strong launch with this drug in and I can tell you we've been invested. And built an organization, we actually have a very focused group now in our U S within our U S business. Whose sole job is to manage this launch. And so I think we're both prepared from a commercial perspective and from a manufacturing perspective with the expectation as I said that this should go well with the very strong quick uptake and the other thing I would highlight is given the strength of the data we do expect to see approval in Europe. Our next year, which we originally thought would require further study. Not only are we preparing in the United States, but we're also preparing in Europe as well and we feel good about both but Caroline anything you would want to add no I think you captured it well dean anything you'd want to yeah. I just wanted to emphasize the powder SAP you know this is the first.

Yeah. Louise this is Rob I'll, maybe jump in and Caroline can add if I Miss anything.

I would tell you that we feel well prepared so obviously.

We've been working to ensure we have supply.

To be able to supply the market upon launch, but as we sit here today, given what is happening in the marketplace. So you are seeing.

Warehousing of patients in anticipation of the launch of some tighter served in the United States and from feedback from key opinion leaders and what we're hearing from the market.

You know the demand for this will be quite high. So our expectation is you will see a strong launch with this drug in and I can tell you we've been invested.

Rob Davis: So our expectation is you will see a strong launch with this drug and I can tell you we've been invested and built an organization, we actually have a very focused group now in our U.S. within our U.S. business, whose sole job is to manage this launch and so I think we're both prepared from a commercial perspective and from a manufacturing perspective with the expectation as I said that this should go with a very strong quick uptake. and the other thing I would highlight is given the strength of the data we do expect to see approval in Europe. Our next year, which we originally thought would require further study. Not only are we preparing in the United States, but we're also preparing in Europe as well and we feel good about both but Caroline anything you would want to add no I think you captured it well dean anything you'd want to yeah. I just wanted to emphasize the powder SAP you know this is the first.

And built an organization, we actually have a very focused group now in our U S within our U S business.

We actually have a very focused group now within our US business whose sole job is to manage this launch.

Whose sole job is to manage this launch.

Robert Davis: And so I think we're both prepared from a commercial perspective and from a manufacturing perspective with the expectation, as I said, that this should go with a very strong quick uptake. And the other thing I would highlight is, given the strength of the data, we do expect to see approval in Europe next year, which we originally thought would require a further study. So not only are we preparing in the United States, but we're also preparing in Europe as well. And we feel good about both. But Caroline, anything you would want to add?

And so I think we're both prepared from a commercial perspective and from a manufacturing perspective with the expectation, as I said, that this should go with a very strong quick uptake. And the other thing I would highlight is, given the strength of the data, we do expect to see approval in Europe next year, which we originally thought would require a further study. So not only are we preparing in the United States, but we're also preparing in Europe as well. And we feel good about both. But Caroline, anything you would want to add?

And so I think we're both prepared from a commercial perspective and from a manufacturing perspective with the expectation as I said that this should go well with the very strong quick uptake and the other thing I would highlight is given the strength of the data we do expect to see approval in Europe.

Rob Davis: And the other thing I would highlight is given the strength of the data we do expect to see approval in Europe next year, which we originally thought would require further study, not only are we preparing in the United States, but we're also preparing in Europe as well and we feel good about both but Caroline anything you would want to add. no I think you captured it well dean anything you'd want to yeah. I just wanted to emphasize the powder SAP you know this is the first.

Our next year, which we originally thought would require further study.

Not only are we preparing in the United States, but we're also preparing in Europe as well and we feel good about both but Caroline anything you would want to add no I think you captured it well dean anything you'd want to yeah. I just wanted to emphasize the powder SAP you know this is the first.

Caroline Litchfield: No I think you captured it well, Dean anything you'd want to yeah. I just wanted to emphasize the powder SAP you know this is the first.

Caroline Litchfield: No I think you captured it well, Dean anything you'd want to

Caroline Litchfield: No, I think you captured it, Rob. Dean, anything you'd want to?

Dean Li: Yeah. I just want to emphasize sotatercept. This is the first drug out there that really is targeting the fundamental genetic basis of the disease. It's going to be the first activin inhibitor. But most important is activin is what the genetics tells you is the imbalance that occurs in pulmonary arterial hypertension. So this is really important. And I said watershed previously. I do think this is going to be a watershed moment for PAH. Rob already talked about the US and EU. And the reason why that happened is because of STELLAR data was quite impressive. And that's what drove the ability to do EU. What I would remind everyone is that we have other trials coming through with ZENITH, HYPERION, and CADENCE. ZENITH, for example, is one that's going to look at mortality and those sort of endpoints as the primary endpoints.

Dean Y. Li: Yeah I just wanted to emphasize Sotatercept you know, this is the first drug out there that really is targeting you know that the fundamental genetic basis of the disease, it's going to be the first active inhibitor, but most important is active in is what the genetics tells you imbalance that occurs in pulmonary arterial hypertension, so this is a really important and I said watershed previously I do think this is going to be a watershed moment for P.H. Bob already talked about the US and EU and the reason why that happened is because of stellar data was, was quite impressive and that's what drove the ability to E.U. You what I would remind every. One is that we have other trials coming through with Zenith Hyperion and cadence Zenith. For example is one that you know going to look at mortality in those sort of endpoint as the primary end point should that read out in the next year or something like that it relatively soon to the launch I think what. Ever estimates that Caroline and. Rob has talked about some patterns. So that will only help the uptake of Patterson and as Rob has mentioned this is a field that many of the physicians. This was a place where I did research back in the academic days you know the phone calls I'm getting is that people are warehousing patients in <unk>. <unk> a patient of that March launch.

First drug out there that really is targeting you know that the fundamental genetic basis of the disease, it's going to be the first active an inhibitor, but most important is active in is what the genetics tells you imbalance that occurs in pulmonary arterial hypertension.

So this is a really important and I said watershed previously I do think this is going to be a watershed moment for P. H, Bob already talked about the U S and EU and the reason why that happened is because of stellar data was was quite impressive and that's what drove the ability to U. A E. You what I would remind every.

Dean Y. Li: What I would remind everyone is that we have other trials coming through with Zenith, Hyperion and CADENCE, Zenith for example is one that, you know, going to look at mortality in those sort of endpoints as the primary end points, should that read out in the next year or something like that, relatively soon to the launch, I think whatever estimates that Caroline and Rob has talked about Sotatercept, that will only help the uptake of Sotatercept and as Rob has mentioned this is a field that many of the physicians, this was a place where I did research back in the academic days, you know the phone calls I'm getting is that people are warehousing patients in anticipation of that March launch.

What I would remind everyone is that we have other trials coming through with ZENITH, HYPERION, and CADENCE. ZENITH, for example, is one that's going to look at mortality and those sort of endpoints as the primary endpoints.

One is that we have other trials coming through with Zenith Hyperion and cadence Zenith. For example is one that you know going to look at mortality in those sort of endpoint as the primary end point should that read out in the next year or something like that it relatively soon to the launch I think what.

Dean Li: Should that read out in the next year or something like that relatively soon to the launch, I think whatever estimates that Caroline and Rob have talked about sotatercept, that will only help the uptake of sotatercept. As Rob has mentioned, this is a field that many of the physicians, this was a place where I did research back in the academic days. The phone calls I'm getting is that people are warehousing patients in anticipation of that March launch.

Should that read out in the next year or something like that relatively soon to the launch, I think whatever estimates that Caroline and Rob have talked about sotatercept, that will only help the uptake of sotatercept. As Rob has mentioned, this is a field that many of the physicians, this was a place where I did research back in the academic days. The phone calls I'm getting is that people are warehousing patients in anticipation of that March launch.

Ever estimates that Caroline and.

Rob has talked about some patterns. So that will only help the uptake of Patterson and as Rob has mentioned this is a field that many of the physicians. This was a place where I did research back in the academic days you know the phone calls I'm getting is that people are warehousing patients in <unk>.

<unk> a patient of that March launch.

Peter Dannenbaum: Thanks, Louise. Next question, please.

Peter Dannenbaum: Thanks Louise next question please.

Operator: Thank you. Our next question comes from Chris Schott with J.P. Morgan. Your line is open.

Thank you. Our next question comes from Chris Schott with J P. Morgan. Your line is open great. Thanks, So much I just had a question on Gardasil. We've seen obviously, some very impressive growth over the past few years, but looking ahead I'm just interested how much more opportunity for you do you see for this franchise to ramp from here. So maybe just elaborate a little bit more on what are the kind of.

Julie Louise Gerberding: Thank you, our next question comes from Chris Schott with J P. Morgan. Your line is open

Chris Schott: Great, thanks so much, I just had a question on Gardasil, we've seen obviously some very impressive growth over the past few years, but looking ahead I'm just interested how much more opportunity for you do you see for this franchise to ramp from here, so maybe just elaborate a little bit more on what are the kind of. Unmet needs at this point, whereas the biggest opportunity to could you kind of roll out the product in and just ultimately how much larger can the franchise to become over time. Thank you Yeah, Chris No I. Appreciate the question. So you know one I would say we feel.

Chris Schott: Great, thanks so much, I just had a question on Gardasil, we've seen obviously some very impressive growth over the past few years, but looking ahead I'm just interested how much more opportunity for you do you see for this franchise to ramp from here, so maybe just elaborate a little bit more on what are the kind of unmet needs at this point, where's the biggest opportunity to could you kind of roll out the product in and just ultimately how much larger can this franchise to become over time, Thank you

Chris Schott: Great. Thanks so much. Just a question on Gardasil. We've seen, obviously, some very impressive growth over the past few years. But looking ahead, I'm just interested in how much more opportunity you see for this franchise to ramp from here. So maybe just elaborate a little bit more on what are the kind of unmet needs at this point? Where is the biggest opportunity to continue to kind of roll out the product? And just ultimately, how much larger can this franchise become over time? Thank you.

Unmet needs at this point, whereas the biggest opportunity to could you kind of roll out the product in and just ultimately how much larger can the franchise to become over time. Thank you Yeah, Chris No I. Appreciate the question. So you know one I would say we feel.

Robert Davis: Yeah. Chris, no, I appreciate the question. So one, I would say we feel very proud of what Gardasil has done and the strength of this business and the fact that people increasingly recognize that we can fundamentally do what's the most important, which is prevent cancer, prevent cervical cancer, and increasingly prevent certain head and neck cancers if we can get people fully vaccinated. So the fact that you are starting to see that progress is important. But as we look at the business going forward, I would start by saying we remain very confident that this is a business that's going to continue to grow and that we will achieve the expectation we've communicated of over $11 billion in revenue by 2030. So nothing's changed in how we see the business. As you know, we've made significant investments in manufacturing capacity. And from that perspective, now we're well positioned.

Rob Davis: Yeah. Chris, no, I appreciate the question. So one, I would say we feel very proud of what Gardasil has done and the strength of this business and the fact that people increasingly recognize that we can fundamentally do what's the most important, which is prevent cancer, prevent cervical cancer, and increasingly prevent certain head and neck cancers if we can get people fully vaccinated.

Rob Davis: Yeah, Chris No, I appreciate the question so you know, one I would say we feel very proud of what Gardasil has done and the strength of this business and the fact that people increasingly recognize that we can fundamentally do what's the most important which is prevent cancer, prevent cervical cancer, increasingly prevent certain head and neck cancers if we can get people fully vaccinated so the fact that you are starting to see that progress is important. As we look at the business going forward I would start by saying we remain very confident that this is a business that's going to continue to grow and that we will. Achieved your expectation, we've communicated of over $11 billion in revenue. By 2030, so nothing's changed in how we see the business as you know we've made significant investments in manufacturing capacity and from that perspective, now we're well positioned we brought on two sides and they're ramping now. And so we're doing quite well from that perspective, and then as far as the opportunities that exist. To potentially continue to drive even beyond. What we just discussed really you know I would put it in three buckets and the our ability to achieve that objective and then potentially exceed that objective really come down to these three variables and first and foremost. While we've had great penetration in the developed world. Huge opportunity still exists in the low and middle income markets and I can tell you we have a focus and an intention to drive this business into the low and middle income markets.

Very proud of what Gardasil has done and the strength of this business and the fact that people increasingly recognize that we can fundamentally.

Do what's the most important which has prevented cancer prevent cervical cancer increasingly prevent certain head and neck cancers. If we can get people fully vaccinated. So the fact that you are starting to see that progress is important.

So the fact that you are starting to see that progress is important. But as we look at the business going forward, I would start by saying we remain very confident that this is a business that's going to continue to grow and that we will achieve the expectation we've communicated of over $11 billion in revenue by 2030. So nothing's changed in how we see the business. As you know, we've made significant investments in manufacturing capacity. And from that perspective, now we're well positioned.

As we look at the business going forward I would start by saying we remain very confident that this is a business that's going to continue to grow and that we will.

Rob Davis: As we look at the business going forward, I would start by saying we remain very confident that this is a business that's going to continue to grow and that we will achieve the expectation we've communicated of over $11 billion in revenue by 2030, so nothing's changed in how we see the business, as you know we've made significant investments in manufacturing capacity and from that perspective now we're well positioned, we brought on two sides and they're ramping now and so we're doing quite well from that perspective and then as far as the opportunities that exist to potentially continue to drive even beyond. What we just discussed really you know I would put it in three buckets and the our ability to achieve that objective and then potentially exceed that objective really come down to these three variables and first and foremost. While we've had great penetration in the developed world. Huge opportunity still exists in the low and middle income markets and I can tell you we have a focus and an intention to drive this business into the low and middle income markets.

Achieved your expectation, we've communicated of over $11 billion in revenue.

By 2030, so nothing's changed in how we see the business as you know we've made significant investments in manufacturing capacity and from that perspective, now we're well positioned we brought on two sides and they're ramping now.

Rob Davis: As you know we've made significant investments in manufacturing capacity and from that perspective now we're well positioned, we brought on two sides and they're ramping now and so we're doing quite well from that perspective and then as far as the opportunities that exist to potentially continue to drive even beyond what we just discussed, really you know I would put it in three buckets and the our ability to achieve that objective and then potentially exceed that objective really come down to these three variables. and first and foremost. While we've had great penetration in the developed world. Huge opportunity still exists in the low and middle income markets and I can tell you we have a focus and an intention to drive this business into the low and middle income markets.

Robert Davis: We've brought on our two sites, and they're ramping now. So we're doing quite well from that perspective. Then, as far as the opportunities that exist to potentially continue to drive even beyond what we just discussed, really, I would put in three buckets. Our ability to achieve that objective and then potentially exceed that objective really come down to these three variables. First and foremost, while we've had great penetration in the developed world, a huge opportunity still exists in the low and middle-income markets. I can tell you we have a focus and an intention to drive this business into the low and middle-income markets. Obviously, that's going to require us to continue to drive down our manufacturing costs, which we have plans to do, and I have confidence that we will do, and to think about lower price points.

We've brought on our two sites, and they're ramping now. So we're doing quite well from that perspective. Then, as far as the opportunities that exist to potentially continue to drive even beyond what we just discussed, really, I would put in three buckets. Our ability to achieve that objective and then potentially exceed that objective really come down to these three variables. First and foremost, while we've had great penetration in the developed world, a huge opportunity still exists in the low and middle-income markets. I can tell you we have a focus and an intention to drive this business into the low and middle-income markets.

And so we're doing quite well from that perspective, and then as far as the opportunities that exist.

To potentially continue to drive even beyond.

What we just discussed really you know I would put it in three buckets and the our ability to achieve that objective and then potentially exceed that objective really come down to these three variables and first and foremost.

While we've had great penetration in the developed world.

Rob Davis: And first and foremost, while we've had great penetration in the developed world a huge opportunity still exists in the low and middle income markets and I can tell you we have a focus and an intention to drive this business into the low and middle income markets, obviously that's going to require us to continue to drive down our manufacturing costs, which we have plans to do and I have confidence that we will do and to think about lower price points, but that said that will be meaningful incremental revenue as we achieve that over time. And then as you look at the established markets there's still. There's a large population too to address you know obviously to date, we've been driving largely through public vaccination programs outside the United States and the United States and international musician program. Primarily aimed at our. Young women and young girls increasingly the opportunity to go to a broader age cohorts as we think about growing now two people, aged 45 that ability to move into the mid adult segment. As a real opportunity in the United States that continues to be a driver of growth, it's increasingly going to be a growth driver. And Europe and it is currently important part of why we're driving growth with the recent expansion we've got in China and there are more markets to come so as we look at that that was going to be another lever of growth. Obviously the difference here is this requires consumer activation.

Huge opportunity still exists in the low and middle income markets and I can tell you we have a focus and an intention to drive this business into the low and middle income markets.

Obviously, that's going to require us to continue to drive down our manufacturing costs, which we have plans to do, and I have confidence that we will do, and to think about lower price points.

Obviously, that's going to require us to continue to drive down our manufacturing costs, which we have plans to do and I have confidence that we will do and just think about lower price points, but that said that will be meaningful.

Robert Davis: But that said, that will be meaningful incremental revenue as we achieve that over time. And then as you look at the established markets, there still is a large population to address. Obviously, to date, we've been driving largely through public vaccination programs outside the United States, in the United States through the National Immunization Program, primarily aimed at young women and young girls. Increasingly, the opportunity to go to broader age cohorts as we think about going now to people age 45, that ability to move into the mid-adult segment is a real opportunity in the United States. It continues to be a driver of growth. It's increasingly going to be a growth driver in Europe, and it is currently an important part of why we're driving growth with the recent expansion we got in China. And there are more markets to come.

But that said, that will be meaningful incremental revenue as we achieve that over time. And then as you look at the established markets, there still is a large population to address. Obviously, to date, we've been driving largely through public vaccination programs outside the United States, in the United States through the National Immunization Program, primarily aimed at young women and young girls. Increasingly, the opportunity to go to broader age cohorts as we think about going now to people age 45, that ability to move into the mid-adult segment is a real opportunity in the United States. It continues to be a driver of growth.

Incremental revenue as we achieve that over time.

Rob Davis: And then as you look at the established markets, there's still, there's a large population to address you know, obviously to date we've been driving largely through public vaccination programs outside the United States, in United States through the National Immunization Program, primarily aimed at young women and young girls, increasingly, the opportunity to go to a broader age cohorts, as we think about growing now to people aged 45, that ability to move into the mid-adult segment is a real opportunity in the United States that continues to be a driver of growth, it's increasingly going to be a growth driver in Europe and it is currently important part of why we're driving growth with the recent expansion we've got in China and there are more markets to come so as we look at that that was going to be another lever of growth. Obviously the difference here is this requires consumer activation.

And then as you look at the established markets there's still.

There's a large population too to address you know obviously to date, we've been driving largely through public vaccination programs outside the United States and the United States and international musician program.

Primarily aimed at our.

Young women and young girls increasingly the opportunity to go to a broader age cohorts as we think about growing now two people, aged 45 that ability to move into the mid adult segment.

Rob Davis: That ability to move into the mid-adult segment is a real opportunity in the United States that continues to be a driver of growth, it's increasingly going to be a growth driver in Europe and it is currently important part of why we're driving growth with the recent expansion we've got in China and there are more markets to come so as we look at that that was going to be another lever of growth. Obviously the difference here is this requires consumer activation.

As a real opportunity in the United States that continues to be a driver of growth, it's increasingly going to be a growth driver.

It's increasingly going to be a growth driver in Europe, and it is currently an important part of why we're driving growth with the recent expansion we got in China. And there are more markets to come.

And Europe and it is currently important part of why we're driving growth with the recent expansion we've got in China and there are more markets to come so as we look at that that was going to be another lever of growth. Obviously the difference here is this requires consumer activation.

Robert Davis: So as we look at that, that's going to be another lever of growth. Obviously, the difference here is this requires consumer activation. That takes commercial investment and a lot of heavy lifting. We've demonstrated we can do it like we've started to do in China and as we're starting to do in the United States. But it is going to take a lot of work and investment, and we're committed to doing that. So that's another variable that we look at. And then lastly, this is still largely seen as a female vaccine. I think it's only 70 markets that have gender-neutral approvals. And even in the markets that do have it, particularly as you look at markets like Europe, there still is a real opportunity to increasingly bring people to understand that this is not just a female cancer vaccine. It is a gender-neutral cancer vaccine.

So as we look at that, that's going to be another lever of growth. Obviously, the difference here is this requires consumer activation. That takes commercial investment and a lot of heavy lifting. We've demonstrated we can do it like we've started to do in China and as we're starting to do in the United States. But it is going to take a lot of work and investment, and we're committed to doing that. So that's another variable that we look at. And then lastly, this is still largely seen as a female vaccine. I think it's only 70 markets that have gender-neutral approvals.

Rob Davis: Obviously the difference here is this requires consumer activation. That takes commercial investment and a lot of heavy lifting we've demonstrated we can do it like we started to do in China and as we're starting to do in the United States, but it is going to take a lot of work and investment and we're committed to doing that so that's another variable we looked at. And then lastly,

That takes commercial investment and a lot of heavy lifting we've demonstrated we can do it like we started to do in China and as we're starting to do in the United States, but it is going to take a lot of work and investment and we're committed to doing that so that's another variable.

We looked at it and then lastly.

We looked at it

Rob Davis: And then lastly, this is still largely seen as a female vaccine, you know we only, I think it's only 70 markets have gender neutral approvals, even in the markets that do have it, particularly as you look at markets like Europe, there still is a real opportunity to increasingly bring people to understand that this is not just a female cancer vaccine, it is a gender neutral cancer vaccine and with the growing incidents of head and neck cancers, which is primarily a male dominated cancer, we do see real opportunitty to continue to push and drive both getting more markets to gender neutral and in the markets where we have those approvals drive vaccination rates up and probably one more bigger near term opportunities is to get gender neutral approved in China, which is an opportunity so across all of those. There's opportunities in potential it's a heavy lift. I don't want to you know. You indicated it's going to be easy and and we're going to invest behind it. But that really will determine ultimately our success across those variables will determine the success, we see long term with this franchise, but maybe dean or Caroline anything you would add yeah I would just emphasize two points one. Directly related to what you said you know this is a this is a highly effective vaccine to prevent women's cancer cervical cancer and that is something that everyone recognizes but the gender neutral part is really important and that MRO, we're advancing studies and filing.

and then lastly.

This is still largely seen as a female vaccine you know.

We only I think it's only 70 markets.

Gender neutral approvals.

And even in the markets that do have it, particularly as you look at markets like Europe, there still is a real opportunity to increasingly bring people to understand that this is not just a female cancer vaccine. It is a gender-neutral cancer vaccine.

Even in the markets do have it.

Particularly as you look at markets like Europe.

Are there still is a real opportunity to increasingly bringing people to understand that this is not just a female cancer vaccine. It is a gender neutral cancer vaccine and with the growing incidents of head and neck cancers, which is primarily a male dominated cancer, we do see real opportunity.

Rob Davis: And with the growing incidents of head and neck cancers, which is primarily a male dominated cancer, we do see real opportunitty to continue to push and drive both getting more markets to gender neutral and in the markets where we have those approvals drive vaccination rates up and probably one more bigger near term opportunities is to get gender neutral approved in China, which is an opportunity, so across all of those. There's opportunities in potential it's a heavy lift. I don't want to you know. You indicated it's going to be easy and and we're going to invest behind it. But that really will determine ultimately our success across those variables will determine the success, we see long term with this franchise, but maybe dean or Caroline anything you would add

Robert Davis: And with the growing incidence of head and neck cancers, which is primarily a male-dominated cancer, we do see real opportunity to continue to push and drive both getting more markets to gender-neutral and, in the markets where we have those approvals, drive vaccination rates up. And probably one of the bigger near-term opportunities is to get gender-neutral approved in China, which is an opportunity. So across all of those, there's opportunities and potential. It's a heavy lift. I don't want to indicate that it's going to be easy, and we're going to invest behind it. But that really will determine ultimately. Our success across those variables will determine the success we see long-term with this franchise. But maybe Dean or Caroline, anything you would add?

And with the growing incidence of head and neck cancers, which is primarily a male-dominated cancer, we do see real opportunity to continue to push and drive both getting more markets to gender-neutral and, in the markets where we have those approvals, drive vaccination rates up. And probably one of the bigger near-term opportunities is to get gender-neutral approved in China, which is an opportunity. So across all of those, there's opportunities and potential. It's a heavy lift. I don't want to indicate that it's going to be easy, and we're going to invest behind it. But that really will determine ultimately.

To continue to push and drive both getting more markets to gender neutral and in the markets, where we have those approvals drive vaccination rates up and probably one more bigger near term opportunities is to get gender neutral approved in China, which is an opportunity so across all of those.

Rob Davis: So across all of those, there's opportunities in potential, it's a heavy lift I don't want to you know, indicate that it's going to be easy and and we're going to invest behind it, but that really will determine ultimately our success across those variables with the determine of success, we see long term with this franchise, but maybe Dean or Caroline anything you would add?

There's opportunities in potential it's a heavy lift.

I don't want to you know.

You indicated it's going to be easy and and we're going to invest behind it.

But that really will determine ultimately our success across those variables will determine the success, we see long term with this franchise, but maybe dean or Caroline anything you would add yeah I would just emphasize two points one.

Our success across those variables will determine the success we see long-term with this franchise. But maybe Dean or Caroline, anything you would add?

Dean Li: Yeah. I would just emphasize two points. One directly related to what you said. This is a highly effective vaccine to prevent women's cancer, cervical cancer. And that is something that everyone recognizes. But the gender-neutral part is really important. And at MRL, we're advancing studies and filings in relationship to make sure that as many places that can adopt gender-neutral can be in that position to do gender-neutral. I also want to just make one comment about cervical cancer itself. We talk about Gardasil in relationship to cervical cancer, but I would also emphasize that at ESMO, we had KEYNOTE-A18. I would remind people that cervical cancer is still the fourth leading cause of women cancer. And this was another trial that showed the effect of Keytruda in earlier stage in combination with chemoradiation. So that, I think, is a PDUFA date that's coming up.

Dean Y. Li: Yeah I would just emphasize two points, one directly related to what you said you know this is a this is a highly effective vaccine to prevent women's cancer cervical cancer and that is something that everyone recognizes but the gender neutral part is really important and that MRO, we're advancing studies and filing. <unk> can relationship to make sure that as many places that can adopt gender neutral tenants, who can't can be in a position to do gender neutral I also wanted to just make one comment about cervical cancer itself, we talk about Carter so in relationship to cervical cancer, but I would also emphasize that at ESMO, we had keynote 818 I. I would remind people that cervical cancer is still the fourth leading cause of women cancer and this was another trial that showed the effect of Keytruda in earlier stage in combination with chemo radiation. So that I think is a producer date, that's coming up and that hopefully might be the ninth. Early stage and I believe that produce the date is among like four that are coming up in the next six months in relationship to cancer. So Garda, so gender neutral, but also cervical cancer being a critical driver in driving into earlier stage. Those are all things that play around what we're trying to do at <unk>. Mark. Thanks for the question, Chris we have time to take some additional questions and go past the hour Julian next question. Please thank.

Dean Y. Li: Yeah I would just emphasize two points, one directly related to what you said, you know this is a this is a highly effective vaccine to prevent women's cancer, cervical cancer and that is something that everyone recognizes but the gender neutral part is really important and that MRO, we're advancing studies and filing in relationship to make sure that as many places that can adopt gender neutral tenants, who can't can be in a position to do gender neutral. I also wanted to just make one comment about cervical cancer itself, we talk about Carter so in relationship to cervical cancer, but I would also emphasize that at ESMO, we had keynote 818 I. I would remind people that cervical cancer is still the fourth leading cause of women cancer and this was another trial that showed the effect of Keytruda in earlier stage in combination with chemo radiation. So that I think is a producer date, that's coming up and that hopefully might be the ninth. Early stage and I believe that produce the date is among like four that are coming up in the next six months in relationship to cancer. So Garda, so gender neutral, but also cervical cancer being a critical driver in driving into earlier stage. Those are all things that play around what we're trying to do at <unk>. Mark.

Directly related to what you said you know this is a this is a highly effective vaccine to prevent women's cancer cervical cancer and that is something that everyone recognizes but the gender neutral part is really important and that MRO, we're advancing studies and filing.

<unk> can relationship to make sure that as many places that can adopt gender neutral tenants, who can't can be in a position to do gender neutral I also wanted to just make one comment about cervical cancer itself, we talk about Carter so in relationship to cervical cancer, but I would also emphasize that at ESMO, we had keynote 818 I.

Dean Y. Li: I also wanted to just make one comment about cervical cancer itself, we talk about Gardasil in relationship to cervical cancer, but I would also emphasize that at ESMO, we had Keynote 818, I would remind people that cervical cancer is still the fourth leading cause of women cancer and this was another trial that showed the effect of Keytruda in earlier stage, in combination with chemo radiation, so that I think is a PDUFA date that's coming up and that hopefully might be the ninth early stage and I believe that PDUFA the date is among like four that are coming up in the next six months in relationship to cancer, so Gardasil gender neutral, but also cervical cancer being a critical driver, driving into earlier stage, those are all things that play around what we're trying to do at Merck.

I would remind people that cervical cancer is still the fourth leading cause of women cancer. And this was another trial that showed the effect of Keytruda in earlier stage in combination with chemoradiation. So that, I think, is a PDUFA date that's coming up.

I would remind people that cervical cancer is still the fourth leading cause of women cancer and this was another trial that showed the effect of Keytruda in earlier stage in combination with chemo radiation. So that I think is a producer date, that's coming up and that hopefully might be the ninth.

Dean Li: And that hopefully might be the ninth early stage. And I believe that PDUFA date is among like four that are coming up in the next six months in relationship to cancer. So Gardasil, gender-neutral, but also cervical cancer being a critical driver and driving into earlier stage, those are all things that play around what we're trying to do at Merck.

And that hopefully might be the ninth early stage. And I believe that PDUFA date is among like four that are coming up in the next six months in relationship to cancer. So Gardasil, gender-neutral, but also cervical cancer being a critical driver and driving into earlier stage, those are all things that play around what we're trying to do at Merck.

Early stage and I believe that produce the date is among like four that are coming up in the next six months in relationship to cancer. So Garda, so gender neutral, but also cervical cancer being a critical driver in driving into earlier stage. Those are all things that play around what we're trying to do at <unk>.

Peter Dannenbaum: Thanks for the question Chris, we have time to take some additional questions and go past the hour, Julie next question please.

Mark.

Peter Dannenbaum: Thanks for the question, Chris. We have time to take some additional questions and go past the hour. Julie, next question, please.

Thanks for the question, Chris we have time to take some additional questions and go past the hour Julian next question. Please thank.

Operator: Thank you. Our next question comes from Jeff Meacham with Bank of America. Your line is open.

Julie Louise Gerberding: Thank you, our next question comes from Geoff Meacham with Bank of America. Your line is open.

Jeff Meacham: Hey, everyone. Thanks for the question. Question for Dean or even Rob on ADCs. So you guys have obviously done a number of deals, have partnered assets, and clearly you think this approach is strategically important for Merck. But the question is, how much of an investment is Merck making in building out a broader ADC platform in-house? I'm just thinking beyond the partner programs and especially, Dean, as you call it out, the I/O paradigm is shifting earlier. Thank you.

Geoff Meacham: Hey, everyone. Thanks for the question. Question for Dean or even Rob on ADCs. So you guys have obviously done a number of deals, have partnered assets, and clearly you think this approach is strategically important for Merck. But the question is, how much of an investment is Merck making in building out a broader ADC platform in-house? I'm just thinking beyond the partner programs and especially, Dean, as you call it out, the I/O paradigm is shifting earlier. Thank you.

Geoffrey Christopher Meacham: Hey, everyone, thanks for the question, a question for Dean or even Rob on ADCs, so you guys have obviously done a number of deals, have partnered assets and clearly you think this approach is strategically important for Merck, but the question is how much of an investment is Merck making in building out a broader ADC platform in house, I'm just thinking you know beyond the partner programs and especially Dean as you called out the IO paradigm is shifting earlier, thank you.

House I'm, just thinking you know beyond the partner programs and especially Deane as you called out the Io paradigm is shifting earlier. Thank you.

Dean Li: Yeah. Thanks for that. I'll grab that one. So we've been very lucky to partner with Kelun and Daiichi Sankyo. And that advances our clinical programs at scale. We also clearly have collaborations with other ADC companies in relationship to Keytruda. So we have a wall of data of understanding what we are hoping that the field might navigate towards. And like everyone has said, there will be different antibodies, different antibody structures to be able to change how one thinks about the tissue targeting component. There will be changes in terms of the linkers. And for right now, there are probably two major payloads that people use: a microtubule-based chemotherapy, as well as a topo-1-based chemotherapy. I would just emphasize that there are not just two classes of chemotherapy out there for the last 30 years. And each one has a reason why they're there.

Dean Y. Li: Yeah, Thanks for that I'll grab that one so, we've been very lucky to partner with Kelun and Daiichi Sankyo and that advances our clinical programs at at scale, We also clearly have collaborations with other ADC companies in relationship to Keytruda, so we have a wall of data of understanding what we are hoping that the field might bite navigate towards. and like everyone has said there will be different antibodies, different antibody structures to be able to change how one thinks about the tissue targeting component there will be changes in terms of the linker is a. And right now there are probably two major payloads that people use a microtubule based chemotherapy as well as a total one. <unk> chemotherapy I would just emphasize that there are only there are not just two classes of chemotherapy out there for the last 30 years and each one has a reason why they are there. So we have invested in an ADC platform that is separate but we'll build off what is learned from our clinical programs both. And the ones that we're doing with Daiichi sankyo and key land as well as those that we're doing where we're collaborating with others and relationship with Keytruda. So we have built and we continue to build that expertise within the company and we hope to see those internal. Programs peering its clinical head in the next couple of years.

We've been very lucky to partner with to Luna and Daiichi Sankyo and that advances our clinical programs at at scale. We also clearly have collaborations with other ADC companies in relationship to Keytruda. So we have a wall of data of understanding what we are hoping that the.

Dean Y. Li: And like everyone has said there will be different antibodies, different antibody structures to be able to change how one thinks about the tissue targeting component there will be changes in terms of the linker is and right now there are probably two major payloads that people use, a microtubule based chemotherapy as well as a total one base chemotherapy, I would just emphasize that there are only, there are not just two classes of chemotherapy out there for the last 30 years and each one has a reason why they are there, so we have invested in an ADC platform that is separate but we'll build off what is learned from our clinical programs both. And the ones that we're doing with Daiichi sankyo and key land as well as those that we're doing where we're collaborating with others and relationship with Keytruda. So we have built and we continue to build that expertise within the company and we hope to see those internal. Programs peering its clinical head in the next couple of years.

Field might bite navigate towards and like everyone has said there will be different antibodies different antibody structures to be able to change how one thinks about the tissue targeting component there will be changes in terms of the linker is a.

And for right now, there are probably two major payloads that people use: a microtubule-based chemotherapy, as well as a topo-1-based chemotherapy. I would just emphasize that there are not just two classes of chemotherapy out there for the last 30 years. And each one has a reason why they're there.

And right now there are probably two major payloads that people use a microtubule based chemotherapy as well as a total one.

<unk> chemotherapy I would just emphasize that there are only there are not just two classes of chemotherapy out there for the last 30 years and each one has a reason why they are there. So we have invested in an ADC platform that is separate but we'll build off what is learned from our clinical programs both.

Dean Y. Li: So we have invested in an ADC platform that is separate but we'll build off what is learned from our clinical programs both in the ones that we're doing with Daiichi Sankyo and Kelun as well as those that we're doing where we're collaborating with others in relationship with Keytruda, so we have built and we continue to build that expertise within the company and we hope to see those internal programs peering its clinical head in the next couple of years.

Dean Li: So we have invested in an ADC platform that is separate, but we'll build off what is learned from our clinical programs, both in the ones that we're doing with Daiichi Sankyo and Kelun, as well as those that we're doing where we're collaborating with others in relationship with Keytruda. So we have built and we continue to build that expertise within the company. And we hope to see those internal programs rearing its clinical head in the next couple of years.

So we have invested in an ADC platform that is separate, but we'll build off what is learned from our clinical programs, both in the ones that we're doing with Daiichi Sankyo and Kelun, as well as those that we're doing where we're collaborating with others in relationship with Keytruda. So we have built and we continue to build that expertise within the company. And we hope to see those internal programs rearing its clinical head in the next couple of years.

And the ones that we're doing with Daiichi sankyo and key land as well as those that we're doing where we're collaborating with others and relationship with Keytruda. So we have built and we continue to build that expertise within the company and we hope to see those internal.

Programs peering its clinical head in the next couple of years.

Peter Dannenbaum: Thanks, Jeff. Next question, please.

Peter Dannenbaum: Thanks, Geoff next question please.

Operator: Thank you. Our next question comes from Steve Scala with TD Cowen. Your line is open.

Thank you. Our next question comes from Steve Scala with TD Cowen. Your line is open. Thank you very much what is that you actually vantiv share in pediatrics now and why hasn't it seen an inflection in the U S sales in line with Merck's prior comments that had held 30% share of the pediatric market.

Julie Louise Gerberding: Thank you, our next question comes from Steve Scala with TD Cowen. Your line is open.

Steve Scala: Thank you very much. What does Vaxneuvance's share in pediatrics now? And why hasn't it seen an inflection in the US sales in line with Merck's prior comments that it held 30% share of the pediatric market with plans to grow from there? I mean, 30% share of a $6 billion market is a big number, and it's well ahead of where current sales are landing. So any color would be appreciated. Thank you.

Steve Scala: Thank you very much what is Vaxneuvance's share in pediatrics now and why hasn't it seen an inflection in the U.S. sales in line with Merck's prior comments that had held 30% share of the pediatric market. With plans to grow from there, I mean 30% share of a $6 billion dollars market it's a big number and it's well ahead of where current sales are landing so any color would be appreciated, Thank you. Yes, Steve I'll jump on that and and then others can jump in but so. Your answer is we are in that. That low 30% sure both on the public and private market. So that is what youre seeing in the quarter are up into. The U S roughly was about. Approaching a $185 million to $200 million of <unk>. <unk> business. For the products so. We're actually seeing growth pretty much consistent with what we expect in the share we got is pretty much what we expected so. We'll have to think through how to.

With plans to grow from there I mean, 30% share of a $6 billion market. It's a big number and it's well ahead of where current sales are landing so any color would be appreciated. Thank you.

Yes, Steve I'll jump on that and and then others can jump in but so.

Robert Davis: Yeah. Steve, I'll maybe jump on that, and then others can jump in. So your answer is we are in that low 30% share, both in the public and private market. That is what you're seeing in the quarter. I think the US roughly was about approaching, I think, $185 to $200 million of total business for the product. So we're actually seeing growth pretty much consistent with what we expect. And the share we got is pretty much what we expected. So we'll have to think through how to the disconnect in what you're seeing. But I can tell you, in fact, we are doing exactly what we expected we would do.

Rob Davis: Yeah. Steve, I'll maybe jump on that, and then others can jump in. So your answer is we are in that low 30% share, both in the public and private market. That is what you're seeing in the quarter. I think the US roughly was about approaching, I think, $185 to $200 million of total business for the product. So we're actually seeing growth pretty much consistent with what we expect. And the share we got is pretty much what we expected. So we'll have to think through how to the disconnect in what you're seeing. But I can tell you, in fact, we are doing exactly what we expected we would do.

Rob Davis: Yes, Steve I'll maybe jump on that and and then others can jump in but so, Your answer is, we are in that low 30% sure both on the public and private market, so that is what you're seeing in the quarter, I think the U.S. roughly was about approaching a $185 to $200 million dollars of total business for the products so, We're actually seeing growth pretty much consistent with what we expect and the share we got is pretty much what we expected so, We'll have to think through how to disconnect in what you're seeing but I can tell you in fact, we are doing exactly what we expected we would do.

Your answer is we are in that.

That low 30% sure both on the public and private market. So that is what youre seeing in the quarter are up into.

The U S roughly was about.

Approaching a $185 million to $200 million of <unk>.

<unk> business.

For the products so.

We're actually seeing growth pretty much consistent with what we expect in the share we got is pretty much what we expected so.

We'll have to think through how to.

The disconnect in what you're seeing but I can tell you in fact, we are doing exactly what we expected we would do.

Caroline Litchfield: This is Caroline. The only thing I'd add to that would be the performance we're also seeing outside of the US. So while we're early in our launch outside the US, we have gained 50% of the tenders in which we have participated, and we're seeing share north of that 1/3. So we're very confident in our ability to continue to drive Vaxneuvance and very much looking forward to augmenting our offering with V116 later next year.

Caroline Litchfield: This is Caroline, the only thing I'd add to that would be the performance we're also seeing outside of the U.S. so while we're only in our launch, outside the U.S. We have gained 50% of the tenders in which we have participated and we should gain shares north of that one side, so we're very confident in our ability to continue to drive Vaxneuvance and very much looking forward to augmenting our offering with V116 later next year.

And our ability to continue to drive <unk>, Nissan and very much looking forward to augmenting our offering with fever. One six later next year.

Robert Davis: Yeah. I would just add, Steve, let me just clarify one thing because I think it's important. I was just reflecting on your question. Just to clarify my comment, it's 30% is our exit share, not overall of the year. So that's an exit share as we're seeing the business grow today.

Rob Davis: Yeah. I would just add, Steve, let me just clarify one thing because I think it's important. I was just reflecting on your question. Just to clarify my comment, it's 30% is our exit share, not overall of the year. So that's an exit share as we're seeing the business grow today.

Yeah, I would just say.

Rob Davis: Steve, Steve let me just clarify one thing because I think it's important I was just, before I get on your question just to clarify my comments, it's 30% is the extra tier, not overall of the year, so that's an extra tier as we were seeing in the business world today. Yeah, I wanted to just make a comment about vaccine events in the setting of what Caroline said about V. One six it's essentially with vaccine events and rebound when six what we're trying to do is to drive you know a precision medicine mindset to vaccine, giving the right. <unk> seen with the right set of serotypes to the right age group at the right time. And we believe that that strategy is important for vacs, new bands and to think about Max new vintage not just on its own but in relationship to be one six and you know we have work cut out to us in relationship to to a potential approval. From the FDA as well as you know we will have to speak to the ACI T. As we advance this concept of a precision medicine mindset to pneumococcal vaccination.

Before I get on your question just to clarify my comments, it's 30% is the extra true not overall of the year. So that's an extra true as we were seeing in the business world today.

Dean Li: Yeah. I wanted to just make a comment about Vaxneuvance in the setting of what Caroline said about V116. It's essentially with Vaxneuvance and V116, what we're trying to do is to drive a precision medicine mindset to vaccine, giving the right vaccine with the right set of serotypes to the right age group at the right time. And we believe that that strategy is important for Vaxneuvance and to think about Vaxneuvance not just on its own, but in relationship to V116. And we have work cut out to us in relationship to a potential approval from the FDA, as well as we'll have to speak to the ACIP as we advance this concept of a precision medicine mindset to pneumococcal vaccination.

Yeah, I wanted to just make a comment about vaccine events in the setting of what Caroline said about V. One six it's essentially with vaccine events and rebound when six what we're trying to do is to drive you know a precision medicine mindset to vaccine, giving the right.

Dean Y. Li: Yeah, I wanted to just make a comment about Vaxneuvance in the setting of what Caroline said about V116, it's essentially with Vaxneuvance and V116 what we're trying to do is to drive, you know, a precision medicine mindset to vaccine, giving the right vaccine, with the right set of serotypes, to the right age group, at the right time and we believe that that strategy is important for Vaxneuvance and to think about Vaxneuvance, not just on its own but in relationship to V116 and you know we have work cut out to us in relationship to a potential approval from the FDA as well as you know we will have to speak to the ACI T. As we advance this concept of a precision medicine mindset to pneumococcal vaccination.

<unk> seen with the right set of serotypes to the right age group at the right time.

And we believe that that strategy is important for vacs, new bands and to think about Max new vintage not just on its own but in relationship to be one six and you know we have work cut out to us in relationship to to a potential approval.

From the FDA as well as you know we will have to speak to the ACI T.

As we advance this concept of a precision medicine mindset to pneumococcal vaccination.

Peter Dannenbaum: Thanks, Steve. Next question, please.

Peter Dannenbaum: Thanks, Steve next question please.

Operator: Thank you. Our next question comes from Evan Seigerman with BMO Capital Markets. Your line is open.

Julie Louise Gerberding: Thank you. Our next question comes from Evan Siegerman with BMO capital markets. Your line is open.

Evan Seigerman: Hi. Well, thank you so much for taking my question. I want to touch on MK-0616. So clearly prioritizing this, given the advancement into multiple phase 3 trials, maybe talk to me about the importance of an oral PCSK9 given the dynamics we've seen in the injectable market with both the antibodies and other long-acting assets. Thank you so much.

Evan David Seigerman: Well Thank you so much for taking my question, I wanted to touch on MK-0616, so clearly prioritizing this time given the advancement into multiple Phase III trials, maybe talk to me about the importance of an oral PCSK9 given the dynamics, we've seen in the injectable market with both the antibodies and other long acting assets. Thank you so much.

Dean Li: Okay. I will take that one. And I will give my homage to Helen Hobbs and Jonathan Cohen at the UT Southwestern Dallas Heart Study. That was really important data in relationship to showing PCSK9. And if you look at that patient population, that patient population is desperately in need of an oral potent LDL-lowering cholesterol medicine. And that's what we're trying to provide. We're trying to democratize that pathway such that people, whether in the rural, or in the inner city, or globally, can get this. And so I would just emphasize the other point, which is cardiovascular disease, atherosclerotic disease, is still the number one killer in the United States and the developed countries. And lowering LDL is known to be important.

Dean Y. Li: Okay, I will take that one and I will give my homage to Helen Hobbs and Jonathan Cohen at the UT Southwestern Dallas Heart study, that was really important data in relationship to showing PCSK9 and if you look at that patient population that patient population is desperately in need of an oral, potent LDL lowering cholesterol medicine, and that's what we're trying to provide we're trying to democratize that pathway such that people, whether they're rural in the inner city or globally can get to this and so I would just emphasize the other point, which is cardiovascular disease <unk>. Colorado disease is still the number one killer in the United States and the developed countries and lowering LDL is known to be important we used to talk about statin resistant or refractory, but my experience is that the level of LDL that youre going to have to drive to that increasingly the. Guidelines are taking is to is forget about whether your refractory or resistant to spend it will be very hard with one agent to get your LDL below 70 or below 55% in some patient populations that patient population do you want to treat you wanted to have that treatment readily available with no. Cold chain and no requirement to go into a hospital system to get it that's what we're trying to do and hopefully our data will support such a move.

And I will give my homage to Helen Hobbs and Jonathan Cohen at the UT Southwestern Dallas Heart study that was really important data in relationship to showing Pcs canine and if you look at that patient population that patient population is desperately in need.

Oral potent LDL lowering cholesterol medicine, and that's what we're trying to provide we're trying to democratize that pathway such that people, whether they're rural in the inner city or globally can get to this and so I would just emphasize the other point, which is cardiovascular disease <unk>.

Dean Y. Li: We're trying to democratize that pathway such that people, whether they're rural, in the inner city or globally can get this and so I would just emphasize the other point, which is cardiovascular disease, atheroesclerotic disease is still the number one killer in the United States and the developed countries and lowering LDL is known to be important, we used to talk about statin resistant or refractory, but my experience is that the level of LDL that you're going to have to drive to that increasingly the Guidelines are taking is to, is forget about whether your refractory or resistant to spend it will be very hard with one agent to get your LDL below 70 or below 55% in some patient populations, that patient population you want to treat you'd want to have that treatment readily available with no cold chain and no requirement to go into a hospital system to get it, that's what we're trying to do and hopefully our data will support such a move.

Colorado disease is still the number one killer in the United States and the developed countries and lowering LDL is known to be important we used to talk about statin resistant or refractory, but my experience is that the level of LDL that youre going to have to drive to that increasingly the.

And lowering LDL is known to be important.

Dean Li: We used to talk about statin-resistant or refractory, but my experience is that the level of LDL that you're going to have to drive to, that increasingly the guidelines are taking us to, is, forget about whether you're refractory or resistant to statins. It will be very hard with one agent to get your LDL below 70 or below 55 in some patient populations. That patient population, you want to treat. You want to have that treatment readily available with no copay and no requirement to go into a hospital system to get it. That's what we're trying to do. And hopefully, our data will support such a move.

We used to talk about statin-resistant or refractory, but my experience is that the level of LDL that you're going to have to drive to, that increasingly the guidelines are taking us to, is, forget about whether you're refractory or resistant to statins. It will be very hard with one agent to get your LDL below 70 or below 55 in some patient populations. That patient population, you want to treat. You want to have that treatment readily available with no copay and no requirement to go into a hospital system to get it. That's what we're trying to do. And hopefully, our data will support such a move.

Guidelines are taking is to is forget about whether your refractory or resistant to spend it will be very hard with one agent to get your LDL below 70 or below 55% in some patient populations that patient population do you want to treat you wanted to have that treatment readily available with no.

Cold chain and no requirement to go into a hospital system to get it that's what we're trying to do and hopefully our data will support such a move.

Peter Dannenbaum: Great. Thanks, Evan. Maybe final question, please, Julie.

Peter Dannenbaum: Great, Thanks, Gavin, maybe final question please Julie

Operator: Thank you. Our next question comes from Mohit Bansal. Your line is open with Wells Fargo.

Julie Louise Gerberding: Thank you. Our next question comes from Mohit Bansal. Your line is open with Wells Fargo.

Our next question comes from Mohit Bansal. Your line is open with Wells Fargo.

Mohit Bansal: Great. Thank you very much. And thanks for squeezing me in. I just want to touch upon among EGFR mutant patients, how are you thinking about a TROP2 ADC versus a HER2 ADC? Because if you look at your data or even AZ's data, it seems like TROP2 seems to be working quite well among those EGFR mutations. So how are you thinking about these two ADCs in that same indication?

Mohit Bansal: Great. Thank you very much and thanks for squeezing me in, I just want to touch upon, among EGFR mutant patients, how are you thinking about a TROP2 ADC versus the HER2 ADC, because if you look at your data all even as these data it seems like charter seems to be working quite well among those ADA mutation so, how are you thinking about these two ADC's in the same indication.

I just wanted to touch upon.

Among egfr.

Mutant patients how are you thinking about a trop two ADC was his or her three D. C. Because if you look at your data all even as these data it seems like charter seems to be working quite well among goes.

A mutation so how are you thinking about.

These 286 in the same indication.

Dean Y. Li: I think that's a great question, I would just answer that I think the TROP2 ADC data is important to look at, but I would also emphasize that the HER3 ADC program is reasonably advanced in that patient population and so we will you know we're interested advancing both in getting the best medicines to the patients as quickly as we can. I do think more as a general statement that the role of Biomarkers for some of these adcs outside of of of of Egfr will be important in relationship to tissue targeting also in relationship more broadly. For Adcs and other combinations. And so we'll have to see how that field is moving but essentially the way I think about adcs is trying to bring chemotherapy in the precision medicine approach and with that we're gonna have to find the right patient population with the right biomarkers to give them the maximum benefit.

Dean Li: I think that's a great question. I would just answer that I think the TROP2 ADC data is important to look at. But I would also emphasize that the HER3 ADC program is reasonably advanced in that patient population. And so we're interested in advancing both and getting the best medicines to the patients as quickly as we can. I do think more as a general statement that the role of biomarkers for some of these ADCs outside of EGFR will be important in relationship to tissue targeting, also in relationship more broadly for ADCs and other combinations. And so we'll have to see how that field is moving. But essentially, the way I think about ADCs is trying to bring chemotherapy and the precision medicine approach.

I think the trop two ADC data is important to look at but I would also emphasize that the her three ADC.

Program is reasonably advanced in that patient population and so we will you know we're interested advancing both in getting the best medicines to the patients as quickly as we can.

Dean Y. Li: I do think more as a general statement that the role of Biomarkers for some of these ADCs outside of EGFR will be important in relationship to tissue targeting also in relationship more broadly For ADCs and other combinations and so we'll have to see how that field is moving, but essentially the way I think about ADCs is trying to bring chemotherapy in the precision medicine approach and with that we're gonna have to find the right patient population with the right biomarkers to give them the maximum benefit.

I do think more as a general statement that the role of Biomarkers for some of these adcs outside of of of of Egfr will be important in relationship to tissue targeting also in relationship more broadly.

For Adcs and other combinations.

And so we'll have to see how that field is moving but essentially the way I think about adcs is trying to bring chemotherapy in the precision medicine approach and with that we're gonna have to find the right patient population with the right biomarkers to give them the maximum benefit.

But essentially, the way I think about ADCs is trying to bring chemotherapy and the precision medicine approach.

Dean Li: With that, we're going to have to find the right patient population with the right biomarkers to give them the maximum benefit.

With that, we're going to have to find the right patient population with the right biomarkers to give them the maximum benefit.

Peter Dannenbaum: Thank you, Mohit. And thank you all for your time and attention today. Please follow up with Investor Relations if you have any additional questions. And we look forward to being in touch soon. Thank you all very much.

Peter Dannenbaum: Thank you and thank you all for your time and attention today, please follow up with Investor Relations if you have any additional questions and we look forward to being in touch soon, thank you all very much.

Operator: Thank you for your participation. Participants, you may disconnect at this time.

Julie Louise Gerberding: Thank you for your participation participants you may disconnect at this time.

Q3 2023 Merck & Co Inc Earnings Call

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