Q1 2024 Merck & Co Inc Earnings Call

April 25, 2024

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Speaker Change: Thank you for standing by welcome to the American Company Q1 sales and earnings Conference call. At this time all participants are in a listen only mode until the question and answer session of today's conference at that time to ask a question press Star one on your phone and record your name at the prompt.

Operator: Thank you for standing by. Welcome to the Merck & Co. Q1 Sales & Earnings conference call. At this time, all participants are in a listen-only mode until the question-and-answer session of today's conference. At that time, to ask a question, press star one on your phone and record your name at the prompt. This call is being recorded.

Operator: This call is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President of Investor Relations. Sir, you may begin.

Speaker Change: Call is being recorded if you have any objections you may disconnect at this time.

Operator: If you have any objections, you may disconnect at this time. I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President of Investor Relations. Sir, you may begin. Thank you, Shirley, and good morning everyone.

If you have any objections, you may disconnect at this time. I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President of Investor Relations. Sir, you may begin.

I would now like turn the call over to Mr. Peter Tannenbaum, Senior Vice President Investor Relations, Sir you may begin.

Peter Dannenbaum: Thank you, Shirley, and good morning everyone. Welcome to Merck's first quarter 2024 conference call. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Lee, President of Merck Research Labs.

Peter Tannenbaum: Thank you Shirley and good morning, everyone welcome to Merck's first quarter 2024 conference call.

Peter Dannenbaum: Welcome to Merck's first quarter 2024 conference call. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Lee, President of Merck Research Labs. Before we get started, I'd like to point out a few items. You will see that we have items in our GAAP results such as acquisition-related charges, restructuring costs, and certain other items. You should note that we have excluded these from our non-GAAP results and provided a reconciliation in our press release.

Welcome to Merck's first quarter 2024 conference call. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Lee, President of Merck Research Labs.

Peter Tannenbaum: On today's call will be Rob Davis, Chairman, and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Routinely President of Merck Research Labs.

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

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

Peter Dannenbaum: I would like to remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Peter Tannenbaum: I would like to remind you that some of the statements that we make today may be considered forward looking statements within the meaning of the safe Harbor provision of the U S. Private Securities Litigation Reform Act of 1995, such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties, if our underlying assumptions prove inaccurate or uncertainties materialize actual results may differ.

Peter Tannenbaum: Materially from those set forth in the forward looking statements, our SEC filings, including item one a on the 20th twenty-three 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.

Peter Dannenbaum: Our SEC filings, including item 1A and the 2023 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.

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

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

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

Robert M. Davis: Thanks, Peter. Good morning, and thank you for joining today's call. We've begun 2024 with continuing momentum in our business. We're harnessing the power of innovation to advance our deep pipeline and are maximizing the impact of our broad commercial portfolio for the benefit of patients. We drove strong growth across key therapeutic areas, executed strategic business development, and are now launching a significant new product in the cardiometabolic space, while also preparing for the potential approval and launch of two additional important candidates in vaccines and oncology. We have significant opportunities ahead of us across all areas of our business, and we're highly focused on reliability.

Rob Davis: We've begun 2024 with continuing momentum in our business. We're harnessing the power of innovation to advance our deep pipeline and are maximizing the impact of a broad commercial portfolio for the benefit of patients with <unk>.

Robert M. Davis: We drove strong growth across key therapeutic areas, executed strategic business development, and are now launching a significant new product in the cardiometabolic space, while also preparing for the potential approval and launch of two additional important candidates in vaccines and oncology. We have significant opportunities ahead of us across all areas of our business, and we're highly focused on reliability.

Rob Davis: Strong growth across key therapeutic areas executing strategic business development and are now launching a significant new product in the cardio metabolic space. While also preparing for the potential approval and launch of two additional important candidates and vaccines and oncology.

Rob Davis: We have significant opportunities ahead of us across all areas of our business and we're highly focused on realizing them.

Rob Davis: I continue to be inspired by the dedication of our talented global team, which is working tirelessly to bring differentiated medicines and vaccines to patients through seamless scientific, commercial, and operational expansion. In March, we received FDA approval for WINREVAIR, a first-in-class treatment for adults with pulmonary arterial hypertension, a rare progressive and ultimately life-threatening condition. This marks the achievement of a significant milestone for our company, it exemplifies the value of our strategic priorities, and demonstrates how our enduring commitment to our purpose is resulting in tangible benefits for patients. Just over two years since adding WINREVAIR to our pipeline,

I continue to be inspired by the dedication of our talented global team, which is working tirelessly to bring differentiated medicines and vaccines to patients through seamless scientific, commercial, and operational expansion. In March, we received FDA approval for WINREVAIR, a first-in-class treatment for adults with pulmonary arterial hypertension, a rare progressive and ultimately life-threatening condition. This marks the achievement of a significant milestone for our company, it exemplifies the value of our strategic priorities, and demonstrates how our enduring commitment to our purpose is resulting in tangible benefits for patients.

Rob Davis: You need to be inspired by the dedication of our talented global team, which is working tirelessly to bring differentiated medicines and vaccines to patients through seamless scientific commercial and operational execution.

Rob Davis: In March we received FDA approval for wind or there are first in class treatment for adults with pulmonary arterial hypertension, a rare progressive and ultimately life threatening disease.

Rob Davis: This marks the achievement of a significant milestone for our company. It exemplifies the value of our strategic priorities and demonstrates how our enduring commitment to our purpose is resulting in tangible benefits for patients.

Just over two years since adding WINREVAIR to our pipeline, our attention now turns to the execution of a strong commercial launch, where we have already seen prescriptions being written. We see a tremendous opportunity to positively impact the lives of people living with PAH. And furthermore, the importance of this therapy to patients provides us with increased confidence and our ability to deliver sustainable long-term value for our shareholders.

Rob Davis: Just over two years since adding a winter of air to our pipeline.

Rob Davis: our attention now turns to the execution of a strong commercial launch, where we have already seen prescriptions being written. We see a tremendous opportunity to positively impact the lives of people living with PAH. And furthermore, the importance of this therapy to patients provides us with increased confidence and our ability to deliver sustainable long-term value for our shareholders. Strategic business development focused on the best external science remains an important priority for our company.

our attention now turns to the execution of a strong commercial launch, where we have already seen prescriptions being written. We see a tremendous opportunity to positively impact the lives of people living with PAH. And furthermore, the importance of this therapy to patients provides us with increased confidence and our ability to deliver sustainable long-term value for our shareholders.

Rob Davis: Our attention now turns to the execution of a strong commercial launch where we have already seen prescriptions being written.

Rob Davis: We see a tremendous opportunity to positively impact the lives of people living with P. A H and further the importance of this therapy to patients provides us with increased confidence in our ability to deliver sustainable long term value for our shareholders.

Rob Davis: Strategic business development focused on the best external science remains an important priority for our company.

Strategic business development focused on the best external science remains an important priority for our company. We've demonstrated that we can leverage our deep discovery prowess to identify important acquisition targets and then add significant value through our powerful clinical research engine, our regulatory expertise, and our commercial scale, which together can serve to accelerate development and enable broad global access to important medical discoveries for patients in need.

Rob Davis: We've demonstrated that we can leverage our deep discovery prowess to identify important acquisition targets and then add significant value through our powerful clinical research engine, our regulatory expertise, and our commercial scale, which together can serve to accelerate development and enable broad global access to important medical discoveries for patients in need. Turning to our first quarter results,

We've demonstrated that we can leverage our deep discovery prowess to identify important acquisition targets and then add significant value through our powerful clinical research engine, our regulatory expertise, and our commercial scale, which together can serve to accelerate development and enable broad global access to important medical discoveries for patients in need.

Rob Davis: Our regulatory expertise and our commercial scale, which together conserve to accelerate development and enable broad global access to important medical discoveries for patients in need.

Turning to our first quarter results, We achieved strong growth, reflecting robust demand for an innovative portfolio. We're pleased to reflect this momentum in our updated full-year guidance, which Caroline will speak about in a moment.

Rob Davis: Turning to our first quarter results, we achieved strong growth, reflecting robust demand for our innovative portfolio.

Rob Davis: We achieved strong growth, reflecting robust demand for an innovative portfolio. We're pleased to reflect this momentum in our updated full-year guidance, which Caroline will speak about in a moment. Turning to our broader research efforts, we're focused on advancing our expansive and diverse pipeline of leading-edge programs for the benefit of patients. In vaccines, we continue to pioneer new approaches to optimize disease prevention. In HPV, we're building on the foundation set by Gardasil-9 to further reduce the global burden of certain HPV related cancers and disease by potentially providing broader protection with a new multivalent HPV vaccine. And by generating data to clearly demonstrate whether or not a single dose of Gardasil-9 provides comparable long-term protection to the approved three-dose regimen in males and females ages 16 to 26.

We achieved strong growth, reflecting robust demand for an innovative portfolio. We're pleased to reflect this momentum in our updated full-year guidance, which Caroline will speak about in a moment.

Rob Davis: We're pleased to reflect this momentum in our updated full year guidance, which Caroline will speak to in a moment.

Rob Davis: Turning to our broader research efforts were focused on advancing our expansive and diverse pipeline of leading edge programs for the benefit of patients.

Turning to our broader research efforts, we're focused on advancing our expansive and diverse pipeline of leading-edge programs for the benefit of patients. In vaccines, we continue to pioneer new approaches to optimize disease prevention. In HPV, we're building on the foundation set by Gardasil-9 to further reduce the global burden of certain HPV related cancers and disease by potentially providing broader protection with a new multivalent HPV vaccine. And by generating data to clearly demonstrate whether or not a single dose of Gardasil-9 provides comparable long-term protection to the approved three-dose regimen in males and females ages 16 to 26.

Rob Davis: In vaccines, we continue to pioneer new approaches to optimize disease prevention and HPV. We're building on the foundations set by Gardasil to further reduce the global burden of certain HPV related cancers and diseases by potentially providing broader protection with a new multi valent HPV vaccine.

In HPV, we're building on the foundation set by Gardasil-9 to further reduce the global burden of certain HPV related cancers and disease by potentially providing broader protection with a new multivalent HPV vaccine. And by generating data to clearly demonstrate whether or not a single dose of Gardasil-9 provides comparable long-term protection to the approved three-dose regimen in males and females ages 16 to 26.

Rob Davis: And by generating data to clearly demonstrate whether or not a single dose of Gardasil nine provides comparable comparable long term protection to the approved three dose regimen and males and females, aged 16 to 26.

Rob Davis: In pneumococcal, we presented additional compelling data for V116, a vaccine that is specifically designed to help protect against the majority of invasive pneumococcal disease in adults ages 65 and older, and look forward to its potential approval in June. Each of these programs is a platform where we can provide meaningful protection to broad populations on a global scale. In HIV in partnership with Gilead, we shared promising data from our revitalized program for a once-weekly combination of IZLOTRIVIR and LENACAPIVIR in the treatment setting.

Rob Davis: And pneumococcal, we presented additional compelling data for V 116, a vaccine that is specifically designed to help protect against the majority of invasive pneumococcal disease in adults, aged 65 and older and look forward to its potential approval in June.

Rob Davis: Each of these programs or platforms, where we can provide meaningful protection the broad populations on a global scale.

Rob Davis: In HIV and partnership with Gilead.

Rob Davis: We shared promising data from our revitalized program for a once weekly combination of <unk> Atlanta cap of year and the treatment settings.

Rob Davis: We're actively progressing our comprehensive clinical program, which is focused on both treatment and prevention strategies to meet the evolving needs of the HIV community. And in oncology, we have initiated several late-stage programs of novel candidates from our diverse pipeline as we work to expand our impact for patients and reinforce our leadership position over the long term. Finally, across our deep pipeline, we have significant clinical momentum in a range of therapeutic areas. Cutting-edge science is at the core of who we are, and I'm confident that Merck is well-positioned to deliver the next wave of important innovations and value to patients, shareholders, and all of our stakeholders.

We're actively progressing our comprehensive clinical program, which is focused on both treatment and prevention strategies to meet the evolving needs of the HIV community. And in oncology, we have initiated several late-stage programs of novel candidates from our diverse pipeline as we work to expand our impact for patients and reinforce our leadership position over the long term.

Rob Davis: We're actively progressing our comprehensive clinical program, which is focused on both treatment and prevention strategies to meet the evolving needs of the HIV community.

Rob Davis: And in oncology, we initiated several late stage programs of novel candidates from our diverse pipeline as we work to expand our impactful patients and reinforce our leadership position over the long term.

Finally, across our deep pipeline, we have significant clinical momentum in a range of therapeutic areas. Cutting-edge science is at the core of who we are, and I'm confident that Merck is well-positioned to deliver the next wave of important innovations and value to patients, shareholders, and all of our stakeholders.

Rob Davis: Finally across our deep pipeline, we have significant clinical momentum and a range of therapeutic areas.

Rob Davis: Cutting edge science is at the core of who we are and I'm confident that mark is well positioned to deliver the next wave of important innovations in value to patients shareholders and to all of our stakeholders.

Rob Davis: In summary, our science-led strategy is delivering compelling proof points that we are creating a sustainable innovation engine that, with continued clinical success, will lead to a more diversified portfolio of drug drivers over the next decade and beyond. I again want to recognize the enormous efforts across our global organization. My confidence is strong and growing that we are well positioned to build on this momentum and drive patient impact and value creation this year and well into the future. With that, I'll turn the call over to Caroline. Thank you, Rob. Good morning.

In summary, our science-led strategy is delivering compelling proof points that we are creating a sustainable innovation engine that, with continued clinical success, will lead to a more diversified portfolio of drug drivers over the next decade and beyond. I again want to recognize the enormous efforts across our global organization. My confidence is strong and growing that we are well positioned to build on this momentum and drive patient impact and value creation this year and well into the future. With that, I'll turn the call over to Caroline.

Rob Davis: In summary, our science led strategy is delivering compelling proof points that we are creating a sustainable innovation engine that with continued clinical success will lead to a more diversified portfolio of growth drivers over the next decade and beyond.

Rob Davis: I again want to recognize the enormous efforts across our global organization.

Rob Davis: Confidence is strong and growing that we are well positioned to build on this momentum and drive patient impact and value creation, this year and well into the future with that I'll turn the call over to Carolina.

Carolina: Thank you Rob Good morning, as Rob noted, we have had a strong start to the year with robust growth across our business, which reinforces the confidence we have in our outlook we.

Caroline Litchfield: Thank you, Rob. Good morning. As Rob noted, we have had a strong start to the year with robust growth across our business, which reinforces the confidence we have in our outlook. We are also making strategic investments to leverage leading-edge science to save and improve lives around the world, positioning us to continue to deliver long-term value for patients, customers, and shareholders.

Caroline Litchfield: As Rob noted, we have had a strong start to the year with robust growth across our business, which reinforces the confidence we have in our outlook. We are also making strategic investments to leverage leading-edge science to save and improve lives around the world, positioning us to continue to deliver long-term value for patients, customers, and shareholders. Now turning to our first quarter results, total company revenues were $15.8 billion, an increase of 9% or 12% excluding the impact of foreign exchange.

As Rob noted, we have had a strong start to the year with robust growth across our business, which reinforces the confidence we have in our outlook. We are also making strategic investments to leverage leading-edge science to save and improve lives around the world, positioning us to continue to deliver long-term value for patients, customers, and shareholders.

Carolina: We are also making strategic investments to leverage leading edge science to save and improve lives around the world positioning us to continue to deliver long term value for patients customers and shareholders now.

Rob Davis: Now turning to our first quarter results.

Now turning to our first quarter results, total company revenues were $15.8 billion, an increase of 9% or 12% excluding the impact of foreign exchange. The impact from exchange is primarily driven by the devaluation of the Argentine peso, which was largely offset by inflation-related price increases, consistent with market practice. The following revenue comments will be on an ex-exchange basis. Our human health business continues its momentum with double-digit growth of 13%, driven by oncology and vaccines. Sales in our animal health business increased 4% across both companion animal and livestock products.

Carolina: Total company revenues were $15 $8 billion, an increase of 9% or 12%, excluding the impact of foreign exchange.

Caroline Litchfield: The impact from exchange is primarily driven by the devaluation of the Argentine peso, which was largely offset by inflation-related price increases, consistent with market practice. The following revenue comments will be on an ex-exchange basis. Our human health business continues its momentum with double-digit growth of 13%, driven by oncology and vaccines. Sales in our animal health business increased 4% across both companion animal and livestock products. Turning to the performance of our key brands, in oncology, sales of Keytruda grew 24% to $6.9 billion, driven by increased uptake from earlier stage cancers and continued strong demand for metastatic indications. In the US, Keytruda grew across a broad range of tumors.

The impact from exchange is primarily driven by the devaluation of the Argentine peso, which was largely offset by inflation-related price increases, consistent with market practice. The following revenue comments will be on an ex-exchange basis. Our human health business continues its momentum with double-digit growth of 13%, driven by oncology and vaccines. Sales in our animal health business increased 4% across both companion animal and livestock products.

Carolina: The impact from exchange is primarily driven by the devaluation of the Argentine peso, which was largely offset by inflation related price increases consistent with market practice.

Carolina: The following revenue comments will be on an ex exchange basis.

Carolina: Our human health business continued its momentum with double digit growth of 13% driven by oncology and vaccines.

Carolina: Sales in our animal health business increased 4% across both companion animal and livestock products.

Carolina: Turning to the performance of our key brands.

Turning to the performance of our key brands, in oncology, sales of Keytruda grew 24% to $6.9 billion, driven by increased uptake from earlier stage cancers and continued strong demand for metastatic indications. In the US, Keytruda grew across a broad range of tumors.

Carolina: In oncology sales of Keytruda grew 24% to $6 $9 billion driven by increased uptake from early stage cancers.

Carolina: Strong demand for metastatic indications.

Carolina: In the U S keytruda across a broad range of Cumulus.

Caroline Litchfield: In earlier stage cancers, the increase was largely attributable to non-small cell lung cancer following the launches of Keynote 671 and Keynote 091. In the metastatic setting, we saw strong uptake from the recent launch of Keynote A39 in first-line advanced urethelial cancer. Outside the U.S., Keytruda growth was driven by continued uptake in earlier-stage cancers, including high-risk, early-stage, triple-negative breast cancer and renal cell carcinoma, as well as continued strong demand from patients with metastatic disease. Inflation-related price increases, consistent with market practice in Argentina, also contributed to growth.

In earlier stage cancers, the increase was largely attributable to non-small cell lung cancer following the launches of Keynote 671 and Keynote 091. In the metastatic setting, we saw strong uptake from the recent launch of Keynote A39 in first-line advanced urethelial cancer.

Carolina: In earlier stage cancers, the increase was largely attributable to non small cell lung cancer. Following the launches of keynote 671 and Kenai 091.

Carolina: In the metastatic setting we saw strong uptake from the recent launch of keynote <unk> 39 in first line advanced Urothelium cancer.

Carolina: Outside the U S. Keytruda growth was driven by continued uptake in earlier stage cancers, including high risk early stage triple negative breast cancer and renal cell carcinoma as well as continued strong demand from patients with metastatic disease.

Outside the U.S., Keytruda growth was driven by continued uptake in earlier-stage cancers, including high-risk, early-stage, triple-negative breast cancer and renal cell carcinoma, as well as continued strong demand from patients with metastatic disease. Inflation-related price increases, consistent with market practice in Argentina, also contributed to growth.

Carolina: Inflation related price increases consistent with market practice in Argentina also contributed to growth.

Caroline Litchfield: Alliance revenue from LIMPARZA and LIMVIMA grew 7% and 10%, respectively. [inaudible] sales more than doubled to $85 million, driven by the additional indication following FDA approval of LightSpark005 for certain patients with previously treated advanced renal cell carcinoma, as well as by increased uptake in certain VHL disease-associated tumors. Our vaccines portfolio delivered strong growth, led by Gardasil, which increased 17% to $2.2 billion, driven by global demand. Sales also benefitted from the timing of shipments in China and CDC purchasing patterns in the US.

Carolina: Alliance revenues from NIM, pasta, and Lindsay MA grew 7% and 10% respectively.

Carolina: <unk> sales more than doubled to $85 million driven by the additional indication following FDA approval of light Sparks 005, assessing patients with previously treated advanced renal cell carcinoma, as well as by increased uptake in Sutton CHL.

Carolina: These associated too much.

Carolina: Our vaccines portfolio delivered strong growth led by Gardasil, which increased 17% to $2 $2 billion driven by global demand.

Carolina: <unk> also benefited from the timing of shipments in China, and CDC purchasing patents in the U S.

Caroline Litchfield: [inaudible] sales grew to $219 million, driven by continuous uptake of the pediatric indication in the U.S. and ongoing launches in international markets, particularly in Europe. In the US, vaccine-advanced cells also benefited from [inaudible] purchasing patterns. Sales in our animal health business grew 4%. Livestock sales growth was driven by price action as well as demand for swine and poultry products. Companion animal growth reflects price action.

Carolina: But she advanced sales grew to $219 million driven by continued uptake of the pediatric indication in the U S and ongoing launches in international markets, particularly in Europe.

Carolina: In the U S. <unk> sales also benefited from CDC purchasing touch it.

Carolina: Sales in our animal health business grew 4%.

Carolina: <unk> sales growth was driven by price actions as well as demand for swine and poultry products.

Caroline Litchfield: Companion animal growth reflects price action. I will now walk you through the remainder of our P&L, and my comments will be on a non-GAP-basis. Gross margin was 81.2%, an increase of 4.3 percentage points, driven by reduced royalty rates for Keytruda and Gardasil, which went into effect at the beginning of this year, as well as favorable product mix. Operating expenses decreased 4% to $6.4 billion, a charge of $656 million related to the acquisition of Harpoon Therapeutics this quarter was lower than the $1.4 billion of charges a year ago for certain business development transactions. Excluding these charges, operating expenses grew 8%.

Companion animal growth reflects price action.

Carolina: Companion animal growth reflects price actions.

I will now walk you through the remainder of our P&L, and my comments will be on a non-GAP-basis. Gross margin was 81.2%, an increase of 4.3 percentage points, driven by reduced royalty rates for Keytruda and Gardasil, which went into effect at the beginning of this year, as well as favorable product mix. Operating expenses decreased 4% to $6.4 billion, a charge of $656 million related to the acquisition of Harpoon Therapeutics this quarter was lower than the $1.4 billion of charges a year ago for certain business development transactions. Excluding these charges, operating expenses grew 8%.

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

Carolina: Gross margin was 81, 2% an increase of four three percentage points driven by reduced royalty rates for Keytruda and got itself, which went into effect at the beginning of this year as well as favorable product mix.

Carolina: Operating expenses decreased 4% to $6 $4 billion.

Carolina: A charge of $656 million related to the acquisition of Harpoon Therapeutics. This quarter was lower than the one 4 billion of charges a year ago assessing business development transactions.

Carolina: Excluding these charges operating expenses grew 8%.

Caroline Litchfield: We remain committed to investing appropriately to realize the promise of our expansive early and late phase pipeline and support the promotion of our key growth drivers. Other expense was $87 million. Our tax rate was 16.1%, including the impact from the Harpoon transaction for which no tax benefit was recorded. Taken together, earnings per share were $2.07, which includes a 26 cent negative impact from the charge related to Harpoon.

Carolina: We remain committed to investing appropriately to realize the promise of our expansive early and late phase pipeline and.

Carolina: And support the promotion of our key growth drivers.

Carolina: Other expense was $87 million.

Carolina: Our tax rate was 16, 1%, including the impact from the Hopkins transaction for which no tax benefit was recorded.

Carolina: Taken together earnings per share with $2, seven which includes a 26% negative impact from the charge related to harpoon.

Carolina: Now turning to our 2024 non-GAAP guidance.

Caroline Litchfield: Now turning to our 2024 non-GAAP guidance, the operational strength of our business has enabled us to raise and narrow our full-year revenue guidance. We now expect revenue to be between $63.1 and $64.3 billion, reflecting strong year-over-year revenue growth of 5% to 7%, including the negative impact from foreign exchange. At the midpoint of this range, operational strength in our business of approximately $600 million, is partially offset by an incremental headwind from foreign exchange of approximately $400 million using mid-April rates, resulting in a full year negative impact from foreign sources of approximately 3%.

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

Carolina: We now expect revenues to be between $63, one and $64 $3 billion.

Carolina: Collecting strong year over year revenue growth of 5% to 7%, including the negative impact from foreign exchange.

Carolina: At the midpoint of this range operational strength in that business of approximately $600 million is partially offset by an incremental headwind from foreign exchange of approximately $400 million using mid April rates, resulting in a full year negative impact from foreign.

Caroline Litchfield: Our gross margin assumption is now expected to be approximately 81%. Our estimated range of operating expenses is between $25.2 and $26.1 billion, which does not assume additional significant potential business development transactions. Other expense is expected to be approximately $250 million. Our full year tax rate is unchanged between 14.5% and 15.5%. We assume approximately 2.55 billion shares outstanding.

Carolina: Exchange of approximately 3%.

Carolina: Our gross margin assumption is now expected to be approximately 81%.

Caroline Litchfield: Our estimated range of operating expenses is between 25 to $26 $1 billion, which does not assume additional significant potential business development transactions.

Carolina: Other expense is expected to be approximately $200 million.

Caroline Litchfield: Our full year tax rate is unchanged between 14, five and 15, 5%.

Caroline Litchfield: 14.5% and 15.5%. We assume approximately 2.55 billion shares outstanding. Taken together, we are increasing and narrowing our expected EPS range to $8.53 to $8.65. This is a 7 cent increase at the midpoint, despite an incremental headwind from foreign exchange of approximately 5 cents using mid-April rates, resulting in a full year negative impact from foreign exchange of more than $0.30.

14.5% and 15.5%. We assume approximately 2.55 billion shares outstanding.

Carolina: We assume approximately 2.55 billion shares outstanding.

Taken together, we are increasing and narrowing our expected EPS range to $8.53 to $8.65. This is a 7 cent increase at the midpoint, despite an incremental headwind from foreign exchange of approximately 5 cents using mid-April rates, resulting in a full year negative impact from foreign exchange of more than $0.30.

Carolina: Taken together, we are increasing and narrowing our expected EPS range to $8.53 to $8 65. This is a 7% increase at the midpoint, despite an incremental headwind from foreign exchange of approximately five cents.

Caroline Litchfield: Using mid April rates, resulting in a full year negative impact from foreign exchange of more than 30 cents.

Caroline Litchfield: As you consider your models there are a few items to keep in mind.

Caroline Litchfield: As you consider your models, there are a few items to keep in mind. The increase in our sales guidance is driven by the strong performance across our current product portfolio, led by Keytruda, which continues to experience growth from additional indications and patient demand. For Gardasil, second quarter ex-US growth will be adversely impacted by shipment timing to China. This year, we expect more evenly distributed quarterly shipments to China.

As you consider your models, there are a few items to keep in mind. The increase in our sales guidance is driven by the strong performance across our current product portfolio, led by Keytruda, which continues to experience growth from additional indications and patient demand.

Caroline Litchfield: The increase in our sales guidance is driven by the strong performance across our current product portfolio led by Keytruda, which continues to experience growth from additional indications and patient demand.

Caroline Litchfield: With Gardasil second quarter ex U S growth will be adversely impacted by shipment timing to China.

For Gardasil, second quarter ex-US growth will be adversely impacted by shipment timing to China. This year, we expect more evenly distributed quarterly shipments to China.

Caroline Litchfield: This year, we expect more evenly distributed quarterly shipments to China.

Caroline Litchfield: Recall, in 2023, we accelerated shipments from the second half to the first half of the year, which primarily impacted the second quarter. Over the near and long term, we remain confident in our ability to protect many more people from HPV-related cancers and drive growth for Gardasil. Sales of Loguevrio in the first quarter were driven by an extended wave of COVID-19 in Asia-Pacific markets. Loguevrio continues to be an important treatment option for certain patients with COVID-19 so we continue to anticipate full-year sales to be lower than last year.

Recall, in 2023, we accelerated shipments from the second half to the first half of the year, which primarily impacted the second quarter. Over the near and long term, we remain confident in our ability to protect many more people from HPV-related cancers and drive growth for Gardasil.

Caroline Litchfield: Recall in 2023, we accelerated shipments from the second half to the first half of the year, which primarily impacted the second quarter.

Caroline Litchfield: Over the near and long term, we remain confident in our ability to protect many more people from HPV related cancers and drive growth of golf sale.

Sales of Loguevrio in the first quarter were driven by an extended wave of COVID-19 in Asia-Pacific markets. Loguevrio continues to be an important treatment option for certain patients with COVID-19 so we continue to anticipate full-year sales to be lower than last year.

Caroline Litchfield: So let's look at free out in the first quarter was driven by an extended waves of COVID-19 in Asia Pacific markets.

Caroline Litchfield: <unk> continues to be an important treatment option for certain patients with COVID-19, but we continue to anticipate full year sales to be lower than last year.

Caroline Litchfield: We are excited to provide a novel treatment option for adult patients with pulmonary arterial hypertension.

Caroline Litchfield: We are excited to provide a novel treatment option for adult patients with pulmonary arterial hypertension. Following the recent FDA approval of WINREVAIR, we are seeing high interest from patient groups and a range of relevant prescribers. We are also making good progress in enabling access. Several payers have already established coverage policies consistent with the label and Stellar Study Criteria, while others are in the process of developing their policies. As we go forward, we intend to provide an appropriate level of transparency to enable insight into the impact we are having on patients, including prescription data and revenue.

Caroline Litchfield: The recent FDA approval of wind River.

Caroline Litchfield: We are seeing high interest from patient groups and a range of relevant prescribe. This we are also making good progress in enabling access.

Caroline Litchfield: Several payers have already established coverage policies consistent with the label and Stella study criteria.

Caroline Litchfield: Others are in the process of developing that policies.

Caroline Litchfield: As we go forward, we intend to provide an appropriate level of transparency to enable insight into the impact we are having on patients, including prescription data and revenue. In summary, we are confident in a successful launch of WINREVAIR, consistent with our prior expectations, and look forward to providing updates on our program. Now turning to capital allocation, where our strategy remains unchanged, we will prioritize investments in our business to drive near and long-term growth.

As we go forward, we intend to provide an appropriate level of transparency to enable insight into the impact we are having on patients, including prescription data and revenue. In summary, we are confident in a successful launch of WINREVAIR, consistent with our prior expectations, and look forward to providing updates on our program.

As we go forward, we intend to provide an appropriate level of transparency to enable insight into the impact we are having on patients, including prescription data and revenue.

Caroline Litchfield: As we go forward, we intend to provide an appropriate level of transparency to enable insight into the impact we are having on patients including prescription data in revenues.

Caroline Litchfield: In summary, we are confident in a successful launch of women with that consistent with our prior expectations and look forward to providing updates on our progress.

In summary, we are confident in a successful launch of WINREVAIR, consistent with our prior expectations, and look forward to providing updates on our program.

Caroline Litchfield: Now turning to capital allocation, where our strategy remains unchanged.

Now turning to capital allocation, where our strategy remains unchanged, we will prioritize investments in our business to drive near and long-term growth. We will continue to invest in our innovative pipeline, including the initiation of many new late-stage clinical trials across multiple novel candidates, each of which has the potential to meaningfully address important unmet medical needs. We remain committed to our dividend and plan to increase it over time. Adding compelling science to our pipeline through business development remains a high priority. We maintain ample capacity given our strong investment-grade credit rating and cash flow to pursue additional, science-driven, value-enhancing transactions. We will continue to execute a modest level of share repurchases.

Caroline Litchfield: We will prioritize investments in our business to drive near and long term growth.

Caroline Litchfield: We will continue to invest in our innovative pipeline, including the initiation of many new late-stage clinical trials across multiple novel candidates, each of which has the potential to meaningfully address important unmet medical needs. We remain committed to our dividend and plan to increase it over time. Adding compelling science to our pipeline through business development remains a high priority. We maintain ample capacity given our strong investment-grade credit rating and cash flow to pursue additional, science-driven, value-enhancing transactions. We will continue to execute a modest level of share repurchases.

Caroline Litchfield: We will continue to invest in our innovative pipeline, including the initiation of many new late stage clinical trials across multiple novel candidates each of which has the potential to meaningfully address important unmet medical needs.

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

Caroline Litchfield: I think compelling science to our pipeline through business development remains a high priority.

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

Caroline Litchfield: We will continue to execute a modest level of share repurchases.

Caroline Litchfield: To conclude, we remain confident in the near and long-term outlook of our business, driven by the global demand for our innovative medicines and vaccines, as well as our exceptional pipeline. Our unwavering commitment to use the power of cutting-edge science to improve the lives of the patients we serve has put us in a position of financial and operational strength. Our excellent execution and continued investment in innovation will enable us to deliver value to patients, customers, and shareholders now and well into the future. With that, I'd now like to turn the call over to Dean.

Caroline Litchfield: To conclude we remain confident in the mid and long term outlook of our business driven by the global demand for our innovative medicines and vaccines as well as our exceptional pipeline.

Caroline Litchfield: Our unwavering commitment to use the power of cutting edge science to improve the lives of the patients. We serve has put us in a position of financial and operational strength.

Caroline Litchfield: Our excellent execution and continued investments in innovation will enable us to deliver value to patients customers and shareholders now and well into the future.

Caroline Litchfield: That I would now like to turn the call over to Dave.

Speaker Change: Thank you Caroline and the first quarter, we continued to make progress with a steady cadence of clinical regulatory milestones across our pipeline today I will provide updates from our cardio metabolic disease portfolio, HIV and vaccine programs and close with advances in our encore.

Dean Lee: Thank you Caroline. In the first quarter, we continued to make progress with a steady cadence of clinical regulatory milestones across our pipeline. Today, I will provide updates on our cardiometabolic disease portfolio, HIV, and vaccine programs, and close with advances in our oncology pipeline. As Rob and Caroline noted, late last month, we received approval from the FDA for WINREVAIR, our first-in-class active and signaling inhibitor for the treatment of adults living with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.

Dean Y. Li: Allergy pipeline.

Dean Y. Li: As Robin Caroline noted late last month, we received approval from the FDA for wind Rivera, our first in class active and signaling inhibitor for the treatment of adults living with pulmonary arterial hypertension to increase exercise capacity improve.

Dean Y. Li: <unk> functional class and reduce the risk of clinical worsening event when revere as a novel therapeutic option that targets, a new ph treatment pathway and is indicated to treat a broad ph population.

Dean Y. Li: WINREVAIR is a novel therapeutic option that targets a new PAH treatment pathway and is indicated to treat a broad PAH population. This approval marks a significant step towards our goal of transforming the treatment journey for many patients with PAH. WINREVAIR is currently being reviewed by the European Medicines Agency, with a decision anticipated in the second half of this year.

Dean Y. Li: This approval marks a significant step towards our goal of transforming the treatment journey for many patients with ph.

Dean Y. Li: When we're vir is currently being reviewed by the European Medicines agency, where the decision anticipated in the second half of this year.

Dean Y. Li: The Phase 3 Zenith and Hyperion studies evaluating patients with more advanced disease and those earlier on in their disease journey, respectively, are ongoing, as well as the Phase II Cadence trial evaluating WHO Group II pulmonary hypertension, a type of left heart disease. Our commitment extends to a broad range of pulmonary hypertension. We are informed by results from the Phase II cohort of the Phase II/III Insignia PAH Study evaluating MK-5475, our inhaled soluble guanylate cyclase stimulator, and the STELLAR trial results for WINREVAIR.

Dean Y. Li: The phase III zenith and Hyperion studies evaluating patients with more advanced disease and those earlier on in their disease journey, respectively are ongoing as well as the phase III cadence trial evaluating W. H O group, two pulmonary hypertension or type of left heart disease.

Dean Y. Li: <unk>.

Dean Y. Li: Our commitment extends to a broad range of pulmonary hypertension.

Dean Y. Li: Form by results from the phase II cohort of the phase II, <unk> III and Cigna ph study evaluating MK 50, 475, or inhaled soluble <unk> cyclase stimulators and the stellar trial results for wind River, where we have made the decision to focus the development of MK 54.

Dean Y. Li: We have made the decision to focus the development of MK-5475 on WHO Group 3.1, homeohypertension associated with COPD, and not further proceed in PAH. HCOPD is an area of significant need with no specific therapies currently approved.

Dean Y. Li: 75 on W. H O grew 3.1 pulmonary hypertension associated with COPD and not further proceed N P. H P.

Dean Y. Li: Ph COPD as an area of significant need with no specific therapies currently approved.

Dean Y. Li: Our HIV pipeline continues to advance last month presentations at the conference on retroviruses and opportunistic infections reinforce progress in our strategy to develop less frequent dosing regimens for managing and treating HIV.

Dean Y. Li: Our HIV pipeline continues to advance. Last month, presentations at the Conference on Retroviruses and Opportunistic Infections reinforced progress in our strategy to develop less frequent dosing regimens for managing and treating HIV. We believe these programs have the potential to help address adherence, stigma, and other challenges faced by some individuals taking daily antiretroviral pills. In collaboration with Gilead, safety and efficacy findings were presented from a Phase II study evaluating a once-weekly oral combination of ESLACHIVIR, an investigational nucleoside reverse transcriptase translocation inhibitor, and LENACAPIVIR, a first-in-class capsid inhibitor, for the treatment of adults living with HIV.

Dean Y. Li: We believe these programs have the potential to help address adherence Sigma and other challenges faced by some individuals taking daily anti retroviral pills.

Dean Y. Li: In collaboration with Gilead safety and efficacy findings were presented from a phase II study evaluating a once weekly oral combination of his Latvia, and investigational nucleoside reverse transcriptase translocation inhibitor and let a cap or a first in class capsid inhibitor for the treatment of <unk>.

Dean Y. Li: Adult living with HIV at 24 weeks the trial met its primary endpoint and in a secondary endpoint maintained a high rate of viral suppression additional longer term data will be presented at a later date.

Dean Y. Li: At 24 weeks, the trial met its primary endpoint and, in a secondary endpoint, maintained a high rate of viral suppression. Additional longer-term data will be presented at a later date. In addition, safety and tolerability data were presented for MK 8527, a novel oral NRTTI candidate from two phase I trials that evaluated ascending single doses and multiple doses in adults 18 to 55 years old not infected with HIV. MK 8527 is being investigated as a potential monthly option for HIV pre-exposure prophylaxis.

Dean Y. Li: In addition, safety and Tolerability data were presented for MK eight 527, a novel oral and our OTT I candidates from two phase one trials that evaluated ascending single dose and multiple doses in adults 18 to 55 years old not infected with HIV.

Dean Y. Li: MK 8527 is being investigated as a potential monthly option for HIV pre-exposure prophylaxis. Vaccines remain an important element of our pipeline, and we are making progress across several programs. Findings from multiple Phase III trials of V116, our investigational 21-valent pneumococcal conjugate vaccine, were presented at the meeting of the International Society of Pneumonia and Pneumococcal Diseases last month. V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine, including a pneumococcal vaccine naive and vaccine experienced adults, as well as those at increased risk for pneumococcal disease.

MK 8527 is being investigated as a potential monthly option for HIV pre-exposure prophylaxis.

Dean Y. Li: Okay, $85 27 is being investigated as a potential monthly option for HIV pre exposure prophylaxis.

Vaccines remain an important element of our pipeline, and we are making progress across several programs. Findings from multiple Phase III trials of V116, our investigational 21-valent pneumococcal conjugate vaccine, were presented at the meeting of the International Society of Pneumonia and Pneumococcal Diseases last month. V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine, including a pneumococcal vaccine naive and vaccine experienced adults, as well as those at increased risk for pneumococcal disease.

Dean Y. Li: Vaccines remain an important element of our pipeline and we are making progress across several programs.

Dean Y. Li: <unk> for multiple phase III trials of <unk> 116, our investigational 21, valent pneumococcal conjugate vaccine were presented at the meeting of the International Society of pneumonia and pneumococcal diseases last month.

Dean Y. Li: 116 was shown to be immunogenic for all 21, serotypes covered by the vaccine, including and pneumococcal vaccine naive and vaccine experience adults as well as those at increased risk for pneumococcal disease.

Dean Y. Li: If approved, V116 would be the first vaccine specifically designed to address the majority of serotypes that cause invasive pneumococcal disease in adults ages 65 and older. The target action date is June 17. The meeting of the CDC's Advisory Committee on Immunization Practices is scheduled shortly thereafter. Since the initial approval of Gardasil, a steady flow of clinical and real-world evidence has been generated to support the favorable efficacy, effectiveness, safety, and long-term durability of protection against certain human papillomavirus-related cancers and diseases in both males and females.

Dean Y. Li: If approved the one six would be the first vaccine specifically designed to address the majority of serotypes that cause invasive pneumococcal disease in adults, aged 65 and older. The target action date is June 17, the meeting of the Cdc's Advisory Committee on immunization practices as Sky.

Dean Y. Li: Joe shortly thereafter.

Dean Y. Li: Since the initial approval of Gardasil, a steady flow of clinical and real world evidence has been generated to support the favorable efficacy effectiveness safety and long term durability of protection against certain human papilloma virus related cancers and diseases in both.

Dean Y. Li: Males and females.

Dean Y. Li: Despite the proven public health benefit of HPV vaccination, the latest global cancer statistics from the International Agency for Research on Cancer indicate there is more to do to help increase vaccination rates. The latest statistics from 2022 rank cervical cancer as the fourth most common cancer globally in terms of incidence and mortality in women and the leading cause of cancer death in 37 countries, predominantly in sub-Saharan Africa, South America, and Southeast Asia regions.

Dean Y. Li: Spike the proven public health benefit of HPV vaccination, the latest global cancer statistics from the International Agency for research on cancer indicate there is more to do to help increase vaccination rates. The latest statistics from 2022 ranked cervical cancer is the fourth most common cancer globe.

Dean Y. Li: In terms of incidence and mortality in women and the leading cause of cancer death in 37 countries.

Dean Y. Li: Dominantly in sub Saharan Africa, South America, and Southeast Asia region.

Dean Y. Li: At the European Congress last month, we disclosed plans to build on the development of guard itself with a new clinical program to identify a novel Multivalent HPV vaccine candidate with the potential to extend protection against a broader array of HBV tax. This includes several types no to disproportionately.

Dean Y. Li: At the [inaudible] Congress last month, we disclosed plans to build on the development of Gardasil with a new clinical program to identify a novel multivalent HPV vaccine candidate with the potential to extend protection against a broader array of HPV types. This includes several types known to disproportionately impact African and Asian populations and individuals of African and Asian descent. First in human study are scheduled to start in the fourth quarter of this year. In addition, we announced plans to conduct two randomized double-blind multi-year clinical trials in females and males, ages 16 to 26 years to examine the short and long term efficacy and immunogenicity of a single dose of Gardasil-9 versus the currently approved three dose regimen. The goal of these studies is to generate data that clearly demonstrates whether or not a single dose of Gardasil-9 provides comparable long term protection to approved regimen, while also satisfying the high standards required by regulatory authorities. The clinical trials are anticipated to start enrolling in the fourth quarter.

Dean Y. Li: Packed African and Asian populations, and individuals' of African and Asian descent bursting.

Dean Y. Li: First in human studies are scheduled to start in the fourth quarter of this year. In addition, we announced plans to conduct two randomized, double-blind, multi-year clinical trials in females and males ages 16 to 26 years to examine the short and long-term efficacy and immunogenicity of a single dose of Gardasil-9 versus the currently approved three-dose regimen. The goal of these studies is to generate data that clearly demonstrates whether or not a single dose of Gardasil-9 provides comparable long-term protection to the approved regimen, while also satisfying the high standards required by regulatory authorities.

First in human studies are scheduled to start in the fourth quarter of this year.

Dean Y. Li: First in human studies are scheduled to start in the fourth quarter of this year.

Dean Y. Li: In addition, we announced plans to conduct two randomized double blind multi year clinical trials in females and males.

In addition, we announced plans to conduct two randomized, double-blind, multi-year clinical trials in females and males ages 16 to 26 years to examine the short and long-term efficacy and immunogenicity of a single dose of Gardasil-9 versus the currently approved three-dose regimen. The goal of these studies is to generate data that clearly demonstrates whether or not a single dose of Gardasil-9 provides comparable long-term protection to the approved regimen, while also satisfying the high standards required by regulatory authorities.

Dean Y. Li: 16% to 26 years to examine the short and long term efficacy and Immunogenicity of a single dose of Gardasil nine versus the currently approved three dose regimen.

Dean Y. Li: The goal of these studies is to generate data that clearly demonstrates whether or not a single dose of Gardasil nine provides comparable long term production to the approved regimen. While also satisfying the high standards required by regulatory authorities the Clint.

Dean Y. Li: In oncology, we continue to focus on our three-pillared strategy comprised of immuno-oncology, precision molecular targeting, and tissue targeting aging. For immuno-oncology, September 2024 will mark a decade since the first approval of Keytruda in metastatic melanoma.

The clinical trials are anticipated to start enrolling in the fourth quarter.

Dean Y. Li: Trials are anticipated to start enrolling in the fourth quarter.

Dean Y. Li: In oncology, we continue to focus on our three pillared strategy comprised of immuno oncology precision molecular targeting and tissue targeting agents.

In oncology, we continue to focus on our three-pillared strategy comprised of immuno-oncology, precision molecular targeting, and tissue targeting aging. For immuno-oncology, September 2024 will mark a decade since the first approval of Keytruda in metastatic melanoma.

Dean Y. Li: In immuno oncology September 2024 will Mark a decade since the first approval of Keytruda in metastatic melanoma Keytruda has since amassed approvals for 39 indication and continues to reinforce its reputation as a foundational therapy for certain types of cancers.

Dean Y. Li: Keytruda has since amassed approvals for 39 indications and continues to reinforce its reputation as a foundational therapy for certain types of cancer. Building on the recent FDA approval for Keytruda in combination with chemotherapy for the treatment of FIGO-2014, Stage 3-4A Cervical Cancer, we recently announced that the Pivotal Keynote A18 trial met its primary endpoint of overall survival, potentially providing a new standard of care for these patients. Our commitment to providing better options to prevent and treat cervical cancer remains strong.

Dean Y. Li: Building on the recent FDA approval for Keytruda in combination with chemotherapy for the treatment of Vigo 2014 stage three through four a cervical cancer, we recently announced that the pivotal keynote a 18 trial met its primary endpoint of overall survival.

Dean Y. Li: Potentially providing a new standard of care for these patients.

Dean Y. Li: Our commitment to providing better options to prevent and treat several cancer remained strong.

Dean Y. Li: Also in women's cancer, the phase III keynote <unk> eight trial known as NRG G. Y 018 was granted priority review by the FDA for the first line treatment of patients with primary advanced or recurrent endometrial carcinoma.

Dean Y. Li: Also, in women's cancer, the Phase III Keynote 86A trial, known as NRG-GY-018, was granted priority review by the FDA for the first-line treatment of patients with primary advanced or recurrent endometrial carcinoma. The agency has set a target action date of June 21.

Dean Y. Li: The agency has set a target action date of June 21.

Dean Y. Li: Outside of the U S. The European Commission approved Keytruda in combination with platinum doublet chemotherapy as neo adjuvant therapy, followed by adjuvant Keytruda in adult patients with non small cell lung cancer at high risk of recurrence based on the phase III keynote 671 study.

Dean Y. Li: Outside of the U.S., the European Commission approved Keytruda in combination with platinum doublet chemotherapy as neoadjuvant therapy, followed by adjuvant Keytruda in adult patients with non-small cell lung cancer at high risk of recurrence, based on the phase III Keynote 671 study. This marks the first approval in Europe for an anti-PD-1, PD-L1 therapy as part of a treatment regimen for the neoadjuvant followed by adjuvant treatment of resectable non-small cell lung cancer based on positive overall survival results.

Dean Y. Li: This marked the first approval in Europe for an anti PD, one PDL one therapy as part of a treatment regimen for the new adjuvant, followed by adjuvant treatment of Resectable and non small cell lung cancer based on positive overall survival results.

Dean Y. Li: Next to precision targeting bill.

Dean Y. Li: Next, the precision targeting. Building on the success of Keytruda for certain patients with non-small cell lung cancer, earlier this month, we announced the initiation of the Phase III clinical trial for MK1084, an investigational oral selective KRAS-D12C inhibitor in combination with Keytruda for the first-line treatment of certain patients with metastatic non-small cell lung cancer. The decision to proceed to Phase III was based on early promising evidence from a Phase I study showing anti-tumor activity and a manageable safety profile. K-RAS is one of the most prevalent oncogenes in human cancers, and G12C is the most common K-RAS mutation in patients with non-small cell lung cancer.

Dean Y. Li: Building on the success of Keytruda for certain patients with non small cell lung cancer earlier. This month, we announced the initiation of the phase III clinical trial for M. K 10, 84, an investigational oral selective <unk> inhibitor in combination with Keytruda for the first line treatment of certain patient with me.

Dean Y. Li: Static non small cell lung cancer.

Dean Y. Li: The decision to proceed to phase III was based upon early promising evidence from our phase one study showing anti tumor activity and a manageable safety profile.

Dean Y. Li: K Ras is one of the most prevalent oncogene and human cancers and G. 12 C is the most common K Ras mutation in patients with non small cell lung cancer.

Dean Y. Li: And the tissue targeting space, we're moving with speed and rigor to advance a broad pipeline of antibody drug conjugates with multiple planned and ongoing phase III trials.

Dean Y. Li: In the tissue targeting space, we are moving with speed and rigor to advance a broad pipeline of antibody drug conjugates with multiple planned and ongoing phase III trials. In just over six months, we have made remarkable progress in our collaboration with Daiichi [inaudible]. Recently, we announced that the first patient has been dosed in the Phase II/III Rejoice Ovarian O1 trial, evaluating the efficacy and safety of Relatudadag Diructacan, an investigational CDH6-directed DXD-ADC in patients with platinum-resistant ovarian cancer.

Dean Y. Li: And just over six months, we have made remarkable progress in our collaboration with Daiichi Sankyo reach.

Dean Y. Li: Recently, we announced that the first patient has been dosed in the phase two slash III rejoice ovarian O. One trial evaluating the efficacy and safety are relative to the dog director can investigational C. D. H six directed dxd ADC in patients with platinum resistant ovarian.

Dean Y. Li: Answer.

Dean Y. Li: We're poised to begin a Phase III study evaluating Infinitumab, Diructacan, a B7H3-directed ADC, and small-cell lung cancer, a notably difficult-to-treat tumor type. New treatment options are desperately needed for these patients where the prognosis remains poor. We are pleased to have recently completed the acquisition of Harpoon Therapeutics, which provides novel T-cell engagers, including MK6070, an investigational delta-like ligand 3 targeting T-cell engager also being evaluated in certain types of small cell lung cancer, as well as neuroendocrine tumors.

Dean Y. Li: We are poised to begin a phase III study evaluating infinitum App directory can be seven H three directed ADC in small cell lung cancer.

Dean Y. Li: Notably difficult to treat tumor type new treatment options are desperately needed for these patients where the prognosis remains poor.

Dean Y. Li: We are pleased to have recently completed the acquisition of Harpoon Therapeutics, which provide novel T cell engages including M. K fixed 070, and investigational Delta like ligand three targeting T cell engaged are also being evaluated in certain types of small cell lung cancer as well as neuro and.

Dean Y. Li: Quinn tumors.

Dean Y. Li: Finally, please mark your calendars for the evening of Monday, June 3rd, where we will host an investor event at ASCO in Chicago and provide an update on our diverse portfolio of immuno-oncology, precision molecular, and tissue targeting agent. Looking forward, June promises to be a busy month with three regulatory action dates, including V116 for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. Keytruda for Primary Advanced or Recurrent Endometrial Carcinoma, and [inaudible] Durukstakan for Advanced EGFR Mutated Non-Small Cell Lung cancer. We continue to execute on our strategy with a focus on operational excellence and look forward to providing further updates on our progress throughout the year. And now, I will turn the call back to Peter.

Dean Y. Li: Finally, please mark your calendars for the evening of Monday June 3rd where we will host an investor event at Astro in Chicago and provide an update on our diverse portfolio of immuno oncology precision molecular and tissue targeting agents.

Dean Y. Li: Looking forward June promises to be a busy month with three regulatory action dates, including the one want to explore a prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.

Dean Y. Li: Katrina for primary advanced or recurrent endometrial carcinoma, and Patricia lab, the rooster can for advanced Egfr mutated non small cell lung cancer.

Dean Y. Li: We continue to execute on our strategy with a focus on operational excellence and look forward to providing further updates on our progress throughout the year and now I will turn the call back to Peter.

Peter Dannenbaum: Thank you, Dean. Surely, we're ready to begin the Q&A. We request that analysts limit themselves to one question today to get to as many different questioners as possible. Thank you

Peter Dannenbaum: Thank you Dean Shirley we're ready to begin Q&A, we request that analysts limit themselves to one question today to get to as many different questioners as possible. Thank you.

Operator: Ladies and gentlemen, if you wish to ask a question, please press star one on your telephone keypad. You may withdraw your question at any time by pressing star two. If you're using a speakerphone, please pick up your handset before pressing the number.

Speaker Change: Ladies and gentlemen, if you wish to ask a question. Please press star one on your telephone keypad.

Operator: You may withdraw your question anytime by pressing star to if youre using a speakerphone. Please pick up your handset before pressing the numbers. Once again, if you have a question you May press star one and one moment. Please for our first question.

Operator: Once again, if you have a question, you may press star one. And one moment please for our first question. Our first question comes from Terence Flynn with Morgan Stanley, you may ask your question. Great, thanks so much for the question. This is probably one for Dean.

Once again, if you have a question, you may press star one. And one moment please for our first question. Our first question comes from Terence Flynn with Morgan Stanley, you may ask your question.

Operator: Our first question comes from Terence Flynn with Morgan Stanley You May ask your question.

Terence Flynn: Great. Thanks, so much for the question.

Terence C. Flynn: Great, thanks so much for the question. This is probably one for Dean. Obviously, you guys have been focused on building out your cardiometabolic franchise. Now you have the Cetatercept launch underway, you've got an oral PCSK9 in late stage development, and you have glucagon also moving forward for NASH, I believe. But I guess I'd just be curious how you think about the opportunity in obesity broadly, as on one hand, it seems like it could align with your current footprint, but on the other hand, it seems like Merck has gone more towards specialty markets and away from some kind of primary care. So maybe I would love your thoughts there, Dean, as you think about building it out.

Terence Flynn: One for Dean.

Dean Y. Li: Obviously, you guys have been focused on building out your cardiometabolic franchise. Now you have the Cetatercept launch underway, you've got an oral PCSK9 in late stage development, and you have glucagon also moving forward for NASH, I believe.

Terence Flynn: Obviously, you guys have been focused on building out your cardio metabolic franchise now you have to switch out or soft launch underway you've got in oral P. C. S. Canine in late stage development do you have a glib glucagon also are moving forward for Nash I believe.

Dean Y. Li: But I guess I'd just be curious how you think about the opportunity in obesity broadly, as on one hand, it seems like it could align with your current footprint, but on the other hand, it seems like Merck has gone more towards specialty markets and away from some kind of primary care. So maybe I would love your thoughts there, Dean, as you think about building it out. Well, thank you very much. Yes, we are excited about the buildup that we have in cardiovascular metabolic.

But I guess I'd just be curious how you think about the opportunity in obesity broadly, as on one hand, it seems like it could align with your current footprint, but on the other hand, it seems like Merck has gone more towards specialty markets and away from some kind of primary care. So maybe I would love your thoughts there, Dean, as you think about building it out.

Terence Flynn: But I guess I'd just be curious how you think about the opportunity in obesity broadly as on one hand, it seems like it could align with your current footprint, but on the other hand, it seems like Merck has gone more towards specialty markets and away from kind of primary care. So maybe just would love your thoughts there Deane as you think about building out.

Dean: Well. Thank you very much yes, we are excited about the buildup that we have in cardiovascular metabolic you pointed out the programs that have the most visibility right now, but let me assure you there will be other programs that you will have more visibility over the coming years in relationship to your question.

Dean Lee: Well, thank you very much. Yes, we are excited about the buildup that we have in cardiovascular metabolic. You've pointed out the programs that have the most visibility right now, but let me assure you, there will be other programs that will have more visibility over the coming years. In relation to your question about the GLP and obesity, I think there are two ways to look at it. You can look at it from a GLP angle, and you can look at it from an obesity angle.

Dean Y. Li: You've pointed out the programs that have the most visibility right now, but let me assure you, there will be other programs that will have more visibility over the coming years. In relation to your question about the GLP and obesity, I think there are two ways to look at it. You can look at it from a GLP angle, and you can look at it from an obesity angle.

Dean Y. Li: About GOP and obesity I think there's two ways to look at it you can look at it from a G. O P angle and you can look at it from an obesity angle. If you look at from a GOP angle.

Dean Y. Li: If you look at it from a GLP angle, there has been really important work showing its impact on diabetes and weight loss more recently and cardiovascular outcomes, most recently in sleep apnea. And you're right, we're very interested in its relationship to MASH. We think that's also an important outcome. And we also think that there will be distinct populations, whether you call them obese or whether you call them MASH or within that GLP space. And in those distinct populations, it will be important to give the benefit of a molecule that really takes care of the primary concern. And that's our play, for example, in MASH, where we think we have a very tolerable drug that has a significant reduction in liver fat and also gives a weight loss of 10 to 12 percent. When you look at that, I think these different outcomes may need different molecules.

Dean Y. Li: No. There there has been really important work showing its impact in diabetes and weight loss more recently in cardiovascular outcomes.

Dean Y. Li: Most recently in sleep apnea, and you're right. We're very interested in relationship to two mash. We think that's also important outcome and we also think that there will be distinct populations, whether you call. It obi, so whether you call it mash or.

Dean Y. Li: Within that G. L. P space and then those distinct populations. It will be important to give a benefit of a molecule that really takes care of the primary concern and that's our play for example in Nash, where we think we have a very tolerable.

Dean Y. Li: And in those distinct populations, it will be important to give the benefit of a molecule that really takes care of the primary concern. And that's our play, for example, in MASH, where we think we have a very tolerable drug that has a significant reduction in liver fat and also gives a weight loss of 10 to 12 percent. When you look at that, I think these different outcomes may need different molecules.

Dean Y. Li: Drug that has significant reduction in liver fat and also gives a weight loss of 10% to 12%. When you look at that I think these different outcomes may need different molecules more generally if you were talking about obesity I do think that there is important work going on right now, but I think that there could be another wave where people.

Dean Y. Li: More generally, if you're talking about obesity, I do think that there is important work going on right now. But I think that there could be another wave where people start thinking about orals, how tolerable they are, the accessibility they are, combinations, how do you maintain, how you preserve muscle, and also additional outcomes. And it may not be that the same molecule is the best molecule that wins out in every one of those subpopulations. And so I wonder if there will be some fractionation of the patient population when you say the word, for example, generally obesity. And we wonder if there is opportunity there.

Dean Y. Li: Start thinking about oils, how tolerable they are the accessibility they are and.

Dean Y. Li: Combinations, how do you maintain how you preserve myself and also additional outcomes and it may not be that the same molecule is the best molecule that wins out in every one of those sub populations and.

Dean Y. Li: And so I wonder if there will be some fractionation of the patient population when you say the word, for example, generally obesity. And we wonder if there is opportunity there. Great. Thank you, Terence. Next question please Shirley.

And so I wonder if there will be some fractionation of the patient population when you say the word, for example, generally obesity. And we wonder if there is opportunity there.

Dean Y. Li: And so I would just I wonder if there will be some fractionation of the of the patient population. When you say the word for example, generally obesity and we wonder if there is opportunity there.

Peter Dannenbaum: Great. Thank you, Terence. Next question please Shirley.

Terence: Great. Thank you Terrence next question please Shirley.

Operator: Thank you. Our next question comes from Evan Singerman with BMO Capital Markets, you may ask your question. Hi guys, thank you so much for taking my question. I wanted to touch on some of your work in lung cancer, specifically with KRAS G12C echoing Dean's comments. So this space is becoming increasingly crowded. Maybe walk me through what you believe differentiates your assets, say, from the currently approved ones or from the pan-KRAS assets in development. Thanks, Dean.

Operator: Thank you. Our next question comes from Evan Singerman with BMO Capital Markets, you may ask your question.

Evan David Seigerman: Thank you. Our next question comes from Evan singer men with BMO capital markets you May ask your question.

Evan Singerman: Hi guys, thank you so much for taking my question. I wanted to touch on some of your work in lung cancer, specifically with KRAS G12C echoing Dean's comments. So this space is becoming increasingly crowded. Maybe walk me through what you believe differentiates your assets, say, from the currently approved ones or from the pan-KRAS assets in development. Thanks, Dean.

Evan David Seigerman: Hey, guys. Thank you so much for taking my question I wanted to touch on some of your work in lung cancer, specifically with K Registry Trophy echoing Dean's comments. So this is basically become an increasingly crowded maybe walk me through what you believe differentiates your asset say from the currently approved one or from the Pan Kay rise assets in development.

Dean: Yes. So this is one of my more favorite project. So I appreciate that you actually asked a question about it.

Dean Lee: Yes, this is one of my favorite projects so I appreciate that you actually asked a question about it. When you look at KRAS, as you point out, it's one of the most important driver mutations in multiple cancers, and if you say more broadly not KRAS but PANRAS, that is also true. In relation to KRAS G12C, that's a small percentage of all the KRAS mutations and all the RAS mutations. But where KRAS G12C is especially prominent is in non-small cell lung cancer. It's depending on the percentage, 12 to 15 percent in that patient population. And I will also emphasize that we have a lot of data in relationship to that patient population in non-small cell lung cancer. It's keynote 189. It's chemo plus IO. You need a potent compound with a KRAS to move it into first line. That's the game that we're trying to play. So it is crowded, but what you're looking for is a potent compound that has tremendous monotherapy efficacy. But most importantly, when you combine it with, for example, Pembro, you maintain the dose, you maintain the ability to not have dose modifications,

Dean Y. Li: When you look at K Ras as you point out there. There is you know it's one of the most important driver mutations in multiple cancers, and if you say more.

Dean Y. Li: Broadly not K Ras by Pan RAF that that is also true in relationship to K Ras G trials see.

Dean Y. Li: That's a that's a small percentage of all the K Ras mutations and all the Ras mutations, but where <unk> is especially prominent in non small cell lung cancer.

Dean Y. Li: It's depending on the percentage, 12 to 15 percent in that patient population. And I will also emphasize that we have a lot of data in relationship to that patient population in non-small cell lung cancer. It's keynote 189. It's chemo plus IO. You need a potent compound with a KRAS to move it into first line.

Dean Y. Li: Depending on the percentage, 12% to 15% in that patient population.

Dean Y. Li: And I will also emphasize that we have a lot of data in relationship to that patient population and non small cell lung cancer. It's keynote 189, it's chemo plus Io do you need a potent compound with a K Ras to move it into first line. That's the game that we're trying to play so.

Dean Y. Li: That's the game that we're trying to play. So it is crowded, but what you're looking for is a potent compound that has tremendous monotherapy efficacy. But most importantly, when you combine it with, for example, Pembro, you maintain the dose, you maintain the ability to not have dose modifications,

Dean Y. Li: It is crowded, but but whats youre looking for is a potent compound that has tremendous monotherapy efficacy, but most importantly, when you combine it with for example, Pembroke you maintain the dose you maintain the ability to not have dose modifications and that's the data that made us.

Dean Y. Li: And that's the data that made us excited about this because I think we reported an ORR of 71 percent when combined. So that's why we're advancing that. The race for us is to get it in first line and then think about other KRAS indications and IO sensitive, insensitive, and also other molecules that are coming through in the lung cancer space, and some of them are related to antibody drug conjugates. So we are very excited about our KRAS G12C program, 1084, which is moving to phase three. Thank you, Evan. Next question please Shirley.

And that's the data that made us excited about this because I think we reported an ORR of 71 percent when combined. So that's why we're advancing that. The race for us is to get it in first line and then think about other KRAS indications and IO sensitive, insensitive, and also other molecules that are coming through in the lung cancer space, and some of them are related to antibody drug conjugates. So we are very excited about our KRAS G12C program, 1084, which is moving to phase three.

Dean Y. Li: Excited about this because I think we reported in all of our 71%.

Dean Y. Li: The combination so that's why we're advancing that they raised for US is to get it in first line and then to <unk>.

Dean Y. Li: About other K Ras indications in I O sensitive insensitive and also other molecules that are coming through in the lung cancer space and some of them are related to antibody drug conjugate. So we are very excited about our K Ras G. 12 C program, 10, 84, which is moving to phase III.

Peter Dannenbaum: Thank you, Evan. Next question please Shirley.

Speaker Change: Thank you and next question please Shirley.

Operator: Thank you. Our next question comes from Chris Shibutani with Goldman Sachs, you may ask your question.

Speaker Change: Thank you. Our next question comes from Chris Shea Bitani with Goldman Sachs. You May ask your question.

Chris Shibutani: Great, thank you very much. Maybe focusing on the pipeline on areas that you do not highlight as often, specifically immunology, and then a lot of the discovery work that you talk about in CNS. For immunology, with the TL1A, can you just help us understand where we are on the Crohn's study there, and also the Pandion acquisition? I think there's a phase two.

Chris Shibutani: Great. Thank you very much maybe focusing on the pipeline on areas that you do not highlight as often specifically immunology and then a lot of the discovery work that you talk about in CNS with immunology with a tier one they can you just uh huh.

Operator: Maybe focusing on the pipeline on areas that you do not highlight as often, specifically immunology, and then a lot of the discovery work that you talk about in CNS. For immunology, with the TL1A, can you just help us understand where we are on the Crohn's study there, and also the Pandion acquisition? I think there's a phase two.

Operator: US understand where we are on the Crohn's study there and also the pantheon acquisition I think there is a phase two and then CNS you highlight how many folks you have doing discovery research how do you feel about the distribution of your efforts in CNS. There. So just two areas not highlighted in the press release, but I think are important Bureau overall portfolio. Thank you.

Dean Y. Li: And then CNS, you highlight how many folks you have doing discovery research, how do you feel about the distribution of your efforts in CNS there? There are two areas not highlighted in the press release but I think are important to your overall portfolio. Thank you.

Dean Y. Li: Thank you very much.

Dean Lee: Thank you very much. So I'll first touch on immunology and specifically in the T01A space. So T01A, we think that it will be highly effective, higher in efficacy, and also not just in terms of efficacy in terms of tolerability. That ulcerative colitis program phase III is started already and is recruiting patients. We are hopeful that we will be announcing the opening of phase III and patients coming in for Crohn's disease over the next few months.

Speaker Change: So I'll first touch immunology, and and specifically in the <unk> space. So that <unk>, we think that it will be a highly effective.

Dean Y. Li: A higher efficacy and and also not just in terms of efficacy in terms of Tolerability that ulcerative colitis program Phase III is is has started already and as recruiting.

Dean Y. Li: We are hopeful that we will be announcing the opening of the phase III in patients coming in for the Crohn's disease over the next few months. So we are very excited about moving the T. L. One a.

Dean Y. Li: So we are very excited about moving T01A eagerly and appropriately, aggressively into phase III to really sort of outline the really differentiated profile that we have seen for T01A and specifically our compound. I should also emphasize that we also are looking at T01A, not just within sort of inflammatory bowel disease, but we're also interested in other diseases. And one of the things that's really interesting about T01A is that it blocks inflammation, but there are reasons to believe that it can have profound effects on fibrosis, and that's our interest in Crohn's disease.

Dean Y. Li: Eagerly and and appropriately aggressively move it in phase III to really sort of outline.

Dean Y. Li: Outline.

Dean Y. Li: They're really differentiated profile that we have seen for <unk> and specifically.

Dean Y. Li: Our our compound I should also emphasize that we also are looking at T 018, not just within sort of inflammatory bowel disease, but we were also interested in other diseases and one of the things that's really interesting about <unk>. It is blocking inflammation, but there there is reasons to believe that it can have profound effects.

Dean Y. Li: On an on fibrosis and that's our interest in Crohn's disease, but there are other diseases. For example in the lung where fibrosis is isn't really important component and we'll be interested to see those we have other assets moving forward both from the permit.

Dean Y. Li: But there are other diseases, for example, in the lung where fibrosis is a really important component, and we'll be interested to see those. We have other assets moving forward, both from the Prometheus acquisition that is not the T01A, as well as other internal that are moving forward with alacrity. In relationship to neuroscience, we hope to be getting the readout with MK 8189. We have other programs that are moving and advancing. And we have made some commitments in the early discovery space from a BD standpoint to accelerate some of our work that has been made public.

But there are other diseases, for example, in the lung where fibrosis is a really important component, and we'll be interested to see those. We have other assets moving forward, both from the Prometheus acquisition that is not the T01A, as well as other internal that are moving forward with alacrity.

Dean Y. Li: Acquisition that is not the tier one eight as well as other internal that are moving forward.

Dean Y. Li: With with Alacrity.

In relationship to neuroscience, we hope to be getting the readout with MK 8189. We have other programs that are moving and advancing. And we have made some commitments in the early discovery space from a BD standpoint to accelerate some of our work that has been made public.

Dean Y. Li: In relationship to neuroscience, we hope to be with getting the readout with with.

Dean Y. Li: MK 80, 189, we have other programs that are moving and advancing and we have made some commitments and the early discovery space and a BD standpoint to accelerate some of our works that have been made public I think over the next one to two years, we'll see readout.

Dean Y. Li: I think over the next one to two years, we'll see readouts, phase IIB, phase I moving to phase II but I think at that point, we will be able to speak more fully. But I think the investment in neuroscience is critically important. From a health care unmet need, you'd have to list from an economic value to the health care system and populations, especially in the United States, neuro disease continues to be a really important place. And I would say neuro disease, not just in terms of degenerative, but not just classic neuro disease but in the psychiatric arena as well. And you've seen others advance business development in that space. We're interested in continuing business development there but also importantly, moving our own internal program, the lead program being MK 8189.

Dean Y. Li: Now phase <unk> phase ones moving to phase II, but I think at that point, we will be able.

Dean Y. Li: Able to speak more fully but I think you know the investment in neuroscience I think is critically important.

Dean Y. Li: Health care, you know unmet need.

Dean Y. Li: Have to list from an economic value to the health care system in populations, especially in the United States.

Dean Y. Li: No.

Dean Y. Li: Neuro disease continues to be a really important place and I would say neuro disease not just in terms of degenerative, but that's not just classic neuro disease, but in the psychiatry.

Dean Y. Li: Arena, as well and you've seen others advance our business development in that space. We're interested in continuing in business development. There, but also importantly, moving our own internal program. The lead program being MK 80 189, great. Thank you Chris next question. Please Shirley.

Dean Y. Li: And you've seen others advance business development in that space. We're interested in continuing business development there but also importantly, moving our own internal program, the lead program being MK 8189. Great. Thank you, Chris. Next question please Shirley.

And you've seen others advance business development in that space. We're interested in continuing business development there but also importantly, moving our own internal program, the lead program being MK 8189.

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

Operator: Thank you. Our next question comes from Daina Graybosch. You may ask your question. Hi, thanks for the question. I want to ask some questions about the pneumococcal vaccine. You mentioned several times that V116 is customized for adults 65 and older.

Operator: Thank you. Our next question comes from Daina Graybosch. You may ask your question.

Daina Michelle Graybosch: Thank you. Our next question comes from Dana Gaba gave US you may ask your question.

Daina Graybosch: Hi, thanks for the question. I want to ask some questions about the pneumococcal vaccine. You mentioned several times that V116 is customized for adults 65 and older. In the ACIP meeting, they discussed a recommendation for adults 50 or older and I wonder if you could comment on where you think that ACIP recommendation will end up for V116. And on V117, I wonder if you could talk about how this vaccine, which I believe is now in phase I, is customized for pediatric patients. Thank you.

Daina Michelle Graybosch: Hi, Thanks for the question I wanted to ask some on pneumococcal vaccine you mentioned several times, even one six is customized for adults 65 and older and the Asa meeting they discussed a recommendation in adults 50 or older and I Wonder if you could comment on where you think that Asa practice mentation.

Rob Davis: In the ACIP meeting, they discussed a recommendation for adults 50 or older and I wonder if you could comment on where you think that ACIP recommendation will end up for V116. And on V117, I wonder if you could talk about how this vaccine, which I believe is now in phase I, is customized for pediatric patients. Thank you. Yeah, maybe I can start, Daina, and then Dean can add. Obviously, I would just start by saying we were very pleased with the overall tone and tenor of the discussion coming out of the ACIP meeting.

In the ACIP meeting, they discussed a recommendation for adults 50 or older and I wonder if you could comment on where you think that ACIP recommendation will end up for V116. And on V117, I wonder if you could talk about how this vaccine, which I believe is now in phase I, is customized for pediatric patients. Thank you.

Speaker Change: And up from 116, and one seven I Wonder if you could talk about how this vaccine, which I believe is now in phase one is customized for pediatric patients. Thank you.

Robert Davis: Yeah, maybe I can start, Daina, and then Dean can add. Obviously, I would just start by saying we were very pleased with the overall tone and tenor of the discussion coming out of the ACIP meeting. And as you look at what we have with V116, we continue to believe, if you look at the strength of the data behind that, and we've talked about, Dean mentioned some of the clinical readouts that have come, but recall, we cover 83% of the serotypes causing disease in adults. That's 30% higher than PCV20, so it's significant, and that was how it was specifically designed, targeting those serotypes which are most prevalent in adult disease.

Speaker Change: Yes, maybe I can start Dana and then Jim can add.

Speaker Change: Obviously I would just start by saying we were very pleased with the overall tone and tenor of the discussion coming out of the CIP meeting and.

Rob Davis: And as you look at what we have with V116, we continue to believe, if you look at the strength of the data behind that, and we've talked about, Dean mentioned some of the clinical readouts that have come, but recall, we cover 83% of the serotypes causing disease in adults. That's 30% higher than PCV20, so it's significant, and that was how it was specifically designed, targeting those serotypes which are most prevalent in adult disease.

Rob Davis: You look at what we have with B one six.

Rob Davis: We continue to believe if you look at the strength of the data behind that and we've talked about Dean mentioned some of the clinical Readouts will come but recall, we cover 83% of the serotypes, causing disease in adults, that's 30% higher than PCB 'twenty. So it's significant in that.

Rob Davis: How it was specifically designed targeting those thorough types, which are most prevalent and adult disease. As a result of that we continue to believe the value proposition of <unk> is very compelling when you look at the cost effectiveness.

Dean Y. Li: As a result of that, we continue to believe the value proposition of V116 is very compelling. If you look at the cost-effectiveness, it's going to be a very cost-effective vaccine, and as a result, I think that's why you started to see the ACIP ask questions about the 50 to 65 age cohort as well as the 65 and older. So I don't want to get ahead of the ACIP and their recommendation, but I would say our belief and conviction in the value of the data and the value this vaccine will bring for patients in the pneumococcal space is significant. And I would expect, overall, that we're going to see broad coverage coming out of the ACIP.

Dean Y. Li: It's going to be a very cost effective vaccine and as a result, I think that's why you started to see the CIP ask questions about the 50 to 65 age cohort as well as the 65, plus so I don't want to get ahead of the CIP in their recommendation, but I would say our belief and conviction in the value of <unk>.

Dean Y. Li: The data and the value of this vaccine will bring for patients in the pneumococcal space is significant.

Dean Y. Li: And I would expect, overall, that we're going to see broad coverage coming out of the ACIP. Yeah, I would just add again, we want to be respectful of ACIP and the FDA, but you did point out something that I think is something that clearly we took notice of. When Rob talks about that 83% versus 50% and 30% more, and the specific question that you're asking about 50 to 64, I would remind everyone that dropping that age for universal vaccination had been considered previously for other vaccines, and they could not come to a situation where they thought that it would be a good idea based on cost effectiveness and the such.

And I would expect, overall, that we're going to see broad coverage coming out of the ACIP.

Dean Y. Li: And I would expect overall that we're going to see broad.

Dean Y. Li: Broad coverage coming out of the ACI P.

Speaker Change: Yeah, I would just add again.

Dean Lee: Yeah, I would just add again, we want to be respectful of ACIP and the FDA, but you did point out something that I think is something that clearly we took notice of. When Rob talks about that 83% versus 50% and 30% more, and the specific question that you're asking about 50 to 64, I would remind everyone that dropping that age for universal vaccination had been considered previously for other vaccines, and they could not come to a situation where they thought that it would be a good idea based on cost effectiveness and the such. And by increasing it from 50 to 83%, we believe that we have changed the calculus and that may be why there is renewed interest in lowering that age based on the broader coverage given for V116.

Dean Y. Li: We want to be respectful of ACI P M and the FDA, but but you did point out something that I think is something that clearly we took notice.

Dean Y. Li: Rob talks about that 83% versus 50% in the 30% more than the specific question that youre asking about 50 to 64, I would remind everyone that the.

Dean Y. Li: Dropping that age for Universal vaccination had been considered previously for other vaccines.

Dean Y. Li: <unk>.

Dean Y. Li: They could not come to a situation where they thought that it would be.

Dean Y. Li: A good idea based on cost effectiveness, and the such and by increasing it from 50% to 83%. We believe that we changed the calculus and that may be why there is renewed interest in lowering that age based on that.

Dean Y. Li: And by increasing it from 50 to 83%, we believe that we have changed the calculus and that may be why there is renewed interest in lowering that age based on the broader coverage given for V116. And I think there was a second question you had, Daina, about V117, I'll just maybe give a general answer, which is, obviously, if you look at the strategy of V116, it's the same strategy as V117. How do we develop an investigational PCV vaccine that is targeted specifically to those serotypes that cause disease in children, in PEDs, without hopefully causing undesired effects? And so it's a model that follows it. We haven't given any details about the additional serotypes or our thinking, but just understand that if you look at the model of V116, V117 is the same thing in PEDs. Great. Thank you, Daina. Next question, please, Shirley. Thank you. Our next question comes from James Chin with Deutsche Bank. Your line is open, you may ask your question.

And by increasing it from 50 to 83%, we believe that we have changed the calculus and that may be why there is renewed interest in lowering that age based on the broader coverage given for V116. And I think there was a second question you had, Daina, about V117, I'll just maybe give a general answer, which is, obviously, if you look at the strategy of V116, it's the same strategy as V117. How do we develop an investigational PCV vaccine that is targeted specifically to those serotypes that cause disease in children, in PEDs, without hopefully causing undesired effects? And so it's a model that follows it. We haven't given any details about the additional serotypes or our thinking, but just understand that if you look at the model of V116, V117 is the same thing in PEDs. Great. Thank you, Daina. Next question, please, Shirley.

And by increasing it from 50 to 83%, we believe that we have changed the calculus and that may be why there is renewed interest in lowering that age based on the broader coverage given for V116.

Dean Y. Li: The broader coverage given 14, one six.

Robert M. Davis: And I think there was a second question you had, Daina, about V117, I'll just maybe give a general answer, which is, obviously, if you look at the strategy of V116, it's the same strategy as V117. How do we develop an investigational PCV vaccine that is targeted specifically to those serotypes that cause disease in children, in PEDs, without hopefully causing undesired effects? And so it's a model that follows it. We haven't given any details about the additional serotypes or our thinking, but just understand that if you look at the model of V116, V117 is the same thing in PEDs.

Dean Y. Li: I think there was a second question you've got Dana Bell B, one seven I'll, just maybe give a general answer which is obviously if you look at the strategy would be 116, it's the same strategy would be 117, how do we.

Dean Y. Li: Develop an investigational PCV vaccine that is targeted specifically to those throw types that cause disease in children in peds without hopefully, causing.

Dean Y. Li: Important effects and so it's a model of the calls that we've not given any details to the additional serotypes or thinking but just understand that if you look at the model <unk> 1617 is the same thing in peds.

Dean Y. Li: And so it's a model that follows it. We haven't given any details about the additional serotypes or our thinking, but just understand that if you look at the model of B.1.1.6, B.1.1.7 is the same thing in PEDs. Great. Thank you, Daina. Next question, please, Shirley. Thank you. Our next question comes from James Chin with Deutsche Bank. Your line is open.

Unknown Attendee: Great. Thank you Dana next question please Shirley.

Unknown Attendee: Our next question comes from James Chen with Deutsche Bank. Your line is open you may ask your question.

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

Unknown Attendee: Hey, good morning, guys. Thank you for the question.

Operator: Thank you. Our next question comes from James Chin with Deutsche Bank. Your line is open, you may ask your question.

Unknown Attendee: Firstly, I know Merck did not provide product level guidance, but given winter here is important and investor focus can you provide any color on when reduced contribution to guidance.

James Chin: Hey, good morning, guys. Thank you for taking my question. Firstly, I know Merck does not provide product-level guidance, but given WINREVAIR's importance and investor focus, can you provide any color on WINREVAIR's contribution to guidance? And then the second one is for Dean on [inaudible] Ovarian, Precision Oncology, to know how much overlap there is between [inaudible] and then for Petrudamab, I know the data for [inaudible] in advanced patients but there's a lot of development in the advanced space so how does Merck envision Petrudamab to be positioned [inaudible]? Thank you. Maybe James I'll start and thank you for the question. The short answer is unfortunately, we don't provide product-level guidance, so I don't think we want to get into trying to tell you what we see in WINREVAIR as being a contributor in 2024. But with that said, I think it's important to make a few points just so you understand how we're seeing it.

Speaker Change: And then second one is for Dean on fee choice ovarian and I suppose precision oncology in general.

Speaker Change: It doesn't feel know how much overlap there is between <unk> six and Fr Alpha and then for Patricia Matt I know the data for HR through her three shows high expression and advanced patients, but theres a lot of development in advance based so how does more conversion to treat about repositioned or sequencing. Thank you.

Operator: Maybe James I'll start and thank you for the question.

Robert M. Davis: Maybe James I'll start and thank you for the question. The short answer is unfortunately, we don't provide product-level guidance, so I don't think we want to get into trying to tell you what we see in WINREVAIR as being a contributor in 2024. But with that said, I think it's important to make a few points just so you understand how we're seeing it.

Dean Y. Li: The short answer is unfortunately, we don't provide.

Dean Y. Li: Product global guidance. So I don't think we want to get into trying to tell you. What we see when we're there has been a contributor in 'twenty four but with that said I think it's important to make a few points. Just so you understand how we're seeing it first of all.

Rob Davis: First of all, we're very excited to provide this novel treatment for patients with PAH. As you know, we think this will be a game-changer in that space. We were well prepared for the launch, and I can tell you the launch, although very early, is going well so far. We've seen an increasing number of prescriptions being written. We've seen repeat prescriptions, and that's coming both from the COE space, from the Centers of Excellence, which are about 150 in the United States, as well as from non-COEs, which is a good development. We've already begun making shipments to patients' homes, and hopefully, we'll have patients being dosed very soon, if not already.

Rob Davis: We're excited to provide this novel treatment for patients with ph as you know we think this will be a game changer in that space, we were well prepared for the launch and I can tell you the launch although very early is going well so far.

Rob Davis: We've seen an increasing number of prescriptions being written. We've seen repeat prescriptions, and that's coming both from the COE space, from the Centers of Excellence, which are about 150 in the United States, as well as from non-COEs, which is a good development. We've already begun making shipments to patients' homes, and hopefully, we'll have patients being dosed very soon, if not already.

Speaker Change: We've seen.

Rob Davis: Increasing number of prescriptions being written we've seen repeat prescriptions.

Rob Davis: And that's coming both from the <unk> space and in the centers of excellence, which has been about 150 in the United States as well as from <unk>, which is a good development, we've already begun making shipments to patients homes.

Rob Davis: And hopefully we will have patients been dosed very soon if not already and then I think the other thing I'd note is the prescribers as well as the locations are both from the centers of excellence and also non CRE. So that's something to note and then finally from a payer perspective, we're seeing good good access no no real limits.

Rob Davis: And then I think the other thing I'd note is that prescribers, as well as the locations, are both from the Centers of Excellence and also non-COEs, so that's something to note. And then finally, from a payer perspective, we're seeing good access, no real limits. In fact, we already have several payers who have established coverage policies, and I think, as Caroline pointed out in the prepared comments, very consistent with the label and what we saw in Stellar. But the fact that we've seen policies enacted giving coverage to patients already this quickly after launch is a good sign. It's obviously early, but everything so far looks quite good. So our confidence in a successful launch has not changed. We continue to see this consistent with our expectations. And as we move forward, we'll give you an appropriate level of transparency. But I did just want to give you some flavor, even though we can't give the specific guidance you were asking for. Dean, I'll let you take the second part of the question.

Rob Davis: In fact, we already have several payers, who have established coverage policies and I think as someone pointed out in the prepared comments very consistent with the label and what we saw in store.

Rob Davis: But the fact that we've seen policies enacted gaming coverage to patients already this quickly after launch we see as a good sign.

Rob Davis: So obviously early.

Rob Davis: But.

Rob Davis: Everything so far looks looks quite good so our confidence in a successful launch has not changed we continue to see this consistent with our expectations and as we move forward, we'll give you appropriate level of transparency, but I did just wanted to get a flavor, even though we can't give the specific guidance you were asking for Dean I'll, let you take the second part of the growth yes.

Rob Davis: So our confidence in a successful launch has not changed. We continue to see this consistent with our expectations. And as we move forward, we'll give you an appropriate level of transparency. But I did just want to give you some flavor, even though we can't give the specific guidance you were asking for. Dean, I'll let you take the second part of the question. Yeah, so I'll just add a little bit in relation to WINREVAIR.

So our confidence in a successful launch has not changed. We continue to see this consistent with our expectations. And as we move forward, we'll give you an appropriate level of transparency. But I did just want to give you some flavor, even though we can't give the specific guidance you were asking for. Dean, I'll let you take the second part of the question.

Dean Lee: Yeah, so I'll just add a little bit in relation to WINREVAIR. I think it's important to emphasize that the indication or the label that we have is a broad indication and is based on Stellar, and there will be potential data flows that will continue to inform and strengthen the field. We have Stellar and Ceteria, which are open-label medicines. We have Zenith, which is advanced and will look at mortality and morbidity, and Hyperion, which is more early in the journey. We have European action that will happen in the second half of 2024. And I would just emphasize that this is something that health care professionals and self-administration are capable of doing. And in relationship to that, there will be a demand for innovation and we hope to provide that innovation as this becomes even more used from a self-administration standpoint.

Dean: I'll just add a little bit in relationship to wind River I think it's important to emphasize that you know the.

Dean Y. Li: I think it's important to emphasize that the indication or the label that we have is a broad indication and is based on Stellar, and there will be potential data flows that will continue to inform and strengthen the field. We have Stellar and Ceteria, which are open-label medicines.

Dean Y. Li: The indication or the label that we have.

Dean Y. Li: Is a broad indication and it's based on stellar and there will be potential data flows that will continue to inform and strengthening the field, we have stellar and superior which is open label, we have zenith, which is advanced and that we'll look at mortality and morbidity and Hyperion, which is in.

Dean Y. Li: We have Zenith, which is advanced and will look at mortality and morbidity, and Hyperion, which is more early in the journey. We have European action that will happen in the second half of 2024. And I would just emphasize that this is something that health care professionals and self-administration are capable of doing. And in relationship to that, there will be a demand for innovation and we hope to provide that innovation as this becomes even more used from a self-administration standpoint. You asked a number of questions, and many of the questions related to, and some of it got blurred out, but some of it related to ovarian cancer, but more broadly speaking, tissue targeting and ADCs,

We have Zenith, which is advanced and will look at mortality and morbidity, and Hyperion, which is more early in the journey. We have European action that will happen in the second half of 2024. And I would just emphasize that this is something that health care professionals and self-administration are capable of doing. And in relationship to that, there will be a demand for innovation and we hope to provide that innovation as this becomes even more used from a self-administration standpoint.

Dean Y. Li: More earlier in the in the journey, we are the your European action that will happen in the second half of 2024 and I would just emphasize that this is something that health care professionals and self administration is possible and in relationship to that there will be a demand for innovation.

Dean Y. Li: And we hope to.

Dean Y. Li: Provide that innovation.

Dean Y. Li: As this becomes even more used in a self administration standpoint.

You asked a number of questions, and many of the questions related to, and some of it got blurred out, but some of it related to ovarian cancer, but more broadly speaking, tissue targeting and ADCs, so I'll just give you an overview. When we look at the field, we look at cancers where there is I.O. and chemo and that combination and where will we see that? We ask ourselves, can you combine an I.O. agent with a chemo agent? And we think about Keytruda and we also thin about next-gen tissue-targeting IO agents, such as, the recent immune engagers that we have from Harpoon. And then on the other hand, we think about chemo, we think of precision targeting like RAS, how can it combine, and we also think in terms of ADC. In the specific case that you're talking about, you have HERS3, Petrudamab, that's moving along in EGFR, non-small cell lung cancer. In B7H3, there's prominent data that's in small cell lung cancer, maybe in prostate. And for CDH6 itself, that ovarian data is quite interesting, and that's Relatudidag. At least for us, it's very interesting because the initial data with our partners in Daiichi Sankyo is striking to us because in that patient population, it looked like all comers did extremely well, and that in some situations, you think about a biomarker, but for the CDH6, the impact across sort of biomarker subsets was quite impressive. So I hope that gives you a general structure, and thank you very much for that question.

Dean Y. Li: You asked a number of questions and many of the questions related and some of it got blurred out, but some of it related to ovarian but more broadly speaking tissue targeting in adcs.

Dean Y. Li: so I'll just give you an overview. When we look at the field, we look at cancers where there is I.O. and chemo and that combination and where will we see that? We ask ourselves, can you combine an I.O. agent with a chemo agent? And we think about Keytruda and we also thin about next-gen tissue-targeting IO agents, such as, the recent immune engagers that we have from Harpoon. And then on the other hand, we think about chemo, we think of precision targeting like RAS, how can it combine, and we also think in terms of ADC. In the specific case that you're talking about, you have HERS3, Petrudamab, that's moving along in EGFR, non-small cell lung cancer. In B7H3, there's prominent data that's in small cell lung cancer, maybe in prostate. And for CDH6 itself, that ovarian data is quite interesting, and that's Relatudidag. At least for us, it's very interesting because the initial data with our partners in Daiichi Sankyo is striking to us because in that patient population, it looked like all comers did extremely well, and that in some situations, you think about a biomarker, but for the CDH6, the impact across sort of biomarker subsets was quite impressive. So I hope that gives you a general structure, and thank you very much for that question. Thanks, James. Next question please Shirley.

so I'll just give you an overview. When we look at the field, we look at cancers where there is I.O. and chemo and that combination and where will we see that? We ask ourselves, can you combine an I.O. agent with a chemo agent? And we think about Keytruda and we also thin about next-gen tissue-targeting IO agents, such as, the recent immune engagers that we have from Harpoon. And then on the other hand, we think about chemo, we think of precision targeting like RAS, how can it combine, and we also think in terms of ADC. In the specific case that you're talking about, you have HERS3, Petrudamab, that's moving along in EGFR, non-small cell lung cancer. In B7H3, there's prominent data that's in small cell lung cancer, maybe in prostate. And for CDH6 itself, that ovarian data is quite interesting, and that's Relatudidag. At least for us, it's very interesting because the initial data with our partners in Daiichi Sankyo is striking to us because in that patient population, it looked like all comers did extremely well, and that in some situations, you think about a biomarker, but for the CDH6, the impact across sort of biomarker subsets was quite impressive. So I hope that gives you a general structure, and thank you very much for that question.

Dean Y. Li: I'll just give you an overview when we look at the field, we look at cancers, where there is I O and chemo and that combination and wherever we see that we ask ourselves can you combine an I O agent with a chemo agent and we think about Keytruda, but we also think about nextgen tissue targeting IL <unk>.

Dean Y. Li: agent with a chemo agent? You know, the recent immune engagers that we have from Harpoon, and then on the other hand, we think about chemo, we think of precision targeting like RAS, how can it combine, and we also think in terms of ADC. In the specific case that you're talking about, you have HERS3, Petridamab, that's moving along in EGFR, non-small cell lung cancer, in B7H3, you know, there's prominent data that's in small cell lung cancer, maybe in prostate, and for CDH6 itself, that ovarian data is quite interesting, and that's Relatudidag, at least for us, it's very interesting because the initial data with our partners in Daiichi Sankyo is striking to us because in that patient population, it looked like all comers did extremely well, and that in some situations, you think about a biomarker, but for the CDH6, the impact across sort of biomarker subsets was quite impressive. So I hope that gives you a general structure, and we're happy to, and thank you very much for that question. Thanks, James.

Dean Y. Li: Agency such as.

Dean Y. Li: The recent immune engagements that we have from harpoon.

And then on the other hand, we think about chemo, we think of precision targeting like RAS, how can it combine, and we also think in terms of ADC. In the specific case that you're talking about, you have HERS3, Petrudamab, that's moving along in EGFR, non-small cell lung cancer. In B7H3, there's prominent data that's in small cell lung cancer, maybe in prostate. And for CDH6 itself, that ovarian data is quite interesting, and that's Relatudidag. At least for us, it's very interesting because the initial data with our partners in Daiichi Sankyo is striking to us because in that patient population, it looked like all comers did extremely well, and that in some situations, you think about a biomarker, but for the CDH6, the impact across sort of biomarker subsets was quite impressive. So I hope that gives you a general structure, and thank you very much for that question.

Dean Y. Li: And then on the other hand, we think about chemo, we think our precision targeting like Ras how can it combined and we also think in terms of ADC in the specific case that you were talking about your first three Patricia map, that's moving along in Egfr non small cell lung cancer and <unk> three.

Dean Y. Li: Prominent data that's in small cell lung cancer may be in prostate and for CCH six itself that ovarian data is quite interesting and that's relative to dag at least for US is very interesting because the initial data with our partners and Daiichi Sankyo.

Dean Y. Li: Striking to us because in that patient population it looked like all commerce did extremely well.

Dean Y. Li: And that in some situations you think about a biomarker, but for the <unk> the impact of cost sort of biomarker subsets, whereas quite an impressive. So I hope that gives you a general structure.

Speaker Change: And we're happy to.

Peter Dannenbaum: Thanks James. Next question please Shirley.

Speaker Change: Thank you very much for that question. Thanks, James next question. Please Shirley.

Operator: Thank you. Our next question comes from Umer Raffat with Evercore, you may ask your question. Hi guys, thanks for taking my question. I'm just trying to think through your next-gen HPV vaccine, and I guess how should we think about potential penetration rates with a revaccination opportunity with the new broader-spectrum HPV, especially in patients who have already taken Gardasil 9? Thank you very much.

Operator: Thank you. Our next question comes from Umer Raffat with Evercore, you may ask your question.

Umer Raffat: Thank you. Our next question comes from Kumar <unk> with Evercore you May ask your question.

Umer Raffat: Hi guys, thanks for taking my question. I'm just trying to think through your next-gen HPV vaccine, and I guess how should we think about potential penetration rates with a revaccination opportunity with the new broader-spectrum HPV, especially in patients who have already taken Gardasil 9? Thank you very much.

Umer Raffat: Hi, guys. Thanks for taking my question.

Umer Raffat: I'm just trying to think through your next Gen HPV vaccine and I guess, how should we think about potential penetration rates with our re vaccination opportunity with the new broader spectrum HPV, especially in patients who have already taken gardasil nine. Thank you very much.

Robert M. Davis: Re-vaccination in relation to HPV, is that what the question was about? With the G9 Plus. I'm struggling to answer your question because I first have to make a G9 Plus that works really, really well. And when I get that, that'll be great because there are patient populations that I think would be extremely well served. But I would also emphasize that we've just talked about cancer, we've talked about early stage cancer, this is the time that you can really treat and potentially cure cancer, but we're in the business of preventing cancers as well. One of the questions that comes to us is that in certain patient populations, you want a vaccine that the data, for example, Scandinavia, it's 90 percent reduction in cancer incidence and then the recent American Cancer Society. We are wondering whether you make a G9 Plus vaccine, whether you can make the argument that if we're successful, if we're successful with G9 Plus and what we hope to aspire for, whether you could fundamentally change how one recommends cancer screening for women in relation to cervical cancer and also the reduction both in men and women of many other cancers outside of cervical cancer.

Dean Y. Li: Okay.

Dean Y. Li: We vaccination in relationship to HPV as that one question.

Dean Y. Li: The New Zealand with the G nine plus.

Dean Y. Li: You know.

Dean Y. Li: I'm struggling to answer your question because I first have to make a G9 Plus that works really, really well. And when I get that, that'll be great because there are patient populations that I think would be extremely well served. But I would also emphasize that we've just talked about cancer, we've talked about early stage cancer,

Speaker Change: I'm struggling to answer your question because I first got to make a G nine plus that works really really well.

Dean Y. Li: And when I get that that'll be great. Because there are patient populations that I think would be extremely well served but I would also emphasize that we've just talked about cancer. We've talked about early stage cancer. This is the time that you can really treat and potentially cure, but we're in the business of preventing.

Dean Y. Li: this is the time that you can really treat and potentially cure cancer, but we're in the business of preventing cancers as well. One of the questions that comes to us is that in certain patient populations, you want a vaccine that the data, for example, Scandinavia, it's 90 percent reduction in cancer incidence and then the recent American Cancer Society. We are wondering whether you make a G9 Plus vaccine, whether you can make the argument that if we're successful, if we're successful with G9 Plus and what we hope to aspire for, whether you could fundamentally change how one recommends cancer screening for women in relation to cervical cancer and also the reduction both in men and women of many other cancers outside of cervical cancer.

Dean Y. Li: Cancers as well one of the questions that come up.

Dean Y. Li: <unk> comes to US is that in certain patient populations you want a vaccine that's you know that.

Dean Y. Li: The data for example, Scandinavia to 90, plus a reduction 90% reduction in cancer.

Dean Y. Li: Incidents and then the recent.

Dean Y. Li: American Cancer Society, we are wondering whether if you make a G nine plus.

Dean Y. Li: Vaccine, whether you can make the argument if we're successful and if we're successful with a G nine plus and what we hope to aspire for whether you could fundamentally change how one recommends cancer screening for women in relationship to cervical cancer and also the reduction both in men.

Dean Y. Li: And women of many other cancers outside of cervical cancer.

Dean Y. Li: This is Caroline I'll, just add that as we sit here today. We all know there are many many people around the world that have not received the fact seat pension again helped protect them from HPV related cancers.

Caroline Litchfield: Umer, this is Caroline. I'll just add that as we sit here today, we all know there are many, many people around the world that have not received a vaccine to prevent them from, or help protect them from, HPV-related cancers. With the possibility of improving upon G9 with a multivalent vaccine, we're hopeful that we can provide further protection, especially for different population groups, and we will price the vaccine appropriately based on the benefit that it will provide. So we're looking forward to continuing to see growth in Gardasil and seeing how the science evolves with our clinical program. Thank you, Umer. Next question please Shirley.

Caroline Litchfield: With the possibility of improving upon Jeannine wisdom multivalent vaccine. We are hopeful that we can provide further protection, especially for different.

Caroline Litchfield: Population growth and we will price the vaccine appropriately based on the benefit that it will provide so we're looking forward to continuing to see pricing got a sale and see how the science evolves with our clinical programs. Thank.

Peter Dannenbaum: Thank you, Umer. Next question please Shirley.

Umer: Thank you Raimo next question please Shirley.

Operator: Thank you. Our next question comes from Tim Anderson with Wolf Research. You may ask your question. Thank you. I have a few questions on Keytruda Sub-Q. It may not be scientifically sexy, but, of course, it could be quite commercially meaningful. So we'll see that data, I believe, later this year, any risk whatsoever with that readout? Or can we consider it to be a slam dunk?

Operator: Thank you. Our next question comes from Tim Anderson with Wolf Research. You may ask your question.

Operator: Thank you. Our next question comes from Tim Anderson with Wolfe Research you May ask your question.

Timothy Anderson: Thank you. I have a few questions on Keytruda Sub-Q. It may not be scientifically sexy, but, of course, it could be quite commercially meaningful. So we'll see that data, I believe, later this year, any risk whatsoever with that readout? Or can we consider it to be a slam dunk?

Timothy Minton Anderson: Well, thank you Ivor.

Timothy Minton Anderson: A few questions on Keytruda sub Q.

Timothy Minton Anderson: May not be scientifically sexy, but of course, it could be quite commercially meaningful.

Timothy Minton Anderson: So we'll see that data I believe later this year any risk whatsoever to that readout or can we consider it to be a slam dunk.

Dean Y. Li: The second question is, when the sub-Q launches in the US, presumably next year, will uptake be fast or slow or somewhere in between? And then, eventually, how much can a sub-Q account for the franchise, either on a volume or a patient basis? Thank you. So I'll take the first part of that. I remind myself that nothing is a slam dunk once you place innovative drugs in patients. So I'll answer that question. But I think you really highlighted the Pembro plus hyaluronidase that we're advancing, I would disagree a little bit, I do kind of think it's sexy in some ways. And that D770, we will be sharing that data by early 2025. The reason I think it's really an important innovation is to really increase the access. You've seen the number of early stage cancer readouts that are coming through with [inaudible] and Keytruda,

The second question is, when the sub-Q launches in the US, presumably next year, will uptake be fast or slow or somewhere in between? And then, eventually, how much can a sub-Q account for the franchise, either on a volume or a patient basis?

Timothy Minton Anderson: Second question is when the sub Q launches in the U S. Presumably next year, while uptake be fast or slow or somewhere in between.

Dean Y. Li: And then eventually how much kind of sub two account for the franchise either on a volume or a patient basis. Thank you.

Dean Lee: Thank you. So I'll take the first part of that. I remind myself that nothing is a slam dunk once you place innovative drugs in patients. So I'll answer that question. But I think you really highlighted the Pembro plus hyaluronidase that we're advancing, I would disagree a little bit, I do kind of think it's sexy in some ways. And that D770, we will be sharing that data by early 2025. The reason I think it's really an important innovation is to really increase the access. You've seen the number of early stage cancer readouts that are coming through with [inaudible] and Keytruda, and especially in the earlier stages when we talk about 671, when we talk about renal cell carcinoma where we have OS benefit. I think this is going to be really, really important for patients. It will also be important for patients for treatment, especially in those who have monotherapy and those, especially, combos with oral agents because it just makes it so much more accessible. So we think this is an important program and that it could have a substantial impact on patients and their access to PD-1 where we know the foundational elements of PD-1. In terms of financial--

Dean Y. Li: So I'll take the first.

Dean Y. Li: Part of that.

Dean Y. Li: I remind myself nothing is slam-dunk once you place.

Dean Y. Li:

Dean Y. Li: Innovative drugs in patients.

Dean Y. Li: I'll answer that that that question, but I think you highlighted really the Pembroke plus hyaluronidase that we're advancing.

Dean Y. Li: I would disagree a little bit I do kind of think it's sexy in some ways.

Dean Y. Li: And that the 770 <unk> that that we will be sharing that data by early 2025. The reason I think it's really an important innovation is to really increase the access you've seen you know the number of early stage cancer readout that that are that are coming through win with <unk>.

Dean Y. Li: and especially in the earlier stages when we talk about 671, when we talk about renal cell carcinoma where we have OS benefit. I think this is going to be really, really important for patients. It will also be important for patients for treatment, especially in those who have monotherapy and those, especially, combos with oral agents because it just makes it so much more accessible. So we think this is an important program and that it could have a substantial impact on patients and their access to PD-1 where we know the foundational elements of PD-1. In terms of financial--

Dean Y. Li: Elisa mapping keytruda and especially in the earlier stages, when we talked about 671, when we talk about renal.

Dean Y. Li: Renal cell carcinoma, where we have OS benefit I think this is going to be really really important for patients. It will also be important in patients for treatment, especially in those who have monotherapy and those especially combos with oral agents because it just makes it so much more accessible so.

Dean Y. Li: We think this is an important program and that it could have substantial impact on patients and their access to a PD, one where we know the foundational elements of PD one in terms of financial.

Robert M. Davis: Yeah, maybe, Tim, I'll just provide some commentary on your questions on uptake and how much of the patient population this can account for. As we think about uptake of this opportunity, I would first point out that it starts with the strength of the clinical data underlying the I.O agent itself, so it's more about the confidence they have in Keytruda, and then, secondarily, it's about the delivery mechanism, which is important as we think about obviously leveraging the data we have and just the breadth of what Keytruda is. But I will tell you that as we think about bringing this forward when we do launch, our goal will be to price appropriately with the goal of driving quick adoption, so we do want to see adoption happen, and we do think you will see it. Obviously, if you look at the size of the patient population where it could be, just to give you a sense, by 2028, if we look at the patients who are on monotherapy with Keytruda, who are using combinations with orals, and those who are moving into earlier stages of disease through some of our adjuvant and neoadjuvant areas with Keytruda, that represents about 50% of the patient population at that time,

Speaker Change: So maybe Jim if I'll just provide some commentary on your questions on uptake and I'm not sure of the patient population that is going to account for as we think about uptake.

Dean Y. Li: Opportunity.

Dean Y. Li: I would first point out that we see really it starts with the strength of the clinical data underlying the Io agent itself. So it's more about the confidence they have in Keytruda and then secondarily, it's about the delivery mechanism, which is important as we think about obviously leveraging the data we have and just the breadth of what Katrina.

Rob Davis: it's more about the confidence they have in Keytruda, and then, secondarily, it's about the delivery mechanism, which is important as we think about obviously leveraging the data we have and just the breadth of what Keytruda is. But I will tell you that as we think about bringing this forward when we do launch, our goal will be to price appropriately with the goal of driving quick adoption,

Rob Davis: But I will tell you that you know as we think about bringing this forward when we do launch our goal will be to price appropriately with the goal of.

Rob Davis: Driving quick adoption, so we do want to see adoption.

Rob Davis: so we do want to see adoption happen, and we do think you will see it. Obviously, if you look at the size of the patient population where it could be, just to give you a sense, by 2028, if we look at the patients who are on monotherapy with Keytruda, who are using combinations with orals, and those who are moving into earlier stages of disease through some of our adjuvant and neoadjuvant areas with Keytruda, that represents about 50% of the patient population at that time,

Rob Davis: And we do think you will see it obviously.

Robert M. Davis: Obviously, if you look at the size of the patient population where it could be, just to give you a sense, by 2028, if we look at the patients who are on monotherapy with Keytruda, who are using combinations with orals, and those who are moving into earlier stages of disease through some of our adjuvant and neoadjuvant areas with Keytruda, that represents about 50% of the patient population at that time, so that is really the addressable market for what we see the sub-Q offering to be. And potentially, we're not foreclosing the opportunity to also look into the metastatic setting and people given care in institutions as well as those moving outside of the institutions, but, obviously, the value to the patient is ease of use, the ability to use it outside of the hospital setting. The time in the chair is obviously less if you're getting a Sub-Q versus an IV. And then, from a cost to the healthcare system, the ability to not have a patient sitting in the chair for as long, allowing for more patients to move through, we think actually drives access and improves the provision of care as well. So we see it both beneficial from a patient perspective and from a provider perspective, and that's why we do think you'll see uptake of this important medicine when we bring it forward.

Rob Davis: If you look at the size of the patient population, where it could be.

Rob Davis: Just to give you a sense by 2028, if we look at the patients who are on monotherapy with Keytruda, who were using combinations with oracles and those who are moving into earlier stages of disease through some of our adjuvant and neo adjuvant.

Rob Davis: Areas with.

Rob Davis: That represents about 50% of the of the patient population at that time, so that is really the addressable market.

Rob Davis: so that is really the addressable market for what we see the sub-Q offering to be. And potentially, we're not foreclosing the opportunity to also look into the metastatic setting and people given care in institutions as well as those moving outside of the institutions, but, obviously, the value to the patient is ease of use, the ability to use it outside of the hospital setting. The time in the chair is obviously less if you're getting a Sub-Q versus an IV.

Rob Davis: For what we see for sub two offering to be and potentially where all we're not foreclosing the opportunity to also look into the metastatic setting and people being given.

Rob Davis: Given care institutions as well as those moving outside of the institutions, but obviously the value to the patient is ease of abuse the ability to use it outside of the hospital setting.

Rob Davis: And shares obviously less if youre getting a sub Q versus an IV and then from a cost to the health care system, the ability to not have a patient sitting in the chair for his long, allowing for more patients to move through we think actually drives access and improves.

Rob Davis: And then, from a cost to the healthcare system, the ability to not have a patient sitting in the chair for as long, allowing for more patients to move through, we think actually drives access and improves the provision of care as well. So we see it both beneficial from a patient perspective and from a provider perspective, and that's why we do think you'll see uptake of this important medicine when we bring it forward. Thank you, Tim. Next question pleas Shirley.

And then, from a cost to the healthcare system, the ability to not have a patient sitting in the chair for as long, allowing for more patients to move through, we think actually drives access and improves the provision of care as well. So we see it both beneficial from a patient perspective and from a provider perspective, and that's why we do think you'll see uptake of this important medicine when we bring it forward.

Rob Davis: The providing of care as well so we see it both beneficial from a patient perspective and from the provider perspective, and that's why we do think Youll see.

Rob Davis: Uptake of this important medicine, when we bring it forward.

Peter Dannenbaum: Thank you, Tim. Next question please Shirley.

Rob Davis: Thank you Tim next question. Please Sheryl.

Operator: Thank you. Our next question comes from Louise Chen with Cantor. You may ask your question. Hi, thanks for taking my question. Just wanted to ask you, for ASCO on June 3rd are there any specific readouts or updates that you're very excited about presenting? Thanks. I think there's just going to be a stream of data, there's going to be follow-ups and a series of keynotes, whether it be gastric, fat, or cellular, biliary, bladder, or non-small cell lung cancer.

Operator: Thank you. Our next question comes from Louise Chen with Cantor. You may ask your question.

Operator: Thank you. Our next question comes from Louise Chen with Cantor you May ask your question.

Louise Chen: Hi, thanks for taking my question. Just wanted to ask you, for ASCO on June 3rd are there any specific readouts or updates that you're very excited about presenting?

Louise Chen: Hi, Thanks for taking my question I just wanted to ask you for ESCO on June 3rd are there any specific read out updates that youre very excited about presenting thank you.

Dean Lee: Thanks. I think there's just going to be a stream of data, there's going to be follow-ups and a series of keynotes, whether it be gastric, fat, or cellular, biliary, bladder, or non-small cell lung cancer.

Operator: I think theres, just going to be a stream of data, there's going to be follow ups and a series of <unk>.

Operator: Whether it be gastric cellular or below rate bladder non small cell lung cancer there'll be discussions of many of the programs that I think youre beginning to see coming up in the clinical trial website and relationship.

Operator: There'll be discussions of many of the programs that I think you're beginning to see coming up in the clinical trial website in relationship to a whole series of phase III related molecules that you're familiar with, but also molecules that are sort of earlier in our phase three development, ranging from Bomadenstet to the KRAS program to many of the ADCs and the updates that we've shown in relationship to not just the Daiichi Sankyo ADCs but the other ADCs, whether it be [inaudible]. So you'll have a whole range of discussions of those compounds, some at the ASCO, but some at the ASCO Investor Event. Great. Thanks, Louise. I know we have several more people in the queue.

There'll be discussions of many of the programs that I think you're beginning to see coming up in the clinical trial website in relationship to a whole series of phase III related molecules that you're familiar with, but also molecules that are sort of earlier in our phase three development, ranging from Bomadenstet to the KRAS program to many of the ADCs and the updates that we've shown in relationship to not just the Daiichi Sankyo ADCs but the other ADCs, whether it be [inaudible]. So you'll have a whole range of discussions of those compounds, some at the ASCO, but some at the ASCO Investor Event.

Operator: A whole series of phase III.

Operator: <unk>.

Operator: Molecules that you're familiar with but also molecules that are sort of earlier in our.

Operator: In our phase III development.

Operator: <unk> from bomber Danstett.

Operator: The K Ras program to many of the Adcs and the updates that we've shown in relationship to not just the Daiichi sankyo adcs, but the other adcs, whether it be Trump to cloud in our neck in so you'll have a whole full array of discussions of those compounds.

Speaker Change: At the <unk>, but some at the <unk> Investor Best Great. Thanks, Louise I know, we have several more people in the queue. We're gonna go an extra five or 10 minutes to try to get to as many questions as possible next question. Please Shirley thank.

Peter Dannenbaum: Great. Thanks, Louise. I know we have several more people in the queue.

Operator: We're going to go an extra five or ten minutes to try to get to as many questions as possible. Next question, please, Shirley. Thank you. Our next question comes from Trung Huynh with UBS. You may ask your question. Your line is open.

Chong Lin: Thank you. Our next question comes from Trung Nguyen with UBS you May ask your question. Your line is open.

Chong Lin: Hi, guys Trung Nguyen from UBS, Thanks for fitting me in.

Chung Huynh: Hi guys. Chung Huynh from UBS, thanks for fitting me in. On the WINREVAIR launch, thanks for the comments today on access and coverage. On approval, you noted that two-thirds of your PAH patients were likely Part D, a third commercial. Perhaps you could expand on the free assistance program that you're hoping to initiate and what proportion of those Part D patients do you think could be receiving free products this year? Thank you.

Operator: On the wind River launch thanks for the comments today on access and coverage on approval you'd noted that two thirds of your P. A H patients would likely part D and commercial.

Operator: Perhaps can you expand on the free assistance program that youre, hoping to initiate and what proportion of those part D. Patients do you think could be receiving free product. This year. Thank you.

Operator: and what proportion of those Part D patients do you think could be receiving free products this year? Thank you.

Speaker Change: Yeah I appreciate the question so as you point out.

Robert M. Davis: Yeah, I appreciate the question. So, as you point out, we are very focused on ensuring that patients get access to medicine. We're very much committed to it and that's why we do have in addition to our normal programs we would run, we do have the access program we run. That program is actually independent of our commercial operations. We don't really report data coming out of that because it's run through a separate foundation and with the goal, frankly, of making sure that patients get medicines there. So that is available, it can be accessed on our website and we're committed to making sure patients get the medicine, but specifics on that we're not going to go into.

Operator: We are very focused on ensuring that patients get access to the medicine, we're very much committed to it and that's why we do have in addition to our normal programs. We would run we do have the access program. We run that program is actually independent of our commercial operations, we don't really report.

Rob Davis: We don't really report data coming out of that because it's run through a separate foundation and with the goal, frankly, of making sure that patients get medicines there. So that is available. It can be accessed on our website.

Rob Davis: Data coming out of that because it is run through a separate foundation.

Rob Davis: And with a goal of frankly, making sure that patients get medicines. There. So that is available it can be accessed on our website and we're committed to making sure patients get the medicine, but specifics on that we're not going to go into.

Operator: And we're committed to making sure patients get the medicine, but specifics on that we're not going to go into. Great. Thank you, Trung.

Trung: Great. Thank you John next question. Please Shirley.

Operator: Great. Thank you Chung. Next question, please, Shirley. Thank you. Our next question comes from Carter Gould with Barclays. You may ask your question.

Peter Dannenbaum: Great. Thank you Chung. Next question, please, Shirley.

Operator: Thank you. Our next question comes from Carter Gould with Barclays. You may ask your question.

Operator: Thank you and this question comes from Carter Gould with Barclays. You May ask your question.

Carter Lewis Gould: Hi, Good morning, Thanks for squeezing me in maybe on on your personalized cancer vaccine with Madonna as the phase III sort of nears completion of enrollment.

Carter Gould: Good morning. Thanks for squeezing me in. Maybe on your personalized cancer vaccine with Moderna, as the Phase III sort of nears completion of enrollment, it of course begs the question around the potential to sort of file based on the existing data you have. Can you maybe just update us on your thoughts there and whether you think you still need Phase III data, or whether manufacturing would preclude an early filing? Any help there would be appreciated. Thank you.

Operator: Thanks for the question around the potential to file based on the existing data you have could you maybe just update us on your thoughts there and whether you think you still need phase III data or manufacturing would preclude an early early filing any help there would be appreciated. Thank you.

Dean Lee: Yeah, I'll take that. I mean, I don't want to speak about whether the FDA will take any action or not, but I'll just reemphasize to everyone what is exciting about our INT program and our excitement that we're working with Moderna. So here, we're inducing and coaxing some sort of immunity, and we're mixing it with a drug that's well known that unleashes pre-existing immunity, which is Keytruda. What we have in our hands is a randomized, early stage, IO-sensitive trial, where it is very clear, very clear of the contribution of components of the INT, not in immunogenicity, but in clinical benefit. So I just want to highlight that about our data as one looks at the data of others.

Speaker Change: Yeah, I'll take that I mean, I don't want to speak about whether the FDA will take what action or not but I'll just reemphasize to everyone. What is exciting about our <unk> program and our excitement will working with Madonna. So here, we're inducing and coaxing sort of immunity and were Mick.

Dean Y. Li: Thing it with a drug that's well known that in leases preexisting immunity, which is keytruda. What we have in our hands is a randomized early stage I O sensitive trial, where it is very clear very clear of the contribution of components of the I N T.

Dean Y. Li: Not an immunogenicity and clinical benefit so I just want to highlight that about our data as one looks at the data of others. We also have begun to show that we are moving it in phase III in adjuvant melanoma in the adjuvant non small cell lung cancer, and our ability to move that with speed and.

Dean Y. Li: We also have begun to show that we are moving it in phase III and adjuvant melanoma and adjuvant non-small cell lung cancer, and our ability to move that with speed and rigor but get patients recruited, which is going well, I think will be very important, because you're going to need a phase III, regardless of what the FDA decides on an accelerated approval or not. And so that's what we're focused on. We're also focused on looking at other IO sensitive tumors, such as renal cell carcinoma

Dean Y. Li: And rigor, but get Ah patients recruited which is going well.

Dean Y. Li: I think will be very important because youre going to need a phase III, regardless of what the FDA decides on an accelerated approval or not and so that's what we're focused on we're also focused on looking at other I O sensitive.

Dean Y. Li: Tumors, such as renal cell carcinoma, and I would just emphasize the strength of the data in relationship to durability is being answered the ability for us to open these trials and successfully advance it is being answered and we clearly have work to do with our colleagues who we are.

Dean Y. Li: And I would just emphasize the strength of the data in relation to durability is being answered, the ability for us to open these trials and successfully advance them is being answered. And we clearly have work to do with our colleagues, who we respect deeply for what they've done in relation to manufacturing all mRNA vaccine. I mean, they've really pushed the envelope here. Our ability to do that will be important to make this an important treatment. As far as the FDA's decision, the FDA will need to make its decision as to how they consider the opportunity.

Dean Y. Li: Deeply for what they've done in relationship to manufacturing any all mrna vaccine.

Dean Y. Li: They've really pushed the envelope here the our ability to do that will be will be important to make this an important treatment as for as far as the fda's decision. The FDA will need to make their decision as to how they consider the opportunity.

Operator: Great. Thank you, Carter. Next question please, Shirley. Thank you. Our next question comes from Chris Schott with J.P. Morgan, you may ask your question. One moment, please.

Peter Dannenbaum: Great. Thank you, Carter. Next question please, Shirley.

Speaker Change: Thank you Carter next question please Shirley.

Operator: Thank you. Our next question comes from Chris Schott with J.P. Morgan, you may ask your question. One moment, please.

Operator: Thank you. Our next question comes from Chris Schott with Jpmorgan you May ask your question.

Speaker Change: One moment please.

Christopher T. Schott: Great. Just a couple of Gardasil questions. You're pointing to more evenly distributed Chinese sales this year, and it seems like a tougher 2Q comp, but can you just directionally talk about growth for Gardasil more broadly for the year? I guess the heart of it is still a healthy growth asset for you this year. And the second one on Gardasil is, if we were to move to a single dose of Gardasil 9, what does that mean commercially and from a sales perspective for the franchise? Thanks so much.

Chris Schott: Great just a couple of gardasil questions, you're pointing to a more evenly distributed China sales this year and it seems like a tougher <unk> comp, but can you just directionally talk about growth, regardless, so more broadly for the year I guess the heart of it is still a healthy growth asset for you this year.

Caroline Litchfield: The second one on Gardasil as if we were to move to a single dose of Gardasil nine what does that mean commercially and from a sales perspective for the for the franchise. Thanks. So much.

Caroline Litchfield: Hi, Chris It's Caroline.

Caroline Litchfield: Hi Chris, it's Caroline. So in terms of the phasing of Gardasil, as you pointed out, during 2023, we saw in China an acceleration of shipment from the second half of the year to the first half of the year, specifically to the second quarter. What that's done is it's provided an actual tailwind to revenue growth in the first quarter for China, but it will provide a more significant headwind in the second quarter and that's what we've called out.

Caroline Litchfield: In terms of the phasing of Gardasil as you pointed out during 2023, we saw in China and acceleration of the shipments from the second half of the year.

Caroline Litchfield: First half of the year, specifically to the second quarter. What that's done is it provided an actual tailwind to revenue growth in the first quarter for China, but it will provide a headwind most significant in the second quarter and that's what we've called out as we look at.

Caroline Litchfield: As we look at overall growth for Gardasil, given where we are with the level of vaccinations across the world, given the manufacturing that we have been scaling up, we're confident in our ability to continue to drive growth during 2024. And in 2025, we will see our manufacturing capacity unconstrained, so enabling us to further supply and support the market. As we've talked in the past, our opportunities for growth are significant as we look to continue to improve on adolescent vaccination rates, as we look to improve gender-neutral vaccinations, as we look to really activate the mid-adult segment, but increasingly get to the lower-income and middle-income markets, which will come at a different price point.

Caroline Litchfield: Overall gross haggadist sale, given where we are with the level of vaccinations across the world given the manufacturing that we have been scaling up with confident in our ability to continue to drive growth during 2024 and in 2025, we will see our map.

Caroline Litchfield: Any factory capacity unconstrained so innate.

Caroline Litchfield: Enabling us to further supply and support the market as we've talked in the past our opportunities for growth are significant as we look to continue to improve on adolescent vaccination rates as we look to improve upon gender neutral vaccination.

Caroline Litchfield: We look to really activate and meet adult segment, but increasingly get to the lower income and middle income markets, which will come at a different price point.

Caroline Litchfield: As we sit here today, we continue to be confident in the outlook for Gardasil over both the near and the long term. As we look at the possibility of a single dose of Gardasil, the study that we are conducting will be a comprehensive study and will take some time to unfold.

Caroline Litchfield: As we sit here today continue to be confident in the outlook for Gardasil I suppose the knee and for long time as we look at the possibility of a single dose of <unk> got to sell the study that we are conducting will be a comprehensive study and we will take some time to unfold what we're seeing in the market place currently is.

Caroline Litchfield: What we're seeing in the marketplace currently is where certain low-income markets are implementing a single dose regimen, they are also increasing the numbers that they are vaccinating by broadening the age cohort or also opting to vaccinate males at this stage. We'll have to see long term how the data plays out with regard to a single dose to ensure that we will price our vaccine based on the benefit that we're bringing and we vaccinate as many people in the world that we can.

Caroline Litchfield: We're assessing low income markets are implementing a single dose.

Caroline Litchfield: Rich and then they are also increasing the numbers of people. They are vaccinating by broadening the age cohort or also opting to vaccinate miles at this stage, we'll have to see long term how the data plays out with regards to a single dose to ensure that we will price.

Caroline Litchfield: Salt vaccine based on the benefit that we're bringing and we vaccinate as many people in the world that we can.

Operator: Great. Thank you Chris. Next question please, Shirley. Thank you. Our next question comes from Luisa Hector of Barenburg. You may ask your question. Thank you very much. I also have questions on the WINREVAIR launch. I just wanted to check how straightforward the subcutaneous administration is and when you might expect to launch an autoinjector. Also, should we actually expect Part D access to come online at a similar pace as commercial?

Great. Thank you Chris. Next question please, Shirley. Thank you. Our next question comes from Luisa Hector of Barenburg. You may ask your question.

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

Operator: Thank you. Our next question comes from Luisa Hector of Barenburg. You may ask your question.

Speaker Change: Great. Thank you Chris next question. Please Shirley thank.

Operator: Thank you. Our next question comes from Luisa Hector with Bamberg you May ask your question.

Luisa Hector: Thank you very much. I also have questions on the WINREVAIR launch. I just wanted to check how straightforward the subcutaneous administration is and when you might expect to launch an autoinjector. Also, should we actually expect Part D access to come online at a similar pace as commercial? I'm just not sure whether that's something that's maybe fitting more into next year. And if I can, just another question on all of that with Part D is that you price for the Part D restructure next year, how do you expect payers to behave when this happens?

Luisa Hector: Thank you very much I also have questions on the <unk> launch and just wanted to check how straightforward the subcutaneous administration and and when you might expect to launch an auto injector.

Operator: Also should we should we actually expect the part D access to come online.

Luisa Hector: At a similar pace of commercial I'm, just not sure whether that something that maybe sitting more into next year.

Dean Y. Li: I'm just not sure whether that's something that's maybe fitting more into next year. And if I can, just another question on all of that with Part D is that you price for the Part D restructure next year, how do you expect payers to behave when this happens?

Luisa Hector: And if I can, just another question on all of that with Part D is that you price for the Part D restructure next year, how do you expect payers to behave when this happens? I can see that the payer will take on a greater burden for higher-priced oral therapies. Do you expect some pushback within the actual drug itself, that you would have higher rebates at that point? Or do you think that incremental burden for the payers might be spread more broadly across all products? It's a kind of bigger picture question [inaudible] brings it into focus. Thank you.

Dean Y. Li: And if I can just another question on all of that with part D is that you price for the part D restructuring next year.

Dean Y. Li: How do you expect.

Dean Y. Li: To behave well.

Dean Y. Li: When this happens.

Caroline Litchfield: I can see that the payer will take on a greater burden for higher-priced oral therapies. Do you expect some pushback within the actual drug itself, that you would have higher rebates at that point? Or do you think that incremental burden for the payers might be spread more broadly across all products? It's a kind of bigger picture question [inaudible] brings it into focus. Thank you.

Dean Y. Li: I can see that the payout will take on a greater burden for high priced Oh therapies.

Caroline Litchfield: Do you expect some pushback within the actual drug that you would have higher rebates at that point or do you think that incremental biogen pay.

Caroline Litchfield: Payers might be spread more broadly.

Caroline Litchfield: <unk>, who will put up since it's a kind of bigger picture question back.

Speaker Change: When was that brings into okay. Thank you.

Dean Lee: Thank you. So this is Dean, I'll answer your questions in terms of delivery of WINREVAIR. We have it in a vial, and we have it in a situation where both a health care provider or self administration is both feasible, possible, and will be used. We believe that the vast majority, with time, that people will use it for self-administration. This is a patient population that is quite used to doing injections, so we think that they will be able to navigate, and that patients will get access. But as you point out, further innovation will be demanded for and an auto-injector will be critically important. We are doing the studies right now to evaluate how we can provide such an option, and we hope to have those options and those plans more public in the near future. But we agree with you totally on the fact that a future auto-injector will be important.

Dean Y. Li: So this is Dan I'll answer your questions in terms of delivery of of when we're there.

Dean: We have it in a vial and we have it in a situation where both a health care provider or self administration is is both feasible possible and will be used we believe that the vast majority with time that people will use it as self administration. This is a patient population.

Dean Y. Li: We believe that the vast majority, with time, will use it for self-administration. This is a patient population that is not quite used to doing injections, so we think that they will be able to navigate, and that patients will get access, but as you point out, further innovation will be demanded, and an auto-injector will be critically important. We are doing the studies right now to evaluate how we can provide such an option, and we hope to have those options and those plans more public in the near future, but we agree with you totally on the fact that a future auto-injector will be important.

Dean Y. Li: That's that's quite used to doing.

Dean Y. Li: Injection, so we think that that will be.

Dean Y. Li: Able to navigate and that the patients will get access, but as you point out further innovation will be.

Dean Y. Li: Demanded for in an auto injector will be critically important and we are doing the studies right now to evaluate how do we.

Dean Y. Li: Provides such an option and we hope to have those options and those those plans more public in the in the near future, but we agree with you totally and the fact that in future auto injector will be important.

Caroline Litchfield: And Luisa, this is Caroline. At this stage, we are seeing a real acceptance of the value proposition of WINREVAIR in the United States. We're seeing policies for coverage equally across both the Medicare and Medicaid patient population, as well as the commercial segment. So as we move forward, we'll look forward to just helping as many patients as we can across all of those segments, regardless of their coverage. Great. Thank you, Luisa. Next question, please Shirley. This will be our last question.

Dean Y. Li: And the way that this is Caroline at this stage, we are seeing a real acceptance of the value proposition of wind river in the United States, We're seeing a policy for tougher H equally across both the Medicare and Medicaid patient population as well as the commercial segment.

Caroline Litchfield: So as we move forward, we'll look forward to just helping as many patients as we can across all of those segments, regardless of their coverage. Great. Thank you, Luisa. Next question, please, Shirley.

Caroline Litchfield: So as we move forward, we'll look forward to just helping as many patients as we can across all of those segments irrelevant of that coverage.

Peter Dannenbaum: Great. Thank you, Luisa. Next question, please Shirley. This will be our last question.

Speaker Change: Great. Thank you Luisa next question please Shirley.

Operator: Thank you. Our next question comes from Seamus Fernandez with Guggenheim. You may ask your question.

Speaker Change: We have time for this will be our last question.

Operator: Thank you. Our next question comes from Seamus Fernandez with Guggenheim You May ask your question.

Seamus Fernandez: Thanks, so much so wanted to ask actually about your RSV targeted antibody.

Seamus Fernandez: Oh, thanks so much. So I wanted to ask you actually about your RSV targeted antibody, how you're thinking about that, the optionality for it, and the market side and Merck's potential participation in this market as it relates to the competitor's global supply constraints at this point in time. It seems like coming to market more aggressively or as aggressively as possible could actually make for a meaningful market opportunity for Merck. And then, just a follow-up, Rob, why don't you just get your sort of qualitative view, three years, four years in, thinking about the evolution of the business, 2028, 2029 still represents a meaningful challenge with Keytruda but as you look forward to the rest of this year and heading into 2025, how important is business development to Merck from here in terms of the size and type of acquisitions? I think investors have certainly applauded what Merck has executed on in the last year for sort of mid to later stage assets. Thanks so much.

Dean Y. Li: How youre thinking about that the optionality for it.

Dean Y. Li: And the market size and merck's potential participation in this market.

Dean Y. Li: As it relates to the competitors global supply constraints at this point in time, it seems like coming to market more aggressively.

Dean Y. Li: Or as aggressively as possible.

Dean Y. Li: Could it actually.

Dean Y. Li: Make for a meaningful market opportunity for Merck and then just a follow up Rob.

Dean Y. Li: I wanted to just get your sort of qualitative view you know three years four years and I'm.

Dean Y. Li: Thinking about the.

Dean Y. Li: Evolution of the business.

Dean Y. Li: 28, 2029 still represents a meaningful challenge with Keytruda, but as you look forward to the rest of.

Dean Y. Li: but as you look forward to the rest of this year and heading into 2025, how important is business development to Merck from here in terms of the size and type of acquisitions? I think investors have certainly applauded what Merck has executed on in the last year for sort of mid to later stage assets. Thanks so much.

Dean Y. Li: This year and heading into 2025, how important is business development to Merck from here in terms of the size and type of acquisitions I think investors have certainly applauded what Merck has executed on.

Dean Y. Li: In the last year.

Dean Y. Li: Poor sort of mid to later stage assets. Thanks, so much.

Dean Lee: Yeah, so I'll take the RSV question. So [inaudible] we're excited about it. As many people know, it's a monoclonal antibody, and it's a way to get passive immunity to infants. We think it's really important, as we have seen recently. And ours is a single fixed dose, and it has the durability in terms of covering a whole RSV season, which I think is critically important and the ability to give this to an infant at any time versus, for example, alternative strategies, which is maternal vaccination.

Speaker Change: Yeah, So I'll take the RSV question.

Speaker Change: So class roadmap, we're excited about it as many of the people know, it's a monoclonal antibody and it's a way to get passive immunity to infants.

Dean Y. Li: We think it's really important, as we have seen recently. And ours is a single fixed dose, and it has, you know, the durability in terms of covering a whole RSV season, which I think is critically important. And the ability to give this to an infant at any time versus, for example, alternative strategies, which are maternal vaccination.

Speaker Change: We think it's really important.

Dean Y. Li: We have seen recently.

Dean Y. Li: And ours is a single fixed dose and it has.

Dean Y. Li:

Dean Y. Li: The durability in terms of covering a whole RSV season, I think is critically important and the ability to give this to.

Dean Y. Li: And infant anytime and versus for example, alternative strategies, which is maternal vaccination.

Dean Y. Li: And then also, we believe that this will be a distinguished monoclonal antibody, and it has a high barrier to resistance. So we're excited about moving and seeing that data and moving with both speed and rigor to get this to the market because we think it will be an important contributor, especially given what we've seen in the RSV season just this past season. I do want to just take this one moment to just say it's not just the RSV vaccine that we're very excited about. We're also very excited because it's very much in the lay press about our Dengue V181, which is a live attenuated tetravalent vaccine. And we're moving with equal eagerness to move that forward into phase III, as we've already seen data from our colleagues at the Institute Butantan about the effectiveness and efficacy of this vaccine. But I'll turn it back to Rob.

Dean Y. Li: And then also we believe that this will distinguish.

Dean Y. Li: Distinguished a.

Dean Y. Li: Monoclonal antibody and its high barrier to resistance. So we're excited about moving and you're seeing that data and moving with with both speed and rigor to get this to the market because we think it will be an important contributor.

Dean Y. Li: Especially given what we've seen in the RSP season, just this past season I do want to just take this one moment to just say, it's not just the RSV vaccine that we're very excited we're also very excited because it's very much in the in the lay press in our dengue the $1 81, which is a live attenuated Petro valent vaccine.

Dean Y. Li: We're also very excited because it's very much in the lay press about our Dengue V181, which is a live attenuated tetravalent vaccine. And we're moving with equal eagerness to move that forward into phase three, as we've already seen data from our colleagues at the Institute Butantan about the effectiveness and efficacy of this vaccine. But I'll turn it back to Rob.

Rob Davis: And we're moving with with with with equal eagerness to move that forward into phase III as we've already seen data from our <unk> colleagues.

Dean Y. Li: Colleagues and Institute <unk> about the effectiveness and efficacy of this vaccine.

Dean Y. Li:

Dean Y. Li: Turn it back to Rob Yes, no. Thanks for the question and.

Robert M. Davis: Yeah, no, thanks for the question. So I would just kind of, I guess, think a little bit about where we've been over the last three years, there are a few points I would want to raise. One, I think we've made tremendous progress in a relatively short period of time. And I give all credit to Dean, to our R&D colleagues, for what they've been able to do, how they have been able to really move just flawlessly products through our pipeline. It's amazing when you think about it, we're three years in and we haven't had really any major failures. The one maybe hiccup was with [inaudible] but that's coming back and so I feel very proud of what our colleagues in R&D have been able to do. And then I think about from a commercial perspective, from a manufacturing perspective, we're pulling the products through, we're showing the fact that we're ready for the launch with WINREVAIR shows how we can build capability very quickly. We did it in Keytruda, we did it in Genuvia, now we're doing it in WINREVAIR, and we'll do it in new spaces going forward, so I feel very good about that. So, across all elements, R&D, commercial, manufacturing, the business of delivering. And so, as we sit here today, if our clinical success continues, I think you're going to see us with a more diversified set of growth drivers over time than, frankly, we've had in many years, if ever. And that's very important and it all really what leads to the confidence you've heard me express in other settings that I'm increasingly less focused on 2028. And I would remind you, by the way, it's a staggered LOE so it's 2028 in the U.S. and China, it's 2031 in Europe and 2032 in Japan. So it's not a one moment event, it actually happens over time.

Rob Davis: So if I would just kind of I guess.

Rob Davis: I think a little bit about where we've been in over the last three years, a few points I would want to rates.

Rob Davis: One, I think we've made tremendous progress in a relatively short period of time. And I give all credit to Dean, to our R&D colleagues, for what they've been able to do, how they have been able to really move just, [inaudible] Winn-Rivera shows how we can build capability very quickly. We did it in Katruda. We did it in Geneva. Now we're doing it in Winn-Rivera, and we'll do it in new spaces going forward. So, I feel very good about that. So, across all elements, R&D, commercial, manufacturing, the business of delivering. And so, as we sit here today, if our clinical success continues, I think you're going to see us with a more diversified set of growth drivers over time than, frankly, we've had in many years, if ever. And that's very important, and it all really what leads to the competence you've heard me express in other settings, that I'm increasingly less focused on 2028. And I would remind you, by the way, it's a staggered LOE. So, it's 2028 in the U.S. and China. It's 2031 in Europe and 2032 in Japan. So it's not a one-off. It actually happens over time.

Rob Davis: One.

Rob Davis: I think we've made tremendous progress in a relatively short period of time and I give all credit to dean to our R&D colleagues.

Rob Davis: What they've been able to do how they have been able to really move.

Rob Davis: Just.

Rob Davis: Flawlessly products through our pipeline, it's amazing you're thinking of it now three years and we haven't had really any major failures. The one maybe hiccup with his long career, but that's coming back.

Rob Davis: And so I feel very proud of what our colleagues in R&D have been able to do and then I think about from a commercial perspective from a manufacturing perspective, we're pulling the products through we're showing value the.

Robert M. Davis: And then I think about from a commercial perspective, from a manufacturing perspective, we're pulling the products through, we're showing the fact that we're ready for the launch with WINREVAIR shows how we can build capability very quickly. We did it in Keytruda, we did it in Genuvia, now we're doing it in WINREVAIR, and we'll do it in new spaces going forward, so I feel very good about that. So, across all elements, R&D, commercial, manufacturing, the business of delivering. And so, as we sit here today, if our clinical success continues, I think you're going to see us with a more diversified set of growth drivers over time than, frankly, we've had in many years, if ever. And that's very important and it all really what leads to the confidence you've heard me express in other settings that I'm increasingly less focused on 2028. And I would remind you, by the way, it's a staggered LOE so it's 2028 in the U.S. and China, it's 2031 in Europe and 2032 in Japan. So it's not a one moment event, it actually happens over time.

Rob Davis: We did it in Geneva. Now we're doing it in Winn-Rivera, and we'll do it in new spaces going forward. So, I feel very good about that. So, across all elements, R&D, commercial, manufacturing, the business of delivering. And so, as we sit here today, if our clinical success continues, I think you're going to see us with a more diversified set of growth drivers over time than, frankly, we've had in many years, if ever. And that's very important, and it all really what leads to the competence you've heard me express in other settings, that I'm increasingly less focused on 2028. And I would remind you, by the way, it's a staggered LOE. So, it's 2028 in the U.S. and China. It's 2031 in Europe and 2032 in Japan. So it's not a one-off. It actually happens over time.

Rob Davis: The fact that we're ready for the launch with with when we're there shows how we can build capabilities very quickly we did it in Keytruda. We did it in Januvia now we're doing it and when we are there and we'll do the new spaces coming forward. So feel very good about that so across all elements R&D commercial.

Rob Davis: <unk> business is delivering and so as we sit here today.

Rob Davis: And so, as we sit here today, if our clinical success continues, I think you're going to see us with a more diversified set of growth drivers over time than, frankly, we've had in many years, if ever. And that's very important, and it all really what leads to the competence you've heard me express in other settings, that I'm increasingly less focused on 2028. And I would remind you, by the way, it's a staggered LOE. So, it's 2028 in the U.S. and China. It's 2031 in Europe and 2032 in Japan. So it's not a one-off. It actually happens over time.

Rob Davis: If our clinical success continues I think youre going to see us with a more diversified set of growth drivers over time, then frankly, we've had in many years if ever and that's very important and it all is really what leads to the confidence you've heard me express in other settings that I'm in.

Rob Davis: Increasingly less focused on 2020, and I would remind you by the way it's a staggered low.

Rob Davis: So it's 2028 in the U S and China, It's 2031 in Europe in 2032 in Japan. So it's not a it's not a one moment event it actually happens over time, but that being said as you've heard me say I see.

Rob Davis: But that being said, as you've heard me say, I see it as more of a hill than a cliff, and my confidence that we're going to come back with fast growth after that is very high and we're very focused on the sustainable engine from 2030 to 2040 at this point. So, I feel good about where we are, but I just want to reinforce that it's a team effort and I've been blessed with a great team.

Rob Davis: It is more of a hill than a cliff and my confidence so we're going to come back with fast growth after that.

Rob Davis: Is very high and we're very focused on the sustainable engine from 2030 to 2040 at this point. So I feel good about where we are but I just want to reinforce it's a team effort.

Seamus Fernandez: Great. Thank you, Seamus, and thank you all for your time and your interest today. I'm hoping to see many of you at our ASCO event on June 3rd, or at a few of the conferences that we'll be attending this quarter. So, thank you all very much. Thank you. And that does conclude today's conference. We thank you for your participation. At this time, you may disconnect your line.

Peter Dannenbaum: Great. Thank you, Seamus, and thank you all for your time and your interest today. I'm hoping to see many of you at our ASCO event on June 3rd, or at a few of the conferences that we'll be attending this quarter. So, thank you all very much.

Seamus Fernandez: I have been blessed with a great team.

Speaker Change: Great. Thank you Seamus and thank you all for your time and your interest today I'm, hoping to see many of you at our <unk> event on June 3rd or a few of the conferences that we'll be attending this quarter. So thank you all very much.

Operator: Thank you. And that does conclude today's conference. We thank you for your participation. At this time, you may disconnect your line.

Seamus Fernandez: Thank you and that does conclude today's conference. We thank you for your participation at this time you may disconnect your lines.

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