Q1 2022 Merck & Co Inc Earnings Press Conference

April 28, 2022

Operator: Good morning. My name is Grace Lacker, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Merck & Co. Q1 Sales and Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. To withdraw your question, please press the pound key. Thank you. I would like to turn the call over to Peter Dannenbaum, Vice President of Investor Relations. Please go ahead.

Operator: Good morning. My name is Grace Lacker, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Merck & Co Q1 Sales and Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. To withdraw your question, please press the pound key. Thank you. I would like to turn the call over to Peter Dannenbaum, Vice President of Investor Relations. Please go ahead.

Good morning. My name is Grace Lacrae, an LBR Conference Operator today. At this time, I would like to welcome everyone to the Merck & Co Q1 Sales & Earnings Conference call. All eyes have been placed on mute to prevent any...

Good morning, My name is Grace lack Ryan and I'll be your conference operator today at this time I would like to welcome everyone to the Merck and co Q1 sales and earnings conference call. All lines have been placed on mute to prevent.

Any background noise and after the Speakers' remarks, there'll be a question and answer session. If you would like to ask a question. During this time simply press Star then the number one on your telephone keypad and to withdraw your question. Please press the panicky. Thank you.

and after the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star then the number one on your telephone keypad. And to withdraw your question, please press the pound.

Thank you. I would like to turn the call over to Peter Denenbaum, Vice President of Investor Relations. Please go ahead.

I'd now like to turn the call over to Peter then in bonds Vice Presidents off Investor Relations. Please go ahead.

Peter Dannenbaum: Thank you, Grace, and good morning. Welcome to Merck's Q1 2022 conference call. Speaking on today's call will be Rob Davis, President 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 items 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.

Thank you, Grace, and good morning. Welcome to Merck's first quarter 2022 conference call. Speaking on today's call will be Rob Davis, President and Chief Executive Officer.

Thank you Grace and good morning, welcome to Merck's first quarter 2022 conference call speaking on today's call will be Rob Davis, President 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.

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 have excluded these items from our non-GAAP results and provide a reconciliation and our press release.

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 items 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 U S private securities.

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 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 statement.

<unk> Reform Act of 1095, such statements are made based on the current beliefs that 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 day into 2021 and 10-K.

Peter Dannenbaum: 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 2021 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, a slide presentation will accompany our speakers' prepared remarks. The presentation, today's earnings release, as well as 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 and the 2021 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, a slide presentation will accompany our speakers' prepared remarks. The presentation, today's earnings release, as well as 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.

Our FCC filings, including item 1A and the 2021 10K, 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 statement.

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 a slide presentation will accompany our speaker's prepared remarks, the presentation today's earnings release as well as our SEC filings.

During today's call, a slide presentation will accompany our speakers' prepared remarks.

presentation, today's earnings release, as well as our FEC 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.

Our all posted to the Investor Relations Relations section of <unk> website with that I'd like to turn the call over to Rob.

Robert M. Davis: Thanks, Peter. Good morning, and thank you for joining today's call. Before I get started, let me take a moment to speak about the ongoing crisis in Ukraine. We are hopeful for an immediate and peaceful resolution to the Russian invasion of the country, and we support the Ukrainian people and stand with them, and recognize what a terrible tragedy this represents. Merck is making every effort to protect the health and safety of our employees and to ensure essential medicines and vaccines continue to reach patients. In addition, we are dedicating meaningful resources to address the humanitarian crisis in the country through multiple channels. Turning to our business, we continue to deliver across our key strategic priorities in Q1. We're sustaining the strong business momentum we delivered in 2021 with robust top and bottom line growth.

Robert Davis: Thanks, Peter. Good morning, and thank you for joining today's call. Before I get started, let me take a moment to speak about the ongoing crisis in Ukraine. We are hopeful for an immediate and peaceful resolution to the Russian invasion of the country, and we support the Ukrainian people and stand with them, and recognize what a terrible tragedy this represents. Merck is making every effort to protect the health and safety of our employees and to ensure essential medicines and vaccines continue to reach patients. In addition, we are dedicating meaningful resources to address the humanitarian crisis in the country through multiple channels. Turning to our business, we continue to deliver across our key strategic priorities in Q1. We're sustaining the strong business momentum we delivered in 2021 with robust top and bottom line growth.

Thanks, Peter. Good morning and thank you for joining today's call. Before I get started, let me take a moment to speak about the ongoing crisis in Ukraine.

Thanks, Peter Good morning, and thank you for joining today's call.

Before I get started let me take a moment to speak about the ongoing crisis in Ukraine.

We are hopeful for an immediate and peaceful resolution to the Russian invasion of the country, and we support the Ukrainian people and stand with them, and recognize what a terrible tragedy this represents.

We are hopeful for an immediate and peaceful resolution to the Russian invasion of the country and.

We support the Ukrainian people and stand with them and recognize what a terrible tragedies. This represents.

Merck is making every effort to protect the health and safety of our employees and to ensure essential medicines and vaccines continue to reach patients.

Merck is making every effort to protect the health and safety of our employees and to ensure our central medicines and vaccines continue to reach patients.

In addition, we are dedicating meaningful resources to address the humanitarian crisis in the country through multiple channels.

Turning to our business, we continue to deliver across our key strategic priorities in the first quarter. We're sustaining the strong business momentum we delivered in 2021 with robust top and bottom line growth.

Turning to our business, we continue to deliver across our key strategic priorities in the first quarter.

We're sustaining the strong business momentum we delivered in 2021.

Robust top and bottom line growth.

Robert M. Davis: We've also achieved significant clinical advancements across our research pipeline and successfully integrated Acceleron. Now moving to our results. We've had a strong start to 2022, achieving very strong top and bottom line growth. Commercially, we continue to execute well across a broad set of key growth drivers, most notably Keytruda, Gardasil, and animal health. Our performance reflects robust underlying demand for our de-risk innovative portfolio and reinforces the importance of our science-led strategy. Legevrio, our COVID-19 antiviral treatment, was a significant contributor as well, but even excluding these sales, our top line growth was still a very healthy 19% versus last year. On Legevrio, we've accelerated broad global access, and it's now established as an important tool for patients and healthcare providers to address the ongoing pandemic. Since receiving emergency use authorization in December, we've delivered approximately 6.4 million courses to more than 30 countries.

We've also achieved significant clinical advancements across our research pipeline and successfully integrated Acceleron. Now moving to our results. We've had a strong start to 2022, achieving very strong top and bottom line growth. Commercially, we continue to execute well across a broad set of key growth drivers, most notably Keytruda, Gardasil, and animal health. Our performance reflects robust underlying demand for our de-risk innovative portfolio and reinforces the importance of our science-led strategy. Legevrio, our COVID-19 antiviral treatment, was a significant contributor as well, but even excluding these sales, our top line growth was still a very healthy 19% versus last year. On Legevrio, we've accelerated broad global access, and it's now established as an important tool for patients and healthcare providers to address the ongoing pandemic. Since receiving emergency use authorization in December, we've delivered approximately 6.4 million courses to more than 30 countries.

We've also achieved significant clinical advancements across our research pipeline and successfully integrated Excelron.

We've also achieved significant clinical advancements across our research pipeline and successfully integrated excel wrong.

Now moving to our results.

We've had a strong start to 2022, achieving very strong top and bottom line growth.

Commercially, we continue to execute well across a broad set of key growth drivers, most notably, Gertruda, Sardicil, and Animal Health. Our performance reflects robust underlying demand for our de-risk innovative portfolio and reinforces the importance of our science-led strategy.

Commercially we continue to execute well across a broad set of key growth drivers, most notably Keytruda gardasil and animal health.

Our performance reflects robust underlying demand for our de risked innovative portfolio and reinforces the importance of our science led strategy.

For Gebrio, our COVID-19 antiviral treatment was a significant contributor as well, but even excluding these sales, our top-line growth was still a very healthy 19% versus last year.

The GAAP Rio our COVID-19, antiviral treatment was a significant contributor as well, but even excluding these sales our topline growth was still a very healthy 19% versus last year.

On the Gavrio, we've accelerated broad global access, and it's now established as an important tool for patients and health care providers to address the ongoing pandemic.

I'll, let Jeff.

<unk> celebrated broad global access and it is now established as an important tool for patients and health care providers to address the ongoing pandemic.

Since receiving emergency use authorization in December , we've delivered approximately 6.4 million courses to more than 30 countries.

Since receiving emergency use authorization in December we've delivered approximately $6 4 million courses to more than 30 countries.

Robert M. Davis: The success we are achieving is reflected in our updated 2022 guidance, which demonstrates our expectation for another year of strong growth and overall business momentum. Our oncology business is benefiting from the continued rollout of new and important indications, including in earlier lines of therapy. Global demand for Gardasil remains strong, and growth will benefit from increased supply as a result of the significant investments we are making to expand manufacturing capacity, and our animal health business remains positioned to grow at above-market rates. Longer term, we remain confident in our ability to deliver strong revenue growth and operating margin expansion through 2025. We're preparing for the post-Keytruda LOE period by continuing to strengthen the levers we have and building upon them in order to deliver long-term growth.

The success we are achieving is reflected in our updated 2022 guidance, which demonstrates our expectation for another year of strong growth and overall business momentum. Our oncology business is benefiting from the continued rollout of new and important indications, including in earlier lines of therapy. Global demand for Gardasil remains strong, and growth will benefit from increased supply as a result of the significant investments we are making to expand manufacturing capacity, and our animal health business remains positioned to grow at above-market rates. Longer term, we remain confident in our ability to deliver strong revenue growth and operating margin expansion through 2025. We're preparing for the post-Keytruda LOE period by continuing to strengthen the levers we have and building upon them in order to deliver long-term growth.

The success we are achieving is reflected in our updated 2022 guidance, which demonstrates our expectation for another year of strong growth and overall business momentum. Oncology business is benefiting from the continued rollout of new and important indications. Including an earlier lines of therapy.

The success, we are achieving is reflected in our updated 2022 guidance, which demonstrates our expectation for another year of strong growth and overall business momentum.

One college business is benefiting from the continued rollout of new and important indications, including in earlier lines of therapy.

Global demand for Gardasil remains strong and growth will benefit from increased supply as a result of the significant investments we are making to expand manufacturing capacity and our animal health business remains positioned to grow at above market rate.

Global demand for Gardner still remains strong.

And growth will benefit from increased supply as a result of the significant investments, we are making to expand manufacturing capacity and our animal health business remains positioned to grow at above market rates.

Longer term, we remain confident in our ability to deliver strong revenue growth and operating margin expansion through 2025.

We're preparing for the post-Katruda LLE period by continuing to strengthen the levers we have and building upon them in order to deliver long-term growth.

We're preparing for the post contributed low period, while continuing to strengthen the levers we have and building upon them in order to deliver long term growth.

Robert M. Davis: In oncology, we remain committed to building on the foundational position that we have achieved with Keytruda, and we aim to expand our presence in this key therapeutic area and to establish an enduring leadership position. In addition, we'll continue to maximize the opportunities we see for our durable growth drivers, such as Gardasil, our pneumococcal portfolio, and animal health, through our proven commercial execution. Beyond our existing portfolio, business development remains a key priority. We remain highly focused in our pursuit of the best external innovation and will be appropriately aggressive when great science and value align. We have a strong track record of business development, but we know we need to do more, and we believe we are well-positioned to quickly deploy capital towards the right strategic assets as they present themselves.

In oncology, we remain committed to building on the foundational position that we have achieved with Keytruda, and we aim to expand our presence in this key therapeutic area and to establish an enduring leadership position. In addition, we'll continue to maximize the opportunities we see for our durable growth drivers, such as Gardasil, our pneumococcal portfolio, and animal health, through our proven commercial execution. Beyond our existing portfolio, business development remains a key priority. We remain highly focused in our pursuit of the best external innovation and will be appropriately aggressive when great science and value align. We have a strong track record of business development, but we know we need to do more, and we believe we are well-positioned to quickly deploy capital towards the right strategic assets as they present themselves.

In oncology, we remain committed to building on the foundational position that we have achieved with Patruda, and we aim to expand our presence in this key therapeutic area and to establish an enduring leadership position.

In oncology, we remain committed to building on the foundational position that we have achieved with Keytruda and we aim to expand our presence in this key therapeutic area and to establish an enduring leadership position.

In addition, we'll continue to maximize the opportunities we see for our durable growth drivers, such as Gardasil, our pneumococcal portfolio, and animal health through our proven commercial execution.

In addition, we will continue to maximize the opportunities we see for our durable growth drivers such as Gardasil, our pneumococcal portfolio in animal health through our proven commercial execution.

Beyond our existing portfolio business development remains a key priority.

Beyond our existing portfolio, business development remains a key priority.

We remain highly focused in our pursuit of the best external innovation and will be appropriately aggressive when great science and value align. We have a strong track record of business development, but we know we need to do more, and we believe we are well positioned to quickly deploy capital towards the right strategic assets as they present themselves.

We remain highly focused in our pursuit of the best external innovation and we'll be appropriately aggressive when great science and value line.

We have a strong track record of business development, but we know we need to do more and we believe we are well positioned to quickly deploy capital towards the right strategic assets as they present themselves.

Robert M. Davis: And finally, we'll continue to advance our broad pipeline across key therapeutic areas in order to deliver medically important innovations to patients. We've taken important steps to provide increased transparency into the opportunities we see in our portfolio and our business, including through two recent investor events. Earlier this month, we provided a detailed description of our growing cardiovascular portfolio and pipeline, and at Merck, we're focusing our efforts where the needs are greatest and where we have the best opportunity to positively impact patients' lives, including in heart failure, pulmonary arterial hypertension, thrombosis, and atherosclerosis. We've made significant advancements across our CV pipeline and believe our broad, differentiated portfolio can have meaningful impacts on patients' lives with at least eight potential new approvals by 2030. We're confident that these important innovations have the potential to be meaningful growth drivers for Merck well into the next decade.

And finally, we'll continue to advance our broad pipeline across key therapeutic areas in order to deliver medically important innovations to patients. We've taken important steps to provide increased transparency into the opportunities we see in our portfolio and our business, including through two recent investor events. Earlier this month, we provided a detailed description of our growing cardiovascular portfolio and pipeline, and at Merck, we're focusing our efforts where the needs are greatest and where we have the best opportunity to positively impact patients' lives, including in heart failure, pulmonary arterial hypertension, thrombosis, and atherosclerosis. We've made significant advancements across our CV pipeline and believe our broad, differentiated portfolio can have meaningful impacts on patients' lives with at least eight potential new approvals by 2030. We're confident that these important innovations have the potential to be meaningful growth drivers for Merck well into the next decade.

And finally, we'll continue to advance our broad pipeline across key therapeutic areas in order to deliver medically important innovations to patients.

And finally, we will continue to advance our broad pipeline across key therapeutic areas in order to deliver medically important innovations for patients.

We've taken important steps to provide increased transparency into the opportunities we see in our portfolio and our business, including through two recent investor events.

We've taken important steps to provide increased transparency into the opportunities, we see in our portfolio and our business, including through two recent investor events.

Earlier this month, we provided a detailed description of our growing cardiovascular portfolio and pipeline. At Merck, we're focusing our efforts where the needs are greatest and where we have the best opportunity to positively impact patients' lives, including heart failure, pulmonary arterial hypertension, thrombosis, and atherosclerosis.

Earlier. This month, we provided a detailed description of our growing cardiovascular portfolio and pipeline at Merck, we're focusing our efforts where the needs are greatest and where we have the best opportunity to positively impact patients lives, including in heart failure.

Pulmonary arterial hypertension thrombosis and atherosclerosis.

We've made significant advancements across our CV pipeline and believe our broad, differentiated portfolio can have meaningful impacts on patients' lives with at least eight potential new approvals by 2030.

We've made significant advancements across our pipeline and believe our broad differentiated portfolio can have a meaningful impact on patients' lives with at least eight potential new approvals by 2030.

We're confident that these important innovations have the potential to be meaningful growth drivers for Merck well into the next decade.

Robert M. Davis: And in February, we hosted our inaugural ESG event, which highlighted our activities in our four priority areas of access to health, employees, environmental sustainability, and ethics and values. Our ESG efforts are grounded in our company's values, and we look forward to building on Merck's legacy of operating responsibly going forward. Before I close, I'd like to take a moment to recognize Dr. Roy Baynes, who has announced his retirement after eight years at Merck. Roy has been instrumental in helping Merck become a leading oncology company, particularly through his leadership and the development of Keytruda. We wish Roy the best in his future endeavors, and we're confident that he leaves behind an outstanding team and program. I'm pleased to report that Dr. Eliav Barr was appointed to succeed Roy.

And in February, we hosted our inaugural ESG event, which highlighted our activities in our four priority areas of access to health, employees, environmental sustainability, and ethics and values. Our ESG efforts are grounded in our company's values, and we look forward to building on Merck's legacy of operating responsibly going forward. Before I close, I'd like to take a moment to recognize Dr. Roy Baynes, who has announced his retirement after eight years at Merck. Roy has been instrumental in helping Merck become a leading oncology company, particularly through his leadership and the development of Keytruda. We wish Roy the best in his future endeavors, and we're confident that he leaves behind an outstanding team and program. I'm pleased to report that Dr. Eliav Barr was appointed to succeed Roy.

And in February , we hosted our inaugural ESG event, which highlighted our activities in our four priority areas of access to health, employees, environmental sustainability, and ethics and values.

And in February we hosted our inaugural ESG event, which highlighted our activities in our four priority areas of access to help employees environmental sustainability and ethics and values.

Our ESG efforts are grounded in our company's values and we look forward to building on Merck's legacy of operating responsibly going forward.

Our ESG efforts are grounded in our company's values and we look forward to building on merck's legacy of operating responsibly going forward.

Before I close, I'd like to take a moment to recognize Dr. Roy Baines, who has announced his retirement after eight years at Merck.

Before I close I'd like to take a moment to recognize Dr. Roy Baynes, who has announced his retirement after eight years at Merck.

Roy has been instrumental in helping become a leading oncology company, particularly through his leadership and the development of the CRUDA.

ROI has been instrumental in helping us become a leading oncology company, particularly through his leadership in the development of Keytruda.

We wish Roy the best in his future endeavors, and we're confident that he leaves behind an outstanding team and program.

We wish all the best in his future endeavors and were confident that he leaves behind an outstanding team and program.

I'm pleased to report that Dr. Elias Barr was appointed to succeed Roy. Elias not only has deep experience having served in several research capacities throughout his more than two decades at Merck, but also has an unwavering commitment to patients consistent with Merck's purpose to save and improve lives.

I am pleased to report the Doctor Elliott bar was appointed to succeed ROI.

Robert M. Davis: Elliott not only has deep experience having served in several research capacities throughout his more than two decades at Merck, but also has an unwavering commitment to patients consistent with Merck's purpose to save and improve lives. In summary, we've begun 2022 with strong operational momentum, and I want to express my sincere thanks to our employees worldwide for their continued focus and commitment. We remain confident in our fundamental strategy, our growth prospects, and in our ability to deliver significant benefits for patients and value to shareholders well into the future. With that, I'll turn the call over to Caroline.

Elliott not only has deep experience having served in several research capacities throughout his more than two decades at Merck, but also has an unwavering commitment to patients consistent with Merck's purpose to save and improve lives. In summary, we've begun 2022 with strong operational momentum, and I want to express my sincere thanks to our employees worldwide for their continued focus and commitment. We remain confident in our fundamental strategy, our growth prospects, and in our ability to deliver significant benefits for patients and value to shareholders well into the future. With that, I'll turn the call over to Caroline.

Not only has deep experience having served in several research capacities throughout his more than two decades at Merck.

But also has an unwavering commitment to patients consistent with merck's purpose to save and improve lives.

In summary, we've begun 2022 with strong operational momentum, and I want to express my sincere thanks to our employees worldwide for their continued focus and commitment. We remain confident in our fundamental strategy, our growth prospects, and in our ability to deliver significant benefits for patients and value to shareholders well into the future. With that, I'll

In summary, we began 2022 with strong operational momentum.

I want to express my sincere thanks to our employees worldwide for their continued focus and commitment we remain confident.

Confident in our fundamental strategy, our growth prospects and in our ability to deliver significant benefits for patients and value to shareholders well into the future.

With that I'll turn the call over to Caroline.

Caroline Litchfield: Thank you, Rob. Good morning. As Rob highlighted, we have had a very strong start to 2022 with exceptional performance in both revenues and earnings. These results further demonstrate that our focus on science and innovation at the core of our strategy, enabled by excellent execution of our dedicated colleagues across the globe, is delivering value for patients, customers, and investors. Total company revenues were $15.9 billion, an increase of 50%. Legevrio contributed $3.2 billion in revenue. Excluding Legevrio, the base business delivered very strong growth of 19%. The remainder of my comments will be on an exchange basis. Our human health business continued its strong momentum. Excluding Legevrio, the human health business grew 21%, driven primarily by our key pillars, as well as the reduced impact of the pandemic.

Thank you, Rob. Good morning. As Rob highlighted, we have had a very strong start to 2022 with exceptional performance in both revenues and earnings.

Thank you Rob good morning.

As Rob highlighted we have had a very strong start to 2022 with exceptional performance in both revenues and earnings.

These results further demonstrate that our focus on science and innovation at the core of our strategy, enabled by excellent execution of our dedicated colleagues across the globe, is delivering value for patients, customers, and investors.

These results further demonstrate that our focus on science and innovation.

Core of our strategy.

Neighbors by excellent execution of our dedicated colleagues across the globe.

It brings value for patients customers and investors.

Total company revenues were $15.9 billion, an increase of 50%.

Total company revenues were $15 9 billion, an increase of 50%.

The Ghebrios contributed $3.2 billion in revenue.

<unk> contributed $3 $2 billion in revenues.

Excluding Luguevrio, the base business delivered very strong growth of 19 percent. The remainder of my

Excluding the gasoline.

This business delivered very strong growth of 19%.

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

Our human health business continued its strong momentum, excluding LeGabrieux, the human health business grew 21%, driven primarily by our key pillars, as well as the reduced impact of the pandemic.

Our human health business continued its strong momentum.

<unk> the human health business grew 21% driven primarily by our key pillars as well as the reduced impact of the pandemic.

Caroline Litchfield: Our animal health business also delivered above-market performance, with sales increasing 9%, driven by growth across both companion animal and livestock segments. Now turning to the first quarter performance of our key brands. In oncology, Keytruda grew 27% to $4.8 billion, reflecting continued robust global demand and the expansion into new indications. In the US, Keytruda continues to demonstrate strong growth across all key tumors and is benefiting from recent launches in earlier stage cancers, including triple-negative breast, renal cell carcinoma, and melanoma. Keytruda is currently approved to treat five indications in earlier stage cancers, and we are excited about the potential opportunity to expand into adjuvant lung cancer based on the encouraging data from Keynote-091. We continue to be confident that Keytruda's robust clinical data, combined with physicians' familiarity and experience with the product, will support expanded use and patient benefit in early stage disease.

Our animal health business also delivered above-market performance, with sales increasing 9%, driven by growth across both companion animal and livestock segments. Now turning to the Q1 performance of our key brands. In oncology, Keytruda grew 27% to $4.8 billion, reflecting continued robust global demand and the expansion into new indications. In the US, Keytruda continues to demonstrate strong growth across all key tumors and is benefiting from recent launches in earlier stage cancers, including triple-negative breast, renal cell carcinoma, and melanoma. Keytruda is currently approved to treat five indications in earlier stage cancers, and we are excited about the potential opportunity to expand into adjuvant lung cancer based on the encouraging data from Keynote-091. We continue to be confident that Keytruda's robust clinical data, combined with physicians' familiarity and experience with the product, will support expanded use and patient benefit in early stage disease.

Our animal health business also delivered above market performance with sales, increasing 9% driven by growth across both companion animal and livestock segment.

Our animal health business also delivered above-market performance, with sales increasing 9%, driven by growth across both companion animal and livestock segments.

Now turning to the first quarter performance of our key brands.

In oncology, Keytruda grew 27% to $4.8 billion, reflecting continued robust global demand and the expansion into new indications.

In oncology Keytruda grew 27% to $4 $8 billion, reflecting continued robust global demand and the.

The expansion into new indications.

In the U.S., Keytruda continues to demonstrate strong growth across all key tumors and is benefiting from recent launches in earlier stage cancers.

In the U S. Keytruda continues to demonstrate strong growth across all key achievements and its benefiting from recent launches in earlier stage cancers, including triple negative breast renal cell carcinoma and melanoma.

including triple negative breast, renal cell carcinoma, and melanoma.

Keytruder is currently approved to treat five indications in earlier stage cancers, and we are excited about the potential opportunity to expand into adjacent lung cancer based on the encouraging data from keynotes 91.

Keytruda is currently approved to treat five indications in earlier stage cancers, and we are excited about the potential opportunity to expand into adjuvant lung cancer based on the encouraging data from keynote <unk> 91.

We continue to be confident that Keytruda's robust clinical data combined with physicians' familiarity and experience with the product will support expanded use and patient benefit in early stage disease.

We continue to be confident that keytruda is robust clinical data combined with physicians familiarity and experience with the product will support expanded use and patient benefit in early stage disease.

Caroline Litchfield: In the metastatic setting, Keytruda continues to maintain its leadership position in non-small cell lung cancer, capturing eight out of ten eligible new patients. Outside the US, Keytruda's growth continues to be driven by lung cancer and the ongoing launches in head and neck cancer, and renal cell carcinoma. Lynparza remains the market-leading PARP inhibitor. Our alliance revenue grew 20%, driven by uptake in metastatic breast cancer. We are also excited by the expanded opportunity in early stage breast cancer, following the recent FDA approval based on the OlympiA study. Further, we look forward to potentially reaching a broad prostate population based on the PROPEL study. Lenvima alliance revenue also had very strong growth, driven by uptake following the launches of Keynote 581 in advanced renal cell carcinoma and Keynote 775 in metastatic endometrial cancer, where we are seeing encouraging new patient share trends across each of these tumor types.

In the metastatic setting, Keytruda continues to maintain its leadership position in non-small cell lung cancer, capturing eight out of ten eligible new patients. Outside the US, Keytruda's growth continues to be driven by lung cancer and the ongoing launches in head and neck cancer, and renal cell carcinoma. Lynparza remains the market-leading PARP inhibitor. Our alliance revenue grew 20%, driven by uptake in metastatic breast cancer. We are also excited by the expanded opportunity in early stage breast cancer, following the recent FDA approval based on the OlympiA study. Further, we look forward to potentially reaching a broad prostate population based on the PROPEL study. Lenvima alliance revenue also had very strong growth, driven by uptake following the launches of Keynote 581 in advanced renal cell carcinoma and Keynote 775 in metastatic endometrial cancer, where we are seeing encouraging new patient share trends across each of these tumor types.

In the metastatic setting, Keytruda continues to maintain its leadership position in non-small cell lung cancer, capturing 8 out of 10 eligible new patients.

In the metastatic setting keytruda continues to maintain its leadership position in non small cell lung cancer, capturing eight out of 10 eligible new patients.

Outside the US, ketoated growth continues to be driven by lung cancer and the ongoing launches in head and neck cancer and renal cell carcinoma.

Outside the U S. Keytruda growth continues to be driven by lung cancer, and the ongoing launches and head and neck cancer and renal cell carcinoma.

Limpasa remains the market-leading PARP inhibitor. Our Alliance revenue grew 20%, driven by uptake in metastatic breast cancer.

Lim pasta remains the market, leading PARP inhibitor.

Our alliance revenue grew 20% driven by uptake in metastatic breast cancer.

We are also excited by the expanded opportunity in early-stage breast cancer following the recent FDA approval based on the Olympia study.

We are also excited by the expanded opportunity in early stage breast cancer. Following the recent FDA approval based on the Olympiad study.

Further, we look forward to potentially reaching a broad prostate population based on the PROPEL study.

Further we look forward to potentially reaching a broad prostate population based on the propel study.

Lenzima Alliance revenue also had very strong growth, driven by uptake following the launches of Keynote 581 in advanced renal cell carcinoma and Keynote 775 in metastatic endometrial cancer, where we are seeing encouraging new patient share trends across each of these tumor types.

Lindsay Alliance revenue also had very strong growth driven by uptake following the launch of the keynote five H, one and advanced renal cell carcinoma, and keynote 775 in metastatic endometrial cancer, where youre seeing encouraging new patient share trends across each of the tumor.

Hi.

Caroline Litchfield: Lynparza growth also benefited from increased demand in hepatocellular carcinoma in China and certain one-time items. We are also excited by the launch of Welireg for patients with certain VHL-associated tumors. Welireg continues to generate strong interest among scientific leaders, providers, and patients. Although still early in its launch, Welireg has had strong uptake, providing a treatment option to the significant unmet needs for these patients. We are working to potentially extend its reach to broader RCC indications in the future. Our vaccines portfolio again delivered excellent performance, led by Gardasil, which increased 60% to $1.5 billion. Outside the US, significant growth was driven by strong underlying demand across key geographies, particularly China, as well as increased supply. In the US, sales increased due to the timing of CDC purchases.

Lynparza growth also benefited from increased demand in hepatocellular carcinoma in China and certain one-time items. We are also excited by the launch of Welireg for patients with certain VHL-associated tumors. Welireg continues to generate strong interest among scientific leaders, providers, and patients. Although still early in its launch, Welireg has had strong uptake, providing a treatment option to the significant unmet needs for these patients. We are working to potentially extend its reach to broader RCC indications in the future. Our vaccines portfolio again delivered excellent performance, led by Gardasil, which increased 60% to $1.5 billion. Outside the US, significant growth was driven by strong underlying demand across key geographies, particularly China, as well as increased supply. In the US, sales increased due to the timing of CDC purchases.

Lindsay growth also benefited from increased demand and have put to cellular carcinoma in China and certain onetime items.

Lymphoma growth also benefited from increased demand in hepatocellular carcinoma in China and certain one-time ices.

We are also excited by the launch of Wellyreg for patients with certain VHL associated tumours.

We are also excited by the launch of <unk> for patients with Dutton BHL associated Kunitz.

Welly-Rec continues to generate strong interest among scientific leaders, providers, and patients.

<unk> continues to generate strong interest amongst scientific leader providers and patients.

Although still early in its launch, Rolireg has had strong uptake, providing a treatment option to the significant unmet need for these patients.

Though still early in its launch really Reg has had strong uptake providing a treatment option to the significant unmet need for these patients.

We are working to potentially extend its reach to broader RCC indications in the future.

Our vaccines portfolio again delivered excellent performance, led by Gardasil, which increased 60% to $1.5 billion.

Our vaccines portfolio again delivered excellent performance led by Gardasil, which increased 60% to one 5 billion.

Outside the U S significant growth was driven by strong underlying demand across key geographies, particularly China as well as increased supply.

In the U.S., sales increased due to the timing of CDC purchase.

In the U S sales increased due to the timing of CDC purchases.

Caroline Litchfield: Global demand for Gardasil remains robust, supported by strong clinical and real-world data, as well as efforts to increase the recognition of Gardasil as a vaccine that can help prevent certain HPV-related cancers in both females and males. In our hospital acute care portfolio, Bridion sales grew 20%, driven by the ongoing recovery in surgical procedures during the quarter and continued strong leadership of the neuromuscular blockade reversal agent class. Our animal health business delivered another quarter of robust growth, with sales increasing 9%. Companion animal sales increased 13%, driven by global demand in parasiticides, including the Bravecto line of products, as well as vaccines. Livestock sales increased 7% due to higher demand in ruminants and poultry. I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis.

Global demand for Gardasil remains robust, supported by strong clinical and real-world data, as well as efforts to increase the recognition of Gardasil as a vaccine that can help prevent certain HPV-related cancers in both females and males. In our hospital acute care portfolio, Bridion sales grew 20%, driven by the ongoing recovery in surgical procedures during the quarter and continued strong leadership of the neuromuscular blockade reversal agent class. Our animal health business delivered another quarter of robust growth, with sales increasing 9%. Companion animal sales increased 13%, driven by global demand in parasiticides, including the Bravecto line of products, as well as vaccines. Livestock sales increased 7% due to higher demand in ruminants and poultry. I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis.

Global demand for Gardasil remains robust supported by strong clinical and real world data as well as efforts to increase the recognition of <unk> as a vaccine that can help prevent certain HPV related cancers in both females and males.

In our hospital acute care portfolio, Viridian cells grew 20% driven by the ongoing recovery in surgical procedures during the quarter and continued strong leadership of the neuromuscular blockade reversal agent class.

In our hospital acute care portfolio greatly on sales grew 20% driven by the ongoing recovery in surgical procedures during the quarter and continued strong leadership of the neuromuscular blockade reversal agent class.

Our animal health business delivered another quarter of robust growth, with sales increasing 9%.

Our animal health business delivered another quarter of robust growth with sales increasing 9%.

Companion animal sales increased 13% driven by global demand in parasiticides, including the Brevecto line of products as well as vaccines.

Companion animal sales increased 13% driven by global demand in parasiticide, including the perfecto line of products as well as vaccines.

Livestock sales increased 7% due to higher demand in ruminants and poultry.

I will now walk you through the remainder of our P&L, and my comments will be on a non-GET basis.

I will now walk you through the remainder of our P&L My comments will be on a non-GAAP basis.

Caroline Litchfield: Gross margin was 70.7%, a decrease of 5.9 percentage points, driven primarily by higher Legevrio sales. As a reminder, we share profits from Legevrio equally with our partner Ridgeback, which is reflected within cost of sales and reduces our gross margin percentage. Gross margin this quarter also reflects the favorable impact of product mix, offset by higher manufacturing costs. Operating expenses increased 7% to $4.8 billion, as we continue to prudently invest behind our growth drivers and pipeline. Other expense was approximately $140 million. Our tax rate was 14%. Taken together, we earned $2.14 per share. Turning now to our 2022 non-GAAP guidance. As a reminder, at the request of the SEC, certain companies in our industry, including ours, have made changes to non-GAAP reporting.

Gross margin was 70.7%, a decrease of 5.9 percentage points, driven primarily by higher Legevrio sales. As a reminder, we share profits from Legevrio equally with our partner Ridgeback, which is reflected within cost of sales and reduces our gross margin percentage. Gross margin this quarter also reflects the favorable impact of product mix, offset by higher manufacturing costs. Operating expenses increased 7% to $4.8 billion, as we continue to prudently invest behind our growth drivers and pipeline. Other expense was approximately $140 million. Our tax rate was 14%. Taken together, we earned $2.14 per share. Turning now to our 2022 non-GAAP guidance. As a reminder, at the request of the SEC, certain companies in our industry, including ours, have made changes to non-GAAP reporting.

Growth margin was 70.7 percent, a decrease of 5.9 percentage points, driven primarily by higher Ligure 3.0 sales.

Gross margin was 77% a decrease of five nine percentage points, driven primarily by higher litho with Breo sales.

As a reminder, we share profits from Lagevrio equally with our partner Ridgeback, which is reflected within cost of sales and reduces our gross margin percentage.

As a reminder, we share profit from look embryos equally with our partner <unk> Bank, which is reflected within cost of sales and reduces our gross margin percentage.

Growth margin this quarter also reflects the favourable impact of product mix offset by higher manufacturing costs.

Gross margin. This quarter also reflects the favorable impact of product mix offset by higher manufacturing costs.

Operating expenses increased 7% to $4.8 billion as we continue to prudently invest behind our growth drivers and pipelines.

Operating expenses increased 7% to $4 8 billion.

We continue to prudently invest behind our growth drivers and pipeline.

Other expense was approximately $140 million. Our tax rate was...

Other expense was approximately $140 million.

Tax rate was 14%.

Taken together, we earned $2.14 per share.

Taken together we earned.

$2 14 per share.

Turning now to our 2022 Non-Gap Guidance.

Turning now to our 2022 non-GAAP guidance.

As a reminder, at the request of the SEC, certain companies in our industry, including ours, have made changes to non-GAAP reporting.

As a reminder, at the request of the SEC certain companies in our industry, including out have made changes to non-GAAP reporting.

Caroline Litchfield: We will no longer exclude significant expenses for upfront and milestone payments related to collaborations and licensing agreements, as well as transactions accounted for as asset acquisitions from non-GAAP results. As a result, $1.7 billion of R&D charges, primarily related to the acquisition of Pandion, are now included in our recast 2021 non-GAAP results. This increased R&D expense by $1.7 billion and decreased non-GAAP EPS by 65%. There was no impact to the first quarters of 2021 and 2022. Our 2022 guidance does not assume any significant transactions that would have previously been excluded from non-GAAP, though this could change in the future quarters if we execute business development, which is a strategic priority. The underlying strength of our business enables us to raise and narrow our full-year guidance.

We will no longer exclude significant expenses for upfront and milestone payments related to collaborations and licensing agreements, as well as transactions accounted for as asset acquisitions from non-GAAP results. As a result, $1.7 billion of R&D charges, primarily related to the acquisition of Pandion, are now included in our recast 2021 non-GAAP results. This increased R&D expense by $1.7 billion and decreased non-GAAP EPS by 65%. There was no impact to the Q1s of 2021 and 2022. Our 2022 guidance does not assume any significant transactions that would have previously been excluded from non-GAAP, though this could change in the future quarters if we execute business development, which is a strategic priority. The underlying strength of our business enables us to raise and narrow our full-year guidance.

We will no longer exclude significant expenses for upfront and milestone payments related to collaboration and licensing agreements as well as transactions accounted for asset acquisitions from non-GAAP results.

As a result, $1.7 billion of R&D charges, primarily related to the acquisition of Pandion, are now included in our recast 2021 non-GAAP results.

As a result, $1 $7 billion of R&D charges, primarily related to the acquisition of Pantheon are now included in our recast 2021 non-GAAP results.

This increased R&D expense by $1.7 billion and decreased non-GAAP EPS by 65 cents.

This increased R&D expense by $1 7 billion.

Decreased non-GAAP EPS of <unk> 65.

there was no impact to the first quarters of 2021 and 2022.

There was no impact to the first quarters of 2021 and 2022.

Our 2022 guidance does not assume any significant transactions that would have previously been excluded from non-GAP, so this could change in the future quarters if we execute business development which is a strategic priority.

Our 2022 guidance does not assume any significant transactions that would have previously been excluded from non-GAAP basis.

Could change in the future quarters, if we execute business development, which is a strategic priority.

The underlying strength of our business enables us to raise and narrow our full year guidance.

Caroline Litchfield: We now expect revenue to be between $56.9 and $58.1 billion, representing growth of 17% to 19%, or 11% to 12%, excluding Legevrio and the impact from foreign exchange. The projected impact from foreign exchange includes an incremental headwind of approximately $200 million using mid-April rates, resulting in a full-year negative impact of just over 2%. We are increasing our gross margin expectation to between 74% and 74.5%. We expect operating expenses of $20.3 to $21.3 billion. At the midpoint, this is consistent with what was implied by our prior guidance. We expect other expense of approximately $350 million. We assume a full-year tax rate between 13.5% and 14.5% due to an increase in estimated US taxes to be paid on foreign income. We assume $2.53 billion shares outstanding.

We now expect revenue to be between $56.9 and $58.1 billion, representing growth of 17% to 19%, or 11% to 12%, excluding Legevrio and the impact from foreign exchange. The projected impact from foreign exchange includes an incremental headwind of approximately $200 million using mid-April rates, resulting in a full-year negative impact of just over 2%. We are increasing our gross margin expectation to between 74% and 74.5%. We expect operating expenses of $20.3 to $21.3 billion. At the midpoint, this is consistent with what was implied by our prior guidance. We expect other expense of approximately $350 million. We assume a full-year tax rate between 13.5% and 14.5% due to an increase in estimated US taxes to be paid on foreign income. We assume $2.53 billion shares outstanding.

We now expect revenues to be between $56.9 and $58.1 billion, representing growth of 17 to 19 percent, or 11 to 12 percent, excluding LaGhevria and the impact from foreign exchange.

And now expect revenue to be between $56 nine and $58 1 billion.

<unk> growth of 17% to 19% or 11% to 12%, excluding <unk> and the impact from foreign exchange.

The projected impact from foreign exchange includes an incremental headwind of approximately $200 million using mid-April rates, resulting in a full-year negative impact of just over 2%.

The projected impact from foreign exchange includes an incremental headwind of approximately $200 million using mid April rates, resulting in a full year negative impact of just over 2%.

we are increasing our growth margin expectation to between 74 and 74.5 percent.

We are increasing our gross margin expectation to between 74 and 74, 5%.

we expect operating expenses of $20.3 to $21.3 billion.

We expect operating expenses of 23 to $21 $3 billion at.

At the midpoint, it is consistent with what was implied by our prior guidance.

At the midpoint. This is consistent with what was implied by our prior guidance.

We expect other expense of approximately $350 million.

We assume a full year tax rate between 13.5% and 14.5% due to an increase in estimated US taxes to be paid on foreign income.

We assume a full year tax rate between 13, five and 14, 5% due to an increase in estimated U S taxes to be paid on foreign income.

We assume 2.53 billion shares outstand.

We assume 253 billion shares outstanding.

Caroline Litchfield: Taken together, we have increased our expected EPS range to $7.24 to $7.36, representing pull-through of the operational strength from our key pillars and operating expense leverage, offset in part by a slight reduction in the top end of our Legevrio sales assumption, the increase in our tax rate, and an incremental 1% headwind from foreign exchange using mid-April rates. As you consider your models, there are a few areas to focus on. First, on Legevrio, we are narrowing the range of our full-year guidance to $5 billion to $5.5 billion. We have entered into supply and purchase agreements for approximately 10 million courses of therapy. Since authorization, we delivered 6.4 million courses of therapy, including $5 million in the first quarter. We expect approximately half of the remaining full-year revenue from Legevrio in the second quarter. We continue to expect strong annual growth for Gardasil, especially in ex-US.

Taken together, we have increased our expected EPS range to $7.24 to $7.36, representing pull-through of the operational strength from our key pillars and operating expense leverage, offset in part by a slight reduction in the top end of our Legevrio sales assumption, the increase in our tax rate, and an incremental 1% headwind from foreign exchange using mid-April rates. As you consider your models, there are a few areas to focus on. First, on Legevrio, we are narrowing the range of our full-year guidance to $5 billion to $5.5 billion. We have entered into supply and purchase agreements for approximately 10 million courses of therapy. Since authorization, we delivered 6.4 million courses of therapy, including $5 million in the Q1. We expect approximately half of the remaining full-year revenue from Legevrio in the second quarter. We continue to expect strong annual growth for Gardasil, especially in ex-US.

Taken together, we have increased our expected EPS range to $7 24.

To $7 36.

Representing pull through of the operational strength from our key pillars.

Operating expense leverage.

Offset in part by a slight reduction in the top end upon the get Breo sales assumption the increase in our tax rate and an incremental 1% headwind from foreign exchange using mid April rates.

As you consider your models, there are a few areas to focus on.

As you consider your models there are a few areas to focus on.

First on Logevrio, we are narrowing the range of our full year guidance to $5 billion to $5.5 billion.

First on the <unk>.

Narrowing the range of our full year guidance to $5 billion.

To five 5 billion.

We have entered into supply and purchase agreements for approximately 10 million courses of therapy.

We have entered into supply and purchase agreement for approximately 10 million courses of therapy.

Since authorization, we delivered 6.4 million courses of therapy, including 5 million in the first quarter.

So suraj station, we delivered $6 4 million courses of therapy, including $5 million in the first quarter.

We expect approximately half of the remaining school year revenue from LaGabria in the second quarter.

We expect approximately half of the remaining full year revenue from <unk> in the second quarter.

We continue to expect strong annual growth for Gardasil, especially in ex-U.S. markets including China.

We continue to expect strong annual growth got itself, especially in ex U S markets, including China.

Caroline Litchfield: Markets, including China. Finally, as a reminder, our other revenue line contains several items, including supply sales to Organon, which we began recording upon the completion of the spinoff last year, and to Johnson & Johnson for its COVID vaccine. Also included are our revenue hedge and royalties. Other revenue in the first quarter also benefited from approximately $100 million in receipts relating to out-licensing agreements. Our capital allocation priorities remain unchanged. First, we will continue to prioritize investments in our business and pipeline to drive near and long-term growth. We will continue to be appropriately aggressive in augmenting our internal pipeline through strategic business development, and we intend to pursue additional value-enhancing opportunities. We remain committed to the dividend, with the goal of increasing it over time. To the extent we have excess cash, we will return it to shareholders through share repurchases.

Markets, including China. Finally, as a reminder, our other revenue line contains several items, including supply sales to Organon, which we began recording upon the completion of the spinoff last year, and to Johnson & Johnson for its COVID vaccine. Also included are our revenue hedge and royalties. Other revenue in the Q1 also benefited from approximately $100 million in receipts relating to out-licensing agreements. Our capital allocation priorities remain unchanged. First, we will continue to prioritize investments in our business and pipeline to drive near and long-term growth. We will continue to be appropriately aggressive in augmenting our internal pipeline through strategic business development, and we intend to pursue additional value-enhancing opportunities. We remain committed to the dividend, with the goal of increasing it over time. To the extent we have excess cash, we will return it to shareholders through share repurchases.

Finally, as a reminder, our other revenue line contains several items including supply sales to Organon, which we began recording upon the completion of the spin-off last year, and to Johnson & Johnson for its COVID vaccine.

Finally, as a reminder.

Other revenue line contains several items, including supply south to organ on which we began recording upon the completion of the spinoff last year and to Johnson <unk> Johnson for a COVID-19 vaccine.

Also included are our revenue hedge and royalty.

Also included are revenue hedge and royalties.

Other revenue in first quarter also benefited from approximately $100 million in receipts relating to out-licensing agreements.

Other revenue in first quarter also benefited from approximately $100 million.

In receipts relating to out licensing agreement.

Our capital allocation priorities remain unchanged first we will continue to prioritize investments in our business and pipeline to drive near and long term growth.

Our capital allocation priorities remain unchanged. First, we will continue to prioritise investments in our business and pipeline to drive near and long-term growth.

We will continue to be appropriately aggressive in augmenting our internal pipeline through strategic business development, and we intend to pursue additional value-enhancing opportunities.

We will continue to be appropriately aggressive in augmenting our internal pipeline.

Business development, and we intend to pursue additional value enhancing opportunities.

We remain committed to the dividend with the goal of increasing it over time.

To the extent we have excess cash, we will return it to shareholders through share repurchase.

To the extent, we have excess cash we will return it to shareholders through share repurchases.

Caroline Litchfield: To conclude, we remain very confident in the growth of our business, driven by the global demand for our innovative medicines and vaccines. We are in a position of financial and operational strength, and our continued execution will enable us to deliver value to patients and our shareholders well into the future. With that, I'd now like to turn the call over to Dean.

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

To conclude, we remain very confident in the growth of our business, driven by the global demand for our innovative medicines and vaccines.

To conclude we remain very confident in the growth of our business driven by the global demand for our innovative medicines and vaccines we.

We are in a position of financial and operational strength and our continued execution will enable us to deliver value to patients and our shareholders well into the future. With that, I'd now like to

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

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

Operator: Thank you, Caroline. It is good to be here to provide an update on our progress. In the first quarter, we continue to demonstrate progress in our pipeline. We made advances across multiple therapeutic areas, including oncology in both advanced and earlier stages of cancer, as well as in cardiovascular disease and vaccines. I will also provide an update on Legevrio. In oncology, we continue to build upon our strong position and execute on our strategy to expand, deepen, and extend benefits to patients and diversify our imprint on cancer. This past quarter, we achieved milestones in several tumor types, as well as different stages of disease. Notably, we continue to expand our treatment impact in earlier stages of disease, where we now have six approvals from the FDA: five for Keytruda and one for Lynparza.

Dean Li: Thank you, Caroline. It is good to be here to provide an update on our progress. In the Q1, we continue to demonstrate progress in our pipeline. We made advances across multiple therapeutic areas, including oncology in both advanced and earlier stages of cancer, as well as in cardiovascular disease and vaccines. I will also provide an update on Legevrio. In oncology, we continue to build upon our strong position and execute on our strategy to expand, deepen, and extend benefits to patients and diversify our imprint on cancer. This past quarter, we achieved milestones in several tumor types, as well as different stages of disease. Notably, we continue to expand our treatment impact in earlier stages of disease, where we now have six approvals from the FDA: five for Keytruda and one for Lynparza.

Thank you, Carolyn. It is good to be here to provide an update on our progress.

Thank you Carolyn.

It is good to be here to provide an update on our progress.

In the first quarter, we continue to demonstrate progress in our pipeline.

In the first quarter, we continued to demonstrate progress in our pipeline.

We made advances across multiple therapeutic areas, including oncology, in both advanced and earlier stages of cancer, as well as in cardiovascular disease and vaccines. I will also provide

We made advances across multiple therapeutic areas, including oncology and both advance and earlier stages of cancer as well as in cardiovascular disease and vaccines.

I will also provide an update on the Gabriel.

In oncology, we continue to build upon our strong position and execute on our strategy to expand, deepen, and extend benefits to patients and diversify our imprint on patients.

In oncology, we continue to build upon our strong position and execute on our strategy to expand and deepen and extend benefits to patients and diversify our imprint on cancer. This past quarter, we achieved milestones in several tumor types as well as different stages of disease.

past quarter, we achieved milestones in several tumor types as well as different stages of disease.

Notably, we continue to expand our treatment impact in earlier stages of disease where we now have six approvals from the FDA, five for Keytruda and one for Lympharzoid.

Notably we continue to expand our treatment impact in earlier stages of disease, where we now have six approval from the FDA for Keytruda and one for Linda.

Operator: At the European Society for Medical Oncology virtual plenary session last month, data from the Keynote-091, or PEARLS trial, evaluating Keytruda for the adjuvant treatment of patients with stage IB to IIIA non-small cell lung cancer following surgical resection were presented. At an interim analysis, Keytruda significantly improved disease-free survival in all comers, one of the study's dual primary endpoints. The trial will continue to analyze the other dual primary endpoint of disease-free survival in patients whose tumors express high levels of PD-L1, which did not meet statistical significance at the time of the planned interim analysis. These latest data provide a strong signal for the benefit of Keytruda in the adjuvant treatment setting.

At the European Society for Medical Oncology virtual plenary session last month, data from the Keynote-091, or PEARLS trial, evaluating Keytruda for the adjuvant treatment of patients with stage IB to IIIA non-small cell lung cancer following surgical resection were presented. At an interim analysis, Keytruda significantly improved disease-free survival in all comers, one of the study's dual primary endpoints. The trial will continue to analyze the other dual primary endpoint of disease-free survival in patients whose tumors express high levels of PD-L1, which did not meet statistical significance at the time of the planned interim analysis. These latest data provide a strong signal for the benefit of Keytruda in the adjuvant treatment setting.

European Society for Medical Oncology Virtual Plenary Session. Last month, data from the Keynote 91 or PEARLS trial, evaluating Keytruda for the adjuvant treatment of patients with stage 1b to 3a non-small cell lung cancer following surgical resection were presented.

European Society for medical oncology virtual plenary session last month data from the chemo 91, or <unk> trial evaluating <unk> for the adjuvant treatment of patients with stage one beat the three eight non small cell lung cancer following surgical resection or present for war presented.

At an interim analysis, Petruta significantly improved disease-free survival in all comers, one of the study's dual primary

But an interim analysis Trudeau has significantly improved disease free survival in all comers what are the studies dual primary endpoints.

The trial will continue to analyze the other dual primary endpoints of disease-free survival in patients whose tumors express high levels of CDL1.

The trial will continue to analyze other dual primary endpoint of disease free survival in patients, whose tumors express high levels of PDL, one which did not meet statistical significance at the time of the planned interim analysis.

did not meet statistical significance at the time of the planned interim analysis.

These latest data provide a strong signal for the benefit of Katruda and the adjuvant treatment.

These latest data provide a strong signal for the benefit of Keytruda in the adjuvant treatment study.

Operator: Additional ongoing studies in earlier stages of non-small cell lung cancer include Keynote-671, which is evaluating neoadjuvant/adjuvant therapy for patients with resectable II, IIIA, and IIIB disease. Keynote-867 is studying stereotactic body radiotherapy with or without Keytruda in adults with unresected stage I or II disease. Keylink-012 is where we are studying Keytruda in combination with Lynparza in stage III disease. Following the approval of Keytruda for the adjuvant treatment of patients 12 years and older with stage IIB or IIC melanoma following complete resection based on Keynote-716, we announced that at a pre-specified interim analysis, the study also met its secondary endpoint of distant metastasis-free survival and showed continued improvement in recurrence-free survival compared to placebo.

Additional ongoing studies in earlier stages of non-small cell lung cancer include Keynote-671, which is evaluating neoadjuvant/adjuvant therapy for patients with resectable II, IIIA, and IIIB disease. Keynote-867 is studying stereotactic body radiotherapy with or without Keytruda in adults with unresected stage I or II disease. Keylink-012 is where we are studying Keytruda in combination with Lynparza in stage III disease. Following the approval of Keytruda for the adjuvant treatment of patients 12 years and older with stage IIB or IIC melanoma following complete resection based on Keynote-716, we announced that at a pre-specified interim analysis, the study also met its secondary endpoint of distant metastasis-free survival and showed continued improvement in recurrence-free survival compared to placebo.

Additional ongoing studies in earlier stages of non-small cell lung cancer include

Additional ongoing studies in earlier stages of non small cell lung cancer include.

Keynote 671, which is evaluating neoadjuvant therapies for patients with respectable 2, 3A, and 3B disease.

671, which is evaluating neo adjuvant adjuvant therapy for patients with Resectable 238, and three D E.

Keynote 867, which is studying stereotactic body radiotherapy with or without Keytruda in adults with unreceptive stage one or two disease, and Keylink 12, where we are studying Keytruda in combination with Lamparza in stage three disease.

<unk>, seven which is studying stereotactic body radiotherapy with or without the intruder in adults with Unresectable stage, one or two of the disease and Kieran 12, where we are studying keytruda in combination with <unk> in phase III disease.

Following the approval of Keytruda for the adjuvant treatment of patients 12 years and older with stage 2b or 2c melanoma following complete resection based on keynote 715.

Following the approval of Keytruda for the adjuvant treatment of patients 12 years and older with stage <unk> or Tuesday melanoma. Following complete resection based on keynote <unk> one six.

We announced that at a pre-specified interim analysis, the study also met its secondary endpoints of distance metastasis-free survival and showed continued improvement in recurrence-free survival compared to preceded.

That had a prespecified interim analysis. The study also met its secondary endpoints of the spin.

The processes free survival and showed continued improvement in our recurrence free survival compared to placebo.

Operator: The data from Keynote-716 reinforces the evidence for Keytruda as adjuvant therapy for appropriate patients with stage IIB and IIC following surgery to help prevent recurrence of disease. Now, similarly, in the earlier stage setting, along with AstraZeneca, we announced Lynparza was approved by the FDA for the adjuvant treatment of patients with germline BRCA mutations with HER2-negative high-risk early breast cancer, previously treated with chemotherapy either before or after surgery based on the OlympiA study. Further, in women's cancer, we received FDA approval for Keytruda for the treatment of patients with microsatellite instability high or mismatch repair deficient advanced endometrial carcinoma based on new data for Keynote-158.

The data from Keynote-716 reinforces the evidence for Keytruda as adjuvant therapy for appropriate patients with stage IIB and IIC following surgery to help prevent recurrence of disease. Now, similarly, in the earlier stage setting, along with AstraZeneca, we announced Lynparza was approved by the FDA for the adjuvant treatment of patients with germline BRCA mutations with HER2-negative high-risk early breast cancer, previously treated with chemotherapy either before or after surgery based on the OlympiA study. Further, in women's cancer, we received FDA approval for Keytruda for the treatment of patients with microsatellite instability high or mismatch repair deficient advanced endometrial carcinoma based on new data for Keynote-158.

The data from Keynote 716 reinforces the evidence for Keytruda as adjuvant therapy for appropriate patients with stage 2B and 2C following surgery to help prevent recurrence of disease.

The data from keynote <unk> reinforces the evidence for Keytruda.

Adjuvant therapy for appropriate patients with stage <unk> following surgery.

Help prevent recurrence of disease.

Now, similarly, in the earlier stage setting, along with AstraZeneca, we announced Lemprasa was approved by the FDA for the adjuvant treatment of patients with germline BRCA mutations with HER2 negative high-risk early breast cancer.

Similarly in the earlier stage studies, along with Astrazeneca, We announced <unk> was approved by the FDA for the adjuvant treatment of patients with Germline BRCA mutations with her two negative high risk early breast cancer.

previously treated with chemotherapy, either before or after surgery, based on the Olympiac study.

Previously treated with chemotherapy either before or after surgery based on the Olympiad study.

Further, in women's cancer, we received FDA approval for Keynote 158 for the treatment of patients with microsatellite instability high or mismatch repair deficient advanced endometrial carcinoma based on new data for Keynote 158.

Further.

Women's cancer, we received FDA approval for Keytruda for the treatment of patients with microsatellite instability high or mismatch repair deficient advanced endometrial carcinoma based on new data for keynote 168.

Operator: Now, this approval is a fourth gynecologic cancer approval for Keytruda and marks the fifth approval derived from the Keynote-158 trial, an innovative trial designed to evaluate the use of predictive tumor biomarkers in patients receiving Keytruda for advanced solid tumor. Next, to prostate cancer. Along with AstraZeneca, positive results were presented at the American Society for Clinical Oncology Genitourinary Cancer Symposium for the PROPEL trial evaluating Lynparza in combination with abiraterone as a first-line treatment for patients with metastatic castration-resistant prostate cancer with and without mutations in a group of homologous recombination repair. At a planned interim analysis, results showed an improvement in radiographic progression-free survival versus the standard of care. These early results also showed a trend towards improved overall survival.

Now, this approval is a fourth gynecologic cancer approval for Keytruda and marks the fifth approval derived from the Keynote-158 trial, an innovative trial designed to evaluate the use of predictive tumor biomarkers in patients receiving Keytruda for advanced solid tumor. Next, to prostate cancer. Along with AstraZeneca, positive results were presented at the American Society for Clinical Oncology Genitourinary Cancer Symposium for the PROPEL trial evaluating Lynparza in combination with abiraterone as a first-line treatment for patients with metastatic castration-resistant prostate cancer with and without mutations in a group of homologous recombination repair. At a planned interim analysis, results showed an improvement in radiographic progression-free survival versus the standard of care. These early results also showed a trend towards improved overall survival.

Now, this approval is the fourth gynecologic cancer approval for Keytruda and marks a fifth approval derived from the Keynote 158 trial, an innovative trial designed to evaluate the use of predictive tumor biomarkers in patients receiving Keytruda for advanced solid tumor.

This approval is a fourth gynecologic cancer approval for Keytruda and Martha disapproval derived from the keynote 158 trial and innovative trial designed to evaluate the use of predictive tumor biomarkers in patients receiving keytruda for solid tumors.

Next the prostate cancer, along with Astrazeneca positive results were presented at the American Society for clinical oncology genital urinary cancers symposium for the propel trial evaluating <unk> combination with avid rather known as a first line treatment for patients with metastatic.

Along with AstraZeneca, positive results were presented at the American Society for Clinical Oncology Genitourinary Cancer Symposium for the PROPEL trial, evaluating Limparza in combination with Everetinone as a first-line treatment for patients with metastatic, catheter-resistant prostate cancer.

To castrate resistant prostate cancer women without mutations and a group of homologous recombination repair genes.

with and without mutations in a group of homologous recombination with therapy.

At a planned interim analysis results showed an improvement in radiographic progression free survival versus the standard of care.

showed an improvement in radiographic progression-free survival versus the standard of care. These early results also showed a trend towards improved overall survival.

These early results also showed a trend towards improved overall survival.

Operator: The trial will continue to assess its key secondary endpoint, and we plan to engage with health authorities to discuss the findings with the aim of bringing this important option to appropriate patients. Prostate cancer represents a significant unmet need, and we are continually gaining important insights into the biology of the tumor. We are keen on making impact for patients with late-stage disease. Last month, we announced the discontinuation of the Keylink-010 study evaluating the combination of Keytruda and Lynparza for the treatment of metastatic castration-resistant prostate cancer. At an interim analysis, the study showed no evidence of superiority to abiraterone or enzalutamide with respect to overall survival and radiographic progression-free survival. Our attention in metastatic castration-resistant prostate cancer now shifts to Keynote-921, a study exploring the combination of Keytruda and chemotherapy, and Keynote-641, which is evaluating the combination of Keytruda and enzalutamide.

The trial will continue to assess its key secondary endpoint, and we plan to engage with health authorities to discuss the findings with the aim of bringing this important option to appropriate patients. Prostate cancer represents a significant unmet need, and we are continually gaining important insights into the biology of the tumor. We are keen on making impact for patients with late-stage disease. Last month, we announced the discontinuation of the Keylink-010 study evaluating the combination of Keytruda and Lynparza for the treatment of metastatic castration-resistant prostate cancer. At an interim analysis, the study showed no evidence of superiority to abiraterone or enzalutamide with respect to overall survival and radiographic progression-free survival. Our attention in metastatic castration-resistant prostate cancer now shifts to Keynote-921, a study exploring the combination of Keytruda and chemotherapy, and Keynote-641, which is evaluating the combination of Keytruda and enzalutamide.

Trial will continue to assess this key secondary endpoint, and we plan to engage with health authorities to discuss the findings with the aim of bringing this important option to appropriate patients. Prostate cancer represents.

While we'll continue to assess the key secondary endpoint and we plan to engage with health authorities to discuss the findings with the aim of bringing this important option to appropriate patients.

Prostate cancer represents a significant unmet need and we are continually gaining important insights into the biology of the tumor.

and we are continually gaining important insights into the biology.

We are keen on making an impact for patients with late stage disease.

We are keen on making impact for patients with late stage disease.

Last month, we announced the discontinuation of the Keeling 10 study, evaluating the combination of Keytruda and Lamparza for the treatment of metastatic castrate-resistant prostate cancer.

Last month, we announced the discontinuation of the key link 10 study evaluating the combination of Keytruda and <unk> for the treatment of metastatic castrate resistant prostate cancer.

Interim analysis. The study showed no evidence of superiority to abiraterone or <unk> with respect to overall survival and radiographic progression free survival.

The study showed no evidence of superiority to abiratinone and to lutemide with respect to overall survival and radiographic progression freezing.

our attention in metastatic catheter-resistant prostate cancer.

Tension in metastatic castrate resistant prostate cancer now shifts to keynote <unk> two one.

Now shift to Keynote 9-2-1, a study exploring the combination of Keynote 9-2-1 and Keynote 9-2-1.

That is exploring the combination of keytruda in chemotherapy and keynote <unk> four one which is evaluating the combination of keytruda and as dilutive.

Keynote 641, which is evaluating the combination of Keytruda and Enzalutamide.

Operator: Outside of the United States, we continue to deliver on our regulatory strategy. Notable actions include positive CHMP opinions for cervical, MSI-H, and early-stage breast cancer in Europe and approvals for the combination regimen of Keytruda plus Lenvima for advanced renal cell carcinoma in Japan. Finally, to coincide with ASCO, in early June, we are planning to host an investor event in Chicago. At our recent cardiovascular investor event, we showcased our growing portfolio of programs targeting a range of conditions, including atherosclerosis, heart failure, pulmonary arterial hypertension, and thrombosis. Following the completion of our acquisition of Acceleron Pharma, we are making strong progress in advancing the development of sotatercept, a potential first-in-class activin receptor type IIA fusion protein. We recently completed enrollment for the Stellar trial ahead of schedule. Stellar is the first of four ongoing phase III studies evaluating sotatercept.

Outside of the United States, we continue to deliver on our regulatory strategy. Notable actions include positive CHMP opinions for cervical, MSI-H, and early-stage breast cancer in Europe and approvals for the combination regimen of Keytruda plus Lenvima for advanced renal cell carcinoma in Japan. Finally, to coincide with ASCO, in early June, we are planning to host an investor event in Chicago. At our recent cardiovascular investor event, we showcased our growing portfolio of programs targeting a range of conditions, including atherosclerosis, heart failure, pulmonary arterial hypertension, and thrombosis. Following the completion of our acquisition of Acceleron Pharma, we are making strong progress in advancing the development of sotatercept, a potential first-in-class activin receptor type IIA fusion protein. We recently completed enrollment for the Stellar trial ahead of schedule. Stellar is the first of four ongoing phase III studies evaluating sotatercept.

Outside of the United States, we continue to deliver on our regulatory strategy.

Notable actions include positive CHMP opinions for cervical, MSI-HIV, and early-stage breast cancer in Europe , and approvals for the combination regimen of Keytruda plasmidema for advanced renal cell carcinoma.

Notable actions include a positive <unk> opinion for cervical.

MSI highs in early stage breast cancer in Europe , and approvals for the combination regimen with Keytruda plus one bema for advanced renal cell carcinoma in Japan.

And finally to coincide with <unk> in early June we are planning to host an investor event in Chicago.

And finally, to coincide with ASCO, in early June we are planning to host an investor event in Chicago.

At our recent cardiovascular investor event, we showcased our growing portfolio programs targeting a range of conditions, including atherosclerosis, heart failure, pulmonary arterial hypertension, and thrombosis.

At our recent cardiovascular investor event, we showcased our growing portfolio of programs targeting a range of conditions, including <unk>.

Sclerosis heart failure pulmonary arterial hypertension and thrombosis.

Following the completion of our acquisition of Excella and Pharma, we are making strong progress in advancing the development of Cipatercept, a potential first in class valuable activin receptor type 2A fusion.

Following the completion of our acquisition of accelerating pharma, we are making strong progress in advancing the development of the powder set a potential first in class valuable activin receptor or to a fusion protein.

We recently completed enrollment for the stellar trial ahead of schedule.

stellar is a first of four ongoing phase three studies evaluating

Stellar three the first of four ongoing phase III studies evaluating <unk> powder stuff.

Operator: This progress reflects enthusiasm from investigators regarding this novel investigational mechanism. For the first time, the 2022 American Heart Association, American College of Cardiology, and Heart Failure Society of America's guidelines for the management of heart failure included Verquvo, which we collaborate on with our partner Bayer, as a class IIB recommendation for the treatment of stage C heart failure with reduced ejection fraction. The guideline highlights the mechanism of SGC, such as Verquvo, and the potential benefits of stimulating soluble guanylate cyclase and increasing cyclic GMP. Based on evidence from the pioneering VICTORIA trial, Verquvo is the first drug specifically studied and approved for patients with worsening heart failure and the only drug recommended in the new guidelines for these patients.

This progress reflects enthusiasm from investigators regarding this novel investigational mechanism. For the first time, the 2022 American Heart Association, American College of Cardiology, and Heart Failure Society of America's guidelines for the management of heart failure included Verquvo, which we collaborate on with our partner Bayer, as a class IIB recommendation for the treatment of stage C heart failure with reduced ejection fraction. The guideline highlights the mechanism of SGC, such as Verquvo, and the potential benefits of stimulating soluble guanylate cyclase and increasing cyclic GMP. Based on evidence from the pioneering VICTORIA trial, Verquvo is the first drug specifically studied and approved for patients with worsening heart failure and the only drug recommended in the new guidelines for these patients.

This progress reflects enthusiasm from investigators regarding this novel investigational method.

This progress reflects enthusiasm from investigators regarding this novel investigational mechanism.

For the first time, the 2022 American Heart Association, American College of Cardiology, and Heart Failure Society of America's Guidelines for the Management of Heart Failure included your Q vote, which we collaborate on with our partner, Bayer.

For the first time, the 2022 American Heart Association American College of Cardiology, and Heart failure Society of America.

<unk> for the management of heart failure included the Cubo, which we collaborate on with our partner there is.

as a class 2B recommendation for the treatment of stage C heart failure with reduced ejection pressure.

As a class III recommendation for the treatment of stage C heart failure with reduced ejection fraction.

The guideline highlights the mechanism of FGC, such as vertubo, and the potential benefits of stimulating soluble guanylate cyclase and increasing cyclic GMP. Based on evidence.

A guideline highlights the mechanism of FTC, such as for Cubo and the potential benefits of stimulating soluble <unk> cyclase and increasing cyclic GMP.

Based on evidence from the pioneering Victoria trial.

Curcuvo is the first drug specifically studied and approved for patients with worsening heart failure and the only drug recommended in the new guidelines for these patients.

For <unk>, the first drug specifically studied and approved for patients with worsening heart failure and the only drug recommended in the new guidelines for these patients.

Operator: Our ongoing VICTOR study is designed to expand on the evidence to date by evaluating Verquvo in patients with chronic heart failure and reduced ejection fraction who have not experienced a recent worsening heart failure event. Merck is uniquely positioned to meaningfully impact the treatment of patients with cardiovascular disease with at least eight potential approvals by 2030, including Verquvo in stable heart failure and Sotatercept, as well as our pipeline of candidates, including an inhaled soluble guanylate cyclase stimulator, a factor XI inhibitor, and an oral PCSK9 inhibitor. Next, to COVID-19 and Legevrio. As the pandemic evolves, there continues to be regional surges in infection rates with the emergence of new COVID-19 variants. Now, some of these strains are resistant to specific monoclonal antibody regimens and appear able to evade some vaccine protection, highlighting the importance of testing and the availability of antiviral options.

Our ongoing VICTOR study is designed to expand on the evidence to date by evaluating Verquvo in patients with chronic heart failure and reduced ejection fraction who have not experienced a recent worsening heart failure event. Merck is uniquely positioned to meaningfully impact the treatment of patients with cardiovascular disease with at least eight potential approvals by 2030, including Verquvo in stable heart failure and Sotatercept, as well as our pipeline of candidates, including an inhaled soluble guanylate cyclase stimulator, a factor XI inhibitor, and an oral PCSK9 inhibitor. Next, to COVID-19 and Legevrio. As the pandemic evolves, there continues to be regional surges in infection rates with the emergence of new COVID-19 variants. Now, some of these strains are resistant to specific monoclonal antibody regimens and appear able to evade some vaccine protection, highlighting the importance of testing and the availability of antiviral options.

Our ongoing VICTOR study is designed to expand on the evidence to date by evaluating VIRCUBO in patients with chronic heart failure and reduced ejection fraction who have not experienced a recent worsening heart failure.

Our ongoing Victor study is designed to expand on the evidence to date by evaluating her cubo in patients with chronic heart failure and reduced ejection fraction, who have not experienced a recent worsening heart failure event.

Merck is uniquely positioned to meaningfully impact the treatment of patients with cardiovascular disease with at least eight potential approvals by 2030, including vertebral and stable heart failure and cicatriceps, as well as our pipeline of candidates, including an inhaled soluble guanylate cyclate stimulator, a factor 11 inhibitor, and an oral PCSK9 inhibitor.

Merck is uniquely positioned to meaningfully impact the treatment of patients with cardiovascular disease with at least a potential approval by 2030, including for Cubo and stable heart failure, that's a tad of staff as well as our pipeline of candidates, including <unk> payout soluble <unk> cyclase.

Stimulator.

After 11 inhibitor and Anoro PCF canine inhibitor.

Next the COVID-19 and <unk>.

As the pandemic evolves, there continues to be regional surges in infection rates with the emergence of new COVID-19 variants.

As the pandemic evolves there continues to be a regional surges in infection rates with the emergence of new COVID-19 vary.

Some of these strains are resistant to specific monoclonal antibody regimens and appear able to evade some vaccine protection, highlighting the importance of testing and the availability of antiviral options.

So some of these spreads are resistant for specific monoclonal antibody regimens.

If you are able to vague some vaccine protection highlighted the importance of attracting and availability of anti viral option.

Operator: At the recent European Congress of Clinical Microbiology and Infectious Diseases, we presented phase III virology outcomes data from MOVe-OUT, adding to the growing body of evidence for the antiviral properties of Legevrio. The PANORAMIC trial evaluating novel antivirals for early treatment, which is being sponsored by the University of Oxford and funded by the UK government, and the MOVe-AHEAD trial evaluating Legevrio for post-exposure prophylaxis are both ongoing. We are working collaboratively with the European Medicines Agency to provide additional data from these trials in order to secure an approval. We remain confident in the safety and efficacy of Legevrio in appropriate patients. In particular, we believe its low propensity for drug-drug interactions makes it an important option for patients. Next, on our pneumococcal program.

At the recent European Congress of Clinical Microbiology and Infectious Diseases, we presented phase III virology outcomes data from MOVe-OUT, adding to the growing body of evidence for the antiviral properties of Legevrio. The PANORAMIC trial evaluating novel antivirals for early treatment, which is being sponsored by the University of Oxford and funded by the UK government, and the MOVe-AHEAD trial evaluating Legevrio for post-exposure prophylaxis are both ongoing. We are working collaboratively with the European Medicines Agency to provide additional data from these trials in order to secure an approval. We remain confident in the safety and efficacy of Legevrio in appropriate patients. In particular, we believe its low propensity for drug-drug interactions makes it an important option for patients. Next, on our pneumococcal program.

At the recent European Congress of clinical microbiology, and infectious diseases, we presented phase III barology outcomes data for move outs.

At the recent European Congress of Clinical Microbiology and Infectious Diseases, we presented phase three virology outcomes data from move out, adding to the growing body of evidence for the antiviral properties of Legevra.

Due to the growing body of evidence for the anti viral properties of <unk>.

Paranoramic trial evaluating novel antivirals for early treatment, which is being sponsored by the University of Oxford and funded by the UK government, and the MUVA-HEAD trial evaluating Leghevrial for post-exposure prophylaxis are both ongoing.

The panoramic trial evaluating novel anti Virals for early treatment, which is being sponsored by the University of Oxford and funded by the UK government and the move ahead trial evaluating <unk> for post exposure prophylaxis.

Both ongoing.

We are working collaboratively with the European Medicines Agency to provide additional data from these trials in order to secure and improve.

We are working collaboratively with the European Medicines agency to provide additional data from these trials in order to secure an approval.

we remain confident in the safety and efficacy of LaGavrio in appropriate patients. In particular, we believe its low propensity for drug-drug interactions makes it an important option for patients.

We remain confident in the safety and efficacy of <unk> in appropriate patients in particular, we believe its low propensity for drug drug interactions makes it an important option for patients.

Next, on our pneumococcal program. Earlier this month, the FDA extended the PDUFA date for the Supplemental Biologics License Application for Vaccine Rents. Our 15-valent conjugate pneumococcal vaccine in infants and children to July 1st, 2022.

Next on our Pneumococcal program.

Operator: Earlier this month, the FDA extended the PDUFA date for the supplemental biologics license application for Vaxneuvance, our 15-valent conjugate pneumococcal vaccine in infants and children, to 1 July 2022. The agency requested additional analyses of data, which we provided. Importantly, no new studies were requested. Also, in our pneumococcal program, we received breakthrough therapy designation for V116, our investigational PCV that is designed to target serotypes responsible for approximately 80% of the residual invasive disease in the older adult population and includes eight unique serotypes not in currently licensed vaccines. We look forward to providing future updates. In closing, I would like to thank Roy Baynes for his many contributions to Merck over the past eight years. As we build upon his legacy, I'm constantly reminded of Roy's wisdom and teaching, and I'm grateful to work with the remarkable team he has trained and mentored.

Earlier this month, the FDA extended the PDUFA date for the supplemental biologics license application for Vaxneuvance, our 15-valent conjugate pneumococcal vaccine in infants and children, to 1 July 2022. The agency requested additional analyses of data, which we provided. Importantly, no new studies were requested. Also, in our pneumococcal program, we received breakthrough therapy designation for V116, our investigational PCV that is designed to target serotypes responsible for approximately 80% of the residual invasive disease in the older adult population and includes eight unique serotypes not in currently licensed vaccines. We look forward to providing future updates. In closing, I would like to thank Roy Baynes for his many contributions to Merck over the past eight years. As we build upon his legacy, I'm constantly reminded of Roy's wisdom and teaching, and I'm grateful to work with the remarkable team he has trained and mentored.

Earlier this month, the FDA extended with a <unk> date for the supplemental biologics license application for vaccines.

Our 15 valent conjugate pneumococcal vaccine in infants and children to July one 2022.

The agency requested additional analyses of data, which we provided. Importantly, no new studies were requested.

Agency requested additional analyses of data, which we provided importantly, no new studies were requested.

Also in our new MoCAPA program, we received breakthrough therapy designation for V116.

Also in our Pneumococcal program, we received breakthrough therapy designation for <unk> six or.

our investigational PCV that is designed to target serotypes responsible for approximately 80 percent of the residual invasive disease in the older adult population and includes eight unique serotypes not in currently licensed vaccines. We look forward to

Our investigational PCB that is designed to target spirit serotypes responsible for approximately 80% of the residual invasive disease in the older adult population and includes eight unique serotypes not in currently licensed vaccine.

We look forward to providing future updates.

In closing, I would like to thank Lloyd Baines for his many contributions to Merck over the past eight years.

In closing I would like to strength <unk> for his many contributions to Merck over the past eight years.

As we build upon his legacy, I'm constantly reminded of Roy's wisdom and teachings.

As we build upon his legacy I am constantly reminded of breweries wisdom, and teaching and I'm grateful to work with a remarkable team he is train and mentor.

and I am grateful to work with a remarkable team he has trained and mentored. One of those mentees, of course.

Operator: One of those mentees, of course, is Eliav Barr. Eliav's experience and commitment to Merck's purpose of saving and improving lives makes him the ideal leader of our global clinical development program. Eliav has a wealth of experience holding leadership roles across an array of therapeutic areas during his 27 years at Merck, including vaccine, infectious disease, and oncology. I look forward to continuing to partner with Eliav to build upon Merck's legacy of innovation and breakthrough science. And now, back to Peter. Thank you, Dean. Grace, if you could please begin the Q&A, and we request that analysts limit themselves to one question each today to get to as many analysts as possible. Thank you. To ask a question, you will need to press star then the number one on your telephone keypad. Again, for the question, you may press star one.

One of those mentees, of course, is Eliav Barr. Eliav's experience and commitment to Merck's purpose of saving and improving lives makes him the ideal leader of our global clinical development program. Eliav has a wealth of experience holding leadership roles across an array of therapeutic areas during his 27 years at Merck, including vaccine, infectious disease, and oncology. I look forward to continuing to partner with Eliav to build upon Merck's legacy of innovation and breakthrough science. And now, back to Peter.

One of those <unk> of course is Elliott bar.

Elliot's experience and commitment to Merck's purpose of saving and improving lives makes him the ideal leader of our global clinical development program.

Elliot experience and commitment to merck's purpose of saving and improving lives makes him the ideal leader of our global clinical development program.

Elliot has a wealth of experience, holding leadership roles across an array of therapeutic areas during his 27 years at Merck, including vaccine, infectious disease, and oncology.

L. A has a wealth of experience.

<unk> leadership roles across an array of therapeutic areas. During his 27 years at Merck, including vaccine infectious disease and oncology.

I look forward to continuing to partner with Elliot to build upon Merck's legacy of innovation and breakthrough science.

I look forward to continuing to partner with Elliott to build upon merck's legacy of innovation and breakthrough science.

Peter Dannenbaum: Thank you, Dean. Grace, if you could please begin the Q&A, and we request that analysts limit themselves to one question each today to get to as many analysts as possible. Thank you.

Now back to Peter.

Okay.

Thank you, Dean. Grace, if you could please begin the Q&A. And we request that analysts limit themselves to one question each today to get to as many analysts as possible. Thank you.

Thank you Dean Grace if you could please begin the Q&A and we request that analysts limit themselves to one question each today to get to as many analysts as possible. Thank you.

Operator: To ask a question, you will need to press star then the number one on your telephone keypad. Again, for the question, you may press star one.

To ask a question, you will need to press star, then the number 1 on your telephone keypad. Again, for the question, you may press star, then the number 1 on your telephone keypad.

To ask a question you will need to press Star then the number one on your telephone keypad again further question you May press Star one.

Okay.

Operator: Your first question comes from the line of Carter Gould from Barclays. Your line is open. Hi, good morning. Thanks for taking our questions. This is Ed Ron for Carter. We wanted to ask about Gardasil. If you could talk about any impacts you're seeing in China, either from a demand perspective or disruptions to manufacturing. And in that context, should we think about cadence, or should we think about cadence over the year being notably different than in the years past? There's just a lot of different crosswinds in play, so any color there would be helpful. Thank you. Carter, this is Caroline. Thank you very much for the question. Gardasil continues to be a great growth driver for our company globally, including China. Specific to China, we saw strong performance in the quarter, and we expect continued strong performance as we go through this year.

Your first question comes from the line of Carter Gould from Barclays. Your line is open.

Your first question comes from the line of Carter Gold from Barclays. Your line is open.

Your first question comes from the line of Carter Gould from Barclays. Your line is open.

Carter Gould: Hi, good morning. Thanks for taking our questions. This is Ed Ron for Carter. We wanted to ask about Gardasil. If you could talk about any impacts you're seeing in China, either from a demand perspective or disruptions to manufacturing. And in that context, should we think about cadence, or should we think about cadence over the year being notably different than in the years past? There's just a lot of different crosswinds in play, so any color there would be helpful. Thank you.

Hi, good morning. Thanks for taking our questions. This is Adam Ronsford-Carter.

Hi, good morning, Thanks for taking our questions that are on for Carter.

We wanted to ask about Gardasil, if you could talk about any impacts you're seeing in China, either from a demand perspective or disruptions to manufacturing, and in that context, should we think about cadence or should we think about cadence over the year being notably different than in the years past? There's just a lot of different crosswinds in play, so any color there would be helpful. Thank you.

We wanted to ask about Cartersville, if you could talk about any impact you're seeing in China.

Either from a demand perspective or disruptions to manufacturing and in that context should we think about cadence or should we think about cadence over the year being notably different than years past. There's just a lot of different crosscurrents in place or any color there would be helpful. Thank you.

Caroline Litchfield: Carter, this is Caroline. Thank you very much for the question. Gardasil continues to be a great growth driver for our company globally, including China. Specific to China, we saw strong performance in the quarter, and we expect continued strong performance as we go through this year.

Cost efficiency Caroline Thank you very much for the question.

Gardasil continues to be a great growth driver for our company, globally.

This still continues to be a great growth driver for our company globally, including China.

Specific to China, we saw strong performance in the quarter and we expect continued strong performance as we go through this year.

saw strong performance in the quarter and we expect continued strong performance as we go through this year.

Operator: We have significant demand in China, and as there are flares as a result of COVID, and potentially lockdowns in one part of the country, we have the ability to ensure that we're supplying more of the Gardasil doses to other parts of the country. So we're therefore not anticipating a significant impact to our Gardasil performance in China as a result of what we're seeing in Shanghai at this moment in time. As it pertains to our supply chain, our company has a very robust supply chain, and we have plan A and plan B if there are any interruptions in the supply chain. So we, again, have no concerns for the reliability of our supply chain, but we remain vigilant and focused on the situation at hand. Thank you, Carter. Next question, please, Grace. Thank you. Next up, we have Mohit Bansal from Wells Fargo.

We have significant demand in China, and as there are flares as a result of COVID, and potentially lockdowns in one part of the country, we have the ability to ensure that we're supplying more of the Gardasil doses to other parts of the country. So we're therefore not anticipating a significant impact to our Gardasil performance in China as a result of what we're seeing in Shanghai at this moment in time. As it pertains to our supply chain, our company has a very robust supply chain, and we have plan A and plan B if there are any interruptions in the supply chain. So we, again, have no concerns for the reliability of our supply chain, but we remain vigilant and focused on the situation at hand.

We have.

Significant demand in China, and as a flag as a result of COVID-19 and potentially locked down in one part of the country. We have the ability to ensure that we're supplying more of the gardasil doses to other parts of the country. So we think we're not anticipating a significant.

as they're off fled as a result of COVID and potentially lockdown.

We have the ability to ensure that we're supplying more of the Gardasil doses to other parts

So we're therefore not anticipating a significant impact to our Gardasil performance in China as a result of what we're seeing.

Impact to opt Autoscope performance in China as a result of what we're seeing in Shanghai at this moment in time, I think pertains to our supply chain. Our company has a very robust supply chain and we have plan a and plan b. If there are any interruption in the supply chain that we again.

As it pertains to our supply chain, our company has a very robust supply chain.

And we have plan A and plan B if there are any interruptions in the supply chain. So we again...

No concerns for the reliability of our supply chain, but we remain vigilant and focused on the situation at times.

the reliability of our supply chain, but we remain vigilant and focused on the situation at hand.

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

Thank you Carter next question please Greg.

Operator: Thank you. Next up, we have Mohit Bansal from Wells Fargo.

And next up we have Mohit Bansal from Wells Fargo, Carolina.

Thank you next up we have Mohit Bansal from Wells Fargo. Your line is open.

Operator: Your line is open. Great. Thanks for taking my question and congrats on the quarter. So one question we are getting a lot is, how do you feel about a potential challenge from a competitor for PD-L1 and TIGIT combo potentially looking better than Keytruda in first-line PD-L1 high lung cancer? Do you see this as a major threat, especially looking at the phase II data from that competitor, TIGIT? Thank you. Hi. Thank you for that question. So I just want to emphasize the question focuses on the addition of another checkpoint inhibitor, TIGIT, on top of a PD-1, and this is a strategy to sort of deepen the response of PD-1s and PD-L1s. I think it'll be very important to see that data and look at the contribution of components.

Your line is open.

Mohit Bansal: Great. Thanks for taking my question and congrats on the quarter. So one question we are getting a lot is, how do you feel about a potential challenge from a competitor for PD-L1 and TIGIT combo potentially looking better than Keytruda in first-line PD-L1 high lung cancer? Do you see this as a major threat, especially looking at the phase II data from that competitor, TIGIT? Thank you.

Great, thanks for taking my question and congrats on the quarter. So, one question we are getting a lot is, how do you feel about a potential challenge from a competitor or for PD-L1 and TIGIT combo potentially looking better than KITUDA and first-line PD-L1 high lung cancer? Do you see this as a major threat, especially looking at the phase 2 data from that competitor, TIGIT? Thank you.

Great. Thanks for taking my question and congrats on the quarter.

One question Youre getting a lot is how do you feel about potential challenge from a competitor.

I did one digit combo potentially looking better than Keytruda in first line PD Lone high lung cancer do you see besides immediate tracks fashion compared to phase II data from the competitors.

Dean Li: Hi. Thank you for that question. So I just want to emphasize the question focuses on the addition of another checkpoint inhibitor, TIGIT, on top of a PD-1, and this is a strategy to sort of deepen the response of PD-1s and PD-L1s. I think it'll be very important to see that data and look at the contribution of components.

Thank you.

Thank you for that question. So, you know, I just want to emphasize the question focuses on the addition of another checkpoint inhibitor digit on top of a

Alright. Thank you for that question. So I just wanted <unk>.

Besides the question focuses on the addition of another checkpoint inhibitor.

On top of a PD one and this is the strategy to sort of deepen the response to PD, one and PDL one.

I think that'll be very important to see that data and look at the contribution of components.

Operator: And really, we have a TIGIT program, but we're also advancing in non-small cell lung cancer and small cell lung cancer. So the field will have to sort of see, as the data evolves, how much does TIGIT add to PD-1 in the lung space. But I do want to make a broader sort of comment, which is you'll see movement in TIGIT. There was recently movement in PD-1s and CTLA-4 and PD-1s and LAG-3. What you recognize is each of those combinations; what they do is if you're able to show a benefit of the additional agent, it doesn't have as broad of an impact as PD-1 has in many different tumors.

And really, we have a TIGIT program, but we're also advancing in non-small cell lung cancer and small cell lung cancer. So the field will have to sort of see, as the data evolves, how much does TIGIT add to PD-1 in the lung space. But I do want to make a broader sort of comment, which is you'll see movement in TIGIT. There was recently movement in PD-1s and CTLA-4 and PD-1s and LAG-3. What you recognize is each of those combinations; what they do is if you're able to show a benefit of the additional agent, it doesn't have as broad of an impact as PD-1 has in many different tumors.

And really, we have a PIDGET program, but we're also...

And really we have a digit program back.

We're also advancing in non small cell lung cancer and small cell lung cancer. So the field will have to sort of see as the data evolves how much this ticket add to PD one in the lung space, but I do want to make a broader sort of comment which is you'll see movement. Then fidgets. There was recent related movement.

So the field will have to sort of see as the data evolves how much does PIDGET add to PD-1 in the long-term?

But I do want to make a broader sort of comment, which is you'll see movements and digits. There was recently movement and, you know.

PD, one and <unk>, four and PD, one and lag three.

What you recognize is each of those combinations, what they do is, if you're able to show a benefit of the additional agent, it doesn't have as broad of an impact as P.

What you recognize each of both combinations with they do it.

If you are able to show a benefit of the additional agent.

It doesn't have as broad of an impact as one has many different tumors until one of the things that I think is important to highlight is our strategy is not to just be invested in luxury not to be just invested in CLO for it not to be just invested in six digits, but to be invested in all three.

Operator: And so one of the things that I think is important to highlight is our strategy is not to just be invested in LAG-3, not to be just invested in CTLA-4, not to be just invested in TIGIT, but to be invested in all three and to focus them in specific tumor types. Great. Thank you, Mohit. Next question, please, Grace. Thank you. Next up, we have Seamus Fernandez from Guggenheim. Your line is open. Oh, great. Thanks for the question. So just really wanted to focus in on Sotatercept and the six-minute walk test as the primary endpoint.

And so one of the things that I think is important to highlight is our strategy is not to just be invested in LAG-3, not to be just invested in CTLA-4, not to be just invested in TIGIT, but to be invested in all three and to focus them in specific tumor types.

highlight is our strategy is not to just be invested in lag three, not to be just invested in CTLA-4, not to be invested in CTLA-5.

Our focus on specific tumor types.

Peter Dannenbaum: Great. Thank you, Mohit. Next question, please, Grace.

Great. Thank you next question please Greg.

Operator: Thank you. Next up, we have Seamus Fernandez from Guggenheim. Your line is open.

Next up I have Seamus Fernandez from Guggenheim, your line is open. Great, thanks for the question. I just really wanted to focus in on SITAS.

Thank you next up we have Seamus Fernandez from Guggenheim. Your line is open.

Seamus Fernandez: Oh, great. Thanks for the question. So just really wanted to focus in on Sotatercept and the six-minute walk test as the primary endpoint.

Oh, great. Thanks for the question so.

Just really wanted to focus in on <unk>.

The six minute walk test.

As the primary endpoint.

Operator: If you guys could just help us understand what is being done in the clinical trial to really manage closely the risk that sort of a subjective endpoint represents, or is your confidence that the magnitude of the difference that you saw in the phase II will comfortably cover the challenges of the six-minute walk test that we've seen in some other studies given some placebo responses that raise levels of concern? So just love to get your thoughts there. Thanks so much. Yeah. So thank you so much for that question in relationship to Sotatercept. So just to reemphasize, we have three different trials all driving towards somewhat different outcomes. The six-minute walk, which is the STELLAR trial. There's also time to clinical worsening, and then there's also even harder outcomes past that.

If you guys could just help us understand what is being done in the clinical trial to really manage closely the risk that sort of a subjective endpoint represents, or is your confidence that the magnitude of the difference that you saw in the phase II will comfortably cover the challenges of the six-minute walk test that we've seen in some other studies given some placebo responses that raise levels of concern? So just love to get your thoughts there. Thanks so much.

Just if you guys could just help us understand.

If you guys could just help us understand what is being done in the clinical trial.

What is being done in the clinical trial.

manage closely the risk that sort of a subjective endpoint represents or

To really manage closely.

Risks that sort of a subjective endpoint represents.

Sure.

Is that the magnitude of the difference that you saw in the phase two.

that the, you know, magnitude of the difference that you saw in the phase two will comfortably cover the challenges of the six-minute walk test that we've seen in some other studies given some placebo responses that raise levels of concern. So just love to get your thoughts there. Thanks so much. Yeah, so thank you so much for...

We will comfortably cover.

The challenges of the six minute walk tests that we've seen in some other studies given given some placebo responses that that raised levels of concern. So just wanted to get your thoughts there. Thanks so much.

Robert Davis: Yeah. So thank you so much for that question in relationship to Sotatercept. So just to reemphasize, we have three different trials all driving towards somewhat different outcomes. The six-minute walk, which is the STELLAR trial. There's also time to clinical worsening, and then there's also even harder outcomes past that.

Yeah. So thank you so much for that question and relationship with Patterson. So just to reemphasize, we have three different trials all driving towards somewhat different outcomes. The six minute walk which is the stellar trial is also the time to clinical worsening and then there's also even harder outcomes Pascal.

So, you know, just to reemphasize, we have three different trials all driving towards somewhat different outcomes. The six-minute walk, which is the stellar trial. There's also time for clinical work.

Operator: And as you point out, each one of those is sort of ratcheting up what Sotatercept can do. In relationship to the first one, which is STELLAR, which is related to what you said, the six-minute walk test, we saw actually quite impressive data in relationship to the phase II. We have very committed patient groups as well as sites who are very well-trained in how to do these trials. And the phase II was really nice data. And the fundamental issue is that we are confident that many of those same sites that were involved with the phase II are involved with phase III. So I think we're confident. We'll see what that data is. But the best predictor of how well we can manage those trials is really the best indicator is the phase II.

And as you point out, each one of those is sort of ratcheting up what Sotatercept can do. In relationship to the first one, which is STELLAR, which is related to what you said, the six-minute walk test, we saw actually quite impressive data in relationship to the phase II. We have very committed patient groups as well as sites who are very well-trained in how to do these trials. And the phase II was really nice data. And the fundamental issue is that we are confident that many of those same sites that were involved with the phase II are involved with phase III. So I think we're confident. We'll see what that data is. But the best predictor of how well we can manage those trials is really the best indicator is the phase II.

And as you point out each one of those is sort of ratcheting up or whats the powder.

Can do in relationship to the first one which is seller, which is related to what you said the six minute walk test.

In relationship to the first one, which is Stellar, which is related to what you said, the six-minute walk.

where we saw actually quite impressive data.

Where we saw actually quite impressive data in relationship to the phase two we have a very committed patient groups as well as sites, who are very well trained in how to do these trials.

We have very committed patient groups as well as sites who are very well-trained in how to do these trials, and the phase two was, you know, was really nice data.

And the phase two was.

What was really nice data and the fundamental issue is that we are confident that many of those same sites that were involved with the phase two RMB of Bob with phase three so I think we're confident we'll see what that data is.

So, I think, you know, we're confident, we'll see what that data is, but the best predictor of how well we can manage those trials is really the best indicator is the Phase II, and we're using very many of the same sites.

But the best predictor of how well we can manage those files is really the best is the best indicator is the phase III.

Operator: And we're using very many of the same sites and the investigators, so we have great confidence in them. Great. Thank you, Seamus. Next question, please, Grace. Thank you. Next, we have Chris Schott from JPMorgan. Great. Thanks so much for the question. Maybe just a two-parter around kind of corporate structure. I guess first, business development landscape. I know you talked about this as a priority. I guess it's been another kind of quarter of weak equity market performance on the biotech side. So I guess, are you seeing any change in willingness on the part of some of the targets to engage or any resets and valuations that could enable some of these business development kind of activities to move forward?

And we're using very many of the same sites and the investigators, so we have great confidence in them.

Are you using there are many of the same sites and the investigators who we have great confidence in them.

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

Great. Thank you Seamus next question please.

Operator: Thank you. Next, we have Chris Schott from JPMorgan.

Thank you next we have Chris Schott from J P. Morgan.

Chris Schott: Great. Thanks so much for the question. Maybe just a two-parter around kind of corporate structure. I guess first, business development landscape. I know you talked about this as a priority. I guess it's been another kind of quarter of weak equity market performance on the biotech side. So I guess, are you seeing any change in willingness on the part of some of the targets to engage or any resets and valuations that could enable some of these business development kind of activities to move forward?

Great. Thanks so much for the question. I'm just a two-parter around kind of corporate structure. I guess first, business development landscape, I know you talk about this as a priority. I guess it's been another kind of quarter of week equity market performance on the biotech side. So I guess, are you seeing any change in willingness on the part of some of the targets to engage or any resets and valuations that could enable some of these business development kind of activities to move forward?

Great. Thanks, so much for the question I may just a two parter around kind of corporate structure I guess first.

This development landscape I know you talked about as a priority spend.

Another kind of quarter of weak equity market performance and the biotech side, So I guess how.

Are you seeing any change in willingness on the part of some of the targets to engage or any reset some valuations that could enable some of these business development kind of activities to move forward.

Operator: And then, Rob, just to kind of a maybe tangential question on that is, broadly across the pharma group, I think we've been seeing asset divestitures of non-traditional pharma businesses. I know you've viewed animal health as more core to the company, but have your thoughts evolved at all, I guess, as your time as CEO and when you look at your implied kind of core pharma valuation given where some of the animal health multiples trade? So just any incremental perspective there would be appreciated. Thanks. Great. Chris, thanks for the question. On the BD landscape question, the short answer is we are not seeing a fundamental shift in seller expectations as of this point.

And then, Rob, just to kind of a maybe tangential question on that is, broadly across the pharma group, I think we've been seeing asset divestitures of non-traditional pharma businesses. I know you've viewed animal health as more core to the company, but have your thoughts evolved at all, I guess, as your time as CEO and when you look at your implied kind of core pharma valuation given where some of the animal health multiples trade? So just any incremental perspective there would be appreciated. Thanks.

And then Rob, just a kind of a tangential question on that is, you know, broadly across the pharma group, I think we've been seeing asset divestitures of nontraditional pharma business.

And then Rob just a kind of a.

Tangential question on that is broadly across the pharma group I think we've been seeing asset divestitures of non traditional pharma businesses.

I know you've viewed animal health as more core to the company, but have your thoughts evolved at all, I guess, as your time as CEO , and when you look at your implied kind of core firm evaluation, given where some of the animal health multiples trade? So to any incremental perspective there, it would be appreciated. Thanks. Great. Chris, thanks for the question. Thanks for the question.

I know you viewed animal health is more core to the company, but have your thoughts evolved they all I guess as your time as CEO and when you look at your implied kind of core form of valuation given where some of the animal health multiples trade, so tiny and incremental perspective, there would be appreciated. Thanks.

Robert Davis: Great. Chris, thanks for the question. On the BD landscape question, the short answer is we are not seeing a fundamental shift in seller expectations as of this point.

Chris Thanks for the question on the BD landscape question.

The short answer is we are not seeing a fundamental shift in seller expectations as of this point. You know, I think as time continues, if we see the market reset to become more permanent and more importantly, if the IPO market continues to be challenged for biotech companies.

The short answer is we are not seeing a fundamental shift in seller expectations.

As of this point.

Operator: I think as time continues, if we see the market reset to become more permanent, and more importantly, if the IPO market continues to be challenged for biotech companies, that might change over time as companies become more cash-constrained. There are some smaller players that do have cash challenges. So I think that's where you could see the movement first, but fundamentally, we've not seen a change in the landscape yet. We'll have to continue to watch. With regards to the animal health business, our view continues to be that the animal health business, as you said, is core to the company. It's core to our strategy as part of a growth driver for the company. But as we've always said, we look at this regularly.

I think as time continues, if we see the market reset to become more permanent, and more importantly, if the IPO market continues to be challenged for biotech companies, that might change over time as companies become more cash-constrained. There are some smaller players that do have cash challenges. So I think that's where you could see the movement first, but fundamentally, we've not seen a change in the landscape yet. We'll have to continue to watch. With regards to the animal health business, our view continues to be that the animal health business, as you said, is core to the company. It's core to our strategy as part of a growth driver for the company. But as we've always said, we look at this regularly.

No I think as time continues if we see the market reset to become more permanent and more importantly, if the IPO market continues to be challenged for biotech companies.

That might change over time as companies become more cash-constrained. There are some smaller players that do have cash challenges, so I think that's where you could see the movement first, but fundamentally, we've not seen the change in the landscape yet. We'll have to continue to watch. With regards to the animal health business.

That might change over time. This company has come become more cash constrained there are some smaller players that do have test challenges. So I think thats, where you could see.

Movement first but fundamentally we've not seen a change in the landscape yet we'll have to continue to watch.

Yards to the animal health business.

You know, our view continues to be that the animal health business, as you said, is core.

Our view continues to be that the animal health business. As you said is core to.

to the company, it's core to our strategy as part of a growth driver for the company.

The company is core to our strategy as part of our as part of a growth driver for the company.

But as we've always said, we look at this regularly. We always are challenging ourselves to ask, what is the long-term value creation opportunity of this business in our hands?

As we've always said we looked at this regularly we always are challenging ourselves to ask what is the long term value creation opportunity of this business in our hands relative to what would it be outside of the company and on a long term view. We continue to believe it is best in our hands, that's part of the company.

Operator: We always are challenging ourselves to ask, what is the long-term value creation opportunity of this business in our hands relative to what would it be outside of the company? And on a long-term view, we continue to believe it is best in our hands as part of the company. But if that situation evolves, we obviously will continue to be objective in how we analyze that. But we do not look at the short-term arbitrage opportunity for us. It's more about the long-term value creation, and that has not changed as of now. Thanks, Chris. Next question, please, Grace. Thank you. Next up, we have Chris Shibutani from Goldman Sachs. Your line is open. Thank you. Good morning. If I could ask a question on Keytruda, the strength, particularly out of the US this quarter, if you could help us with some of the underpinnings there.

We always are challenging ourselves to ask, what is the long-term value creation opportunity of this business in our hands relative to what would it be outside of the company? And on a long-term view, we continue to believe it is best in our hands as part of the company. But if that situation evolves, we obviously will continue to be objective in how we analyze that. But we do not look at the short-term arbitrage opportunity for us. It's more about the long-term value creation, and that has not changed as of now.

relative to what would it be outside the company, and on a long-term view, we continue to believe it is best in our hands as part of the company, but if that...

situation evolves, we obviously will continue to be objective in how we analyze that, but we do not look at the short term.

Situation evolved we obviously will continue to be objective and how we analyze that but we do not look at the short term.

arbitrage opportunity. For us, it's more about the long-term value creation, and that has not changed as of now. Thanks.

Arbitrage opportunity for us it's more about the long term value creation and that has not changed as of now.

Peter Dannenbaum: Thanks, Chris. Next question, please, Grace.

Thanks, Chris next question please Greg.

Operator: Thank you. Next up, we have Chris Shibutani from Goldman Sachs. Your line is open.

Thank you. Next up we have Chris Srivattani from Goldman Sachs, your line is open.

Thank you next up we have Chris <unk> with tiny from Goldman Sachs. Your line is open.

Chris Shibutani: Thank you. Good morning. If I could ask a question on Keytruda, the strength, particularly out of the US this quarter, if you could help us with some of the underpinnings there.

Thank you. Good morning. If I could ask questions on Keytruda, the strength, particularly out of the U.S. this quarter. If you could help us with some of the underpinnings there, and relatedly, longer-term 2025. I think you framed how, Keytruda, your objective is to have, I guess, the wording change slightly. You were previously looking for 30 percent coming from adjuvant with your focus framed around the U.S.

Thank you and good morning, if I could ask a question on Keytruda.

Strength, particularly out of the U S. This quarter, if you could help us with some of the underpinnings, there and relatedly longer term 2025, I think you've framed how keytruda. Your objective is to have I guess the wording changed slightly you were previously looking for 30% coming from adjuvant with your focus framed around the U S.

Operator: Relatedly, longer-term 2025, I think you framed how Keytruda, your objective is to have, I guess the wording changed slightly. You were previously looking for 30% coming from adjuvant with your focus framed around the US. If I'm reading it correctly, you've broadened the framework here to now think about it as 25% on a global basis. Maybe update us on where you feel you are in terms of making progress towards achieving those objectives of the adjuvant revenue contribution. Thank you. Yeah. So Chris, this is Rob. Maybe I'll take the first part of the question, then Caroline can jump in for the second part.

Relatedly, longer-term 2025, I think you framed how Keytruda, your objective is to have, I guess the wording changed slightly. You were previously looking for 30% coming from adjuvant with your focus framed around the US. If I'm reading it correctly, you've broadened the framework here to now think about it as 25% on a global basis. Maybe update us on where you feel you are in terms of making progress towards achieving those objectives of the adjuvant revenue contribution. Thank you.

If I'm reading it correctly, you've brought in the framework here to now think about it as 25% on a global basis. Maybe update us on where you feel you are in terms of making progress towards achieving those objectives of the adjuvant revenue contribution. Thank you.

Reading it correctly you brought in the framework here to now think about it as 25% on a global basis, maybe update us on where you feel you are in terms of making progress towards achieving those objectives of the adjuvant revenue contribution. Thank you, yes. So.

Robert Davis: Yeah. So Chris, this is Rob. Maybe I'll take the first part of the question, then Caroline can jump in for the second part.

Yeah. So, Chris, this is Rob. Maybe I'll take the first part of the question, then Caroline can...

So Chris this is Rob maybe I'll take the first part of the question then Caroline can can jump in for the second part.

Can jump in for the second part, you know, on the strength of the growth we're seeing in the United States. This is really a.

Operator: On the strength of the growth we're seeing in the United States, this is really a testament to what we've been talking about all along, which is, as we continue to roll out new indications, we are continuing to see our share grow as the leading IO agent. And importantly, I would highlight that the growth we saw, among other things in the quarter, continuation of our position in renal cell carcinoma, continuation of the growth we're seeing in head and neck. In RCC, obviously, being a first-line treatment in the metastatic setting as well as now having adjuvant therapy as well, we've covered pretty much the waterfront of RCC, and we have the opportunity to continue to grow there. But the standout, frankly, for the quarter, and it's, I think, really important to understand, is triple-negative breast cancer, both in the metastatic setting and in the adjuvant setting.

On the strength of the growth we're seeing in the United States, this is really a testament to what we've been talking about all along, which is, as we continue to roll out new indications, we are continuing to see our share grow as the leading IO agent. And importantly, I would highlight that the growth we saw, among other things in the quarter, continuation of our position in renal cell carcinoma, continuation of the growth we're seeing in head and neck. In RCC, obviously, being a first-line treatment in the metastatic setting as well as now having adjuvant therapy as well, we've covered pretty much the waterfront of RCC, and we have the opportunity to continue to grow there. But the standout, frankly, for the quarter, and it's, I think, really important to understand, is triple-negative breast cancer, both in the metastatic setting and in the adjuvant setting.

On the strength of the growth, we're seeing in the United States.

This is really a testament to what we've been talking about all along which is as we continue to rollout new indications.

to what we've been talking about all along, which is, as we continue to roll out new indications.

We are continuing to see our share grow as.

We are continuing to to see our share grows.

as the leading IO agent, and importantly, I would highlight that the growth we saw among other things in the quarter, continuation of our position in renal cell carcinoma, continuation of the growth we're seeing in head and neck.

As the leading Io agents.

And importantly, I would highlight is the growth we saw among other things in the quarter continuation of our position in renal cell carcinoma continuation of the growth, we're seeing in head and neck.

In RCC, obviously being a first line treatment.

In RCC, obviously, being a first-line treatment in the metastatic setting, as well as now having adjuvant therapy as well, we've covered pretty much the waterfront of RCC, and we have the opportunity to continue to grow there. But the standout, frankly, for the quarter, and it's, I think, really important to understand is triple negative breast cancer, both in the metastatic setting and in the adjuvant setting. We are seeing incredible growth in that space.

In the metastatic setting as well as not having adjuvant chemotherapy as well will recover pretty much the waterfront of RCC and we have the opportunity to continue to grow there, but the standout frankly for the quarter.

And it's I think really important to understand as triple negative breast cancer, both in the metastatic setting and the adjuvant settings, we are seeing incredible growth in that space.

Operator: We are seeing incredible growth in that space, and it's something that we feel very proud of because I think we're going to have a meaningful difference there. The reason I highlight that is both if you look at the adjuvant opportunity there and the growth we're getting, as well as, as I mentioned, in adjuvant RCC, I think it just reinforces what we see as the future, which is the growth contribution from the earlier lines of therapy long-term. But with that, maybe Caroline can be specific to some of the guidance we've provided. So to Rob's point, we are extremely excited about the opportunities we have for adjuvant and the impact that that has on patients. We initially shared that we expected 50% of our growth to come from adjuvant, representing 30% of the US business.

We are seeing incredible growth in that space, and it's something that we feel very proud of because I think we're going to have a meaningful difference there. The reason I highlight that is both if you look at the adjuvant opportunity there and the growth we're getting, as well as, as I mentioned, in adjuvant RCC, I think it just reinforces what we see as the future, which is the growth contribution from the earlier lines of therapy long-term. But with that, maybe Caroline can be specific to some of the guidance we've provided.

and it's something that we feel very proud of because I think we're going to have a meaningful difference there.

And it's something that we feel very proud of because I think we're going to have a meaningful difference there.

My reason to highlight that is both if you look at the adjuvant opportunity there and the growth we're getting, as well as what I mentioned in adjuvant RCC.

I highlight that is both if you look at the adjuvant opportunity there in this growth, we're getting as well as I mentioned, an adjuvant in RCC.

I think it just reinforces what we see as the future, which is the growth contribution from the earlier lines of therapy long-term. But with that, maybe Caroline can be specific to some of the guidance we've provided. So to Rob's point, we are extremely excited about the opportunities we have for adjuvant and the impact that that has on patients. We initially shared that we expected 50% of our growth to come from adjuvant, representing 30% of the U.S. citizens.

I think it just reinforces what we see as the future, which is the growth contribution from the earlier lines of therapy.

Long term, but with that maybe Caroline can be specific to some of the guidance we provided.

Caroline Litchfield: So to Rob's point, we are extremely excited about the opportunities we have for adjuvant and the impact that that has on patients. We initially shared that we expected 50% of our growth to come from adjuvant, representing 30% of the US business.

To Rob's point, we are extremely excited about the opportunities we have for adjuvant and the impact that that has on patients. We initially shared that we expected expense growth to come from adjuvant, representing 30% of the U S business.

Operator: We have now extended that to say 50% of the growth will come from adjuvant, representing 25% of our global business in the year 2025. To Rob's point, our early introductions into the earlier stage cancers with five indications now in Keytruda are putting us on a very good course to have this impact. Great. Thank you, Chris. Next question, please, Grace. Thank you. Next, we have Umar Raffat from Evercore ISI. Your line is open. Hi, guys. Thanks for taking my question. Maybe let me touch up on Molnupiravir real quick. I think the total utilization to date is about 200,000 courses through mid-April. And it looks like, at least based on third-party data sets, that the Pfizer regimen is getting used 8 to 10x more than Molnupiravir.

We have now extended that to say 50% of the growth will come from adjuvant, representing 25% of our global business in the year 2025. To Rob's point, our early introductions into the earlier stage cancers with five indications now in Keytruda are putting us on a very good course to have this impact.

We have now extended that to say 50% of the growth will come from adjuvants, representing 25% of our global business in the year 2025. And to Rob's point, our early introductions into the earlier stage cancers, with five indications now in Keytruda, are putting us on a very good course to have this impact. Great.

We have now extended that to say, 50% for growth will come from adjuvant, representing 25% of our global business in the year 2025 and to Rob's point early introduction into the earliest stage cancers with five indications now and Keytruda are putting us on a very good call.

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

To have this impact.

Great. Thank you Chris next question please.

Operator: Thank you. Next, we have Umar Raffat from Evercore ISI. Your line is open.

Thank you. Next we have Umar Afad from Evercore Eyes Eye. Your line is open.

Thank you next we have Omar Saad from Evercore ISI. Your line is open.

Umar Raffat: Hi, guys. Thanks for taking my question. Maybe let me touch up on Molnupiravir real quick. I think the total utilization to date is about 200,000 courses through mid-April. And it looks like, at least based on third-party data sets, that the Pfizer regimen is getting used 8 to 10x more than Molnupiravir.

Hi guys, thanks for taking my question. Maybe let me touch up on Malno-Perevier real quick. I think the total utilization to date is about 200,000 courses through mid-April. And it looks like, at least based on third-party data sets, that the Pfizer regimen is getting used 8 to 10x more than Malno-Perevier.

Hi, guys. Thanks for taking my question, maybe let me touch up on Mono pair me real quick.

The total utilization to date is about 200000 courses through mid April and it looks like at least based on third party datasets that the Pfizer regimens getting used eight to 10 X more than mom appear here.

Operator: So I guess my question is, if only a couple hundred thousand courses have been used through mid-April and 3.1 million courses were contracted to the US, is there any recourse for the US to return a chunk of these courses back? And I'm asking because some of these sales have been recorded in P&L. I just want to make sure they're permanent sales. Yeah. I'll let Caroline maybe address this. So Umar, thanks for the question. First, let me start with proud of Molnupiravir, Lagevrio, everywhere, and the impact that it can have on the world. And it has impacts to the comments that Dean made given its importance, especially in patients that have drug-to-drug interactions. The data that we have access to suggests that we have actually had utilization by 500,000 patients globally at this stage. We have shipped 6.4 million courses as of now.

So I guess my question is, if only a couple hundred thousand courses have been used through mid-April and 3.1 million courses were contracted to the US, is there any recourse for the US to return a chunk of these courses back? And I'm asking because some of these sales have been recorded in P&L. I just want to make sure they're permanent sales.

so i guess my question is if only a couple hundred thousand courses have been used through mid-april and three point one million courses were contracted the u s is there any recourse for u s to return a chunk of the course is back and i'm asking because of the field of the recording p and i want to make sure they're permanent sales

So I guess my question is if only a couple of hundred thousand courses have been used through mid April and $3 1 million courses were contracted the U S is there any recourse for U S to return a chunk of these courses back and I'm asking because somebody sales had been recorded in the P&L I just want to make sure they're permanent sales.

Robert Davis: Yeah. I'll let Caroline maybe address this.

Yeah, I'll let Caroline maybe address this. So, Irma, thanks for the question. First, let me start with proud of monipiravir, look at the impact that it can have on the world. And it has impact to the comments that Dean made, given its importance, especially in patients that have drug-to-drug interactions.

Yeah, I'll, let Caroline maybe address this so thanks for the question.

Caroline Litchfield: So Umar, thanks for the question. First, let me start with proud of Molnupiravir, Lagevrio, everywhere, and the impact that it can have on the world. And it has impacts to the comments that Dean made given its importance, especially in patients that have drug-to-drug interactions. The data that we have access to suggests that we have actually had utilization by 500,000 patients globally at this stage. We have shipped 6.4 million courses as of now.

Let me start with proud of Monte Paraphasia look every R&D impacts or it can have on the world and it has impacts to the comments that Dave made given its importance, especially in patients that have dropped to truck interactions. The data that we have access to suggest that we have actually had utilization by 500.

The data that we have access to suggests that we have actually had utilization by 500,000 patients globally at this stage.

<unk> patients globally at this stage, we have shipped $6 4 million cost saves as of now.

We have shipped 6.4 million courses as of now.

Operator: Those shipments represent expectations for utilization over a period of time. We're actually seeing extremely strong utilization, especially in ex-US markets, where the statistics you quote are actually reversed in some of the markets. We have a very strong market share. So as we sit here today, we've guided on the $5 to 5.5 billion based on the contracts that we have in hand, and we are confident in that in our financials. Great. Thank you, Umar. Next question, please. Thank you. Next, we have Daina Graybosch from SVB Leerink. Your line is open. Hi. Thank you for the question. I have another one on Keytruda and early stage. Can you please talk to how the success of Opdivo plus chemotherapy in neoadjuvant lung cancer changes your expectations or strategy for the early-stage opportunities in lung cancer, and in any other tumor? Yeah.

Those shipments represent expectations for utilization over a period of time. We're actually seeing extremely strong utilization, especially in ex-US markets, where the statistics you quote are actually reversed in some of the markets. We have a very strong market share. So as we sit here today, we've guided on the $5 to 5.5 billion based on the contracts that we have in hand, and we are confident in that in our financials.

those shipments represent expectations for utilization over a period of time. And we're actually seeing extremely strong utilization, especially in ex-US markets, where the statistics you quote are actually reversed in some of the markets. We have a very strong market share.

Both shipments represent expectations for utilization over a period of time, and we're actually seeing extremely strong utilization, especially in ex U S market, but the statistics you quote are actually with us in some of the markets. We have a very strong market share. So as we sit here today.

So as we sit here today, we've guided on the 5 to 5.5 billion based on the contracts that we have in hand, and we are confident in that in our financials.

<unk> guided on the five to $5 5 billion based on the contracts that we have been <unk> and we are confident in that in our financials.

Peter Dannenbaum: Great. Thank you, Umar. Next question, please.

Great. Thank you next question please.

Operator: Thank you. Next, we have Daina Graybosch from SVB Leerink. Your line is open.

Thank you. Next we have Dana Graybush from SVP Leroy. Your line is open.

Thank you next we have Dana great Bostrom SVP Leerink your line is open.

Daina Graybosch: Hi. Thank you for the question. I have another one on Keytruda and early stage. Can you please talk to how the success of Opdivo plus chemotherapy in neoadjuvant lung cancer changes your expectations or strategy for the early-stage opportunities in lung cancer, and in any other tumor?

Hi, thank you for requesting the question. I have another one on Keytruda and early stage. Can you please talk to how the success of updevo plus chemotherapy and neoadjuvant lung cancer changes your expectations or strategy for the early stage opportunities in lung cancer and in any other.

Hi, Thank you for your question. The question I have another one on Keytruda in early stage, but could you. Please talk to how the success of Opdivo plus chemotherapy in neo adjuvant lung cancer.

Changes your expectations or strategy for the early stage opportunities in lung cancer and in any other tumor.

Dean Li: Yeah.

Yeah, thank you very much for that question in relationship to sort of just earlier stage.

Operator: Thank you very much for that question. In relationship to sort of just earlier stage in lung cancer, I think it's really important to emphasize there's a series of different ways to approach it. One is neoadjuvant, adjuvant, one is adjuvant. And I just think all of these signals just demonstrate throughout a variety of different studies just the impact that PD-1s can have. So our point of view of it is it shouldn't change our strategy. It should just make our strategy pretty comprehensive. And the fundamental thing is we have Keynote-091, which is in the adjuvant. So that's post-surgery, and that's usually given by a medical oncologist. The disease-free survival was positive in all comers, regardless of PD-L1. There was a trend to TPS greater than 50%, but not statistically significant. And OS, there was a favorable trend regardless of PD-L1.

Thank you very much for that question. In relationship to sort of just earlier stage in lung cancer, I think it's really important to emphasize there's a series of different ways to approach it. One is neoadjuvant, adjuvant, one is adjuvant. And I just think all of these signals just demonstrate throughout a variety of different studies just the impact that PD-1s can have. So our point of view of it is it shouldn't change our strategy. It should just make our strategy pretty comprehensive. And the fundamental thing is we have Keynote-091, which is in the adjuvant. So that's post-surgery, and that's usually given by a medical oncologist. The disease-free survival was positive in all comers, regardless of PD-L1. There was a trend to TPS greater than 50%, but not statistically significant. And OS, there was a favorable trend regardless of PD-L1.

Yes. Thank you very much for that question and relationship to sort of just earlier stage in lung.

lung cancer. I think it's really important to emphasize there's a series of different ways to approach it. One is neoadjuvant adjuvant.

Lung cancer, I think it's really important that <unk>.

Emphasize there is there is a series of different ways to approach it wanted to neo adjuvant and adjuvant adjuvant and I just think all of these signals jet demonstrate throughout a variety of different.

And I just think all of these signals just demonstrate throughout a variety of different

studies just the impact that PD-1s can have. So our point of view of it is it shouldn't change our strategy, it should just make our strategy pretty comprehensive.

Studies, just that impact that PD ones can have.

So our point of view of it is it shouldnt change our strategy. It should just make our strategy pretty comprehensive the fundamental thing is we have a keynote 91, which is in the adjuvant. So that's post surgery and thats, usually given by a metal medical oncologists.

The fundamental thing is we have Keynote 91, which is in the adjuvant, so that's post-surgery, and that's usually given by a medical oncologist.

disease-free survival was positive in all comers, regardless of PD-L1.

Yeah disease free survival was positive in all comers, regardless of PD L. One.

There was a trend to TPS greater than 50%, but not statistically significant. And OS, it was a favorable trend regardless of PDL.

The trends the TPS greater than 50%, but not statistically significant and OLED. There was a favorable trend regardless of PD lone so wont be letting that data mature as we continue to discuss with the FDA, but didnt going to your point, it's not just 91 as keynote <unk> 71.

Operator: So we'll be letting that data mature as we continue to discuss with the FDA. But going to your point, it's not just Keynote-091. It's Keynote-671. It's Keynote-867. It's Keylink-012. It's all in the earlier stage. So our desire to really push that earlier stage is going to be, if anything, our commitment towards that is even greater. The one thing I would just add in relationship to some of the comments that Caroline and Rob made is that I think it's very important to think about melanoma, renal cell carcinoma, and triple-negative breast cancer, where at least my experience being in the hospital, there's a concept of really looking at that earlier stage. And I think uptake may be sort of built in the medical system.

So we'll be letting that data mature as we continue to discuss with the FDA. But going to your point, it's not just Keynote-091. It's Keynote-671. It's Keynote-867. It's Keylink-012. It's all in the earlier stage. So our desire to really push that earlier stage is going to be, if anything, our commitment towards that is even greater. The one thing I would just add in relationship to some of the comments that Caroline and Rob made is that I think it's very important to think about melanoma, renal cell carcinoma, and triple-negative breast cancer, where at least my experience being in the hospital, there's a concept of really looking at that earlier stage. And I think uptake may be sort of built in the medical system.

So, we'll be letting that data mature as we continue to discuss with the FDA. But going to your point, it's not just Keno 91, it's Keno 671, it's Keno 867, it's Key Link 12. It's all in the earlier stage, so our desire to really push that earlier stage is going to be...

<unk> key linked well, it's all in the earlier stage, so our desire to really push that earlier stage is going to be.

If anything, our commitment towards that is even greater. The one thing I would just add in relationship to some of the comments that Caroline and Rob made.

If anything our commitment towards that is even greater.

One thing I would just add in relationships with some of the comments that Carolina Ralph made.

is that I think it's very important to think about melanoma, renal cell carcinoma, and triple negative breast cancer, where at least my experience being in the hospital, there's a concept of really looking at that earlier stage. I think uptake may be sort of built in the medical.

Is that I think it's very important that think about melanoma renal cell carcinoma, and triple negative breast cancer, where at least my experience being in the hospital. There was a there was a concept that really looking at that earlier stage I think uptake maybe sort of built in the medical system I think all of us.

Operator: I think all of us, including us and other companies, as well as patient advocacy and medical centers, are going to have to require diligent investment to really, really maximize the important scientific impacts of Keytruda and PD-1s and PD-L1s in the early lung stage. Great. Thank you, Daina. Next question, please, Grace. Thank you. Next, we have Andrew Baum from Citi. Your line is open. Thank you. I'd just like to thank Roy for all the contributions and insights over the years. The question is on your Factor XI monoclonal. Given your background in cardiology, and I'm sure your familiarity with hemostasis, there's clearly been a number of indications where the DOACs were unsuccessful compared to warfarin for both efficacy and safety, potentially speaking to different underlying mechanisms for thrombosis and the different indications. I'm thinking about ESIS. I'm thinking about mechanical heart valves.

I think all of us, including us and other companies, as well as patient advocacy and medical centers, are going to have to require diligent investment to really, really maximize the important scientific impacts of Keytruda and PD-1s and PD-L1s in the early lung stage.

I think all of us, including us and other companies, as well as patient advocacies and medical centers, are going to have to require diligent investment to really, really maximize the important scientific impacts of Keytruda and PD-1s and PD-L1s in the early lung space. Great, thank you.

<unk> us and other companies as well as patient advocacy and medical centers are going to have to require a diligent investments to really really maximize the important scientific impacts of keytruda and PD, one and PDL, one and the early loan space.

Peter Dannenbaum: Great. Thank you, Daina. Next question, please, Grace.

Great. Thank you Dana next question. Please thank.

Operator: Thank you. Next, we have Andrew Baum from Citi. Your line is open.

Thank you. Next we have Andrew Baum from Citi. Your line is open.

Thank you next we have Andrew Baum from Citi. Your line is open.

Andrew Baum: Thank you. I'd just like to thank Roy for all the contributions and insights over the years. The question is on your Factor XI monoclonal. Given your background in cardiology, and I'm sure your familiarity with hemostasis, there's clearly been a number of indications where the DOACs were unsuccessful compared to warfarin for both efficacy and safety, potentially speaking to different underlying mechanisms for thrombosis and the different indications. I'm thinking about ESIS. I'm thinking about mechanical heart valves.

Thank you. I'd just like to thank Roy for all the contributions and insights over the years. The question is on your factor 11 monoclonal. Given your background in cardiology, and I'm sure familiarity with hemostasis, there's clearly been a number of indications where the DOAC

Thank you I'd just like to thank Roy for all the contributions and insights over the years.

The question is on your factor 11 monoclonal.

Given your background in cardiology and Im sure.

Many actually with Hemostasis Steve.

There's clearly been a number of indications where the docs.

were unsuccessful compared to Warfarin for both efficacy and safety, potentially speaking to different underlying mechanisms for thrombosis and the different indications. I'm thinking about ESUS, I'm thinking about mechanical heart valves. Given what you know about Factor XI biology and the intrinsic pathway nature of the inhibition, what indications would you actively avoid or be somewhat cautious about taking?

Successful compared to warfarin for both efficacy and safety.

Potentially speaking to different underlying mechanisms.

For thrombosis in a different indication as I'm thinking about E systems thinking about mechanical heart valves, given what you know about factor 11, biology, and the intrinsic pathway nature of the inhibition.

Operator: Given what you know about Factor XI biology and the intrinsic pathway nature of the inhibition, what indications would you actively avoid or be somewhat cautious about taking a Factor XI inhibitor into, be it yours or someone else's? Yeah. So let me just step back for just a moment. The benefit-risk of whether it's platelet or coagulation factors in terms of clotting is something that's actually very topical in the news. I would just emphasize for years, for probably a decade or more, aspirin has been just everywhere. And recently, people realized the benefit-risk, one has to be very careful. There has been a major change in the guidelines. So that impacts how I think about it.

Given what you know you about Factor XI biology and the intrinsic pathway nature of the inhibition, what indications would you actively avoid or be somewhat cautious about taking a Factor XI inhibitor into, be it yours or someone else's?

What indications would you actively avoid or be somewhat cautious about taking.

a factor 11 inhibitor into, be it yours or someone else's.

After 11 inhibitor into bit yours or someone else's.

Roy Baynes: Yeah. So let me just step back for just a moment. The benefit-risk of whether it's platelet or coagulation factors in terms of clotting is something that's actually very topical in the news. I would just emphasize for years, for probably a decade or more, aspirin has been just everywhere. And recently, people realized the benefit-risk, one has to be very careful. There has been a major change in the guidelines. So that impacts how I think about it.

Yeah, so let me just step back for just a moment that the benefit risk of whether it's platelet or coagulation factors in terms of clotting is something that's actually very topical in the news. I would just emphasize, you know, for years, for probably a decade or more, you know, aspirin has been just everywhere. And recently, people realized the benefit risk, one has to be very careful.

Yes, So let me just step back for just a moment the the benefit risk of whether its platelets or coagulation factors in terms of clotting.

That's actually very topical in the news I would just emphasize.

For years for probably a decade or more aspirin has been just everywhere and recently people realize the benefit risk one has to be very careful.

There has been a major change in the guidelines. So that impacts how I.

There has been a major change in the guidelines so that that impacts how I think about it.

Operator: The other sort of thing that impacts is if you look at Factor XI, the fundamental advantage of that is that you can get blockage of the coagulation cascade with, by genetics, very little impact in relationship to adverse effects. So for me, the critical thing is to prove that as quickly as possible. We immediately go, where is the problem where thrombosis and bleeding is both impacted there? That's why we ran to end-stage renal disease. But I could see in the future mechanical devices. One of my favorite sort of things is left ventricular assist device. I think those will continue to need to be monitored in the future. So that's a place where the risk of bleeding and the risk of thrombosis is really high.

The other sort see in the future mechanical devices. One of my favorite sort of things is left ventricular assist device. I think those will continue to need to be monitored in the future. So that's a place where the risk of bleeding and the risk of thrombosis is really high.

The other sort of thing that I impact is, if you look at Factor XI, the fundamental advantage of that is that you can get blockage of the coagulation cascade with, by genetics, very little impact in relationship to adverse effects.

Other sort of thing that in practice. If you look at factor 11, the fundamental advantage of that is that you can get blockage of the coagulation cascade with by genetics very little impact in relationship to adverse effects.

And so for me, the critical thing is to prove that as quickly as possible. So we immediately go, where is the problem where thrombosis and bleeding is both impacted?

And so for me the critical thing is to prove that as quickly as possible. So we immediately go where is the problem with thrombosis and bleeding is both impacted there and so that's why we ran to end stage renal disease, but I could see it in the future.

And so that's why we ran and studied renal disease. But I could see in the future.

you know, mechanical devices, you know, I would, you know, one of my favorite sort of things is left ventricular assist device. I think those.

Mechanical devices.

One of my favorite sort of things has left ventricular assist device I think those will continue to need to be monitored in the future. So that's a place where the risk of bleeding and the risk of thrombosis is really high where we have chosen to be a little bit careful is for example, broader sort of things such as atrial fibrillation.

will continue to need to be monitored in the future. So that's a place where the risk of bleeding and the risk of thrombosis is really high. Where we have chosen to be a little bit...

Operator: Where we have chosen to be a little bit careful is, for example, broader sort of things such as atrial fibrillation and the risk relationship to stroke because we look at the Factor X as very effective. There are bleeding complications, but to make a safety argument for it, you're talking about a very, very large trial. So we are racing to places where the benefit-risk of thrombosis and clotting and bleeding, where that differential would make something like a Factor XI have the biggest impact. Thank you, Andrew. Next question, please. Thank you. Next, we have Louise Chen from Cantor. Your line is open. Hi. Thanks for taking my question. I wanted to ask you about your pneumococcal conjugate vaccine and how you think your more targeted approach will be a competitive advantage versus the one-size-fits-all that we're seeing now.

Where we have chosen to be a little bit careful is, for example, broader sort of things such as atrial fibrillation and the risk relationship to stroke because we look at the Factor X as very effective. There are bleeding complications, but to make a safety argument for it, you're talking about a very, very large trial. So we are racing to places where the benefit-risk of thrombosis and clotting and bleeding, where that differential would make something like a Factor XI have the biggest impact.

is, for example, broader sort of things such as atrial fibrillation and the risk relationship to stroke, because we look at the factor 10 as very effective.

<unk> and the risk relationship to stroke, because we look at the factory.

There are bleeding complications, but to make a safety argument for it, you're talking about a very, very large...

Our effective there are bleeding complications, but to make a safety argument for it you're talking about a very very large trials. So we're racing to places where the benefit risk of <unk>.

So we are racing to places where the benefit risk of thrombosis and clotting and bleeding, where that differential would make something like a factor 11 have the biggest impact. Thank you, Andrew. Next question, please.

From bonuses and clotting and bleeding.

That differential would make something like a factor 11 have the biggest impact.

Peter Dannenbaum: Thank you, Andrew. Next question, please.

Operator: Thank you. Next, we have Louise Chen from Cantor. Your line is open.

Thank you Andrew next question please.

Thank you next we have Louise Chen from Cantor Your line is open.

Louise Chen: Hi. Thanks for taking my question. I wanted to ask you about your pneumococcal conjugate vaccine and how you think your more targeted approach will be a competitive advantage versus the one-size-fits-all that we're seeing now.

Hi, thanks for taking my question. I wanted to ask you about your pneumococcal conjugate vaccine and how you think your more targeted approach will be a competitive advantage versus the one-size-fits-all that we're seeing now. And is there any precedence to what you're doing with V116 and 117? And maybe just lastly, how will you make that message clear to physicians? Since if everything goes as planned, you'll have several PCVs on the market. Thank you.

Hi, Thanks for taking my question I wanted to ask you about your pneumococcal conjugate vaccine and how you think you're more targeted approach will be a competitive advantage versus the one size fits all that we're seeing now and is there any precedent as to what youre doing with V. One six and one seven and maybe just lastly, how would you make that message <unk>.

Operator: And is there any precedent to what you're doing with V116 and V117? And maybe just lastly, how will you make that message clear to physicians since if everything goes as planned, you'll have several PCVs on the market? Thank you. Yeah. First of all, we need to get the data to demonstrate that we have an advantage in the different patient populations. But I think you point out a really important point, which is essentially what we're trying to do is, for lack of a better word, we're, you want to call it precision-targeted vaccination, right? So the fundamental thing is V114 is adult-approved, and we're driving towards a pediatric approval for the 15-valent. And so that will be in the pediatric population. In the V116, where we have a breakthrough designation, we're trying to demonstrate that we can target 85% of the residual serotypes.

And is there any precedent to what you're doing with V116 and V117? And maybe just lastly, how will you make that message clear to physicians since if everything goes as planned, you'll have several PCVs on the market? Thank you.

Physicians since if everything goes as planned youll have several pcbs under market. Thank you.

Robert Davis: Yeah. First of all, we need to get the data to demonstrate that we have an advantage in the different patient populations. But I think you point out a really important point, which is essentially what we're trying to do is, for lack of a better word, we're, you want to call it precision-targeted vaccination, right? So the fundamental thing is V114 is adult-approved, and we're driving towards a pediatric approval for the 15-valent. And so that will be in the pediatric population. In the V116, where we have a breakthrough designation, we're trying to demonstrate that we can target 85% of the residual serotypes.

Yeah, first of all, we need to get the data to demonstrate that we have an advantage in the different patient populations. But I think you point out a really important point, which is essentially what we're trying to do is, for lack of a better word, we're, you know, you want to call it precision targeted vaccination, right? So, the fundamental thing is the 1, 1, 4 is adult approved and we're driving towards a pediatric approval for the 15 valence and so, you know, that will be in the pediatric population.

Yeah. So first of all we need to get the data to demonstrate that we have an advantage in the different patient populations, but I think you point out a really important.

<unk>, which is essentially what we're trying to do it.

For lack of a better word.

Do you want to call it precision targeted vaccination right. So the fundamental thing is the 114 as adult approved and we're driving towards a pediatric approval for the 15 valent.

And so that.

That will be in the pediatric population and the V. One six where we have a breakthrough.

In the V116, where we have a breakthrough designation, we're trying to demonstrate that we can target 85% of the residual serotypes. And you know, I would just sit there and say it would be eight unique serotypes in relationship to all the different currently approved ones.

Designation before trying to demonstrate that we can target 85% of the residual serotypes and I would just sit there and say it would be eight unique serotypes involved.

Operator: And I would just sit there and say it would be eight unique serotypes in relationship to all the different currently approved ones. And I think that patient population, I reflect a little bit about COVID, but it's that older population that especially has risk factors who you really want to make sure that that whole population, that adult population, is covered. And so I do think the fundamental thing is we'll have to have the data, but our concept is the adult has a different set of serotypes, and they need to be protected. And we'll have to get the data to demonstrate that. But I think if we can demonstrate it, the uptake will be quite good. Thank you, Louise. Next question, please. Thank you. Next, we have Mara Goldstein from Mizuho. Your line is open. Thanks for taking the question.

And I would just sit there and say it would be eight unique serotypes in relationship to all the different currently approved ones. And I think that patient population, I reflect a little bit about COVID, but it's that older population that especially has risk factors who you really want to make sure that that whole population, that adult population, is covered. And so I do think the fundamental thing is we'll have to have the data, but our concept is the adult has a different set of serotypes, and they need to be protected. And we'll have to get the data to demonstrate that. But I think if we can demonstrate it, the uptake will be quite good.

In relationship to all of the different currently approved ones and I think that patient population.

And I think that patient population, you know, I reflect a little bit about COVID, but it's that older population that especially has risk factors who really want to make sure that that whole population, that adult population is covered. And so I do think the, you know, the fundamental thing is we'll have to have the data, but our concept is the adult.

I reflect a little bit about COVID-19 , but it's that that older population that especially as the risk factors, who really want to make sure that that that whole population that adult population is covered and so I do think the fundamental thing is we'll have to have the data.

But our concept is the adults have a different set of serotypes and they need to be protected and we'll have to get the data to demonstrate that but I think if we can demonstrate that the uptake will be quite good.

have a different set of serotypes and they need to be protected, and we'll have to get the data to demonstrate that. But I think if we can demonstrate it, the uptake will be quite good.

Peter Dannenbaum: Thank you, Louise. Next question, please.

Thank you Luis next question please.

Operator: Thank you. Next, we have Mara Goldstein from Mizuho. Your line is open.

Thank you. Next we have Meyer Goldstein from Mizuho. Your line is open.

Thank you next we have Mara Goldstein from Mizuho. Your line is open.

Mara Goldstein: Thanks for taking the question.

Thanks for taking the question. I'm just hoping maybe we can return for a second back to the question of novel targets in combination with Keytruda, and maybe if you could just give us a very high level perhaps rationale for which targets you're looking at and which indications, and I'm referring here obviously to things like TIGIT, LAG-3, ILT-3, and the like.

Thanks for taking the question I'm, just hoping maybe we can return for a second back to the question of novel targets in.

Operator: I'm just hoping maybe we can return for a second back to the question of novel targets in combination with Keytruda. Maybe if you could just give us a very high-level, perhaps rationale for which targets you're looking at and which indications. I'm referring here, obviously, to things like TIGIT, LAG3, ILT3, and the like. All right. So let me just sort of separate. So we always talk about expand, deepen, and extend. When we talk about deepen, we're trying to get a deeper response with PD-1s. There's a series of things that we do with what I call non-IO agents, which is chemotherapy. We're doing stuff with many other people as well as ourselves with ADCs. There are RAS programs that are advancing. So we think that that sort of combination. There's large precedent throughout our portfolio already, and there will continue to be.

I'm just hoping maybe we can return for a second back to the question of novel targets in combination with Keytruda. Maybe if you could just give us a very high-level, perhaps rationale for which targets you're looking at and which indications. I'm referring here, obviously, to things like TIGIT, LAG3, ILT3, and the like.

In combination with Keytruda and maybe if you could just give us a very high level, perhaps rationale for which targets, you're looking at and which indications and I'm, referring to here, obviously, two things like ticket Blackberry Iot.

Dean Li: All right. So let me just sort of separate. So we always talk about expand, deepen, and extend. When we talk about deepen, we're trying to get a deeper response with PD-1s. There's a series of things that we do with what I call non-IO agents, which is chemotherapy. We're doing stuff with many other people as well as ourselves with ADCs. There are RAS programs that are advancing. So we think that that sort of combination. There's large precedent throughout our portfolio already, and there will continue to be.

And the like.

All right, so let me just sort of separate. So we always talk about expand, deepen, and extend. And when we talk about deepen, we're trying to get a deeper response with PD-1s. And there's a series of things that we do with what I call non-IO agents.

Alright, So let me just sort of separate so we always talk about expand deepen and extend and when we talk about deeper and we're trying to get a deeper response with PD ones. In there. There is a series of things that we do with what I'd call non I O agents, which is chemotherapy.

therapy. We're doing stuff with many other people as well as ourselves with ADCs. There are RAS programs that are advancing. So we think that

We're doing stuff with many other people as well as ourselves with Adcs are Ras programs are advancing so we think that that sort of combination there is.

combination, there's large precedence throughout our portfolio already, and there will continue to be. And that's also true with Dima and Lampard.

Two large precedent throughout our portfolio already.

Operator: And that's also true with lymphedema and lymphoma. The specific question I think you're driving to is combinations of IO with IO agents and LAG-3, CTLA-4, and TIGIT. So at least in our minds, we do recognize that there was demonstration of LAG-3 adding to PD-1 in melanoma. And I think that's an important signal for us. Where we focus our efforts with LAG-3 is in MSS-CRC. So we know that PD-1s work in MSI high, and no one's really been able to crack MSS-CRC, so that's very important. And also in classic Hodgkin's. I would say in relationship to CTLA-4, there was recent data with HDC. I would make a comment that I think would make some of the people from Merck smile a little bit. We were the ones who actually did the study with PD-1 and CTLA-4 in relationship to lung.

And that's also true with lymphedema and lymphoma. The specific question I think you're driving to is combinations of IO with IO agents and LAG-3, CTLA-4, and TIGIT. So at least in our minds, we do recognize that there was demonstration of LAG-3 adding to PD-1 in melanoma. And I think that's an important signal for us. Where we focus our efforts with LAG-3 is in MSS-CRC. So we know that PD-1s work in MSI high, and no one's really been able to crack MSS-CRC, so that's very important. And also in classic Hodgkin's. I would say in relationship to CTLA-4, there was recent data with HDC. I would make a comment that I think would make some of the people from Merck smile a little bit. We were the ones who actually did the study with PD-1 and CTLA-4 in relationship to lung.

And they will continue to be and that's also true with lymphedema inland Plaza. The specific question I think youre driving to is combinations of Io with I O agents, Yeah, and lastly, <unk> foreign antigen. So at least in our minds, we do recognize that there.

The specific question I think you're driving to is combinations of IO with IO agents, and LAC-3, CTLA-4, and PIDGEN.

So, at least in our mind, we do recognize that, you know, there was demonstration of LAD3 adding to PD-1 in melanoma. And I think that's an important signal for us where we focused our efforts with LAD3.

Demonstration of last three adding for PD, one in melanoma, and I think thats, an important signal for us where we've focused our efforts with lag three is in MSS CRC. So we know that PD ones work in MSI high and no one's really been able to crack MFS.

is in MFS-CRC. So we know that PD-1s work in MSI-HI, and no one's really been able to crack MFS-CRC, so that's very important, and also in classic Hodgkin's. I would say in relationship to CCLA-4, there was recent data with HCC.

So that's very important and also in classic Hodgkin's I would say in relationships with <unk>. Four there was recent data with HCC I would make a comment that I think would make some of the people from Merck smile a little bit.

I would make a comment that I think would make some of the people from Merck smile a little bit. You know, we were the ones who actually did the study with PD-1 and CKLA-4 in relationship to lung.

We were the ones, who actually did the study with PD, one and <unk> four in relationship to lung and we could not show a clear contribution of component of CCI for over PD. One so that is not a place that we think is an important place for patients and that is not a place that we're going because we have.

Operator: We could not show a clear contribution of component of CTLA-4 over PD-1. So that is not a place that we think is an important place for patients, and that is not a place that we're going because we did the study to demonstrate that. Where we think there could be is clearly other people have recently released ADC. We're focused in, for example, in renal cell carcinoma. And in PD-1 and TIGIT, our initial focus is in non-small cell lung cancer and also small cell lung cancer. And we're advancing a series of trials in that. So I hope that gave a comprehensive view of LAG-3, CTLA-4, and TIGIT in relationship to ILT4, other checkpoint inhibitors such as CD27, or in relationship to cytokines.

We could not show a clear contribution of component of CTLA-4 over PD-1. So that is not a place that we think is an important place for patients, and that is not a place that we're going because we did the study to demonstrate that. Where we think there could be is clearly other people have recently released ADC. We're focused in, for example, in renal cell carcinoma. And in PD-1 and TIGIT, our initial focus is in non-small cell lung cancer and also small cell lung cancer. And we're advancing a series of trials in that. So I hope that gave a comprehensive view of LAG-3, CTLA-4, and TIGIT in relationship to ILT4, other checkpoint inhibitors such as CD27, or in relationship to cytokines.

And we could not show a clear contribution of component for CCLA-4 over P.

So that is not a place that we think is an important place for patients and that is not a place that we're going because we have, we did the study to demonstrate that. Where we think there could be is clearly other people have recently released HDC, we're focused in, for example, in renal cell carcinoma and then PD-1 and Digit, our initial focus is in non-small cell lung cancer and also small cell lung cancer and we're advancing.

We did this study to demonstrate that where we think there could be as clearly other people have recently released HTC. We're focused in for example in renal cell carcinoma, and then PD one and visit our initial focus is in non small cell lung cancer and also small cell lung cancer and we're advancing.

series of trials in that. So I hope that gave a comprehensive view of LAB3, CTLA-4, and TIGIT in relationship to IL-T4, other checkpoint inhibitors such as CD27, or in relationship to cytokines. I think the data that we're doing in earlier stages will have to play out for us to be able to answer that more clearly.

A series of trials in that so I hope that gave a comprehensive view of lab III E. Tailing four antigen in relationship to Iot for other checkpoint inhibitors, such as <unk> 'twenty seven or in relationship to cytokines I think the data that we're doing in earlier stages will have to play out for us to be able to add.

Operator: I think the data that we're doing in earlier stages will have to play out for us to be able to answer that more completely. Great. Thank you, Mara. I think we have time for one more question, then Rob will have a few closing comments. Thank you. Your last question comes from the line of Colin Bristow from UBS. Your line is open. Hey, good morning. Congrats on the quarter. And also wanted to say all the best to Roy. It's been really great working with you. And also congrats to Eliav. So I just wanted to piggyback on a Gardasil question. Could you maybe just give us a little more detail on how you expect the Gardasil supply to increase? And then maybe just help us think through what is the supply-demand mismatch right now?

I think the data that we're doing in earlier stages will have to play out for us to be able to answer that more completely.

Peter Dannenbaum: Great. Thank you, Mara. I think we have time for one more question, then Rob will have a few closing comments.

Answer that more completely.

Great. Thank you, Mara. I think we have time for one more question and Rob will have a few closing comments.

Great. Thank you Mary I think we have time for one more question and Rob will have a few closing comments.

Operator: Thank you. Your last question comes from the line of Colin Bristow from UBS. Your line is open.

I think your last question comes from the line of Colin Brestow from UBS, your line is open.

Thank you. Your last question comes from the line of Colin Bristow from UBS. Your line is open.

Colin Bristow: Hey, good morning. Congrats on the quarter. And also wanted to say all the best to Roy. It's been really great working with you. And also congrats to Eliav. So I just wanted to piggyback on a Gardasil question. Could you maybe just give us a little more detail on how you expect the Gardasil supply to increase? And then maybe just help us think through what is the supply-demand mismatch right now?

Hey, good morning. Congrats on the quarter and also wanted to say all the best to Roy. It's been really great working with you and also congrats to Elliot. So I just wanted to piggyback on a Gardasil question.

Hey, good morning, Congrats on the quarter and also wanted to say all the best ROI. It didn't really great working with you and also congrats to Elliot. So I just wanted to piggyback on <unk> question could you, maybe just give us a little more detail on how you expect that.

Could you maybe just give us a little more detail on how you expect the Gardasil supply to increase, and then maybe just help us think through what is the supply-demand mismatch right now? Some of your prior comments suggested that there may not be such, but I know you said supply has been a...

Got it to a supply increase.

And then maybe just help us think through what is the supply demand mismatch right. Now you know some of your prior comments suggested that.

Operator: Some of your prior comments suggested that there may not be such, but I know you said supply has been an issue over the past sort of couple of years. So we'd love to get some expanded thoughts there. Thanks. Thank you for the question. This is Caroline. So let me start first with the supply-demand. There is significant demand for Gardasil. This cancer-preventing vaccine in the HPV area has only reached today 9% of the global eligible population. So there is significant runway ahead of us to protect lives and to drive growth for Merck. Indeed, we've stated that we expect the revenue in the year 2030 to be double the $5.7 billion we achieved in 2021. So we have significant opportunity ahead of us. In order to achieve that opportunity, we are building new facilities that will be coming online from 2023, 2024, and 2025.

Some of your prior comments suggested that there may not be such, but I know you said supply has been an issue over the past sort of couple of years. So we'd love to get some expanded thoughts there. Thanks.

May not be such but I know you said supply has been.

an issue over the past sort of couple of years. So we'd love to get some expanded thoughts there. Thanks. Thank you.

Initiatives over the past couple of years, so we'd love to get some expanded thoughts there. Thanks.

Caroline Litchfield: Thank you for the question. This is Caroline. So let me start first with the supply-demand. There is significant demand for Gardasil. This cancer-preventing vaccine in the HPV area has only reached today 9% of the global eligible population. So there is significant runway ahead of us to protect lives and to drive growth for Merck. Indeed, we've stated that we expect the revenue in the year 2030 to be double the $5.7 billion we achieved in 2021. So we have significant opportunity ahead of us. In order to achieve that opportunity, we are building new facilities that will be coming online from 2023, 2024, and 2025.

Thank you for the question Nick as Caroline.

So let me start first with the supply demand. There is significant demand for Gardasil. This.

We start first with the supply demand there is significant demand for Gardasil. This Ken the presenting vaccine and the HPV area has only reached today, 9% of the global eligible population. So there is significant runway ahead of us to protect.

The cancer-preventing vaccine in the HPV area has only reached today 9% of the global eligible population. So there is significant runway ahead of us to protect lives and to drive growth for Merck. Indeed, we've stated that we expect the revenue in the year 2030 to be double the $5.7 billion we achieved.

Life and to drive growth for Mac. Indeed, we stated that we expect the revenue in the year 2020 to be double the $5 7 billion. We achieved in 2021. So we have significant opportunity ahead of us in order to achieve that opportunity we are building new.

So we have significant opportunity ahead of us.

In order to achieve that opportunity, we are building new facilities that will be coming online from 2023, 4 and 5. So we're going to have a step up in the level of supply to the market that will happen over that period.

Facilities that will be coming online from 'twenty to 'twenty three four and five so we are going to have a step up in the level of supply to the market that will happen over that period specific to this year, we will see a continuation of the supply into the market as weak.

Operator: So we're going to have a step up in the level of supply to the market that will happen over that period. Specific then to this year, we will see a continuation of the supply into the market as we did in 2021, albeit not quite at the same step up that we achieved in 2021. So we remain really confident in our ability to drive strong growth for Gardasil both in 2022 and the years to come. Great. Thank you, Colin. Rob? Well, just let me say thank you for your time and your interest today. And I'd just like to conclude by, again, thanking the Merck team globally for their focus and commitment, and really in driving the results you've heard about today, but in continuing to ensure we keep the purpose of the company front and center, which is to deliver for patients.

So we're going to have a step up in the level of supply to the market that will happen over that period. Specific then to this year, we will see a continuation of the supply into the market as we did in 2021, albeit not quite at the same step up that we achieved in 2021. So we remain really confident in our ability to drive strong growth for Gardasil both in 2022 and the years to come.

Specific then to this year, we will see a continuation of the supply into the market as we did in 2021, albeit not quite at the same step up that we achieved in 2021.

In 2021, albeit not quite at the same desktop that we achieved in 2021. So we remain really confident in our ability to drive strong growth regardless. So both in 2022 and are yet to come.

So we remain really confident in our ability to drive strong growth for Gardasil both in 2022 and the years to come.

Peter Dannenbaum: Great. Thank you, Colin. Rob?

Great. Thank you Rob.

Robert Davis: Well, just let me say thank you for your time and your interest today. And I'd just like to conclude by, again, thanking the Merck team globally for their focus and commitment, and really in driving the results you've heard about today, but in continuing to ensure we keep the purpose of the company front and center, which is to deliver for patients.

Well, just let me say thank you for your time and your interest today, and I'd just like to conclude by, again, thanking the Merck team globally for their focus and commitment, and really in driving the results you've heard about today, but in continuing to ensure we keep the purpose of the company front and center, which is to deliver for patients.

Just wanted to say thank you for your time and your interest today and I just wanted to conclude by again thanking the Merck team globally for their focus and commitment.

And driving the results you've heard about today, but continuing to ensure we keep the purpose of the company front center, which is to deliver for patients.

Operator: Hopefully, you get the sense. We are very confident in the business momentum we have. I'd like to say as well, we are feeling better and better about the evolution of our pipeline. I think you've heard today, we're starting to expand. We're doing all of the things we need to do. We have more to do, but we're making great progress. That's why I have such confidence in the sustainability of our business long-term. We look forward to continuing to share these results with you to deliver for the patients that count on us and, in turn, bring value to the shareholders. With that, I'd say thank you and have a great day.

Hopefully, you get the sense. We are very confident in the business momentum we have. I'd like to say as well, we are feeling better and better about the evolution of our pipeline. I think you've heard today, we're starting to expand. We're doing all of the things we need to do. We have more to do, but we're making great progress. That's why I have such confidence in the sustainability of our business long-term. We look forward to continuing to share these results with you to deliver for the patients that count on us and, in turn, bring value to the shareholders. With that, I'd say thank you and have a great day.

Hopefully, you get the sense we are very confident in the business momentum we have. And I'd like to say as well, we are feeling better and better about the evolution of our pipeline. And I think you've heard today, we're starting to expand, we're doing all of the things we need to do. We have more to do, but we're making great progress. And that's why I have such confidence in the sustainability of our business long term. So we look forward.

You get the sense, we are very confident in the business momentum, we have and I'd like to say as well, we're feeling better and better about the evolution of our pipeline and you've heard today, we're starting to expand we're doing all of the things we need to do we have more to do but we're making great progress and that's why I have such confidence confidence in the.

The inability of our business long term. So we look forward to continuing to share. These results with you to deliver for the patients that count on us and in turn bring value to the shareholders. So with that I'd say, thank you and have a great day.

to continue to share these results with you to deliver for the patients that count on us and in turn bring value to the shareholders. So with that, I'd say thank you and have a great day.

Yeah.

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