Merck Q4 2025 Merck & Co Inc Earnings Call | AllMind AI Earnings | AllMind AI
Q4 2025 Merck & Co Inc Earnings Call
Speaker #1: At this time, if you'd like to ask a question, you may press star one on your phone and record your name at the prompt. This call is being recorded.
Speaker #1: If you have any objections, you may disconnect at this time. I would now like to turn the conference over to Mr. Peter Dannenbaum. Senior Vice President, Investor Relations, sir, you may begin.
Relations. Sir, you may begin.
Peter Dannenbaum: Thank you, Shirley, and good morning, everyone. Welcome to the Q4 2025 Conference Call from Merck & Co., Inc., Rahway, New Jersey, USA. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer; Caroline Litchfield, Chief Financial Officer; and Dr.
Speaker #2: Thank you, Shirley, and good morning, everyone. Welcome to the fourth quarter 2025 conference call from Merck & Co., Inc., Rahway, New Jersey, USA. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer; Caroline Litchfield, Chief Financial Officer; and Dr. Dean Li, President of Merck Research Labs.
Robert M. Davis: Dean Li, President of Research Labs. Before we get started, I'd like to point out that we have items in our GAAP results such as acquisition-related charges, restructuring costs, and certain other items that we have excluded from our non-GAAP results. There is a reconciliation in our press release. I will also 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 our company'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.
Dean Li, President of Research Labs. Before we get started, I'd like to point out that we have items in our GAAP results such as acquisition-related charges, restructuring costs, and certain other items that we have excluded from our non-GAAP results. There is a reconciliation in our press release. I will also 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 our company'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.
Speaker #2: Before we get started, I'd like to point out that we have items in our gap results, such as acquisition-related charges, restructuring costs, and certain other items that we have excluded from our non-gap results.
Speaker #2: There is a reconciliation in our press release. I will also 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.
Speaker #2: Private Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of our company's management and our subject to significant risks and uncertainties.
Speaker #2: If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A and the 2024 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.
Robert M. Davis: Our SEC filings, including Item 1A and the 2024 10-K, identify certain risk factors in 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 & Co., Inc., Rahway, New Jersey, US undertakes no obligation to publicly update any forward-looking statements. During today's call, a slide presentation will accompany our speaker's prepared remarks. These slides, along with the earnings release, today's prepared remarks, and our SEC filings are all posted to the Investor Relations section of our company's website. With that, I'd like to turn the call to Rob. Thanks, Peter. Good morning, and thank you for joining today's call. Our company's purpose to save and improve lives guides everything we do.
Our SEC filings, including Item 1A and the 2024 10-K, identify certain risk factors in 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 & Co., Inc., Rahway, New Jersey, US undertakes no obligation to publicly update any forward-looking statements. During today's call, a slide presentation will accompany our speaker's prepared remarks. These slides, along with the earnings release, today's prepared remarks, and our SEC filings are all posted to the Investor Relations section of our company's website. With that, I'd like to turn the call to Rob.
Speaker #2: Merck & Company Incorporated, Raleigh, New Jersey USA, undertakes no obligation to publicly update any forward-looking statements. During today's call, a slide presentation will accompany our
Speaker #1: Speakers' prepared remarks, these slides, and the earnings release—as well as today's prepared remarks and our SEC filings—are all posted to the Investor Relations section.
Speaker #1: Are all posted to the Investor Relations section of our company's website . With that , I'd like to turn the call to Rob Thanks , .
Robert Davis: Thanks, Peter. Good morning, and thank you for joining today's call. Our company's purpose to save and improve lives guides everything we do.
Speaker #1: Peter .
Speaker #2: , and Good morning thank you for joining today's call . Our company's purpose to save and improve Lives guides everything we do . In 2025 , we advanced key programs across all phases of development , furthering our mission to deliver transformative medicines and vaccines that will improve health outcomes for patients around the world .
Robert M. Davis: In 2025, we advance key programs across all phases of development, furthering our mission to deliver transformative medicines and vaccines that will improve health outcomes for patients around the world. I'm very proud of the significant progress we are making. As we look ahead, we'll remain intently focused on bringing forward breakthrough science and innovation, which is the foundation for creating sustainable, long-term value for both patients and shareholders. The transformation of our portfolio is well underway, and momentum is building as we continue to execute on our strategy. In 2025, our business benefited from successful new product launches, the advancement of important clinical programs, and the expansion of our respiratory and infectious disease portfolios through the acquisitions of Verona Pharma and Cidara Therapeutics.
In 2025, we advance key programs across all phases of development, furthering our mission to deliver transformative medicines and vaccines that will improve health outcomes for patients around the world. I'm very proud of the significant progress we are making. As we look ahead, we'll remain intently focused on bringing forward breakthrough science and innovation, which is the foundation for creating sustainable, long-term value for both patients and shareholders. The transformation of our portfolio is well underway, and momentum is building as we continue to execute on our strategy. In 2025, our business benefited from successful new product launches, the advancement of important clinical programs, and the expansion of our respiratory and infectious disease portfolios through the acquisitions of Verona Pharma and Cidara Therapeutics.
Speaker #2: I'm very proud of the significant progress we are making . And as ahead , we'll we look remain intently focused on bringing forward breakthrough science and innovation , which is the foundation for creating sustainable , long term value for both patients and shareholders .
Speaker #2: The transformation of our portfolio is well underway, and momentum is building as we continue to execute on our strategy in 2025. Our business benefited from successful new product launches.
Speaker #2: The advancement of important clinical programs , and the expansion of our respiratory and infectious disease portfolios through the acquisitions of Verona Pharma and Cidara Therapeutics .
Robert M. Davis: As a result of this progress, we now have line of sight to over $70 billion of potential commercial opportunity by the mid-2030s, $20 billion more than just a year ago and more than double consensus 2028 peak Keytruda revenue of $35 billion. While we still have more to do, this meaningful progress further bolsters my already high confidence in our ability to deliver sustainable growth post the Keytruda LOE period. Now, turning to our results and initial outlook for 2026. Growth in 2025 reflects demand for an innovative portfolio, including for Keytruda, which continues to benefit more patients with cancer globally, increasing contributions from new launches in cardiometabolic and respiratory, as well as vaccines, and strong performance of animal health. We're well positioned to achieve commercial success across key products in 2026 while we make important investments behind our new product launches and expanded pipeline, which Caroline will speak to momentarily.
As a result of this progress, we now have line of sight to over $70 billion of potential commercial opportunity by the mid-2030s, $20 billion more than just a year ago and more than double consensus 2028 peak Keytruda revenue of $35 billion. While we still have more to do, this meaningful progress further bolsters my already high confidence in our ability to deliver sustainable growth post the Keytruda LOE period. Now, turning to our results and initial outlook for 2026. Growth in 2025 reflects demand for an innovative portfolio, including for Keytruda, which continues to benefit more patients with cancer globally, increasing contributions from new launches in cardiometabolic and respiratory, as well as vaccines, and strong performance of animal health. We're well positioned to achieve commercial success across key products in 2026 while we make important investments behind our new product launches and expanded pipeline, which Caroline will speak to momentarily.
Speaker #2: As a result of this progress , we now have line of sight to over $70 billion of potential commercial opportunity by the mid 2030s .
Speaker #2: $20 billion more than just a year ago, and more than double consensus 2028 peak Keytruda revenue of $35 billion. While we still have more to do, this meaningful progress further bolsters my already high confidence in our ability to deliver sustainable growth.
Speaker #2: Post the Keytruda low period . Now , turning to our results and initial outlook for 2026 . Growth in 2025 reflects demand for our innovative portfolio , including for Keytruda , which continues to benefit more patients with cancer globally , increasing contributions from new launches in cardiometabolic and respiratory , as well as vaccines and strong performance of animal health We're well .
Speaker #2: positioned to achieve commercial success across key products in 2026 , while we make important investments behind our new product launches and expanded pipeline , which Caroline will speak to momentarily .
Robert M. Davis: Our research colleagues continue to achieve remarkable progress across our broad and deep pipeline. Focusing on a few key events from Q4: In cardiometabolic and respiratory, at AHA, we presented phase 3 results for MK-0616 that underscore the practice-changing potential of an oral PCSK9 inhibitor. Cardiovascular disease is the leading cause of death globally, and we look forward to bringing a potential new option to help address the CV epidemic. For Winrevair, we announced phase 2 top-line findings from the CADENCE trial that are supportive of its continued development in a different type of pulmonary hypertension. And building on recent momentum in HIV, we shared positive top-line results for islatravir in combination with doravirine for treatment-naïve adults living with HIV.
Our research colleagues continue to achieve remarkable progress across our broad and deep pipeline. Focusing on a few key events from Q4: In cardiometabolic and respiratory, at AHA, we presented phase 3 results for MK-0616 that underscore the practice-changing potential of an oral PCSK9 inhibitor. Cardiovascular disease is the leading cause of death globally, and we look forward to bringing a potential new option to help address the CV epidemic. For Winrevair, we announced phase 2 top-line findings from the CADENCE trial that are supportive of its continued development in a different type of pulmonary hypertension. And building on recent momentum in HIV, we shared positive top-line results for islatravir in combination with doravirine for treatment-naïve adults living with HIV.
Speaker #2: Our research colleagues continue to achieve remarkable progress across our broad and deep pipeline , focusing on a few key events from the fourth quarter and cardiometabolic and respiratory .
Speaker #2: At . We presented phase three results for enlisted . That underscore the practice changing potential of an oral Pcsk9 inhibitor . Cardiovascular disease is the leading cause of death globally , and we look forward to bringing a potential new option to help address the CV epidemic for when .
Speaker #2: We announced Phase Two top-line findings from the Cadence trial that are supportive of its continued development in a different type of pulmonary hypertension and building on recent momentum in HIV.
Speaker #2: We shared positive top line results for Islatravir in combination with Doravirine for treatment , naive adults living with HIV . Finally , we're pleased that both enlisted and SACC tmt our investigational trop2 directed antibody drug conjugate , were granted commissioners national priority vouchers by the FDA .
Robert M. Davis: Finally, we're pleased that both MK-0616 and Sac-TMT, our investigational TROP2-directed antibody-drug conjugate, were granted Commissioner's National Priority Vouchers by the FDA, which may expedite review of these important investigational candidates after applications are filed. We recently completed the acquisition of Cidara, which complements our portfolio and builds on our long legacy in combating infectious diseases. MK-1406, formerly CD388, is a potentially first-in-class, long-acting antiviral candidate designed to help prevent influenza infection in individuals at higher risk of developing serious complications. There is a substantial unmet need for influenza prevention in a large at-risk population, and Phase 2 results were very promising. We believe MK-1406 has greater than $5 billion in revenue potential and can be a meaningful driver of growth later this decade and through the next. We're excited to welcome the Cidara team to our company and look forward to advancing this novel preventative antiviral agent.
Finally, we're pleased that both MK-0616 and Sac-TMT, our investigational TROP2-directed antibody-drug conjugate, were granted Commissioner's National Priority Vouchers by the FDA, which may expedite review of these important investigational candidates after applications are filed. We recently completed the acquisition of Cidara, which complements our portfolio and builds on our long legacy in combating infectious diseases. MK-1406, formerly CD388, is a potentially first-in-class, long-acting antiviral candidate designed to help prevent influenza infection in individuals at higher risk of developing serious complications. There is a substantial unmet need for influenza prevention in a large at-risk population, and Phase 2 results were very promising. We believe MK-1406 has greater than $5 billion in revenue potential and can be a meaningful driver of growth later this decade and through the next. We're excited to welcome the Cidara team to our company and look forward to advancing this novel preventative antiviral agent.
Speaker #2: Which may expedite review of these important investigational candidates after applications are filed . We recently completed the acquisition of Cidara , which complements our portfolio and builds on our long legacy in combating infectious diseases .
Speaker #2: MK 1406 , formerly CD 88 , is a potentially first in class long acting antiviral candidate designed to help prevent influenza infection in individuals at higher risk of developing serious complications .
Speaker #2: There is a substantial unmet need for influenza prevention in a large at risk population , and phase two results were very promising . We believe MK 1406 has greater than $5 billion in revenue potential and can be a meaningful driver of growth later this decade and through the next .
Speaker #2: We're excited to welcome the team to our company and look forward to advancing this novel preventative antiviral agent today. Our business is anchored by an important set of commercial products that address critical unmet needs.
Robert M. Davis: Today, our business is anchored by an important set of commercial products that address critical unmet needs. We're also executing on the transformation of our portfolio with initial launches from over 20 potential new growth drivers that have the promise to advance the practice of medicine and change patient lives. 10 of these programs could be substantially clinically de-risked over the next 2 years and represent the majority of our $70 billion of non-risk-adjusted commercial opportunity by the mid-2030s. Our long-term outlook is further bolstered by the strong growth we expect in our animal health business, by the many early-phase programs that will enter phase 2 in the near term, and through additional potential science-led, disciplined, and value-enhancing business development. We're entering a particularly robust period of first-time phase 3 data readouts from novel candidates.
Today, our business is anchored by an important set of commercial products that address critical unmet needs. We're also executing on the transformation of our portfolio with initial launches from over 20 potential new growth drivers that have the promise to advance the practice of medicine and change patient lives. 10 of these programs could be substantially clinically de-risked over the next 2 years and represent the majority of our $70 billion of non-risk-adjusted commercial opportunity by the mid-2030s. Our long-term outlook is further bolstered by the strong growth we expect in our animal health business, by the many early-phase programs that will enter phase 2 in the near term, and through additional potential science-led, disciplined, and value-enhancing business development. We're entering a particularly robust period of first-time phase 3 data readouts from novel candidates.
Speaker #2: We're also executing on the transformation of our portfolio, with initial launches from over 20 potential new growth drivers that have the promise to advance the practice of medicine and change patient lives.
Speaker #2: Ten of these programs could be substantially clinically de-risked over the next two years , and represent the majority of our $70 billion of non-risk adjusted commercial opportunity by the mid 2030s , and our long term outlook is further bolstered by the strong growth we expect in our animal health business by the many early phase programs that will enter phase two in the near term and through additional potential science led , disciplined and value enhancing business development .
Speaker #2: We're entering a particularly robust period of first time phase three data readouts from novel candidates in 2026 . These include islatravir combined with Lenacapavir , potentially the first once weekly oral treatment regimen for people living with HIV .
Robert M. Davis: In 2026, these include islatravir combined with lenacapavir, potentially the first once-weekly oral treatment regimen for people living with HIV; MK-3000, potentially the first new mechanism of action in two decades for patients with certain retinal diseases; and tulisokibart, where we expect to see Phase 3 results in ulcerative colitis, as well as Phase 2 data in other autoimmune diseases. There is an even richer array of expected readouts in 2027, including Phase 3 results for Sac-TMT, which we believe is a differentiated TROP2 ADC; for I-DXd, our B7-H3 antibody-drug conjugate, being studied in small-cell lung cancer and other tumor types; for MK-1406, as well as for a number of other important programs. In summary, we're successfully executing multiple product launches, making significant clinical advancements, and augmenting our pipeline with strategic business development.
In 2026, these include islatravir combined with lenacapavir, potentially the first once-weekly oral treatment regimen for people living with HIV; MK-3000, potentially the first new mechanism of action in two decades for patients with certain retinal diseases; and tulisokibart, where we expect to see Phase 3 results in ulcerative colitis, as well as Phase 2 data in other autoimmune diseases. There is an even richer array of expected readouts in 2027, including Phase 3 results for Sac-TMT, which we believe is a differentiated TROP2 ADC; for I-DXd, our B7-H3 antibody-drug conjugate, being studied in small-cell lung cancer and other tumor types; for MK-1406, as well as for a number of other important programs. In summary, we're successfully executing multiple product launches, making significant clinical advancements, and augmenting our pipeline with strategic business development.
Speaker #2: MK 3000 , potentially the first new mechanism of action in two decades for patients with certain retinal diseases and Tulsa , where we expect to see phase three results in ulcerative colitis , as well as phase two data in other autoimmune diseases .
Speaker #2: There is an even richer array of expected readouts in 2027 , including phase three results for TMT , which we believe is a differentiated trop2 ADC for Idcd .
Speaker #2: Our B7-H3 antibody-drug conjugate is being studied in small cell lung, other cancer, and tumor types for MK-1406, as well as for a number of other important programs.
Speaker #2: In summary, we're successfully executing multiple product launches, making significant clinical advancements, and augmenting our pipeline with strategic business development. We're also making the necessary investments that will sustain our success over the long term.
Robert M. Davis: We're also making the necessary investments that will sustain our success over the long term. Our progress and momentum positions us to continue delivering on our purpose for patients and create durable value for shareholders. I want to recognize and thank our global teams for their commitment. While there is more to do, the actions taken, the progress we've made, and our continued disciplined execution provide me with strong confidence that we're well positioned for our next chapter of success. With that, I'll turn the call over to Caroline. Thank you, Rob. Good morning. As Rob noted, in 2025, we made meaningful progress in benefiting patients and customers around the world with our portfolio of innovative medicines and vaccines. Our business delivered growth driven by continued strength in oncology and animal health, as well as increasing contributions from new product launches.
We're also making the necessary investments that will sustain our success over the long term. Our progress and momentum positions us to continue delivering on our purpose for patients and create durable value for shareholders. I want to recognize and thank our global teams for their commitment. While there is more to do, the actions taken, the progress we've made, and our continued disciplined execution provide me with strong confidence that we're well positioned for our next chapter of success. With that, I'll turn the call over to Caroline.
Speaker #2: Our progress and momentum position us to continue delivering on our purpose for patients and create durable value for shareholders. I want to recognize and thank our global teams for their commitment.
Speaker #2: While there is more to do , the actions taken , the progress we've made and our continued disciplined execution provide me with strong confidence that we're well positioned for our next chapter of success .
Caroline Litchfield: Thank you, Rob. Good morning. As Rob noted, in 2025, we made meaningful progress in benefiting patients and customers around the world with our portfolio of innovative medicines and vaccines. Our business delivered growth driven by continued strength in oncology and animal health, as well as increasing contributions from new product launches.
Speaker #2: With that , I'll turn the call over to Caroline .
Speaker #3: Thank you . Rob . Good morning . As Rob noted in 2025 , we made meaningful progress in benefiting patients and customers around the world with our portfolio of innovative medicines and vaccines .
Speaker #3: Our business delivered growth driven by continued strength in oncology and animal health, as well as increasing contributions from new product launches. These results demonstrate the enduring strength of our business and give us confidence in our outlook as we enter a period with many new launches.
Robert M. Davis: These results demonstrate the enduring strength of our business and give us confidence in our outlook as we enter a period with many new launches. Our commercial and operational execution enable us to invest in discovering, developing, and launching the next generation of innovations, which will drive long-term value for patients, customers, and shareholders. Now, turning to our Q4 results. Total company revenues were $16.4 billion, an increase of 5%, or 4% excluding the impact of foreign exchange. The following revenue comments will be on an ex-exchange basis. In oncology, sales of the Keytruda family of products, which includes Keytruda and Keytruda SC, increased 5% to $8.4 billion, with global growth driven by robust uptake in earlier-stage cancers and strong demand from metastatic indications. Utilization in tumors that primarily affect women, including breast, cervical, and endometrial cancers, continues to be a key contributor to growth.
These results demonstrate the enduring strength of our business and give us confidence in our outlook as we enter a period with many new launches. Our commercial and operational execution enable us to invest in discovering, developing, and launching the next generation of innovations, which will drive long-term value for patients, customers, and shareholders. Now, turning to our Q4 results. Total company revenues were $16.4 billion, an increase of 5%, or 4% excluding the impact of foreign exchange. The following revenue comments will be on an ex-exchange basis. In oncology, sales of the Keytruda family of products, which includes Keytruda and Keytruda SC, increased 5% to $8.4 billion, with global growth driven by robust uptake in earlier-stage cancers and strong demand from metastatic indications. Utilization in tumors that primarily affect women, including breast, cervical, and endometrial cancers, continues to be a key contributor to growth.
Speaker #3: Our commercial and operational execution enable us to invest in discovering, developing, and launching the next generation of innovations, which will drive long-term value for patients, customers, and shareholders.
Speaker #3: Now , turning to our fourth quarter results . Total company revenues were $16.4 billion , an increase of 5% , or 4% , excluding the impact of foreign exchange .
Speaker #3: The following revenue comments will be on an X exchange basis . In oncology , sales of the Keytruda family of products , which includes Keytruda and Keytruda , Culex increased 5% to $8.4 billion with global growth driven by robust uptake in earlier stage cancers and demand strong from metastatic indications .
Speaker #3: Utilization in tumors that primarily affect women, including breast, cervical, and endometrial cancers, continues to be a key contributor to growth.
Robert M. Davis: In addition, we saw increased use of Keytruda in combination with Padcev in locally advanced or metastatic urothelial cancer. In the US, growth was negatively impacted by approximately $200 million due to the timing of purchases. We are pleased with the positive provider feedback following the recent launch of Keytruda SC. As expected, sales in the quarter were $35 million. We look forward to having a greater impact on patients and healthcare systems following implementation of a permanent J-code in the US, which we continue to expect to occur in the beginning of April. Our broader oncology portfolio achieved another quarter of strong growth. Notably, Welireg sales increased 37% to $220 million, predominantly driven by increased use in certain patients with previously treated advanced renal cell carcinoma in the US, as well as continued uptake from ongoing launches in certain international markets.
In addition, we saw increased use of Keytruda in combination with Padcev in locally advanced or metastatic urothelial cancer. In the US, growth was negatively impacted by approximately $200 million due to the timing of purchases. We are pleased with the positive provider feedback following the recent launch of Keytruda SC. As expected, sales in the quarter were $35 million. We look forward to having a greater impact on patients and healthcare systems following implementation of a permanent J-code in the US, which we continue to expect to occur in the beginning of April. Our broader oncology portfolio achieved another quarter of strong growth. Notably, Welireg sales increased 37% to $220 million, predominantly driven by increased use in certain patients with previously treated advanced renal cell carcinoma in the US, as well as continued uptake from ongoing launches in certain international markets.
Speaker #3: In addition, we saw increased use of Keytruda in combination with Padcev in locally advanced or metastatic urothelial cancer in the U.S. Growth was negatively impacted by approximately $200 million due to the timing of purchases.
Speaker #3: We are pleased with the positive provider feedback following the recent launch of Keytruda , Culex . As expected , sales in the quarter were $35 million .
Speaker #3: We look forward to having a greater impact on patients and healthcare systems following implementation of a permanent J-code in the US, which we continue to expect to occur at the beginning of April.
Speaker #3: broader Our oncology portfolio achieved another quarter of strong growth Welireg sales , notably , increased 37% to $220 million , predominantly driven by increased use in certain patients with previously treated advanced renal cell carcinoma .
Speaker #3: In the US , as well as continued uptake from ongoing launches in certain international markets . We look forward to potentially reaching more patients with renal cell carcinoma following positive data from the light spark 11 and 22 studies in vaccines .
Speaker #3: In the US , as well as continued uptake from ongoing launches in certain international markets . We look forward to potentially reaching more patients with renal cell carcinoma following positive data from the light spark 11 and 22 studies in vaccines sales Gardasil were $1 billion , a decrease of 35% , driven by lower demand in China and Japan .
Robert M. Davis: We look forward to potentially reaching more patients with renal cell carcinoma following positive data from the LITESPARK-011 and LITESPARK-022 studies. In vaccines, Gardasil sales were $1 billion, a decrease of 35% driven by lower demand in China and Japan. Other international markets grew 8%, benefiting from the timing of purchases. In the US, sales grew 7%, largely due to price. In pneumococcal, the Capvaxive launch continues to progress well, with sales of $279 million, driven by demand from both retail pharmacies and non-retail customers, including uptake from increased seasonal immunization activity in the US. In RSV, Clesrovimab sales were $21 million. Initial uptake has been constrained by a lower-than-expected infant immunization rate, coupled with high levels of total RSV monoclonal antibody inventory in the market. In cardiometabolic and respiratory, Winrevair continues to have a positive impact for patients with pulmonary arterial hypertension.
We look forward to potentially reaching more patients with renal cell carcinoma following positive data from the LITESPARK-011 and LITESPARK-022 studies. In vaccines, Gardasil sales were $1 billion, a decrease of 35% driven by lower demand in China and Japan. Other international markets grew 8%, benefiting from the timing of purchases. In the US, sales grew 7%, largely due to price. In pneumococcal, the Capvaxive launch continues to progress well, with sales of $279 million, driven by demand from both retail pharmacies and non-retail customers, including uptake from increased seasonal immunization activity in the US. In RSV, Clesrovimab sales were $21 million. Initial uptake has been constrained by a lower-than-expected infant immunization rate, coupled with high levels of total RSV monoclonal antibody inventory in the market. In cardiometabolic and respiratory, Winrevair continues to have a positive impact for patients with pulmonary arterial hypertension.
Speaker #3: Other international markets grew 8% , benefiting from the timing of purchases in the US . Sales grew 7% , largely due to price pneumococcal .
Speaker #3: Capvaxive continues to progress well, with sales of $279 million, driven by demand from both retail pharmacies and non-retail customers, including uptake from increased seasonal immunization activity in the US in RSV and influenza.
Speaker #3: Sales were $21 million . Initial uptake has been constrained by a lower than expected infant immunization rate , coupled with high levels of total RSV monoclonal antibody inventory in the market .
Speaker #3: In cardio metabolic and respiratory . River Wind , continues to have a positive impact for patients with pulmonary arterial hypertension . Global sales were $467 million , a reflection of the continued strong demand for this important treatment in the US .
Robert M. Davis: Global sales were $467 million, a reflection of the continued strong demand for this important treatment. In the US, more than 1,500 new patients received a prescription, and over 27,000 total prescriptions were dispensed. We also saw an increase in the proportion of patients whose background therapies do not include prostacyclin. Outside the US, we continue to progress with securing approvals and reimbursement. We are excited to build upon the successful US launch of Ohtuvayre, a maintenance treatment for adults with COPD, with a novel mechanism of action. In the quarter, sales were $178 million, reflecting revenues following the acquisition of Verona Pharma on October 7. We delivered strong growth in new patient starts and total patients treated. We also saw physicians prescribe Ohtuvayre to more of their patients and an increase in the total number of prescribing physicians.
Global sales were $467 million, a reflection of the continued strong demand for this important treatment. In the US, more than 1,500 new patients received a prescription, and over 27,000 total prescriptions were dispensed. We also saw an increase in the proportion of patients whose background therapies do not include prostacyclin. Outside the US, we continue to progress with securing approvals and reimbursement. We are excited to build upon the successful US launch of Ohtuvayre, a maintenance treatment for adults with COPD, with a novel mechanism of action. In the quarter, sales were $178 million, reflecting revenues following the acquisition of Verona Pharma on October 7. We delivered strong growth in new patient starts and total patients treated. We also saw physicians prescribe Ohtuvayre to more of their patients and an increase in the total number of prescribing physicians.
Speaker #3: More than 1,500 new patients received a prescription, and over 27,000 total prescriptions were dispensed. We also saw an increase in the proportion of patients whose background therapies do not include a prostacyclin.
Speaker #3: Outside the US , we continue to progress with securing approvals and reimbursement . We are excited to build upon the successful US launch of O2 via a treatment for maintenance adults with COPD , with a novel mechanism of action in the quarter , sales were $178 million , reflecting revenues following the acquisition of Verona on October the 7th , we delivered strong growth in new patient starts and total patients treated .
Speaker #3: We also saw physicians prescribe O2 to more of their patients , and an increase total in the number of prescribing physicians . As a reminder , we expect seasonality in the early part of the year as deductibles are Medicare reset .
Robert M. Davis: As a reminder, we expect seasonality in the early part of the year as Medicare deductibles are reset. We are making investments to maximize the ongoing launch in the US and look forward to benefiting more adult patients with COPD. Our animal health business delivered another quarter of strong growth, with sales increasing 6%. Livestock sales grew 9%, driven by higher demand across all species. Companion animal sales were flat, as growth from new product launches was offset by a reduction in vet visits. I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. Gross margin was 79.7%, a decrease of 1.1 percentage points due to higher inventory reserves, partially offset by favorable product mix. Operating expenses decreased to $6.8 billion. A charge of $150 million related to an agreement with Dr.
As a reminder, we expect seasonality in the early part of the year as Medicare deductibles are reset. We are making investments to maximize the ongoing launch in the US and look forward to benefiting more adult patients with COPD. Our animal health business delivered another quarter of strong growth, with sales increasing 6%. Livestock sales grew 9%, driven by higher demand across all species. Companion animal sales were flat, as growth from new product launches was offset by a reduction in vet visits. I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. Gross margin was 79.7%, a decrease of 1.1 percentage points due to higher inventory reserves, partially offset by favorable product mix. Operating expenses decreased to $6.8 billion. A charge of $150 million related to an agreement with Dr.
Speaker #3: We are making maximize the investments to ongoing launch in the US . And look forward to benefiting more adult patients with COPD . Our animal health business delivered another quarter of strong growth , with sales increasing 6% .
Speaker #3: Livestock sales grew 9%, driven by higher demand across all species. Companion animal sales were flat, as growth from new product launches was offset by a reduction in vet visits.
Speaker #3: I will now walk you through the remainder of our PNL , and my comments will be on a non-GAAP basis . Gross margin was 79.7% , a decrease of 1.1 percentage points due to higher inventory reserves , partially offset by favorable product mix .
Speaker #3: Operating expenses decreased to $6.8 billion. A charge of $150 million related to an agreement with Dr. Falk Pharma to acquire Sol Global rights to MK-8690 was lower than the $700 million in business development charges.
Robert M. Davis: Falk Pharma to acquire sole global rights to MK-8690 was lower than the $700 million in business development charges a year ago. Excluding these charges, operating expenses were flat, reflecting an increase in investment in support of our innovative pipeline and key growth drivers, offset by the benefits of our multi-year optimization initiative. Other expense was $226 million. Our tax rate was 15.4%. Taken together, earnings per share were $2.04. Now, turning to our 2026 non-GAAP guidance. We expect revenue to be between $65.5 and $67 billion, representing growth of 1% to 3%, including a positive impact from foreign exchange of approximately 1 percentage point using mid-January rates. Our gross margin assumption is approximately 82%. Operating expenses are assumed to be between $35.9 and $36.9 billion, which includes a one-time charge of approximately $9 billion related to the acquisition of Cidara.
Falk Pharma to acquire sole global rights to MK-8690 was lower than the $700 million in business development charges a year ago. Excluding these charges, operating expenses were flat, reflecting an increase in investment in support of our innovative pipeline and key growth drivers, offset by the benefits of our multi-year optimization initiative. Other expense was $226 million. Our tax rate was 15.4%. Taken together, earnings per share were $2.04. Now, turning to our 2026 non-GAAP guidance. We expect revenue to be between $65.5 and $67 billion, representing growth of 1% to 3%, including a positive impact from foreign exchange of approximately 1 percentage point using mid-January rates. Our gross margin assumption is approximately 82%. Operating expenses are assumed to be between $35.9 and $36.9 billion, which includes a one-time charge of approximately $9 billion related to the acquisition of Cidara.
Speaker #3: A year ago . Excluding these charges , operating expenses were flat , reflecting an increase in support of our investment in innovative pipeline and key growth drivers , offset by the benefits of our multi-year optimization initiative .
Speaker #3: Other expense was $226 million . Our tax rate was 15.4% . Taken together , earnings per share were $2.04 . Now , turning to our 2026 non-GAAP guidance .
Speaker #3: We expect revenue to be between 65.5 and $67 billion , representing growth of 1 to 3% , including a positive impact from foreign exchange of approximately one percentage point .
Speaker #3: Using mid January rates . Our gross margin assumption is approximately 82% . Operating expenses are assumed to be between 35.9 and $36.9 billion , which includes a one time charge of approximately $9 billion .
Speaker #3: Related to the acquisition of Sedera, as a reminder, our guidance does not assume additional significant potential business development transactions. Other expense of approximately $1.3 billion includes financing costs for Sedera and Verona.
Robert M. Davis: As a reminder, our guidance does not assume additional significant potential business development transactions. Other expense of approximately $1.3 billion includes financing costs for Cidara and Verona Pharma. We assume a full-year tax rate between 23.5% and 24.5%, which reflects the non-tax deductible one-time charge for Cidara. We assume approximately 2.48 billion shares outstanding. Taken together, we expect EPS of $5 to $5.15, with a midpoint of $5.08, including a positive impact from foreign exchange of approximately $0.10 using mid-January rates. Excluding approximately $3.65 per share related to the upfront charge for the acquisition of Cidara, as well as $0.30 per share of ongoing costs to advance MK-1406 and finance the transaction, our midpoint would be $9.03. As you consider your models, there are a few items to keep in mind.
As a reminder, our guidance does not assume additional significant potential business development transactions. Other expense of approximately $1.3 billion includes financing costs for Cidara and Verona Pharma. We assume a full-year tax rate between 23.5% and 24.5%, which reflects the non-tax deductible one-time charge for Cidara. We assume approximately 2.48 billion shares outstanding. Taken together, we expect EPS of $5 to $5.15, with a midpoint of $5.08, including a positive impact from foreign exchange of approximately $0.10 using mid-January rates. Excluding approximately $3.65 per share related to the upfront charge for the acquisition of Cidara, as well as $0.30 per share of ongoing costs to advance MK-1406 and finance the transaction, our midpoint would be $9.03. As you consider your models, there are a few items to keep in mind.
Speaker #3: We assume a full year tax rate between 23.5 and 24.5% , which reflects the non-tax deductible one time charge for Sedera . We assume approximately 2.48 billion shares outstanding .
Speaker #3: Taken together , we expect EPs of $5 to $5.15 , with a midpoint of $5.08 , including a positive impact from foreign exchange of approximately $0.10 .
Speaker #3: Using mid January rates , excluding approximately $3.65 per share related to the upfront charge for the acquisition of Sedera , as well as $0.30 per share of ongoing costs to advance MK 1406 and finance .
Speaker #3: The transaction. Our midpoint would be $9.03. As you consider your models, there are a few items to keep in mind.
Robert M. Davis: We expect to deliver growth in 2026 driven by increasing contributions from our new launches, as well as continued strength in oncology and animal health, despite a headwind of approximately $2.5 billion from generic competition, IRA price setting, and the restructured agreement for Koselugo. Generic competition primarily impacts the Januvia family of products, Bridion, and Dificid. We also expect significantly lower sales of Legevrio due to continued soft demand. Now, turning to capital allocation, where our strategy remains unchanged. We will prioritize investments in our business to drive near and long-term growth, including new product launches and our robust pipeline. We remain committed to the dividend with the goal of increasing it over time. Business development remains a high priority. We are well positioned to pursue additional transactions when science and value align.
We expect to deliver growth in 2026 driven by increasing contributions from our new launches, as well as continued strength in oncology and animal health, despite a headwind of approximately $2.5 billion from generic competition, IRA price setting, and the restructured agreement for Koselugo. Generic competition primarily impacts the Januvia family of products, Bridion, and Dificid. We also expect significantly lower sales of Legevrio due to continued soft demand. Now, turning to capital allocation, where our strategy remains unchanged. We will prioritize investments in our business to drive near and long-term growth, including new product launches and our robust pipeline. We remain committed to the dividend with the goal of increasing it over time. Business development remains a high priority. We are well positioned to pursue additional transactions when science and value align.
Speaker #3: We expect to deliver growth in 2026 , driven by increasing contributions from our new launches , as well as continued strength in oncology and animal health .
Speaker #3: Despite a headwind of approximately $2.5 billion from generic competition, IRA price setting, and the restructured agreements for Ugo, generic competition primarily impacts the Januvia family of products.
Speaker #3: Bridion and Dificid. We also expect significantly lower sales of Lagevrio due to continued soft demand. Now turning to capital allocation, where our strategy remains unchanged.
Speaker #3: We will prioritize investments in our business to drive near- and long-term growth, including new product launches and our robust pipeline. We remain committed to the dividend, with the goal of increasing it over time.
Speaker #3: Business development remains a high priority . We are well positioned to pursue additional transactions when science and value align . Our guidance assumes approximately $3 billion of share remain , and we to repurchases not having cash excess .
Robert M. Davis: Our guidance assumes approximately $3 billion of share repurchases, and we remain committed to not having excess cash build on the balance sheet. To conclude, we enter 2026 with confidence in the outlook for our business, driven by global demand for our innovative medicines and vaccines, including the exciting progress of our many launches and upcoming clinical milestones from our promising pipeline. We maintain our longstanding commitment to bringing forward medically significant innovations that will enable us to deliver value to patients, customers, and shareholders well into the future. With that, I'd now like to turn the call over to Dean.
Our guidance assumes approximately $3 billion of share repurchases, and we remain committed to not having excess cash build on the balance sheet. To conclude, we enter 2026 with confidence in the outlook for our business, driven by global demand for our innovative medicines and vaccines, including the exciting progress of our many launches and upcoming clinical milestones from our promising pipeline. We maintain our longstanding commitment to bringing forward medically significant innovations that will enable us to deliver value to patients, customers, and shareholders well into the future. With that, I'd now like to turn the call over to Dean.
Speaker #3: Build on the balance sheet . To conclude , we enter 2026 with confidence in the outlook for our business driven by global demand for our innovative medicines and vaccines , including the exciting progress of our many launches and upcoming clinical milestones from our promising pipeline .
Speaker #3: We maintain our long-standing commitment to bringing forward medically significant innovations that will enable us to deliver value to patients, customers, and shareholders well into the future.
Speaker #3: With that , I'd now like to turn the call over to Dean .
Peter Dannenbaum: Thank you, Caroline. Good morning, everyone. Progress continues across programs spanning multiple therapeutic areas. Today, I will provide updates across cardiometabolic and respiratory, infectious disease, and oncology programs, then conclude with a summary of highlights from 2025 and upcoming milestones for this year. Starting with advancements across our cardiometabolic and respiratory pipeline and programs. MK-0616, our investigational oral PCSK9 inhibitor, has been designed to deliver antibody-like efficacy while offering a simple, once-daily oral treatment option with the potential to help address the CV epidemic. Data from two phase 3 studies evaluating MK-0616 for the treatment of adults with elevated LDL cholesterol were presented at the American Heart Association scientific sessions in November.
Dean Li: Thank you, Caroline. Good morning, everyone. Progress continues across programs spanning multiple therapeutic areas. Today, I will provide updates across cardiometabolic and respiratory, infectious disease, and oncology programs, then conclude with a summary of highlights from 2025 and upcoming milestones for this year. Starting with advancements across our cardiometabolic and respiratory pipeline and programs. MK-0616, our investigational oral PCSK9 inhibitor, has been designed to deliver antibody-like efficacy while
Speaker #4: Thank you . Caroline . Good morning everyone . Progress continues across programs spanning multiple therapeutic areas . Today I will provide updates across cardio , metabolic and respiratory , infectious disease , and oncology programs .
Speaker #4: Then conclude summary of highlights from 2025 and upcoming milestones for this year . Starting with advancements across our cardiometabolic and pipeline and respiratory programs elicited our investigational oral Pcsk9 inhibitor has been designed to deliver antibody like efficacy while offering a simple , once daily oral treatment option with the potential to help address the CV epidemic .
offering a simple, once-daily oral treatment option with the potential to help address the CV epidemic. Data from two phase 3 studies evaluating MK-0616 for the treatment of adults with elevated LDL cholesterol were presented at the American Heart Association scientific sessions in November.
Speaker #4: Data from two phase three studies evaluating LCT for the treatment of adults with elevated LDL cholesterol were at the American presented Heart Association Scientific Sessions in November in both the coral reef Lipid Study , which included a broad population of adults with or at risk for atherosclerotic cardiovascular disease on background lipid lowering therapies , or with statin intolerance and the coral reef .
Peter Dannenbaum: In both the CORALreef lipid study, which included a broad population of adults with or at risk for atherosclerotic cardiovascular disease on background lipid-lowering therapies or with statin intolerance, and the CORALreef HeFH study in adults with familial heterozygous hypercholesterolemia, MK-0616 demonstrated statistically significant sustained reductions in multiple atherogenic factors including LDL-C, ApoB, non-HDL-C, and Lp(a). The findings from the CORALreef HeFH were published in the Journal of the American Medical Association, and from CORALreef lipids have been accepted to the New England Journal of Medicine. In addition, positive results of the third phase 3 trial, CORALreef add-on, evaluating MK-0616 comparing to other oral non-statin therapies in adults with hypercholesterolemia and treated with a statin, will be presented at the American College of Cardiology Congress in March. The phase 3 CORALreef outcome study is ongoing and fully enrolled.
In both the CORALreef lipid study, which included a broad population of adults with or at risk for atherosclerotic cardiovascular disease on background lipid-lowering therapies or with statin intolerance, and the CORALreef HeFH study in adults with familial heterozygous hypercholesterolemia, MK-0616 demonstrated statistically significant sustained reductions in multiple atherogenic factors including LDL-C, ApoB, non-HDL-C, and Lp(a). The findings from the CORALreef HeFH were published in the Journal of the American Medical Association, and from CORALreef lipids have been accepted to the New England Journal of Medicine. In addition, positive results of the third phase 3 trial, CORALreef add-on, evaluating MK-0616 comparing to other oral non-statin therapies in adults with hypercholesterolemia and treated with a statin, will be presented at the American College of Cardiology Congress in March. The phase 3 CORALreef outcome study is ongoing and fully enrolled.
Speaker #4: He FH study in adults with familial heterozygous hypercholesterolemia demonstrated and statistically significant sustained reductions in multiple atherogenic factors , including Ldl-c , Apob , Non-hdl-c , and LP .
Speaker #4: The findings from the coral reef Hefh were published in the Journal of the American Medical Association , and from coral reef lipids have been accepted to the New England Journal of Medicine .
Speaker #4: In addition, positive results of the third Phase 3 trial, Coral Reef, add-on evaluating and comparing to other oral non-statin therapies in adults with hypercholesterolemia and treated with a statin will be presented at the American College of Cardiology Congress in March.
Speaker #4: The Phase 3 outcome study for Coral Reef is ongoing and fully enrolled for Wind River. We continue to make progress on our global regulatory strategy.
Peter Dannenbaum: For Winrevair, we continue to make progress on our global regulatory strategy. Last month, the European Commission approved an expanded indication in adults with pulmonary arterial hypertension with WHO Functional Class II, III, and IV based on the phase III Zenith study. We are continuing to evaluate Winrevair in an additional indication associated with progressive vascular remodeling and resistance. The phase II Cadence study met its primary endpoint, achieving statistically significant and clinically meaningful reduction of pulmonary vascular resistance compared to placebo in adults with combined post and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction. These findings support proof of concept, which will inform a phase III program in this population. Detailed results will also be presented at the American College of Cardiology Congress in March. Next, infectious disease. Last month, we completed the acquisition of Cidara Therapeutics.
For Winrevair, we continue to make progress on our global regulatory strategy. Last month, the European Commission approved an expanded indication in adults with pulmonary arterial hypertension with WHO Functional Class II, III, and IV based on the phase III Zenith study. We are continuing to evaluate Winrevair in an additional indication associated with progressive vascular remodeling and resistance. The phase II Cadence study met its primary endpoint, achieving statistically significant and clinically meaningful reduction of pulmonary vascular resistance compared to placebo in adults with combined post and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction. These findings support proof of concept, which will inform a phase III program in this population. Detailed results will also be presented at the American College of Cardiology Congress in March. Next, infectious disease. Last month, we completed the acquisition of Cidara Therapeutics.
Speaker #4: Last month, the European Commission approved an expanded indication in adults with pulmonary arterial hypertension with functional class II, III, and IV based on the phase 3 ZENITH study.
Speaker #4: We are continuing to evaluate Winrevair in an additional indication associated with progressive vascular remodeling and resistance. The Phase 2 CADENCE study met its primary endpoint, achieving statistically significant and clinically meaningful reduction of pulmonary vascular resistance compared to placebo in adults with combined post- and pre-capillary pulmonary hypertension due to heart failure with preserved ejection fraction.
Speaker #4: These findings support proof of concept, which will inform a Phase 3 program in this population. Detailed results will also be presented at the American College of Cardiology Congress in March next year.
Speaker #4: Infectious disease . Last month , we completed the acquisition of Sidera Therapeutics scale , the of the ongoing seasonal flu outbreak in the Northern hemisphere reinforces the threat posed by influenza .
Peter Dannenbaum: The scale of the ongoing seasonal flu outbreak in the northern hemisphere reinforces the threat posed by influenza, the corresponding burden on healthcare systems, and importantly, the need for improved prevention strategies specifically for those individuals at high risk of serious complications. The phase 3 ANCHOR study evaluating MK-1406, a potentially first-in-class long-acting preventative strain-agnostic antiviral with a differentiated mechanism of action, completed enrollment in November in the northern hemisphere. In parallel, we will enroll participants in the southern hemisphere to ensure the collection of a robust dataset spanning a broad patient population, including adults who are immunocompromised, and to capture additional data on diverse circulating strains. Furthermore, it is also important for the study to encompass those who have been vaccinated against the flu and those who have not.
The scale of the ongoing seasonal flu outbreak in the northern hemisphere reinforces the threat posed by influenza, the corresponding burden on healthcare systems, and importantly, the need for improved prevention strategies specifically for those individuals at high risk of serious complications. The phase 3 ANCHOR study evaluating MK-1406, a potentially first-in-class long-acting preventative strain-agnostic antiviral with a differentiated mechanism of action, completed enrollment in November in the northern hemisphere. In parallel, we will enroll participants in the southern hemisphere to ensure the collection of a robust dataset spanning a broad patient population, including adults who are immunocompromised, and to capture additional data on diverse circulating strains. Furthermore, it is also important for the study to encompass those who have been vaccinated against the flu and those who have not.
Speaker #4: The corresponding burden on healthcare systems and , importantly , the need for improved prevention strategies , specifically for those high individuals at risk of serious complications .
Speaker #4: The phase three anchor study evaluating MK 1406 , a potentially first in class long acting preventative , strain agnostic antiviral with a differentiated mechanism of action completed enrollment in November in the Northern Hemisphere .
Speaker #4: In parallel , we will enroll participants in the Southern Hemisphere to ensure the collection of a robust data set spanning a broad patient population , including adults who are immunocompromised and to capture additional data on diverse circulating strains .
Speaker #4: Furthermore, it is also important for the study to encompass those who have been vaccinated against the flu and those who have not. Who—turning to HIV, too.
Peter Dannenbaum: Turning to HIV, in November, we announced positive top-line results for our investigational once-daily, single-tablet, two-drug regimen of doravirine and islatravir, a next-generation nucleoside analog leveraging translocation inhibition from a phase 3 study in previously untreated adults with HIV-1 infection. This is the first two-drug regimen without an HIV integrase strand transfer inhibitor to demonstrate non-inferior efficacy and safety versus the broadly used three-drug INSTI-based regimen, Biktarvy. Based on its potent antiviral properties and barrier to resistance, it is our ambition that islatravir will serve as a novel anchor medicine across multiple two-drug treatment regimens, providing new daily and weekly options for people living with HIV. Detailed results will be presented at an upcoming medical congress. Moving to oncology, data continue to demonstrate Keytruda's impact in treating a wide spectrum of cancers. In bladder cancer, there were two recent notable developments.
Turning to HIV, in November, we announced positive top-line results for our investigational once-daily, single-tablet, two-drug regimen of doravirine and islatravir, a next-generation nucleoside analog leveraging translocation inhibition from a phase 3 study in previously untreated adults with HIV-1 infection. This is the first two-drug regimen without an HIV integrase strand transfer inhibitor to demonstrate non-inferior efficacy and safety versus the broadly used three-drug INSTI-based regimen, Biktarvy. Based on its potent antiviral properties and barrier to resistance, it is our ambition that islatravir will serve as a novel anchor medicine across multiple two-drug treatment regimens, providing new daily and weekly options for people living with HIV. Detailed results will be presented at an upcoming medical congress. Moving to oncology, data continue to demonstrate Keytruda's impact in treating a wide spectrum of cancers. In bladder cancer, there were two recent notable developments.
Speaker #4: In November , we announced positive topline results for our investigational once daily single tablet , two drug regimen of Doravirine and Islatravir , and next generation nucleoside .
Speaker #4: analog Leveraging translocation inhibition from a phase three study in previously untreated adults with HIV one infection , this is the first two drug regimen without an HIV integrase strand transfer inhibitor to demonstrate noninferior efficacy and safety versus the broadly used three drug insti based regimen , biktarvy .
Speaker #4: Based on its potent antiviral properties and barrier to resistance, it is our ambition that islatravir will serve as a novel anchor medicine across multiple two-drug treatment-providing regimens, offering new daily and weekly options for people living with HIV.
Speaker #4: Detailed results will be presented at an upcoming medical congress. Moving to oncology, data continued to demonstrate Keytruda's impact in treating a wide spectrum of cancers, including bladder cancer.
Speaker #4: There were two recent notable developments . First , the FDA approved Keytruda and Keytruda , each in combination with pazza as neoadjuvant treatment and continued after Cystectomy as adjuvant treatment for adults with muscle , invasive bladder cancer who are ineligible for cisplatin containing chemotherapy based on the phase three Keynote 905 trial .
Peter Dannenbaum: First, the FDA approved Keytruda and Keytruda SC, each in combination with Padcev as neoadjuvant treatment and continued after cystectomy as adjuvant treatment for adults with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy based on the Phase III KEYNOTE-905 trial. This is the first PD-1 inhibitor plus antibody-drug conjugate regimen approved for this population. Second, we announced positive top-line results from the Phase III KEYNOTE-B15 study. The combination of Keytruda plus Padcev, given as neoadjuvant and adjuvant treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival, overall survival, and pathologic complete response rates versus neoadjuvant chemotherapy and surgery. This is the first and only perioperative immunotherapy plus ADC regimen shown to extend survival for cisplatin-eligible patients with muscle-invasive bladder cancer. Detailed results will be presented later this month at the ASCO Genitourinary Cancers Symposium.
First, the FDA approved Keytruda and Keytruda SC, each in combination with Padcev as neoadjuvant treatment and continued after cystectomy as adjuvant treatment for adults with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy based on the Phase III KEYNOTE-905 trial. This is the first PD-1 inhibitor plus antibody-drug conjugate regimen approved for this population. Second, we announced positive top-line results from the Phase III KEYNOTE-B15 study. The combination of Keytruda plus Padcev, given as neoadjuvant and adjuvant treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival, overall survival, and pathologic complete response rates versus neoadjuvant chemotherapy and surgery. This is the first and only perioperative immunotherapy plus ADC regimen shown to extend survival for cisplatin-eligible patients with muscle-invasive bladder cancer. Detailed results will be presented later this month at the ASCO Genitourinary Cancers Symposium.
Speaker #4: This is the first PD one inhibitor plus antibody drug conjugate regimen approved for this population . Second , we announced positive topline results from the phase three keynote B15 study .
Speaker #4: The combination of Keytruda plus passive given as neoadjuvant and adjuvant treatment demonstrated statistically significant and clinically meaningful improvements in event free survival . Overall survival , and pathologic complete response rates versus neoadjuvant chemotherapy and surgery .
Speaker #4: This is the first and only perioperative immunotherapy plus ADC regimen shown to extend survival for cisplatin-eligible patients with muscle-invasive bladder cancer.
Speaker #4: Detailed results will be presented later this month at the Asco Genitourinary Cancer Symposium . Together , these regimens have the potential to offer patients with muscle , invasive bladder cancer who are either eligible or ineligible for cisplatin chemotherapy , a karuta based option .
Peter Dannenbaum: Together, these regimens have the potential to offer patients with muscle-invasive bladder cancer who are either eligible or ineligible for cisplatin chemotherapy a Keytruda-based option. Three additional Phase III studies are ongoing evaluating Keytruda across different stages of bladder cancer, including KEYNOTE-992, KEYNOTE-866, and KEYNOTE-676. In collaboration with Moderna, we recently announced 5-year follow-up data for the Phase IIB KEYNOTE-942 study evaluating V940, an individualized neoantigen therapy candidate, in combination with Keytruda in patients with high-risk Stage III or IV melanoma following complete resection. In the follow-up analysis, the study demonstrated a sustained improvement in recurrence-free survival with a 49% reduction in the risk of recurrence or death compared to Keytruda alone, building on the previously announced primary and 3-year analyses from the trial. The Phase III INTERPATH-001 trial in adjuvant melanoma is ongoing and fully enrolled.
Together, these regimens have the potential to offer patients with muscle-invasive bladder cancer who are either eligible or ineligible for cisplatin chemotherapy a Keytruda-based option. Three additional Phase III studies are ongoing evaluating Keytruda across different stages of bladder cancer, including KEYNOTE-992, KEYNOTE-866, and KEYNOTE-676. In collaboration with Moderna, we recently announced 5-year follow-up data for the Phase IIB KEYNOTE-942 study evaluating V940, an individualized neoantigen therapy candidate, in combination with Keytruda in patients with high-risk Stage III or IV melanoma following complete resection. In the follow-up analysis, the study demonstrated a sustained improvement in recurrence-free survival with a 49% reduction in the risk of recurrence or death compared to Keytruda alone, building on the previously announced primary and 3-year analyses from the trial. The Phase III INTERPATH-001 trial in adjuvant melanoma is ongoing and fully enrolled.
Speaker #4: Three additional phase three studies are ongoing evaluating Keytruda across different stages of bladder cancer , including Keynote 902 , keynote 866 , and Keynote 676 .
Speaker #4: In collaboration with Moderna . We recently announced five year follow up data for the phase two keynote , 942 study evaluating entities Autogene and individualized Neoantigen therapy candidate in combination with Keytruda .
Speaker #4: In patients with high risk stage 3 or 4 melanoma . Following complete resection . In the follow up analysis , the study demonstrated a sustained improvement in recurrence free survival with a 49% reduction in the risk of recurrence or death compared to Keytruda alone .
Speaker #4: Building on the previously announced primary and three year analyses from the trial , the phase three interpath 001 trial in adjuvant melanoma is ongoing and fully enrolled in European November , the Commission approved a subcutaneous injection of pembrolizumab and bear hyaluronidase alpha marketed in the EU as Keytruda SC for use in all 33 Keytruda indications for adult patients .
Peter Dannenbaum: In November, the European Commission approved a subcutaneous injection of pembrolizumab and hyaluronidase alpha, marketed in the EU as Keytruda SC, for use in all 33 Keytruda indications for adult patients. It is the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered in one minute every three weeks or in two minutes every six weeks. The availability of more rapid subcutaneous pembrolizumab administration is being integrated into our clinical development programs. Canolyt 007, a phase 3 study evaluating Olomorasib in investigational oral selective KRAS G12C inhibitor in combination with Keytruda SC for the first-line treatment of patients with KRAS G12C mutant advanced or metastatic non-squamous non-small cell lung cancer.
In November, the European Commission approved a subcutaneous injection of pembrolizumab and hyaluronidase alpha, marketed in the EU as Keytruda SC, for use in all 33 Keytruda indications for adult patients. It is the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered in one minute every three weeks or in two minutes every six weeks. The availability of more rapid subcutaneous pembrolizumab administration is being integrated into our clinical development programs. Canolyt 007, a phase 3 study evaluating Olomorasib in investigational oral selective KRAS G12C inhibitor in combination with Keytruda SC for the first-line treatment of patients with KRAS G12C mutant advanced or metastatic non-squamous non-small cell lung cancer.
Speaker #4: It is the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered in one minute every three weeks , or in two minutes every six weeks .
Speaker #4: The availability of more rapid subcutaneous pembrolizumab administration is being integrated into our clinical development programs . Candlelit 007 , A phase three study evaluating kolasib and investigational oral , selective Kras g12c inhibitor in combination with Keytruda .
Speaker #4: For the first line treatment of patients Kras with g12c mutant advanced or metastatic Non-squamous non-small cell lung cancer . In December , at the Society of we meeting , Hematology American annual highlighted across progress our hematology pipeline with positive data spanning multiple candidates , including MK 1045 and investigational Cd19 , CD3 , T cell , engager in adults with relapsed or refractory B-cell acute lymphoblastic leukemia .
Peter Dannenbaum: In December, at the American Society of Hematology annual meeting, we highlighted progress across our hematology pipeline with positive data spanning multiple candidates, including MK-1045, an investigational CD19/CD3 T-cell engager in adults with relapsed or refractory B-cell acute lymphoblastic leukemia, nemtabrutinib, an investigational non-covalent BTK inhibitor in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, and bomedemstat, an investigational LSD-1 inhibitor in patients with polycythemia vera who were resistant or intolerant to cytoreductive therapy. In addition, there are two ongoing phase 3 studies evaluating bomedemstat in essential thrombocythemia and orphan disease. 2025 was marked by significant pipeline progress, including positive data announced from 18 phase 3 trials and the initiation of 21 phase 3 trials spanning cardiometabolic, respiratory, immunology, infectious disease, oncology, and ophthalmology.
In December, at the American Society of Hematology annual meeting, we highlighted progress across our hematology pipeline with positive data spanning multiple candidates, including MK-1045, an investigational CD19/CD3 T-cell engager in adults with relapsed or refractory B-cell acute lymphoblastic leukemia, nemtabrutinib, an investigational non-covalent BTK inhibitor in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, and bomedemstat, an investigational LSD-1 inhibitor in patients with polycythemia vera who were resistant or intolerant to cytoreductive therapy. In addition, there are two ongoing phase 3 studies evaluating bomedemstat in essential thrombocythemia and orphan disease. 2025 was marked by significant pipeline progress, including positive data announced from 18 phase 3 trials and the initiation of 21 phase 3 trials spanning cardiometabolic, respiratory, immunology, infectious disease, oncology, and ophthalmology.
Speaker #4: Nemtabrutinib, an investigational non-covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, and an investigational LSD1 inhibitor in patients with polycythemia vera who were resistant or intolerant to cytoreductive therapy.
Speaker #4: In addition , there are two ongoing phase three studies evaluating that in essential thrombocythemia and orphan disease 2025 was marked by significant , including data positive progress pipeline from 18 phase three trials and the initiation of 21 phase three trials spanning cardiometabolic and respiratory immunology , infectious disease oncology and ophthalmology .
Peter Dannenbaum: We also secured regulatory approvals across therapeutic areas, including in oncology, Keytruda SC and additional Keytruda-based regimens, including in patients with cisplatin-ineligible MIBC and locally advanced head and neck squamous cell carcinoma. In infectious disease, Clesrovimab, a long-acting monoclonal antibody for the prevention of respiratory syncytial virus lower respiratory tract disease in infants born during or entering their first RSV season. And in cardiovascular, the label update for Winrevair in PAH. Finally, we continue to deliver on our one pipeline strategy by leveraging our clinical expertise and robust business development capabilities. The acquisition of Verona Pharma and Cidara Therapeutics further strengthened our pipeline and bring forward promising candidates with the potential to serve areas of significant unmet patient need.
We also secured regulatory approvals across therapeutic areas, including in oncology, Keytruda SC and additional Keytruda-based regimens, including in patients with cisplatin-ineligible MIBC and locally advanced head and neck squamous cell carcinoma. In infectious disease, Clesrovimab, a long-acting monoclonal antibody for the prevention of respiratory syncytial virus lower respiratory tract disease in infants born during or entering their first RSV season. And in cardiovascular, the label update for Winrevair in PAH. Finally, we continue to deliver on our one pipeline strategy by leveraging our clinical expertise and robust business development capabilities. The acquisition of Verona Pharma and Cidara Therapeutics further strengthened our pipeline and bring forward promising candidates with the potential to serve areas of significant unmet patient need.
Speaker #4: We also secured regulatory approvals across therapeutic areas, including in oncology: Keytruda and additional Keytruda-based regimens, including in patients ineligible for MIBC and locally advanced head and squamous neck cell carcinoma.
Speaker #4: In infectious disease influenza , our long acting monoclonal antibody for the prevention of respiratory syncytial virus , lower respiratory tract disease in infants born during or entering their first RSV season , and in cardiovascular .
Speaker #4: The label update for winrevair in Pah . continue Finally , we to deliver on our one pipeline strategy by leveraging our clinical expertise and development robust business The capabilities .
Speaker #4: acquisition Verona of Pharma and Therapeutics further strengthen our pipeline and bring forward promising candidates with the potential to serve areas of significant unmet patient need .
Peter Dannenbaum: Building on our momentum in 2025, we anticipate a series of milestones across multiple therapeutic areas in the coming months, including in oncology, the 20 February 2025 PDUFA date for certain patients with platinum-resistant recurrent ovarian cancer based on the KEYNOTE-096 trial; presentation of detailed findings at ASCO GU 2024; Welireg, our first-in-class oral HIF-2 alpha inhibitor across adjuvant and certain types of advanced renal cell carcinoma based on the phase 3 LITESPARK-011 and LITESPARK-022 trials; and for KEYNOTE-B15 in cisplatin-eligible patients with MIBC. In HIV, the 28 April 2025 PDUFA date for doravirine and islatravir, a once-daily oral two-drug treatment regimen. Top-line data from the phase 3 ISLENT-1 and ISLENT-2 trials evaluating islatravir and lenacapavir as a once-weekly oral two-drug treatment regimen in collaboration with Gilead. In cardiometabolic and respiratory, the presentation of detailed results at ACC in March.
Building on our momentum in 2025, we anticipate a series of milestones across multiple therapeutic areas in the coming months, including in oncology, the 20 February 2025 PDUFA date for certain patients with platinum-resistant recurrent ovarian cancer based on the KEYNOTE-096 trial; presentation of detailed findings at ASCO GU 2024; Welireg, our first-in-class oral HIF-2 alpha inhibitor across adjuvant and certain types of advanced renal cell carcinoma based on the phase 3 LITESPARK-011 and LITESPARK-022 trials; and for KEYNOTE-B15 in cisplatin-eligible patients with MIBC. In HIV, the 28 April 2025 PDUFA date for doravirine and islatravir, a once-daily oral two-drug treatment regimen. Top-line data from the phase 3 ISLENT-1 and ISLENT-2 trials evaluating islatravir and lenacapavir as a once-weekly oral two-drug treatment regimen in collaboration with Gilead. In cardiometabolic and respiratory, the presentation of detailed results at ACC in March.
Speaker #4: Building on our momentum in 2025 , we anticipate a series of milestones across multiple therapeutic areas in the coming months , including in oncology , the February 20th date for certain patients with platinum resistant recurrent ovarian cancer .
Speaker #4: Based on the keynote B96 trial presentation of detailed findings at Asco GU for Welireg , our first in class oral Hif2 alpha inhibitor across adjuvant and certain types of advanced renal cell carcinoma based on the phase three , spark 11 and 22 trials , and for , B15 and keynote cisplatin eligible patients with Mibc in HIV , the April 28th date for sharing and islatravir a daily once oral two drug treatment and regimen data top line from the phase three island one and two trials evaluating Islatravir and Lenacapavir as a once weekly oral two drug treatment regimen in collaboration with Gilead in cardiometabolic and Respiratory .
Speaker #4: The presentation of detailed results at ACC in March for women from the phase two cadence study in a subset of pulmonary hypertension due left heart to disease and for elicited from the phase three coral reef add on trial in immunology , data for Tullus or Tll1 , inhibitor based on the phase three atlas , UC trial in ulcerative colitis and phase two Athena study in SSC , ILD .
Peter Dannenbaum: For Winrevair, from the phase 2 CADENCE study in a subset of pulmonary hypertension due to left heart disease. And for Elicitide, from the phase 3 CORALreef add-on trial. In immunology, data for tulisokibart, our TL1A inhibitor, based on the phase 3 ATLAS-UC trial in ulcerative colitis, and phase 2 Athena study in SSC ILD. Finally, in ophthalmology, data from the phase 3 Brunella study of MK-3000, our novel Wnt agonist being evaluated in diabetic macular edema. And the phase 2 RIOHA study of MK-8748, our potential first-in-class Tie2 agonist VEGF inhibitor being evaluated for the treatment of certain retinal diseases. We continue to advance our diversified pipeline with a focus on executing with speed and rigor. I look forward to providing further updates through 2026. And now, I turn the call back to Peter. Thank you, Dean. Shirley, we're now ready for Q&A.
For Winrevair, from the phase 2 CADENCE study in a subset of pulmonary hypertension due to left heart disease. And for Elicitide, from the phase 3 CORALreef add-on trial. In immunology, data for tulisokibart, our TL1A inhibitor, based on the phase 3 ATLAS-UC trial in ulcerative colitis, and phase 2 Athena study in SSC ILD. Finally, in ophthalmology, data from the phase 3 Brunella study of MK-3000, our novel Wnt agonist being evaluated in diabetic macular edema. And the phase 2 RIOHA study of MK-8748, our potential first-in-class Tie2 agonist VEGF inhibitor being evaluated for the treatment of certain retinal diseases. We continue to advance our diversified pipeline with a focus on executing with speed and rigor. I look forward to providing further updates through 2026. And now, I turn the call back to Peter.
Speaker #4: Finally , an ophthalmology data from the phase three Brunella of study MK 3000 . Our novel antagonist , being evaluated in diabetic macular edema and the phase two .
Speaker #4: The Rioja study of MK-8748, a potential first-in-class PI2 agonist VEGF inhibitor, is being evaluated for the treatment of certain retinal diseases.
Speaker #4: We continue to advance our diversified pipeline with a focus on executing with speed and rigor . I to look forward providing further updates through 2026 and now I turn the call back to Peter .
Peter Dannenbaum: Thank you, Dean. Shirley, we're now ready for Q&A.
Speaker #1: Thank you , Dean Shirley . We're now ready for Q&A . We have a hard stop today at 10 a.m. , so I'd like to request that analysts limit themselves to one question , please .
Peter Dannenbaum: We have a hard stop today at 10:00 AM, so I'd like to request that analysts limit themselves to one question, please.
We have a hard stop today at 10:00 AM, so I'd like to request that analysts limit themselves to one question, please.
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 the 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. Our first question comes from Mohit Bansal with Wells Fargo. Your line is open. You may ask your question.
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 the 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. Our first question comes from Mohit Bansal with Wells Fargo. Your line is open. You may ask your question.
Speaker #5: Ladies and gentlemen , if you wish to ask a question , please press Star One on your telephone keypad . You may withdraw your question time by at any pressing star two .
Speaker #5: If you're using speakerphone, please pick up the handset before pressing the numbers. Once you have again, if you have a question, you may press star one.
Speaker #5: And one moment please . For our first question . Our from first question comes Moet Benzel with Wells Fargo . is open . You may ask your Your line question .
[Analyst] (Wells Fargo): Great. Thank you very much for taking my question and congrats on all the pipeline progress. Maybe if we can double-click on the CD388 asset and potential for interim here. So the flu season appears to be strong this season, so it would seem like that event rates may be occurring ahead of the plan in the anchor trial. But we'd love to understand your thoughts around running the full trial. Is it based on generating robust data across two geographies, two seasons, or anything you are seeing from the event rates point of view in the ongoing trial? And should we expect an interim disclosure in March or after March or not? Thank you.
Mohit Bansal: Great. Thank you very much for taking my question and congrats on all the pipeline progress. Maybe if we can double-click on the CD388 asset and potential for interim here. So the flu season appears to be strong this season, so it would seem like that event rates may be occurring ahead of the plan in the anchor trial. But we'd love to understand your thoughts around running the full trial. Is it based on generating robust data across two geographies, two seasons, or anything you are seeing from the event rates point of view in the ongoing
Speaker #6: Great . Thank you taking my very much for question . And congrats on all pipeline the progress . if you Maybe double can click on on the Cd338 asset potential and for interim here .
Speaker #6: So the flu season appears to be strong . This season . So it would seem like that event rates may be occurring ahead of the plan .
Speaker #6: Plan in the anchor trial . But we'd love to understand your thoughts around running the full trial it based on . Is generating robust data across two geographies ?
Speaker #6: Two seasons or anything you are seeing from the event rates point of view in the ongoing trial? And should we expect an interim disclosure in March or not?
trial? And should we expect an interim disclosure in March or after March or not? Thank you.
Speaker #6: after March Thank you
Dean Y. Li: Thank you very much. This is Dean. I do think your point about the relatively severe season, especially for many of us in the Northeast for the flu, demonstrates how important this month could be. We have completed enrollment in the northern hemisphere. I want to emphasize, as I said in the prepared, we are in parallel recruiting in this southern hemisphere. This is an event-driven trial. I want to have the right trial size. I want the powering of the assumptions. But most importantly, I need to make sure that I have strong data throughout a series of subpopulations that will be important for the future label. So at this time, we have not spoken. Communication plans following IA, but we are excited about this first-in-class, once-per-season, strain-agnostic antiviral agent, which I think will have increasing need as the years go by.
Dean Li: Thank you very much. This is Dean. I do think your point about the relatively severe season, especially for many of us in the Northeast for the flu, demonstrates how important this month could be. We have completed enrollment in the northern hemisphere. I want to emphasize, as I said in the prepared, we are in parallel recruiting in this southern hemisphere. This is an event-driven trial. I want to have the right trial size. I want the powering of the assumptions. But most importantly, I need to make sure that I have strong data throughout a series of
Speaker #6: .
Speaker #4: Thank you, Dean. I think your point about the severity of the flu season is a very important one, especially for many of us in the Northeast. It demonstrates how important this is.
Speaker #4: We have completed enrollment in the Northern Hemisphere. I want to emphasize, as I said in the prepared remarks, we are in parallel recruiting in the Southern Hemisphere.
Speaker #4: This event driven trial . I want to have the right size . trial I want the powering of the assumptions . But most importantly , I need to make sure that I have strong data throughout a series of subpopulations that will be important for for the for the future label .
subpopulations that will be important for the future label. So at this time, we have not spoken. Communication plans following IA, but we are excited about this first-in-class, once-per-season, strain-agnostic antiviral agent, which I think will have increasing need as the years go by.
Speaker #4: So at this time , we have not spoken to communication plans following IA , but you know , we're excited about this . First in class per season once strain agnostic antiviral agent , which I think will have increasing need as the years go by .
Peter Dannenbaum: Great. Thanks, Mohit. Next question, please.
Peter Dannenbaum: Great. Thanks, Mohit. Next question, please.
Speaker #1: Great, thanks, Mo. And next question, please.
Operator: Thank you. Our next question comes from Akash Tewari with Jefferies. Your line is open. You may ask your question.
Operator: Thank you. Our next question comes from Akash Tewari with Jefferies. Your line is open. You may ask your question.
Speaker #5: Thank you. Next question comes from Akash Tiwari with Jefferies. Your line is open. You may ask your question.
[Analyst] (Jefferies): Hey, thanks so much. Are there any plans to explore Sac-TMT in a first-line NSCLC setting in PD-1 low-expressing patients or head-to-head against the keynote 189 regimen, given some of the emerging data you're seeing out of China? I'm kind of curious why your TROP2 development strategy seems to be relatively conservative versus what AstraZeneca and Daiichi are exploring, especially if you have a differentiated asset. Thank you.
Akash Tewari: Hey, thanks so much. Are there any plans to explore Sac-TMT in a first-line NSCLC setting in PD-1 low-expressing patients or head-to-head against the keynote 189 regimen, given some of the emerging data you're seeing out of China? I'm kind of curious why your TROP2 development strategy seems to be relatively conservative versus what AstraZeneca and Daiichi are exploring, especially if you have a differentiated asset. Thank you.
Speaker #7: Hey , thanks so much . Are there any plans to explore in a first line NSCLC setting in PD one ? Low expressing patients or head to head against the 189 regimen .
Speaker #7: Given some of the emerging data you're seeing out of China, I'm kind of curious why your TROP development strategy seems to be relatively conservative versus what AstraZeneca and Daiichi are exploring, especially if you have a differentiated asset.
Dean Y. Li: Thank you very much for that question. So as we've said repeatedly, we think this is a workhorse ADC. We also think that I look at the HER2 field and I sit there and I go, "You just changed the linker and the payload," and all of a sudden you have very different readouts from an antibody-drug conjugate. And so we think Sac-TMT has the potential to be best-in-class TROP2 directed ADCs. What I would say when you talk about the ambition, I mean, we have 16 phase III studies, 11 that we view are first-in-class. The other 5 are differentiated. So I think we're very ambitious with our Sac-TMT program. In relationship to the specific question, in relationship to non-small cell lung cancer and breast cancer, we think that we have differentiated approaches to others.
Dean Li: Thank you very much for that question. So as we've said repeatedly, we think this is a workhorse ADC. We also think that I look at the HER2 field and I sit there and I go, "You just changed the linker and the payload," and all of a sudden you have very different readouts from an antibody-drug conjugate. And so we think Sac-TMT has the potential to be best-in-class TROP2 directed ADCs. What I would say when you talk about the ambition, I mean, we have 16 phase III studies, 11 that we view are first-in-class.
Speaker #7: Thank you .
Speaker #4: Thank you very much for that question . So as we've said repeatedly , we think this is a workhorse ADC . We also that , you think know , look at the Her2 field and I sit there and I go , you just change the linker and the all of a payload , and sudden you have very different readouts from an antibody drug conjugate .
Speaker #4: And so we think TMT has a potential to be best in class. Trop2-directed ADCs. You know what I would say when you talk about the ambition?
Speaker #4: I mean , we 16 have phase three studies , 11 that we view our first in other differentiated . five are So I The just I think we're very ambitious with our TMT program in relationship to to the specific question in relationship to and cell lung breast cancer think cancer .
The other 5 are differentiated. So I think we're very ambitious with our Sac-TMT program. In relationship to the specific question, in relationship to non-small cell lung cancer and breast cancer, we think that we have differentiated approaches to others.
Speaker #4: that we have differentiated approaches to others , most but We important , also have it we in tissue types and tumor types where we are hoping to be first .
Dean Y. Li: But most important, we also have it in tissue types and tumor types where we are hoping to be first. So I would challenge a little bit the characterization that we do not have a robust and ambitious program. We have 16 phase 3 studies.
But most important, we also have it in tissue types and tumor types where we are hoping to be first. So I would challenge a little bit the characterization that we do not have a robust and ambitious program. We have 16 phase 3 studies.
Speaker #4: So I would— I would challenge a little bit the characterization that we do not have a robust and ambitious program. We have 16 Phase III studies.
Peter Dannenbaum: Great. Thank you, Akash. Next question, please, Shirley.
Peter Dannenbaum: Great. Thank you, Akash. Next question, please, Shirley.
Speaker #1: Right . Thank you Akash . Next question please . Shirley .
Operator: Thank you. Our next question comes from Alex Hammond with Wolfe Research. Your line is open.
Operator: Thank you. Our next question comes from Alex Hammond with Wolfe Research. Your line is open.
Speaker #5: Thank you. Our next question comes from Alex Hammond with Wolfe Research. Your line is open.
[Analyst] (Wolfe Research): Thanks for taking the question. So consensus currently anticipates Keytruda's full LOE to occur in 2028. However, Merck's SPC filing suggests potential for two additional patents that expire in 2029. So I guess, how should we model the IP runway for Keytruda, and how should we think about the timing associated with Keytruda SC's ramp prior to Keytruda's IV biosimilar introduction?
Alex Hammond: Thanks for taking the question. So consensus currently anticipates Keytruda's full LOE to occur in 2028. However, Merck's SPC filing suggests potential for two additional patents that expire in 2029. So I guess, how should we model the IP runway for Keytruda, and how should we think about the timing associated with Keytruda SC's ramp prior to Keytruda's IV biosimilar introduction?
Speaker #8: for taking Thanks the question . So consensus currently anticipates Keytruda's us low to occur in However , Merck's SEC filings suggests potential for two additional patents that in 29 .
Speaker #8: So I guess, how should we model the IP runway for Keytruda? And how should we think about the timing associated with Q1's ramp prior to Keytruda's IV biosimilar introduction?
Caroline Litchfield: Yeah. Thanks for the question. As you look at the intellectual property situation for Keytruda, when the original invention was filed for approval with the patent office, there were actually four patents that made up the patent estate that was the original innovation. One of those is the compound patent, which expires December 2028. Two of those, one a method of making patent, actually is extended out to May 2029, and the second one, a method of use patent, goes out to November 2029. And so as we looked at this, initially, we were conservative in our assumptions and always based off the compound patent, always though with the intent that we would defend the entire patent estate. I think what has evolved over time is that as case law has emerged, our confidence that we will be able to defend those additional two patents has grown.
Robert Davis: Yeah. Thanks for the question. As you look at the intellectual property situation for Keytruda, when the original invention was filed for approval with the patent office, there were actually four patents that made up the patent estate that was the original innovation. One of those is the compound patent, which expires December 2028. Two of those, one a method of making patent, actually is extended out to May 2029, and the second one, a method of use patent, goes out to November 2029.
Speaker #2: Yeah , thanks for the question . As you look at the the intellectual property situation for Keytruda , there was when the original invention was filed for for approval with the there were patent office , actually four patents that made up the patent estate .
Speaker #2: That was the original innovation . One of those is the compound patent , which expires December of 2028 . Two of those , one , a method of making patent actually is extended out to May of 2029 .
Speaker #2: In the second one . A method of use patent goes November out to And so as we looked at this initially , we were conservative in our assumptions and always based off the compound patent .
And so as we looked at this, initially, we were conservative in our assumptions and always based off the compound patent, always though with the intent that we would defend the entire patent estate. I think what has evolved over time is that as case law has emerged, our confidence that we will be able to defend those additional two patents has grown.
Speaker #2: Always , though , with the intent that we would defend the patent estate . I think what has evolved over time as is that case law has emerged , our confidence that we will be able to defend those additional two patents has grown and there is a thus potential that you're going to see protection actually make it through .
Caroline Litchfield: Thus, there is a potential that you're going to see protection actually make it through either May or November of 2029. For planning purposes, we continue to assume 2028 because I think that's the conservative assumption. We'll have to see where it goes. I would also remind you that we do face the IRA as of the beginning of 2029. As we think about the Keytruda SC adoption, we continue to think we're going to see 30% to 40% adopted as you get out to 2028, and we will drive that as high as we can. As you know, we have priced this to drive for the adoption from Keytruda IV to Keytruda SC. So that will continue. That strategy is underway. Frankly, whether it's 2028 or 2029 does not change the strategy we're following.
Thus, there is a potential that you're going to see protection actually make it through either May or November of 2029. For planning purposes, we continue to assume 2028 because I think that's the conservative assumption. We'll have to see where it goes. I would also remind you that we do face the IRA as of the beginning of 2029. As we think about the Keytruda SC adoption, we continue to think we're going to see 30% to 40% adopted as you get out to 2028, and we will drive that as high as we can. As you know, we have priced this to drive for the adoption from Keytruda IV to Keytruda SC. So that will continue. That strategy is underway. Frankly, whether it's 2028 or 2029 does not change the strategy we're following.
Speaker #2: Either May or November of 2029 for planning purposes. We continue to assume 2028, because I think that's the conservative assumption, and we'll have to see where it goes.
Speaker #2: And I would also remind you that we do face the IRA as of the beginning as we think about the of 2029 , Culex adoption , we continue to think we're going to see 30 to 40% adopted .
Speaker #2: As you get out to 2028 , and we will drive that as , as , as high as we can . And as you know , we have priced this to drive for the adoption from Keytruda .
Speaker #2: I've to, so will that continue. That strategy is underway. And frankly, whether it's 28 or 29 does not change the strategy.
Peter Dannenbaum: Great. Thanks, Alex. Next question, please.
Peter Dannenbaum: Great. Thanks, Alex. Next question, please.
Speaker #2: We're following .
Speaker #1: Great. Thanks, Alex. Next question, please.
Operator: Thank you. Our next question comes from Evan Seigerman with BMO Capital Markets. You may ask your question.
Operator: Thank you. Our next question comes from Evan Seigerman with BMO Capital Markets. You may ask your question.
Speaker #5: Thank you. Next question comes from Evan Siegelman with BMO Capital Markets. You may ask your question.
[Analyst] (BMO Capital Markets): All right. Thank you so much for taking my question. I want to touch on the HIV data that you were discussing. Can you just contextualize the importance of a dual regimen versus the standard of care of Biktarvy? And kind of what's the feedback in more broadly unmet need for a dual regimen versus the standard of care triple? Thank you.
Evan Seigerman (BMO Capit: All right. Thank you so much for taking my question. I want to touch on the HIV data that you were discussing. Can you just contextualize the importance of a dual regimen versus the standard of care of Biktarvy? And kind of what's the feedback in more broadly unmet need for a dual regimen versus the standard of care triple? Thank you.
Speaker #9: Hi, guys. Thank you so much for taking my question. I want to touch on the HIV data that you were discussing.
Speaker #9: You know , can you just contextualize the importance of a dual regimen versus a standard of care ? Bictegravir a and kind of what's the feedback in more , more broadly , unmet needs for a dual regimen versus the standard of care ?
Speaker #9: thank Triple you .
Dean Y. Li: Yeah. So thank you very much for that question. So as you highlight, we're really excited about islatravir because we really think it's a next-generation nucleoside analog. It leverages a unique mechanism of translocation inhibition that gives it high potency and a high degree of resistance. In relationship to two drugs and three drugs, there have been always a need for different options. You see it already. There is a two-drug regimen out there in relationship to three-drug, and there have been considerable switching that occurs in this patient population just as a general rule. So the ability to send a different sort of repertoire of compounds, especially if you can spare the integrase, would be potentially very important. For some people, that's often viewed in light of metabolic and long-term issues with HIV treatment.
Dean Li: Yeah. So thank you very much for that question. So as you highlight, we're really excited about islatravir because we really think it's a next-generation nucleoside analog. It leverages a unique mechanism of translocation inhibition that gives it high potency and a high degree of resistance. In relationship to two drugs and three drugs, there have been always a need for different options. You see it already. There is a two-drug regimen out there in relationship to three-drug, and there have been considerable switching that occurs in this patient
Speaker #4: Yeah . So thank you very much for that . That question . So as you highlight we're really excited about Islatravir because we really think it's a next generation nucleoside analog .
Speaker #4: So leverage is a unique mechanism of translocation inhibition that gives it high potency and a high , high degree of resistance in relationship to two drugs and three drugs .
Speaker #4: There have been always a need for different options . You see it already . There is a two drug regimen out there in relationship to three drug , and there have been considerable switching that occurs in this patient population .
population just as a general rule. So the ability to send a different sort of repertoire of compounds, especially if you can spare the integrase, would be potentially very important. For some people, that's often viewed in light of metabolic and long-term issues with HIV treatment.
Speaker #4: Just as a general rule, so the ability to send a different sort of repertoire of compounds, especially if you can spare the integrase, would be potentially very important for some people.
Speaker #4: That's often viewed in light of metabolic and long term issues with HIV treatment . So I think there will be a an excitement of having a two drug combo without an insti backbone .
Dean Y. Li: So I think there will be an excitement of having a two-drug combo without an INSTI backbone. Equally important, I just want to make sure, is we're driving a two-drug regimen for the first q-weekly offering. And we have one with our partners Gilead, and we have another one with ulovirenine. So I think all of those, that two-drug for daily but also that two-drug for weekly, is something there is no weekly three-drug or two-drug. So we think there will be an important opportunity for patients to experience a q-weekly option. And finally, we have a q-monthly PrEP oral PrEP. There is no other q-monthly oral PrEP. Although it's not islatravir, it's a related compound, which is MK-8527.
So I think there will be an excitement of having a two-drug combo without an INSTI backbone. Equally important, I just want to make sure, is we're driving a two-drug regimen for the first q-weekly offering. And we have one with our partners Gilead, and we have another one with ulovirenine. So I think all of those, that two-drug for daily but also that two-drug for weekly, is something there is no weekly three-drug or two-drug. So we think there will be an important opportunity for patients to experience a q-weekly option. And finally, we have a q-monthly PrEP oral PrEP. There is no other q-monthly oral PrEP. Although it's not islatravir, it's a related compound, which is MK-8527.
Speaker #4: Equally important , I just want to make sure is we're driving a two drug regimen for the first Q weekly offering , and we have one with with our partners , Gilead , and we have another one with Aav9 .
Speaker #4: So I think all that two drug those of for daily , but also that two drug for weekly is something there is no there's no weekly , three drug or two drug .
Speaker #4: So we think there will be important opportunity for patients to , to , to experience a two weekly option . And finally we have a Q monthly prep or we don't .
Speaker #4: There is no other Q monthly oral prep , although it's not as it's a related compound , which is MK 8005 27 .
Peter Dannenbaum: Great. Thanks, Evan. Next question, please, Shirley.
Peter Dannenbaum: Great. Thanks, Evan. Next question, please, Shirley.
Speaker #1: Great . Thanks , Evan . Next question please . Shirley .
Operator: Thank you. Our next question comes from Steve Scala with TD Cowen. You may ask your question.
Operator: Thank you. Our next question comes from Steve Scala with TD Cowen. You may ask your question.
Speaker #5: Thank you. Next question comes from Steve Scala with TD Cowen. You may ask your question.
[Analyst] (TD Cowen): Thanks so much. A bigger picture question for Rob. But in 2025, Merck achieved the sales guidance it provided to start the year, and you dealt with the Gardasil pressure all year long. But in any year for any company, there will be some challenges. So this is likely to be more of the rule rather than the exception. And Merck has some growth products too. So in what might be a typical year, Merck grew minimally. And in 2026, you are again looking for minimal top-line growth with the Keytruda LOE still a couple of years off. So the question is, is this what we should expect from Merck going forward, a company that grows modestly in good times and significantly pressured in less good times? Or can Merck achieve sustainable, strong sales growth in the decade ahead despite what will be inevitable challenges? Thank you.
Steve Scala: Thanks so much. A bigger picture question for Rob. But in 2025, Merck achieved the sales guidance it provided to start the year, and you dealt with the Gardasil pressure all year long. But in any year for any company, there will be some challenges. So this is likely to be more of the rule rather than the exception. And Merck has some growth products too. So in what might be a typical year, Merck grew minimally. And in 2026, you are again looking for minimal top-line growth with the Keytruda LOE still a couple of years off.
Speaker #10: Thanks so much. A bigger picture question for Rob. But in 2025, Merck achieved the sales guidance it provided to start the year.
Speaker #10: And you dealt with the Gardasil pressures all year long. But year for any, in any company, there will be some challenges.
Speaker #10: So this likely to be more is the rule rather than the exception . Merck has And some growth products too . So when what might be a typical year Merck grew minimally .
Speaker #10: And in 2026 you are again looking for minimal top line growth with Keytruda low still , a couple of years off . So the question is , is this what we should expect from Merck going forward ?
So the question is, is this what we should expect from Merck going forward, a company that grows modestly in good times and significantly pressured in less good times? Or can Merck achieve sustainable, strong sales growth in the decade ahead despite what will be inevitable challenges? Thank you.
Speaker #10: A company that grows modestly in good times and significantly pressured in less good times or can Merck achieve sustainable , strong sales growth decade ahead in the , despite what will be inevitable challenges ?
Speaker #10: Thank you .
Caroline Litchfield: Yeah. No, Steve, I appreciate the question. I would just reemphasize as we look forward, and I think what you're hearing in our confidence and why we think over time we will be a strong growing company. So I'm not sure I agree with your characterization that we will be a modest growing company in every year or less depending on what happens. That's, I think, taking one year out of context. But if you look over the longer term, that $70 billion we have of potential is significant when you think that that is as you look at it, it's more than double what Keytruda will be at its consensus peak in 2028 of $35 billion. And importantly, $20 billion higher than where we were and driven by probably the broadest and widest pipeline we've had in years.
Robert Davis: Yeah. No, Steve, I appreciate the question. I would just reemphasize as we look forward, and I think what you're hearing in our confidence and why we think over time we will be a strong growing company. So I'm not sure I agree with your characterization that we will be a modest growing company in every year or less depending on what happens. That's, I think, taking one year out of context. But if you look over the longer term, that $70 billion we have of potential is significant when you think that that is as you look at it, it's more than double what Keytruda
Speaker #2: Yeah . No , Steve , I appreciate the question . I would just reemphasize as we look forward and I think hearing in our confidence and why we over time we will be a strong , growing company .
Speaker #2: So I I'm not sure I agree with your characterization that we will be a company in every year or less , depending on what happens .
Speaker #2: You know , that's I think , taking one year out of context . longer you But if term , that's $70 billion . We have of potential is , is significant .
Speaker #2: you think When that that is all , you know , as you look at it , it's more than double what Keytruda will be at its consensus peak in 28 of 35 billion .
will be at its consensus peak in 2028 of $35 billion. And importantly, $20 billion higher than where we were and driven by probably the broadest and widest pipeline we've had in years.
Speaker #2: And importantly, $20 billion higher than where we were, and driven probably by the broadest and widest pipeline we've had in years. So our belief in our ability to have sustainable growth once we get past the highs and lows is as high as it's ever been, and we're not done.
Caroline Litchfield: So our belief in our ability to have sustainable growth once we get post the LOE is as high as it's ever been. And we're not done. We have early-stage pipeline assets that we believe will be reading out in the next two years and will allow us to continue to bring some of those assets into this period, plus additional business development. And as you know, none of this includes the animal health business, which we expect to more than double out to the mid-2030s as well as the base of Keytruda over time. So I think that's important to understand. And the other thing I'd highlight, of the $70 billion, we're going to de-risk substantially all of that by the time we get to the end of 2027.
So our belief in our ability to have sustainable growth once we get post the LOE is as high as it's ever been. And we're not done. We have early-stage pipeline assets that we believe will be reading out in the next two years and will allow us to continue to bring some of those assets into this period, plus additional business development. And as you know, none of this includes the animal health business, which we expect to more than double out to the mid-2030s as well as the base of Keytruda over time. So I think that's important to understand. And the other thing I'd highlight, of the $70 billion, we're going to de-risk substantially all of that by the time we get to the end of 2027.
Speaker #2: We have early-stage pipeline assets that we believe will be reading out in the next two years and will allow us to continue to bring some of those assets into this period.
Speaker #2: Plus additional business development . And as you know , none of this includes the animal health business , which expect to more than double out to the mid 2030s , as well as the base of Over Keytruda .
Speaker #2: time . So I think that's understand . other thing I'd important to And the highlight , you know , of the 70 billion .
Speaker #2: De-risk—we’re going to, substantially, all of the time, by the time we get to the end of 2027. So, you’ll know the portfolio that’s going to drive our growth into the next decade.
Caroline Litchfield: So you'll know the portfolio that's going to drive our growth into the next decade by the time you get out to 2027. And that's, I think, also important as people start to want clarity on the long-term future. The last thing I would just add, if you look at 2025 as an example, what we saw in the quarter is really a strong growth profile. And as you look forward, if you adjust for the LOE period we had that we've noted with Januvia, with Dificid, with Bridion, plus Legevrio and Koselugo, we actually are giving guidance of growth in, I think, the 4% to 7% or roughly 5% to 8% range over time, which actually is pretty strong growth. And I think that is more the focus.
So you'll know the portfolio that's going to drive our growth into the next decade by the time you get out to 2027. And that's, I think, also important as people start to want clarity on the long-term future. The last thing I would just add, if you look at 2025 as an example, what we saw in the quarter is really a strong growth profile. And as you look forward, if you adjust for the LOE period we had that we've noted with Januvia, with Dificid, with Bridion, plus Legevrio and Koselugo, we actually are giving guidance of growth in, I think, the 4% to 7% or roughly 5% to 8% range over time, which actually is pretty strong growth. And I think that is more the focus.
Speaker #2: By the time you get out to 2027—and that's, I think, also important as people start to want clarity on the future.
Speaker #2: The last thing I would long term just add , if you look at at 2025 as an example , you know what we in the quarter is really a strong growth profile .
Speaker #2: And as you look forward , if you adjust for the low period , we had that we've noted with Januvia , with Dificid , with Bridion , plus Lagevrio and Koselugo , we are actually giving of guidance growth in , I think , the 4 to 7% or roughly 5 to 8% range over which time , actually is pretty strong growth .
Speaker #2: And , you know , I think that is more the focus . What is the sustainable strategic growth of those assets long term , what are the one time not nonstrategic lows we're facing this year
Caroline Litchfield: What is the sustainable strategic growth of those assets long-term, not what are the one-time non-strategic LOEs we're facing this year?
What is the sustainable strategic growth of those assets long-term, not what are the one-time non-strategic LOEs we're facing this year?
Peter Dannenbaum: Great. Thanks, Steve. Next question, please.
Peter Dannenbaum: Great. Thanks, Steve. Next question, please.
Operator: Thank you. Our next question comes from James Shin with Deutsche Bank. Your line is open. You may ask your question.
Operator: Thank you. Our next question comes from James Shin with Deutsche Bank. Your line is open. You may ask your question.
Speaker #1: Next please Thanks , Steve . ? Great .
Speaker #1: question
Speaker #5: Thank you . next Our question comes from Jane Chen with Deutsche Bank . Your line is open . You may ask your question .
[Analyst] (Deutsche Bank): Good morning. Thank you for the question. One for Dean. On cadence of data presentation, can you help level set what we should and should not expect to learn? Also, any color on which potential endpoints may be explored in the phase 3 for PH due to HFpEF/HFrEF? Thank you.
James Shin: Good morning. Thank you for the question. One for Dean. On cadence of data presentation, can you help level set what we should and should not expect to learn? Also, any color on which potential endpoints may be explored in the phase 3 for PH due to HFpEF/HFrEF? Thank you.
Speaker #11: Good morning. Thank you for the question. One for Dean on Cadence's help presentation. Can you level set what we should and should not expect to learn?
Speaker #11: Also , any color on which potential endpoints may be explored in the phase three for CPC pH . Due to Hf-pef . Thank you .
Dean Y. Li: Yeah. You broke up for a little bit there, so I'll hope that I answer your questions. I think we'll provide the data from that Phase II. There's a primary endpoint, but there's also important secondary endpoints that will also be provided. In relationship to what you've just asked in terms of a future Phase III that we've discussed, we're in the middle of those discussions with the FDA. I think just as a general sort of statement, generally, we'll have to think about things like functional activity. You often have clinical events that will be important. There'll be biomarkers. But it'll be very important to align with the FDA because in this patient population, which should be an orphan indication patient population, we'll have to level set as to how one thinks about the outcomes and the primary secondary endpoints.
Dean Li: Yeah. You broke up for a little bit there, so I'll hope that I answer your questions. I think we'll provide the data from that Phase II. There's a primary endpoint, but there's also important secondary endpoints that will also be provided. In relationship to what you've just asked in terms of a future Phase III that we've discussed, we're in the middle of those discussions with the FDA. I think just as a general sort of statement, generally, we'll have to think about things like functional activity.
Speaker #4: You broke up for a little bit there , so I'll hope answer your that I questions . I We'll provide the data from that phase two .
Speaker #4: There's a primary endpoint , but there's also an important secondary endpoints that will also be provided in relationship to what you've just asked .
Speaker #4: In terms of the of a future phase discussed , we're in the middle of three that we've those with the discussions FDA , and I think , you know , just as a sort of statement general know , we'll generally , you have to think about things like functional activity .
You often have clinical events that will be important. There'll be biomarkers. But it'll be very important to align with the FDA because in this patient population, which should be an orphan indication patient population, we'll have to level set as to how one thinks about the outcomes and the primary secondary endpoints.
Speaker #4: You often have clinical events that will be important . There'll be biomarkers , but it will be very important to align with the FDA because in this patient population , which should be an orphan indication , patient population , we'll have to level set as to how one thinks about the the the outcomes and the primary secondary endpoints .
Dean Y. Li: But we're eager to provide that data at ACC, and we're continuing to have discussions with the FDA as we define, essentially, a new population that we're going to target with this drug. And so some of the questions you had in terms of the endpoints are things that are important discussions right now.
But we're eager to provide that data at ACC, and we're continuing to have discussions with the FDA as we define, essentially, a new population that we're going to target with this drug. And so some of the questions you had in terms of the endpoints are things that are important discussions right now.
Speaker #4: But we're eager to provide that data at ACC. And we're continuing the discussions with the HAV as we define, essentially, new populations that we're—.
Speaker #4: Going to target with this drug . And so some of the questions you had of the in terms endpoints are things that are important discussions right now .
Peter Dannenbaum: Great. Thanks, James. Next question, please.
Peter Dannenbaum: Great. Thanks, James. Next question, please.
Speaker #1: Great. Thanks. Next question, please.
Operator: Thank you. Our next question comes from Carter Gould with Cantor Fitzgerald. Your line is open. You may ask your question.
Operator: Thank you. Our next question comes from Carter Gould with Cantor Fitzgerald. Your line is open. You may ask your question.
Speaker #5: Thank you . Next question
Speaker #5: The next question comes from Carter Gould with Cantor. James, your line is open. You may ask your question.
[Analyst] (Cantor Fitzgerald): Great. Good morning. Thanks for taking the questions. Another one for Dean. I recognize on your TL1A, the near-term focus is on ATLAS-UC. At the same time, we're seeing the incumbent IL-23 players step up, sort of all sorts of combinations as well as multi-specifics, rapidly intensify their efforts with pretty sizable partnerships. So again, recognizing ATLAS-UC as a near-term focus, but how does Merck think about the importance and speed it may need to pursue combinations on the back of those data later this year? Thank you.
Carter Gould: Great. Good morning. Thanks for taking the questions. Another one for Dean. I recognize on your TL1A, the near-term focus is on ATLAS-UC. At the same time, we're seeing the incumbent IL-23 players step up, sort of all sorts of combinations as well as multi-specifics, rapidly intensify their efforts with pretty sizable partnerships. So again, recognizing ATLAS-UC as a near-term focus, but how does Merck think about the importance and speed it may need to pursue combinations on the back of those data later this year? Thank you.
Speaker #12: morning . Thanks for taking the Great . Good questions . Another one for Dean . I recognize on your tl1 a the near-term focus is on Atlas UC .
Speaker #12: At the same time , we're seeing the entrenched IL 23 players step up sort of all sorts of combinations and as well as Multi-specific rapidly intensify their efforts with , you know , pretty sizable partnerships .
Speaker #12: So again, recognizing Atlas UC as a near-term focus, focus. But how does Merck think about the importance and speed it may need to pursue combinations on the back of data later this year?
Dean Y. Li: Yeah. So I love your question. Just so that we all level set, essentially, in this field, TNF and IL-23 has dominated. And the big question is whether there's a third node or a third class, which is TL1A. And our ambition is to be the first and best-in-class TL1A. We're studying it in six diseases. But as you highlight, it is the ulcerative colitis and the Crohn's disease that's coming up very quickly. If those are successful, like in every immunology indication, the question will become patient populations, other diseases. But then people will start talking about combinability. They'll talk about combinability in terms of two separate antibodies. They'll talk about bispecifics. And increasingly, they'll talk about orals. And I can assure you that that concept of we intend to be first and best but also that we have a robust plan for being next is well in line.
Dean Li: Yeah. So I love your question. Just so that we all level set, essentially, in this field, TNF and IL-23 has dominated. And the big question is whether there's a third node or a third class, which is TL1A. And our ambition is to be the first and best-in-class TL1A. We're studying it in six diseases. But as you highlight, it is the ulcerative colitis and the Crohn's disease that's coming up very quickly. If those are successful, like in every immunology indication, the question will become patient populations, other diseases.
Speaker #12: Thank you those .
Speaker #4: Yeah . So , you know , I love your question . Just so that level we all set essentially in this field . You know , TNF and IL 23 has dominated .
Speaker #4: And the big question is whether there's a third class, which is node or a TL1A. And our ambition is to be the first and best in class TL1.
Speaker #4: We're studying it in six diseases , but as you highlight , it is the ulcerative colitis and Crohn's disease that's coming up very quickly .
Speaker #4: If those are successful , like in every immunology indication , the question will become patient populations . Other diseases . But then people will start talking about combinability .
But then people will start talking about combinability. They'll talk about combinability in terms of two separate antibodies. They'll talk about bispecifics. And increasingly, they'll talk about orals. And I can assure you that that concept of we intend to be first and best but also that we have a robust plan for being next is well in line.
Speaker #4: They'll talk about combinability in terms of two , two separate antibodies . I'll talk about Bispecifics and increasingly they'll talk about orals . And I can I can assure you that that concept of intend to we be first and best , but also that we have a robust plan for being next is well in line .
Dean Y. Li: But that's probably something that I don't want to say in a public call at this time.
But that's probably something that I don't want to say in a public call at this time.
Speaker #4: But that's probably something that I don't want to say in a public call at this time.
Peter Dannenbaum: Thank you, Carter. Next question, please.
Peter Dannenbaum: Thank you, Carter. Next question, please.
Speaker #1: Thank you, Carter. Next question, please.
Operator: Thank you. Our next question comes from Jeff Meacham with Citi. You may ask your question.
Operator: Thank you. Our next question comes from Jeff Meacham with Citi. You may ask your question.
Speaker #5: Our next thank you. Question comes from Geoff Meacham with Citi. You may ask your question.
[Analyst] (Deutsche Bank): Hey, guys. Morning, and thanks for the question. Another one on Winrevair. So you're about to hit two years on the market. Can you guys speak to trends on duration of therapy or maybe real-world safety tolerability, and if anything is different versus phase 3? And then beyond CADENCE, how are you guys thinking about related pulmonology indications just where the mechanism may have an impact? Thank you.
Geoff Meacham: Hey, guys. Morning, and thanks for the question. Another one on Winrevair. So you're about to hit two years on the market. Can you guys speak to trends on duration of therapy or maybe real-world safety tolerability, and if anything is different versus phase 3? And then beyond CADENCE, how are you guys thinking about related pulmonology indications just where the mechanism may have an impact? Thank you.
Speaker #11: Hey , guys .
Speaker #13: Morning , and thanks for the question . Another one on on Winrevair . So you're about to hit two years on the market .
Speaker #13: Guys, can you speak to trends on duration of therapy or maybe real-world tolerability? And if anything is different versus Phase 3.
Speaker #13: And then beyond cadence , how are you guys thinking related about pulmonology indications just for the mechanism may have an impact . Thank you .
Dean Y. Li: So I'll start. There were a lot of questions from a scientific standpoint. But I just want to emphasize that Winrevair is reshaping the standard of care in PAH. It's doing it because it is a differentiated pathway and a molecule. All the other drugs, you would look at this, and you would say they're classic vasodilators. This is a drug that gets to the underlying biology through the genetics. And the way that I would actually begin to think about Winrevair and what Winrevair may be doing to right heart failure and PAH is similar to what Merck showed for ACE inhibitors back in the day in relationship to left heart failure. So when you ask me that question, I'm sitting there like, "I think we are already reshaping the standard of care." I would imagine guidelines will be coming out and will be shaped by that clinical data.
Dean Li: So I'll start. There were a lot of questions from a scientific standpoint. But I just want to emphasize that Winrevair is reshaping the standard of care in PAH. It's doing it because it is a differentiated pathway and a molecule. All the other drugs, you would look at this, and you would say they're classic vasodilators. This is a drug that gets to the underlying biology through the genetics. And the way that I would actually begin to think about Winrevair and what Winrevair may be doing to right heart failure and PAH is similar to what Merck showed
Speaker #4: So I'll start . There was a lot of questions from a scientific standpoint , but I just want to emphasize that when we're there is reshaping the standard of care .
Speaker #4: In PAH, it's doing it because it is a differentiated pathway and a molecule. All the other drugs, you would look at this and you would say they're classic vasodilators.
Speaker #4: This is a drug that gets to the underlying biology through the genetics, and the way that I would actually begin to think about when Revere and what Revere may be doing to right heart failure and PAH is similar to what Merck showed for ACE inhibitors back in the day, in relationship to left heart failure.
for ACE inhibitors back in the day in relationship to left heart failure. So when you ask me that question, I'm sitting there like, "I think we are already reshaping the standard of care." I would imagine guidelines will be coming out and will be shaped by that clinical data.
Speaker #4: So when you ask me that question , I'm sitting there like , I think we are already reshaping the care . I standard of would imagine guidelines will be coming out and will be shaped by that , by that clinical data in relationship to to adverse and long effects term treatment .
Dean Y. Li: In relationship to adverse effects and long-term treatment, I actually just came from a tour in Texas of sites, and they're quite bullish on not only the drug but also the sustainability and the concept that all of a sudden, they begin, in their minds, talking about blunting cardiac remodeling. So that's with this. We are advancing in relationship to heart failure, as the previous question did, in CADENCE. But I love your question because much of it is focused on what is the stress on the right heart. And, as you point out, there could be pulmonary indications where you get pulmonary hypertension that we have to think carefully about where and when to use this drug. But there are investigators who have posed that question to us.
In relationship to adverse effects and long-term treatment, I actually just came from a tour in Texas of sites, and they're quite bullish on not only the drug but also the sustainability and the concept that all of a sudden, they begin, in their minds, talking about blunting cardiac remodeling. So that's with this. We are advancing in relationship to heart failure, as the previous question did, in CADENCE. But I love your question because much of it is focused on what is the stress on the right heart. And, as you point out, there could be pulmonary indications where you get pulmonary hypertension that we have to think carefully about where and when to use this drug. But there are investigators who have posed that question to us.
Speaker #4: You know , I actually just came from a tour of in Texas of sites and they're quite bullish on on not only the drug but also the sustainability and the concept that all of a sudden they begin in their minds , talking about , you know , cardiac blunting , cardiac remodeling .
Speaker #4: So that's with this. We are advancing in relationship to heart failure as the previous question did in cadence. But I love your question because much of it is focused on what is the stress on the right heart.
Speaker #4: And as you point out, there could be pulmonary indications where you get pulmonary hypertension that we have to think about carefully—when and how to use this drug.
Speaker #4: And as you point out , there could be pulmonary indications where you get pulmonary hypertension that we have to think about carefully when and to use this drug . But there are who have investigators posed that question to us , and they also pose the question that when you look at pH , there's different patient populations , but quite a number of them have connective tissue disorders .
Dean Y. Li: And they also pose the question that when you look at PAH, there are different patient populations, but quite a number of them have connective tissue disorders. So they immediately go, "Connective tissue disorders are also related to pulmonary fibrosis and other pulmonary disease." So those are discussions, and those are things that people are exploring as we speak. And we will see some of those data, and that will guide our decisions in the future.
And they also pose the question that when you look at PAH, there are different patient populations, but quite a number of them have connective tissue disorders. So they immediately go, "Connective tissue disorders are also related to pulmonary fibrosis and other pulmonary disease." So those are discussions, and those are things that people are exploring as we speak. And we will see some of those data, and that will guide our decisions in the future.
Speaker #4: So they immediately go, you know, connective tissue disorders are also related to pulmonary fibrosis, pulmonary and other disease. So those are discussions.
Speaker #4: And those are things that people are exploring as we speak. And we will see some of those data, and that will guide our decisions in the future.
Caroline Litchfield: And maybe, Jeff, I would just add, if you look at where we are today, just to give you a sense of the breadth, we have over 110,000 prescriptions which have been dispensed. There's now over 9,100 patients who have started therapy. And if you look, our overall compliance continues to be quite high. We are seeing a slow increase in the rates of discontinuation, but frankly, it's generally in line with what or slightly better than what we're seeing with other PAH products. And so we feel good about where that is. And then on the safety side, we continue to be very confident in the safety profile, and it's consistent with label.
Robert Davis: And maybe, Jeff, I would just add, if you look at where we are today, just to give you a sense of the breadth, we have over 110,000 prescriptions which have been dispensed. There's now over 9,100 patients who have started therapy. And if you look, our overall compliance continues to be quite high. We are seeing a slow increase in the rates of discontinuation, but frankly, it's generally in line with what or slightly better than what we're seeing with other PAH products.
Speaker #2: maybe , And Jeff , I would just add , if you look at where we are today and just to give sense of the you a breadth , we have over 110,000 prescriptions which have been dispensed .
Speaker #2: There's now over 9,100 patients who have started therapy. And if you look, our overall compliance continues to be quite high. We are seeing a slow increase in the rates of discontinuation.
Speaker #2: But frankly, it's generally in line with what or slightly better than what we see with PAH products. And so we're seeing and feel good about where that is.
And so we feel good about where that is. And then on the safety side, we continue to be very confident in the safety profile, and it's consistent with label.
Speaker #2: And then on the safety side, we continue to be very confident in the safety profile, and it's consistent with the label.
Caroline Litchfield: And I'd also point out now, as you've seen across what we've reported with Hyperion as well as with Zenith, and then looking back at Stellar, and then what we've also brought forward as some of the long-term data from Zoteria, across all of those, the safety profile is very consistent. And so we feel very good about where we are with compliance, where we are with safety. Everything's tracking as you would expect.
And I'd also point out now, as you've seen across what we've reported with Hyperion as well as with Zenith, and then looking back at Stellar, and then what we've also brought forward as some of the long-term data from Zoteria, across all of those, the safety profile is very consistent. And so we feel very good about where we are with compliance, where we are with safety. Everything's tracking as you would expect.
Speaker #2: And I'd also point out now , as you've seen across what we've reported with Hyperion , as well as with zenith , and then looking back at stellar and then what we've also brought forward is some of the long term data from Soteria across all of those , the safety profile is very consistent .
Speaker #2: And so we feel very good about where we are with compliance, where we are with safety. Everything's tracking as you would expect.
Peter Dannenbaum: Great. Thanks, Jeff. Next question, please.
Peter Dannenbaum: Great. Thanks, Jeff. Next question, please.
Speaker #1: Great . Thanks , Jeff . Next question please .
Operator: Thank you. Our next question comes from Umar Raffat with Evercore ISI. Your line is open. You may ask your question.
Operator: Thank you. Our next question comes from Umar Raffat with Evercore ISI. Your line is open. You may ask your question.
Speaker #5: Thank you. Our next question comes from Umer Raffat with Evercore. Your line is open. You may ask your question.
[Analyst] (Evercore ISI): Morning, guys. Thanks for taking my question. Rob, I'm trying to balance today the fact that you're laying out a $70 billion non-risk-adjusted revenue opportunity for the current pipeline as well as all the prior track record of sort of $5 billion revenue opportunities acquired for about $10 billion or under versus the large deal that's been in the press lately. I'm just trying to balance it all.
Umer Raffat: Morning, guys. Thanks for taking my question. Rob, I'm trying to balance today the fact that you're laying out a $70 billion non-risk-adjusted revenue opportunity for the current pipeline as well as all the prior track record of sort of $5 billion revenue opportunities acquired for about $10 billion or under versus the large deal that's been in the press lately. I'm just trying to balance it all.
Speaker #14: Good morning guys . Thanks for taking my question , Rob . I'm trying to balance today the fact that you're laying out a 70 billion non-risk adjusted revenue opportunity for the current pipeline , as well as all the track record prior of sort of $5 billion revenue opportunities acquired for about 10 billion or under versus the large deal that's been in the press lately .
Speaker #14: I'm just trying to balance it all.
Caroline Litchfield: Yeah, Umar, I appreciate the question. Obviously, we don't comment or speculate on market rumors. If you look at our BD strategy and where we are, I would start by just pointing to the fact that, as you highlight, with the $70 billion of commercial potential we've highlighted and the fact that that's $20 billion better than where we were a year ago, I am very proud of the progress we're making, and it's why my confidence is so high. And obviously, we still have more time to continue to do more, both in terms of advancing our early-stage pipeline, which we think can have impact in this area, as well as adding additional assets through BD, which we've indicated we are continuing to be very interested in doing.
Robert Davis: Yeah, Umar, I appreciate the question. Obviously, we don't comment or speculate on market rumors. If you look at our BD strategy and where we are, I would start by just pointing to the fact that, as you highlight, with the $70 billion of commercial potential we've highlighted and the fact that that's $20 billion better than where we were a year ago, I am very proud of the progress we're making, and it's why my confidence is so high. And obviously, we still have more time to continue to do more, both in terms of advancing our early-stage pipeline, which
Speaker #2: I Yeah , appreciate the question . You know , obviously we don't comment or speculate on on market rumors . If you look at our BD strategy and where we are , I would start by just pointing to the fact that as you highlight with the $70 billion of commercial potential , we've and the highlighted fact that that's 20 billion better than where we were a year ago , I am very proud of the progress we're making , and it's why my confidence is so high .
Speaker #2: And obviously we still have more time to continue to do more , both in terms of advancing our early stage pipeline , which we think can have this area impact in , as well as adding additional assets through BD , which we've indicated we are continuing to be very interested in doing .
we think can have impact in this area, as well as adding additional assets through BD, which we've indicated we are continuing to be very interested in doing.
Caroline Litchfield: If you look at where we're focused, it's where we've always said, which is for opportunities where we see significant scientific advancement addressing an unmet need aligned with our strategy and, importantly, where we see value creation. Where we see those things align, we move. But we've always done it with discipline. You've seen that across all the deals we've done, and we will continue to do so as we move forward. Obviously, looking in the area, up to $15 billion is our sweet spot. But as we've also highlighted, for the right scientific deal, we'd go bigger. But using the same methods, the same discipline, the same approach, we've used across everything we've done to date.
If you look at where we're focused, it's where we've always said, which is for opportunities where we see significant scientific advancement addressing an unmet need aligned with our strategy and, importantly, where we see value creation. Where we see those things align, we move. But we've always done it with discipline. You've seen that across all the deals we've done, and we will continue to do so as we move forward. Obviously, looking in the area, up to $15 billion is our sweet spot. But as we've also highlighted, for the right scientific deal, we'd go bigger. But using the same methods, the same discipline, the same approach, we've used across everything we've done to date.
Speaker #2: If you look at where we're focused , it's where we've always said , which is for opportunities , where we see significant scientific advancement , addressing an unmet need aligned with our strategy and importantly , value where we see creation .
Speaker #2: We see those things align . We move . But we've always done it with discipline . You've seen that across all the deals we've done , and we will continue to do so as we move forward .
Speaker #2: Obviously , looking in the area , up to 15 billion is our sweet spot . But as we've also highlighted , for the right scientific deal , we'd go bigger .
Speaker #2: But using the same methods, the same discipline, the same approach we've used across everything we've done to date.
Peter Dannenbaum: Great. Thanks, Umar. Next question, please.
Peter Dannenbaum: Great. Thanks, Umar. Next question, please.
Speaker #1: Great . Thanks , Umer . Next question please .
Operator: Thank you. Our next question comes from Chris Schott with J.P. Morgan. You may ask your question.
Operator: Thank you. Our next question comes from Chris Schott with J.P. Morgan. You may ask your question.
Speaker #5: Our next Thank you . question comes from Chris Schott with J.P. Morgan . You may ask your question .
[Analyst] (Cantor Fitzgerald): Great. Thanks so much. Just on MK-3000, it's obviously a new mechanism but also listed as one of your key near-term products for de-risking that $70 billion. Can you just help set the stage a little bit in terms of what gives you such confidence in this asset and how large of an opportunity you see, assuming we get some positive data this year? Thank you.
Chris Schott: Great. Thanks so much. Just on MK-3000, it's obviously a new mechanism but also listed as one of your key near-term products for de-risking that $70 billion. Can you just help set the stage a little bit in terms of what gives you such confidence in this asset and how large of an opportunity you see, assuming we get some positive data this year? Thank you.
Speaker #15: Great . Thanks so much . Just on on . MK 3000 , it's obviously a new mechanism , but also listed as one of your key near-term products for de-risking that 70 billion .
Speaker #15: Can you just help set the stage a little bit in terms of what gives you such confidence in this asset, and how large of an opportunity do you see?
Speaker #15: Assuming we get some positive data this year? Thank you.
Dean Y. Li: I'll let others speak about how big the opportunity is. But diabetic macular edema and wet age-related. I'm sorry. AMD and DME are really important indications and have important molecules out there. They are all based on vascular endothelial growth factor. This is the first pathway that is based on the genetics of vascular stability in the eye. And we have the first agonistic antibody towards that. So we're really interested in seeing whether this mechanism will work because it will be the first non-vascular endothelial growth factor that's going to be driving to the indications of age-related macular degeneration and diabetic macular edema. Just historically, up to 40% of individuals have suboptimal response to VEGFs. We think that that's an important opportunity for us.
Dean Li: I'll let others speak about how big the opportunity is. But diabetic macular edema and wet age-related. I'm sorry. AMD and DME are really important indications and have important molecules out there. They are all based on vascular endothelial growth factor. This is the first pathway that is based on the genetics of vascular stability in the eye. And we have the first agonistic antibody towards that. So we're really interested in seeing whether this mechanism will work because it will be the first non-vascular endothelial growth factor that's going to be
Speaker #4: I'll let others speak about how big the the opportunity is , but diabetic macular edema and wet age related . I'm sorry AMD and and DME are really important indications and have have important molecules out there .
Speaker #4: They are all based on vascular endothelial growth factor. This is the first pathway that is based on the genetics of vascular stability in the eye.
Speaker #4: And we have the first agonistic antibody towards that. So we're really interested in seeing whether this mechanism will work because it will be the first non-vascular endothelial growth factor.
driving to the indications of age-related macular degeneration and diabetic macular edema. Just historically, up to 40% of individuals have suboptimal response to VEGFs. We think that that's an important opportunity for us.
Speaker #4: That's going to be driving to the indications of age related macular degeneration . And diabetic macular edema . historically Just , you know , up to individuals have 40% have suboptimal response to Vegfs .
Speaker #4: We think that that's an important opportunity for us. But I also want to just make sure that people recognize that even in patients who have had no responses to vascular endothelial growth factor, MK-3000 could also be part of the repertoire with which they're treated, as well.
Dean Y. Li: But I also want to just make sure that people recognize that even in patients who have responses to vascular endothelial growth factor, MK-3000 could also be part of the repertoire with which they're treated as well.
But I also want to just make sure that people recognize that even in patients who have responses to vascular endothelial growth factor, MK-3000 could also be part of the repertoire with which they're treated as well.
Caroline Litchfield: And maybe just to add, Chris, to some thoughts here on market potential, as you know, if you look at what you see with diabetic macular edema, there is about 1.6 million people with DME today in the United States. It's the leading cause of vision loss due to diabetes. And I'd add, you've got, with wet AMD, an additional 1.5 million patients in the United States. So if you look across the total of that market, that's about a $15 billion market. And as Dean just pointed out, 30% to 40% of patients are only partially or not responsive at all to anti-VEGF therapy. So the opportunity to bring a new mechanism into this space is quite meaningful. And the only thing I'd add is, while you're speaking about MK-3000 in DME now, we are also studying it in wet AMD, in RVO.
Robert Davis: And maybe just to add, Chris, to some thoughts here on market potential, as you know, if you look at what you see with diabetic macular edema, there is about 1.6 million people with DME today in the United States. It's the leading cause of vision loss due to diabetes. And I'd add, you've got, with wet AMD, an additional 1.5 million patients in the United States. So if you look across the total of that market, that's about a $15 billion market. And as Dean just pointed out, 30% to 40% of patients are only partially or not responsive at all to anti-VEGF therapy.
Speaker #2: And maybe , just to add , Chris , to some some thoughts here on market potential . As you know , if you look at what you see with diabetic macular edema , there is about 1.6 million people with DME today in the United States .
Speaker #2: It's the leading cause of vision loss due to, and I'd, diabetes. Add, you've got with wet AMD, an additional 1.5 million patients in the United States.
Speaker #2: If you look, so across the total of that market, that's about a $15 billion market. And as Dean just pointed out, 30 to 40% of patients are only partially or not responsive at all to the opportunity therapy.
So the opportunity to bring a new mechanism into this space is quite meaningful. And the only thing I'd add is, while you're speaking about MK-3000 in DME now, we are also studying it in wet AMD, in RVO.
Speaker #2: anti-VEGF So the mechanism into this space is quite meaningful . And the only thing I'd add is while you're speaking about MK 3000 , in in DME , now , we are also studying it in wet AMD and Rvo and importantly , we have MK 8788 , which is the novel bispecific antibody antibody that Agonizes tie2 while inhibiting VEGF were excited very that .
Caroline Litchfield: And importantly, we have MK-8748, which is the novel bispecific antibody that agonizes Type 2 while inhibiting VEGF. We're very excited about that. It's really the combination of both of those assets that why we believe this is a greater than $5 billion opportunity as we look forward. And I would say it's probably one of the more underappreciated areas, I think, from the Street in what this really can be.
And importantly, we have MK-8748, which is the novel bispecific antibody that agonizes Type 2 while inhibiting VEGF. We're very excited about that. It's really the combination of both of those assets that why we believe this is a greater than $5 billion opportunity as we look forward. And I would say it's probably one of the more underappreciated areas, I think, from the Street in what this really can be.
Speaker #2: It's really the combination of both of those assets that is why we believe this is a greater than $5 billion opportunity. And looking forward, as we— and I would say it's probably one of the more underappreciated areas, I think, from the Street, and what this really can be.
Peter Dannenbaum: Great. Thanks, Chris. We're going to try and squeeze in one more question, please, Shirley.
Peter Dannenbaum: Great. Thanks, Chris. We're going to try and squeeze in one more question, please, Shirley.
Speaker #2: .
Speaker #1: Thanks , Chris . Great . We're going to try and squeeze in one more question , please . Shirley .
Operator: Thank you. Our question comes from Daina Graybosch with Leerink Partners. Your line is open.
Operator: Thank you. Our question comes from Daina Graybosch with Leerink Partners. Your line is open.
Speaker #5: Thank you. Our question comes from Dana Grabosch with the Ring partners. Your line is open.
[Analyst] (Leerink Partners): Hi. Thanks for the question. I'll finish with a Sac-TMT one. I wonder if you could update us on your biomarker strategy given a TROP2 ADC competitor recently announced they're changing some primary endpoints of phase III to narrow on TROP2 expressors. I know you guys are cooking something. And will we see that in any of the phase IIIs?
Daina Graybosch: Hi. Thanks for the question. I'll finish with a Sac-TMT one. I wonder if you could update us on your biomarker strategy given a TROP2 ADC competitor recently announced they're changing some primary endpoints of phase III to narrow on TROP2 expressors. I know you guys are cooking something. And will we see that in any of the phase IIIs?
Speaker #16: Hi .
Speaker #17: Thanks for the question. I'll finish with a TMT one. I wonder if you could update us on your biomarker strategy, given a TROP2 ADC competitor recently announced they're changing some primary endpoints of Phase Three to narrow to expressors.
Speaker #17: I know you guys are cooking something, and will we see that in any of the phase three?
Dean Y. Li: Yeah. I'll just kind of answer the question the way that I answered it a few years ago, which is we think that Sac-TMT has an ability to be best in class. But it's also important to put it in the right tumor types and to have the right strategy in those tumor types. There will be tumor types where we do not believe that a biomarker will be needed. But we also believe that there are places where that biomarker will be needed, especially if you look at how good the comparator you have to go against. So a lot of it is context-dependent on the tumor but also what other treatments are there and how high of a bar you have to beat to beat that comparator.
Dean Li: Yeah. I'll just kind of answer the question the way that I answered it a few years ago, which is we think that Sac-TMT has an ability to be best in class. But it's also important to put it in the right tumor types and to have the right strategy in those tumor types. There will be tumor types where we do not believe that a biomarker will be needed. But we also believe that there are places where that biomarker will be needed, especially if you look at how good the comparator you have to go against.
Speaker #4: Yeah , I'll just kind of answer the way that I answered it a question the few years ago , which is we think that TMT has an ability to be best in class , but it's also important to put it in the right tumor types and to have the right strategy for in those tumor types .
Speaker #4: There will be tumor types where we do not believe that a biomarker will be needed, but we also believe that there are places where that biomarker will be needed, especially if you look at how good the comparator you have to go against.
So a lot of it is context-dependent on the tumor but also what other treatments are there and how high of a bar you have to beat to beat that comparator.
Speaker #4: So a lot is of it context dependent on the tumor . But also what other treatments are there and how high of a you have to bar beat to beat that , that comparator .
Peter Dannenbaum: Great. Thank you, Dean. Thank you all for your time and attention this morning. If you have any follow-ups, please reach out to the IR team. Take care.
Peter Dannenbaum: Great. Thank you, Dean. Thank you all for your time and attention this morning. If you have any follow-ups, please reach out to the IR team. Take care.
Speaker #1: Great . thank you all for Thank you , Dana , and your time and this attention have any morning . follow If you reach out to the ups , please team .
Speaker #1: Take IR care .
Operator: Thank you. This concludes today's conference. We thank you for your participation. At this time, you may disconnect your lines.
Operator: Thank you. This concludes today's conference. We thank you for your participation. At this time, you may disconnect your lines.
